Biopharma News

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.

The entities announced that they will partner to improve access to cancer treatments and diagnostics in Ethiopia, Uganda, and Tanzania.

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 company has appointed Albert Bourla, PhD, as its new COO.

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.

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 will pay a $205-million upfront payment and have the option to develop and commercialize two antibody targets globally.

The collaboration aims to improve the pharmacokinetics of anti-C3 proteases developed by Catalyst to develop therapeutics for severe eye disorders.

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.

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.

Russian biotechnology company BIOCAD plans to enter the European market with oncological and autoimmune medicines.

The $72-million investment, part of a larger $850-million investment into its US operations, will allow the drugmaker to replace an outdated insulin vial-filling line and to upgrade technology at its Indianapolis manufacturing plant.

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.

Through the support of the Japanese agency, Daiichi Sankyo intends to further develop its genetic vaccine platform focused around its new nucleic acid delivery technology.

Baxter and FDA are working together to prevent shortages of the company’s sodium chloride 0.9% injection bags after recent hurricanes damaged the island.

The committee has voted unanimously to approve Spark Therapeutics’ gene therapy candidate, Luxturna (voretigene neparvovec), for treating a genetically inherited blindness.

The company is investing EUR 170 million (US$201 million) to expand its vaccine manufacturing site in France for its newest influenza vaccine.

NIH has entered a five-year, $215-million collaboration with leading biopharmaceutical companies to advance the development of cancer immunotherapies.

Amgen is seeking approval for an additional indication in glucocorticoid-induced osteoporosis for its blockbuster osteoporosis therapeutic, Prolia.

AstraZeneca is seeking approval for its anti-cancer monoclonal antibody, Imfinzi, for treating non-small cell lung cancer in the European Union.

BARDA has entered a $12-million contract with biopharmaceutical firm Achaogen for the late-stage development of an antibiotic against resistant bacteria, and as a potential treatment for biowarfare agents.