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Endocrinology Newsmakers: Drugmakers work on triple agonist treatments, gene therapies to fight diabetes

Endocrinology, a medicinal branch that deals with endocrine and metabolic disorders, is witnessing cutting-edge drug research to develop advanced drugs that can treat diabetes, obesity, hypoparathyroidism and other disorders.The endocrinology market is witnessing impressive growth — it is growing at a compound annual growth rate (CAGR) of 7.82 percent. Between 2023 and 2027, the market is poised to increase by US$ 36.5 billion. It includes treatments for various medical conditions, such as type 1 and type 2 diabetes, obesity, hypogonadism (a condition where the body’s sex glands produce little or no hormones), dwarfism, hypo or hyperparathyroidism, acromegaly (abnormal growth of the hands, feet, and face, caused by the overproduction of growth hormone by the pituitary gland) and congenital adrenal hyperplasia (a genetic disorder that affects the adrenal glands).The market is dominated by diabetes treatment drugs — valued at around US$ 48.7 billion in 2018, these are expected to generate US$ 78.3 billion by the end of 2026. The market for obesity drugs is also expected to reach US$ 50 billion by 2030.The top companies in this segment include Novo Nordisk, Eli Lilly, Merck, Sanofi, AstraZeneca and Boehringer Ingelheim. Several biotech companies have joined the race to capture a share of the lucrative market for diabetes and obesity drugs.Access the Endocrinology Newsmakers Dashboard (Free Excel)Lilly’s Mounjaro, Novo’s Wegovy gear up for larger share of obesity pieIn May 2022, Lilly’s potential blockbuster Mounjaro (tirzepatide) was approved by the US Food and Drug Administration (FDA) as a once-weekly subcutaneous injection to treat adults with type 2 diabetes. Mounjaro is the first and only dual targeted glucose-dependent insulinotropic peptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist on the market, and has helped patients achieve a body weight loss of over 20 percent in clinical trials. Novo Nordisk’s Wegovy (semaglutide), the first and only once-weekly GLP-1 receptor agonist approved for weight management in people with obesity, has been found to help patients lose up to 15 percent of their body weight in over 68 weeks. In late 2022, the drug received FDA approval to treat obesity in pediatric patients aged 12 years and older.Last October, FDA granted fast track review designation to Mounjaro as a treatment for obesity. Lilly plans to go to the FDA soon and expects to get approval for the drug this year. Once approved, Mounjaro will give Wegovy a tough fight in the obesity market. Analysts predict Mounjaro to generate around US$ 8.1 billion in annual sales by 2028, while Wegovy is expected to bring in US$ 7 billion by 2030. Meanwhile, Amgen’s AMG 133 is also in early-stage trials for obesity. Access the Endocrinology Newsmakers Dashboard (Free Excel) ‘Skinny shot’ diabetes drugs face supply shortages; Lilly plans to double capacityFollowing its approval in the US in mid-2021, Wegovy quickly became the go-to “skinny shot” drug in Hollywood, thanks to its impressive weight reduction data. But the drug hit a supply shortage in late 2021 due to manufacturing issues, which the manufacturer managed to fix in the second half of 2022. Novo’s blockbuster type 2 diabetes drug Ozempic is also in limited supply, but the drugmaker expects the availability to return to normal around mid-March.The supply constraints of Wegovy and Ozempic, coupled with the craze around using diabetes drugs for weight loss, sparked interest in Lilly’s Mounjaro. But Mounjaro, along with another Lilly drug Trulicity, began facing supply issues last December. While Lilly has fixed Mounjaro’s supply issues for the time being, it plans to double its manufacturing capacity by the year end to avoid any such shortages in the future.Meanwhile, the American Diabetes Association and Mutual Aid Diabetes have sounded an alarm, saying the off-label use of diabetes drugs for weight loss may cause shortages and affect diabetes patients.Access the Endocrinology Newsmakers Dashboard (Free Excel)Provention launches treatment for type 1 diabetes; Novo retains market dominanceIn November, Provention Bio’s Tzield (teplizumab) bagged FDA approval as a preventive treatment for