Biogen announces $5 billion buyback days after shelving Alzheimers trials Garima26 March 2019 9:25 AM ISTBiogen had lost more than $18 billion of its value last week after the company and partner Eisai Co Ltd ended two late-stage trials of their...
Court allows ED to seek assistance from 21 countries in Sterling Biotech bank fraud case Garima25 March 2019 12:25 PM ISTNew Delhi: A Delhi court has allowed the Enforcement Directorate to send letters rogatory (LR) to 21 countries, involving the UK and the UAE, seeking...
Saracatinib gets Orphan Drug Designation for idiopathic pulmonary fibrosis Farhat Nasim25 March 2019 12:03 PM ISTThe US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for saracatinib, a potential new medicine for the treatment of...
Alkem Labs gets 8 USFDA observations for St Louis facility Farhat Nasim24 March 2019 9:50 AM ISTThe United States Food and Drug Administration (USFDA) had issued eight observations after inspecting the company's manufacturing plant at St Louis...
Setback: USFDA rejects Sanofi, Lexicon Sotagliflozin for type 1 diabetes Farhat Nasim24 March 2019 9:45 AM ISTThe decision comes about two months after an FDA advisory panel failed to reach a consensus over whether the once-daily oral drug, sotagliflozin,...
Jury finding upends Bayer Roundup defense strategy-Experts Garima24 March 2019 9:00 AM IST"The fact that Bayer lost this trial despite it being set up in the most favourable way for them is a huge setback," said Thomas Rohback, a...
Sterling Biotech: Accused in Rs 8100 crore loan fraud held in Albania Farhat Nasim23 March 2019 10:05 AM ISTThe ED had ensued a red corner notice against him from the Interpol on March 11. The detention has happened based on this warrant, the officials said....
Alembic Pharma gets USFDA nod for Azelastine Hydrochloride Ophthalmic Solution Farhat Nasim23 March 2019 10:00 AM ISTAlembic Pharma has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Azelastine...
Syngene International wins CMO Leadership Awards Garima23 March 2019 9:45 AM ISTSyngene was successfully rated across the six categories - Capabilities, Compatibility, Expertise, Quality, Reliability and Service – that were used...
Jazz Pharma gets USFDA nod to Solriamfetol to treat sleep disorder Farhat Nasim23 March 2019 9:15 AM ISTThe drug, solriamfetol, will treat excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea (OSA).U.S: The U.S. Food and Drug...
Zydus Cadila gets USFDA nod to Lurasidone Hydrochloride Tablets Farhat Nasim22 March 2019 4:59 PM ISTZydus Cadila has got final approval from the US Food and Drug Administration (USFDA) to market Lurasidone Hydrochloride Tablets USP in the strengths...
NPPA fixes retail price of Certain Hard Gelatin Capsules; Check Details Meghna A Singhania22 March 2019 3:25 PM ISTNew Delhi: Through a recent notice, the drug price regulator National Pharmaceutical Pricing Authority (NPPA) has fixed the retail price of hard...
