Industry News

Pfizer Limited announced that its Board of Directors has appointed Meenakshi Nevatia as an Additional Director and the Managing Director for a period of five years with effect from 3rd April 2023. She succeeds S.Sridhar, who announced his early retirement in August 2022.

Sun Pharma including its subsidiaries and/or associate companies) announced that one of its wholly owned subsidiaries has received final approval from US FDA for its Abbreviated New Drug Application (ANDA) for generic lenalidomide Capsules, 5mg, 10mg, 15mg, 25mg and tentative approval for 2.5mg, 20mg.

The respective product approval is based on Revlimid® Capsules, 5mg, 10mg, 15mg, 25mg and 2.5mg, 20mg as a reference product.

Lupin Limited announced that it has received tentative approval from the United States Food and Drug Administration (FDA) under the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application for Dolutegravir, Emtricitabine and Tenofovir Alafenamide (DETAF) Tablets. This product would be manufactured at Lupin’s Nagpur facility in India.

DETAF would be a welcome new addition in the management of HIV infections and will be available for supplies to low- & middle-income countries.

Pfizer said that it has conducted research where the original SARS-CoV-2 virus has been used to express the spike protein from new variants of concern. This work is undertaken once a new variant of concern has been identified by public health authorities.

Alkem has announced the launch of its novel anti-infective Ceftazidime-Avibactam injection, under the brand name, Zidavi in India. It is known to be effective against multi-drug resistance, MDR infections.

In India, with the rise in carbapenem-resistant Gram-negative organisms, there is a need for treatments more effective than the existing antibiotics. Zidavi is a 3rd generation antibiotic.

The World Health Organization (WHO) and Gilead Sciences have signed a new agreement for the donation of 304,700 vials of AmBisome (liposomal amphotericin B for injection), for the treatment of visceral leishmaniasis in countries most impacted by the disease, extending their previous agreement to 2025.

Glenmark Pharmaceuticals Ltd, an innovation-driven, global pharmaceutical company, is the first to launch in India a unique I.V. injection formulation, AKYNZEO® I.V., for the prevention of chemotherapy-induced nausea and vomiting (CINV), under an exclusive licensing agreement with Helsinn, a Swiss biopharma group company.

Granules India Limited announced that the US Food & Drug Administration (US FDA) has approved the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals, Inc (GPI)., a wholly-owned foreign subsidiary of the company, for Amphetamine Mixed Salts, 5mg, 10mg, 15mg, 20mg, 25mg, and 30mg Extended-Release (ER) capsules. It is bioequivalent to the reference listed drug product (RLD), Adderall XR® Extended-Release capsules of Takeda Pharmaceuticals USA Inc.

Sun Pharmaceutical Industries Limited  and Concert Pharmaceuticals, Inc announced that they have executed a definitive agreement under which Sun Pharma will acquire all outstanding shares of Concert through a tender offer for an upfront payment of 8.00 USD per share of common stock in cash, or 576 USD million in equity value.