type 1 diabetes in individuals eight years or older who are in stage 2 of the disease. The injectable drug is the first treatment in the US to delay progression of the autoimmune disease.Novo remained the dominant player in the diabetes and obesity market, clocking sales of US$ 22.8 billion (DKK 156.4 billion) in 2022 in this segment. Ozempic’s sales increased by 77 percent to US$ 8.6 billion (DKK 59.8 billion). The Danish company consolidated its position further by purchasing Dicerna Pharma for US$ 3.3 billion in 2021 for its RNA interference (RNAi) technology.Novo is planning to file for approval of its once-weekly insulin icodec for type 2 diabetes in the US, the EU and China in the first half of 2023. It is also running a phase 1 trial of Ozempic as a once-weekly oral treatment.In 2022, sales of Lilly’s blockbuster drug Trulicity (dulaglutide) touched US$ 7.4 billion. Two other drugs, Humalog and Jardiance, generated US$ 2.1 billion each in sales. In addition, Lilly’s partner Boehringer Ingelheim also reported US$ 2.55 billion (€ 2.5 billion) sales of Jardiance in the first half of 2022.Biosimilar drugmaker Biocon Biologics acquired Viatris’ biosimilars business for a total of US$ 3.34 billion, strengthening its presence in the diabetes, tumors and autoimmune diseases market. Viatris’ portfolio is expected to generate sales of over US$ 1 billion for Biocon in 2023.Access the Endocrinology Newsmakers Dashboard (Free Excel)Drugmakers work on triple agonist therapies to treat diabetes, obesitySeveral drugmakers are working on triple agonist therapies that target multiple receptors, such as GLP-1, GIP and glucagon (GCG). These drugs, such as Novo and partner Marcadia’s MAR423, Hanmi’s HM1521, Sanofi’s SAR441255, and Eli Lilly’s retatrutide, are currently in early- to mid-stage trials. Studies have shown that these triple agonists are more effective in reducing body weight and improving glucose control compared to mono- or dual-incretin receptor agonists.In addition, a few triple drug combinations containing metformin, DPP4 inhibitors and SGLT2 inhibitors have recently been approved. Treatments such as Astra’s Qternmet XR and Lilly-BI’s Trijardy XR have shown significant improvement in glycemic control and are generally well tolerated by patients.Access the Endocrinology Newsmakers Dashboard (Free Excel)TheracosBio’s oral med for diabetes approved; gene therapies gather interest Recently, TheracosBio’s Brenzavvy was approved by the agency as an oral medication for type 2 diabetes. And Marinus Pharmaceuticals’ oral testosterone replacement therapy Kyzatrex received FDA’s nod last year for a range of diseases in men that arise from deficiency or absence of endogenous testosterone. New York-based Oramed is currently conducting a phase 1 trial of its oral GLP-1 drug – ORMD-0901 – as a treatment for type 2 diabetes.Meanwhile, Vertex and Arbor Biotechnologies are working on a gene therapy (VX-880) for type 1 diabetes. BridgeBio Pharma’s BBP-631 adeno-associated virus (AAV) gene therapy for congenital adrenal hyperplasia is in phase 1/2 trials. And Swedish biotech Diamyd is carrying out phase 3 trials of its type 1 diabetes vaccine.In other medical conditions, Ascendis Pharma’s TransCon PTH, a long-acting prodrug of parathyroid hormone, has a PDUFA date in April 2023. If approved, it would become the first hormone replacement therapy to address the underlying cause of hypoparathyroidism. Crinetics Pharmaceuticals’ Paltusotine, a non-peptide somatostatin type 2 (SST2) receptor agonist, is currently in phase 3 trials for acromegaly, representing a new class of oral once-daily medication.Access the Endocrinology Newsmakers Dashboard (Free Excel)Our viewDiabetes and obesity have reached epidemic proportions in the recent decades, while other endocrine disorders such as hypoparathyroidism are also growing rapidly the world over.According to the World Health Organization, around 422 million people worldwide have diabetes, and 1.5 million deaths are directly attributed to diabetes each year.While factors such as long working hours, sedentary lifestyles, and unhealthy eating and drinking habits are contributing to the rise of these diseases, drugmakers are doing some cutting edge research for these conditions. Given this scenario, endocrinology should see a lot of pathbreaking drugs in the coming years.

