Bio/Pharma News

AstraZeneca is seeking approval for its anti-cancer monoclonal antibody, Imfinzi, for treating non-small cell lung cancer in the European Union.

BARDA has entered a $12-million contract with biopharmaceutical firm Achaogen for the late-stage development of an antibiotic against resistant bacteria, and as a potential treatment for biowarfare agents.

Xellia Pharmaceuticals invests US$25 million in its Copenhagen, Denmark site to expand sterile manufacturing of products for treating antimicrobial resistant infections.

The company is considering options for a full or partial separation of its Consumer Healthcare business, either through a spin-off, sale, or other transaction.

Johnson & Johnson’s Janssen Sciences Ireland UC will invest more than EUR 300 million (US$355 million) to expand manufacturing capacity for biologic medicines at its Ireland facility.

Under Project BioShield, the agency could provide more than $170 million in funding to purchase and support late-stage development of Ebola vaccines and therapeutic drugs.

The Danish biotechnology company has been awarded a sole-source BARDA contract valued at more than $539 million for a freeze-dried smallpox vaccine.

The alliance gives Celgene an option to acquire programs run by Nimbus Therapeutics for developing therapeutics to treat autoimmune disorders.

A grant from the Bill & Melinda Gates Foundation will advance PnuVax’s pneumonia vaccine’s clinical development and biomanufacturing scale-up using a low-cost manufacturing approach.

Amgen will collaborate with China’s Simcere Pharmaceutical Group, a R&D-driven pharmaceutical company, to co-develop four biosimilars for the Chinese market.

AbbVie, Amgen, AstraZeneca, Bristol-Myerse Squibb, and Eli Lilly and Company said they are working to restore normal operations at their respective facilities and continuing recovery efforts.

FDA rejected the company’s biologics license application for its anti-rheumatoid arthritis biologic and has requested additional clinical safety data.

This latest FDA approval expands the blockbuster anti-cancer biologic’s indications in oncology.

Glythera gains exclusive access to Cancer Research UK’s novel CDK11 inhibitor program for the development of ADCs conjugated using its highly stable conjugation platform, PermaLink.

The collaboration will evaluate the combination of BMS’ Opdivo immunotherapy with an investigational antibody drug conjugate in development by AbbVie.

Under this partnership, Johnson & Johnson and BARDA will focus on the advanced development of a small-molecule drug and vaccine for the pandemic flu.

The partners will develop a lead anti-platelet, anti-coagulant (APAC) product for treating blood vessel wall injury. Clinical trials are set for 2019 in India.

The approval marks the first biosimilar approved in the United States for treating cancers.

European Medicines Agency’s Committee for Medicinal Products for Human Use grants a positive opinion for the approval of the biosimilar for treating breast cancer.

The meeting, to be held jointly with the European Centre for Disease Prevention and Control, is part of the agency’s effort to raise awareness about the threat of antimicrobial resistance.

Alexion’s restructuring will reduce its global workforce by 20%, including closing a manufacturing facility in Rhode Island.

J&J’s Janssen ends a 2015 collaboration with Achillion Pharmaceuticals with a strategic decision to discontinue further development of a hepatitis C therapy in favor of pursuing hepatitis B therapeutics.

The pharma major anticipates an annualized cost savings of roughly $500 million starting in 2018 based on a significant reduction in its global workforce.

As Merck KGaA continues its strategic shift into a science and technology company, it is considering options for its Consumer Health business, including a potential sale.

Merck KGaA completes the divestment of its biosimilars business as part of its strategy to focus on developing a pipeline of innovator drugs.

With this acquisition, Merck gains a lead anti-tumor drug candidate and a proprietary technology that can potentially induce immediate and long-term anti-tumor immunity.

Roche’s subsidiary, Genentech, issued the voluntary recall of the anti-stroke drug because of compromised vials containing sterile water that were packaged with the drug.

Pfizer’s Mylotarg, an anti-body drug conjugate once voluntarily withdrawn, returns to the market under a new dosing regimen for treating leukemia.

Novartis has appointed Dr. Vasant Narasimhan as CEO.

Bristol-Myers Squibb (BMS) and Daiichi Sankyo announced a collaboration to evaluate the combination of Opdivo (nivolumab) and antibody drug conjugate (ADC) DS-8201 for treating breast and bladder cancers.