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Amgen’s biosimilar to AbbVie’s Humira (adalimumab) is the first inflammation biosimilar from Amgen's portfolio to launch in Europe.

Novartis’ Sandoz has reached a global patent resolution for Hyrimoz (adalimumab), its biosimilar to AbbVie’s Humira (adalimumab).

The companies will develop and commercialize ARO-HBV, a Phase I/II subcutaneous, ribonucleic acid interference therapy candidate being investigated for the treatment of chronic hepatitis B viral infection.

Novartis will sell selected portions of its Sandoz United States portfolio to Aurobindo Pharma USA for $900 million in cash, plus $100 million in potential earn-outs.

Guidances for regulatory changes, batch testing, and reporting address situations resulting from “no-deal” Brexit scenario.

As a contingency against border delays resulting from a “no-deal” Brexit, the Department of Health and Social Care (DHSC) directs pharma companies to stock extra medicines.

The new drug, Onpattro (patisiran), by Alnylam Pharmaceuticals, is in a new class of drugs called small interfering ribonucleic acid (siRNA) treatment.

The European Medicines Agency (EMA) will temporarily scale back activities as it copes with “significant staff loss” and prepares for the next phase in its continuity plan.

The company has run into a snag in producing Kymriah for the diffuse large B-cell lymphoma patient population, the second indication for which the therapy was recently approved by FDA.

In launching FDA’s Biosimilar Action Plan, Gottlieb takes innovator companies to task for delaying competitive biosimilar products.

The agency is releasing six new draft guidances to provide a regulatory framework for handling gene therapies.

The company has received clearance from the United States Federal Trade Commission for the proposed acquisition of Shire, a deal valued at $62 billion.

Pfizer creates separate business units for innovator medicines, generic drugs, and consumer products.

Biogen will pay Samsung BioLogics approximately $700 million to increase its stake in Samsung Bioepis to approximately 49.9%.

The pharma major intends to spinoff Alcon as a stand-alone eye-care devices company.

Strategic restructuring is designed to position GE Healthcare as a pure-play healthcare company.

GW Research’s Epidiolex, which treats two forms of epilepsy, receives FDA’s approval; spurs FDA reminders about unapproved products.

The acquisition is expected to strengthen Sanofi’s R&D strategy with Ablynx’s nanobody technology platform.

The acquisition is expected to strengthen Roche’s personalized healthcare strategy.

Bayer completed its acquisition of Monsanto, the largest in Bayer’s history.

Bayer received conditional approval from the Antitrust Division of the United States Department of Justice to acquire Monsanto in a deal worth $66 billion.

The acquisition is expected to strengthen Novartis’ gene therapy pipeline.

Eli Lilly will acquire ARMO BioSciences to strengthen Lilly's immuno-oncology program.

President Donald Trump announced his strategy for making prescription medicines more affordable and accessible in the United States.

Johnson & Johnson’s Janssen Biotech will acquire biotechnology company BeneVir Biopharm to strengthen Janssen’s immunotherapy platform.

Takeda expands its global and therapy base with announced acquisition of Shire.

Smaller review divisions will bring experts closer to decision processes and reduce bottlenecks, FDA leaders say.

Fresenius Kabi claims that Akorn failed to fulfill several closing conditions.

Global investment firm Advent to acquire and invest in Sanofi’s European generics business, Zentiva, to boost its position in European market.

The transaction is part of Merck KGaA’s strategy to actively shape its product portfolio and focus on innovation-driven business.