Friday, September 22, 2023 – KFF Well being Information
Fda Panel Rejects Drug-System Tech For Managing Form 2 Diabetes
A panel of clinical advisers quashed hopes of a Cambridge biotech that its process would be reconsidered for approval, right after being turned down 2 times. The device’s advantages were being outweighed by its basic safety pitfalls, the panel concluded. In other sector news: contamination at a U.S. Novo Nordisk plant, wellbeing care strikes, and a lot more.
The Boston World:
Food and drug administration Advisory Panel Rejects Drug-Device Mixture To Deal with Style 2 Diabetic issues
A panel of professional medical advisers on Thursday unanimously dashed a Cambridge biotech’s hopes that US regulators would reconsider a 2 times-turned down implantable system created for grown ups with uncontrolled blood sugar stemming from Style 2 diabetic issues. In a 19- vote, the panel concluded the device’s positive aspects have been outweighed by its safety dangers, together with the potential for kidney and heart challenges. The vote essentially upheld the Food and Drug Administration’s earlier rejections, although some associates known as for new scientific experiments to tackle protection and dosing worries. (Weisman, 9/21)
Stat:
Intarcia’s Product-Drug Diabetic issues Treatment Shut Down By Food and drug administration Panel
An advisory panel to the Food stuff and Drug Administration unanimously voted versus a diabetic issues implant from Intarcia Therapeutics — a former biotech unicorn that faltered after the Fda turned down claimed implant not when, but two times. (Lawrence, 9/21)
In other drug improvement information —
Stat:
Drug For Exceptional Kidney Disorder Narrowly Misses Mark In Scientific Trial
Travere Therapeutics said Thursday that a research meant to validate the gain of its recently permitted drug for a unusual kidney dysfunction narrowly failed. (Mast, 9/21)
Reuters:
AstraZeneca And Daiichi’s Breast Cancer Drug Meets Aim In Research
AstraZeneca (AZN.L) mentioned on Friday its experimental precision drug had slowed the progression of a prevalent form of breast most cancers in a late-stage demo, a enhance for the enterprise immediately after its shares fell in July on final results from a individual trial of the exact same drug for lung cancer. The drug, datopotamab deruxtecan, which AstraZeneca is jointly producing with Japan’s Daiichi Sankyo (4568.T), is remaining closely watched by analysts and traders in part due to the assure of the course of medicine to which it belongs, regarded as antibody drug conjugates (ADC). (Fick, 9/22)
On other well being industry developments —
Boston Globe:
Thermo Fisher Plant For Manufacturing Gene Therapies To Grow
Thermo Fisher Scientific’s giant plant to manufacture gene therapies for drug companies is barely a year aged, but executives at the maker of scientific applications are by now chatting about growing. Standing inside a cavernous unfinished part of the plant, Paul Fitzgerald, vice president and common manager of the web page, told a group of biotech executives, journalists, and other guests that he’s eager to completely transform it into laboratories. So far, the business is only working with about 290,000 of the plant’s extra than 400,000 square ft. (Saltzman, 9/21)
The Wall Avenue Journal:
Contamination Is Uncovered At Novo Nordisk Plant In U.S.
Novo Nordisk found micro organism in batches of the main component for a diabetic issues pill that is a cousin to preferred diabetes and excess weight-decline medication and was built at a North Carolina plant earlier this yr, according to a federal inspection report reviewed by The Wall Avenue Journal. (Loftus, 9/21)
Boston Globe:
Dana-Farber Split With Brigham Provides Uncertainty For Cancer Clients
When Sarah, a mom of two, was diagnosed with breast most cancers in 2021 at the age of 43, she thoroughly thought of the place to go for treatment. She experienced been referred by her medical professional to Beth Israel Deaconess Health care Middle, in which she gained a mammogram and the most cancers prognosis. But Sarah, who questioned that her past identify not be applied, in the long run selected the Dana-Farber Most cancers Institute, seeking a location that was recognised for cancer procedure. (Bartlett, 9/21)
On staffing issues —
Modern-day Healthcare:
Kaiser Permanente Strike: Union Prepares For Potential Strike
Kaiser Permanente and a union representing 85,000 employees are preparing for a attainable strike Oct. 1 as the two sides continue being considerably apart on agreement proposals. An overwhelming bulk of the far more than 77,000 members of the Coalition of Kaiser Permanente Unions who solid ballots authorized a strike if the well being system and union really don’t reach an agreement during what are currently being known as remaining bargaining sessions this week. (Devereaux, 9/21)
Stat:
Why Are Kaiser Permanente Staff members Thinking of A Strike?
