Pharma News

Antitrust case filed against Dr Reddys Labs in the US over maintaining a shared monopoly in the sale of brand and generic Revlimid through their respective settlements of patent litigation with other pharmaceutical companies.

Dr Reddys Lab along with Celgene, Bristol Myers Squibb and several generic pharmaceutical companies, were named as defendants in a complaint filed on November 18, 2022, in the District of New Jersey, USA.

Amneal Pharmaceuticals, Inc announced the commercial launch of RELEUKO® (filgrastim-ayow), a biosimilar referencing Neupogen®. RELEUKO® is used to treat neutropenia which is commonly experienced by patients undergoing chemotherapy. This product was developed in collaboration with Kashiv Biosciences, LLC located in Chicago, Illinois.

With the continuous emergence of new variants and the risk of new strains of the virus, the development of innovative therapies against SARS-CoV-2 remains a major public health challenge. Currently, the proteins that are on the surface of the virus and/or are involved in its replication are the preferred therapeutic targets, like the Spike protein targeted by vaccines. One of them, the non-structural protein Nsp1, had been little studied until now.

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.

Flu shots can save the lives of people with cardiovascular disease by reducing cardiac complications as well as preventing influenza.

An international study led by McMaster University researchers and published in The Lancet Global Health has found that influenza vaccines greatly reduce both pneumonia and cardiovascular complications in people with heart failure.