Pharma News

Bayer Corporation and its related entities have agreed to pay USD 40 million to resolve alleged violations of the False Claims Act in connection with the drugs Trasylol, Avelox and Baycol.

The settlement announced yesterday arose from two whistleblower lawsuits filed and pursued by Laurie Simpson, a former employee of Bayer who worked in its marketing department. 

The U.S. Food and Drug Administration is the first regulatory authority to approve spesolimab as a treatment option for generalized pustular psoriasis (GPP) flares in adults, Boehringer Ingelheim announced today.

Spesolimab, marketed in the U.S. as SPEVIGO, is a novel, selective antibody that blocks the activation of the interleukin-36 receptor (IL-36R), a signaling pathway within the immune system shown to be involved in the pathogenesis of GPP.

Amneal Pharmaceuticals has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for IPX203, a novel, oral formulation of carbidopa/levodopa (CD/LD) extended-release capsules for the treatment of Parkinsons disease (PD).

IPX203 is a novel, oral formulation of CD/LD extended-release capsules designed for the treatment of Parkinson’s disease.

Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) to market Venlafaxine Extended-Release Tablets and Pregabalin Extended-Release Tablets.

USFDA has approved Venlafaxine Extended-Release Tablets, USP 37.5 mg, 75 mg, 150 mg and 225 mg Extended-Release (ER) Tablets and Pregabalin ER Tablets, USP 82.5 mg, 165 mg and 330 mg which is generic of Lyrica CR.

​Breakthrough discovery made by University of British Columbia scientists by developing an oral insulin tablet which will work as replacement for daily insulin injections.

Research from Indian roots and currently involved in research at  University of British Columbia Dr. Anubhav Pratap Singh’s team developed a different kind of tablet that isn’t made for swallowing, but instead mouth-dissolving which dissolves when placed between the gum and cheek.

Dolutegravir-based antiretroviral therapies (ART) for HIV-1 are more effective for pregnant people than some other ART regimens commonly used in the U.S. and Europe, according to a study led by Harvard T.H. Chan School of Public Health researchers.

A new study from Washington University School of Medicine in St. Louis suggests a simple blood test administered before CAR-T cell treatment is initiated may identify which patients are predisposed to developing neurotoxic side effects after CAR-T cell therapy. Severe side effects can include seizures, brain swelling and strokes. Evidence of a stroke (red arrows) is seen on this MRI scan of the brain of a patient who developed neurotoxic side effects after CAR-T cell therapy.

Biological E. Limited (BE)'s 14-valent paediatric vaccine (investigational pneumococcal polysaccharide conjugate vaccine PCV14) is approved by the Subject Expert Committee of CDSCO  against S. pneumoniae infection in infants.

Streptococcus pneumoniae infection continues to be a leading cause of child mortality under 5 years of age in India and in developing countries. With the PCV14 vaccine, Biological E hopes to contribute to the prevention of invasive pneumococcal disease and protect millions of lives globally.

Cervavac was launched on September 1, 2022, after the Drugs Controller General of India had granted market authorization to Serum Institute of India. Cervavac is developed by a partnership of DBT and BIRAC with the Bill and Melinda Gates Foundation, supported by Serum Institute of India for the indigenous development of quadrivalent vaccines.

Dr Jitendra Singh said, this affordable and cost effective vaccine marks an important day for DBT and BIRAC as it takes India a step closer to PM Modi’s vision of Atmanirbhar Bharat.