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CLINICAL TRIAL STANDARDS
Drug companies directed to step up vigil on adverse reactionsIndia's drug regulator, CDSCO, has mandated all drug companies to establish systems for tracking adverse drug reactions. This move comes am...
FDA approval puts Wockhardt’s Zaynich in $9 billion antibiotics marketWockhardt's new antibiotic, Zaynich, has received US FDA approval. This drug uses a novel mechanism to fight drug-resistant bacteria. It ta...
Johnson & Johnson prostate cancer drug reduces risk of cancer spread and death in late-stage studyThe study, which followed patients for over five years, found that those who received the regimen were nine times more likely to have lit...
Could space-grown stem cells unlock faster cancer treatments and revolutionize organ regeneration breakthroughs? NASA’s ISS experiments are revealing surprising answers about the power of microgravity medicineSpace stem cell research is rapidly changing cancer treatment and regenerative medicine worldwide. Scientists aboard the International Spac...
Wockhardt shares jump 8%, extend rally after CDSCO nod for Zaynich antibioticWockhardt shares surged after the company received CDSCO approval for its breakthrough antibiotic Zaynich in India. Strong Phase 3 trial re...
Wockhardt gets CDSCO nod for Zaynich antibioticWockhardt Ltd has secured approval from the CDSCO for its new antibiotic, Zaynich. This drug is developed in India and will be used to trea...
Tata-backed MedTherapy claims CAR-T breakthrough with one-day productionTata Sons-backed biotech startup MedTherapy said it has developed a next-generation CAR-T cell therapy manufacturing platform that can redu...
Hantavirus: Britain secures experimental Japanese drug to strengthen responseBritain has received experimental favipiravir from Japan to treat a deadly hantavirus outbreak. The drug is not licensed in the UK and its ...
Want to jump into the 'China is back' rally? Tread carefullyInvestors are increasingly betting that “China is back” as the economy rebounds from years of deflation, helped by strong manufacturing, ex...
Drugmakers must report safety data from launch date, not approval date: CDSCOIndia's drug regulator has issued a new directive for pharmaceutical companies. Periodic Safety Update Reports for new drugs must now be su...
Chinese medicines bring relief to India’s cancer patientsIndia’s cancer treatment landscape is seeing a shift as lower-cost immunotherapy drugs developed in China and marketed through Indian partn...
Are millions aging faster because of hidden vitamin B12 deficiency? New Cornell University research links low B12 to muscle weakness and metabolic declineVitamin B12 and healthy aging are now linked by striking new evidence from Cornell University. A landmark study published in the Journal of...
US judge rejects Bayer bid to block Johnson & Johnson prostate cancer drug claimsA US judge has dismissed Bayer's plea to halt Johnson & Johnson's advertising for its prostate cancer drug Erleada. Bayer alleged false cla...
Must explore how AFMS can make meaningful contribution in domain of clinical trials: Rajnath SinghDefence Minister Rajnath Singh highlighted the need for clinical trial reforms in India. He suggested the Armed Forces Medical Services can...
Roche Pharma partners with 10 govt hospitals to bolster clinical trial capabilities in IndiaRoche Pharma collaborates with ten government hospitals. The goal is to improve clinical trial capabilities across India. Nearly 400 profes...
CDSCO waives local trials for drugs approved in major marketsThe Central Drugs Standard Control Organisation (CDSCO) has decided to waive local clinical trials for certain drugs approved in select ICH...
Government looks to fast-track approvals for clinical trialsThe central drug regulator plans to fast track the approval process for clinical trials while ensuring that the contract research organisat...