News Wire

The FDA has approved vemurafenib (Zelboraf, Genentech) for Erdheim-Chester disease (ECD) with BRAF V600 mutation. ECD is a rare, serious blood disease characterized by the abnormal multiplication of white blood cells called histiocytes, which can invade normal tissues and organs in the body. The approval…
Nivolumab (Opdivo, Bristol-Myers Squibb) showed a three-year survival benefit over everolimus (Afinitor, Novartis) in advanced renal cell carcinoma (RCC) in a phase 3 study, reducing the risk of death by 26%. The three-year overall survival (OS) update from the CheckMate -025 study, evaluating previously…
Canagliflozin (Invokana, Janssen) improved renal outcomes and demonstrated potential renal protective effects in patients with type-2 diabetes mellitus (T2DM) who have heart disease or are at risk for it, new analyses from the CANVAS clinical trial program show. The data were presented at the American…
California’s Medicaid health plans have made a nifty profit partly as a result of the state increasing payments to Medicaid insurers in anticipation that expansion of the program under the ACA would lure many sicker beneficiaries. But that didn’t happen, reports Kaiser Health News. The…
The details remain murky about just what’s going on regarding a possible merger of CVS and Aetna, news of which broke last week, but experts say that such a corporate entity could challenge the sweet position occupied by UnitedHealth Group and its PBM affiliate OptumRX. OptumRX is just one of the…
The drug approval process should include an only-in-research (OIR) step that would gauge real-world effectiveness. That’s the argument put forth by Anirban Basu, a professor at the University of Washington, in a Health Affairs blog post. Basu says that at the completion of phase 2 trials, the manufacturer…
The FDA has approved latanoprostene bunod ophthalmic solution, 0.024% (Vyzulta,  Bausch + Lomb) for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Vyzulta, a once-daily monotherapy, is the first prostaglandin analog that has nitric oxide (NO)…
The drug approval process should include an only-in-research (OIR) step that would gauge real-world effectiveness. That’s the argument put forth by Anirban Basu, a professor at the University of Washington, in a Health Affairs blog post. Basu says that at the completion of phase II trials, the manufacturer…
A panel convened by President Donald Trump to tackle the opioid crisis has called for more treatment programs, tighter prescribing guidelines, and additional drug courts to help reduce overdose deaths, Reuters reports. The commission, led by New Jersey Governor Chris Christie, said the recommendations…
FDA advisory committees voted in a joint session to endorse two proposed products for the treatment of opioid problems: CAM2038 (Braeburn Pharmaceuticals, Inc.) and RBP-6000 (Indivior PLC). The agency is not obliged to follow the recommendations of its advisory committees, but it often does so. Braeburn…
Lackluster study results are leading global pharmaceutical giants to reconsider their development of interleukin (IL)-4 and IL-13 inhibitors in the treatment of lung ailments, Fierce Biotech reports. Sanofi disclosed that it has “decided to stop the development of SAR156597 in idiopathic pulmonary…
The FDA has granted accelerated approval to acalabrutinib (Calquence, AstraZeneca) for the treatment of adults with mantle cell lymphoma who have received at least one prior therapy. “Mantle cell lymphoma is a particularly aggressive cancer,” said Richard Pazdur, MD, director of the FDA’s Oncology…
Opioid addicts saved by the overdose reversal medication naloxone are still in danger following their close brush with death, a new study shows. About 10% of overdose patients saved with naloxone (Narcan, Adapt Pharma, Inc.) in Massachusetts hospitals ended up dying within a year, Harvard researchers…
An independent nonprofit organization that evaluates the clinical and cost effectiveness of new medicines in the U.S. has received significant new funding that will enable it to greatly expand its work, the organization has announced.  The Boston-based Institute for Clinical and Economic Review (ICER)…
Forty-six state attorneys general taking part in a wide-ranging antitrust investigation of the generic drug industry are asking a federal court for permission to file a new complaint in the states’ pending lawsuit that increases the number of generic-drug manufacturer defendants from six to 18 and…

Pages