SETBACK: Novartis Zolgensma study halted by USFDA amid safety concerns Medical Dialogues Bureau31 Oct 2019 9:45 AM ISTNovartis shares fell 1% at 0715 GMT, while other European drugmakers rose. Analysts said more information was needed to assess whether these findings...
GSK lifts annual profit forecast after third quarter beat on vaccines strength Medical Dialogues Bureau31 Oct 2019 9:00 AM ISTGSK now expects full-year profit to be roughly flat compared to last year at constant currency, up from a previous forecast of a fall of 3% to 5%.New...
New tests shows NO sign of asbestos in recalled JnJ baby powder Medical Dialogues Bureau30 Oct 2019 1:18 PM ISTBut Johnson & Johnson (JnJ) said in a statement that dozens of tests by two outside firms did not detect any asbestos in JnJ's baby powder.New...
Pfizer cancer drug Ibrance higher sales beat Q3 profit estimates Medical Dialogues Bureau30 Oct 2019 9:30 AM ISTPfizer said it expects to earn between $2.94 per share and $3.00 per share, up from a prior estimate of $2.76 to $2.86. Analysts on average were...
Dr Reddys Srikakulam plant gets 4 USFDA observations Farhat Nasim29 Oct 2019 10:00 AM ISTThe audit of Dr Reddy's API Srikakulam Plant (SEZ) by the United States Food and Drug Administration (USFDA) was completed on Friday, the...
Alkem Labs Bioeguivalcnce Center at Taloja clears USFDA inspection Medical Dialogues Bureau28 Oct 2019 10:00 AM IST"This is to inform that the US FDA had conducted an inspection at Alkem Laboratories Ltd's Bioequivalence Center located at Taloja, Maharashtra from...
CDSCO committee tells Roche to submit Phase III clinical trial data of blood cancer combo drug Farhat Nasim27 Oct 2019 11:30 AM ISTNew Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO), recently recommended drugmaker,...
Shilpa Medicare Telangana facility gets EIR from USFDA Medical Dialogues Bureau26 Oct 2019 11:46 AM IST"The USFDA has concluded that the inspection classification of Jadcherla facility was "voluntary action indicated". This facility is in an acceptable...
Dr Reddys recalls Ranitidine products in US over cancer-causing impurity Medical Dialogues Bureau24 Oct 2019 9:30 AM ISTThis recall follows the USFDA's caution note alerting patients and healthcare professionals that NDMA was found in certain samples of ranitidine, Dr...
Cipla acquires novel anti-infective Elores to further antimicrobial stewardship in critical care in India Medical Dialogues Bureau18 Oct 2019 1:50 PM ISTMumbai: Cipla Limited announces the acquisition of a novel and patented anti-infective product, Elores, from Venus Remedies Limited ("VRL") for the...
Illegal renting of licences to Chemists: 241 Gujarat Pharmacists lose Registration Medical Dialogues Bureau17 Oct 2019 12:19 PM IST"This is the first time in India when such large number of pharmacists have been penalised. We have also issued warnings to around 3,000 pharmacists...
Mylan moves application with DCGI to launch new TB drug Pretomanid in India Medical Dialogues Bureau16 Oct 2019 4:10 PM IST"We have submitted the new drug application to the office of DCGI. We are in an advanced stage of discussion and are working with the office of...
