Industry News

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.

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.

The U.S. Food and Drug Administration has approved Xenpozyme for the treatment of non-central nervous system manifestations of acid sphingomyelinase deficiency in adult and pediatric patients.

Xenpozyme is the first therapy indicated specifically for the treatment of ASMD (acid sphingomyelinase deficiency), and is currently the only approved treatment for this disease.

Aspen Pharmacare has concluded a ten-year agreement with Serum Institute of India, the world’s largest vaccine producer, for Aspen SA operations to manufacture, market and distribute four Aspen-branded routine vaccines in Africa, excluding certain markets due to the Serum Institute having grated prior rights to third parties.

U.S. Food and Drug Administration (USFDA) issues Form 483s to three sites of Biocon Biologics at India and Malaysia. USFDA issues 11 observations each for the two sites in Bengaluru and 6 observations for the Malaysia site.

USFDA conducted three on-site inspections of Biocon Biologics seven manufacturing facilities spanning two sites in Bengaluru, India and one at Johor, Malaysia. These inspections started with the Bengaluru site on August 11, 2022 and concluded with the Malaysia site on August 30, 2022.