This week, the Coalition of Kaiser Permanente Unions is negotiating a new nationwide deal with the health and fitness care giant. Extra than 75,000 Kaiser Permanente overall health care staff throughout the country have voted to authorize a strike if Thursday and Friday’s bargaining sessions do not stop in an suitable deal. (Trang, 9/21)
The Boston World:
Resident Union Accuses Mass Standard Brigham Of Unfair Labor Moves
The union for healthcare people and fellows at Mass Typical Brigham has submitted unfair labor follow fees towards the state’s biggest wellbeing system with the National Labor Relations Board, documents clearly show. … “Changes to trainee gains, which incorporated a $10,000 stipend for citizens and clinical fellows, were being introduced in March prior to both of those the petition for unionization and subsequent vote,” Mass Normal Brigham claimed in a assertion. (Andersen, 9/21)
Also —
Fashionable Health care:
UnitedHealth Group To Trim Medicare Gain Programs In 2024
UnitedHealth Group plans to trim its Medicare Gain choices up coming 12 months, the business informed vendors in a notice dispersed Thursday. UnitedHealthcare is the primary Medicare Benefit insurer with a 29% industry share, in accordance to information analyzed by KFF, and expects membership to develop by a lot more than 900,000 this yr. (Tepper, 9/21)
Crain’s Chicago Company:
End result Health’s Rishi Shah Invested Around $6M Fighting Fraud Costs
Final result Wellbeing co-founder Rishi Shah spent more than $6 million on defense attorneys to struggle federal fraud prices, but he preferred to expend much additional. Which is why he warrants a new demo, he states in a new courtroom filing. It’s a curious, convoluted argument that underscores how far the millionaire startup founder is going to dangle on to his money and his liberty for as very long as he can. (Pletz, 9/21)
Reuters:
Walgreens Hit With Lawsuit After Fda Warning About Eyedrops
Walgreens was hit with a proposed course action in Florida federal courtroom above promises it mislabeled eyedrops for managing pink eye and misled customers into believing the products was risk-free and powerful. The lawsuit, filed Wednesday, follows warning letters that the Food and drug administration despatched to Illinois-based Walgreens and several other providers past week about marketing and internet marketing eye treatment solutions that the agency stated posed a chance to users. The Food and drug administration has not accredited the goods at difficulty. (Novak Jones, 9/22)
Modern-day Health care:
Walgreens Promises More Co-Branded VillageMD Places of work
Walgreens reaffirmed its dedication to starting to be a thoroughly integrated health care organization on Wednesday, demonstrating off its most current Village Healthcare at Walgreens principal care spot in suburban Chicago. Walgreens moved aggressively into health care companies less than previous CEO Roz Brewer, who stepped down before this month as the firm’s U.S. health care companies phase has struggled to gain traction. A look for is underway for a permanent CEO. (Eastabrook, 9/21)
Fortune:
Top rated 100 Hospitals 2023: Fortune/PINC AI
Fifty-just one of the winning hospitals appeared on very last year’s listing. As is the situation every single yr, hospitals do not implement for the 100 Top rated Hospitals award, and winners do not pay out to industry this honor. This year’s study, which was primarily based on publicly obtainable Medicare info from 2021, showed minimal modify from 2020 for the business on most measures. The one particular exception for hospitals in the examine was earnings margin, which improved drastically owing to COVID-19 aid bucks hospitals received that calendar year. People pandemic funds are long gone, of training course, boosting the stakes for hospitals to be at the top of their activity. (9/21)
