The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.
The US Senate Committee on Health, Education, Labor and Pensions (HELP) held a hearing this week (June 12, 2018) with Secretary of the Department of Health and Human Services (HHS) Alex Azar to examine President Donald Trump’s blueprint, announced...
Johnson & Johnson (J&J) has agreed to sell its LifeScan business, a diabetes-care unit, to Platinum Equity, a private investment firm, for approximately $2.1 billion by accepting the binding offer for the business made by Platinum Equity in...
The US Food and Drug Administration (FDA) has issued an Establishment Inspection Report (EIR) to Sun Pharmaceutical Industries, a Mumbai, India-headquartered pharmaceutical company, for Sun Pharmaceutical’s injectables facility in Gujarat, India...
Alexion Pharmaceuticals, a New Haven, Connecticut-based pharmaceutical company, and Complement Pharma, a pharmaceutical company headquartered in Amsterdam, the Netherlands, have partnered to co-develop Complement Pharma’s preclinical C6 complement...
The US Food and Drug Administration (FDA) has issued one of four planned draft guidances to describe how patient-experience data and other information from patients and caregivers can be collected and used for medical-product development and...
US Food and Drug Administration (FDA) Commissioner Scott Gottlieb has outlined steps the agency is taking to advance value-based healthcare by advancing medical product communications through the issuance of two final guidance documents.
The...
A roundup of the latest drug approvals, including from the pharmaceutical majors, featuring news from Roche, AbbVie, AstraZeneca, and Amgen.
Editor's Note: This article was updated on a continuous basis for news announced from Wednesday June...
A roundup of the latest market developments from the pipelines of the pharmaceutical majors, featuring news from Pfizer.
Editor's Note: This article was updated on a continuous basis for news announced from Wednesday, June 6, 2018 to Tuesday, June...
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 a deal worth up to $357...
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...
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 develop mRNA vaccines for...
Bayer has completed its $63-billion acquisition of Monsanto, an agrochemical and seed company, ending a two-year effort to acquire the company and marking the largest acquisition in Bayer’s history. It is also cements Bayer's strategic shift to...
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 companies in April...
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 outsourcing of...
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 management of...
