News

Drug shortages are declining, but they’re still a serious concern for regulatory authorities, policy makers, and bio/pharmaceutical manufacturers.

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 agency is enlisting members of European pharmaceutical associations and industry representatives to participate in IDMP task force.

MedImmune will provide funds and access to monoclonal antibodies to seven postdoctoral associates for the creation of protein measurement and characterization tools.

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

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

The draft guidance contains policies for drugs that are processed with additional manufacturing steps such as remixing, dilution, and repackaging.

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

FDA announced that it approved Lenvima to treat patients with differentiated thyroid cancer after it was submitted under a priority review and orphan drug programs.

The agency releases five draft guidance documents related to drug compounding and repackaging.

FDA gives an update on currently approved Risk Evaluation and Mitigation Strategies.

The ongoing battle over drug reimbursement and pricing has raised questions about whether the pharmaceutical industry can continue to rely on high United States revenues to fund biopharmaceutical R&D.

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.

The new center represents AmerisourceBergen’s first facility erected specifically for clinical trial and commercial third-party logistics activities.

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

The National Institute for Health and Care Excellence released an updated version of its biosimilar approach guidance, including increased consideration for technology appraisal, references in documentation, and the production of “evidence summaries”.

The Center for Drug Evaluation and Research seeks a more flexible system for assessing biotech product quality.

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

The industry reacts to the departure of Commissioner Margaret Hamburg.

On February 3, 2015, the FDA published a notice in the Federal Register that it is soliciting input on the collection of data to support interchangeability claims in biosimilar applications.

FDA has approved Genetech’s Lucentis to treat retinopathy in patients with diabetic macular edema.

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 agency releases guidance documents on Individual Patient Expanded Access Applications and disclosing risk information to patients.

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.