Share prices for Protalix Biotherapeutics were up more than 3 percent this morning after the company reported positive results from its Phase I/II open label extension trial of pegunigalsidase alfa, PRX-102, for the treatment of Fabry disease. Despite that positive news on its pipeline, Protalix is reportedly set to terminate 50 employees, which amounts to about 20 percent of its workforce.
Cochlear Limited received U.S. Food and Drug Administration approval for the first remote feature to allow follow-up programming sessions for the Nucleus Cochlear Implant System through a telemedicine platform.
Biogen Inc. licensed Alkermes Plc’s multiple sclerosis drug, further boosting its position in the race for the next treatment amid slowing sales of its own flagship MS drug Tecfidera.
Teva Pharmaceutical Industries announced a new organization and leadership structure aimed to achieve better commercial focus and drive value creation.
Regeneron Pharmaceuticals is dropping plans to develop a new eye drug combination, marking a setback for the U.S. biotech company as Swiss rival Novartis seeks to snatch sales from its existing Eylea medicine.
Bayer is seeking to defend its pharmaceuticals business that will be diluted in importance by the takeover of Monsanto.
The Boston Business Journal first reported that Ensemble Therapeutics has shut its doors for good. Focused on developing small molecule therapies for cancer and other disease, Ensemble Therapeutics quietly closed up shop after 13 years.
FDA approves first implanted lens that can be adjusted after cataract surgery to improve vision without eyeglasses in some patients
The U.S. Food and Drug Administration approved the RxSight Inc. Light Adjustable Lens and Light Delivery Device, the first medical device system that can make small adjustments to the artificial lens’ power after cataract surgery so that the patient will have better vision when not using glasses.
Roche company Genentech is suing Pfizer in a federal court in Wilmington, Delaware, over Pfizer’s biosimilar for Genentech’s Herceptin. Genentech claims that Pfizer’s proposed biosimilar infringes 40 of its patents.
Opioid drug abuse cost the U.S. economy as much as $504 billion in 2015, White House economists said in a report.
The pace slowed in the third week of enrollment for 2018 Obamacare individual insurance as nearly 800,000 people signed up through the federal government website HealthCare.gov, down about 75,000 people from the previous week, a U.S. government agency reported.
A unit of AmerisourceBergen Corp. – one of the largest U.S. drug wholesalers – agreed to pay $625 million to resolve a U.S. government probe involving pre-filled syringes.
The U.S. Food and Drug Administration approved the first two-drug regimen to treat HIV, aimed at lessening the side effect burden of current treatments that combine three or four medicines.
Ardelyx decided to shutter development of RDX7675 – an experimental medicine for hyperkalemia – including the onset-of-action trial and Phase III studies.
Researchers at Stanford University School of Medicine with the National Cancer Institute have identified another cancer-surface molecule, CD22, and begun trials on B-cell acute lymphoblastic leukemia patients using an immuno-oncology approach similar to CAR-T.
Statement from FDA Commissioner Scott Gottlieb, M.D., on steps to promote development of generic versions of opioids formulated to deter abuse
“As we continue to confront the staggering human and economic toll created by opioid abuse and addiction, we’re focused on taking actions that reduce the scope of new addiction by decreasing unnecessary exposure to opioids. …”
Drugmakers are racing to implement Brexit contingency plans to prepare for a jolt to their regulatory system as the EMA is uprooted from London to Amsterdam.
Johnson & Johnson’s blockbuster multiple myeloma drug Darzalex when added to a standard therapy regimen reduced the risk of disease progression or death by 50 percent compared with the standard therapy alone in patients not previously treated for the blood cancer, according to released data.
Patients with a type of leukemia that had relapsed who received the new drug Venclexta in combination with Rituxan went significantly longer without the disease worsening than those treated with Rituxan and Treanda, according to interim results from a pivotal late-stage study released on Tuesday.
Cytokinetics Inc. will stop developing one of its treatments for ALS – which afflicts Stephen Hawking – after the drug failed in a late-stage trial, sending the company’s shares tumbling about 35 percent.