Spotlight Falls On Obscure FDA Program Shunting Money Into Costly Drugs

Bloomberg: Expensive Drugs From Big US Pharma Get More Money From FDA Program
Vertex Pharmaceuticals Inc. has made over $20 billion in worldwide sales from a cystic fibrosis drug approved four years ago that can cost up to $300,000 a year. With blockbuster sales like that, Vertex wouldn’t appear to need government assistance. But thanks to an obscure program designed to incentivize companies to make drugs for uncommon or neglected diseases, the Food and Drug Administration also awarded Vertex a bonus certificate that it can either use to expedite a future drug approval or sell for around $100 million. (Langreth, Rutherford, and Meghjani, 12/21)

Bloomberg: Hospital Prices: Medicare Warns Companies On Price Transparency
Some of the largest US hospital chains and most prestigious academic medical centers have violated federal rules by not posting the prices they charge for care, according to records obtained by Bloomberg News. For-profit HCA Healthcare Inc., the nation’s largest hospital system, and big nonprofit operators including Ascension and Trinity Health have been cited for failing to make prices fully available to the public, enforcement letters Bloomberg obtained through a public records request show. (Tozzi and Meghjani, 12/20)

In other health care industry news —

Modern Healthcare: Fitch: Healthcare Hiring, Retention Rates Growing
Hospital employment numbers have increased, while healthcare job openings are on the decline—though the industry is still recovering from the effects of the COVID-19 pandemic. About 17.2 million individuals were on the payroll at healthcare organizations in November 2023, compared with 16.6 million in December 2022, according to the latest data from the Bureau of Labor Statistics. (Devereaux, 12/20)

Roll Call: Spending Fights, Supply Chain Delays Slow Mobile Health Boom 
Nan’s Donuts, located in the central Pennsylvania region of Sugar Valley, is only open Wednesdays and Saturdays. That’s why Don Lynch parks Evangelical Community Hospital’s mobile health clinic in the parking lot of the adjoining Amish grocery on the first Wednesday of each month. (Clason, 12/20)

Modern Healthcare: Final Merger Guidelines May Limit M&A
Federal regulators subtly changed the final merger guidelines this week as the agencies outlined their plan to limit consolidation in all industries, including healthcare. The updated guidelines from the Federal Trade Commission and Justice Department could have a wide-ranging impact on many types of deals, including cross-market health system mergers and acquisitions of physician practices by hospitals and insurers. (Kacik, 12/20)

Bay Area News Group: Sutter Health Eyes Huge Santa Clara Lease In Boost For Office Market
Sutter Health has struck a deal to lease three office buildings at a high-profile Santa Clara campus in a deal that bolsters the Bay Area’s wobbly commercial property sector. ... Sutter Health intends to use the three buildings as medical office sites, according to the commercial property experts familiar with the leasing deal. It wasn’t immediately clear when Sutter Health would be moving into the buildings. Financial terms of the lease weren’t disclosed. (Avalos, 12/20)

Bloomberg: UnitedHealth Receives $610 Million Offer For Brazil Unit
UnitedHealth Group Inc received an offer from local entrepreneur Nelson Tanure valuing its Brazil unit at 2.5 billion to 3 billion reais ($509 million to $610 million), people familiar with the matter said. Private equity firm Bain Capital LP and another Brazilian entrepreneur, Jose Seripieri Filho, have also made acquisition proposals, the people said, asking not to be named because negotiations are private. A decision from the US company about the offers is expected soon, though negotiations could end without a deal, the people said. (Gamarski, Lucchesi, and Tozzi, 12/21)

Stat: SEC Charges Former Device Maker CEO With $41 Million Fraud
The Securities and Exchange Commission on Tuesday charged the former CEO of Stimwave, a company that sold devices containing dummy pieces of plastic, with defrauding investors out of $41 million. (Lawrence, 12/20)

Stat: Medical Marijuana Companies Are Using Pharma’s Sales Tactics With Little Of The Same Scrutiny
Medical marijuana companies sell medicine, just like pharmaceutical companies. But they’re not playing by the same rules — and that’s putting patients at risk. (Florko, 12/21)

Also —

The Wall Street Journal: FDA Says Merck’s Chronic Cough Treatment Didn’t Show Substantial Evidence Of Effectiveness
Merck’s candidate to treat chronic cough didn’t show substantial evidence of effectiveness, according to the Food and Drug Administration. The Rahway, N.J.-based pharmaceutical company said Wednesday it received a complete response letter from the FDA regarding its new drug application for gefapixant, a potential treatment for refractory chronic cough or unexplained chronic cough in adults. (Glickman, 12/20)

Reuters: US FDA Declines To Approve Merck's Chronic Cough Drug
The U.S. Food and Drug Administration (FDA) declined to approve Merck's (MRK.N) drug for chronic cough, the company said on Wednesday, marking the second rejection in less than two years. The health regulator concluded the company's application for the drug, gefapixant, did not meet substantial evidence of effectiveness for treating refractory chronic cough and unexplained chronic cough. Currently, there are no approved treatments in the United States for coughing bouts that don't go away despite treatment of underlying conditions or have no identifiable cause. (12/20)

Reuters: US FDA Approves Sweden-Based Calliditas' Kidney Disease Drug
The U.S. Food and Drug Administration (FDA) granted full approval to Swedish drugmaker Calliditas Therapeutics' (CALTX.ST) drug to treat rare kidney disease IgA Nephropathy (IgAN), the company said on Wednesday. The company's U.S.-listed shares rose 29% after the bell. The FDA decision makes the drug, branded as Tarpeyo, the first to be granted a full approval in the United States for IgAN, ahead of Travere Therapeutics' (TVTX.O) Filspari which won accelerated approval earlier this year. (Sunny and Santhosh, 12/20)

Stat: In Another Setback, Argenx Drug Fails Trial In Skin Blistering Condition
The Belgian company Argenx said Wednesday that its closely watched antibody therapy failed to outperform placebo in a Phase 3 trial in an autoimmune condition that causes the skin to blister — the second setback in less than a month for the biotech and its drug. (Joseph, 12/20)

Bloomberg: Sanofi Ends Lung Cancer Drug Study After Trial Failure
Sanofi will stop developing an experimental lung cancer medicine after it failed to impress in a late-stage trial. The French drugmaker is terminating the program for tusamitamab ravtansine, an antibody-based treatment that failed to outperform a chemotherapy in treating some patients with metastatic non-squamous non-small cell lung cancer. (Loh, 12/21)

Stat: Can The FDA Get Companies To Test Drugs In People Of Color?
Sometime next year drug and medical device companies will have to tell the Food and Drug Administration how they plan to include people of color in clinical trials. But planning isn’t the same as doing, the industry’s track record isn’t great, and it’s not clear whether the FDA will twist arms, experts told STAT. (Wilkerson, 12/21)