Biopharma News

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

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

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investment, part of a larger $850-million investment into its US operations, will allow the drugmaker to replace an outdated insulin vial-filling line and to upgrade technology at its Indianapolis manufacturing plant.

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.

The company is considering options for a full or partial separation of its Consumer Healthcare business, either through a spin-off, sale, or other transaction.

Johnson & Johnson’s Janssen Sciences Ireland UC will invest more than EUR 300 million (US$355 million) to expand manufacturing capacity for biologic medicines at its Ireland facility.

The Danish biotechnology company has been awarded a sole-source BARDA contract valued at more than $539 million for a freeze-dried smallpox vaccine.

Under Project BioShield, the agency could provide more than $170 million in funding to purchase and support late-stage development of Ebola vaccines and therapeutic drugs.

The alliance gives Celgene an option to acquire programs run by Nimbus Therapeutics for developing therapeutics to treat autoimmune disorders.

A grant from the Bill & Melinda Gates Foundation will advance PnuVax’s pneumonia vaccine’s clinical development and biomanufacturing scale-up using a low-cost manufacturing approach.

Amgen will collaborate with China’s Simcere Pharmaceutical Group, a R&D-driven pharmaceutical company, to co-develop four biosimilars for the Chinese market.

FDA sent a warning letter to Shandong Vianor Biotech Co., Ltd. that claimed the company failed to follow proper data integrity and quality control procedures.