Industry News

Aurobindo Pharma receives 6 observations after inspection of Aurobindo Pharma Jedcherla plant.

The United States Food and Drug Administration (US FDA) inspected Aurobindo Pharma's Unit VII, an oral manufacturing facility situated at Jedcherla, Hyderabad, from 2nd to 10th May 2022.

US FDA has conducted a Good Manufacturing Practices (GMP) inspection of Sun Pharmaceutical Industries Limited Halol facility Gujarat from April 26 to May 9, 2022. At the conclusion of the inspection, the US FDA issued a Form-483, with 10 observations.

US Pharma giant Pfizer has set up its global drug development centre at the Indian Institute of Technology-Madras Research Park with an investment of around 150 crore. This facility employs more than 250 scientists and professionals from a range of scientific disciplines, including Formulation Scientists and Pharmacists, Analytical Scientists, Life Science specialists such as Microbiologists and Biotechnologists, Chemical Engineers, Data Scientists and Program Managers.

Biocon Biologics Limited a subsidiary of Biocon Ltd announced that its subsidiary Biocon Sdn. Bhd. in Malaysia has been awarded a three-year contract, valued at USD 90 million* (MYR 375 million), for its recombinant human insulin brand Insugen®, by the Ministry of Health (MoH), Malaysia.

Moderna, Inc a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that it has submitted a request for emergency use authorization (EUA) for its COVID-19 vaccine (mRNA-1273) in children 6 months to under 2 years and 2 years to under 6 years of age to the U.S. Food and Drug Administration and that similar requests are underway with international regulatory authorities. The requests are based on a 25 μg two-dose primary series of mRNA-1273.

Gesynta Pharma AB announces that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to the company's drug candidate GS-248 for the treatment of systemic sclerosis. GS-248 is currently being evaluated in a Phase II clinical trial as a treatment for Raynaud’s phenomenon secondary to systemic sclerosis.

Pfizer Inc and BioNTech SE submitted an application to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of a 10-µg booster dose of the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age (also referred to as children ages 5 through <12).

Zydus Lifesciences announced the publication of two manuscripts detailing the DREAM-ND and DREAM-D Phase 3 study results of Desidustat, a novel HIF-PH inhibitor in the prestigious American Journal of Nephrology.

ERYTECH Pharma a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, today announced the sale of its U.S. manufacturing facility to Catalent, a leading contract development and manufacturing organization (CDMO) in advanced therapies.