While disability advocates and lawmakers have decried the use of quality-adjusted life years (QALY) in recent years, some argue that it is an indispensable measure that is unfairly maligned. For example, patient advocates argue that the focus on quality of life devalues the lives of disabled people […]
Eisai CEO Not too Worried About Leqembi After CMS Keeps Anti-Amyloid Rule
Eisai’s CEO Ivan Cheung told Fierce Pharma he is not too worried about the long-term success of Leqembi in light of the US Centers for Medicare and Medicaid Services (CMS) declined to change its rule about reimbursement for drugs in its class. The rule states that drugs targeting amyloid, a key […]
Takeda Reveals Pricing for Dengue Vaccine
Fresh off approval of its dengue vaccine in Brazil, Takeda has announced its pricing strategy for the shot. Prices will be determined by endemic status of the disease in a given country. Indonesia, where the virus is endemic, will see the vaccine priced at $40 per dose, while travel markets like […]
Ozempic and Mounjaro Back on Shelves
Novo Nordisk’s Ozempic and Eli Lilly’s Mounjaro, both diabetes drugs used off-label for weight loss, have been on a backlog for months due to an explosion of popularity. According to the US Food and Drug Administration, most doses of the two drugs are back in stock. This excludes the higher doses of […]
Linda Goler Blount, MPH, to Join ICER Governance Board
Linda Goler Blount, MPH, has been elected to join the governance board of the Institute for Clinical and Economic Review. Blount has worked in health policy and is currently the president of the Black Women’s Health Imperative. She has built a career on addressing health disparities, especially […]
US FDA Still Mulling Over Biogen ALS Treatment Approval Despite Disappointing Phase III Results
Briefing documents from a US Food and Drug Administration (FDA) advisory committee show that Biogen’s ALS drug tofersen is still in the running for approval despite a recent failure in a Phase III trial. The favorable outlook is due, in part, due to its effects on reducing a key protein hallmark of […]
US FDA to Review Ipsen’s Rare Bone Growth Disease Therapy
The US Food and Drug Administration (FDA) has set a date to decide on Ipsen’s new drug application for its drug candidate palovarotene in the treatment of fibrodysplasia ossificans progressive (FOP), a rare disorder where extra-skeletal tissues like muscles and tendons are converted into bone […]
FDA Adcomm Recommends Paxlovid for Mild-to-Moderate COVID-19
Pfizer’s Paxlovid has received a nod from the US Food and Drug Administration’s (FDA’s) Antimicrobial Drug Advisory Committee for use in mild-to-moderate cases of COVID-19 in adults. The 16-1 vote came after Pfizer’s previous request for full approval hit a roadblock last year when the agency […]
Exclusivity Loss Looms for Ten Key Drugs in 2023
As the year marches on, Fierce Pharma takes a look at 10 major drugs facing exclusivity losses in 2023. One of the most notable is Humira, AbbVie’s historically expensive blockbuster, which will face stiff competition from several upcoming biosimilars. Other drugs on the list include J&J’s […]
FDA Allows Dose Increase in Dravet Syndrome Clinical Trial
The US Food and Drug Administration (FDA) has released a hold blocking a Phase I/IIa clinical trial testing an increased dose of STK-001, Stoke Therapeutics’ drug candidate for Dravet syndrome. Dravet syndrome is a rare form of severe childhood epilepsy that comes with a short life expectancy and […]
