Pharma News

Alembic Pharmaceuticals Limited announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Ivabradine Tablets, 5 mg and 7.5 mg. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Corlanor Tablets, 5 mg and 7.5 mg, of Amgen Inc. (Amgen).

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.

How does a cell “decide” what type of cell to become? The question of “cell fate” has been explored for decades now, especially in the context of stem cell biology, but there are still gaps in our understanding. For example, any multicellular organism is made up of different cell types that play specific roles, while they all work together to sustain the organism as a whole.

Researchers have found that treating prostate cancer cells with novel cyclin-dependent kinase 19 (CDK19) and homologous cyclin-dependent kinase 8 (CDK8) inhibitors reduces their potential to migrate into and invade surrounding structures. These molecules may be used as single or combination therapy for patients with advanced disease to prevent and treat metastatic spread. The results appear in The American Journal of Pathology, published by Elsevier.

Noninvasive sound technology developed at the University of Michigan breaks down liver tumors in rats, kills cancer cells and spurs the immune system to prevent further spread an advance that could lead to improved cancer outcomes in humans.  By destroying only 50% to 75% of liver tumor volume, the rats’ immune systems were able to clear away the rest, with no evidence of recurrence or metastases in more than 80% of animals.

Scientists at Scripps Research and the National Institute of Dental and Craniofacial Research have discovered a special type of cell that resides in salivary glands and is likely crucial for oral health.