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AbbVie CDMO has been working with global companies to develop, manufacture & scale biopharmaceutical products.
  • A CDMO that focuses on the development, manufacturing & marketing of niche finished formulations is looking for suppliers of IP/USP Grade Anastrozole (0.8 kg) API for commercial purposes. The suppliers must support this enquiry with CoA.
    18 Mar 2024

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    A company that focuses on distribution of various pharmaceutical products is looking for suppliers of Adalimumab API for commercial purposes. The required quantity is MOQ. The suppliers must support this enquiry with CoA.
    18 Mar 2024
  • A company that focuses on trading of various pharmaceutical products is looking for suppliers of BP Grade Metformin HCl (30 MT) API for commercial purposes. The suppliers must support this enquiry with CoA.
    18 Mar 2024
    A company that focuses on the development and manufacturing of tablets, capsules, liquids, ointments, dry syrups & sachets is looking for suppliers of Pimecrolimus (1 kg) API for development purposes. The suppliers must support this enquiry with CoA.
    16 Mar 2024
  • A pharmaceutical company that specializes in the formulation of parenteral is looking for suppliers of Ibandronate (1 kg) API for development purposes. The suppliers must support this enquiry with CoA.
    16 Mar 2024
    A pharmaceutical company that specializes in the formulation of parenteral is looking for suppliers of Haloperidol (1 kg) API for development purposes. The suppliers must support this enquiry with CoA.
    16 Mar 2024
  • A company that focuses on manufacturing, development, marketing & distribution of branded and generic FDFs is looking for suppliers of Various Finished Formulations. The supplier must support this enquiry with relevant dossiers.
    1. Mebeverine (200 mg) ER Capsule
    4. Nifedipine (30 mg) ER Capsule
    5. Nifedipine (60 mg) ER Capsule
    6. Nifedipine (90 mg) ER Capsule
    12 Mar 2024
    A company based in Singapore that focuses on the development, marketing and distribution of a wide range of finished formulations is looking for suppliers of Tretinoin (0.025%) Gel or cream for development purposes. The supplier must support this enquiry with TGA & EU Dossiers.
    11 Mar 2024
  • A company based in Singapore that focuses on the development, marketing and distribution of a wide range of finished formulations is looking for suppliers of Adapalene (0.1% & 0.3%) Gel for development purposes. The supplier must support this enquiry with EU Dossier.
    08 Mar 2024
    A company that focuses on distribution of various finished formulations in hospitals is looking for Amphotericin (50 mg) Vial for commercial purposes. The required quantity is a 230 units. The supplier must support this enquiry with GMP, ECTD & Stability Zone IV.
    07 Mar 2024
  • A company that focuses on development of innovative prescription products for aesthetic medicine and medical dermatology is looking for CMO to manufacture Liniment for the treatment of Crow’s feet and hyperhidrosis. The required packaging is 1 ml in dropper. The project launch time is in 2026. The required quantity is 10 batches of 100 kg. The country of distribution is United States. The geographical preference for service provider is United States.
    22 Feb 2024
    A company based in United States that focuses providing solutions in areas specifically defense, intelligence, health & bioscience, transport, energy and critical infrastructure is looking for GMP certified CDMO for intravenous injectables. The country of distribution is United States.
    09 Feb 2024
  • A CMO that focuses on manufacturing, licensing & marketing of various OTC & Rx finished formulations is looking for a GMP certified CDMO for Tech Transfer of Solid, Liquid and Semi-Solid finished formulations. The projected annual manufacturing volume is 30 MT – 1000 MT. The country of distribution is Europe & United Kingdom and the geographical preference for service provider is Europe.
    20 Jan 2024
    A company based in India which focuses on providing multiple services under one roof ranging from custom synthesis to trading of novel chemicals, intermediates, nutraceuticals and excipients is looking for CDMO for Spray Drying for Granules. The required packaging is in 50 kg Carboy. The projected annual manufacturing volume is 1500 kg. The country of distribution is the Saudi Arabia and the geographical preference for service provider is India.
    05 Jan 2024
  • A multinational pharmaceutical manufacturing company that has over 200 products covering the whole spectrum of disease areas spanning gastroenterology, oncology, pain management, cardiovascular, dermatology, urology, nephrology, rheumatology, and diabetes is looking for suppliers of Various Excipients for development purposes. The supplier must support this enquiry with CoA.
    1. Capilectine Excipient
    2. Octenidine Dihydrochloride Excipient
    3. Polydextrose Excipient
    15 Mar 2024

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    A company that focuses on research, development, manufacturing and marketing of various pharmaceutical branded and non-branded formulations is looking for suppliers of Polyoxyl 40 Stearate (50 g) Excipient for development purposes. The supplier must support this enquiry with CoA.
    12 Mar 2024
  • A company that focuses on manufacturing of various finished formulations of veterinary is looking for suppliers of Lactose Monohydrate (150 mesh & 80 mesh) Excipient for commercial purposes. The required quantity is 6,000 kg. The supplier must support this enquiry with CoA.
    08 Mar 2024
    A MNC which focuses on manufacturing and distribution of various health, hygiene & nutrition products is looking for suppliers of various excipient for commercial purposes. The supplier must support this enquiry with GMP & CoA.
    1. Sodium Edetate (2,700 kg) Excipient
    2. Xanthan gum (8,050 kg) Excipient
    04 Mar 2024

