Industry News

In the U.K., a new four-year initiative has been launched to streamline drug development and manufacturing by leveraging better computer-based process modeling and simulation.

A reformulated version of Rose Bengal, PV-10, may be used to treat melanoma when injected directly into tumors.

The Eppendorf and Science Prize for Neurobiology is a research prize of $25,000, given to young scientists for their contributions in neurobiology.

The agency has revised its good pharmacovigilance practices guide on risk management systems.

Repligen reported a revenue increase of 45% at constant currency in the fourth quarter of 2015, which was driven primarily by strong growth in sales of its bioprocessing products, Jon K. Snodgrass, CFO of Repligen, noted during a fourth-quarter conference call. Specifically, the increased revenue came from the sales of its growth factors, ATF (alternating tangential flow) systems and consumables, and products from its chromatography group (e.g., OPUS columns, Protein A resins, and ELISA kits).

Robert Califf has been confirmed by the US Senate as FDA commissioner.

The lawsuit alleges EnzymeWorks and its founder engaged in willful patent infringement, misappropriation of trade secrets, and breach of confidence, in addition to other claims.

Sandoz filed a petition with the US Supreme Court to review a Federal Circuit Court’s July 2015 judgment of the Biologics Price Competition and Innovation Act (BPCIA). The pharmaceutical company filed the writ of certiorari with the court on Feb.

Researchers discovered more than 300 antibodies that reacted with the Ebola virus’s surface glycoprotein and could be used to neutralize many strains of the virus.

The agency published guidance on immunogenicity-related considerations for low molecular weight heparin.

The company issues a voluntary recall of a lot of 0.9% sodium chloride solution due to particulate matter.

The directorate is looking for experts to join the European Pharmacopoeia network.

The agency is continuing CDER’s Regulatory Project Management Site Tours and Regulatory Interaction Program.

Growth in finished dosage formulations triggers a new CPhI Worldwide event.

GRAM completed a fourth FDA inspection of its parenteral manufacturing facility with no Form 483 observation issues.

Vaccine R&D has grown exponentially in recent years, spurred by ethical and medical needs to combat lethal infectious outbreaks and increased funding from public and private agencies and organizations.

There was scant praise from the medical community for the eighth and final budget plan from the Obama administration.

Metrohm USA awards the 2016 Young Chemist Award to PhD candidate developing wearable sensors that can non-invasively monitor physiologically relevant chemicals.

3M Drug Delivery Systems, Ei Solutionworks, IDT Biologika join CMO/CDMO association

The agency prepares a plan to implement new packaging safety features.

FDA staff said Celltrion’s biosimilar form of infliximab is highly similar to Remicade.

Barvarian Nordic, Evaxion Biotech, and the Technical University of Denmark announced plans to collaborate on the development of a vaccine for MRSA.

In a hearing held on Feb. 4, 2016, executives from Valeant and Turing had a hard time explaining their rationales for exorbitant price hikes of older drugs.

Several biopharmaceutical companies announce plans to launch R&D into Zika vaccine candidates.

The International Society for Pharmaceutical Engineering (ISPE) Facility of the Year Awards (FOYA) program announced its 2016 Category Award winners for operational excellence, sustainability, process innovation, project execution, equipment innovation, and facility integration.

The Biosimilars Forum launched Partnership for Biosimilars Education and Access, an education initiative raising awareness of biosimilars in the US.

Pfizer and Bristol-Myers Squibb enter into agreement with Portola to develop and commercialize andexanet alfa in Japan.

CDER’s Office of Pharmaceutical Quality plans on promoting modernization as a way to ensure drug quality.

The body’s over-editing of synaptic interactions is recognized as a probable cause of schizophrenia in a landmark study.

Novartis announced the companies plan to boost growth at Alcon, the company’s vision care division.