Biopharma News

Pii is now responsible for commercial drug product production of fulvestrant, a breast cancer drug, while Sagent Pharmaceuticals, its abbreviated new drug application holder, will sell, market, and distribute the drug product in the United States.

The companies will focus on identifying peptides applicable to the affinity chromatography process used in the purification of biopharmaceuticals.

FDA has approved Novo Nordisk’s Rybelsus (semaglutide), a glucagon-like peptide receptor protein treatment in oral tablet form for type 2 diabetes.

The Committee for Medicinal Products for Human Use of the European Medicines Agency has granted a positive opinion recommending marketing authorization for Bavencio (avelumab) in combination with axitinib for treating kidney cancer.

In parallel to the priority review designation for its biologics license application, Merck plans to scale up its doses of the investigational Ebola vaccine to meet global outbreak response needs.

The company will supply its heparin sodium injection in prefilled syringe form.

The Phase III clinical studies for the drug candidate, elenbecestat, were discontinued based on a recommendation by a data safety monitoring board.

The acquisition gives PPF a 19.2% stake in Autolus and provides a pipeline of cell therapy product candidates.

The acquisition will enhance Lundbeck’s brain disease therapy portfolio as well as its antibody process and development capabilities.

The companies aim to integrate glucose sensing with insulin delivery technologies to help change the way diabetes is managed.

TrakCel and McKesson have formed a collaboration that is aimed at accelerating commercialization of cell and gene therapies by leveraging services to enable a more efficient development pathway.

FDA approved the drug after a successful open-label study of children aged six to 11 years and living with the condition.

The companies will develop and commercialize a Phase III cell therapy candidate for treating chronic low back pain in a deal worth potentially $1 billion.

Xeris Pharmaceuticals has received FDA approval for GVOKE (glucagon), a liquid glucagon for treating hypoglycemia.

Passage Bio has licensed a sixth gene therapy development program under its partnership with the University of Pennsylvania for the clinical development of a potential treatment for a nerve disorder.

The organization will utilize the cancer center’s Research for Biologics and Immunotherapy Translation platform for the development of therapeutic monoclonal antibodies against a novel immune checkpoint target.

In a Phase III trial for advanced small-cell lung cancer, the investigational antibody drug conjugate, Rova-T (rovalpituzumab tesirine), did not demonstrate a survival benefit for patients taking it.

The company has received breakthrough therapy designation for its prophylactic respiratory syncytial virus vaccine candidate for treating adults aged 60 years or older.

Roche has extended its offering period for the purchase of Spark to provide US and UK regulatory authorities with additional time to complete their review of the acquisition.

Vertex will use the acquisition to develop cell-based treatments for type 1 diabetes.

Valo Therapeutics has acquired a technology from Helsinki University that is expected to broaden its approach and expand the capability of its cancer vaccines platform, PeptiCRAd.

Gerresheimer has announced it will be expanding its ClearJect product line of pre-fillable syringes with a new 2.25-mL cyclic olefin polymer (COP) staked in needle (SIN) syringe.

The new facility, located in Ness Ziona, Israel, will support clinical phage manufacturing and can be expanded in the future to support commercial-scale manufacturing.

A global agreement with Polpharma Biologics gives Sandoz commercialization rights to a proposed biosimilar natalizumab for relapsing-remitting multiple sclerosis.

Alvotech and Prestige Biopharma, have announced the formation of a new contract manufacturing partnership for the commercial production of a biosimilar.

BioCity has revealed it will be investing in Kinomica, an early-stage precision medicine biotech company that was spun out of Barts Cancer Institute, Queen Mary University of London.

LBB Specialties and Meggle Excipients & Technology will work to distribute excipient products to companies in the American pharmaceutical and nutraceutical industries.

While downgrading the impact of nitrosamine impurities on patients, FDA vows to step up investigations for other drug types.

iBio granted a license to CC-Pharming for the commercialization of its iBio Rituximab drug for treatment of B cell non-Hodgkin lymphomas, chronic lymphocytic leukemia, and autoimmune diseases.

GSK will handle the development, regulatory, commercialization activities, and costs of the drug, while Ionis will obtain license fees and milestone payments of up to $262 million, including a $25 million license fee.