Interviews #SpeakPharma

  • “LGM operates as a trusted partner by seeking out optimal source of APIs for clients”
    This week, SpeakPharma interviews Selwyn Lustman, Senior Vice President, Global Sourcing and Procurement, LGM Pharma, a tailored active pharmaceutical ingredient (API) and contract development and manufacturing services provider (CDMO) for the full drug product lifecycle. Lustman discusses the kind of regulatory support LGM provides its clients, while also talking about its methodology for selecting the optimum source of APIs for its clients. Excerpts:Can you briefly take us through the history of LGM Pharma?We were established in 2005, and since inception we have been on a dedicated mission to excel in the sourcing and distribution of top-tier APIs, offering comprehensive API supply chain solutions spanning R&D to commercialization.In 2020, LGM Pharma acquired the formulation development and drug product manufacturing business of Nexgen Pharma, Inc. This acquisition merged LGM’s global leadership in API sourcing, distribution, and supply chain management with Nexgen Pharma’s comprehensive drug product CDMO services.What are some of the risks involved in sourcing APIs? And how can drugmakers manage these risks?The primary challenges associated with API sourcing encompasses quality and regulatory considerations, necessitating the assurance of a material source aligned with the specific quality and regulatory standards applicable to the ultimate dosage product launch.Efficient supply chain distribution hinges on establishing a collaborative partnership with a manufacturer capable of seamlessly supporting the entire spectrum, from early research and development (R&D) stages to the culmination of full-scale commercialization.Price considerations also come to the fore, demanding that the chosen manufacturer not only meets but surpasses safety, environmental, and health requirements. Working with a seasoned sourcing partner serves as a proactive measure to mitigate these risks, as such a partner brings forth invaluable expertise to navigate the intricate landscape of regulatory and quality guidelines.What kind of regulatory support do you provide your clients?LGM Pharma offers a comprehensive suite of regulatory expertise to its clients, encompassing a spectrum of critical services. This includes evaluation of active substances and the meticulous technical writing and compilation of US Drug Master Files.Throughout the development process, LGM provides expert regulatory CMC (chemistry, manufacturing and controls) compliance guidance, overseeing the writing and assessment of quality/CMC regulatory documents (Module 2 and 3).LGM Pharma ensures seamless coordination with clinical trial partners to guarantee eCTD (electronic common technical document) compliance (Module 5) and conducts critical writing and reviews of drug substance and drug product documentation.LGM’s commitment extends to adherence to Code of Federal Regulations and guidance documents, ensuring the timely approval of new abbreviated new drug applications (ANDAs), amendments, and post-approval changes.LGM Pharma also exhibits agility in responding to inspection requests (IRs) and commitment resolutions (CRs) prior to due dates, engages in regulatory authority interactions, including serving as a US agent, and conducts regulatory compliance gap analyses with adept issue resolution. Additionally, LGM conducts scientific, regulatory, and due diligence review of regulatory documents and submissions, reinforcing its commitment to regulatory excellence.LGM Pharma has a strategic approach to API sourcing. Can you throw some light on this approach, and its benefits to your clients?LGM Pharma distinguishes itself from conventional distributors by adopting a unique approach – one that sets it apart in the industry. Unlike distributors aligned with specific API manufacturers, LGM takes on a consultative role, prioritizing the representation of its clients’ interests.Operating as a trusted advisor, LGM actively seeks out the optimal source of API for clients to serve as their primary drug substance supplier. In contrast to distributors affiliated with particular manufacturers, who inherently advocate for their associated companies, LGM positions itself as an unbiased entity capable of objectively confirming the selection of the best manufacturer. This client-centric approach ensures a discerning and tailored choice in the dynamic landscape of pharmaceutical ingredient sourcing.What role does logistics play in API sourcing? How does LGM Pharma help out its clients with regulatory compliance?Logistics plays a critical role in API sourcing, influencing the efficiency, reliability, and regulatory compliance of the supply chain. LGM Pharma, as a specialized pharmaceutical ingredient supplier addresses these logistics challenges in the following ways:- Supply chain management: LGM is involved in managing the end-to-end supply chain, ensuring the timely and secure movement of APIs from manufacturers to clients. This involves coordinating transportation, handling custom clearance, and optimizing inventory levels to prevent disruptions to the supply chain. - Quality assurance in transportation: Given the sensitivity of pharmaceutical APIs, LGM implements stringent quality assurance measures during transportation to maintain the integrity of the APIs. - Regulatory compliance: LGM assists clients in navigating the complex regulatory landscape associated with API sourcing. This includes adherence to GMP regulations, compliance with international standards, and ensuring that the transportation and storage of APIs meet regulatory requirements. - Documentation and record keeping: LGM maintains detailed documentation related to the transportation and handling of APIs, facilitating regulatory audits and compliance checks. Accurate record-keeping is essential for demonstrating compliance with regulatory guidelines. 

    Impressions: 2444

    https://www.pharmacompass.com/speak-pharma/lgm-operates-as-a-trusted-partner-by-seeking-out-optimal-source-of-apis-for-clients

