Biopharma News

Sanofi will tap into Boehringer Ingelheim’s therapeutic monoclonal antibody manufacturing capabilities.

The move represents Hospira’s first biosimilar submission in the United States.

The new partnership between NeoStem and Invetech focuses on the development of a closed processing system for cell-based therapy manufacturing.

Shire adds rare-disease portfolio with acquisition of NPS Pharma.

The decision to skip an FDA panel advisory may allow the medication to be approved more quickly.

Biogen Idec’s investigational monoclonal antibody met its primary endpoints in a recent Phase II for the treatment of acute optic neuritis.

The exclusivity deal mirrors that of the recent deal between Express Scripts and AbbVie for Viekira Pak.

In 2014, FDA approved 41 new molecular entities, which is the highest number since 1996.

Although competing therapies will continue to be released in the immune-oncology space, efficacy profiles, combination regimens, and administration setting may influence a drug’s preferred status more than price.

The partnership will focus on the discovery of antibodies against proteins that are not easily purified in functional form.

The Cell Therapy Catapult, a UK non-profit center for advancing cell and gene therapies, will manage the manufacturing center, which will be used for late-phase clinical trials and commercial supply.

Merck announced that it acquired OncoEthix, a biotechnology company specializing in oncology drug development, for up to $375 million.

The first stem-cell medication approved in the EU promotes regeneration and healing to the outer layer of the cornea.

Roche will use Dutalys’ DutaMab technology for the engineering of bispecific therapeutic antibodies.

Roche will use Dutalys’ DutaMab technology for the engineering of bispecific therapeutic antibodies.Roche Acquires Bispecific Antibody Developer Dutalys

Halozyme will receive an initial payment of $15 million for Enhanze, its technology that enables biologics to be delivered as a simple subcutaneous injection.

The multi-product biopharmaceutical manufacturing facility is scheduled to start up in 2017.

Reference product manufacturers and trade groups support automatic medication switches in new biosimilar “compromise” terms.

US Department of Health and Human Services announced a declaration to provide immunity to legal claims made in the US in relation to three investigational Ebola vaccines.

On December 8, Pfizer announced that it will establish a research program in gene therapy, and collaborate with Spark Therapeutics in Philadelphia, to develop potential gene therapy treatments for hemophilia.

Under an NIH contract, Paragon Bioservices will design a manufacturing process for recombinant human rhE-selectin protein.

The acquisition will enhance Merck's "superbug" medication portfolio.Merck announced Dec. 8, 2014 that it would acquire Cubist Pharmaceuticals for a total transaction value of approximately $9.5 billion, including a little over $1 million in debt. The deal will add to Merck’s portfolio of drugs treating antibiotic-resistant bacteria, such as Cubist’s antibiotic Cubicin (daptomycin for injection), the only approved once-a-day therapy for both Staphylococcus aureus bacteremia and complicated skin and skin structure infections.

Sandoz announces their version of filgrastim, a follow-on biologic for the treatment of neutropenia, is as safe and effective as Amgen's Neupogen.

Sanofi executives are being charged in a whistleblower lawsuit for allegedly granting illicit payments to healthcare providers.

Amgen's bispecific T-cell engager (BiTE) antibody constructs help the body fight malignant cancer cells.

CytRx receives formal written communication from FDA on a prior decision for a partial clinical hold for CytRx's trials involving chemotherapeutic agent aldoxorubicin.

Japanese drugmaker Otsuka announced plans to buy CNS-specialist Avanir Pharmaceuticals for $3.5 billion in an all-cash tender offer.

Ranbaxy and Epirus announce the launch of India's first biosimilar for Remicade.