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02 Mar 2023

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Top drugs and pharmaceutical companies of 2019 by revenues

Acquisitions and spin-offs dominated headlines in 2019 and the tone was set very early with Bristol-Myers Squibb acquiring New Jersey-based cancer drug company Celgene in a US$ 74 billion deal announced on January 3, 2019. After factoring in debt, the deal value ballooned to about US$ 95 billion, which according to data compiled by Refinitiv, made it the largest healthcare deal on record. In the summer, AbbVie Inc, which sells the world’s best-selling drug Humira, announced its acquisition of Allergan Plc, known for Botox and other cosmetic treatments, for US$ 63 billion. While the companies are still awaiting regulatory approval for their deal, with US$ 49 billion in combined 2019 revenues, the merged entity would rank amongst the biggest in the industry. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available) The big five by pharmaceutical sales — Pfizer, Roche, J&J, Novartis and Merck Pfizer continued to lead companies by pharmaceutical sales by reporting annual 2019 revenues of US$ 51.8 billion, a decrease of US$ 1.9 billion, or 4 percent, compared to 2018. The decline was primarily attributed to the loss of exclusivity of Lyrica in 2019, which witnessed its sales drop from US$ 5 billion in 2018 to US$ 3.3 billion in 2019. In 2018, Pfizer’s then incoming CEO Albert Bourla had mentioned that the company did not see the need for any large-scale M&A activity as Pfizer had “the best pipeline” in its history, which needed the company to focus on deploying its capital to keep its pipeline flowing and execute on its drug launches. Bourla stayed true to his word and barring the acquisition of Array Biopharma for US$ 11.4 billion and a spin-off to merge Upjohn, Pfizer’s off-patent branded and generic established medicines business with Mylan, there weren’t any other big ticket deals which were announced. The Upjohn-Mylan merged entity will be called Viatris and is expected to have 2020 revenues between US$ 19 and US$ 20 billion and could outpace Teva to become the largest generic company in the world, in term of revenues. Novartis, which had followed Pfizer with the second largest revenues in the pharmaceutical industry in 2018, reported its first full year earnings after spinning off its Alcon eye care devices business division that had US$ 7.15 billion in 2018 sales. In 2019, Novartis slipped two spots in the ranking after reporting total sales of US$ 47.4 billion and its CEO Vas Narasimhan continued his deal-making spree by buying New Jersey-headquartered The Medicines Company (MedCo) for US$ 9.7 billion to acquire a late-stage cholesterol-lowering therapy named inclisiran. As Takeda Pharmaceutical Co was busy in 2019 on working to reduce its debt burden incurred due to its US$ 62 billion purchase of Shire Plc, which was announced in 2018, Novartis also purchased the eye-disease medicine, Xiidra, from the Japanese drugmaker for US$ 5.3 billion. Novartis’ management also spent a considerable part of 2019 dealing with data-integrity concerns which emerged from its 2018 buyout of AveXis, the gene-therapy maker Novartis had acquired for US$ 8.7 billion. The deal gave Novartis rights to Zolgensma, a novel treatment intended for children less than two years of age with the most severe form of spinal muscular atrophy (SMA). Priced at US$ 2.1 million, Zolgensma is currently the world’s most expensive drug. However, in a shocking announcement, a month after approving the drug, the US Food and Drug Administration (FDA) issued a press release on data accuracy issues as the agency was informed by AveXis that its personnel had manipulated data which the FDA used to evaluate product comparability and nonclinical (animal) pharmacology as part of the biologics license application (BLA), which was submitted and reviewed by the FDA. With US$ 50.0 billion (CHF 48.5 billion) in annual pharmaceutical sales, Swiss drugmaker Roche came in at number two position in 2019 as its sales grew 11 percent driven by its multiple sclerosis medicine Ocrevus, haemophilia drug Hemlibra and cancer medicines Tecentriq and Perjeta. Roche’s newly introduced medicines generated US$ 5.53 billion (CHF 5.4 billion) in growth, helping offset the impact of the competition from biosimilars for its three best-selling drugs MabThera/Rituxan, Herceptin and Avastin. In late 2019, after months of increased antitrust scrutiny, Roche completed its US$ 5.1 billion acquisition of Spark Therapeutics to strengthen its presence in gene therapy. Last year, J&J reported almost flat worldwide sales of US$ 82.1 billion. J&J’s pharmaceutical division generated US$ 42.20 billion and its medical devices and consumer health divisions brought in US$ 25.96 billion and US$ 13.89 billion respectively. Since J&J’s consumer health division sells analgesics, digestive health along with beauty and oral care products, the US$ 5.43 billion in consumer health sales from over-the-counter drugs and women’s health products