(Reuters) - The U.S. Food and Drug Administration said on Tuesday it had approved Amgen Inc’s osteoporosis treatment for postmenopausal women who are at high risk of fracture. Postmenopausal osteoporosis is a chronic condition resulting from progressive bone loss beginning around menopause. The monthly injection, Evenity, developed jointly with Belgium-based UCB SA, helps reduce the risk of fracture by increasing bone mass and mildly inhibiting the break down of bone minerals. Evenity comes with a boxed warning, the FDA’s strictest warning, flagging increased risk of heart attack, stroke and cardiovascular-related death. The approval is expected to augment sales at Amgen, which faces competition from cheaper rivals for two of its biggest selling products - the white blood cell booster Neulasta and rheumatoid arthritis drug Enbrel. However, William Blair analyst Matt Phipps expects the initial demand to be slow due to the cardiovascular risks, and expects peak sales of … [Read more...] about Amgen’s postmenopausal osteoporosis drug gets FDA greenlight
Drug at fda
(Reuters) - The U.S. Food and Drug Administration said on Tuesday it had approved Amgen Inc’s osteoporosis treatment for postmenopausal women at high risk of fracture. Postmenopausal osteoporosis is a chronic condition resulting from progressive bone loss beginning around menopause. The monthly injection, Evenity, developed jointly with Belgium-based UCB SA, helps reduce the risk of fracture by increasing the formation of new bones and mildly inhibiting the break down of bone minerals. (bit.ly/2U4oqZ7) Evenity comes with a boxed warning, the FDA’s harshest, flagging increased risk of heart attack, stroke and cardiovascular-related death. “It’s important to carefully select patients for this therapy, which includes avoiding use in patients who have had a heart attack or stroke within the previous year,” said Hylton Joffe, a director at FDA’s Center for Drug Evaluation and Research. William Blair analyst Matt Phipps expects the drug to have slow … [Read more...] about Amgen’s postmenopausal osteoporosis drug gets FDA approval
By Letters To The Editor | Bay Area News Group PUBLISHED: April 4, 2019 at 1:10 am | UPDATED: April 4, 2019 at 1:12 am Self-regulation also anissue at FDA, EPA, etc. Adam Zyglis’ “Cartoonist’s view” (Opinion section, April 2) of the failure of self-regulation in the chemical and airline industries and the financial sector depicts a fact of government regulation that is well-recognized by lawyers who take on defective products and consumer frauds on behalf of injured and damaged families. The history of government regulation shows that regulatory agencies are created at the behest of the producers. Next, the regulated capture the agency and promulgate regulations to advance their cause and insulate them from accountability. The Food and Drug Administration, Environmental Protection Agency, National Highway Traffic and Safety Administration and the Federal Aviation Administration all offer striking examples of the failure of corporations to self-certify … [Read more...] about Letter: FAA isn’t alone — self-regulation also an issue at FDA, EPA, etc.
WASHINGTON — Dr. Jeffrey Shuren was adamant: The United States would never cut corners to fast-track the approval of medical devices. "We don't use our people as guinea pigs in the U.S.," Shuren said, holding firm as the new director of the U.S. Food and Drug Administration's medical devices division. Again and again in 2011 — four times in all — Shuren was summoned before Congress. Lawmakers accused the agency of being too slow and too demanding in reviewing new devices like heart valves and spinal implants, driving U.S. manufacturers overseas where products faced less rigorous review. Each time, he pushed back. And yet the next year, Shuren and his team adopted an approach that surprised even some of his closest colleagues: The FDA would strive to be "first in the world" to approve devices it considered important to public health. The agency's shift mirrored the talking points of the $400 billion medical device industry — a lobbying behemoth on Capitol Hill … [Read more...] about At FDA, a new goal, then a push for speedy device reviews
(Reuters) - Alnylam Pharmaceuticals Inc’s drug for a rare hereditary disease won U.S. regulatory approval on Friday, becoming the first approved treatment from a new class of medicines that use gene silencing technology. Alnylam’s patisiran, commercially named Onpattro, was approved to treat polyneuropathy in patients with hereditary ATTR amyloidosis, a potentially fatal condition that affects an estimated 50,000 people worldwide. Patients with the disease have a genetic mutation that prevents a type of protein from keeping its normal structure, instead causing it to fold into an incorrect shape and accumulate in the heart, nerves and other organs. This leads to loss of sensation, heart issues, eye, kidney and thyroid diseases. Polyneuropathy, a symptom of the disease, is the simultaneous malfunction of nerves resulting in tingling, numbness and kidney dysfunction. Using RNA interference (RNAi), a Nobel prize-winning mechanism hailed as a breakthrough in the 1990s, … [Read more...] about Alnylam’s gene silencing drug wins FDA approval