    13 Dec 2023

Data Compilation & Company Tracker #PharmaFlow

  • FDA steps in to address challenges faced by cell and gene therapies
    The year 2023 was a rather tough one for cell and gene therapy (CGT) companies. There was news about smaller CGT players finding it difficult to get finance, with many drastically downsizing their operations by laying off hundreds of employees. Many others had to shut shop, making us wonder if innovation in the biopharma industry is in for a setback.The new year began on a sour note, with the FDA shooting off letters to six manufacturers of cancer therapies that use CAR-T technology to add a boxed warning on their label after the agency found a serious risk of developing secondary cancer. These therapies include Bristol-Myers Squibb’s Abecma and Breyanzi, Janssen Biotech’s Carvykti, Gilead’s Yescarta, Novartis’ Kymriah and Kite Pharma’s Tecartus. “Boxed warnings” or “black box warnings” are the highest safety warnings. A week later, FDA stepped in and finalized guidance for companies and academic researchers working on CAR-T cell therapies.In this article, PharmaCompass looks at some of the challenges being faced by CGT firms, and the growth prospects of this sunrise sector.A field with complex manufacturing, high costs of developmentThere are several ways in which CGTs can target a disease, giving rise to various kinds of such therapies. These include gene addition, gene silencing, gene editing, DNA therapy (such as DNA plasmids and viral vectors), RNA therapy (ribosomal RNA, messenger RNA, microRNA, small interfering RNA and transfer RNA), antisense oligonucleotides and gene-modified cell therapy (such as CAR T-cell therapies and Treg cell therapies). CGTs are being deployed to treat several kinds of diseases, such as various types of cancers, including brain tumors, breast and colon cancers, as well as leukemia. Other major therapeutic areas CGTs are making an impact on are genetic and rare diseases like sickle cell disease (SCD), β-thalassemia, hemophilias, and paraplegia. CGTs are also being explored for treating Duchenne muscular dystrophy, Alzheimer`s disease, Parkinson’s disease, multiple sclerosis, type 1 diabetes and macular edema.Going by FDA’s Purple Book, there are 35 CGT products approved in the US. With three FDA approvals, bluebird bio tops the list (with Lyfgenia, Zynteglo, and Skysona), followed by Bristol Myers Squibb (with Abecma and Breyanzi), Kite Pharma (with Tecartus and Yescarta), and Novartis (with Zolgensma and Kymriah). Recently, FDA approved Vertex Pharma-CRISPR Therapeutics’ Casgevy, the first gene-editing therapy that uses the Nobel-prize-winning CRISPR technology.Though CGTs are personalized therapies, they come with potential risks, such as developing certain kinds of cancers, genotoxicity, allergic reactions, damage to the organs etc.Another challenge faced by CGTs is costs. Apart from the high R&D costs, these biotechs face other challenges such as high costs of reagents like clinical-grade lentiviral vectors or gene editing reagents, as well as cell processing materials, GMP facilities and personnel costs.Little wonder then that the selling price of some of the CGTs run into millions of dollars. CSL Behring and uniQure’s Hemgenix, a first-of-its-kind drug for hemophilia B, is the most expensive drug in the world. It costs a whopping US$ 3.5 million. Similarly, bluebird bio’s Lyfgenia, a therapy that has the potential to resolve vaso-occlusive events and is custom-designed to treat the underlying cause of SCD, costs US$ 3.1 million.Smaller CGT firms get strapped for funds, fail to land Big Pharma dealsTypically, innovation for CGTs happens at small biotechs or universities. Many of the small firms get acquired by bigger drugmakers or tie up with larger pharma companies so that volumes can be scaled up once the therapy is approved.Last year, scores of biotechs announced bankruptcies. Many smaller biotechs failed to land Big Pharma deals. They had to contend with narrower funding options, forcing several startups in the sector to shut shop. For example, Intergalactic Therapeutics shut down last year, after being around for less than two years. The company said: “The current environment has led to challenging times for companies to raise capital,” even though Intergalactic’s programs have “shown promise”. Other CGT firms that shut shop last year were Locanabio, Vedere Bio II and CODA Biotherapeutics.Companies that laid off employees to cut costs are base editing biotech Beam Therapeutics, Editas Medicine, Sangamo Therapeutics, Graphite Bio, UniQure, Generation Bio, Candel Therapeutics, Lyell Immunopharma, BrainStorm Cell Therapeutics and Nkarta. CRISPR Therapeutics, ElevateBio and Atsena also reportedly laid off employees. FDA lines up initiatives, to make 2024 ‘breakout’ year for gene therapiesThe “personalized nature” of CGTs makes them highly effective. But this trait also gives rise to multiple challenges. Acknowledging this, in January, FDA announced a pilot program called Collaboration on Gene Therapies Global Pilot (CoGenT Global) to streamline regulations pertaining to this sector. The agency has also addressed challenges such as the high cost of manufacturing, clinical development timelines, macroeconomic conditions (such as high interest rates), and operational issues being faced by CGTs. FDA is promising to make 2024 a “breakout” year for gene therapies, with a number of initiatives to promote clinical development, approvals and uptake. FDA’s Center for Biologics Evaluation and Research (CBER) is sponsoring research and encouraging collaboration with the National Institutes of Health’s Bespoke Gene Therapy Consortium. The agency has made gene editing therapies eligible for accelerated approval and detailed the information that should be provided in an investigational new drug (IND) application. It has also launched a pilot program Support for clinical Trials Advancing Rare disease Therapeutics (START), with the intention of speeding up development.Our viewIn 2022, Precedence Research estimated the CGT market at US$ 15.46 billion, expecting it to increase fivefold by 2032 to touch US$ 82.24 billion, with therapeutic areas such as oncology (US$ 10.4 billion) and genetic disorders (US$ 8.57 billion) expected to draw most revenues.FDA approved seven CGTs in 2023, including Casgevy. But this year, FDA and European regulators may approve as many as 17 gene therapies. A McKinsey report says in 2024 alone, “up to 21 cell therapy launches and as many as 31 gene therapy launches—including more than 29 adeno-associated virus (AAV) therapies—are expected.” Given these estimates, we have little doubt that 2024 will be a “breakout year” for CGTs.  

    Impressions: 1310

    https://www.pharmacompass.com/radio-compass-blog/fda-steps-in-to-address-challenges-faced-by-cell-and-gene-therapies

