Pharma News

Dolutegravir-based antiretroviral therapies (ART) for HIV-1 are more effective for pregnant people than some other ART regimens commonly used in the U.S. and Europe, according to a study led by Harvard T.H. Chan School of Public Health researchers.

A new study from Washington University School of Medicine in St. Louis suggests a simple blood test administered before CAR-T cell treatment is initiated may identify which patients are predisposed to developing neurotoxic side effects after CAR-T cell therapy. Severe side effects can include seizures, brain swelling and strokes. Evidence of a stroke (red arrows) is seen on this MRI scan of the brain of a patient who developed neurotoxic side effects after CAR-T cell therapy.

Biological E. Limited (BE)'s 14-valent paediatric vaccine (investigational pneumococcal polysaccharide conjugate vaccine PCV14) is approved by the Subject Expert Committee of CDSCO  against S. pneumoniae infection in infants.

Streptococcus pneumoniae infection continues to be a leading cause of child mortality under 5 years of age in India and in developing countries. With the PCV14 vaccine, Biological E hopes to contribute to the prevention of invasive pneumococcal disease and protect millions of lives globally.

Cervavac was launched on September 1, 2022, after the Drugs Controller General of India had granted market authorization to Serum Institute of India. Cervavac is developed by a partnership of DBT and BIRAC with the Bill and Melinda Gates Foundation, supported by Serum Institute of India for the indigenous development of quadrivalent vaccines.

Dr Jitendra Singh said, this affordable and cost effective vaccine marks an important day for DBT and BIRAC as it takes India a step closer to PM Modi’s vision of Atmanirbhar Bharat.

Aurobindo Pharma to invest Rs. 300 crores for expanding its mammalian cell culture manufacturing facility of CuraTeQ Biologics which is a fully owned subsidiary of the Drug maker.

There was a meeting held on 1st september where all the board members agreed to expand its operations by establishing another mammalian cell culture manufacturing facility of higher capacity to cater to the future requirements. The capital expenditure for ramping up capacities is estimated to be around Rs.300 crores.

Novo Nordisk and Forma Therapeutics, Holdings Inc. announced that they have entered into a definitive agreement under which Novo Nordisk will acquire Forma Therapeutics for USD 20 per share in cash, which represents a total equity value of USD 1.1bn. Forma Therapeutics is a clinical-stage biopharmaceutical company focused on transforming the lives of patients with sickle cell disease (SCD) and rare blood disorders.

Novo Nordisk has agreed to pay USD 6.3 million to resolve allegations that it violated the False Claims Act by selling items to the United States that were manufactured in non-designated countries.

The settlement resolves allegations that Novo Nordisk violated the Trade Agreements Act, which restricts the procurement of goods under certain government contracts to purchases from specific designated countries, by submitting false claims for payment for medical devices that were manufactured in non-designated countries.

Novartis is making strong immunology portfolio by investing in immunological diseases such as spanning hidradenitis suppurativa (HS), chronic spontaneous urticaria (CSU), Sjogrens syndrome, axial spondyloarthritis, and psoriasis.

Novartis will showcase data from its leading immunology portfolio and emerging pipeline at the upcoming 31st European Academy of Dermatology and Venereology (EADV) Congress and the 15th International Symposium on September 7–10, 2022.

Pfizer Inc. and BioNTech announced that the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) of a 30-µg booster dose of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent for individuals ages 12 years and older.

And on the same day,  Moderna, Inc. has also received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its Omicron-targeting bivalent COVID-19 booster vaccine.