US Child-Care Costs at $40,000 Force Parents to Get Second Jobs

 

• Parents embrace more demanding work schedules to offset costs
• Families paying for child care dip into savings at faster rate

A dramatic increase in child-care costs since the pandemic is forcing parents to find new ways of making ends meet, from working part time at a daycare for a discount to driving for a ride-share service on weekends.

In a sign of how extraordinary the financial pressure has become — at a time when housing, groceries and other everyday items have also grown more expensive — even workers with full-time positions at the likes of big banks and tech firms are among those embracing such solutions, according to interviews with nearly two dozen parents.

https://www.bloomberg.com/news/articles/2023-12-20/us-child-care-costs-rise-in-post-covid-economy-pushing-parents-into-second-job

Panbela Therapeutics' stock tumbles, after more than tripling the past 2 days

 Shares of Panbela Therapeutics Inc. (PBLA) dropped 21.7% in premarket trading, as they paused after a two-day "meme"-like rally of 243.5%. The two-day rally in the biopharmaceutical company's stock, which followed a record-low close of 45.7 cents on Friday, was fueled by positive news from the U.S. Food and Drug Administration regarding a treatment for child cancer. The FDA had approved US WorldMeds' new drug application for the use of eflornithine as a therapy for high-risk patients with neuroblastoma, which contributes to nearly 15% of pediatric cancer deaths. Panbela said that approval is a "prerequisite for considerable development milestone payments" to the company. Despite the big two-day rally, the stock was still down 98.2% year to date.

https://www.morningstar.com/news/marketwatch/20231220272/panbela-therapeutics-stock-tumbles-after-more-than-tripling-the-past-2-days

Guardant Health shares slide as colon cancer test is set for FDA advisory committee review

 Shares of Guardant Health Inc. (GH) dropped 9.5% premarket on Wednesday after the company said late Tuesday that a U.S. Food and Drug Administration advisory committee will review its colorectal cancer screening test early next year. Guardant earlier this year sought FDA premarket approval for the product, a blood-based test called Shield. Approval was expected in the first quarter of next year, so the scheduling of an advisory committee meeting on March 28 "likely comes as a surprise," Leerink Partners analysts said in a note Tuesday. The timeline for potential approval has been pushed out to the second quarter of next year, the analysts said. "We welcome the opportunity to engage in a discussion with key opinion leaders about our study results and the power of Shield in closing the screening gap once FDA approved," AmirAli Talasaz, co-CEO of Guardant Health, said in a statement. The proposed timing of the meeting is in line with the company's expectation to complete the application process and launch the product in 2024, Talasaz said. Guardant shares have gained 2.6% in the year to date, while the S&P 500 is up 24%.

https://www.morningstar.com/news/marketwatch/20231220295/guardant-health-shares-slide-as-colon-cancer-test-is-set-for-fda-advisory-committee-review

RedHill Biopharma shares jump as Ebola treatment shows promise

 RedHill Biopharma Ltd. American depositary receipts (RDHL) climbed 10% premarket on Wednesday after the company said two of its experimental drugs, when individually combined with remdesivir, showed promise in combating the Ebola virus. The drugs, opaganib and RHB-107, "show a distinct synergy in terms of viral inhibition while maintaining cell viability" when either is combined with remdesivir, U.S. Army Major Jeffrey Kugelman, a branch chief in the Army's Medical Research Institute of Infectious Diseases and leader of the study's bioinformatics analysis, said in a statement. Ebola virus disease is a rare but often fatal illness, and the virus often spreads to people through infected animals or human transmission. Remdesivir is an antiviral medication developed by Gilead Sciences Inc. (GILD) and sold under the brand name Veklury. RedHill shares have dropped 76% in the year to date, while the S&P 500 has gained 24%.

https://www.morningstar.com/news/marketwatch/20231220302/redhill-biopharma-shares-jump-as-ebola-treatment-shows-promise

Pump Prices in US Post Biggest Jump in Four Months

 

• Gasoline prices track oil’s rally amid Red Sea disruptions
• Prices rise as nearly 104 million Americans ready to hit road

US pump prices had their biggest jump in more than four months, tracking gains in oil, as many Americans get ready for holiday road trips.

Regular gasoline now costs an average of $3.097 a gallon after notching the biggest one-day increase since August with a 0.6% gain, according to data from the American Automobile Association. The group estimates that nearly 104 million people will drive to their holiday destinations this year, the second highest on record.

https://www.bloomberg.com/news/articles/2023-12-20/us-pump-prices-post-biggest-jump-since-august-as-oil-gains

Merck Secures FDA Decision Date for Pneumococcal Vaccine, Race Heats Up with Pfizer

 Merck is looking to challenge Pfizer in the pneumococcal vaccine space with Tuesday’s announcement that the FDA has granted priority review for a Biologics License Application for V116, Merck’s investigational 21-valent pneumococcal conjugate vaccine.

The regulator has set a Prescription Drug User Fee Act date of June 17, 2024.

If the V116 vaccine is approved, it would be the first pneumococcal conjugate vaccine that is “specifically designed to address the serotypes that cause most adult invasive pneumococcal disease,” according to Merck CMO Eliav Barr.  

