Merck’s Ervebo gets its first regulatory greenlight. A decision from the US Food and Drug Administration is expected in the next few months. Read more
Merck, like many of its Big Pharma peers, is working to focus more on innovative drugs. But as part of that ongoing shift, the company is eliminating 500 positions nationwide. Read more
J&J, which is facing thousands of lawsuits from people who claim its talc products caused cancer, said it had initiated the voluntary recall of one lot of baby powder, produced and shipped in the US in 2018, out of “an abundance of caution”. Read more
Torrent Pharma recalls drugs from US, Puerto Rico: As per the report, Torrent Pharma Inc is recalling 17,088 bottles of Losartan Potassium /Hydrochlorothiazide tablets, USP 50mg/12.5mg from the same markets.
The FDA has approved Novartis-subsidiary AveXis Inc’s spinal muscular atrophy (SMA) gene therapy Zolgensma (onasemnogene abeparvovec-xioi). The company wants to set the price tag at $2,125m per dose.
A pair of drugmakers in India that the U.S. is counting on to produce generic blood-pressure pills after a far-reaching recall have been faulted by regulators for quality-control issues. Cadila Healthcare Ltd., Alkem Laboratories Ltd. both won approvals in March from the Food and Drug Administration to make generic versions of valsartan for the U.S. market. Neither company made any of the recalled valsartan, but both companies have recently been cited by agency inspectors for quality-control failures that echo problems at other drugmakers — renewing questions about the safety of some of the world’s most widely prescribed medicines.
A new drug to treat spinal muscular atrophy (SMA) approved by the Food and Drug Administration (FDA) on Friday will come with a price tag of $2.1 million, making it the most expensive medicine in the world.
Artificial Intelligence (AI) ‘deep learning’ has been found to detect malignant lung nodules on low-dose chest computed tomography (LDCT) scans sooner than radiologists.
Amgen has agreed to buy Swedish biotech Nuevolution for around $167 million to boost its drug pipeline after an R&D collaboration showed promise.
- The Optimizer Smart System, created by Impulse Dynamics, monitors heart activity and delivers non-excitatory electrical signals to the right heart valve.