Vertex Pharmaceuticals DMF, CEP, Written Confirmations, FDF, Prices, Patents, Patents & Exclusivities, Dossier, Manufacturer, Licensing, Distributer, Suppliers, News, GMP

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FAMAR CDMO- From early development to commercial manufacturing.

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INTERVIEW #SpeakPharma, VLOG #PharmaReel, DATA COMPILATION #PharmaFlow, 683 NEWS #PharmaBuzz

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INTERVIEW #SpeakPharma
VLOG #PharmaReel
DATA COMPILATION #PharmaFlow
683 NEWS #PharmaBuzz

DEVELOPMENTS

103 Drugs in Development

103 Drugs in Development

FINISHED DOSAGE FORMULATIONS

77 FDF Dossiers, 18 FDA Orange Book, 25 Europe, 34 Canada

77 FDF Dossiers
18 FDA Orange Book
25 Europe
34 Canada

INSPECTIONS & REGISTRATIONS

1 WHO-GMP

inspections
1 WHO-GMP

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About

At Vertex, we have some of the industry's best and brightest people helping us achieve our mission of discovering transformative medicines to help people with serious diseases like cystic fibrosis. Whether they are in the lab, part of our business development team or on the phones with patients, we depend on a talented global workforce to lead the charge as we work toward developing tomorrow's breakthrough medicines.

CPhI Worldwide, MilanCPhI Worldwide, Milan

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08-10 October, 2024

Fiera Milano, Italy
26th North American IS...26th North American ISSX

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Not Confirmed

15-18 September, 2024

Hawaii, USA
DDF Summit, USDDF Summit, US

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Not Confirmed

16-17 September, 2024

Hyatt Regency LA Jolla, San Diego

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INTERVIEW #SpeakPharma

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“We’re unlocking life-changing potential in complex molecules, without sacrificing time to market”

This week, SpeakPharma interviews Mike Riley, CEO of Veranova, a leading contract development and manufacturing organization (CDMO) confidently mastering complex APIs as it marks its second year as an independent company. Riley discusses Veranova’s key achievements, including a US$ 30 million investment in their Devens, Massachusetts (US) site to expand capabilities in antibody-drug conjugates (ADCs) and highly potent APIs (HPAPIs), and how it is navigating the increasing complexity of molecules. 🔑 HIGHLIGHTS// Veranova’s key achievements / navigating the increasing complexity of molecules Veranova is celebrating its second year as a stand-alone company. Can you share Veranova’s key milestones and achievements in its first two years? We have achieved incredible milestones over the last two years, thanks to the dedication and hard work of our team. Our first 12 months focused on establishing ourselves as an independent CDMO by building on the 50 years of expertise that we brought with us. In addition, we expanded our capabilities and applied a more agile approach available to us as a company singularly focused on life sciences. This has allowed us to move into our second year with clear and strategic goals for generating growth in our sites, people, capabilities, and offerings. Since being appointed as CEO in May 2023, I’ve had the pleasure of witnessing some exciting growth milestones of my own. Most recently, we announced an estimated US$ 30 million investment in our Devens, Massachusetts, site. This expansion will allow us to build upon existing development and manufacturing capabilities in ADCs and HPAPIs that will address the growing demand for strong US-based capacity in these key drug modalities. We also appointed our Advisory Board, thereby bolstering Veranova’s in-house expertise. Made up of four distinguished leaders in pharma and biopharma – including Dr. Carolyn Bertozzi, the 2022 Nobel Laureate in Chemistry – the Board has provided thought-leadership, guidance and expertise as we develop and execute our strategic growth and ideas. We were also proud to be recognized as one of the Society of Chemical Manufacturers and Affiliates’ 12 companies for industry-leading safety programs in 2023 and as a part of the Medicine Maker’s Power List in 2024. 