FTC Requests Additional Info in Roche’s $4.3-Billion Acquisition of Spark Therapeutics
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Roche and Spark Therapeutics, a commercial gene-therapy company based in Philadelphia, have received a request for additional information from the US Federal Trade Commission (FTC) regarding Roche’s pending $4.3-billion acquisition…

Otsuka Chemical Acquires Cefixime API Assets from Astellas Pharma
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Otsuka Chemical, a manufacturer of chemicals, has agreed to acquire certain assets from Astellas Pharma relating to the active pharmaceutical ingredient (API), cefixime, a cephalosporin antibiotic. Under the agreement, Otsuka…

Luxembourg, Netherlands Join EU-US Mutual Recognition Agreement for GMP Inspections
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Luxembourg and the Netherlands have joined the mutual recognition agreement between the European Union (EU) and the US Food and Drug Administration (FDA) for good manufacturing practice (GMP) inspections. The…

Krigen Pharmaceuticals Invests $7 Million in US Injectables Mfg Facility
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Krigen Pharmaceuticals, a privately held Indian pharmaceutical company, is investing $7 million in a new US manufacturing facility in Lillington, North Carolina. Krigen will manufacture IV bags and liquid injectables…

FDA Approves Roche’s Antibody Drug Conjugate Cancer Drug Polivy
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The US Food and Drug Administration (FDA) has approved Roche’s Polivy (polatuzumab vedotin-piiq) to treat adult patients with diffuse large B-cell lymphoma (DLBCL) that has progressed or returned after at…

Athenex Suspends Production at API Plant in China
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Athenex, a pharmaceutical company specializing in the discovery, development and commercialization of cancer therapies, has voluntarily suspended production activities at its active pharmaceutical ingredient (API) plant in China.   The…

Merck & Co. Agrees To Acquire Tilos Therapeutics For $773 Million
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Merck and Co. has agreed to acquire Tilos Therapeutics, a biopharmaceutical company developing therapeutics targeting the latent TGFβ complex against cancer, fibrosis and autoimmune diseases, in a deal valued up…

Sanofi CEO To Retire; Novartis Pharma Head Named New CEO
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Sanofi has announced that its current Chief Executive Officer (CEO) Olivier Brandicourt plans to retire, effective September 1, 2019, and has named Paul Hudson, most recently head of Novartis Pharmaceuticals,…

Biogen Acquires Nightstar Therapeutics for $800 Million
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Biogen has completed its previously announced acquisition of Nightstar Therapeutics (NST), a clinical-stage gene therapy company based in London, for a total transaction value of approximately $800 million, taking into…

Fujifilm To Invest $10 Million in Continuous Bioprocessing
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Fujifilm Corporation has announced an initial $10-million investment in a full-scale, fully integrated continuous processing facility for non-GMP manufacturing of biopharmaceuticals at the Billingham, UK site of Fujifilm Diosynth Biotechnologies,…