Biopharma News

ABP 215, an investigational biosimilar for Avastin, was shown to be as safe and effective as its branded counterpart in trials for the treatment of advanced non-squamous non-small cell lung cancer.

The fully humanized monoclonal antibody is licensed to Bristol-Myers Squibb.

Under terms of the agreement, Amgen will license Xencor’s XmAb technology platform for five Amgen programs and one Xencor program.

Novovax’s investigational vaccine targeting respiratory syncytial virus (RSV) demonstrated clinical effectiveness in animal models.

Nexvet Biopharma, a veterinary biologics developer, secured a dedicated, cGMP biologics manufacturing facility in Tullamore, Ireland, and plans to invest in disposable technology.

Daiichi Sankyo signed an exclusive licensing agreement with clinical-stage biopharmaceutical company Translational Sciences to develop and commercialize its novel thrombus (blood clot) dissolving agent, TS23.

According to AstraZeneca, the purchase of the biologics bulk plant will double the company's biologics manufacturing capacity in the US.

Aragen Bioscience has licensed ProteoNic Biotechnology’s 2G UNic recombinant protein production technology, which increases manufacturing efficiency and reduces cost of goods for recombinant biologicals.

The investigational monoclonal antibody targets interleukin-17 and is in clinical trials for the treatment of plaque psoriasis.

When should CMOs and their pharma clients share the details of their partnerships with outside parties?

The drug was the first PCSK9 inhibitor approved in Europe and the second approved in the US.

GSK announces plan to divest its rights in ofatumumab for auto-immune indications for up to $1 billion.

The company announced plans to begin PIONEER, a Phase IIIa program comprising seven trials of approximately 8000 people with type 2 diabetes.

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.

The company’s purification platform is thought to reduce the number of purification steps that are currently required for the manufacture of complex therapeutics.

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.