CDC Weighs New Opioid Guidance; Digital Therapeutics Face Challenges

The New York Times: C.D.C. Proposes New Guidelines For Treating Pain, Including Opioid Use 
The federal government on Thursday proposed new guidelines for prescribing opioid painkillers that remove its previous recommended ceilings on doses for chronic pain patients and instead encourage doctors to use their best judgment. But the overall thrust of the recommendations was that doctors should first turn to “nonopioid therapies” for both chronic and acute pain, including prescription medications like gabapentin and over-the-counter ones like ibuprofen, as well as physical therapy, massage and acupuncture. (Hoffman, 2/10)

Axios: FTC May Probe Pharmacy Benefit Managers 
The Federal Trade Commission will vote Thursday on whether it will study how pharmacy benefit managers affect drug prices and the businesses of pharmacies. Why it matters: PBMs are powerful, secretive and heavily consolidated, and it appears the FTC is open to scrutinizing the industry that got significantly more concentrated under the FTC's own watch. (Herman, 2/14)

Stat: Akili Filings Lays Bare The Challenges Ahead For Digital Therapeutics
Akili Interactive, the maker of a Food and Drug Administration-cleared video game to treat ADHD, has long been bullish on the tremendous potential of its technology to reach wide swaths of the population. The difficulty of realizing that dream was laid bare in the company’s freshly filed paperwork as it looks to go public. In January, Akili announced that it would enter the markets via a merger with Social Capital Suvretta Holdings Corp. I, a special purpose acquisition company run by venture capitalist and former Facebook executive Chamath Palihapitiya. The deal valued the company at about $1 billion. On Monday, the companies filed an S-4 with the Securities Exchange Commission detailing the merger and giving the first good look at Akili’s finances and a thorough accounting of the hurdles that the company – and some of Akili’s competitors – could face. (Aguilar, 2/14)

Modern Healthcare: BIO Report Paints Bleak Picture Of Antibiotic Pipeline, With Some Solutions
There are a shrinking number of antibiotic drug makers and investors, who see little payoff in a market that reimburses new drugs on volume, rather than their benefits to public health, according to a new report from a trade group known as the Biotechnology Innovation Organization. About 80% of new antibiotics that are being developed in clinical trials come from small, emerging biotechnology companies, as larger manufacturers have exited the market. And, over the past decade, venture capital funding for U.S. antibiotic development was 17 times less than for oncology drugs. (Gillespie, 2/14)

CIDRAP: Launch Of First Human Trial Of Nipah Virus Vaccine Announced
Public Health Vaccines (PHV), based in Massachusetts, yesterday announced the launch of a phase 1 clinical trial for its Nipah virus vaccine, the first of its kind to be tested in people. The vaccine was developed by scientists at the National Institute of Allergy and Infectious Diseases, which licensed the product to PHV. The vaccine's development has been supported by the Coalition for Epidemic Preparedness Innovations (CEPI), which in 2017 flagged Nipah virus as one of four diseases that has the capability to trigger a major global epidemic. (2/10)

Stat: Belgium Discloses Penalties For Failing To Report Clinical Trial Results
In the latest move to crack down on wayward clinical trial sponsors, Belgium may now fine companies, hospitals, and universities that fail to publicly disclose study results, a sign that more European regulators are growing concerned about a lack of transparency surrounding medical data. As of this month, the Federal Agency for Medicines and Health Products can impose fines of $550 to $280,000 and threaten imprisonment of up to two years. The penalties, set forth in a 2017 law, did not go into effect for trial results until now because they were tied to European Union regulations that began in January. However, a new remedy adopted by the agency would permit violators to reach a settlement of at least $4,500 or otherwise face further proceedings, an FAMHP spokesperson explained. (Silverman, 2/14)

Cincinnati Enquirer: Covington Biotech Research Lab Critical To Retain Cincinnati Start-Ups
Many smaller biotechnology companies get their start in incubator labs, which allow them to rent lab and office space instead of purchasing their own equipment. But labs like these are lacking in the Cincinnati area. The city of Covington and a group of local companies are seeking to change that. Plans are in development for a new life sciences research wet lab, which would be located in Covington. (Berry, 2/14)

Axios: A Startup For Starting A Family
On this day of love, Gaia is debuting its personalized in-vitro fertilization (IVF) insurance product on the Lloyds of London market and announcing a fresh round of $20 million in Series A funding led by Atomico, the company's founder tells Axios. Why it matters: Fertility treatment is a heavily opaque sector of the health care industry that's just as convoluted as it is inequitable. Did we mention how expensive it is? (Brodwin, 2/14)

Modern Healthcare: CaptureRx Agrees To Pay $4.75M To Settle 2021 Data Breach Lawsuit
CaptureRx has agreed to pay $4.75 million to settle a proposed class-action lawsuit related to a data breach it experienced last year, according to court documents filed Friday. The settlement would end a lawsuit stemming from a hack at San Antonio-based NEC Networks, a prescription claims processor that does business under the name CaptureRx. The proposed settlement agreement, filed in a Texas district court, consolidates six lawsuits filed last year, according to a proposed order granting preliminary approval of the class-action settlement agreement. (Cohen, 2/14)