Bio/Pharma News

The acquisition, valued at EUR 520 million (US$631 million), would expand Takeda’s late-stage pipeline in gastroenterology and would extend an already existing collaboration between the two companies.

A Takeda and Denali collaboration includes three named programs for treating Alzheimer’s disease and other neurodegenerative diseases, using Denali’s antibody transport vehicle (ATV) technology to enhance blood-brain barrier penetration.

Athenex is moving forward with the construction of a new 320,000-square-foot pharmaceutical manufacturing facility in Dunkirk, NY, and has hired the German engineering firm, M+W, to design and construct the facility.

The company announced 15 new collaborations focused on addressing unmet medical needs, including using artificial intelligence in the early detection of Alzheimer’s disease, saliva testing for throat cancers, and using the microbiome to treat sleep disorders.

The companies aim to develop a potential zinc finger protein transcription factor-based gene therapy for treating Lou Gehrig’s disease.

The companies aim to discover and develop locked nucleic acid oligonucleotides as orally available therapies for treating inflammatory bowel diseases.

Mallinckrodt has agreed to acquire biopharmaceutical company Sucampo Pharmaceuticals for $18 per share, or a transaction value of approximately $1.2 billion.

Roche has agreed to acquire Ignyta, an oncology company specializing in precision medicines, in an all-cash transaction valued at $1.7 billion.

FDA has approved a new gene therapy for treating patients born with a rare, inherited vision loss.

Sanofi Genzyme and its partner, Alnylam Pharmaceuticals, have filed a marketing authorization application with EMA for an investigational RNAi therapeutic for treating a genetic-based disease.

The company has completed development of a first-generation production process for its chimeric antigen receptor regulatory T cell product portfolio and is selecting a CMO for clinical supply.

The European Commission has closed its infringement procedure against Roche after the company completed remedial actions.

The US Court of Appeals for the Federal Circuit has decided in favor of Novartis’ Sandoz in rendering the opinion that Amgen cannot use state laws to prohibit or delay the marketing of biosimilars.

Cycle and Aprecia will use Aprecia's 3DP Technology to improve rare disease drug formulations.

The company is seeking approval from FDA for use of the drug, migalastat, to treat Fabry disease in patients who have amenable mutations.

The approval for Admelog (insulin lispro injection) marks the first short-acting insulin approved as a “follow-on” product.

In partnership with Indian pharmaceutical firm, Torrent Pharmaceuticals, Novo Nordisk has expanded an insulin manufacturing facility at Torrent’s Indrad, Gujarat, India site.

The companies will co-develop and co-commercialize the lead candidate generated from their earlier collaboration to treat genetic blood disorders.

The partnership aims to develop and commercialize a skin-care drug candidate being developed to treat actinic keratosis, which, left untreated, can progress to cancer.

The agency has approved Nucala (mepolizumab) to treat Eosinophilic Granulomatosis with Polyangiitis (EGPA) to GlaxoSmithKline. This indication is the first FDA-approved therapy specifically to treat EGPA.

FDA has accepted for review Eli Lilly and Company’s biologic drug candidate that is in development for treating migraine.

Gilead Sciences will acquire Cell Design Labs to further cell-therapy research and development efforts.

FDA has approved Mylan’s biosimilar to Roche’s blockbuster anti-cancer biologic, Herceptin.

The acquisition deepens Astellas’ involvement in the development of a pipeline of therapeutics focused on mitochondrial function.

The company has opened a new California facility that, combined with its existing site in Foster City, CA, will quadruple its laboratory footprint for gene therapy products.

The joint venture will focus on the discovery, development, and commercialization of potential new drugs for the global market as well as speed delivery of new medicines to China.

In the wake of generic-drug pricing pressure and declining revenues, Teva has restructured its commercial business and made executive leadership changes.

The opnME.com platform offers scientists access to best-in-class molecules supported by comprehensive data packages.

Ontruzant is the first biosimilar of Roche’s Herceptin (trastuzumab) to be approved in Europe.

The agency has approved a biologic-based new molecular entity for treating hemophilia A and has expanded the indication for a leukemia drug to now treat a common form of non-Hodgkin lymphoma.