Industry News

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.

Amgen announces FDA will review the company’s BLA for ABP 501.

The agency is seeking industry input on product-specific recommendations to facilitate generic drug development.

NICE announces plans to back biosimilar alternatives to Merck’s Remicade.

The partnership will focus on the identification and analysis of host-cell proteins in biologics.

Novartis announced on Jan. 5, 2016 that the company is collaborating with Qualcomm to develop cloud-based technology for COPD patients.

GS1 US announces the expansion of its advisory services program to address industry needs.

FDA’s Center for Drug Evaluation and Research publishes a list of upcoming new and revised guidance documents for 2016.

FDA issued a warning letter to Chan Yat Hing Medicine Factory for CGMP violations.

More than 80 pharmaceutical, biotechnology, generics, and diagnostics companies draft and sign the Declaration on Combating Antimicrobial Resistance.

Serialization, combination products, emerging markets, outsourcing, TVF, and adherence are identified as the key themes in drug delivery and packaging for 2016.

The European Pharmacopoeia rewrites in its general chapter on Raman spectroscopy.

BioMarin Pharmaceutical announced FDA issued a complete response letter to dirsapersen, disclosing that the NDA was not approved.

Patheon announced the appointment of Gilles Cottier as president of the company’s pharmaceutical development services.

AstraZeneca and Moderna Therapeutics set to collaborate on mRNA therapeutic candidates for the treatment of cancer.

A US district judge entered a consent decree of permanent injunction on behalf of FDA, between the United States and pharmaceutical company, Downing Labs.

FDA approved 45 novel new drugs in 2015, led by therapies for orphan diseases and and expedited approvals.

The Office of Prescription Drug Promotion issues all-time low number of violation letters in 2015.

The company has voluntarily recalled one lot of magnesium sulfate in water for injection because of incorrect labeling.

FDA issues a Warning Letter to Cadila Healthcare Limited for cGMP violations.