FDA May Approve RSV Vaccine From Pfizer On Expedited Basis
Pfizer said Tuesday that the Food and Drug Administration is expected to make a decision on its respiratory syncytial virus vaccine in August. Separately, Teva has secured FDA approval for a modified formulation of its nervous system disorders drug Asustedo.
CNBC:
Pfizer RSV Vaccine For Infants Could Receive FDA Approval This Summer
Pfizer’s vaccine that protects infants from respiratory could receive Food and Drug Administration approval by the end of this summer. Pfizer on Tuesday said the FDA is reviewing the vaccine on an expedited basis. The agency is expected to make a decision on whether to clear the shot in August, just before respiratory virus season. (Kimball, 2/21)
FiercePharma:
Teva's Flagship Drug Austedo Scores New Approval At The FDA
Attuned to the burdens of people living with Huntington’s disease (HD) chorea and tardive dyskinesia (TD), Teva has been eager to cut the amount of pills patients need to take in half. Now, it's scored an FDA approval to do just that. (Kansteiner, 2/21)
Reuters:
Eli Lilly's Diabetes Drug Back To Shelf After Two-Month Shortage
Eli Lilly & Co (LLY.N) said on Tuesday all doses of its new diabetes drug Mounjaro were now available with wholesalers having inventory on hand after a two-month-long shortage. "Because Mounjaro is still a launch product with dynamic demand, some pharmacies may continue to experience intermittent delays from time to time," Eli Lilly told Reuters in an emailed statement. (2/22)
In other industry news —
Stat:
AbbVie Sued By Dutch Group Over Humira Pricing, Human Rights
A Dutch public interest group has filed a lawsuit claiming AbbVie breached a duty to human rights by using unfair and excessive pricing to bolster sales of its Humira drug and dominate the market at the expense of the health care system in the Netherlands. (Silverman, 2/21)
Fierce Healthcare:
UnitedHealth's $5.4B LHC Group Buy Set To Close This Week
Another controversial UnitedHealth Group acquisition is set to close this week. According to a notice filed with the Nasdaq, home health provider LHC Group will halt trading on the exchange after markets close Wednesday, and its merger with UHG is "tentatively scheduled" to close the following morning before trading begins. Should the deal close as planned, LHC's shares will be suspended on Friday, Feb. 24. (Minemyer, 2/21)
CNN:
Only 5.7% Of US Doctors Are Black, And Experts Warn The Shortage Harms Public Health
Only about 5.7% of physicians in the United States identify as Black or African American, according to the the latest data from the Association of American Medical Colleges. This statistic does not reflect the communities they serve, as an estimated 12% of the US population is Black or African American. And while the proportion of Black physicians in the US has risen over the past 120 years, some research shows, it’s still extremely low. (Howard, 2/21)
Fierce Healthcare:
Program Promises To Take A Team Approach To Tackling Severe Kidney Disease
Kidney disease often advances quietly and then falls on patients, providers and payers like an avalanche of complex medical conditions that cost a lot of money to control. To address this, Providence Health Plan is teaming up with Interwell Health, a company that focuses on care for patients with severe kidney complications, to mitigate these challenges before they become costly, life-disrupting emergencies. (Diamond, 2/21)
On the impact of a fight over the orphan drug program —
KHN:
A Bitter Battle Over The ‘Orphan Drug’ Program Leaves Patients’ Pocketbooks At Risk
A prescription drug that helps Lore Wilkinson walk and talk despite a rare muscle disease cost her so little for more than a decade that she didn’t even use her insurance to pay for it. But now, her Medicare insurance is shelling out about $40,000 for a one-month supply of the drug, and she fears she’ll be slammed with a $9,000 copayment. (Tribble, 2/22)
Also —
KHN:
Listen To The Latest ‘KHN Health Minute’
“Health Minute” brings original health care and health policy reporting from the KHN newsroom to the airwaves each week. (2/21)
