Biopharma News

The Berlin-Buch facility will begin manufacture of the company’s immune cell therapy.

Hospira’s Inflectra (infliximab), a biosimilar for Remicade, is approved by the European Commission.

Juno's new manufacturing facility in Washington state will support clinical trials for immunotherapies.

The companies partnered to create more effective biopharmaceuticals through the exploitation of PASylation.

Genzyme will partner with Voyager Therapeutics for the discovery, development, and commercialization of novel gene therapies for central nervous system disorders.

Pfenex announced that it entered into an agreement to partner with Hospira on the development and commercialization of PF582, a biosimilar candidate to Lucentis.

Amgen announced that it met primary and secondary endpoints in its biosimilar evaluation of adalimumab for the treatment of rheumatoid arthritis, when compared to Humira.

The recent mergers, partnerships, and incentive-laden deals in pharma may keep the industry from continuing to experience diminishing returns, according to IMS’ Michael Kleinrock.

The deal may offset billions of dollars in waning sales from Pfizer drugs slated to lose patent protection and provides Pfizer with a whole portfolio of biosimilar products.

The cyclin-dependent kinase 4/6 inhibitor for the treatment of metastatic breast cancer was approved more than two months ahead of the prescription drug user fee goal date.

Sanofi launched a rapidly absorbed, short-acting inhalable insulin in the US to help control type 1 and type 2 diabetes.

The Shantha facility will be Sanofi's second, in addition to its site in Frankfurt, for production of Insuman insulin.

EMD Millipore will provide process development services for Precision Biologics’ preclinical monoclonal antibody.

Developing intellectual property standards for biological products is a point of conflict as negotiations on the Trans-Pacific Partnership continue.

Bristol-Myers Squibb and Johnson & Johnson announced FDA-approval of Evotaz and Prezcobix, combination HIV-1 infection treatments.

AstraZeneca will team up with various organizations to employ CRISPR technology for precise gene editing in recombinant cell lines.

The pharmaceutical manufacturer pledged to freeze vaccine prices for Gavi-eligible countries for a decade.

The potential blockbuster treatment targets a protein involved in cholesterol homeostasis.

Under terms of the agreement, Zymeworks could earn up to $164 million per successful drug candidate.

Bristol-Myers Squibb has announced that Giovanni Caforio will be the company’s chief executive officer effective May 5; Lamberto Andreotti has been named chairman.

Boehringer Ingelheim announced that it would partner with Vanderbilt University to research and develop Ras inhibitors for the treatment of cancers affected by Ras mutation.

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.