Biogen Indicates EU Won’t Approve Alzheimer’s Drug

The New York Times: Biogen’s Alzheimer’s Drug Is Unlikely To Win E.U. Approval
The drug maker Biogen said on Wednesday that a panel of drug reviewers in the European Union had indicated that its new Alzheimer’s drug was unlikely to be approved there, the latest setback for a medication that has been mired in controversy since it was approved in the United States in June. Biogen said a committee of experts that advises the European Medicines Agency had issued a “negative trend vote” — a preliminary signal that typically precedes a recommendation that the drug not be approved — on the company’s application for the drug, Aduhelm, this month. The panel will formalize its recommendation at a meeting next month. (Robbins, 11/17)

Stat: What A European Rejection Of An Alzheimer's Drug Would Mean For Biogen
In a potentially huge setback for Biogen (BIIB), a European regulatory panel signaled that it is unlikely to recommend the company’s controversial Alzheimer’s treatment should be approved. And while a final decision by the European Medicines Agency will not be known until next month, Wall Street is quickly discounting the possibility the medication will generate revenues from the vast European market. (Silverman, 11/17)

In health industry staffing news —

The Wall Street Journal: Pfizer Searches For New CFO As Frank D’Amelio Retires
Pfizer Inc. is looking for a new chief financial officer following the retirement of its longtime CFO, Frank D’Amelio. The New York-based drugmaker said Wednesday that it is conducting an external search for Mr. D’Amelio’s successor. Mr. D’Amelio has served as CFO since joining the company in 2007 from telecommunications giant Alcatel-Lucent. He plans to remain with Pfizer until a successor is found. (Broughton, 11/17)

Stat: Alnylam’s Maraganore Reflects On His Successor And His Next Steps
John Maraganore’s decision to step down as Alnylam Pharmaceuticals’ CEO after almost 20 years came as a shock to people outside of the company — enough to send the company’s stock tumbling by more than 16% that day. But it was a shock, too, to people within Alnylam, Maraganore recalled at the 2021 STAT Summit in Boston on Tuesday. Including, even, his successor as CEO, Yvonne Greenstreet. (Sheridan, 11/17)

The Wall Street Journal: Nurse Salaries Rise As Demand For Their Services Soars During Covid-19 Pandemic
Nurses are winning raises worth thousands of dollars a year from hospitals, the latest employer reckoning with a tight labor market. HCA Healthcare Inc., HCA 0.89% one of the nation’s largest hospital chains, increased nurse pay this year to handle heavy Covid-19 pandemic case loads and keep pace with rivals that are also trying to fill vacancies and hold on to existing staff, the company’s human resources chief said. Raises varied by market; an HCA spokesman declined to say by what amounts. (Evans, 11/17)

Also —

The Wall Street Journal: Former Pittsburgh Steel Mill To Become Biomedical-Manufacturing Plant With Mellon Grant 
The Richard King Mellon Foundation announced a $100 million grant to fund a center for biomedical manufacturing, the latest piece in a plan to redevelop a stretch of riverfront outside Pittsburgh nearly half the size of the city’s downtown. The 178-acre property known as Hazelwood Green is the site of a former LTV Steel mill that shut in the 1990s. The $100 million grant will fund a bio-manufacturing facility called the Pitt BioForge to be run by the University of Pittsburgh, with the aim of attracting companies that produce cell and gene therapies to treat cancer and other health conditions. (Maher, 11/17)

Los Angeles Times: Whistleblower Or Flamethrower? California Medical Board Member Calls Out His Colleagues
The pleas for help find him. They arrive by email or seep into his social media account. One showed up in a tightly sealed letter to his home. After years of feeling ignored by the Medical Board of California, the writers hope he’ll finally be the one who hears them. Eserick “TJ” Watkins can guess the types of allegations that could be waiting inside: the stories of a doctor’s misconduct that left an over-prescribed teen addicted, a father missing a limb, a daughter dead. He has heard hundreds of these cases as a member of the medical board, which oversees the discipline of doctors in the state. (Gutierrez, 11/17)

