Industry News

Sanofi and Provention Bio, Inc., a U.S.-based, publicly traded biopharmaceutical company focused on intercepting and preventing immune-mediated diseases including type 1 diabetes (T1D), have entered into an agreement under which Sanofi has agreed to acquire Provention Bio, Inc., for 25.00 per USD share in cash, representing an equity value of approximately 2.9 billion USD.

Global pharma major Lupin Limited announced that the United States Food and Drug Administration (U.S. FDA) has completed a Pre-Approval and GMP Inspection of its API manufacturing facility located in Visakhapatnam (Vizag), India. The inspection was conducted from March 6 to March 10, 2023 and concluded with no observations.

Pfizer Inc announced the U.S. Food and Drug Administration (FDA) has approved ZAVZPRET™ (zavegepant), the first and only calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray for the acute treatment of migraine with or without aura in adults. In its pivotal Phase 3 study, ZAVZPRET was statistically superior to placebo on the co-primary endpoints of pain freedom and freedom from most bothersome symptom at two hours post-dose.

Marksans Pharma Limited hereby announces that it has received final approval from US Food & Drugs Administration for its Abbreviated New Drug Application (ANDA) of Famotidine Tablets USP, 10 mg and 20 mg for over-the-counter (OTC) use.

The product is bioequivalent to the reference listed drug (RLD), Pepcid AC® tablets, a registered trademark of Johnson & Johnson Consumer Inc. which has sales of over $ 200 million in the US market.

NATCO Pharma Limited announces the launch of additional strengths for the generic version of Revlimid® (lenalidomide capsules), in 2.5 mg, and 20 mg strengths, in the United States, through its marketing partner Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd.

With this launch the companies made available all the strengths of lenalidomide in the US market. Lenalidomide capsules are a prescription medicine used in adults for the treatment of multiple myeloma.

Amneal Pharmaceuticals, Inc. announced the U.S. Food and Drug Administration (FDA) has accepted for review the Abbreviated New Drug Application (ANDA) for naloxone hydrochloride nasal spray, USP, 4mg, which is the generic version of Narcan® and is used in the treatment of a known or suspected opioid overdose emergency.

Alembic Pharmaceuticals Limited announced it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Fluorouracil Injection USP, 2.5 g/50 mL (50 mg/mL) Pharmacy Bulk Vial. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Fluorouracil Injection, 2.5 g/50 mL (50 mg/mL), of Spectrum Pharmaceuticals, Inc. (Spectrum).

Hetero group to invest Rs. 1000 crore in Andhra Pradesh to expand its pharmaceutical and specialist business, said Vamsi Krishna Bandi, Managing Director of Hetero.

There was Global Investors Summit 2023 organised at Visakhapatnam where he said, "We are committed to Andhra Pradesh and will continue to expand our presence here. We'll be investing about Rs 1,000 crore in Andhra Pradesh over the next two years to grow our pharmaceutical and specialty business. This will generate employment for a minimum of 3,000 people."

Dr. Reddy's Laboratories SA, wholly-owned subsidiary of Dr. Reddy’s Laboratories Ltd announced that it has entered into a definitive agreement to acquire the U.S. generic prescription product portfolio of Salisbury, Australia, based Mayne Pharma Group Limited.