Trump FDA’s selection of Makary may bring relief to biotech and pharmaceutical companies | Wilnesh News

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Happy Tuesday! President-elect Donald Trump’s choice to lead the Food and Drug Administration appears to have quelled fears of significant disruption to the biotech and pharmaceutical industries over the next four years.

Trump on Friday Nominate Dr. Marty Makary, a pancreatic surgeon at Johns Hopkins University, serves as FDA commissioner. If confirmed by the Senate, Macari would oversee food, thousands of vaccines and other drugs, medical devices and tobacco products.

He will respond to Trump’s more controversial choice to head the Department of Health and Human Services, Robert F. Kennedy Jr. Environmental lawyers, also require Senate confirmation.

Both Kennedy and Macari have publicly criticized federal health agencies, and both lashed out recently The government is not prioritizing chronic diseases.

But unlike Kennedy, Macari is an experienced doctor with a more traditional health background. Makary is also a senior executive at telemedicine company Sesame, which connects consumers with doctors who can prescribe compounded versions of popular weight-loss drugs.

BMO Capital Markets analyst Evan Seigerman wrote in a report on Sunday that Macari may take a “more sensible approach to managing the FDA than people fear,” adding that Macari “appears to be well-versed in U.S. the entire system of health care and supports evidence-based medical interventions.”

“All in all, we think the FDA’s selection should give biopharma investors some breathing room, remove uncertainty, and potentially reverse the steep declines that followed the week RFK Jr. was nominated to head HHS,” Segelman said.

Some health experts and investors worry that Trump will choose someone who lacks the proper medical background to lead the FDA and could politicize the agency’s drug regulatory process, threatening broader new product approvals and innovation.

“We expect Makari to promote technology/innovation in some way, providing support for those concerned about the sector versus different virtues,” Jared Holz, equity strategist at Mizuho Healthcare, said in an email last week. More consistent ones provide some respite.

He added that Makary’s “familiarity with the (healthcare) industry we believe will be noted frequently.”

So, what does Macari have to say about America’s health?

Macari has long challenged the U.S. medical establishment, researching and publishing books on the high cost of health care, lack of transparency and medical errors.

Macari does not appear to hold the same anti-vaccine views as Kennedy, but recently issued a statement expressing support for Kennedy’s “Make America Healthy Again Platform.” Makari said earlier this year that “the biggest perpetrator of misinformation is the U.S. government with its food pyramid.”

Macari has been a controversial figure in other ways, particularly during the Covid-19 pandemic. In some ways he aligns with traditional public health experts, Supports universal blocking and early doses of vaccine.

But Macari also opposes mandatory vaccinations and questions the value of booster shots for children. He also questioned lockdowns and other tools pushed by public health officials. In addition, he became a critic of the FDA during the epidemic, criticizing the agency for moving too slowly in authorizing certain COVID-19 products.

Segelman said Macari’s support for informed patient choice could lower the bar for product approval. This may be offset by higher thresholds for disclosing drug risks and benefits to patients and more requirements for monitoring treatment after approval.

“We view it as positive that Dr. Makary is willing to criticize the system and that his opinions are flexible, reasonable, and supportive of patient choice,” Segelman said.

But Segelman noted that he was far more cautious about Trump’s choice to lead the Centers for Disease Control and Prevention, Rep. Dave Weldon, a physician and Republican congressman from Florida. That’s because Weldon has long criticized vaccinations.

We’ll be watching closely to see if Trump’s health choices are confirmed by the Senate, so stay tuned for our coverage.

Please feel free to send Annika any tips, suggestions, story ideas and data: annikakim.constantino@nbcuni.com.

Neuralink is building a brain-computer interface (BCI) that allows paralyzed people to control external devices such as computers and smartphones with their thoughts. According to Neuralink, the company’s flagship implant uses 64 “threads” inserted directly into the brain to record neural signals website.

To date, two human patients have been implanted with BCIs as part of Neuralink’s “PRIME study,” which aims to prove the system is safe and useful. Neuralink’s new trial, called the CONVOY study, will explore whether patients can use the same BCI to operate a robotic arm, the company said in a statement. Post on Xwhich is what Musk also owns. Patients will be able to cross-enroll in both studies.

“This is an important first step in restoring not just digital freedom, but personal freedom as well,” Neuralink said in the post.

It’s unclear when the study will begin or how many patients will participate. According to the X post, Neuralink plans to share more information about the research.

The company did not respond to CNBC’s request for comment.

Neuralink also announced last week that it had received approval to launch its first international trial in canada. According to a blog post, like the PRIME study, the goal of the Canadian trial is to prove the safety and effectiveness of Neuralink technology.

Neuralink said patients with quadriplegia due to spinal cord injury or degenerative diseases such as amyotrophic lateral sclerosis (ALS) may be eligible and recruitment has begun. a post on X.

Academic circles have been researching brain-computer interfaces for decades, and competition in the industry has become increasingly fierce in recent years. In addition to Neuralink, companies such as Synchron, Paradromics and Precision Neuroscience are also developing their own BCI systems.

Some of these groups are conducting human trials, but no BCI company has received approval from the U.S. Food and Drug Administration to commercialize its device.

Please feel free to send any tips, suggestions, story ideas and data to Ashley at ashley.capoot@nbcuni.com.