was only used in our assessment of J&J’s total pharmaceutical revenues. With combined pharmaceutical sales of US$ 47.63 billion, J&J made it to number three on our list. While the sales of products like Stelara, Darzalex, Imbruvica, Invega Sustenna drove J&J’s pharmaceutical business to grow by 4 percent over 2018, the firm had to contend with generic competition against key revenue contributors Remicade and Zytiga. US-headquartered Merck, which is known as MSD (short for Merck Sharp & Dohme) outside the United States and Canada, is set to significantly move up the rankings next year fueled by its cancer drug Keytruda, which witnessed a 55 percent increase in sales to US$ 11.1 billion. Merck reported total revenues of US$ 41.75 billion and also announced it will spin off its women’s health drugs, biosimilar drugs and older products to create a new pharmaceutical company with US$ 6.5 billion in annual revenues. The firm had anticipated 2020 sales between US$ 48.8 billion and US$ 50.3 billion however this week it announced that the coronavirus pandemic will reduce 2020 sales by more than $2 billion. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available) Humira holds on to remain world’s best-selling drug AbbVie’s acquisition of Allergan comes as the firm faces the expiration of patent protection for Humira, which brought in a staggering US$ 19.2 billion in sales last year for the company. AbbVie has failed to successfully acquire or develop a major new product to replace the sales generated by its flagship drug. In 2019, Humira’s US revenues increased 8.6 percent to US$ 14.86 billion while internationally, due to biosimilar competition, the sales dropped 31.1 percent to US$ 4.30 billion. Bristol Myers Squibb’s Eliquis, which is also marketed by Pfizer, maintained its number two position and posted total sales of US$ 12.1 billion, a 23 percent increase over 2018. While Bristol Myers Squibb’s immunotherapy treatment Opdivo, sold in partnership with Ono in Japan, saw sales increase from US$ 7.57 billion to US$ 8.0 billion, the growth paled in comparison to the US$ 3.9 billion revenue increase of Opdivo’s key immunotherapy competitor Merck’s Keytruda. Keytruda took the number three spot in drug sales that previously belonged to Celgene’s Revlimid, which witnessed a sales decline from US$ 9.69 billion to US$ 9.4 billion. Cancer treatment Imbruvica, which is marketed by J&J and AbbVie, witnessed a 30 percent increase in sales. With US$ 8.1 billion in 2019 revenues, it took the number five position. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available) Vaccines – Covid-19 turns competitors into partners This year has been dominated by the single biggest health emergency in years — the novel coronavirus (Covid-19) pandemic. As drugs continue to fail to meet expectations, vaccine development has received a lot of attention. GSK reported the highest vaccine sales of all drugmakers with total sales of US$ 8.4 billion (GBP 7.16 billion), a significant portion of its total sales of US$ 41.8 billion (GBP 33.754 billion). US-based Merck’s vaccine division also reported a significant increase in sales to US$ 8.0 billion and in 2019 received FDA and EU approval to market its Ebola vaccine Ervebo. This is the first FDA-authorized vaccine against the deadly virus which causes hemorrhagic fever and spreads from person to person through direct contact with body fluids. Pfizer and Sanofi also reported an increase in their vaccine sales to US$ 6.4 billion and US$ 6.2 billion respectively and the Covid-19 pandemic has recently pushed drugmakers to move faster than ever before and has also converted competitors into partners. In a rare move, drug behemoths — Sanofi and GlaxoSmithKline (GSK) —joined hands to develop a vaccine for the novel coronavirus. The two companies plan to start human trials in the second half of this year, and if things go right, they will file for potential approvals by the second half of 2021. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available) Our view Covid-19 has brought the world economy to a grinding halt and shifted the global attention to the pharmaceutical industry’s capability to deliver solutions to address this pandemic. Our compilation shows that vaccines and drugs for infectious diseases currently form a tiny fraction of the total sales of pharmaceutical companies and few drugs against infectious diseases rank high on the sales list. This could well explain the limited range of options currently available to fight Covid-19. With the pandemic currently infecting over 3 million people spread across more than 200 countries, we can safely conclude that the scenario in 2020 will change substantially. And so should our compilation of top drugs for the year. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)

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29 Apr 2020

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FDA chief named in payments controversy; fake vaccine scandal impacts Indonesian children

