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CLINICAL TRIAL WAIVER
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...- Generic HIV drug rollout to take a hit on trial pushIndia's decision to reject a waiver for local clinical trials of a new HIV drug, lenacapavir, is causing concern. Public health experts war...
- Govt prescribes faster access to medicines for rare diseasesIndia is streamlining access to rare disease drugs by waiving local clinical trials for some medications. The drug regulator is expediting ...
- India denies clinical trial waivers for In-vitro diagnostics despite global approvalsIndia's Drugs Technical Advisory Board decides against waiving clinical trials for In-vitro Diagnostics despite their approval in other cou...
- Quick access to key HIV drug hinges on waiver of local clinical trials: ExpertsFaster access to HIV drug lenacapavir in India hinges on the waiver of local clinical trials. Six companies, including three from India, ha...
- 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...
- India waives clinical trial requirement for drugs approved in developed marketsIndia has waived clinical trial requirements for new drugs with significant therapeutic advances that have been approved in the US, UK, Jap...
- CBI Probe: Biocon denies bribery charges, says it followed due process of lawThe Bengaluru-headquartered company, in a statement, said it is governed by a strong code of conduct and condemns any acts of corruption an...
- Biocon arm denies bribery charges, says cos follows code of conductThe guidelines provide a framework for waiver of phase III clinical trials in India based on a commitment to undertake a phase IV trial, th...
- Biocon Biologics denies bribery charge; says it follows due regulatory process for product approvalsThe CBI has arrested Joint Drugs Controller S Eswara Reddy, Associate Vice President of Biocon Biologics L Praveen Kumar and three others i...
- SEC no to clinical trial waiver for Pfizer's Covid pillThe SEC asked the companies to conduct bioavailability and bioequivalence (BA/BE) studies and submit safety data at its meeting on Friday, ...
- SEC denies emergency nod to Natco Covid-19 drugNatco had in December sought a waiver of the clinical trial requirement for the emergency use of baricitinib tablets in Covid-19 treatment,...
- US pharma giant seeks marketing authorisation from India for remdesivir"Gilead Sciences has applied seeking marketing authorisation for its anti-viral drug remdesivir to India's Central Drugs Standard Control O...
- Cipla and Hetero seek clinical trial waiver for RemdesivirWhile all new drugs must undergo trials before getting marketing approval in India, the regulator can grant exemptions in public interest a...
- Mylan, TB Alliance seeks clinical trial waiver for Pretomanid drugPretomanid, a new oral treatment is a shorter more convenient option for people with extensively drug resistant (XDR) TB. The dossier for g...
- Sanofi continues to seek clinical trial waiver in India for controversial dengue vaccinePhase 3 trials are the last phase of clinical trials that a company conducts before it receives approval to market the drug here.
- Centre mulls waiving off clinical trials on humans for critical drugsThough such waivers are still approved by the drug regulator on case to case basis, the ministry now plans to bring in legal provisions und...
- India waives large-scale clinical trials for Sanofi's dengue vaccineAn expert consultative committee of the Indian drug regulatory agency has waived a large-scale clinical trial for a dengue vaccine develope...
- Hepatitis C cure may cost as low as Rs 67,000India is now one of the few countries where generics are available for interferon-free treatment of Hepatitis C.
- Government panel moots clinical trial waiver for two cancer drugsThe two medicines - Aflibercept and Trastuzumab emtansine - are used in treatment of metastatic colorectal cancer and metastatic breast can...
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