Bayer has obtained approval from the US Department of Justice for its proposed $66-billion acquisition of Monsanto, an agrochemical and seed company, conditioned upon certain divestments worth up to $9 billion. The company expects to receive other outstanding approvals required for completing the deal very shortly and to complete its divestments within two months. Read More

The European Commission (EC) has approved Zessly (infliximab), a biosimilar of Johnson & Johnson’s (J&J) Remicade (infliximab), an anti-inflammatory drug, from Novartis’ Sandoz. Remicade had 2017 global sales of $6.3 billion. Read More

Allergan said it plans to sell its women’s health and infectious disease businesses following a strategic review and will focus on four main therapeutic areas (medical aesthetics, central nervous system, eye care, and gastrointestinal). Read More

Avara Pharmaceutical Services has agreed to acquire Novartis’ sterile manufacturing facility and the adjacent Sandoz Development Center in Boucherville, Quebec. Read More

Celltrion has resubmitted a biologics license application (BLA) to the FDA for its biosimilar of Roche’s Rituxan (rituximab) and plans to resubmit a BLA for a biosimilar of Roche’s Herceptin (trastuzumab) following progress in addressing manufacturing issues at the plant producing the drugs. Read More

WuXi Biologics, part of WuXi AppTec, a Shanghai-headquartered contract service provider, plans to invest 80 million Singapore dollars (US $60 million) to build a biologics manufacturing facility in Singapore. It will be WuXi Biologics’ tenth global drug-substance manufacturing facility. Read More

The US Senate Committee on Health, Education, Labor and Pensions plans to hold a hearing on June 12 with Secretary of the Department of Health and Human Services Alex Azar to examine President Donald Trump’s blueprint for reducing the cost of prescription drugs. Read More

The FDA has issued draft guidances to improve the Risk Evaluation and Mitigation Strategy (REMS) process to facilitate generic-drug development and approval. Read More

In preparation for the UK’s exit of the European Union (EU) (i.e., Brexit), the European Medicines Agency (EMA) has begun construction for its new headquarters building in Amsterdam. Read More

Alcami, a CDMO of active pharmaceutical ingredients and drug products, has agreed to be acquired by Madison Dearborn Partners, LLC (MDP), a Chicago-based private-equity firm. MDP will acquire a majority ownership position in Alcami from existing shareholder Ares Capital Corporation. Read More