News & Insights

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In what segments are contract manufacturers expanding development and manufacturing capabilities? DCAT Value Chain Insights examines the latest in fine chemical and small-molecule active pharmaceutical ingredient manufacturing. Reflecting increased product development in biologics, biologic-based API manufacturing and parenteral drug-product manufacturing have been an active area of investment by CDMOs/CMOs, but how has small-molecule fared? DCAT Value Chain Insights examines the latest developments. A roundup of recent activity: small molecules Several contract manufacturing organizations and fine chemical producers have announced or completed...
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The Biosimilars Council, a division of the Association for Accessible Medicines (formerly the Generic Pharmaceutical Association) filed an amicus brief with the US Supreme Court to offer its position regarding a six-month market exclusivity issue regarding biosimilars. So what are the issues at play? Earlier this year, the US Supreme Court agreed to hear a case regarding a 180-day notification requirement by a biosimilar developer to the innovator company that arose in patent litigation with Sandoz, a division of Novartis, and Amgen. At issue is the timing of such notification, which impacts the exclusivity period granted to an innovator product. DCAT...
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Pharmaceutical companies, CDMOs, CMOs, and excipient producers need to continually evaluate their strategies, technologies, and capabilities in formulation development, drug delivery, and drug-product manufacturing. How does your company's toolbox measure up? The DCAT Week '17 Education Program, Market Opportunities: Advanced Formulation and Next-Generation Drug Delivery Technologies , provides perspectives from leading pharma companies and industry experts on what will be required in the near- and long-term. Market overview So where are the market opportunities for pharmaceutical companies and contract development and manufacturing organizations...
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Almac has appointed Leeona Galligan, PhD, as vice president UK Operations within Almac Diagnostics with effect from January 1, 2017. Dr. Galligan joined Almac Diagnostics in September 2009 as a senior scientist in the research and development department. She was appointed as the manager of the newly formed clinical testing laboratory in 2012 and was subsequently promoted to head of UK laboratory-based operations in January 2014. In this role, Dr. Galligan assumed overall responsibility for commercial biomarker discovery, CLIA/FDA compliant analytical validation and downstream clinical testing. She has also overseen the development of a new manufacturing...
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Lonza Houston, the viral gene and cell-therapy manufacturing unit of Lonza, has entered into a strategic manufacturing agreement with Selecta Biosciences, a Watertown, Masachusetts-based clinical-stage biopharmaceutical company, under which Lonza will produce an Anc80-AAV-based gene therapy product for Selecta’s proprietary program for treating methylmalonic acidemia (MMA), a rare inborn error of metabolism. Also under the agreement, Lonza may in the future produce other Anc80-based products for which Selecta holds exclusive options. The partnership will leverage Lonza’s expertise in developing industry-scale manufacturing platforms for viral-based...
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Pfizer CentreOne, al contract manufacturing organization (CMO) within Pfizer, has expanded its fill-finish services at its Kalamazoo, Michigan site. The facility now provides vial-filling of sterile suspensions along with vial-filling of small molecules and biologics. Pfizer CentreOne’s vial-filling services at the Kalamazoo site encompass small molecules and biologics, sterile suspensions, potent and controlled substances, aqueous and oil-based formulations, lyophilization, vials in 1-mL to 100-mL sizes, bulk formulation ranging from less than 1 liter to 1,600 liters, and technical transfer. The CMO was formed by the union of Pfizer CentreSource...
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Catalent has completed its previously announced acquisition of Accucaps Industries Limited, an Ontario, Canada-based developer and manufacturer of over-the-counter (OTC), high potency, and conventional pharmaceutical softgels. The company announced the acquisition in November 2016 . The acquisition complements Catalent’s global OTC and prescription pharmaceutical softgel capabilities and capacity, adding a portfolio of products supplied to pharmaceutical companies in North America, and two facilities offering integrated softgel development, manufacturing, and packaging. Financial details of the transaction were not disclosed. Accucaps’ more...
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Quotient Clinical, a Nottingham, UK-based early phase drug development services provider, has acquired QS Pharma, Charles River Laboratories International’s contract development and manufacturing organization unit based near Philadelphia. Founded in 2002, QS Pharma specializes in the formulation development and manufacturing of small-molecule drug products and supports customer programs from the development stage through to commercialization. Quotient gains QS Pharma’s capability in potency molecule manufacturing. This acquisition expands Quotient’s footprint in the US following its recent acquisition of SeaView Research, a Miami, Florida-based...
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Arc Trinova (trading as Arcinova), an Alnwick, UK-based research and development company, has received approval for funding from the Rural Growth Network Fund to expand its capabilities, including the construction of a new active pharmaceutical ingredient (API) manufacturing plant. The £60,000 ($75,000) grant funding awarded from the Rural Growth Network Fund will supplement capital investment from the company. The Rural Growth Network Fund is supplied by the North East Rural Growth Network in the UK, a national pilot scheme to stimulate economic growth in rural locations spanning Northumberland, Durham, and Gateshead. The expansion project will include...
