News

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

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

The commission adopts 24 new and 72 revised texts for inclusion in the European Pharmacopoeia.

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.

The event will take place at the Jakarta International Expo, Indonesia from April 8–10, 2015.

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

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

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

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

Recipharm expects to be rolling out further serialization projects during 2015.

The investments made in analytical and process development equipment will enable Laurus Synthesis to offer chemistry services to its clients.

International day for fighting infection sees European infection specialists advocating vaccines as a viable solution to tackle antimicrobial resistance.

UPS expands its special commodities program to more countries.

Several chromatographic resins are available for downstream purification.

Member of parliament, Desmond Swayne, will officially open the 42,000-square-foot facility on March 20, 2015.

Sharon Johnson, senior vice president, Global Quality & Regulatory Affairs, will head the organization.

The new flow sensors, BioPAT Flow, enable precise, reproducible data to be collected on flow rates and mass balances without coming in contact with the medium during measurement.

The manufacture and scale up production mark a significant milestone in the commercialization route of Nanobiotix lead product, NBTXR3.

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

Kite Pharma announced that it acquired T-Cell Factory B.V. in an effort to strengthen its T-cell portfolio.

NSF's consensus-based standard incorporates multiple regulatory and industry requirements into a single rigorous standard for the manufacturing and distribution of pharmaceutical excipients.

Penn Pharma's equipment addition meets growing need for continuous dry granulation and for handling of highly potent drugs.

Valeant announced that it would increase its original acquisition agreement with Salix to approximately $15.8 billion.

Remsima has demonstrated comparability to the reference product, Remicade, in terms of safety, efficacy, and quality.

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.

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

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.

Zogenix agreed to sell Zohydro, its controversial pain medication, to Pernix for $100 million.

Dr. Reddy’s announced that it expanded its facilities to include a formulation development laboratory at its Miyapur, Hyperabad, India plant.