    #PharmaFlow by PharmaCompass
    22 Feb 2024

Monthly Stock Recap #PipelineProspector

  • Pipeline Prospector Feb 2024: Novo’s parent buys Catalent for US$ 16.5 bn, FDA okays Iovance’s cell therapy
    February was a good month for the pharma sector, complete with some important deals, successes from clinical trials and healthy fourth quarter (Q4) results announced by some drugmakers. The market cheered the good news — the Nasdaq Biotechnology index gained 1 percent from 4,385.06 to 4,428.56, the SPDR S&P Biotech ETF index spiked 12 percent to 98.42 after ending January at 87.43. The S&P Biotechnology Select Industry Index (SPSIBI) soared 16 percent from 6,815.3 to 7,896.47 in February.The month saw some big acquisitions. Novo Holdings, the parent company of Novo Nordisk, acquired contract development and manufacturing organization (CDMO) Catalent for US$ 16.5 billion. Novo Holdings plans to sell three of Catalent’s “fill-finish” sites to Novo Nordisk for US$ 11 billion. Novo’s game plan hasn’t gone down well with its arch rival in the diabetes and obesity segment Eli Lilly. The Indianapolis-headquartered drugmaker has called for a scrutiny of the deal as it relies on Catalent for some of its diabetes and obesity drugs that compete with Novo’s meds.Both Novo and Lilly have been struggling to meet the demand for their weight loss meds. With the acquisition of this key CDMO, Novo has scored an edge over competition.Meanwhile, Gilead boosted its liver portfolio with the US$ 4.3 billion acquisition of CymaBay Therapeutics. And Novartis announced the acquisition of cancer treatment developer MorphoSys for € 2.7 billion (US$ 2.9 billion). With this buyout, Novartis gets a late-stage, rare bone-marrow cancer treatment — pelabresib — that holds plenty of promise.Several drugmakers announced their Q4 results last month. Notable amongst them was Eli Lilly, as it posted a 28 percent increase in revenues — from US$ 7.3 billion in Q4 2022 to US$ 9.4 billion led by its new products Mounjaro and Zepbound. GSK touted the “exceptional launch of Arexvy”, the world`s first RSV vaccine, as it brought in sales of £ 1.2 billion (US$ 1.52 billion) in 2023. And Merck’s Keytruda saw a 19 percent increase in its sales in 2023 — at US$ 25 billion.Access the Pipeline Prospector Dashboard for February 2024 Newsmakers (Free Excel)FDA okays Iovance’s T-cell therapy; Roche’s asthma med okayed for food allergiesThe US Food and Drug Administration (FDA) granted accelerated approval to Iovance Biotherapeutics’ cell therapy — Amtagvi (lifileucel) — for treating the deadliest form of skin cancer. Amtagvi is the first and only one-time, individualized T cell therapy to receive FDA approval for a solid tumor cancer. Iovance hopes to start reporting noteworthy revenue in the second quarter of 2024, despite the fact that Amtagvi comes with a boxed warning (the highest safety warning) for treatment-related mortality. FDA also approved Takeda’s Eohilia as the first oral treatment for an allergic inflammation of the esophagus. Eohilia (budesonide oral suspension) was on course to becoming the first treatment for eosinophilic esophagitis (EoE) until it was rejected by the FDA in December 2021.In January, Sanofi and Regeneron’s jab Dupixent had pipped Eohilia to become the first FDA drug approved for EoE. The chronic condition can make it very hard for patients to consume food. Dupixent (dupilumab) is injected weekly or biweekly and two pens cost US$ 3,803.20. In contrast, Takeda’s drug is taken twice daily and costs US$ 1,875 per month.Roche and Novartis’ asthma drug Xolair (omalizumab) became the first FDA-approved med to help people with food allergies avoid severe reactions following accidental exposure. This opens the drug to around 17 million people in the US whose allergies can potentially be deadly.Access the Pipeline Prospector Dashboard for February 2024 Newsmakers (Free Excel) Boehringer’s obesity candidate, Lilly’s tirzepatide show promise in trials for MASHBoehringer Ingelheim announced promising phase 2 trial data for its experimental obesity drug survodutide in treating metabolic dysfunction-associated steatohepatitis (MASH), a liver disease. The drug is being developed in collaboration with Zealand Pharma. It had received a fast-track designation from the FDA in June 2021. MASH causes histologic liver damage and occurs in patients who are not alcoholics and who are often obese or have type 2 diabetes.The trial met its primary endpoint with survodutide reaching a biopsy-proven improvement in MASH after 48 weeks. Survodutide also met all secondary endpoints, including a statistically significant improvement in liver fibrosis. The companies said this potentially positions it as a “best-in-class” treatment. The drug belongs to the glucagon-like peptide 1 (GLP-1) class of drugs.In another trial, Eli Lilly announced positive results from a phase 2 study of tirzepatide in adults with MASH — 74 percent of participants were cured of MASH and their fibrosis also did not worsen at 52 weeks (as compared to nearly 13 percent for participants in the placebo group).Access the Pipeline Prospector Dashboard for February 2024 Newsmakers (Free Excel) J&J’s autoimmune drug posts trial gains; Sanofi’s frexalimab shows benefit in MSOne of Johnson & Johnson’s most watched experimental drugs — nipocalimab — posted positive results in trials for the treatment of two autoimmune disorders. In a phase 3 study, nipocalimab significantly reduced symptoms of generalized myasthenia gravis (GMG). And, in a phase 2 study, it helped reduce the severity of Sjögren’s disease (SjD). GMG weakens the skeletal muscles and particularly affects control of the limbs, throat, mouth, and eyes. SjD is an immune disorder that is identified by symptoms like dry eyes and dry mouth. J&J expects over US$ 5 billion from this drug. In a phase 2 trial, Sanofi’s frexalimab significantly slowed disease activity in people with relapsing multiple sclerosis (MS). In December last year, the French multinational had named frexalimab as one of three “pipeline-in-a-product” assets with the potential of generating annual peak sales in excess of €5 billion (US$ 5.4 billion). The phase 2 results give credence to those expectations.In trial failures, Gilead (stock down 8 percent) said the FDA has paused all trials of its drug magrolimab in the treatment of two blood cancers – acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) – because of increased risk of patient death (when used in combination with azacitidine plus venetoclax). Magrolimab was the lead candidate of Gilead’s US$ 4.9 billion acquisition of Forty Seven in 2020.Access the Pipeline Prospector Dashboard for February 2024 Newsmakers (Free Excel) Our viewThe year has gotten off to a good start with drugmakers posting healthy Q4 results and the indices showing some positive growth month-on-month. Several drugmakers have entered 2024 with a simplified business model and an increased strategic focus on R&D. Given the favorable demand, we are hopeful of a better year for the industry, as opposed to the volatility of the last two years.Access the Pipeline Prospector Dashboard for February 2024 Newsmakers (Free Excel) 

