Amneal Pharmaceuticals and Impax Laboratories have closed on their previously announced business combination to form what the companies say is now the fifth largest generic-drug company in the US. Following the close of the deal, the combined company announced plans to close facilities and operations in Hayward, California. Read More

Kite Pharma, Gilead Sciences’ cell-therapy subsidiary, has leased and purchased new facilities in the US and Europe to expand its cell-therapy manufacturing capabilities. Read More

The FDA has approved Pfizer’s Retacrit (epoetin alfa-epbx), a biosimilar to Amgen’s Epogen (epoetin alfa) and Johnson and Johnson’s Procrit/Eprex (epoetin alfa) for treating anemia. Epogen had 2017 global sales of $1.1 billion, and Procrit/Eprex had 2017 global sales of $972 million. Read More

At a recent investors' meeting on May 16, Novartis CEO Vas Narasimhan highlighted the company’s growth strategy, which includes 10 potential blockbuster launches in the next three years, further investment in gene therapy and oncology products, an increased focus on digital technologies, and improving profitability for Sandoz, its generics arm. Read More

WuXi Biologics, part of WuXi AppTec, a contract service provider, plans to build an integrated biologics development, clinical, and commercial manufacturing center in Shijiazhuang, Hebei province, North China. The initial phase of the center will be operational in 2020. Read More

Eli Lilly and Company has agreed to acquire AurKa Pharma, a Montreal, Quebec-based special-purpose company created to develop an oncology drug, a kinase Aurora inhibitor that it previously acquired from Lilly, in a deal worth up to $575 million. Read More

In a speech on May 11, President Donald Trump highlighted his plan for addressing drug pricing in the US by increasing drug competition. Some measures include speeding up the approval process for over-the-counter products, requiring price disclosures in commercials, and addressing patent protection. He also discussed giving Medicare Part D plans new tools to negotiate lower prices. Read More

Fujifilm Holdings has agreed to acquire its remaining stake in Toyama Chemical, a company developing small-molecule pharmaceuticals, to give it full ownership. Fujifilm is acquiring the remaining stake from Toyama Chemical’s parent company, Taisho Pharmaceutical Holdings, which currently owns 34% of the company while Fujifilm now owns 66%. Read More

FDA Commissioner Scott Gottlieb outlined FDA's plan to increase access of samples of branded drugs needed by generic-drug developers for testing. Its measures include increasing transparency and reforming elements of the Risk Evaluation and Mitigation Strategy system. Read More

The FDA has published a proposed rule to amend its regulations concerning the classification of products as biological products, devices, drugs, or combination products and their assignment to agency components for premarket review and regulation. Read More