This week Phispers brings you scandals such as that of fake vaccines in Indonesia, studies and analyses on drug prices and VC investments in biotech firms, scrutiny on clinical trials done in India, new initiatives such the one undertaken by the FDA on cancer, regulatory action, court cases and other interesting pharma industry news from across the world. Did the FDA commissioner receive payments from GSK and AstraZeneca?A database of pharmaceutical company payments to physicians updated by the US Centers for Medicare & Medicaid Services (CMS), includes the name of the current US Food and Drug Administration (FDA) Commissioner Robert Califf. “The database says Califf received five payments from GlaxoSmithKline for travel, lodging, food and beverages, as well as a more than US $ 5,000 consulting fee from AstraZeneca in 2015. In 2014, when he was not working for the FDA, Califf received almost US $ 32,000 from companies and in 2013, he received more than US $ 28,000.” An FDA spokesperson said Commissioner Califf has filed a dispute with CMS in regard to the reported data. The news comes at a time when awareness on pharma companies and their dealings with doctors is on the rise. In the UK, the NHS has warned that drugs firms should stop paying doctors and health service officials who refuse to be named in a new transparency register. In Ireland, doctors and other healthcare professionals were paid €6.8 million by pharmaceutical companies last year. J&J to pay US $ 70 million to family of boy who developed breastsLast week, a jury in America awarded US $ 70 million to the family of a boy who developed breasts after taking Johnson & Johnson (J&J) unit Janssen Pharmaceuticals' antipsychotic drug Risperdal. The jury found that the company failed to warn the boy's healthcare providers about the risk of gynecomastia, which is breast growth in men or boys caused by a hormonal imbalance. According to a copy of the verdict, the company intentionally falsified, destroyed or concealed evidence in the case. Johnson & Johnson and Janssen are facing more than 12,000 claims over Risperdal, according to J&J's most recent quarterly report. Warning letters for Chinese factories; two Indian firms on import alert It was a busy week for the US FDA as it issued warning letters to three facilities in China – Shanghai Desano Pharmaceutical, Chongqing Lummy Pharmaceutical and Guangzhou Haishi Biological Technology. The laboratory personnel at Desano were found conducting “unofficial” testing to an order that the FDA inspectors concluded that “the volume of data in these auxiliary ‘test folders’ suggests that performing unofficial analyses is a common practice at your facility.” Chongqing Lummy which had been placed on the FDA’s import alert list earlier this year had investigators finding analysts manipulating results for multiple batches of API distributed to the US. Guangzhou Haishi, which unlike Desano and Lummy, produces finished formulations for the United States had investigators unveiling that the company released finished batches of drug products without complete testing. And despite the violations uncovered, Haishi’s quality unit released multiple batches of drug products for distribution.While warning letters were being issued to companies based in China, two Indian companies – Harika Drugs and Silverline Chemicals – which refused FDA inspections were placed on the import alert list. As all the news of compliance troubles was accumulating, Strides Shasun successfully passed an FDA inspection in India; while regulators in the United States and Europe discussed ways on increasing collaboration to reduce the inspection load. VCs continue to invest in American biotech startupsWhile 2015 proved to be the biggest year on record for venture investing in American biotech firms, this year could be equally big. In 2015, a total of US $ 7.7 billion flowed into a range of startups. These were largely clustered in Boston/Cambridge and San Francisco. This year, the IPO window for drug developers has dropped considerably, but the VC money seems to be flowing into the biotech space at the same pace as last year. Millions of Indonesian children to be revaccinated due to fake vaccine scandal Fake vaccines, that have been distributed across Indonesia since 2003, will have the Indonesian government reinoculate children aged 10 and under. While it is not clear how many children will receive their jabs again, it is estimated that the number runs in millions. The Indonesian police have arrested 15 suspects and seized hundreds of bogus vaccines, including substances that passed off as vaccines for polio and hepatitis B. The fake-vaccine manufacturing and distribution rackets uncovered in Indonesia follows a similar public-health outcry that occurred in China a few months back. Scrutiny on clinical trials performed in India continues Last week, two regulators -- Medicines and Healthcare products Regulatory Agency (MHRA) and European Medicines Agency (EMA) – took action pertaining to clinical trials conducted in India. The MHRA suspended marketing approval for a widely used antibiotic – erythromycin – that had won clearance based on