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.

During a Q4 call with Merck, executives admitted the company's market share for Remicade (infliximab) has begun to dwindle. Remicade's share of the market decreased 5% (from 90% to 85%) from the third quarter to the fourth quarter. 

ViaCyte and Janssen Biotech have entered Phase I/Phase II clinical trials for VC-01, a candidate treatment for the treatment of type 1 diabetes.

Sartorius releases financial results for 2015, announcing a 16% increase in group sales revenue.

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.

LabConnect built a biorepository facility in Tennessee.

AstraZeneca received conditional marketing authorization for Tagrisso, a tablet for the treatment of adults with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer.

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

Can the feds negotiate Medicare Part D prices?

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.

FDA and industry seek a more consistent, flexible CMC review process for breakthrough therapies.

Novasep is building a new synthesis laboratory and adding capacity for kilogram-scale batches of synthetic molecules that are needed for biological testing and preclinical trials, at its Pennsylvania, US facility.

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.

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.

On Jan. 27, 2016 FDA announced it plans to review Merck’s investigational antitoxin prevention bezlotoxumab.

Baxter has voluntarily recalled lots of IV solutions due to potential container leakages and particulate matter.

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

The new website, dubbed “Integrated Solutions”, helps clients implement single-use solutions and hybrid biomanufacturing processes.

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

The European Directorate for the Quality of Medicines & Healthcare announces the publication of a chemometric methods chapter in the European Pharmacopoeia.

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

Austrianova completes facility for GMP cell banking and fill/finish services for cell therapy products.