News & Insights

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This year thus far has seen several high-profile deals and expansion moves in the contract development and manufacturing sector for drug products. So what moves should be on your radar? There have been several noteworthy moves shaping the competitive landscape of contract development and manufacturing organizations (CDMOs) and contract manufacturing organizations (CMOs) of drug products as well as excipient manufacturers. DCAT Value Chain Insights highlights the top 10 moves thus far in 2017. The top 10 moves thus far in 2017 1. Thermo Fisher’s $7.2-billion acquisition of Patheon. Among the largest deals in the market for formulation development ...
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Piramal Pharma Solutions, part of Piramal Enterprises, has appointed John Fowler as its chief operating officer. As chief operating officer, Fowler will be responsible for global operations and research and development. Most recently, Fowler served as the divisional chief executive officer of the Global Fine Chemicals business at Johnson Matthey (JM). There, he had responsibility for JM's Services (custom active pharmaceutical ingredient development, manufacturing, catalyst & chiral technologies), and products (generics development and manufacturing) portfolio. Before leading JM's Fine Chemical Division, Fowler held senior leadership roles in several business ...
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Bormioli Rocco Pharma, a Fidenza, Italy-headquartered glass and plastic manufacturer, is strengthening its services in North America for pharmaceutical glass packaging with a dedicated sales team and with innovative products, particularly for parenteral drugs. The company is making its Delta-molded Type I glass vials and complete line of glass and plastic containers and closures available in North America. Bormioli Rocco Pharma’s Delta molded glass vials are available in multiple sizes and capacities for pharmaceutical injectables. Delta products seek to offer hydrolytic resistance and internal surface homogeneity to protect against delamination and ensure ...
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Kaneka Eurogentec, a Liège Belgium-headquartered contract development and manufacturing organization, has approved the construction of a new GMP biomanufacturing facility adjacent to its current facility and equipped with a 2,200-liter fermenter. The expansion will allow for the large-scale production of biopharmaceuticals, including recombinant proteins, antibody fragments, and plasmid DNA. The multi-product facility will include the capability for large-scale production using Eurogentec technologies such as the production of x proteins by secretion from yeasts and the production of kilo-scale plasmid DNA for viral and non-viral gene and cell therapies. ...
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Fujifilm Diosynth Biotechnologies, a contract development and manufacturing organization of biologic-based drug substances, has opened its 10,000-square foot, cell-culture process development laboratories in Wilton Center, Teesside, England. These laboratories were realized through a 1 billion JPY ($9 million) investment, which is part of the greater 14 billion JPY ($130 million) expansion previously announced by Fujifilm Corporation in April 2017. A grant from Let’s Grow, which is part of The Regional Growth Fund, a venture capital firm in England, also contributed to the overall investment as part of Fujifilm Diosynth Biotechnologies’ continued growth in ...
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Emergent BioSolutions, a specialty pharmaceutical company and contract manufacturing organization, has been awarded a contract valued at approximately $63 million by the US Department of Health and Human Services’ Biomedical Advanced Research and Development Authority to develop an antidote spray device for treating known or suspected acute cyanide poisoning. The single-use intranasal spray device will deliver a stabilized form of isoamyl nitrite (SIAN) and is intended for use by first responders and medical personnel following a cyanide incident. Under the five-year contract, Emergent will work together with Southwest Research Institute, a San Antonio, ...
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CordenPharma, a contract development and manufacturing organization of drug substances and drug products, has completed an early-development suite for highly potent, oral solid dosage products at its site in Plankstadt, Germany. The new facility allows for the production of small batches, from 100 g to approximately 1,000 g. CordenPharma Plankstadt’s setup has engineering controls to allow for the production of compounds with various potencies and degrees of containment. All steps can be performed, starting from dispensing to film coating, in an engineering controlled environment. CordenPharma Plankstadt, located near Heidelberg, Germany, provides development ...
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Recipharm, a Swedish contract development and manufacturing organization, and Clinical Trial Consultants (CTC), a contract research organization, have partnered to launch a new service, Pathway to Clinic, which is designed to deliver a streamlined pathway to first-in-human milestones. Recipharm Pathway to Clinic takes projects from early-phase formulation development through to clinical trial implementation. Recipharm performs formulation development, GMP clinical supply manufacture, and bioanalysis from its development sites in Solna and Uppsala, Sweden. CTC supports customers with hospital-based early-phase (0/I/IIa) clinical trials, including patient recruitment, ...
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Recipharm, a Swedish contract development and manufacturing organization, and Kancera, a Swedish biotechnology company focused on cancer therapy, have signed a contract for the development and manufacture of Kancera’s pharmaceutical candidate, KAND567, which is being developed for counteracting the onset of autoimmune disorders as well as neuritis and pain in connection with chemotherapy against cancer. As part of the collaboration, Recipharm will develop the preparation that is required for release of KAND567 from capsules as well as manufacturing the pharmaceutical product. The work will be performed at Recipharm’s development facility in Solna, Sweden. ...
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Catalent Pharma Solutions is investing $5.5 million at its 200,000+ square foot site in Philadelphia, Pennsylvania, to expand clinical packaging and storage capacity. The 22,000-square foot expansion will see a 40% increase in pallet space for both refrigerated and ambient storage; the addition of multiple cold-chain packaging areas; and a new clinical label control area. The building will also feature a new environmental monitoring and building management system that is being installed at the Philadelphia site. All work is scheduled to be completed and validated by November 2017. Source: Catalent Pharma Solution
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Johnson Matthey (JM) and Snapdragon Chemistry, a Cambridge, Massachusetts-headquartered provider of flow-chemistry process design and technology development services, have formed a collaboration to provide integrated continuous manufacturing services for flow chemistry from development to full-scale good manufacturing practice (GMP) manufacturing. The collaboration is designed to enable an end-to-end offering that can provide process development and manufacturing services from flow-chemistry route conception to GMP bulk production. The agreement combines Snapdragon Chemistry’s flow chemistry design, development, and characterization capabilities with JM’s ...