    Impressions: 762

    https://www.pharmacompass.com/pipeline-prospector-blog/pipeline-prospector-feb-2024-novo-s-parent-buys-catalent-for-us-16-5-bn-fda-okays-iovance-s-cell-therapy

    PharmaCompass.com
    07 Mar 2024

Weekly News Recap #Phispers

  • FDA approves Wegovy to reduce cardiovascular risks; delays action on Lilly’s Alzheimer’s drug
    In this week’s news, Novo Nordisk’s Wegovy became the first obesity drug cleared by the US Food and Drug Administration (FDA) to lower the risk of cardiovascular death, heart attack, and stroke.There was a fair bit of unfortunate news for patients with neurological disorders. First, FDA delayed the approval of Eli Lilly’s donanemab for Alzheimer’s and called for further scrutiny of its safety and efficacy. Second, Amylyx Pharmaceuticals’ lead candidate Relyvrio bombed in a large, phase 3 clinical trial for amyotrophic lateral sclerosis (ALS), raising questions about its future.The Biotechnology Innovation Organization (BIO), an industry trade group based in Washington, is taking steps to remove China’s WuXi-AppTec from its membership. The staff at FDA has raised doubts over the benefit of giving Johnson & Johnson and Bristol Myers Squibb’s cell therapies, Carvykti and Abecma, to blood cancer patients as an early treatment.Serum Institute of India, which teamed up with AstraZeneca to produce the Covishield vaccine, has repurposed its manufacturing facilities for newer vaccines against malaria and dengue. And, India’s Sun Pharma was forced to recall 55,000 bottles of the gout drug febuxostat from the US market due to microbial contamination in stagnant water in the duct of the manufacturing equipment.Wegovy approved in US to lower risk of serious heart problems in obese adultsFDA has approved Wegovy (semaglutide) to reduce the risk of cardiovascular death, heart attack, and stroke in obese or overweight adults with cardiovascular disease. The move makes Wegovy the first weight loss medication that is also approved to help prevent life-threatening cardiovascular events and is hailed as a major advance for public health. In a trial spanning 17,604 patients, over a mean duration of 33 months, Wegovy lowered the risk of non-fatal heart attack by 28 percent, heart-related death by 15 percent, and non-fatal stroke by seven percent.FDA delays action on Lilly’s closely watched Alzheimer’s drug donanemabThe much anticipated approval of Eli Lilly’s donanemab scheduled for this month has been deferred as FDA has opted to convene a panel of independent experts to assess the drug’s safety and efficacy. The decision took Alzheimer’s experts and Lilly by surprise as the latter said, “it is unusual for an advisory committee to occur after the anticipated FDA action date.” The decision underscores the high stakes and challenging history of developing Alzheimer’s treatments.According to a Lilly press statement, FDA is likely to convene a meeting of its advisory committee that looks into peripheral and central nervous system drugs to discuss its trial that evaluated the efficacy and safety of donanemab in early symptomatic Alzheimer’s disease.Roche’s persistence for Alzheimer’s therapy sees promising results: After two failures to bring an Alzheimer’s drug to the market, Roche touted “best-in-class potential” for trontinemab in treating the disease. Though the antibody is still in early phase 2 trials, Roche came out with promising data that showed trontinemab cleared clumps of amyloid protein from patients’ brains faster than Leqembi and donanemab. Trontinemab’s delivery uses the Swiss pharma’s proprietary “Brainshuttle” platform which allows it to penetrate the blood-brain barrier resulting in more exposure to the brain and broader distribution across the central nervous system.Biotech trade group severs ties with China’s WuXi AppTec over security concernsThe Biotechnology Innovation Organization (BIO), an industry trade group based in Washington, said it is taking steps to remove China’s WuXi-AppTec from its membership. BIO’s new CEO, a former Naval Intelligence Officer, said it was part of “several important steps to reaffirm the organization’s position with regards to national security.” Last week, the Senate’s homeland security committee voted to pass a bill that prohibits federal agencies from having contracts with four Chinese biotechs, including WuXi AppTec.Amylyx’s ALS drug Relyvrio flunks late-stage trial, could get pulled from marketJust under two years ago, Relyvrio (sodium phenylbutyrate and taurursodiol) became one of only three treatments approved by the FDA for ALS, commonly called Lou Gehrig's disease. The agency had done so on the back of results from a phase 2 trial. The debilitating condition robs patients of the ability to walk, talk, and eventually breathe within five years. Now, the results of a 48-week trial in 664 patients are in, and Relyvrio failed to demonstrate that it worked better than a placebo.“We’re deeply saddened, and I’d say it’s been a really, really tough day for the ALS community,” Amylyx Co-CEO Justin Klee said. The Cambridge, Massachusetts-based biotech said it might withdraw Relyvrio from the market and will announce its plans within eight weeks.Acadia to stop trials for its antipsychotic drug: Acadia Pharmaceuticals’ antipsychotic drug Nuplazid (pimavanserin) failed to meaningfully improve negative symptoms of schizophrenia in a phase 3 trial. Those symptoms included “blunted affect, poor socialization, and lack of motivation.” Nuplazid was the first FDA-approved drug to treat psychosis-related delusions and hallucinations experienced by certain patients with Parkinson’s disease. However, previous attempts to expand the drug’s use to treat dementia and Alzheimer’s disease had also resulted in failure.SII shifts focus to malaria, dengue vaccines: Adar Poonawalla, CEO of Serum Institute of India (SII), has said his company has bolstered its manufacturing capabilities ahead of launches of shots against dengue and malaria planned over the next few years. During the pandemic, SII had invested US$ 2 billion to boost production. Now, with the demand for Covid-19 products waning, the world’s largest vaccine maker has repurposed its facilities for newer shots.FDA tells Sun Pharma to recall 55,000 bottles of gout med due to contaminationThe New Jersey unit of Indian drugmaker Sun Pharma is recalling 55,000 bottles of generic gout treatment Febuxostat, according to FDA’s enforcement report. Deviations from current good manufacturing practices (cGMPs) have caused microbial contamination in stagnant water in the duct of the manufacturing equipment. The lots in question were made in Dadra (India) for Memphis-based Northstar Rx LLC.Carvykti, Abecma may not benefit patients with early-stage blood cancerThe staff at FDA has raised doubts over the benefits of giving J&J and Bristol Myers Squibb’s cell therapies, Carvykti and Abecma, to blood cancer patients as an early treatment. Both are chimeric antigen receptor (CAR) T-cell therapies. An FDA advisory committee will vote Friday on whether the two therapies have a favorable benefit-risk ratio in earlier lines of multiple myeloma treatment.  