🔑 HIGHLIGHTS// US$ 30 million investment in our Devens, Massachusetts, site / appointed our Advisory Board Molecules are becoming increasingly complex. Can you elaborate on how Veranova’s current capabilities are strategically designed to address this trend in the coming years? The pharmaceutical pipeline is witnessing an increasing number of complex and highly potent molecules. This trend is driven by the demand for more targeted, patient-centric therapeutics and the focus on innovative modalities such as ADCs and other bioconjugates. At Veranova, our expertise, world-class facilities, and scientific excellence enable us to provide our customers with the clarity and solutions needed to manage this development and manufacturing complexity and ultimately deliver the required treatments to customers and patients. Our people are key to this approach. We have an expert team ready to collaborate with customers at any point, from early development through large-scale commercial production. Our services include world-leading crystallization development, process development, and specialized manufacturing expertise for complex synthetic molecules, including those requiring chromatography capabilities. In many cases, we can provide all these under one roof. Our service offering to our customers is also based on the foundational element of strong quality and compliance systems. We operate multiple facilities approved by the US FDA, UK’s MHRA and other regulatory authorities and are continually focused on ways to strengthen our global quality management system. Looking ahead, we are focused on continually investing in our facilities and team to meet growing complexity, as evidenced by our recent announcement of new investment in our Devens site. This investment signals our commitment to providing state-of-the-art capacity and capabilities to enable these next-generation therapies to reach patients. It is a key milestone as we advance Veranova’s broader growth strategy. 🔑 HIGHLIGHTS// provide our customers with clarity and solutions / world-leading crystallization development / expertise for complex synthetic molecules / strong quality and compliance systems How is Veranova approaching the challenge of designing and manufacturing effective linker molecules for ADCs? As a leader in complex linker-payload synthesis, Veranova is committed to unlocking the life-changing potential of ADCs without letting their complexities slow down the development of much-needed cancer therapies. ADCs are intricate, multi-component molecules that require extensive expertise and agile collaboration to overcome unique development challenges. With over a decade of experience in ADC linker-payload systems, we have developed the ability to anticipate challenges and avoid common pitfalls. The ADC linker-payload components are complex structures that are difficult to crystallize and require specialized high-potent handling. Veranova’s differentiated combination of world-leading crystallization development capabilities, complex synthesis experience, chromatography expertise and high-potent-handling experience put us in a unique position to solve these challenges for customers and speed their products to the clinic. We prioritize getting it right the first time, minimizing change orders and ensuring high-quality results. We have developed a robust phase-appropriate strategy that is backed by state-of-the-art analytical equipment and regulatory procedures to ensure our partners can rapidly progress their ADC projects from pre-clinical to commercialization. 🔑 HIGHLIGHTS// unlocking the life-changing potential of ADCs / ensuring our partners can rapidly progress their ADC projects Can you specify how Veranova is using artificial intelligence (AI) to optimize manufacturing processes that can reduce costs and environmental footprint as well as speed up development? In May 2024, Veranova announced a partnership with Phorum.AI to leverage AI to optimize pharmaceutical manufacturing processes. This collaboration aims to enable the rapid development of processes that can drive efficiency and reduce costs while maximizing environmental sustainability. Our goal is to combine Veranova’s extensive empirical manufacturing dataset of owned APIs and drug master files with Phorum.AI’s computational chemistry engine in order to create a more powerful process-development tool for the benefit of Veranova’s and Phorum’s customers. At Veranova, we are constantly looking to employ innovative technologies and approaches to improve efficiency, accelerate time to market and reduce environmental footprint. We have the means to work with a variety of partners who have unique project requirements, without sacrificing time to market. 🔑 HIGHLIGHTS// partnership with Phorum.AI / create a more powerful process-development tool / improve efficiency, accelerate time to market and reduce environmental footprint

