FDA report details problems at Global Pharma plant involved in eye drop recall
March 31, 2023... The FDA inspection occurred shortly after Global Pharma Healthcare recalled two different brands of eye drops over contamination concerns.
Medical device companies now need to prove to FDA they’re protected against cyberattacks
March 29, 2023... Hidden in this year’s federal spending bill lies a little-noticed change with big implications: a mandate to protect medical devices from hacks or ransomware attacks.
Pharmalittle: FDA panel backs conditional approval for Biogen ALS drug; pharma fights tactic for lowering specialty med costs
March 23, 2023... A FDA advisory panel concluded that a Biogen treatment for a rare, genetic form of ALS should be conditionally approved, despite unanswered questions.
Pharmalittle: U.K. regulator to streamline clinical trial approvals; NIH won’t seize patents to cut price of cancer drug
March 22, 2023... The NIH rejected a petition urging the agency to use a controversial provision of federal law to widen access to a cancer drug by forcing the manufacturers to license their patents.
Carrying the torch of his slain brother, a Chicago ER doctor struggles against the violence around him
March 22, 2023... Health disparities are not just the stuff of dry statistics and academic studies for University of Chicago ER physician Abdullah Pratt; they are his life.
Pharmalittle: FDA official wants to use accelerated approval for gene therapies; pharma asks Biden for tax breaks in the semiconductor package
March 21, 2023... A top FDA official says the agency needs to start using accelerated approval to advance gene therapies for rare diseases.
The lab leak conversation shows it’s time to rethink our biosecurity infrastructure, not just policies
March 21, 2023... With biosecurity at the forefront of people’s minds, this is an opportune moment to think differently.
Top FDA official: Agency needs to start using accelerated approval for gene therapies
March 20, 2023... An FDA official says accelerated approval should be extended to gene therapies for rare diseases — comments that come as the agency considers a gene therapy for Duchenne muscular dystrophy.
Karuna’s treatment for schizophrenia achieves study goals, bolsters FDA filing plans
March 20, 2023... Karuna Therapeutics said its treatment for schizophrenia reduced psychosis reported by patients — achieving the main goal of a large clinical trial.
Pharmalittle: Sanofi cuts price on a popular insulin by 78%; Califf criticizes insurers for doing too little on drug research
March 17, 2023... FDA Commissioner Robert Califf wants private insurers to chip in on doing post-approval clinical research on drugs.
FDA to convene advisory panel for Sarepta’s gene therapy for Duchenne
March 16, 2023... In a sudden about-face, the Food and Drug Administration will hold a meeting of outside experts to consider whether or not to approve Sarepta’s experimental gene therapy for Duchenne muscular dystrophy.
Pharmalittle: Alzheimer’s group starts lobbying for Medicare to cover new drug; U.S. judge seems sympathetic to abortion-pill challenge
March 16, 2023... The federal judge who could upend access to an abortion medication pressed government lawyers in a hearing about the safety and approval process for the drug.
Momentum grows to subject medical devices to medicine’s gold standard — the placebo treatment
March 16, 2023... “If you’re going to unleash something into the public space, I think it’s morally and ethically crucial to know it works,” said one cardiac electrophysiologist.
Texas judge hears arguments in lawsuit to pull long-used abortion pill off the market
March 15, 2023... A conservative federal judge in Texas heard arguments Wednesday from a Christian group seeking to overturn the FDA's more than 2-decade-old approval of an abortion medication.
Pharmalittle: Biden administration to fine drugmakers for price hikes on 27 meds; Dems push pharmacy chains over access to abortion pill
March 15, 2023... The Biden administration will fine drugmakers that hiked prices faster than the inflation rate on 27 medicines administered in physician offices.
Democratic lawmakers press pharmacy chains on abortion pill access
March 14, 2023... Pharmacies are in "a little bit of a damned if you do, damned if you don’t situation," one expert said. .
Veterans Health Administration will cover the newest Alzheimer’s drug
March 13, 2023... In an unexpected move, the Veterans Health Administration announced Monday that it will widely cover a new Alzheimer’s treatment, even as Medicare has decided to wait for additional data about the medicine before taking the same step.
Denied by AI: How Medicare Advantage plans use algorithms to cut off care for seniors in need
March 13, 2023... A STAT investigation found artificial intelligence is driving Medicare Advantage denials to new heights, cutting off care for seniors.
FDA approves first treatment for Rett syndrome, a genetic neurological disease
March 11, 2023... The FDA has approved the first treatment for Rett syndrome, a genetic disease mostly affecting girls that causes severe neurologic impairments.
Clearing the patent thicket: A pathway to faster generic drug approvals
March 10, 2023... While efforts to reduce poor-quality drug patents are well-intentioned, they do not go to the heart of the problem: fixing the laws that enable patent abuses.
BridgeBio’s treatment for genetic cause of dwarfism accelerates growth in small study
March 6, 2023... A novel drug for the most common cause of dwarfism accelerated children’s growth in a small but closely watched clinical trial, the company BridgeBio said.
New weight loss drugs are changing the narrative on obesity, with a push from pharma
March 5, 2023... A new generation of obesity drugs is transforming patients’ lives, dividing medical experts, and spurring the biggest business battle in years. And pharma is steering the discussion.
Pharmalittle: How Lilly’s cuts will affect other efforts to lower insulin prices; pharma rebukes U.K. over clawbacks
March 3, 2023... Lilly's slashing of prices for some of its insulin products raised questions about what will happen to other efforts to provide low-cost insulin.
Pharmalittle: FDA panel backs a GSK vaccine for RSV; opioid wholesalers cleared of liability to Georgia families
March 2, 2023... A FDA advisory panel backed a GSK respiratory syncytial virus vaccine, setting it up for a race with Pfizer to have the first approved U.S. shot against RSV.
Pharmalittle: Eli Lilly cuts prices for some insulin products; congressional committee opens probe into PBMs
March 1, 2023... House Republicans have launched an investigation into PBMs, dialing up the scrutiny of the middlemen who play an important role in how much medicines cost.
Covid-19 surveillance added new burdens on essential workers — and gave them little data to protect their health
March 1, 2023... Surveillance technologies deployed during the Covid-19 pandemic added new burdens on essential workers — and gave them little data to protect their health.
FDA approves Reata’s treatment for rare neurological disease
Feb. 28, 2023... The Food and Drug Administration approved the first drug to treat Friedreich’s Ataxia, a rare, neurological disease.
New head of FDA’s neuroscience office takes over at crucial time
Feb. 28, 2023... The new head of the FDA's Office of Neuroscience is stepping into an increasingly powerful position at the agency.
One type of artificial sweetener may increase heart attack risk, preliminary study says
Feb. 27, 2023... The sweetener erythritol, which is becoming increasingly popular in snack bars and low-sugar ice cream substitutes, may increase the risk of heart attacks and strokes, according to a new study.