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Biotech and Pharmaceuticals Medicine

  • The outside of the Food and Drug Administration headquarters is seen in White Oak, Md., on Monday, November 9, 2015.

    South Korea's Samsung Bioepis wins U.S. FDA nod for biosimilar of J&J's Remicade.

  • The U.S. Food and Drug Administration approved Renflexis, developed by Samsung Bioepis Co. of South Korea. Its U.S. partner, Merck& Co. of Kenilworth, New Jersey, will market Renflexis. The first biosimilar for Remicade, Inflectra from New York- based Pfizer Inc., went on sale in November at a 15 percent discount.

  • The Food and Drug Administration said Friday that it approved Renflexis, developed by Samsung Bioepis Co. of South Korea. It will be marketed by its U.S. partner, Merck& Co. of Kenilworth, New Jersey. Without insurance, Remicade generally costs more than $30,000 annually for adults; dosage varies with the patient's weight.

  • April 21- A European Medicines Agency panel said on Friday it recommended granting marketing approval to Sanofi and Regeneron's experimental drug to treat rheumatoid arthritis. The Committee for Medicinal Products for Human Use gave a positive opinion on the drug, Kevzara, citing its ability to reduce the signs and symptoms of rheumatoid arthritis.

  • April 21- Canadian drugmaker Valeant Pharmaceuticals International Inc said it had priced its recently approved plaque psoriasis treatment at $3,500 per month, ahead of an expected U.S. launch in the second half of 2017.. Taltz is priced at about $6,000 per month, while Cosentyx at $5,400 per month as per the recommended dosing schedules, she said.

  • April 21- Canadian drugmaker Valeant Pharmaceuticals International Inc said it had priced its recently approved plaque psoriasis treatment at $3,500 per month, ahead of an expected U.S. launch in the second half of 2017.. Drugmakers are facing intense criticism from politicians, insurance companies and patient advocacy groups in the United States over the...

  • April 20- Doctors have struggled for years to deliver medication effectively to the inner ear, but two companies are vying to be first to introduce new treatments which, if successful, could together chalk up some $800 million in peak sales. Darius Kohan, chief of otology/neurotology at New York- based Lenox Hill Hospital. San Diego- based Otonomy and Swiss biotech...

  • April 19- AbbVie Inc said on Wednesday that its experimental cancer drug, veliparib, failed to meet the main goals of two late-stage studies. The trials evaluated the effect of veliparib, in combination with a chemotherapy regimen, on patients with non-small cell lung cancer and triple-negative breast cancer. Tesaro's niraparib won the U.S. Food and Drug...

  • April 19- AbbVie Inc said on Wednesday that its cancer drug, veliparib, failed to meet the main goals of two late-stage studies. The trials evaluated the effect of veliparib, in combination with a chemotherapy regimen, on patients with non-small cell lung cancer and triple negative breast cancer. Veliparib belongs to a closely watched class of new medicines...

  • *Merck, Bristol, Roche also have important upcoming news. LONDON, April 19- Three years after Pfizer's failed bid for AstraZeneca, the British drugmaker aims to prove in the coming weeks that its cancer immunotherapy can deliver on bold sales forecasts made during that takeover battle. "I think there will be multiple approvals in the first-line space," Naiyer Rizvi,...

  • MIAMI BEACH, Fla.— Thousands of bacteria-infected mosquitoes were released in the wild Tuesday near Key West, testing a new way to kill mosquitoes that carry Zika and other viruses. The infected mosquitoes were flown in cardboard tubes— similar to ones used in paper towel rolls— from Lexington, Kentucky, to Key West on Tuesday morning. At the Stock Island test site,...

  • April 18- Bioelectronic healthcare company electroCore LLC said on Tuesday that the U.S. Food and Drug Administration had approved its hand-held device to treat cluster headaches. The company anticipates the product will be available in the United States in the third quarter. The device, which can be self-administered, is already approved for use in South...

  • For the deaf and hard of hearing, there’s a promising new world of technological innovation.

  • GENEVA, April 18- Merck KGaA said it is developing a children's formula of its drug to treat schistosomiasis, a parasitic worm disease that infects millions of poor people in Africa and Asia. Schistosomiasis kills 280,000 people each year in Africa alone, the German drugmaker said on Tuesday. But the pill is large, bitter and difficult for children to swallow,...

  • April 17- Genentech, a unit of Swiss drugmaker Roche Holding AG, said on Monday it got approval from the U.S. Food and Drug Administration for its already approved immunotherapy drug, Tecentriq, to treat advanced bladder cancer. Tecentriq, also known as atezolizumab, received the go-ahead under the FDA's accelerated approval program as a first-line treatment...

  • April 17- OncoMed Pharmaceuticals Inc said on Monday its experimental lung cancer drug failed a mid-stage study, sending its shares tumbling 30 percent in premarket trading. Lung cancer is the second most common cancer in men and women and is by far the leading cause of cancer death, according to the American Cancer Society. The company's shares were down 25...

  • April 17- OncoMed Pharmaceuticals Inc said on Monday its experimental drug failed a mid-stage study for the treatment of lung cancer. The trial was testing the combination of Oncomed's tarextumab and chemotherapy, compared with chemotherapy and a placebo. The main goal was to slow the progression of the disease.

  • Doctors carve from hip to hip, slicing off skin, tightening muscles, tugging at innards. Patients often need strong painkillers for days or even weeks, but Mary Hernandez went home on just over-the-counter ibuprofen. The Houston woman was helping test a novel medicine aimed at avoiding opioids, potent pain relievers fueling an epidemic of overuse and addiction.

  • The Food and Drug Administration said in a letter to the company that it needed more information about the drug's safety and the best doses, Lilly said Friday in a statement. Lilly said it disagrees with FDA's conclusions but will work with the agency on a plan to eventually get the drug, baracitinib, approved for U.S. patients. Eli Lilly& Co. and Incyte Corp., its...

  • WASHINGTON, April 14- The U.S. Food and Drug Administration on Friday declined to approve a new drug for rheumatoid arthritis made by Eli Lilly and Co and partner Incyte Corp, the companies said on Friday. FDA indicated that additional clinical data was needed to determine the most appropriate doses of the drug, Olumiant, known also as baricitinib, and to further...