OBI Pharma gets USFDA clearance for OBI-999 to treat pancreatic cancer Medical Dialogues Bureau29 Dec 2019 9:15 AM ISTNew Delhi: OBI Pharma, a Taiwan biopharma company, recently announced that the U.S. Food and Drug Administration (FDA) has cleared an investigational...
Luye Pharma seeks USFDA nod for antidepressant drug LY03005 Medical Dialogues Bureau29 Dec 2019 9:00 AM ISTNew Delhi: Luye Pharma Group has announced that the New Drug Application (NDA) for Risperidone Extended-Release Microspheres for Injection (LY03004),...
JnJ to pay Rs 230 crore fine for not passing GST rate cut benefits to customers Farhat Nasim28 Dec 2019 4:03 PM ISTNew Delhi: Healthcare major, Johnson and Johnson (JnJ) recently landed in soup after the National Anti-profiteering Authority (NAA) found that its...
Towa Pharma to acquire ESTEVE generic division Pensa Investments for 320 million euros Medical Dialogues Bureau28 Dec 2019 9:15 AM ISTThe purchase price of Pensa will be an all-cash deal with an upfront payment of 320 million euros. This acquisition is scheduled to be completed by...
Immunomedics BLA resubmission for sacituzumab govitecan to treat breast cancer accepted by USFDA Farhat Nasim28 Dec 2019 9:10 AM ISTSacituzumab govitecan has been awarded both Fast Track Designation and Breakthrough Therapy Designation by the USFDA, Immunomedics said in its recent...
Spring Bank Pharma halts dosing of Inarigivir patients in phase-2 trial to treat chronic HBV Medical Dialogues Bureau28 Dec 2019 9:00 AM ISTNew Delhi: Spring Bank Pharmaceuticals, Inc. (Nasdaq: SBPH), a clinical-stage biopharmaceutical company developing novel therapeutics for the...
Granules India Independent Director C Parthasarathy resigns Medical Dialogues Bureau27 Dec 2019 3:55 PM ISTC Parthasarathy was serving the company since May 27, 2009. However, he submitted his resignation from the Board of Governors of Granules India Ltd....
Zydus Cadila to divest two major units- Vivo, Gynova for Rs 1200 crore: Report Farhat Nasim27 Dec 2019 1:12 PM ISTNew Delhi: Envisioning to off-load the burden of debts, one of India's top drugmakers- Zydus Cadila aka Cadila Healthcare is likely to vend its...
Lupin Ankleshwar facility wins India Manufacturing Excellence Awards 2019 Medical Dialogues Bureau27 Dec 2019 9:30 AM ISTThe 2019 evaluation was done on the basis of an organisations’ Manufacturing Capability, Extended Supply Chain Reliability and Technology Adoption,...
Astellas Pharma acquires Xyphos for USD 665 million Farhat Nasim27 Dec 2019 9:25 AM ISTJapan's second-biggest drugmaker by sales paid $120 million upfront for Xyphos and the rest will be milestone payments, Astellas Pharma and Xyphos...
Correvio Pharma heart drug Brinavess fails to get USFDA nod Medical Dialogues Bureau27 Dec 2019 9:22 AM ISTIn the so-called complete response letter, the USFDA stated that while the submitted data provide substantial evidence of the drug's effectiveness,...
Lannett gets USFDA nod for Butalbital, Acetaminophen and Caffeine Capsules Medical Dialogues Bureau27 Dec 2019 9:20 AM ISTThe two dosage strengths of BAC Capsules, have a combined estimated IQVIA market value of approximately $68.6 million for the 12 months ending October...