Industry News

Rhizen Pharmaceuticals AG, a Switzerland-based privately held, clinical-stage oncology & inflammation-focussed biopharmaceutical company, announced the release of data on its differentiated next-generation clinical-stage PARP (Poly ADP-Ribose Polymerase) and DHODH (DiHydro Orotate DeHydrogenase) inhibitor programs at the American Association for Cancer Research (AACR) 2022 Annual Meeting.

Novartis announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval to Vijoice (alpelisib) for the treatment of adult and pediatric patients 2 years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) who require systemic therapy. Vijoice is the first FDA-approved treatment for PROS, a spectrum of rare conditions characterized by overgrowths and blood vessel anomalies impacting an estimated 14 people per million.

Saladax Biomedical, Inc. (Saladax) is pleased to announce that it has acquired a patent portfolio for antipsychotic drug testing from Janssen Pharmaceutica NV. This intellectual property (IP) portfolio includes 17 patent families and has resulted in 33 U.S. patents and 296 patents in ex-U.S. countries. This IP, along with the current Saladax IP, covers the major antipsychotic drugs that are prescribed worldwide and places Saladax in a premier position in the antipsychotic drug testing field.

Alembic Pharmaceuticals Limited has acquired the balance 40 percent stake in Aleor Dermaceuticals Limited from its JV Partner Orbicular Pharmaceutical Technologies Private Limited to strengthen its skin-related manufacturing and marketing footprint. Aleor has product offerings across Cream, Gel, Ointment, Shampoo, Lotion, Solutions, Sprays, Foams, Microsponge and Nanoparticulate platform-based products.

The Japanese Ministry of Health, Labor, and Welfare (MHLW) has granted marketing authorization for Xenpozyme  (olipudase alfa) for the treatment of adult and pediatric patients with non-central nervous system (non-CNS) manifestations of acid sphingomyelinase deficiency (ASMD), a rare, progressive, and potentially life-threatening genetic disease.

Pharma Giant Pfizer recalls blood pressure medicines, brand name as Accuretic from the US market over presence of cancer causing impurities. Accuretic is a combination of quinapril HCl and hydrochlorothiazide.

Abbott received permission from the Subject Expert Committee to market a fixed dose combination (FDC) of Lidocaine and Diltiazem, after detailed deliberation by committee.

Abbott has presented a Phase III clinical trial report before the committee and after detailed deliberation, the committee recommended grant of permission for manufacturing and marketing of the proposed FDC.

Indoco Remedies Ltd. announces final approval from the United States Food and Drug Administration (USFDA) for Lacosamide Tablets USP 50 mg, 100 mg, 150 mg and 200 mg, the generic version of Vimpat Tablets of UCB, Inc.

Lacosamide Tablets are indicated for the prevention and control of seizures. It is an anticonvulsant / antiepileptic drug.

Novavax, Inc a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, and Serum Institute of India Pvt. Ltd. (SII), the worlds largest vaccine manufacturer by volume, announced that the Drugs Controller General of India has granted emergency use authorization (EUA) for Novavax protein-based COVID-19 vaccine for adolescents aged ≥12 to <18 years in India.