Industry News

​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.

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.

Aurobindo Pharma to invest Rs. 300 crores for expanding its mammalian cell culture manufacturing facility of CuraTeQ Biologics which is a fully owned subsidiary of the Drug maker.

There was a meeting held on 1st september where all the board members agreed to expand its operations by establishing another mammalian cell culture manufacturing facility of higher capacity to cater to the future requirements. The capital expenditure for ramping up capacities is estimated to be around Rs.300 crores.

Novo Nordisk and Forma Therapeutics, Holdings Inc. announced that they have entered into a definitive agreement under which Novo Nordisk will acquire Forma Therapeutics for USD 20 per share in cash, which represents a total equity value of USD 1.1bn. Forma Therapeutics is a clinical-stage biopharmaceutical company focused on transforming the lives of patients with sickle cell disease (SCD) and rare blood disorders.

Novo Nordisk has agreed to pay USD 6.3 million to resolve allegations that it violated the False Claims Act by selling items to the United States that were manufactured in non-designated countries.

The settlement resolves allegations that Novo Nordisk violated the Trade Agreements Act, which restricts the procurement of goods under certain government contracts to purchases from specific designated countries, by submitting false claims for payment for medical devices that were manufactured in non-designated countries.