    Impressions: 1691

    https://www.pharmacompass.com/radio-compass-phisper/fda-approves-wegovy-to-reduce-cardiovascular-risks-delays-action-on-lilly-s-alzheimer-s-drug

    #Phispers by PharmaCompass
    14 Mar 2024

Content #LearnMore

  • View Sharp`s clinical trial supply & contract pharmaceutical packaging services for injectables and oral dosage forms on PharmaCompass.
    View Sharp`s clinical trial supply & contract pharmaceutical packaging services for injectables and oral dosage forms on PharmaCompass. What is pharmaceutical contract packaging and how is Sharp a reliable packaging partner for the pharmaceutical and biotech industries? Pharmaceutical packaging can be defined as a set of operations including filling, sealing, packaging, and labeling of semi-finished or finished products. Pharma packaging is an economical means to present, preserve, identify, provide information, maintain product integrity, and ensure stability. It also plays a crucial role in the transportation of sensitive and strictly controlled products. Pharmaceutical contract packaging refers to packaging that is executed and supplied by a licensed third-party service provider that comprises both initial packaging and repackaging. These contract packaging service providers may offer clinical and commercial packaging solutions for pharmaceutical products. Pharmaceutical contract packaging organizations are well-equipped to offer a comprehensive range of primary, secondary, and tertiary packaging solutions. Primary packaging surrounds the pharmaceutical formulation and includes bottles, blisterings, pouches, sachets, tubes, auto-injector pens, etc. Whereas secondary packaging offers further external protection and includes artwork design, labeling for parenteral and injectables, child-resistant and compliance prompting packaging, etc. Additionally, tertiary packaging is used during transportation to absorb physical impacts, moisture, and dust and includes cardboard boxes, stretch wraps, shrink films, and wooden and plastic pallets. Sharp is a leading contract packaging organizations that offer pharmaceutical packaging services among others. It has more than 70 years of experience in pharmaceutical clinical packaging, clinical trial supply services, and small-scale sterile manufacturing. Sharp has more than 2,000 employees who work in its state-of-the-art GMP facilities in the US, UK, Belgium, and the Netherlands. Sharp, offers contract manufacturing and packaging services and support from phase I clinical trial supplies to commercial launch and lifecycle management to its pharmaceutical and biotechnology partners across the world. It has deep expertise in clinical trial packaging and labeling along with a skilled global design team that utilizes cutting-edge software and technology ensuring patient-friendly and differentiated packaging for drug products. Apart from this, Sharp is also a reliable partner for sourcing packaging material and offers integrated pharmaceutical packaging and labeling services along with over-encapsulation of oral solids and the production of placebo capsules for study blinding. Sharp is a contract packaging organization that offers commercial packaging services including contract blister packaging services, bottle packaging, sachet packaging, injectable packaging, and other solid dose packaging solutions. Additionally, it offers clinical packaging and labeling solutions such as clinical trial material packaging, clinical trial packaging and labeling, clinical trial logistics and packaging, and clinical trial supply services, or clinical supplies. Its clinical and commercial packaging services are outlined below: Clinical Packaging Solutions Sharps clinical packaging solutions encompass primary packaging and labeling and secondary packaging. Its pharmaceutical primary packaging offers reliable clinical packaging services, clinical supply chain services, primary packaging solutions, and cold-chain secondary packaging and labeling at 2-8°C, -20°C, and even at -70°C. Sharp also provides reliable clinical pharma packaging services and labeling, secondary packaging solutions, pharmaceutical clinical packaging and labeling solutions along with expertise and capabilities in handling cold-chain pharmaceutical labeling and packaging from 2-8°C to -70°C. Commercial Packaging Solutions For more than 65 years, Sharp has been providing a full range of commercial primary and secondary packaging solutions, blister packaging, and contract manufacturing and packaging services for pharmaceutical oral solid dosage forms. It offers contract blister packaging services and bottle packaging for pharmaceutical drug products. Apart from this Sharp provides pharma packaging contract services for small and large-volume batch sizes of injectables. It offers pharmaceutical packaging services for cold chain storage, packaging in temperature- and light-controlled environments, serialization, and customized distribution. Additionally, Sharp is involved in the pharma packaging of oral solids, liquids, and semi-solids. Moreover, Sharp is a premier commercial packaging service provider for high-value, low-volume gene therapy. It also offers pharmaceutical packaging services, expertise, and powerful technology that facilitates product serialization and aggregation. Therefore, Sharp’s pharma packaging contract services, spanning from clinical supplies to commercial include pharma clinical trial material manufacturing, clinical primary packaging services, clinical secondary packaging solutions, clinical trial packaging and labeling, and clinical trial logistics and packaging. Furthermore, Sharp’s contract manufacturing and packaging services encompass commercial pharma packaging solutions and labeling and supply services. Consequently, all the aforementioned offerings position Sharp as a one-stop-shop contract pharmaceutical packaging service provider for clinical and commercial scales. How does Sharp address challenges related to clinical labeling and secondary packaging? Sharp has over 70 years of experience and is a pioneer in clinical trial supply services and pharmaceutical packaging. Dedicated to the right-first-time principle, Sharp is a reliable partner for secondary packaging and clinical pharmaceutical labeling and packaging. It offers a wide range of quick, scalable clinical trial packaging services and labeling and packaging solutions in all formats, with capabilities spanning the complete lifespan of investigational medicinal products (IMPs). Moreover, Sharp can also address challenges related to packaging and labeling and offers pharmaceutical packaging and labeling services and clinical packaging and labeling services to its clients. Additionally, its clinical packaging and labeling