Biopharma News
FDA Approves Pfizer Biosimilar to J&J’s Remicade
FDA has approved a Pfizer biosimilar to J&J’s top-selling anti-inflammatory biologic, Remicade.
FDA Approves Sanofi’s Follow-On Insulin
The approval for Admelog (insulin lispro injection) marks the first short-acting insulin approved as a “follow-on” product.
Novo Nordisk Expands Insulin Manufacturing Facility in India
In partnership with Indian pharmaceutical firm, Torrent Pharmaceuticals, Novo Nordisk has expanded an insulin manufacturing facility at Torrent’s Indrad, Gujarat, India site.
Vertex and CRISPR Therapeutics Partner on Gene Therapy for Blood Disorders
The companies will co-develop and co-commercialize the lead candidate generated from their earlier collaboration to treat genetic blood disorders.
Almirall and Athena Partner on Skin-Care Drug
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.
FDA Approves First Drug for EGPA
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.
SGS Adds GMP DNA Sequencing Capabilities at Glasgow Facility
SGS has introduced a Sanger sequencing service at its Glasgow, United Kingdom, laboratory to support genetic stability testing and perform identity testing on cell banks, plasmids, and viral seeds/vectors.
FDA Accepts Lilly’s Application for Migraine Biologic
FDA has accepted for review Eli Lilly and Company’s biologic drug candidate that is in development for treating migraine.
Gilead Sciences and Kite to Acquire Cell Design Labs
Gilead Sciences will acquire Cell Design Labs to further cell-therapy research and development efforts.
FDA Approves First Biosimilar to Roche’s Herceptin
FDA has approved Mylan’s biosimilar to Roche’s blockbuster anti-cancer biologic, Herceptin.
Astellas Acquires Mitobridge in $450-Million Deal
The acquisition deepens Astellas’ involvement in the development of a pipeline of therapeutics focused on mitochondrial function.
Orchard Therapeutics Opens Gene Therapy Laboratory Facility
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.
AstraZeneca Establishes Joint Venture in China to Develop Innovator Drugs
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.
Boehringer Ingelheim Launches Open-Access Platform of Selected Preclinical Molecules
The opnME.com platform offers scientists access to best-in-class molecules supported by comprehensive data packages.
Samsung Bioepis Receives Approval for First Trastuzumab Biosimilar, Ontruzant, in Europe
Ontruzant is the first biosimilar of Roche’s Herceptin (trastuzumab) to be approved in Europe.
FDA Approves Roche’s Hemophilia A Biologic and Expands Indication for Leukemia Drug
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.
Novartis, ASCP, and ACS Partner for African Cancer Initiative
The entities announced that they will partner to improve access to cancer treatments and diagnostics in Ethiopia, Uganda, and Tanzania.
Bayer in $1.5-Billion Deal with Loxo Oncology for Anti-Cancer Drugs
Bayer will make a $400-million upfront payment to develop and commercialize two anti-cancer compounds in Loxo Oncology’s portfolio.
J&J and Zymeworks in Bispecific Antibody Pact Worth Nearly $1.5 Billion
As part of the deal, J&J’s Janssen will pay an upfront payment of $50 million to research, develop, and commercialize up to six bispecific antibodies.
Pfizer Appoints New COO
The company has appointed Albert Bourla, PhD, as its new COO.
AstraZeneca Gets Positive EMA Opinion on Respiratory Biologic
The EMA’s Committee for Medicinal Products for Human Use has recommended marketing authorization approval for AstraZeneca’s benralizumab, a monoclonal antibody for treating severe asthma.
Dynavax Wins FDA Approval for Hep B Vaccine
The company expects to commercially launch the new vaccine in the US in the first quarter of 2018.
FDA Grants Breakthrough Therapy Designation to GSK’s Multiple Myeloma Treatment
The agency gave Breakthrough Therapy Designation to GSK’s GSK2857916 monotherapy for the treatment of patients with multiple myeloma who have failed at least three prior lines of therapy.
Catalent and Grid Therapeutics Form Immuno-Oncology Pact
The companies will collaborate to develop and manufacture Grid’s lead therapeutic candidate for the treatment of solid tumors.
FDA Approves GSK’s Shingles Vaccine
The vaccine is approved for the prevention of shingles in adult patients aged 50 years and older.
Incyte and MacroGenics in mAb Deal Worth Up to $900 Million
As part of the $900-million deal, Incyte will pay $150 million upfront to develop and commercialize an anti-PD-1 drug candidate from biopharmaceutical company, MacroGenics.
AbbVie and Alector Partner on Alzheimer’s Disease Immunotherapies
AbbVie will pay a $205-million upfront payment and have the option to develop and commercialize two antibody targets globally.
Catalyst Biosciences and Mosaic Biosciences Partner on Eye Disorder Therapeutics
The collaboration aims to improve the pharmacokinetics of anti-C3 proteases developed by Catalyst to develop therapeutics for severe eye disorders.
Inovio Reports on DNA Vaccine It is Developing with US Army
Inovio has reported results from a study with non-human primates that showed 100% effectiveness with a DNA vaccine the company is developing with the US Army.
Five Prime Therapeutics Appoints New CEO
The company’s board of directors has appointed Aron Knickerbocker as the new president and CEO to succeed Lewis Williams, MD, PhD, effective Jan. 1, 2018.
