Biopharma News

One day after Ocular Therapeutix sent FDA a detailed response highlighting manufacturing improvements, FDA rejected its application for Dextenza, a new drug designed to alleviate post-operative eye pain.

FDA advisory committee has recommended for approval Novartis CAR-T cell therapy CTL019 for the treatment of relapsed and refractory B-cell acute lymphoblastic leukemia in pediatric and young adult patients.

The acquisition will add recombinant-based influenza vaccine to Sanofi Pasteur’s portfolio

After FDA found a “significant shift in the route of abuse,” Endo voluntarily removes OPANA ER from the market.

SOBI003 is a chemically modified variant of a recombinant human sulfamidase product candidate, using Sobi’s proprietary glycan modification technology.

A new probe developed by researchers at the University of Melbourne, Australia, would allow NMR to be used without the use of microwaves, and with smaller machines.

The company has broken ground on a R&D and process development facility in Missouri.

Two recently-signed agreements will transfer Takeda’s measles and acellular pertussis vaccine technologies to India-based multinational company Biological E. Limited to develop low-cost combination vaccines including diphtheria, tetanus and acellular pertussis (DTaP), and measles-rubella (MR) vaccines.

The companies expanded their alliance to develop plasmid DNA drugs.

The European Commission approved Rixathon for use in all indications of its reference medicine, MabThera.

Basilea Pharmaceutica International Ltd. entered into a distribution and license agreement with Pfizer and Avir Pharma Inc. to distribute Basilea’s antifungal treatments.

The company said it expects to transaction to close on June 16, 2017.

The companies will collaborate on the development of dual amylin calcitonin receptor agonists for patients with Type 2 diabetes.

The company released an interim analysis from its JULIET study with CTL019.

Amgen filed a complaint against FDA claiming the agency unlawfully denied the company pediatric exclusivity for its secondary hyperparathyroidism treatment Sensipar.

The company entered two separate collaborations with Advaxis and Array Biopharma involving its PD-1 immune checkpoint inhibitor Opdivo.

The company entered a collaboration with Protagonist to develop, manufacture, and commercialize PTG-200.

This marks the first FDA approval of a treatment based on a specific biomarker.

The Competition and Market’s Authority is accusing Merck Sharp & Dohme of offering a discount for Remicade that may have restricted the sale of biosimilar competition in the UK.

The agency’s Committee for Medicinal Products for Human Use recommended AstraZeneca’s brodalumab for the treatment of moderate-to-severe plaque psoriasis.

Ablynx will receive EUR15 million in milestone payment following Merck’s decision to advance ALX-1141 into clinical development. The nanobody was developed by Ablynx under a 2011 collaboration between both parties.

Janssen filed a lawsuit in a US District Court in New Jersey against Samsung Bioepis, claiming the company’s new biosimilar infringed on its Remicade patents.

The company purchased Cirara from Remedy Pharmaceuticals for $120 million.

The companies entered a license agreement that includes Sangamo’s SB-525, one of the company’s lead product candidates for the treatment of Hemophilia A.

Licensing agreement will expand Oxford Genetics bio-therapeutic discovery, design, and development service business.

Novartis entered separate license agreements with bluebird bio and Celyad for patents related to the manufacture of CAR-T cells.

Fresenius Kabi enters biosimilars market with acquisition of Merck KGaA’s Biosimilars Business

GSK invests $139 million to expand production capacity for Benlysta (belimumab) in Rockville, MD.