Industry News

Glenmark Pharmaceuticals Inc., USA (Glenmark) and Glenmark Pharmaceuticals Limited have reached a settlement agreement with Pfizer Inc., PF Prism C.V., and PF Prism IMB B.V. (Pfizer) for Axitinib Tablets, 1 mg and 5 mg, the generic version of their Inlyta®1 Tablets, 1 mg and 5 mg.

Glenmark had previously announced it received tentative approval by the United States Food & Drug Administration (U.S. FDA) for their generic Axitinib Tablets, 1 mg and 5 mg on November 30, 2020.

USFDA has issued Form 483 with 10 observations for the Gundlamachnoor facility of Aurobindo Pharma.

The United States Food and Drug Administration (US FDA) inspected the Company Unit - IX, an intermediate facility situated at Gundlamachnoor Village, Sangareddy District, Telangana, from November 10 to November 18, 2022.

The U.S. Food and Drug Administration approved Tzield (teplizumab-mzwv) injection to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years and older who currently have stage 2 type 1 diabetes.

Sun Pharmaceutical Industries Limited announced that the U.S. Food and Drug Administration (US FDA) has approved SEZABY  (phenobarbital sodium powder for injection) for the treatment of neonatal seizures. With this approval, SEZABY becomes the first and only product specifically indicated in the U.S. for the treatment of neonatal seizures in term and preterm infants. SEZABY is expected to be available in the U.S. in Q4FY23.

Strides Pharma Science Limited announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Potassium Chloride Oral Solution USP, 40 mEq/15mL (20%) from the United States Food & Drug Administration (USFDA).The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Potassium Chloride Oral Solution USP, 40 mEq/15 mL (20%) of Genus Lifesciences Inc.

BioNTech SE announced its Singapore affiliate BioNTech Pharmaceuticals Asia Pacific Pte. Ltd. had entered into an agreement with Novartis Singapore Pharmaceutical Manufacturing Pte. Ltd. to acquire one of its GMP-certified manufacturing facilities. The acquisition is part of BioNTech’s expansion strategy to strengthen its global footprint in Asia. Supported by the Singapore Economic Development Board (“EDB”), the facility will serve as BioNTech’s Regional Headquarters and become its first mRNA manufacturing facility in Singapore.

Bayer announced the acquisition of German biotech start-up Targenomix. The spin-off of the Max Planck Institute for Molecular Plant Physiology (MPI MPP) uses novel systems biology and computational life science tools to identify new modes of action for crop protection compounds.

Novartis announced results from the Phase II open-label extension ORION-3 trial, which showed that Leqvio provides effective low-density lipoprotein cholesterol (LDL-C) reduction over a four-year period in patients with either atherosclerotic cardiovascular disease (ASCVD) or ASCVD risk equivalent, and elevated LDL-C despite maximally tolerated statin therapy.

Viatris intends to create an ophthalmology franchise by acquiring Oyster Point Pharma and Famy Life Sciences.