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. With the acquisition, the crop-science business will now be the largest piece of Bayer by revenue, eclipsing its pharmaceutical business, which accounted for nearly 50% of the company’s sales in 2017. Read More

GlaxoSmithKline (GSK) has completed its acquisition of Novartis’ 36.5% stake in the companies’ consumer healthcare joint venture for $13 billion, which grants GSK full ownership of the business. GSK and Novartis formed the joint venture in 2015. Read More

The FDA has approved Fulphila (pegfilgrastim-jmbd), a biosimilar to Amgen’s Neulasta (pegfilgrastim), from Mylan and Biocon, a Bangalore, India-based pharmaceutical company, for treating neutropenia after chemotherapy. Neulasta had 2017 global sales of $3.93 billion. Read More

The FDA has issued a Complete Response Letter to Amgen regarding its biologics license application for a biosimilar to Roche’s Herceptin (trastuzumab), a cancer drug with 2017 global sales of CHF 7.01 billion ($7.5 billion). Amgen is developing the biosimilar with Allergan. Read More

Fujifilm has completed its $800-million acquisition of cell-culture media companies, Santa Ana, California-based Irvine Scientific Sales Company and Tokyo-based IS Japan. The acquisitions are part of a strategy by Fujifilm to increase its position in biomanufacturing and related technologies. Read More

Gilead Sciences and Hookipa Biotech, a biopharmaceutical company developing immunotherapies for cancer and infectious diseases, have formed a research and license pact worth up to $410 million that grants Gilead rights to Hookipa's arenavirus vector-based immunization technologies for treating hepatitis B virus and HIV. Read More

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 matter on the syringe plunger. Read More

FDA Commissioner Scott Gottlieb has outlined further steps that the agency is considering to better address drug shortages, including increasing information-sharing requirements and requiring risk assessments in companies’ supply chains. Read More

The FDA has proposed changes to modernize the new drug regulatory program through process changes and organizational restructuring. Overall, the FDA estimates the changes will improve efficiency by at least 20% and better target resources for product reviews. Read More

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 the new business will focus on collaborating with research institutes and biotechnology firms for commercializing new drug candidates. Read More