Sanofi has completed its $4.8-billion acquisition of Ablynx, a Ghent, Belgium-based biopharmaceutical company developing proprietary therapeutic proteins based on single-domain antibody fragments. Sanofi says the acquisition continues its focus on technologies addressing multiple disease targets with single multi-specific molecules. Read More

Roche has agreed to acquire full ownership of Foundation Medicine, a molecular information company, by acquiring the outstanding shares not already owned by Roche for approximately $2.4 billion. Roche now owns more than 50% of the company. Read More

Celltrion, an Incheon, South Korea-based biopharmaceutical company of biosimilars and innovator drugs, has resubmitted a biologics license application to the FDA for its biosimilar candidate that references Roche’s Herceptin (trastuzumab), a cancer drug. Herceptin had 2017 global sales of CHF 7.01 billion ($7.5 billion). Read More

The European Medicines Agency (EMA) has updated two guidances designed to help pharmaceutical companies prepare for the UK's withdrawal from the European Union (i.e., Brexit). Read More

A federal US district court has granted Indivior, a UK-based pharmaceutical company, a temporary restraining order that compels Dr. Reddy’s Laboratories to cease launch activities related to its generic of Indivior’s Suboxone Film (buprenorphine and naloxone), a drug for treating opioid dependence. The FDA approved generics of Suboxone to Dr. Reddy’s and Mylan in June 2018.  Read More

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 aspects of the generic-drug review process. Read More

A bipartisan group of 31 senators has asked FDA Commissioner Scott Gottlieb to have the agency's Drug Shortage Task Force provide recommendations to Congress on how to address nationwide drug shortages by no later than the end of 2019. Read More

The FDA has provided an update on how the agency is addressing drug shortages for what it considers “critical” products, including saline, opioid analgesics, and EpiPen, Mylan’s self-injectable epinephrine product used for emergency-care situations. Read More

WuXi Biologics, part of WuXi AppTec, a Shanghai, China-headquartered contract service provider, has begun construction of an antibody-drug conjugate (ADC) service center in Wuxi, China. The facility is scheduled to be operational in 2019. Read More

Novacap, a Lyon, France-headquartered company providing custom manufacturing services for pharmaceuticals, advanced specialties and cosmetics, has agreed to acquire PCI Synthesis, a CDMO of small-molecule active pharmaceutical ingredients.  Read More