Biologic Drugs in Development

Sanofi Genzyme and its partner, Alnylam Pharmaceuticals, has 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.

FDA has approved a Pfizer biosimilar to J&J’s top-selling anti-inflammatory biologic, Remicade.

Children with a rare brainstem-based cancer might be helped by a new immunotherapy that targets a mutated protein found exclusively in cancer cells.

Abzena has entered into a Master Services Agreement with a US biotech company to provide process development and manufacturing services to progress a novel antibody-drug conjugate (ADC) to clinical trials.

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

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

Lonza has entered into strategic license agreements for exclusive rights to a gene-therapy platform for developing treatments for hearing and balance disorders.

Biocad and Sothema Labs have partnered to release cancer-treating biosimilars into the North African market.

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.

Bayer will make a $400-million upfront payment to develop and commercialize two anti-cancer compounds in Loxo Oncology’s portfolio.

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.

The use of therapeutic vaccines presents a new way to manage diseases, such as cancer and sexually transmitted diseases.

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.

The company expects to commercially launch the new vaccine in the US in the first quarter of 2018.

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.

The companies will collaborate to develop and manufacture Grid’s lead therapeutic candidate for the treatment of solid tumors.

Anna Kireieva/Shutterstock.comSpeed to market is essential in the biopharmaceutical industry today.

The vaccine is approved for the prevention of shingles in adult patients aged 50 years and older.

The API manufacturer has announced that it has completed the expansion of large-scale manufacturing capabilities at its Charles City, Iowa site.

This approval marks the second gene therapy to be approved by FDA and the first to be approved for certain types of non-Hodgkin lymphoma.

The companies aim to use CureVac’s proprietary messenger RNA technology to develop and commercialize up to five potential cancer vaccine products.

The vaccine is a non-live, recombinant subunit vaccine that combines an antigen and an adjuvant system to trigger a targeted and long-lasting immune response to the shingle-causing virus.

Stelara (ustekinumab), already approved for treating adults, is now also approved for treating adolescents with moderate to severe plaque psoriasis.

Samsung BioLogics’ second facility adds 152,000 L of mAb drug substance capacity.