Biopharma News

McNeil-PPC pleads guilty in connection with adulterated infants' and children's over-the-counter liquid medications.

AbbVie’s acquisition of Pharmacyclics establishes the combined company as an emerging leader in hematological oncology.

Canon announced that it established Canon BioMedical, a wholly owned biomedical business to develop, manufacture, and market operations related to Canon’s life-science and molecular diagnostics platform.

The company voluntarily recalls product due to FDA observations of potential sterility problems.

Baxter announced that its new biopharmaceutical arm, scheduled to become independent from Baxter in 2015, will be located in Bannockburn, Illinois.

Leased facilities in California will expand Kite Pharma's capacity for T-cell therapies.

The agency cites Apotex’s Bangalore facility with quality system failures.

Brandicourt will leave Bayer HealthCare AG to begin his new role as CEO of Sanofi in April 2015.

The Patent and Trademark Office sends notice rejection of the company’s Remicade patent.

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.