Industry News

Regulatory submission for the treatment of anaemia of chronic kidney disease based on the ASCEND phase III clinical trial programme, consisting of five trials that all met their primary efficacy and safety endpoints in non-dialysis and dialysis patients.

US FDA regulatory submission acceptance is the third major regulatory milestone for daprodustat following the European Medicines Agency (EMA) regulatory submission acceptance and approval of Duvroq in Japan

Takeda announced that it has received manufacturing and marketing approval from the Japan Ministry of Health, Labour and Welfare (MHLW) for Nuvaxovid® Intramuscular Injection (Nuvaxovid), a novel recombinant protein-based COVID-19 vaccine, for primary and booster immunization in individuals aged 18 and older. Novavax licensed and transferred its manufacturing technologies to enable Takeda to develop and manufacture the vaccine at its facility in Hikari. Takeda will begin distribution of Nuvaxovid doses purchased by the Government of Japan as soon as possible.

Serum institute of India, SII, gets exemption for Pneumococcal Polysaccharide Conjugate Vaccine from price control by National Pharmaceutical Pricing Authority  for five years.

Basilea Pharmaceutica Ltd a commercial-stage biopharmaceutical company committed to meeting the needs of patients with infectious diseases and cancer, reported today that promising preclinical data on the anti-cancer activity of its three oncology drug candidates, BAL0891, derazantinib and lisavanbulin, have been presented at the Annual Meeting of the American Association for Cancer Research (AACR) that took place April 8-13, 2022, in New Orleans, USA.

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.