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Sanofi has entered into three service agreements with Selexis, a Geneva, Switzerland-based company that specializes in mammalian cell-line generation, under which Selexis will develop research cell banks for Sanofi using Selexis’ SUREtechnology platform. Under the three agreements, Selexis will develop a cell line for a naked antibody, a new cell line for a bispecific antibody, and a new cell line for the expression of a complex recombinant vaccine protein. Selexis’ proprietary SUREtechnology Platform facilitates the production of recombinant protein and integrates biologics and vaccine development. Source: Selexis
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Abzena, a Cambridge, UK-based life sciences group that provides services and technologies for biopharmaceuticals, has signed a manufacturing agreement with University College London (UCL) in London, UK to manufacture magacizumab, an antibody created using Abzena’s Composite Human Antibody technology. Under earlier agreements with UCL, Abzena conducted antibody humanization and developed the manufacturing cell line for magacizumab. Abzena’s Composite Human Antibody technology combines previous humanization and deimmunization technologies to generate fully humanized therapeutic antibodies devoid of CD4+ T-cell epitopes, according to information...
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Takeda Pharmaceutical has partnered with PRA Health Sciences, a Raleigh, North Carolina-based contract research organization, to establish a 50/50 joint venture in Japan to provide clinical trial delivery and pharmacovigilance services as a strategic partner of Takeda in Japan. Under the agreement, Takeda will transfer all shares of Takeda Pharmaceutical Data Services, a wholly-owned subsidiary of Takeda, to PRA in the second quarter of 2017 with approximately 60 employees supporting Takeda Development Center Japan. The newly established joint venture will leverage its internal resources and expertise to manage a portfolio of studies for Takeda across Phase...
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Eisai has entered into a marketing and distribution agreement in China with Orion Corporation, an Espoo, Finland-headquartered, pharmaceutical company, for two of Orion’s Parkinson’s disease drugs, Comtan (entacapone) and Stalevo (levodopa/entacapone/carbidopa combination agent). Under the agreement, Eisai acquired from Orion the exclusive rights to market the two products in China and began distribution and promotion through its Chinese subsidiary, Eisai China. The two drugs expand Eisai’s portfolio of neurology products in China, which includes Eldepryl (monoamine oxidase inhibitor), for treating Parkinson’s disease, Aricept (donepezil...
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Janssen Biotech, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (J&J), has expanded its collaboration with X-Chem, a Waltham, Massachusetts-based privately owned biotechnology company, to discover new drug leads for treating inflammatory disease. The expanded deal builds on an existing discovery and license partnership that the companies entered into in December 2014, facilitated by Johnson & Johnson Innovation, the unit within J&J that focuses on accelerating innovation and forming collaborations between entrepreneurs and J&J’s global healthcare businesses. This latest agreement will apply to the DNA-encoded...
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Gilead Sciences has agreed to sell its aldehyde dehydrogenase 2 (ALDH2) inhibitor, a drug candidate with the potential to treat behavior and substance addictions, to Amygdala Neurosciences, a Palo Alto, California-based biopharmaceutical company focused on addiction disorders. The ALDH2 inhibitor drug candidate, GS-6637, is a Phase-II ready compound that modifies dopaminergic tone by preventing pathophysiologic dopamine surges and associated craving without changes to basal dopamine, according to Amygdala. The drug has the potential to be used as a pharmacotherapy for substance and behavior-based addictions. Financial terms of the transaction were not disclosed....
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Swedish Orphan Biovitrum (Sobi), a Stockholm, Sweden-headquartered specialty healthcare company, has elected to add a product candidate for the potential treatment of hemophilia B to the company’s collaboration agreement with Bioverativ, the Waltham, Massachusetts-headquartered company recently created from the spin-off of Biogen’s hemophilia business. Sobi has the right to include the product candidate, rFIXFc-XTEN fusion protein, into its collaboration agreement with Bioverativ. Sobi will make a one-time payment to Bioverativ for an opt-in right to participate in the final development and commercialization of this product candidate. The opt-in...
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Dr. Reddy’s Laboratories has expanded its commercial operations in Europe with the introduction of its generic drug portfolio in France, where the company plans to make its generic products available to the hospital market in March 2017. The company will supply generic oncology drugs and anti-infectives, including antimycotics, to hospitals in France. Dr. Reddy’s recently launched select products of its hospital portfolio in Italy and Spain and is looking to further strengthen its presence in the two countries with the launch of anti-HIV products this year. The company has a diversified portfolio of injectables and complex generics and has...
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Actavis Inc,, part of Teva Pharmaceutical Industries, has issued a Class II voluntarily recall of 499,320 units of glipizide extended-release tablets, 2.5 mg, a drug for treating Type 2 diabetes, due to failed dissolution specifications, specifically for being.above out of specification for the dissolution rate observed at the 10-hour testing point. Teva acquired Actavis Generics, the generics business of Allergan in 2016. The recall was initiated in January 2017. The recall was noted by the US Food and Drug Administration (FDA) on February 15, 2017. A Class II recall is a situation in which use of or exposure to a violative product may cause temporary...
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The US Food and Drug Administration (FDA) has posted a Warning Letter to Sato Pharmaceutical, a Tokyo-headquartered manufacturer of over-the-counter drugs, following an inspection of the company’s drug manufacturing facility in Tokyo for violations of current good manufacturing practice regulations for finished pharmaceuticals. The inspection occurred from February 8 to 12, 2016. The FDA noted that Sato failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas and failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products...
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A roundup of the latest market developments from the pipelines of the pharmaceutical majors and other related news, featuring news from Amgen and Pfizer. Editor's Note: This article is updated on a continuous basis for news announced from Wednesday February 15, 2017 to Tuesday February 21, 2017. Amgen Submits Supplemental Filing for Leukemia Drug Amgen has submitted a supplemental biologics license application (sBLA) to the US Food and Drug Administration (FDA) for Blincyto (blinatumomab) to include overall survival data from a Phase III study, supporting the conversion of Blincyto's accelerated approval to full approval. The sBLA also includes...
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