Biopharma News

Sandoz reveals plans to complete a Phase III development program for Pfizer’s infliximab and file for registration in the EU.

Pfizer names executive leadership team for combined organization upon close of proposed Allergan transaction.

FDA granted Immunomedics breakthrough therapy designation for the company’s investigational antibody drug conjugate for treatment of triple negative breast cancer.

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.

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.

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.

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.

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

Samsung Bioepis receives approval from the European Commission for the Enbrel Biosimilar, Benepali.

The denial marks a setback for Amgen, who’s Humira biosimilar ABP 501 is the first submitted to FDA for adalimumab.

Takeda Pharmaceutical Company and enGene have entered into a strategic alliance to develop novel therapies for specialty gastrointestinal diseases.

Adimab and Merck have entered into a definitive agreement to transfer Adimab’s antibody technology to Merck Research Laboratories.

Cell Therapy Catapult and Synpromics announced a collaboration to increase scale and efficiency of viral vector manufacturing.

Shire’s acquisition of Baxalta creates a leading company for rare disease drugs.

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

Novartis enters into alliance and licensing agreement with Surface Oncology.

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

Takeda Pharmaceuticals announced the acquisition of a biopharmaceuticals manufacturing plant in Minnesota.

The Cell Therapy Catapult, University of Birmingham, and Cancer Research Technology collaborate on CAR-T cell immuno-oncology therapy development.

Health Canada approved AbbVie’s Humira for the treatment of adults with hidradenitis suppurativa.

Ionis Pharmaceuticals receives orphan drug designation for HTTRx for the treatment of Huntington’s disease.