Pharma News

Cedars-Sinai investigators have developed an investigational therapy using support cells and a protective protein that can be delivered past the blood-brain barrier. This combined stem cell and gene therapy can potentially protect diseased motor neurons in the spinal cord of patients with amyotrophic lateral sclerosis, a fatal neurological disorder known as ALS or Lou Gehrig's disease.

In the first trial of its kind, the Cedars-Sinai team showed that delivery of this combined treatment is safe in humans.

​​​​The overall Indian pharmaceutical market grown around 12.1 percent by value and 4.8 percent by volume in month of August as per the market research firm AWACS.

Almost all the therapy areas have shown a robust double-digit growth or in case of units the growth may be single digit due to NLEM permission to hike price come into the picture and number of companies have shown a good price driven growth for the month of August.

In a recent study researchers from Karolinska Institutet, among others, have characterised the new omicron variant BA.2.75, comparing its ability to evade antibodies against current and previous variants. The study, published in the journal The Lancet Infectious Diseases, suggests that BA.2.75 is not more resistant to antibodies than the currently dominating BA.5, which is positive news.

Men with low testosterone who develop COVID-19 are at elevated risk of becoming seriously ill and ending up in the hospital, according to a study by researchers at Washington University School of Medicine in St. Louis and Saint Louis University School of Medicine.

​Subject Expert Committee of CDSCO recommended amendment of indication of Typhoid Vi conjugate vaccine of Zydus Lifesciences to include the age group of 45-65 years for single dose only.

Earlier, Zydus Lifesciences had presented its proposal for grant of permission for the additional indication of Typhoid Vi conjugate vaccine for age group 45-65 years along with the Phase III clinical trial report.

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.