LONDON (Reuters)—GlaxoSmithKline has won U.S. approval for a new and improved shingles vaccine, the second of three key products for which the British drugmaker expects approval this year. It also secured a recommendation from U.K. cost authorities for a $700,000 gene therapy for so-called “bubble boy” disease—a step forward for the field of fixing faulty…
Articles by Natasha Yetman
FDA Teams with Medical Companies in Puerto Rico to Tackle Shortages
(Reuters)—The head of the U.S. Food and Drug Administration said the agency was working with several pharmaceutical and medical device companies in Puerto Rico to prevent shortages of medical products in the U.S. as it joins a massive effort to help rebuild the island that was ravaged by Hurricane Maria.1 Drugmakers are working to get…
Obamacare Whiplash Leaves States, Insurers with Dueling Price Plans
NEW YORK (Reuters)—President Donald Trump’s reversals in the past week on maintaining Obamacare subsidies to insurers are sowing new confusion over what kind of health insurance will be available to consumers, and at what price, when enrollment for 2018 begins in two weeks. Trump said last week his administration would stop paying billions of dollars…
Biosimilar Infliximab Appears Safe, Effective in Pediatric IBD
NEW YORK (Reuters Health)—A biosimilar version of infliximab appears as effective as the original for treating pediatric inflammatory bowel disease (PIBD), and less costly, new research shows. “These baseline data have now enabled us to confidently switch patients from originator to biosimilar, adopting the same prospective methodology to monitor effectiveness, safety and cost,” Dr. Lisa…
U.S. Judge in Texas Invalidates Allergan Patents on Restasis
(Reuters)—A U.S. judge invalidated patents on Allergan Plc’.s dry eye medicine Restasis on the grounds that the patents cover obvious ideas, a decision that drove the pharmaceutical company’s shares down more than 6%. Judge William Bryson issued the ruling in federal court in Marshall, Texas, in a longstanding dispute between Allergan and generic drugmakers led…
U.S. Senators Reach Bipartisan Deal on Obamacare Backed by Trump
WASHINGTON (Reuters)—On Tuesday, two U.S. senators announced a bipartisan breakthrough to shore up Obamacare for two years by reviving federal subsidies for health insurers that President Donald Trump planned to scrap, and the president voiced support for the plan. The agreement worked out by Sen. Lamar Alexander (R-Tenn.) and Sen. Patty Murray (D-Wash.) would meet…
GlaxoSmithKline’s Shingles Vaccine Gets Approval in Canada
(Reuters)—Canadian health regulators have approved GlaxoSmithKline’s shingles vaccine, the company said on Friday.1 Shingrix, the British pharma company’s shingles vaccine for people aged 50 years or older, was unanimously recommended for approval by a U.S. Food and Drug Administration (FDA) advisory panel last week. Older people are most at risk of an outbreak of shingles,…
U.S. States Plan Suit to Block Trump Obamacare Subsidies Cut
WASHINGTON/SAN FRANCISCO (Reuters)—On Friday, California, New York and others states vowed to sue President Donald Trump’s administration to stop him from scrapping a key component of Obamacare, subsidies to insurers that help millions of low-income people pay medical expenses, even as Trump invited Democratic leaders to negotiate a deal. One day after his administration announced…
After Medical Errors, Patients Want Doctors to Hear Them Out
(Reuters Health)—When medical errors lead to serious injuries, patients and families may feel better when doctors take the time to listen to their feelings about the mistake and explain what can be done to prevent it from happening again, a small study suggests. The research team interviewed 27 patients, three family members and 10 staff…
Flexion’s Knee Pain Drug Gets FDA Approval
(Reuters)—Flexion Therapeutics Inc. said its injectable drug to treat osteoarthritis-related knee pain was approved by the U.S. Food and Drug Administration. The approval comes at a time when U.S. federal authorities are implementing a slew of measures to combat opioid abuse, with President Donald Trump in August declaring the opioid epidemic a national emergency. The…
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