Biopharma News

Merus announced new investors and the sale of $80.5 million in shares to advance its immuno-oncology programs.

Pfizer agrees to divest four sterile injectable assets to clear the way to complete acquisition of Hospira.

Biopharmaceutical company BeiGene plans to build facility in Suzhou to expand its clinical capability and prepare for commercial manufacturing.

The acquisition occurs one day after FDA approval of Sprout’s Addyi, the first medication to treat hypoactive sexual desire disorder in women.

Novartis will develop AVEO’s AV-380, an investigational humanized antibody targeting growth differentiation factor 15.

Licenses could potentially bring antibody R&D to areas beyond oncology, such as diabetes treatments

The company is in discussions with Europe’s Adaptive Pathways Group on clinical trials that would evaluate its PLX cells for the treatment of specific diseases.

Deal includes rights to Inovio’s INO-3112 HPV cancer vaccine and preclinical collaboration to develop additional cancer vaccine candidates.

Flexion will have a dedicated manufacturing suite at Patheon's Swindon, England facility for Flexion's osteoarthritis injectable steroid drug product.

US generics manufacturer Amneal acquires a former J&J plant in Ireland.

Shire takes its offer for an all-stock transaction to combine with Baxalta to shareholders after Baxalta declines to discuss the proposal.

The agreement gives Merck a non-exclusive license to use Codexis’ proprietary CodeEvolver protein engineering platform technology to develop novel enzymes for use in the manufacture of Merck’s pharmaceutical products.

ARGX-110-based combination therapies have demonstrated potential in treatment-resistant cancers.

Financial expectations for Baxter’s biopharma solutions arm will drop 10% as the result of a client’s decision to move its manufacturing in house.

A broad indication for GSK’s investigational mAb mepolizumab, coupled with an upcoming FDA decision date, could give the manufacturer a competitive advantage in the biologic asthma market.

The collaboration will focus on advancing bi-specific antibodies that target hematologic and solid cancers, either as monotherapies or in combination regimens with other immune modulating treatments.

A new study published in JAMA Internal Medicine found that manufacturers do not report a portion of adverse events to FDA within the federally mandated time frame of 15 days.

Will AbbVie stave off biosimilar competitors by following Teva’s model for Copaxone?

FDA approved the drug for a more narrow indication in the US than did EMA for Repatha, Praluent’s fiercest competitor.

 Teva announced that it has signed a definitive agreement to acquire the generic-drug business of Allergan in a transaction valued at $40.5 billion. The deal is expected to close in the first quarter of 2016.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has announced a positive scientific opinion for GlaxoSmithKline’s (GSK’s) malaria candidate vaccine Mosquirix (RTS,S) for use outside of the European Union (EU) in children aged 6 weeks to 17 months.

MedImmune will provide funding and in-kind contributions to support University of Sheffield research projects to address key challenges in cell engineering.

The PD-1 inhibitor was approved as a first-line therapy and for previously treated patients with advanced melanoma.

The decision makes Bristol-Myers Squibb’s therapy the first PD-1 checkpoint inhibitor approved in Europe.

Amgen says the approval makes Repatha the first PCSK9 inhibitor to be approved in the world.

Biogen will take ownership of Eisai's Research Triangle Park manufacturing campus and will manufacture both oral solid-dose and parenteral drugs for Eisai.

A Federal circuit appeals court ruled that a biosimilar manufacturer will have to wait 6 months after FDA approval to commercially launch its medication.

Baxter has initiated a voluntary recall of two lots of IV solutions due to the potential presence of particulate matter.