News

FDA has approved another indication for Eylea, a treatment for diabetic retinopathy in patients with diabetic macular edema.

Genentech plans to invest more than $125 million in an expansion of its fill/finish facility in Hillsboro, OR.

Emergent BioSolutions announced FDA approval of Anthrasil, an inhalable treatment that targets Anthrax toxins, as well as a contract with BARDA to develop NuThrax, an anthrax vaccine candidate.

Clinical trial results suggest that monoclonal antibodies targeting the function of proinflammatory cytokine IL-17A in psoriasis may be significantly superior to other treatments.

The agency provides guidance on determining the need for environmental assessments for gene therapies, vectored vaccines, and viral and microbial products.

The company’s new corporate name will be simply Biogen.

The new 2000-L bioreactor will double Rentschler’s single-use manufacturing capabilities.

Guidance provides labeling standards and an implementation guide for electronic submission of lot distribution reports.

Biogen Idec says its investigational candidate is the first drug to both reduce amyloid plaque in the brain and slow cognitive decline.

Under a new agreement, Sigma-Aldrich will be the single supplier for Roche’s Biochemical Reagents product portfolio.

The bill, originally introduced in 2013, seeks to terminate sequestration to payments for certain drugs and biologicals.

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.

 FDA approved Sandoz’s Zarxio (filgrastim-sndz) on March 6, 2015. The approval is a groundbreaking decision, as Sandoz is the first pharmaceutical company to have a biosimilar product approved in the United States. Known as Zarzio outside of the US, Sandoz says its biosimilar filgrastim is already available in more than 60 countries worldwide, has generated more than 7.5 million patient-days of exposure, and is "the most widely used filgrastim in Europe."

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.