News

WuXi's new US facility will manufacture CAR T-cell therapies and other cancer immunotherapies.

Treatment with monoclonal antibodies that inhibit the activity of PCSK9 was shown to significantly lower LDL cholesterol levels and have a strong cardiovascular benefit.

The company will build an R&D team to find promising drug targets with genetic information submitted by customers in its database.

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

BIO and the Colorado BioScience Association urge Colorado Governor Hickenlooper to sign a bill that will help patients gain access to interchangeable biologic products following FDA approvals.

Early access to Merck’s Keytruda in the United Kingdom is granted under the UK’s Early Access to Medicines Scheme.

Drug spending rose last year at the highest rate since 2003, driven by specialty medicines, according to a report from pharmacy benefit manager Express Scripts.

Mallinckrodt Pharmaceuticals has bought Ikaria, a privately-held critical care company, for $2.3 billion.

The agency will employ a ring vaccination method similar to the one used to eradicate smallpox.

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

Patheon cites expanded API services with acquisition of IRIX Pharmaceuticals.

The upgrades will offer the opportunity for higher product yields and higher purity levels.

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.

FDA announced that it would postpone a meeting that would be critical for the advancement of Celltrion’s Remicade biosimilar in the US.

Remsima will now be available for patients in 12 additional countries in the European Union.

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.

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.

Actavis says it plans to use the Allergan corporate name for its branded products.

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