The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.
Oncobiologics, a Cranbury, New Jersey-based biopharmaceutical company developing monoclonal antibody (mAb) biosimilars, has launched a contract development and manufacturing (CDMO) business. It further formed a master services agreement (MSA) with...
Celltrion, an Incheon, South Korea-based biopharmaceutical company of biosimilars and innovator drugs, has resubmitted a biologics license application (BLA) to the US Food and Drug Administration (FDA) for its biosimilar candidate that references...
Glenmark Pharmaceuticals, a Mumbai, India-headquartered pharmaceutical company, has received approval of its first abbreviated new drug application by the US Food & Drug Administration (FDA) made at the company’s new manufacturing facility in...
Pacira Pharmaceuticals, a Parsippany, New Jersey-based specialty pharmaceutical company, and Nuance Biotech, a Shanghai, China-based specialty pharmaceutical company, have formed an agreement to develop and commercialize Exparel (bupivacaine...
Sanofi has completed its $4.8-billion acquisition of Ablynx, a Ghent, Belgium-based biopharmaceutical company focused on developing and commercializing proprietary therapeutic proteins based on single-domain antibody fragments. The deal was...
Roche has agreed to acquire full ownership of Foundation Medicine’ a Cambridge, Massachusetts-based molecular information company, by acquiring the outstanding shares not already owned by Roche for approximately $2.4 billion. Roche now owns more...
US Food and Drug Administration (FDA) Commissioner Scott Gottlieb issued a statement to highlight President Donald Trump’s fiscal year 2019 budget request for the FDA that includes funding of $37.6 million to fund two initiatives to modernize...
A federal US district court has granted Indivior, a Slough, UK-headquartered pharmaceutical company, a temporary restraining order (TRO) that compels Dr. Reddy’s Laboratories to immediately cease launch activities related to its generic...
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...
