Industry News

​U.S. Food and Drug Administration (FDA) is alerting health care providers about potential clip lock malfunctions with MitraClip Delivery Systems manufactured by Abbott.

An increased rate of reports of clip lock malfunctions has been observed before and after clip deployment. These events appear to occur in approximately 1.3% of MitraClip procedures and have been observed with all device models, said Abbott.

Cipla and Dr Reddys Lab receives FDA nod for marketing of generic version of REVLIMID (lenalidomide) Capsules. Both companies have received final approval of its Abbreviated New Drug Application (ANDA) for Lenalidomide Capsules.

With this volume-limited launch, Dr. Reddy’s Lab is eligible for first-to- market, 180 days of generic drug exclusivity for Lenalidomide Capsules in 2.5 mg and 20 mg strengths.

AstraZeneca’s Forxiga (dapagliflozin), a sodium-glucose cotransporter 2 (SGLT2) inhibitor, has been approved in China to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease (ESKD), cardiovascular (CV) death and hospitalisation for heart failure (hHF) in adults with chronic kidney disease (CKD) at risk of progression with and without type-2 diabetes (T2D).

Lupin and DKSH have signed an exclusive license and supply agreement to commercialize five of Alvotechs proposed biosimilars in the Philippines. The biosimilars planned under this agreement include biosimilar Prolia, Xgeva, Simponi, and Eylea as well as two undisclosed proposed biosimilars for immunology and oncology.

GE Healthcare, a leading global medical technology, diagnostics and digital solutions innovator, has announced the launch of its first Made in India, AI-powered Cath lab - Optima IGS 320 to advance cardiac care in India.

​​​​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.

​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.