Study Finds A Cancer Drug Could Help Quash HIV Infections
Pembrolizumab, also known as Keytruda, may be able to flush out HIV from immune cells in people who've controlled their infections. Among other news, a Gilead anti-cancer drug may have hit a serious safety snag in trials, and out-of-pocket expenses for hepatitis B drugs have been rising.
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Early Research Suggests Cancer Drug Could Help Target Latent HIV
Antiretroviral therapy, the standard treatment for HIV, can remove any trace of the virus from the blood, but a hidden reservoir of HIV persists in patients who are in treatment. That means patients are never truly cured and need to be on HIV drugs for the rest of their lives. Researchers have yet to discover a way to eliminate the virus in its latent stage, but new, early-stage research suggests a landmark cancer drug — pembrolizumab, also known as Keytruda — may be able to help. In a study published Wednesday in Science Translational Medicine, researchers looked at 32 patients that had both cancer and HIV and found that pembrolizumab, which revives the immune system and encourages it to attack tumors, also has the ability to flush HIV out of its hiding spot in immune cells. (Chen, 1/26)
In other pharmaceutical news —
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Future Of Gilead Blood Cancer Drug Is Clouded After Studies Are Stopped
The development of a blood cancer drug acquired by Gilead Sciences — the centerpiece of a $5 billion deal — has been interrupted by a potentially serious safety issue. On Tuesday, the Food and Drug Administration placed a partial clinical hold on five clinical trials investigating the combination of the Gilead drug, called magrolimab, with another commonly used blood cancer medicine. The agency stepped in because of an “apparent imbalance in investigator-reported suspected unexpected serious adverse reactions” between study arms in one or more of the trials, Gilead said in a statement. The company provided no clarifying information about the type of safety issue reported in the magrolimab studies, but said there was “no clear trend” and that the safety signal was not new. (Feuerstein, 1/26)
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Akili, Maker Of Prescription Video Game For ADHD, To Go Public Via SPAC
SPACs aren’t all fun and games, until they are. Akili Interactive, which makes a video game that treats attention problems in young people, announced plans Wednesday to go public in a merger with Social Capital Suvretta Holdings Corp, a special purpose acquisition company run by venture capitalist and former Facebook executive Chamath Palihapitiya. The deal could value the company up to about $1 billion after investment. Akili received Food and Drug Administration clearance for EndeavorRx, its prescription-only treatment for children with attention deficit hyperactivity disorder, in 2020. The Boston-based company has since cautiously gone to market as it hopes for the broader payer coverage and patient adoption that could make its product a blockbuster success. (Aguilar, 1/26)
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Out-Of-Pocket Spending For Hepatitis B Meds Kept Rising Despite Competition
File this under ‘How curious.’ After generic versions of a key hepatitis B treatment debuted in 2014, they helped patients save money over the next few years. Yet at the same time, the average out-of-pocket spending on those generics actually rose, even though nearly a dozen copycat versions were available, suggesting competition failed to work sufficiently. How so? Once the initial generics appeared, the brand-name medicine, known as entecavir, sold for an average of $118 for a 30-day supply, and eventually leveled off at $165 two years later. Meanwhile, the average 30-day supply for generics cost $41 in 2014 before settling at $52 in 2018, the last year for which data was available, according to the analysis published in JAMA Network Open. (Silverman, 1/26)
CIDRAP:
Report Details Where Top 100 Brand-Name Rx Drugs Are Made
While a range of consumer goods, from clothing to food, report the country of manufacture on their label, this is not the case for brand-name prescription medications. US drug marketers aren't required to disclose this information—and many don't—leaving patients whose health depends on these drugs in the dark about where their drug was made. (Van Beusekom, 1/26)
Also —
Roll Call:
Groups Seek To Shape Final Rule To Ease Hearing Aid Accessibility
The Food and Drug Administration is working to finalize a rule that would make it easier for many adults to get hearing aids, a policy change five years in the making that is sparking intense lobbying. The change comes after a 2017 law required a regulation for selling over-the-counter hearing aids. Implementation was delayed in part because of the agency’s shift in 2020 to focus on the COVID-19 pandemic, but the FDA issued a proposed rule in October. Now, interest groups and the lawmakers who worked on the law are pushing for the FDA to finalize the policy as hearing loss policies garner more interest in Washington. (McIntire, 1/26)
Hattiesburg American:
Mississippi Pain Cream Scheme: Bolton Pharmacist Sentenced, Must Repay Millions
One of the last defendants to be sentenced in a more than $515 million fraud involving high-priced compounded pain creams and other medications will serve five years in prison. David "Jason" Rutland pleaded guilty in July to conspiracy to solicit and pay kickbacks for his role in the fraud. Rutland and co-conspirators Mitchell "Chad" Barrett and Tommy Shoemaker admitted their culpability for more than $182.5 million of the fraud. Rutland, 41, of Bolton, appeared in U.S. District Court in Hattiesburg before Senior Judge Keith Starrett, who ordered Rutland to pay $182,595,945 in restitution. (Beveridge, 1/26)
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Insufficient Progress Is Being Made In Reporting Clinical Trial Results In The U.S.
As scrutiny into clinical trial disclosure intensifies, a new analysis finds that a number of leading U.S. universities and hospitals are still failing to report clinical trial results to a federal database. The findings reflect little change from a previous report issued last fall that examined the extent to which clinical trial sponsors report study results to the ClinicalTrials.gov database, according to the TranspariMed advocacy group, which ran the analysis. A few sponsors improved. The University of Florida reported results for 10 trials, for instance, but several of the worst violators did not make any progress. (Silverman, 1/25)
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A Former FDA Official On Making The Jump To Health Tech Startups
Since stepping down from his post at the Food and Drug Administration last year, Anand Shah has gone from toiling on the country’s Covid-19 response to updating his LinkedIn with a flurry of new advisory roles at promising startups. On Wednesday, Shah, who was previously deputy commissioner for medical and scientific affairs, added another job to his profile. He will become the newest member of the board of mental health app developer Big Health, which last week announced it had raised $75 million in new funding led by Japanese mega-investor SoftBank. It’s the fourth board position Shah has taken on in recent months. (Aguilar, 1/26)