Stat: FDA Urged To Disqualify A Hospital, Two Doctors Over Clinical Trial Missteps
The Food and Drug Administration is being urged to disqualify a Minnesota hospital and two physicians from running clinical trials after the agency found studies that violated regulations on human research. In a petition, the Public Citizen advocacy group noted FDA inspectors recently warned Hennepin County Medical Center and two physicians for failing to obtain consent from subjects in trials that tested the safety and effectiveness of the medications for managing agitation. The studies involved antipsychotics and the potent anesthetic ketamine on patients in emergency rooms or prior to their arrival. (Silverman, 11/17)

NBC News: Some Firms Thrived During Covid And Then Got Their PPP Covid Relief Loans Forgiven
In late June, Sharps Compliance, a Houston-based medical waste management company, reported spectacular financial results. The rollout of Covid-19 vaccines had increased demand for the company’s services, Sharps said, and its earnings had more than quadrupled. The company’s board granted Sharps’ top three executives twice the compensation they’d received a year earlier based on the performance; the trio shared almost $1 million more than they’d received in fiscal 2020, Securities and Exchange Commission filings show. (Morgenson, 11/18)

On financial matters —

Modern Healthcare: Aetna Sues COVID-19 Testing Companies, Alleges Fraud
Aetna is taking a group of related radiology companies to court and accusing them of overcharging for unauthorized COVID-19 tests to the tune of at least $580,000. (Tepper, 11/17)

Modern Healthcare: Healthcare Professional Data Startup H1 Reels In $100 Million In Funding
H1 Inc., a startup that pitches itself as a social network and database for healthcare professionals, raised $100 million in new financing, according to a company blog post on Tuesday. Altimeter Capital led the Series C funding round, with additional investments from Goldman Sachs Asset Management and Flex Capital. H1 plans to use the new money to grow its existing business and expand into new markets, having primarily focused on helping life sciences companies connect with doctors for clinical trials to this point. (Brady, 11/17)

Modern Healthcare: ProMedica, AAA Pilot Joint Venture For Aging Americans
ProMedica and AAA Club Alliance on Wednesday announced plans for a new healthcare joint venture targeting aging Americans. AAA HealthCONNECT powered by ProMedica will officially launch in early 2022 in Ohio and will be available to those 55 and older who sign up for a membership. The goal is for the offering to be a "one-stop shop" that will help people "navigate the aging process," said Tom Wiedemann, president and CEO of AAA Club Alliance. (Christ, 11/17)

KHN: Stranded By The Pandemic, He Had Only Travel Insurance. It Left Him With A $38,000 Bill
Duy Hoa Tran, a retired Vietnamese schoolteacher, arrived in Los Angeles in February 2020 to visit his daughter and 2-month-old grandson. Two weeks later, the door closed behind him. To prevent the spread of covid-19, Vietnam shut its borders. No commercial flights would be allowed into the country for the next 18 months. Tran’s daughter, An Tran, who has a doctorate in business administration and teaches marketing at the University of La Verne in California, did what she thought was necessary to ensure medical coverage for her then-65-year-old father during the pandemic. But the only option for a visitor on a tourist visa was travel insurance. In early March 2020, An Tran found and purchased a policy, for about $350 a month, from a company called Seven Corners. (Allen, 11/18)

In news about the Theranos trial —

CNBC: Theranos Patient Says Blood Test Came Back With False Positive For HIV
Erin Tompkins, who got her blood drawn from a Theranos device at a Walgreens in Arizona, said the test misdiagnosed her as having an HIV antibody, sending her into a panic. “I was quite emotional at the time,” Tompkins told jurors on Wednesday in the criminal trial of Theranos founder Elizabeth Holmes. Tompkins, a witness to the prosecution and the second patient to testify, said she first read about Theranos in Forbes. She later learned more about the blood-testing company on Facebook from a friend who was looking for affordable health-care options. (Khorram, 11/17)