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VLOG #PharmaReel

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Full-Service Generic API Company

DATA COMPILATION #PharmaFlow

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Excipient Market Overview: Roquette, Seqens, Evonik make strategic moves; new guidelines deal with contamination

The pharmaceutical industry has long recognized the critical role excipients or inactive ingredients play in drug formulation and delivery. Excipients can comprise up to 90 percent of a medicine's total ingredients and serve crucial functions as binders, disintegrants, coatings, preservatives, colors, and flavorings. According to recent market research, the pharmaceutical excipients market was valued at US$ 9.27 billion in 2023. It is growing at a compound annual growth rate (CAGR) of 7.03 percent and is projected to reach US$ 18.48 billion by 2032. The main factors driving market growth is an increased demand for multifunctional excipients, coupled with the expanding use of generic medications. The development in the biologics sector and advancements in nanotechnology are also contributing significantly to market growth. Major excipient providers include BASF, Evonik, Merck KGaA owned MilliporeSigma, Gangwal Healthcare, Roquette Frères, DuPont, Croda International, Seqens, Boai NKY Pharmaceuticals, PMC Isochem, Minakem, Kewpie Corporation, Ashland Global, SPI Pharma, Pfanstiehl, Nanjing Well Pharmaceutical, ICE Pharma, Anhui Ribobay Pharmaceutical and Nippon Fine Chemical. View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available) WHO, India’s CDSCO tighten regulations; new GMP guidelines implemented to curb contamination Last year, the World Health Organization (WHO) issued a health alert linking at least 300 child deaths in the Gambia, Uzbekistan, and Indonesia to the ingestion of contaminated cough syrups containing unacceptable levels of diethylene glycol (DEG) and ethylene glycol (EG). In response to the tragic events, the WHO released two draft appendices to its guideline on good manufacturing practices (GMPs) for excipients this year. Manufacturers are now required to use suitable risk assessment tools to identify and mitigate potential hazards. Since India-made cough syrups had been linked to the deaths, India’s drug regulator — Central Drugs Standard Control Organization (CDSCO) — took steps to prevent contamination, and advised drugmakers to only use pharmaceutical-grade excipients from approved sources. Furthermore, the Indian Health Ministry proposed amendments to the Drugs and Cosmetics Rules, 1945 to include details of excipients on drug labels. While listing all excipients on every strip of medicine may be challenging, the ministry suggested mentioning those causing hypersensitivity on the label. Applicants now mandatorily need to submit evidence of stability and safety of excipients. These regulatory developments have significant implications for excipient manufacturers and pharmaceutical companies worldwide. Leading pharmaceutical excipient firms like Gangwal Healthcare, Sigachi Industries, and Nitika Pharmaceuticals are well-positioned to meet these heightened quality and safety standards, given their long-standing commitment to producing high-quality, compliant excipients. View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available) Roquette buys IFF’s pharma unit for US$ 2.85 bn; Evonik opens new spray-drying facility in Darmstadt In a significant industry move, France-based Roquette entered into an agreement to acquire IFF's pharma solutions business in a deal valued at US$ 2.85 billion. This acquisition is set to rebalance family-owned Roquette’s portfolio around health and nutrition. The deal is expected to accelerate Roquette’s growth and significantly strengthen its presence in the excipients market. Evonik has opened a new facility for drying aqueous dispersions of its Eudragit polymers at its site in Darmstadt, Germany. The facility will help Evonik meet increasing demand from drugmakers for its oral drug delivery solutions. The plant uses green energy solutions. The company has also partnered University of Mainz to commercialize a new class of polyethylene glycols (PEG) lipids for nucleic acid delivery. Evonik’s Health Care business has been growing its nucleic acid drug and vaccine delivery portfolio. Germany’s Johannes Gutenberg University of Mainz was the first to develop randomized polyethylene glycols (rPEGs). This collaboration aims to expand Evonik’s toolbox of technologies for nucleic acid-based medicines, offering an improved immunogenicity profile for lipid nanoparticle carriers used in mRNA vaccines and therapeutics. Asahi Kasei made significant strides in addressing a pressing industry concern that emerged in 2018 when potentially carcinogenic nitrosamine impurities were detected in several pharmaceuticals. Guided by regional authorities, such as the European Medicines Agency and the US Food and Drug Administration, the pharmaceutical industry has been carrying out extensive assessments and research to identify the cause of these impurities. In response to this challenge, Asahi Kasei developed its Ceolus microcrystalline cellulose with extremely low nitrite levels. The Japanese company achieved nitrite concentrations of 0.1 micrograms per gram or less, which is equivalent to 0.1 parts per million (ppm). The company also started full commercial operation of its second manufacturing facility for Ceolus in Japan, enhancing supply capacity and stability. JRS Pharma and Gujarat Microwax opened a state-of-the-art cotton-based croscarmellose sodium plant in Mehsana, Gujarat (India). This facility aims to produce high-quality excipients that meet global standards, potentially reducing India's dependency on imports and boosting its presence in the global excipient market. The Indian excipient industry accounts for less than 1 percent of the global market share. View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available) Seqens to advance innovative polymer; biologics, personalized medicine create demand for specialized excipients Recent industry collaborations highlight the ongoing innovation in novel excipients. France’s Seqens, with over 20 years of polymer development experience, was chosen by Pleryon Therapeutics to advance its leading osteoarthritis candidate – an innovative GMP polymer. This collaboration leverages Seqens’ newly expanded and modernized cGMP plant in Aramon, France, demonstrating the industry’s commitment to investing in advanced manufacturing capabilities for novel excipients. The rise of biologics and personalized medicine has created a demand for specialized excipients capable of stabilizing complex molecules and enabling targeted drug delivery. Roquette’s launch of Lycagel Flex, a hydroxypropyl pemix for nutraceutical and pharmaceutical softgel capsules, exemplifies this trend. Built on Roquette’s market-first Lycagel pea starch technology, this plant-based alternative to gelatin offers manufacturers the flexibility to customize formulations for a range of production and end-user needs. The innovative pea starch foundation also underscores the industry’s move towards sustainable bio-based excipients. The trend towards patient-centric drug development has also influenced excipient innovation. Excipients that can improve palatability, ease of swallowing, or enable novel dosage forms (such as orally disintegrating tablets) are in high demand. For example, IFF brought a super disintegrant Ac-Di-Sol, that supports faster disintegration and drug dissolution in oral disintegrating tablets, improving patient experience. View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available) Our view The heightened regulatory scrutiny on excipients due to product contamination incidents has created a high risk perception and uncertainty around the regulatory acceptance of novel excipients. That said, novel excipients are central to the development of new drug modalities and therapies. Going forward, sustainability will also become an increasingly important factor in excipient selection and development. As the industry innovates towards biologics, personalized therapies, and patient-centric formulations, the role of high-quality, multifunctional excipients will only grow more vital in ensuring drug stability, bioavailability, and patient compliance. Companies that can navigate the complex regulatory landscape, invest in R&D, and offer high-quality, multifunctional excipients will be well-positioned to succeed in this evolving market.