Bio/Pharma News

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.

Takeda will build a new production facility at its existing Grange Castle site in Ireland.

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

BioVectra will open its new microbial fermentation and complex chemistry site, including the capability to handle high-potency APIs, by the end of 2017.

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.

The company will expand its production facilities in Carlow and Cork to meet increased global demand for its medicines and vaccines produced in Ireland.

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.

The drug is approved to treat postmenopausal women with osteoporosis and is the first anabolic bone building agent approved in the US in approximately 15 years.

With two acquisitions, German company Fresenius Kabi enters biosimilars market and expands in US.

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.

Sanofi filed an antitrust lawsuit with a district court in New Jersey alleging Mylan took steps to restrict access to a competing epinephrine autoinjector.

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.

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.

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

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.

FDA denies the NDA for the RA drug developed by Eli Lilly and Incyte, citing the need for more data.

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.

The recall was issued because of a defective delivery system; the units affected had possible package leakage.