GSK gets USFDA nod for Benlysta to treat pediatric patients with lupus Medical Dialogues Bureau30 April 2019 9:15 AM ISTNew Delhi: GlaxoSmithKline (GSK) has won the US Food and Drug Administration's (USFDA) approval for its Benlysta (belimumab) intravenous (IV) infusion...
Pfizer gets CHMP opinion for Talzenna for patients with metastatic breast cancer Farhat Nasim29 April 2019 9:35 AM ISTThe positive CHMP opinion of TALZENNA follows the medicine's approval by the U.S. Food and Drug Administration (FDA) in October 2018.New Delhi:...
Roche withdraws refiling of Premerger Notification, Report Form under the HSR Act Farhat Nasim28 April 2019 9:45 AM ISTRoche has elected to withdraw and refile the Premerger Notification and Report Form under the HSR Act.New Delhi: Roche and Spark Therapeutics, Inc....
Sun Pharma gets 11 USFDA observations for Dadra plant, BSE asks for response: Report Farhat Nasim26 April 2019 2:20 PM ISTNew Delhi: Sun Pharmaceutical (Sun Pharma) Industries Ltd's Dadra plant has reportedly received 11 observations, "serious" in nature from the U.S....
Zydus Cadila gets final USFDA nod for Leflunomide tablets to treat arthritis Farhat Nasim26 April 2019 12:49 PM ISTLeflunomide tablet is used to treat rheumatoid arthritis, a condition affecting multiple small and large joints of the body.New Delhi: Drug firm Zydus...
Indoco Remedies: USFDA retains OAI status for Goa plant Farhat Nasim25 April 2019 9:50 AM ISTIndoco Remedies' spokesperson said that the move is likely to withhold approval of pending abbreviated new drug applications (ANDAs) from Goa...
Rochester Drug Cooperative fined $20 million in criminal case against drug distributor over opioids Medical Dialogues Bureau24 April 2019 9:00 AM ISTThe company where the executives worked, Rochester Drug Cooperative (RDC), is one of the country's largest distributors of prescription opioids. It...
Mylan, TB Alliance to commercialize Pretomanid to treat TB Farhat Nasim23 April 2019 10:00 AM ISTTB Alliance began preclinical development of pretomanid in 2002, and it has since studied pretomanid in 20 clinical trials alone or in combination...
Eli Lilly to sell legacy antibiotics brands Ceclor, Vancocin, China facility to Eddingpharm Farhat Nasim23 April 2019 9:45 AM ISTINDIANAPOLIS: Eli Lilly and Company today announced that it has entered into an agreement to sell the rights in China for two legacy Lilly antibiotic...
Cipla appoints Dr Raju Mistry as Global Chief People Officer Medical Dialogues Bureau23 April 2019 9:15 AM ISTIn her role at Cipla, Raju Mistry will oversee Human Resources, and Administration and Facilities Management. She will be a member of the Management...
Patent Infringement: Cadila Healthcare, two others prohibited from launching Linagliptin Metformin Hydrochloride tablets Meghna A Singhania22 April 2019 2:07 PM ISTAHMEDABAD: In a major setback, three Gujarat based pharmaceutical companies including Cadila Healthcare, West Coast Pharmaceutical Works Ltd and Maan...
Drugs registered on SUGAM portal to be exempted from obtaining licence for purpose of examination, test, analysis Meghna A Singhania21 April 2019 2:26 PM ISTThe exemption from obtaining a licence for Form 29 is subject to the condition that the information about the manufacturing of approved drugs for...
