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U.S. FDA concludes inspection of Lupin’s Goa facility with seven observations
News | September 20, 2021

U.S. FDA concludes inspection of Lupin’s Goa facility with seven observations

The company said in a regulatory filing that it was confident of addressing the observations satisfactorily


RxDx Healthcare receives NABL accreditation
Clinical Trials | September 20, 2021

RxDx Healthcare receives NABL accreditation

RxDx is a chain of primary care driven multispecialty healthcare clinics with two main branches situated in Whitefield and Malleswaram in Bengaluru


Imfinzi plus chemotherapy tripled patient survival at 3 years
Biotech | September 20, 2021

Imfinzi plus chemotherapy tripled patient survival at 3 years

The CASPIAN Phase III trial in extensive-stage small-cell lung cancer is the longest survival follow-up ever reported for immunotherapy treatment in this setting


Novartis’ Kisqali data indicates longest median survival in advanced breast cancer
Drug Approval | September 20, 2021

Novartis’ Kisqali data indicates longest median survival in advanced breast cancer

With the MONALEESA-2 final analysis, only Kisqali has reported statistically significant overall survival (OS) benefit with an aromatase inhibitor for postmenopausal women with HR+/HER2- advanced breast cancer in the first-line (1L) setting


India to resume export of Covid-19 vaccines from October
Policy | September 20, 2021

India to resume export of Covid-19 vaccines from October

The country’s vaccine production has more than doubled since April and is set to touch 300 million doses next month


Excision receives U.S. FDA clearance for first-in-human CRISPR Phase I/II trail for HIV
Biotech | September 18, 2021

Excision receives U.S. FDA clearance for first-in-human CRISPR Phase I/II trail for HIV

Initiation of EBT-101 Phase 1/2 clinical trial expected later this year


India extends concession on life-saving Covid-19 drugs till December 2021
News | September 18, 2021

India extends concession on life-saving Covid-19 drugs till December 2021

The council has also reduced the GST to 5 per cent on a few more Covid-19 medicines


Roche receives positive CHMP opinion for Gavreto
Drug Approval | September 18, 2021

Roche receives positive CHMP opinion for Gavreto

If approved, Gavreto will be the first and only targeted treatment approved by the EMA that includes first-line treatment of people with RET fusion-positive advanced NSCLC


BMS receives positive CHMP opinion for Opdivo
Drug Approval | September 18, 2021

BMS receives positive CHMP opinion for Opdivo

The recommendation is based on positive results from the pivotal Phase 3 CheckMate -649 trial in which Opdivo plus chemotherapy demonstrated superior overall survival versus chemotherapy


Pharmexcil exhibition and conference on Sept 21-22
Events | September 18, 2021

Pharmexcil exhibition and conference on Sept 21-22

The event will include an exhibition and sector-wise sessions for two days with participation by officials from the Ministry of Commerce, export promotion councils and members of the industry