Enzyvant regenerative therapy for rare immune disorder rejected by USFDA over manufacturing concerns Medical Dialogues Bureau8 Dec 2019 9:02 AM ISTEnzyvant was hoping to win its first approval for the therapy, RVT-802, aimed at treating congenital athymia, a disorder affecting babies born without...
UCB psoriasis drug Bimekizumab beats AbbVie blockbuster Humira in late-stage trial Medical Dialogues Bureau8 Dec 2019 8:59 AM ISTUCB's drug, Bimekizumab, also met the main goal of clearing or almost clearing the skin of plaques or rashes in a late-stage study, as assessed by an...
Dr Reddys launches generic version of Hemabate injection indicated for abortion in US Medical Dialogues Bureau7 Dec 2019 12:46 PM ISTCarboprost Tromethamine injection for aborting a pregnancy is a generic version of Pfizer's Hemabate injection in the strength of 250 mcg/mL, Dr...
Take action against chemists selling prescription drugs OTC sans authorization: HC directs Govt Medical Dialogues Bureau7 Dec 2019 10:07 AM ISTThe petition had alleged that chemists dealing in the retail sale of medicines are selling antibiotics and medicines mentioned in Schedule H and H1 of...
Diabetes drug Metformin under USFDA lens for presence of cancer-causing impurities Medical Dialogues Bureau7 Dec 2019 9:35 AM ISTMetformin is a first-line medication for the treatment of type 2 diabetes. It helps control high blood sugar and is marketed under a number of brand...
Eli Lilly new cancer research unit Loxo Oncology to be run by Loxo executives Medical Dialogues Bureau7 Dec 2019 9:15 AM ISTThe new unit, to be called Loxo Oncology at Lilly, will include experimental cancer drugs from both Eli Lilly's and Loxo's developmental pipelines.New...
Insurance coverage for CAR-T cell therapies from Novartis, Gilead get Swiss Govt nod Medical Dialogues Bureau7 Dec 2019 9:10 AM ISTThe health department said the decision covered Novartis's Kymriah and Gilead's Yescarta.New Delhi: The Swiss government approved on Friday health...
Biogen builds case for its Alzheimers drug aducanumab, skeptics say more data needed Medical Dialogues Bureau7 Dec 2019 9:00 AM ISTIf approved, Biogen Inc's aducanumab would be the first treatment designed to delay the progression of the fatal, mind-robbing disease for millions of...
Zydus Cadila files NDA with DCGI for liver disease drug Saroglitazar Magnesium Medical Dialogues Bureau6 Dec 2019 1:31 PM ISTSaroglitazar Magnesium was launched in India during September 2013, for the treatment of hypertriglyceridemia and diabetic dyslipidemia in patients...
FIRST: Mankind Pharma unveils infertility drug Dydrogesterone in India Farhat Nasim6 Dec 2019 11:04 AM ISTWith the launch of generic Dydrogesterone tablets, Mankind Pharma has become the first Indian and second global firm to develop the drug for the...
Profitability of pharma firms unhurt by proposed cap on trade margins: Fitch Medical Dialogues Bureau6 Dec 2019 9:20 AM IST"India's proposal to cap trade margins...will not significantly hurt the profitability of pharmaceutical companies, as the proposal does not restrict...
Shilpa Medicare Raichur facility gets EIR from USFDA Medical Dialogues Bureau6 Dec 2019 9:15 AM ISTThe company announced successful closure of the inspection conducted at its active pharmaceutical ingredient (API) manufacturing site at Raichur with...