clinical trials conducted by India's Quest Life Sciences, due to concerns over the integrity of trial data. The MHRA's decision bars the sale of a generic version of erythromycin that is being sold in the UK by Dawa Ltd, a Kenyan drug maker. The EMA, on the other hand, has recommended the suspension of drug Riluzole Alkem, for which studies were conducted at the Alkem Laboratories site in Taloja (Maharashtra). Advertising Standards Authority bans Reckitt Benckiser’s painkiller ad There are strict rules that govern the advertising for pharmaceuticals and Reckitt Benckiser recently found out that there can be a blowback if you astray from the rules. The company was selling targeted painkillers for different ailments: period pain, migraines and headaches. The Advertising Standards Authority (ASA) banned an advertisement for Nurofen Joint and Back because, despite appearances, the pills in the range have no specific targeting powers. AstraZeneca and Genzyme were recently shamed in advertisements for separate breaches of the Association of the British Pharmaceutical Industry's (ABPI) Code of Practice. AstraZeneca apparently breached three clauses of the Code by producing a leave piece which provided misleading instructions on how to use the EMIS Web clinical system – which allows healthcare professionals to record, share and use vital information.Similarly, Genzyme breached the Code when it made a presentation about Fabrazyme (agalsidase beta) to an expert advisory group, that the PMCPA (Prescriptions Medicines Code of Practice Authority) says was “misleading, inconsistent with the Fabrazyme SPC and disparaging of a competitor product.” New age antibiotics, a golden opportunity for Big PharmaAfter decades of ignoring the antibiotics business due to scant rewards, Big Pharma is back to developing new antibiotics. Research incentives from governments are spurring drug makers to renew efforts to fight antimicrobial resistance and replenish the arsenal of infection-fighting drugs. Giants such as Roche Holding and Merck are stepping up their efforts. Several startups are seeking partners to help market new products.“Some large pharmaceutical companies are re-entering the space, and new companies focused on antibacterial development are emerging as industry darlings,” said Ankit Mahadevia, chief executive officer of Spero Therapeutics LLC, a biopharmaceutical company in Massachusetts that’s developing novel treatments for bacterial infections. An analysis that decodes drug price hikes, discounts and inflationA Bloomberg analysis of 39 medicines sold in the US with global sales of more than US $ 1 billion per annum revealed that 30 of them logged price increases of more than double the rate of inflation from 2009 to 2015, even after estimated discounts were factored in. Only six drugs had price increases in line with or below inflation. The analysis is based on discount estimates from SSR Health, an investment research firm that compared estimates of gross sales for each drug, based on prescription data, to company-reported US net sales. According to the analysis, discounts vary according to the disease type and competition. For instance, the price increases in Humalog, the popular, short-acting insulin made by Eli Lilly were wiped out by even-bigger discounts. Gilead, Massachusetts find middle ground on Hepatitis C drugAfter threatening Gilead Sciences over the cost of its hepatitis C treatments, the commonwealth of Massachusetts has reached a deal with the drug maker for rebates for some of its residents who are infected with the chronic disease. The cost of hepatitis C drugs for about 2,800 people covered by MassHealth, which is the commonwealth’s Medicaid programme, has so far totaled about US $ 318 million from late 2014 through early 2016. The deal is expected to save the state a significant amount of money. Meanwhile, Gilead Sciences recently raised prices on a pair of older HIV medications that face patent expiration. This is part of the company’s strategy to encourage patients to switch to newer HIV treatments. However, this sort of pricing strategy is triggering criticism by AIDS activists. FDA strengthens its cancer initiative Richard Pazdur – who has been with the Food and Drug Administration for 20 years – was recently elevated to a new role. He will be running a new Oncology Center of Excellence that will coordinate all of the FDA’s clinical efforts in cancer. This oncology centre is part of the American Vice President Joseph Biden’s US $ 1 billion National Cancer Moonshort effort. At the FDA, Pazdur was evaluating new cancer drugs.Cancer medicines now account for 40 percent of the drugs under development. According to the FDA commissioner, Robert Califf, a few years ago, pharma companies were worried that their drug pipelines had run dry. Now, they are filing drug applications at a dizzying pace. Add to that, he says, new technologies like DNA sequencing and 3D printing, and there is an “avalanche” of new products coming. “We have to be prepared for this,” Califf says.

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