The BLA for the vaccine is based on data from the Phase III STRIDE-3 trial which put Merck’s vaccine up against Pfizer’s Prevnar 20. In November 2023, Merck announced the results from the STRIDE-3 study , revealing that in adults 50 and over the vaccine produced “non-inferior immune responses” compared to PCV20 for all 10 serotypes of both vaccines at day 30. Immune responses to the vaccine “were superior” for 10 of the 11 serotypes included in the V116 vaccine but not in PCV20.

For adults 18 to 49 years of age, the vaccine had “non-inferior immune responses” compared to adults aged 50 to 64. For both groups of patients, V116 had a safety profile that was “comparable” to PCV20. While Merck initially gave no other detailed figures, according to the CDC, the serotypes covered by the V116 vaccine are responsible for an estimated 83% of invasive pneumococcal disease in people 65 and older.  

“These results provide strong evidence to support the immunogenicity of V116 compared to the standard of care in the prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults,” Barr said at the time.

In July 2023, the STRIDE-3 and STRIDE-6 trials showed that V116 outperformed a standard 20-valent vaccine  providing an immune response in those who have not been immunized before. 

“Invasive forms of pneumococcal disease can cause severe and sometimes life-threatening complications, such as pneumococcal pneumonia, pneumococcal meningitis and bacteremia, especially for older or immunocompromised adults,” Sady Alpizar, principal investigator at the Clinical Research Trials of Florida, who serves as a principal investigator of the study, said in a statement. 

Pfizer had its 20-valent vaccine Prevnar 20 approved by the FDA in infants and children from six months to age 17 in April 2023. The vaccine was approved in adults in 2021. The Prevnar family of vaccines saw a 15% boost in sales in the third quarter of 2023, bringing in over $4.8 billion in revenue. 

https://www.biospace.com/article/merck-secures-fda-decision-date-for-pneumococcal-vaccine-race-heats-up-with-pfizer/

Failed Illumina and Sanofi Deals Shine Light on FTC Antitrust Crackdown

 The news earlier this week that Illumina is divesting GRAIL marked the beginning of the end for a yearslong battle over cancer testing development—and another demonstration of the Federal Trade Commission’s increased scrutiny around potential antitrust violations. Just last week, another FTC challenge made headlines when Sanofi dropped a planned licensing agreement with California-based Maze Therapeutics to develop treatments for Pompe.

On Monday, the FTC released new merger guidelines, which emphasize that deals should not “increase concentration in a highly concentrated market.” Pharmaceutical markets are often highly consolidated, according to Diana Moss, director of competition policy at the Progressive Policy Institute, making them a frequent target.

“Sanofi/Maze and Illumina/Grail reflect antitrust concerns that are increasingly being taken up by enforcers, including the loss of competition in R&D markets and the elimination of smaller, nascent innovative competitors,” Moss told BioSpace.

Will the FTC’s Shift Help or Hurt Drug Development?

At the heart of the proposed collaboration between Sanofi and Maze is a rare genetic disorder called Pompe disease, which affects fewer than 10,000 people worldwide. The FTC argued that Sanofi gaining control of Maze’s lead asset MZE001 would give the former a monopoly in the space and lead to higher costs for patients, but Sanofi countered that the collaboration would expedite the delivery of much-needed therapies.

Indeed, many in the pharmaceutical industry argue that mergers and acquisitions foster innovation. Earlier this year, 31 pharma companies formed the Partnership for the U.S. Life Science Ecosystem (PULSE) to challenge this new approach, which the coalition said would harm “pro-innovation” mergers and acquisitions.

In response to the Sanofi decision, a PULSE spokesperson told BioSpace that the FTC’s approach “undermines the type of partnerships that can have a meaningful benefit for patients.”

“The reality is that early-stage companies benefit and often need the support, expertise and efficiency that a larger firm can provide when it comes to specific disease states or therapeutic categories,” the spokesperson said. “These types of licensing partnerships offer the opportunity for a potential new treatment for patients; unfortunately, that’s a more uncertain reality given the FTC’s actions.”

Ryan Colburn, a rare disease research consultant who lives with Pompe disease, said the FTC decision on Sanofi/Maze has hurt patients in the short term by delaying the development of MZE001. When the FTC interviewed him earlier this year, Colburn directly expressed his concerns about the agency’s approach to interviewers, he told BioSpace.

Colburn said that the FTC’s role in curating competition is important, but there needs to be transparency about decision-making and an understanding of the landscape that drug companies operate in. “The FTC saying Sanofi having 99% of the market share is evidence of a monopoly is a wild misunderstanding of the rare disease space. . . . I don’t feel protected by the FTC on this.”

Takeaways for Industry from the Latest Squashed Deals

Experts told Endpoints News that the FTC’s intervention in the Sanofi/Maze case suggests it knew more about the deal than what is publicly available, and that the agency followed an “easier” legal pathway than an earlier challenge to the Amgen/Horizon merger. In that case, instead of arguing that there would be reduced competition, the FTC focused on the potential for Amgen to include Horizon drugs in its rebate program—what one antitrust expert called a novel legal argument.

“Both of these ‘theories of harm’ are pretty straightforward and reflect potentially anticompetitive incentives faced by pharma companies in defending their market positions,” Moss wrote in an email to BioSpace. “The FTC will be on the lookout for these incentives, as applied to modern pharma business models.”

The industry is still expected to see “healthy” M&A activity in 2024, according to a PwC report.

https://www.biospace.com/article/failed-illumina-and-sanofi-deals-shine-light-on-ftc-antitrust-crackdown/