Company News

Biogen Inc announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending a marketing authorization under exceptional circumstances for QALSODY® (tofersen) for the treatment of adults with amyotrophic lateral sclerosis (ALS), associated with a mutation in the superoxide dismutase 1 (SOD1) gene.

Bristol Myers Squibb announced two regulatory acceptances for applications for neoadjuvant Opdivo (nivolumab) with chemotherapy followed by surgery and adjuvant Opdivo for the perioperative treatment of resectable stage IIA to IIIB non-small cell lung cancer (NSCLC). The U.S. Food and Drug Administration (FDA) accepted the supplemental Biologics Application (sBLA) and assigned a Prescription Drug User Fee Act (PDUFA) goal date of October 8, 2024.

AstraZeneca Pharma India Limited has received permission to import pharmaceutical formulations of new drug for sale or for distribution in Form CT-20 from Central Drugs Standard Control Organisation for Palivizumab (Synagis) solution for injection 100 mg/ml (r-DNA origin) (50mg/0.5mL & 100 mg/mL presentations in single-dose vials administered through intramuscular route).

Johnson & Johnson has reached a deal in the long-running lawsuit against its talc-based products. Thousands of people have sued the company over the past decade, claiming the products - including its iconic baby powder - caused cancer.

Granules India inaugurated and launched its packaging facility through its Granules Consumer Health (GCH) step-down subsidiary which is located in Manassas, Virginia, US. The facility is over 79,000 square feet and is equipped with packaging lines and clean rooms to package and ship prescription and over-the-counter products across the U.S. market. The facility recently received US FDA approval with zero 483 observations.

Granules India Limited announced that the US Food & Drug Administration (US FDA) has approved its Abbreviated New Drug Application (ANDA) for Losartan Potassium Tablets USP, 25 mg, 50 mg, and 100 mg.

It is bioequivalent to the reference listed drug product (RLD), Cozaar Tablets of Organon LLC. Granules now has a total of 54 ANDA approvals from US FDA (52 Final approvals and 2 tentative approvals).

For the first time Sun Pharma secured the top position by doctor prescriptions. It outperforms Mankind Pharma long stand, according to market research firm, SMSRC.

Sun Pharma is the largest Indian pharma company by capital, but Mankind Pharma was leading market rank for number of doctor prescriptions for a long time. Recently as per market research firm, SMSRC, Sun Pharma, which has topped India’s pharma retail market for years, has now become the leader in prescriptions, bolstered by an increase in field force and a sharper focus on core therapies.

BioIVT, a leading provider of biospecimens, research models and services for drug and diagnostic development announced the launch of its Good Manufacturing Practice (GMP-) grade VivoSTART  leukopaks. Leukopaks contain concentrated white blood cells and are used to research and manufacture cell and gene therapies.

Bharat Biotech has entered into a partnership with Biofabri, a Spanish biopharmaceutical firm, for the development, manufacturing and marketing of a new tuberculosis vaccine. This partnership will guarantee the supply of TB vaccines in more than 70 countries especially in Southeast Asia, and sub-Saharan Africa with a high TB incidence.