Biopharma News

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.

On April 24, 2017, the European Federation of Pharmaceutical Industries and Associations (EFPIA) and a group of executives from several big pharma companies composed an open letter to the European Medicines Agency (EMA) regarding its relocation.

Companies believe that biologics and biosimilars would experience the fastest growth over the next year; there is also interest on increasing market penetration of generic drugs.

Sandoz, a Novartis division, announced  that the Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions recommending the approval of its biosimilars rituximab and  etanercept in Europe, for the same indications as the respective reference medicines.

The agency approved Renflexis, a biosimilar to Janssen’s blockbuster rheumatoid arthritis treatment.

Amgen is once again asking the court to weigh in on a patent infringement case. In March 2017, Sanofi and Regeneron asked a federal court to issue a declaratory judgment of non-infringement indicating that their drug Dupixent (dupilumab) does not infringe on Amgen’s ‘487 patent covering IL-4 inhibitors. Although the court has not yet responded to this request, in early April 2017 Amgen issued a complaint of patent infringement against Sanofi/Regeneron involving the same ‘487 patent.

Valeant’s Siliq (brodalumab) injection will be listed for $3500 a month in the United States, the company said on April 21, 2017. In a statement, Valeant said this makes Siliq the lowest-priced injectable biologic to treat psoriasis on the US market.

On April 20, 2017 UniQure announced that it will not pursue marketing authorization renewal in the European Union for Glybera (alipogene tiparvovec), the first gene-therapy approved by EMA. Glybera’s marketing authorization is set to expire on Oct. 25, 2017.

Cobra will increase capacity in response to customer demand for DNA and viral vector production.

The two companies will develop translational biomarkers for fibrotic diseases, including non-alcoholic steatohepatitis (NASH).

BMS is licensing two investigational compounds in separate deals with Roche and Biogen for a total of $470 million in upfront payments.

Pharmaceutical Technology spoke with Ben Locwin and Tom Fox ahead of their CPhI North America presentation to discuss drug pricing, compliance challenges, and corporate social responsibility in the bio/pharmaceutical industry.

The companies will work to co-develop FIN-524, a live biotherapeutic product composed of cultured bacteria strains.

Janssen will have access to PeptiDream’s proprietary Peptide Discovery Platform System technology, which will be used to identify peptides against multiple metabolic and cardiovascular targets.

The company received priority review for its investigational CAR-T therapy to treat leukemia.

The mAb is the first approved treatment that targets the progressive form of the disease.

FDA approved Dupixent for the treatment of atopic dermatitis amidst a preemptive lawsuit filed by Sanofi/Regeneron involving the drug and an Amgen patent covering IL-4 inhibitors.

The company has signed two separate agreements with the Agency for Science, Technology, and Research (A*STAR) and the Nanyang Technological University (NTU) to progress its therapeutic stem cell pipeline.