Supreme Court Preserves Access to Mifepristone
The Supreme Court on Friday preserved access to mifepristone (Mifeprex), a drug used in medication abortions by millions of women since its approval more than two decades ago, rejecting restrictions set to be imposed by lower courts while the case can be fully heard. “Although the Supreme Court has kept mifepristone available to patients for […]
The Drug Company That Prospered Without Creating Any Drugs
The new drug looked so promising — except for that one warning sign. At the American College of Rheumatology’s annual meeting in 2008, Duke University’s John Sundy, MD, proudly announced that pegloticase (Krystexxa), a drug he helped develop, was astoundingly effective at treating severe gout, which affects perhaps 50,000 Americans. In about half of those […]
Investigational ALS Drug May Have Clinical Benefit, FDA Staff Says
Tofersen, an investigational antisense drug developed to treat amyotrophic lateral sclerosis (ALS) associated with a mutation in the SOD1 gene (SOD1-ALS), may have clinical benefit, FDA reviewers indicated in briefing documents ahead of an advisory committee meeting. On Wednesday, the Peripheral and Central Nervous System Drugs Advisory Committee will vote on whether evidence supporting a […]
First Treatment Approved for Rare Genetic Neurologic Disorder
The FDA approved trofinetide (Daybue), the first drug to treat adult and pediatric patients age 2 and older with Rett syndrome, drugmaker Acadia Pharmaceuticals announced Friday. “Now, for the first time after decades of clinical research, healthcare providers finally have a treatment option to address a range of core behavioral, communication, and physical symptoms for […]
MedPAC Considers Reference Pricing and Other Ideas for Cutting Part B Drug Costs
Congress will need to use a multipronged approach to bring down prescription drug costs in the Medicare Part B program, members of the Medicare Payment Advisory Commission (MedPAC) agreed at their March meeting on Thursday. MedPAC members discussed three draft recommendations being considered for inclusion in the commission’s June report to Congress. The recommendations addressed […]
FDA Authorizes First At-Home Test That Can Detect Flu And COVID-19
The Food and Drug Administration (FDA) authorized the first over-the-counter at-home test to detect and differentiate influenza (commonly known as the flu) and COVID-19. The test, made by California-based Lucira Health, works similarly to standard at-home COVID tests where users swirl a self-collected nasal swab in a vial and place it in a test unit. […]
Senate Committee Puts PBMs Under the Microscope
Pharmacy benefit managers (PBMs) — middlemen between pharmacies, health insurers, and drug companies — are responsible for driving up prescription drug prices and shuttering independent pharmacies, witnesses said during a hearing held by the Senate Commerce, Science, & Transportation Committee. Three of the four witnesses — an economist, a physician, and a pharmacist — called […]
Drug Czar Issues Challenge to Docs: Help Us Devise Better Substance Use Tx Options
WASHINGTON — The Biden administration’s drug czar has a challenge for America’s doctors, especially members of the American Medical Association (AMA): help figure out the best way to treat substance use disorder (SUD) patients. “While the Biden administration has improved access to care for millions of people with OUD [opioid use disorder], we’ve got a […]
More Antipsychotics Given for Dementia During Pandemic
Antipsychotic drug prescribing rates among people with dementia increased markedly during the early months of the COVID-19 pandemic, a multinational database study showed. Notably, those rates did not return to prepandemic levels after the acute phase of the pandemic had ended, Kenneth K.C. Man, PhD, of University College London School of Pharmacy, and colleagues reported […]
Congressional Probe of Alzheimer’s Drug Approval Finds Fault With FDA Actions
The FDA broke with its own protocols in reviewing and subsequently approving Alzheimer’s drug aducanumab (Aduhelm), by inappropriately collaborating with drugmaker Biogen on briefing documents, holding unreported meetings, and failing to gain internal consensus before engaging in such collaborations, according to an in-depth congressional investigation of the interactions between the agency and the drugmaker. The […]