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Bharat Biotech updates on the Lancet study on Covaxin efficacy
News | November 25, 2021

Bharat Biotech updates on the Lancet study on Covaxin efficacy

An effectiveness result of 50 per cent achieved during the peak delta variant Covid-19 wave in India, in a highrisk study population of physicians and healthcare workers, in a hospital environment, provides insights into the efficacy and effectiveness of Covaxin


Arrowhead Pharmaceuticals enters agreement with GSK to develop NASH drug candidate
Biotech | November 24, 2021

Arrowhead Pharmaceuticals enters agreement with GSK to develop NASH drug candidate

Arrowhead to receive US $ 120 million upfront payment for Phase 1/2 program for NASH and is eligible to receive potential milestone payments and royalties on commercial sales


U.S. FDA approves first treatment for drug-resistant post-transplant infection
Drug Approval | November 24, 2021

U.S. FDA approves first treatment for drug-resistant post-transplant infection

The approval is for Cytomegalovirus, a type of Herpes virus


Zydus Cadila submits NDA to Drug Controller General of India for Chronic Kidney Disease
Biotech | November 23, 2021

Zydus Cadila submits NDA to Drug Controller General of India for Chronic Kidney Disease

The NDA for Desidustat is based on positive data from the DREAM-ND and DREAM-D Phase 3 trials in patients with Chronic Kidney Disease (CKD) Not on Dialysis and Dialysis


Alembic receives tentative U.S. FDA approval for Dabigatran Etexilate capsules
Drug Approval | November 23, 2021

Alembic receives tentative U.S. FDA approval for Dabigatran Etexilate capsules

Dabigatran Etexilate capsules are indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, and for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE)


Indian pharma CEOs bet big on innovation to achieve US $130 bn
News | November 23, 2021

Indian pharma CEOs bet big on innovation to achieve US $130 bn

While industry steps out of its comfort zone to innovate, the government has to support by allocating funds across research lifecycle and offer incentives for innovation


Obseva announces U.S. FDA acceptance of new drug application for linzagolix
Biotech | November 23, 2021

Obseva announces U.S. FDA acceptance of new drug application for linzagolix

Obseva announced previously that the company has entered into a partnership with Syneos Health to support commercialization of linzagolix in the US and EU


Boehringer Ingelheim gets CDSCO nod for Jardiance
Drug Approval | November 23, 2021

Boehringer Ingelheim gets CDSCO nod for Jardiance

Jardiance is the first SGLT2-inhibitor therapy to prove reduction in risk of cardiovascular death in people with type-II diabetes and established cardiovascular disease


FDA grants Theradaptive Breakthrough Medical Device designation
Medical Device | November 22, 2021

FDA grants Theradaptive Breakthrough Medical Device designation

Theradaptive's regenerative implants are best-in-class and are designed to permit precise tissue regeneration for a variety of tissue types and clinical indications


Merck showcases potential for several cancers, MS and lupus
News | November 22, 2021

Merck showcases potential for several cancers, MS and lupus

Five potential first-in-class assets aimed at delivering significant long-term growth. Over 14 clinical development programs underway across portfolio and 11 new studies to start in 2022 across early- and late-stage pipeline