solutions also include in-house auxiliary variable data printing outsourced booklet labels; client-supplied randomization fully supported; and annex 13 compliant and 21 CFR Part 11 compliant PRISYM software for label design. Sharp's pharmaceutical packaging and labeling services include single and multi-panel labels and booklets; 2D barcoding capabilities, randomized and open; 128 barcoding. It also offers; regulatory and translation services; sequentially numbered, variable text; code break, and randomized generation among other clinical packaging and labeling solutions. Sharp is a leader in providing pharmaceutical clinical packaging, contract packaging services, and labeling and supply services in compliance with strict regulatory guidelines. It has special pharma packaging and labeling expertise and capabilities for packaging drug products. Sharp addresses various challenges related to pharma packaging and labeling which includes: Sharp can provide cold-chain pharmaceutical labeling and packaging from 2-8°C to -70°C for drug products that need low temperatures for their transportation and storage. Sharp can support the secondary packaging for most complex drug candidates, such as controlled substance packaging (DEA schedule I-V), and has the capabilities to scale up to commercial supplies. Its design and logistics staff can also assist with the challenges of blinding products and syringes for clinical trial services. Sharp does this by providing annex 13 compliant and 21 CFR Part 11 compliant PRISYM software for label design, client-supplied randomization fully supported, and in-house auxiliary variable data printing outsourced booklet labels. With issues related to timely delivery and efficient labeling, Sharp provides pharmaceutical labeling and packaging solutions by using Scan assembly technology and Interactive Response Technologies (IRT), storage, and distribution. To overcome the label readability issues for clients worldwide, Sharp designs and prints multilingual clinical labels. Therefore, Sharp acts as a one-stop-shop packaging organization that provides pharmaceutical contract packaging services, clinical primary packaging services, primary and secondary clinical packaging, and labeling and supply services to its clients worldwide. What range of packaging design and kitting services does Sharp offer? Sharp is a market leader in the design and delivery of primary and secondary packaging. Due to its structural, graphic, and design engineers as well as its understanding of supply chain and regulatory issues, Sharp excels in pharmaceutical packaging. Sharp has years of experience in creating cutting-edge pharma packaging solutions. It is skilled in brand creation, modifying current artwork, marketing research, FDA filing standards, 3D rendering, senior, child-friendly, or child-resistant design, and labeling and supply services. Sharp's global design team provides the creativity and accuracy required to design highly functional and compliant primary and secondary commercial and clinical pharma packaging services. Sharp offers a wide range of design services and pharmaceutical packaging solutions using the latest tools and technologies to guarantee premium and user-friendly product packaging. Additionally, it provides structural and graphic design development for quick launch and regular upgrades for commercial artwork. Sharp’s wide range of packaging design services for pharmaceutical products includes: Artwork Design Services: Sharp can provide pharma packaging contract services including customized artwork as per specific markets from initial mock-ups to product registration. Packaging Samples: Sharp’s contract pharmaceutical packaging services can create production-quality models for use in marketing presentations, human factor research, and photography that closely match the commercial package. Tray Design: Sharp precisely assesses product components to create a tray design that best suits the drug. 3D Printing: Sharp can rapidly confirm that all product components fit by using its technology to create 3D printed prototypes of trays and other packaging component designs. Shipper and Pallet Design: The structural designers at Sharp develop pallet layouts and shippers based on finished items to guarantee drug safety during distribution and storage. CR/SF Compliant Design and Testing: Sharp offers pharmaceutical contract packaging services and can determine the level of toxicity in child-friendly packaging. Various structural design services offered by Sharp include end-user interactions and compliance; child-resistant, senior-friendly (CR/SF) design; tamper evident features; multiple-component kitting requirements; and sustainable or specified materials. Additionally, Sharp’s graphic design capabilities include serialization artwork; brand identity; complete package graphics; product and package illustrations; and late-stage customization. Sharp’s broad range of tailored kitting options for medical devices, pharmaceuticals, and biotechnology calls for the packaging of multiple components into a single, self-contained unit. The design team at Sharp offers commercial packaging solutions and helps clients create a kit that best meets the end-user needs and product specifications. Its kitting services include labeling, tray packing, and boxing with comprehensive verification inspection to ensure the highest level of quality. How does Sharp manage the packaging of sterile formulations to ensure product integrity? Sharp has almost seven decades of packaging experience and it provides pharmaceutical packaging solutions for sterile and non-sterile formulations while maintaining the integrity and quality of products. It offers contract pharmaceutical packaging services and package design services from its US and EU facilities for injectables containing both small and large-volume batch sizes. For product launch and sample programs, its international design team works with clients to provide pharma packaging solutions and determine the optimal vial, prefilled syringe, and autoinjector packaging options. Through its partnership with Berkshire Sterile Manufacturing (BSM), Sharp also offers small-scale isolator-based sterile fill-finish options. It specializes in pharmaceutical clinical packaging and commercial packaging in cold chain storage, packaging in temperature and light-controlled environments, and specialty distribution for injectable drug products.  