Industry News

The agency now allows production of water for injection by non-distillation technologies.

The agency cited Emcure Pharmaceuticals with CGMP violations.

During a clinical trial of 48 participants, 100% of those that received the TV003 vaccine were protected from infection.

The European Medicines Board elects Christa Wirthumer-Hoche as chair of their Management Board.

PhRMA says the proposals are aimed at modernizing the drug discovery and development process, promoting value-driven health care, engaging and empowering consumers, and addressing market distortions.

Doctors and oncologists agree with pharma companies in opposing the latest proposal from the CMS to revise how it pays for drugs administered in doctors’ offices.

The company recalls one lot of amikacin sulfate injection USP, 1 gram/4mL (250 mg/mL) vials due to the potential presence of glass particulate in one vial.

The committee suggests there may be a connection between the Zika virus and other neurological disorders in some affected areas.

The group is inviting additional industry stakeholders to participate in the technology roadmapping process to address complexity of the current industry structure, which the group says has held back innovation.

The agency strengthens its support for treatments of unmet medical needs with launch of new PRIME scheme.

The researchers examine the top 20 cancer drugs dosed by body size in the US, and estimate that drug companies will earn $1.8 billion in 2016 in revenue from leftover cancer drugs.

TxCell’s new facilities are based in Sophia Antipolis, France, on the premises of GenBiotech.

The US DEA will allow Kannalife access to pharmaceutical-grade cannabidiol to conduct feasibility studies for a potential treatment for neurodegenerative diseases.

The new group is made up of over 15 scientists who formerly worked in GSK's computational biology and genetics departments

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.