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Catalent has agreed to acquire Cook Pharmica, a Bloomington, Indiana-based contract development and manufacturing organization (CDMO), for $950 million.  Cook Pharmica is a CDMO of biologic-based drug substances and parenteral drug products. The purchase price is $950 million, with $750 million to be paid at closing and the balance to be paid in equal installments, without interest, on each of the next four anniversaries of the closing. Catalent says the acquisition will help the company in the area of biologics development and analytical services, manufacturing, and finished product supply. Cook Pharmica has capabilities in biologics development, clinical ...
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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 Samsung Bioepis, Tesaro, Johnson & Johnson, Teva Pharmaceutical Industries, GlaxoSmithKline, Astellas, and Bayer.  Editor's Note: This article was updated on a continuous basis for news announced from Wednesday, September 13, 2017 to Tuesday, September 19, 2017. EMA Advisory Committee Gives Positive Opinion on Samsung Bioepis’ Herceptin Biosimilar The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on a biosimilar candidate referencing Roche’s ...
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A roundup of the latest drug approvals, including from the pharmaceutical majors, featuring news from Bayer. Editor's Note: This article was updated on a continuous basis for news announced from Wednesday, September 13, 2017 to Tuesday, September 19, 2017. Bayer Receives FDA Approval for Lymphoma Drug The US Food and Drug Administration (FDA) has approved Bayer’s Aliqopa (copanlisib), 60-mg vial for injection, as a new molecular entity for treating adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies. Copanlisib is an intravenous phosphatidylinositol-3-kinase (PI3K) inhibitor with inhibitory ...
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Immunocore, a Milton, England-headquartered biotechnology company focused on immunotherapy, has received funding from the Bill & Melinda Gates Foundation to support the development of Immunocore’s soluble T-Cell Receptor (TCR)-based therapeutics for infectious diseases. The Bill & Melinda Gates Foundation will invest up to $40 million in Immunocore to support development of Immunocore’s ImmTAV (Immune mobilizing monoclonal TCRs Against Virus) and ImmTAB (Immune mobilizing monoclonal TCRs Against Bacteria) therapeutics. The collaboration will discover and develop ImmTAV and ImmTAB molecules for treating tuberculosis and human immunodeficiency virus. Immunocore ...
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Halozyme Therapeutics, a San Diego, California-headquartered biopharmaceutical company, has partnered with Bristol-Myers Squibb (BMS) and Roche respectively in two drug-delivery pacts. In the first deal, Halozyme has partnered with BMS to develop subcutaneously administered BMS immuno-oncology medicines using Halozyme’s Enhanze drug-delivery technology. In a separate move, Halozyme has also licensed its Enhanze drug-delivery technology to Roche for exclusive development of an undisclosed therapeutic target. The Halozyme Enhanze technology is based on a proprietary recombinant human hyaluronidase enzyme (rHuPH20) that temporarily degrades hyaluronan -- ...
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Aspen Global Incorporated (AGI), part of the Aspen Group, has agreed to acquire the residual rights to AstraZeneca’s anesthetic medicines in a deal worth up to $770 million. These medicines include: Diprivan (propofol), EMLA (lidocaine 2.5% and prilocaine 2.5%), Xylocaine/Xylocard/Xyloproct (lidocaine HCl), Marcaine (bupivacaine hydrochloride), Naropin (ropivacaine Hcl), Carbocaine (mepivacaine), and Citanest (prilocaine). AsraZeneca entered into an agreement with AGI in June 2016, under which AGI gained the exclusive commercialization rights to the medicines in markets outside the US. Under the new agreement, AGI will acquire the remaining rights to the ...
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US Congressman Lloyd Doggett (D-TX) and eight other Democrats in the US House of Representatives have written a letter to the US Centers for Medicare and Medicaid Services (CMS) asking for information on its outcomes-based payment approach for Novartis’ new chimeric antigen receptor T-cell (CAR-T) treatment, Kymriah (tisagenlecleucel). The drug was   approved   in September 2017 for treating certain pediatric and young adult patients with a form of acute lymphoblastic leukemia. In support of the product, Novartis formed a collaboration with the CMS focused on improving efficiencies in current regulatory requirements to deliver value-based care and ensure ...
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Teva Pharmaceutical Industries has agreed to sell the remaining assets of its specialty global women’s health business for $1.38 billion. Proceeds from these sales, combined with proceeds from the recently announced sale of its contraceptive, Paragard (intrauterine copper contraceptive), total $2.48 billion and will be used by Teva to progress repayment of term loan debt. Under the agreement, CVC Capital Partners Fund VI will acquire a portfolio of products within Teva’s global women’s health business across contraception, fertility, menopause, and osteoporosis for $703 million in cash. The portfolio of products, which is marketed and sold outside the US, ...
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The Subcommittee on Health of the US House of Representatives’ House Energy & Commerce Committee held a hearing to examine draft legislation for establishing an over-the-counter (OTC) monograph user-fee program at the US Food and Drug Administration (FDA). The program, subject to Congressional authorization, would provide funding to supplement Congressional non-user-fee appropriations and support FDA review of the efficacy and safety of ingredients included in or proposed for inclusion in OTC monographs. In August 2017, the FDA released draft goals and procedures for the potential program. The subcommittee reviewed draft legislation, the Over-the-Counter ...
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