News Wire

The FDA has approved infliximab-qbtx (Ixifi, Pfizer), the third biosimilar to Remicade (Johnson and Johnson)––and the second one from Pfizer, which already markets Inflectra in the U.S. Pfizer and Celltrion Inc. launched Inflectra in late 2016. The other Remicade biosimilar, Renflexis, is made by…
The FDA, seeking to get critical updates on antibiotics and antifungal drugs to health care professionals more quickly, has created a website that will provide direct and timely access to information about when bacterial or fungal infections are likely to respond to a specific drug. The new tool is…
The FDA has approved the Vercise Deep Brain Stimulation (DBS) System (Boston Scientific Corporation) to treat the symptoms of Parkinson’s disease (PD), a degenerative condition that affects more than one million people in the United States and 10 million worldwide. DBS works by stimulating a targeted…
Omeros Corporation has received FDA approval to expand the indication for Omidria (phenylephrine and ketorolac intraocular solution) 1%/0.3% to include use in pediatric patients (from birth through 17 years). Omidria is used during cataract surgery or intraocular lens replacement to prevent intraoperative…
The FDA has approved Admelog (insulin lispro injection, Sanofi-Aventis U.S.), a short-acting insulin indicated to improve control in blood sugar levels in adults and pediatric patients ages 3 years and older with type-1 diabetes mellitus and adults with type-2 diabetes mellitus. Admelog is the first…
The FDA has expanded the approved use of mepolizumab (Nucala, GlaxoSmithKline) to treat adult patients with eosinophilic granulomatosis with polyangiitis (EGPA), a rare autoimmune disease that causes vasculitis, an inflammation in the wall of blood vessels of the body. This new indication provides the…
The Pharmaceutical Research and Manufacturers of America (PhRMA) has announced a multiyear, multimillion-dollar initiative to address the opioid crisis, which will include a partnership with the Addiction Policy Forum to fund state and local programs, as well as support for new public policies that…
A year or more after a single infusion of axicabtagene ciloleucel (Yescarta, Gilead Sciences), 42% of lymphoma patients continued to respond to therapy––including 40% with a complete remission.  Gilead’s Kite subsidiary announced long-term follow-up data from the pivotal ZUMA-1 study of axicabtagene…
The combination of atezolizumab (Tecentriq) and bevacizumab (Avastin) improved progression-free survival compared with sunitinib (Sutent, Pfizer) as initial treatment for patients whose advanced kidney disease expressed programmed death-ligand 1 (PD-L1) in the phase 3 IMmotion151 trial, Genentech has…
Sildenafil citrate (Viagra, Pfizer), the little blue pill with big annual sales, has gone generic. Teva Pharmaceutical Industries Ltd. has announced the launch of its version, and Pfizer is offering its own generic that ditches the blue color (it’s white) and half of the $65-a-pill retail price. Viagra…
Patients with an advanced type of lung cancer had a 38% lower risk of death or worsening disease when atezolizumab (Tecentriq) was added to their regimen of bevacizumab (Avastin) and chemotherapy in the phase 3 IMpower150 study, Genentech has announced. The pivotal IMpower150 study compared treatment…
Treatment with SAGE-217 (Sage Therapeutics) led to significant improvements on a depression rating scale and remission among 64% of patients with major depressive disorder (MDD) at day 15, according to phase 2 data released by the company.  “If successfully developed, SAGE-217 has the potential to…
About 15 million Americans will have either Alzheimer's dementia or mild cognitive impairment by 2060, up from approximately 6.08 million this year, according to a new study by researchers at the UCLA Fielding School of Public Health. The findings highlight the need to develop measures that could slow…
The FDA has approved semaglutide injection 0.5 mg or 1 mg (Ozempic, Novo Nordisk), a once-weekly glucagon-like peptide (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes. The medication is administered once weekly, on the…
French drug-maker Sanofi will shut down further development of its Clostridium difficile vaccine following a review by an independent data-monitoring committee that found the study unlikely to meet its primary goal, according to a BioPharma Dive report. The trial, known as Cdiffense, tested Sanofi’s…

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