It also supports multi-country launches from the US and EU. Sharp has experience in parenteral and injectable format labeling and packaging such as vials, autoinjectors, syringes, and pens. Its specialized commercial and clinical services for injectables and parenterals include primary and secondary labeling of vials, IV bags, pre-filled syringes, and IV bottles in ambient, cold and ultra-cold environments; custom label generation; kitting; serialization and aggregation; and storage and distribution. Some of Sharp’s sterile packaging capabilities for injectable drug products include: Vial Labeling and Packaging: Sharp has decades of packaging experience and offers pharmaceutical packaging and labeling services for vials. Its contract packaging services include an automated visual inspection of labeling, tray and carton packing, cartoning of single and multipacks, tamper-evident solutions, cold-chain storage (2-8°C), and ultra-low temperature freezer banks (-20°C/-70°C). In addition to these services, Sharp provides package design; kitting; and segregated suites to handle highly potent APIs (HPAPI), cytotoxins, hormones; serialization and aggregation; and specialty distribution. Autoinjector and Pen Assembly, Labeling, and Packaging: Sharp excels in managing the complexities related to autoinjector or pen device labeling and packaging from its US and EU facilities. Moreover, its YpsoMate autoinjector device delivers a high level of technical accuracy required for the assembly of prefilled syringes into YpsoMate autoinjectors. Sharp’s experts also offer clinical trial packaging services and specialize in managing the challenges related to clinical trial logistics and packaging of biological formulations. Pre-Filled Syringe Assembly, Labeling, and Packaging: Sharp is a leader in the assembly, labeling, and packaging of pre-filled syringes and safety devices. It provides customized commercial and clinical pharma packaging services for both small and large-volume batch sizes for injectables. Small Scale Sterile Fill-Finish: Sharp partners with Berkshire Sterile Manufacturing (BSM) and offers high-quality, manufacturing, packaging, and distribution solutions for flexible fillers, BSM fills vials, cartridges, syringes, and lyophilization. Gene Therapy Clinical and Commercial Packaging: Sharp has over 70 years of experience in packaging complex pharmaceuticals such as low-volume, high-value gene therapies. Sharp is also engineered to provide demand-led supply commercial and clinical services including batch sizes as small as 1 vial, or packaging, labeling, and distribution in cold, ultra-cold, or cryogenic conditions. Sharp also has dedicated facilities in Bethlehem, PA, US, Heerenveen, and the Netherlands for handling gene therapies. These facilities are equipped with HEPA air handling systems; controlled temperature; humidity and dew point; full-sized -80°C freezer banks in dedicated production suites; constant monitoring of time-out-of-refrigeration, and specific freeze-thaw cycles. These facilities help in providing clinical trial packaging services and clinical secondary packaging solutions along with commercial packaging of sterile formulations. What range of pharmaceutical packaging solutions does Sharp offer for solid and liquid drug products? With a history spanning more than 70 years, Sharp is a pioneer in providing pharmaceutical packaging services that include primary and secondary packaging of solid, liquid, and semi-solid drug products for clinical and commercial scales from its state-of-the-art facilities. Sharp offers innovative and economical clinical packaging services for investigational medicinal products (IMP). It also supports the packaging of various dosage forms including bottling of solid formulations, and thermo and cold forming blister packaging for oral solids. Sharp also supports the packaging of powder and OSDs in sachets and pouches, oral and transdermal films in strips, and injectables in vials, syringes, and cartridges. Moreover, it is also involved in the packaging of semi-solids such as cream and ointment in tubes. Some of Sharp’s pharmaceutical packaging solutions for solid and liquid drug products are mentioned below: Bottle Packaging for Solids and Semi-solids: Sharp provides pharma packaging contract services for bottle packaging that include component sourcing, carton printing and in-line cartoning or bundling, comprehensive onsite engineering and validation support, serialization and aggregation, and strict quality control for packaged drugs. Sharp also offers high-quality nitrogen flush bottles and bottle packaging for moisture and oxygen-sensitive drugs. Blister Packaging for Oral Solids: Sharp provides various blister packaging solutions including thermoform and cold form blisters, patient packs, hospital unit dose packs, wallet cards, child-resistant lidding, sustainable foil and blister materials, and multiple products per blister. Apart from this, Sharp’s contract blister packaging services also involve multi-color foil printing, in-house tooling design and fabrication, polymer laminates (Aclar, PVC/PVDC, etc.) heat-seal coating resins, and automated visual inspection. Pouches and Sachets for Solids and Transdermal Patches (Primary and Secondary Packaging Services): Sharp has expertise in pouch and sachet packaging filled with solid dose, powder, thin film, and transdermal patch drug products. Sharp’s solid dose packaging solutions offer considerable pouch and sachet packaging backed by quality operations and project management knowledge. Sharp is home to a sizable assemblage of form, fill, and seal technologies. Based on decades of practical expertise, Sharp uses a wide range of innovative film structure materials, such as coated papers, high-barrier foils, and polymer laminates, and offers pharma packaging contract services. It also can support the production of multiple dosage forms for pharmaceutical products. Oral Thin Film and Transdermal Patches: Sharp provides primary and secondary packaging services for oral thin films and transdermal patches. Sharp specializes in die-cutting and pouching sublingual and oral dissolvable films, and transdermal drug delivery systems, and offers specialized pharmaceutical packaging services through quality procedures. It utilizes the most up-to-date solid dose packaging solutions and processes to safely package and safeguard specialty drug products. Sharp’s oral thin film and transdermal patch capabilities include highly accurate dosing by die-cutting laminated products to any size and shape; in-line printing of drug info, bar codes, lot number, expiration date, serialization with optical character verification (OCV); etc. Therefore, Sharp is a pharmaceutical contract packaging organization that offers clinical services, cold chain packaging, clinical packaging and labeling, and commercial packaging. Its pharmaceutical contract packaging service also encompasses primary and secondary clinical and commercial packaging. 

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    04 Mar 2024