Amylyx Pulls ALS Drug From US Market After Study Shows No Benefit
Amylyx Pharmaceuticals announced Thursday that it is voluntarily halting sales in the U.S. and Canada of Relyvrio, a drug contentiously approved by the FDA for patients with ALS, also known as Lou Gehrig’s disease. A recent clinical trial showed the medicine failed to extend life or improve symptoms.
AP:
Why Amylyx Is Pulling ALS Drug Relyvrio From US Market After Study
The maker of a drug for Lou Gehrig’s disease that recently failed in a large study said Thursday it will pull the medicine from the market, acknowledging it didn’t help patients with the deadly neurological condition. Amylyx Pharmaceuticals announced it will voluntarily halt sales and marketing of the drug in the U.S. and Canada, where new patients will no longer be able to get a prescription. (Perrone, 4/4)
CIDRAP:
FDA Approves New Antibiotic For Multiple Bacterial Infections
The US Food and Drug Administration (FDA) yesterday approved the novel antibiotic Zevtera (ceftobiprole medocaril sodium for injection) for treating serious bacterial infections in adults and children. The approval of the cephalosporin antibiotic is for three indications: (1) Staphylococcus aureus bacteremia (SAB), including right-sided infective endocarditis, in adults; (2) acute bacterial skin and skin-structure infection (ABSSSI) in adults; (3) and community-acquired bacterial pneumonia (CABP) in adults and children as young as 3 months. (Dall, 4/4)
Reuters:
AstraZeneca's Imfinzi Shows Promise In Treating Aggressive Lung Cancer
AstraZeneca said on Friday its blockbuster cancer drug Imfinzi helped improve overall and progression-free survival in patients with limited-stage small cell lung cancer. The drug demonstrated "statistically significant and clinically meaningful improvement" in the dual primary goals of overall survival and progression-free survival in patients for whom the disease had not worsened following concurrent chemoradiotherapy in a late-stage trial, according to AstraZeneca. (4/5)
Reuters:
Boehringer To Lay Off Salespeople As Humira Biosimilar Sales Lag
Boehringer Ingelheim on Thursday said it will lay off some of its salesforce due to poor U.S. sales of its biosimilar version of AbbVie’s (ABBV.N) blockbuster arthritis treatment Humira.The German drugmaker said it planned to reduce its customer-facing teams in favor of a hybrid in-person and virtual sales model by June 30, in large part because pharmacy benefit managers (PBMs) had kept branded Humira on their lists of medicines for reimbursement. (Wingrove, 4/5)
Politico:
FDA Says Regulatory Solution Is Needed For Hemp-Derived Products
Top FDA officials working on cannabis policy said Thursday that regulatory uncertainty for hemp-derived products is a problem, but argued that only Congress can create a new regulatory pathway to fix the issue. “[CBD and Delta-8 regulation] are two problems that are the consequence of the 2018 Farm Bill,” said FDA Senior Science Advisor and Cannabis Products Committee Lead Patrick Cournoyer. “Both of those problems need a solution.” (Fertig, 4/4)
On covid vaccines and treatments —
CIDRAP:
Among Fully Vaccinated, Study Shows Paxlovid Does Not Shorten Symptoms
A new study in the New England Journal of Medicine suggests that, for those fully vaccinated against COVID-19 but having at least one risk factor for severe COVID, the antiviral drug Paxlovid did little to reduce symptom duration, but experts caution the findings might not apply to older patients. ... A total of 654 participants took Paxlovid, and 634 participants took the placebo. The study was conducted from July 2021 to July 2022. (Soucheray, 4/4)
Undark:
Interview: Puncturing Misconceptions About Vaccine Hesitancy
According to pediatrician David M. Higgins, parental vaccine hesitancy is not nearly as widespread as many believe. (Falk, 4/5)
