Biogen To Acquire Phase II Stroke Drug in $357-Million Deal
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Biogen has formed an option agreement with TMS Co., a Tokyo-headquartered clinical-stage biopharmaceutical company, to acquire TMS’ investigational Phase II drug for post-stroke treatment as well as backup compounds in…

Emergent To Invest $50 Million To Expand Fill/Finish Facility
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Emergent BioSolutions, a Gaithersburg, Maryland-headquartered specialty pharmaceutical company and contract manufacturer, has started a $50-million expansion to the company’s fill / finish facility in Baltimore, Maryland. The multi-year expansion is…

Sanofi Pasteur, Translate Bio Form $805-Million mRNA Vaccine Pact
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Sanofi Pasteur, Sanofi’s vaccines global business unit, and Translate Bio, a clinical-stage messenger RNA (mRNA) therapeutics company, have formed a multi-year research and development (R&D) pact and licensing deal to…

Fujifilm Completes $800-Million Acquisition of Two Cell-Culture Media Companies
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Fujifilm has completed its $800-million acquisition of two cell-culture media companies, Santa Ana, California-based Irvine Scientific Sales Company (ISUS) and Tokyo-based IS Japan (ISJ). Fujifilm agreed to acquire the two…

Celltrion Launches Biologics CDMO Business
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Celltrion, an Incheon, South Korea-based biopharmaceutical company of biosimilars and innovator drugs, plans to launch a contract development and manufacturing business, Bio CDMO.   Celltrion says that Bio CDMO will handle…

FDA Posts ICH Q12 for Managing Post-Approval CMC Changes
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The FDA has made available a draft guideline by the International Council for Harmonization (ICH), Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management, which seeks to facilitate the…

Pfizer’s Hospira Recalls Two Lots of Opioid Overdose Antidote Naloxone
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Hospira, a Pfizer company, is voluntarily recalling two lots of naloxone hydrochloride injection, an opioid antagonist, to the hospital/institution level due to the potential presence of embedded and loose particulate…

Gilead Sciences, Hookipa in $410-Million Immunotherapy Deal for HIV, Hepatitis B
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Gilead Sciences and Hookipa Biotech, a Vienna, Austria-headquartered biopharmaceutical company developing immunotherapies for cancer and infectious diseases, have formed a research and license pact worth up to $410 million that…

Two More EU Countries Join EU-US Mutual Recognition Agreement
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Lithuania and Ireland have joined the countries participating in a mutual recognition agreement (MRA) for good manufacturing practice (GMP) inspections between the US and European Union (EU). There are now…

Mylan, Biocon, Lilly Lead Drug Approval News
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A roundup of the latest drug approvals, including from the pharmaceutical majors, featuring news from Mylan, Biocon, and Eli Lilly and Company. Editor’s Note: This article was updated on a continuous…