FDA Panel Rejects Drug-Device Tech For Treating Type 2 Diabetes

The Boston Globe: FDA Advisory Panel Rejects Drug-Device Combination To Treat Type 2 Diabetes
A panel of medical advisers on Thursday unanimously dashed a Cambridge biotech’s hopes that US regulators would reconsider a twice-rejected implantable device designed for adults with uncontrolled blood sugar stemming from Type 2 diabetes. In a 19-0 vote, the panel concluded the device’s benefits were outweighed by its safety risks, including the potential for kidney and heart problems. The vote essentially upheld the Food and Drug Administration’s earlier rejections, although some members called for new clinical studies to address safety and dosing concerns. (Weisman, 9/21)

Stat: Intarcia’s Device-Drug Diabetes Therapy Shut Down By FDA Panel
An advisory panel to the Food and Drug Administration unanimously voted against a diabetes implant from Intarcia Therapeutics — a former biotech unicorn that faltered after the FDA rejected said implant not once, but twice. (Lawrence, 9/21)

In other drug development news —

Stat: Drug For Rare Kidney Disease Narrowly Misses Mark In Clinical Trial
Travere Therapeutics said Thursday that a study meant to confirm the benefit of its newly approved drug for a rare kidney disorder narrowly failed. (Mast, 9/21)

Reuters: AstraZeneca And Daiichi's Breast Cancer Drug Meets Goal In Study
AstraZeneca (AZN.L) said on Friday its experimental precision drug had slowed the progression of a common type of breast cancer in a late-stage trial, a boost for the company after its shares fell in July on results from a separate trial of the same drug for lung cancer. The drug, datopotamab deruxtecan, which AstraZeneca is jointly developing with Japan's Daiichi Sankyo (4568.T), is being closely watched by analysts and investors in part due to the promise of the class of drugs to which it belongs, known as antibody drug conjugates (ADC). (Fick, 9/22)

On other health industry developments —

Boston Globe: Thermo Fisher Plant For Manufacturing Gene Therapies To Expand
Thermo Fisher Scientific’s giant plant to manufacture gene therapies for drug companies is barely a year old, but executives at the maker of scientific tools are already talking about expanding. Standing inside a cavernous unfinished section of the plant, Paul Fitzgerald, vice president and general manager of the site, told a group of biotech executives, journalists, and other visitors that he’s eager to transform it into laboratories. So far, the company is only using about 290,000 of the plant’s more than 400,000 square feet. (Saltzman, 9/21)

The Wall Street Journal: Contamination Is Found At Novo Nordisk Plant In U.S. 
Novo Nordisk found bacteria in batches of the main ingredient for a diabetes pill that is a cousin to popular diabetes and weight-loss drugs and was made at a North Carolina plant earlier this year, according to a federal inspection report reviewed by The Wall Street Journal. (Loftus, 9/21)

Boston Globe: Dana-Farber Split With Brigham Adds Uncertainty For Cancer Patients
When Sarah, a mother of two, was diagnosed with breast cancer in 2021 at the age of 43, she carefully considered where to go for care. She had been referred by her doctor to Beth Israel Deaconess Medical Center, where she received a mammogram and the cancer diagnosis. But Sarah, who asked that her last name not be used, ultimately chose the Dana-Farber Cancer Institute, wanting a place that was known for cancer treatment. (Bartlett, 9/21)

On staffing matters —

Modern Healthcare: Kaiser Permanente Strike: Union Prepares For Potential Strike
Kaiser Permanente and a union representing 85,000 employees are preparing for a possible strike Oct. 1 as the two sides remain far apart on contract proposals. An overwhelming majority of the more than 77,000 members of the Coalition of Kaiser Permanente Unions who cast ballots authorized a strike if the health system and union don’t reach an agreement during what are being called final bargaining sessions this week. (Devereaux, 9/21)

Stat: Why Are Kaiser Permanente Staff Considering A Strike?
This week, the Coalition of Kaiser Permanente Unions is negotiating a new national contract with the health care giant. More than 75,000 Kaiser Permanente health care workers across the country have voted to authorize a strike if Thursday and Friday’s bargaining sessions do not end in an acceptable deal. (Trang, 9/21)

The Boston Globe: Resident Union Accuses Mass General Brigham Of Unfair Labor Moves
The union for medical residents and fellows at Mass General Brigham has filed unfair labor practice charges against the state’s largest health system with the National Labor Relations Board, records show. ... “Changes to trainee benefits, which included a $10,000 stipend for residents and clinical fellows, were announced in March prior to both the petition for unionization and subsequent vote,” Mass General Brigham said in a statement. (Andersen, 9/21)

Also —

Modern Healthcare: UnitedHealth Group To Trim Medicare Advantage Plans In 2024
UnitedHealth Group plans to trim its Medicare Advantage offerings next year, the company informed providers in a notice distributed Thursday. UnitedHealthcare is the leading Medicare Advantage insurer with a 29% market share, according to data analyzed by KFF, and expects membership to grow by more than 900,000 this year. (Tepper, 9/21)

Crain's Chicago Business: Outcome Health's Rishi Shah Spent Over $6M Fighting Fraud Charges
Outcome Health co-founder Rishi Shah spent more than $6 million on defense attorneys to fight federal fraud charges, but he wanted to spend much more. That’s why he deserves a new trial, he says in a new court filing. It’s a curious, convoluted argument that underscores how far the millionaire startup founder is going to hang onto his money and his freedom for as long as he can. (Pletz, 9/21)

Reuters: Walgreens Hit With Lawsuit After FDA Warning Over Eyedrops
Walgreens was hit with a proposed class action in Florida federal court over claims it mislabeled eyedrops for treating pink eye and misled consumers into believing the product was safe and effective. The lawsuit, filed Wednesday, follows warning letters that the FDA sent to Illinois-based Walgreens and several other companies last week about selling and marketing eye care products that the agency said posed a risk to users. The FDA has not approved the products at issue. (Novak Jones, 9/22)

Modern Healthcare: Walgreens Promises More Co-Branded VillageMD Offices
Walgreens reaffirmed its commitment to becoming a fully integrated healthcare company on Wednesday, showing off its latest Village Medical at Walgreens primary care location in suburban Chicago. Walgreens moved aggressively into healthcare services under former CEO Roz Brewer, who stepped down earlier this month as the company's U.S. healthcare services segment has struggled to gain traction. A search is underway for a permanent CEO. (Eastabrook, 9/21)

Fortune: Top 100 Hospitals 2023: Fortune/PINC AI
Fifty-one of the winning hospitals appeared on last year’s list. As is the case every year, hospitals do not apply for the 100 Top Hospitals award, and winners do not pay to market this honor. This year’s study, which was based on publicly available Medicare data from 2021, showed little change from 2020 for the industry on most measures. The one exception for hospitals in the study was profit margin, which increased significantly due to COVID-19 relief dollars hospitals received that year. Those pandemic funds are gone, of course, raising the stakes for hospitals to be at the top of their game. (9/21)