Amy Baxter
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Articles by Amy Baxter
Calcium influx through T-type calcium channels regulates secondary necrosis and inflammation through recruitment of ATG9A-mediated membrane repair
Abstract Approximately 200–300 billion cells die daily through apoptosis, a prominent form of programmed cell death, to maintain tissue homoeostasis. If apoptotic cells are not efficiently removed by phagocytes, they progress to secondary necrosis when the plasma membrane (PM) becomes permeabilised and release proinflammatory damage-associated molecular patterns (DAMPs) such as HMGB1 and ATP, which drive inflammation and contribute to autoimmune diseases.
Reimagining the Brace: From Immobilizer to Active Therapeutic
By: Amy Baxter, MD FAAP FACEP Clinical Professor, Augusta University | CEO & chief science officer, Pain Care Labs & Harmonic Pain Solutions VibraCool Pro is the a wearable neuromodulation device that uses mechanical stimulation therapy. Photo: Pain Care Labs The “movement is medicine” concept now pervades physical therapy. Motion speeds recovery, activates growth at a cellular level, and reduces pain by increasingly known and complex mechanisms.
Reducing vaccination pain using a multidermatomal or deltoid region buzzy® applications versus control: A randomized controlled study
Keywords Vaccination Buzzy Nursing Children Multidermatomal application Neuromodulation Get full text access Log in, subscribe or purchase for full access. Data availability Individual participant data that underlie the results reported in this article, after deidentification, will be shared with researchers who provide a methodologically sound proposal. References 1.
A brewing GLP-1 showdown, from Big Pharma pills to a biotech implant
This audio is auto-generated. Please let us know if you have feedback. Eli Lilly and Novo Nordisk are the uncontested leaders of the obesity market even as upstart entrants nip at their heels with more than 100 new drug candidates under development. With a potentially long runway for GLP-1s, newcomers are working out how they’ll differentiate themselves for patients.
FDA’s new accelerated pathway may open pharma up to risks, as well as benefits
The Food and Drug Administration is pushing for faster drug reviews with an unconventional twist. As part of a new accelerated approval pathway, the agency will consider drug affordability as one of the priorities of its new voucher-based program, FDA Commissioner Marty Makary said last month. Pricing scrutiny is a novel dynamic in the drug review process, which typically doesn’t include those kinds of questions.
FDA’s new accelerated pathway could open pharma up to risks, as well as benefits
This audio is auto-generated. Please let us know if you have feedback. The FDA is pushing for faster drug reviews with an unconventional twist. As part of a new accelerated approval pathway, the agency will consider drug affordability as one of the priorities of its new voucher-based program, FDA Commissioner Dr. Marty Makary said last month. Pricing scrutiny is a novel dynamic in the drug review process, which typically doesn’t include those discussions until further down the line.
MAHA may take aim at pharma DTC ads
A much-anticipated report from the Make America Healthy Again Commission was postponed earlier this month. But nestled within leaked documents is a strategy that reveals more about health leaders’ goals, including potential new oversight of pharma’s direct-to-consumer advertising practices. DTC advertising has long been a target of Health and Human Services Secretary and MAHA leader Robert F.
MAHA leaders may take aim at pharma DTC advertising
This audio is auto-generated. Please let us know if you have feedback. A report from the Make America Healthy Again Commission was postponed earlier this month, but nestled within leaked documents is a strategy that reveals more about health leaders’ goals, including potential new oversight of pharma’s direct-to-consumer advertising practices. DTC advertising has long been a target of HHS Secretary and MAHA monarch Robert F.
Despite FDA ruling, compounded GLP-1s are still giving Novo and Lilly headaches on the market
This audio is auto-generated. Please let us know if you have feedback. When the FDA took Novo Nordisk and Eli Lilly’s GLP-1 medications off of the drug shortage list, the move should have been a death knell for copycat compounded versions. But then something unexpected took place. Compounding pharmacies found a loophole and continued making off-brand versions of the lucrative weight loss drugs. Months later, compounded GLP-1s are still for sale on direct-to-patient platforms like Hims & Hers.
With FDA PreCheck, drugmakers may get a manufacturing boost
The Trump administration recently added to an ongoing push to boost pharmaceutical manufacturing in the U.S., launching a new program dubbed PreCheck that aims to ease the process of bringing domestic facilities online.
With FDA PreCheck, drugmakers may get a manufacturing boost
This audio is auto-generated. Please let us know if you have feedback. The Trump administration is greasing the wheels of pharma manufacturing in the U.S., most recently with a new program dubbed PreCheck that aims to ease the process of bringing domestic facilities online.
3 ways the GLP-1 market has changed shape this year
This audio is auto-generated. Please let us know if you have feedback. The obesity market still only has two clear leaders with approved GLP-1 medications, and frontrunners Eli Lilly and Novo Nordisk are doing all they can to secure their dominance. The two pharma giants recently revealed what they see as the emerging market opportunities, pitfalls and changing dynamics as they continue to compete head to head.
Drugmakers score policy win in fight against 340B
The Trump administration unveiled new healthcare policies last week,among them a pilot program that will trial a major change that could favor the pharmaceutical industry. Through the pilot, drugmakers will have an opportunity to test replacing upfront discounts with rebates for certain prescription drugs they provide through the 340B Drug Pricing Program, which provides discounted medications to healthcare centers that serve low-income or uninsured patients.
Drugmakers score policy win in a prolonged fight against 340B
This audio is auto-generated. Please let us know if you have feedback. The Trump administration unveiled a string of new healthcare policies last week, introducing a pilot program that introduces a major shift in favor of the pharma industry.
Roche pushes ahead with late-comer strategy in obesity
This audio is auto-generated. Please let us know if you have feedback. Roche’s efforts to break into the lucrative obesity market haven’t abated. The pharma giant sealed the largest deal in the space earlier this year when it announced a collaboration with Zealand Pharma for more than $5 billion. The agreement built on Roche’s $2.7 billion deal to pick up Carmot Therapeutics and its suite of early- and mid-stage obesity candidates in 2023.
FDA invites more data from abroad - with a wary eye on China
This audio is auto-generated. Please let us know if you have feedback. The FDA green-lit four drugs last year without any U.S. trial participants, according to CDER’s drug trials snapshot report, which summarizes the various demographics of clinical trials for approved drugs. Among the four approvals were drugs for a blood disorder, UTIs, cancer, and an ultra-rare disease.
Need a DTC platform? Here’s how one company built its own.
This audio is auto-generated. Please let us know if you have feedback. When George Hampton saw patients struggling to access his company’s weight loss treatment, Contrave, he knew what to do. This was five years ago — before the COVID-19 pandemic had pushed patients toward telehealth offerings, followed by pharma giants launching direct-to-consumer platforms to sell GLP-1 drugs in the booming obesity market.
As its cancer vaccine moves through the clinic, Transgene sets sights on manufacturing
This audio is auto-generated. Please let us know if you have feedback. Welcome to First 90 Days, a series dedicated to examining how pharma executives and other leaders are planning for success in their new roles.
GLP-1 roadblocks: Discontinuation rates soar as insurers clamp down
This audio is auto-generated. Please let us know if you have feedback. The GLP-1 arena has turned into a boxing match between heavyweights Novo Nordisk and Eli Lilly as the two pharma giants square off for market leadership. Newcomers with obesity drugs in development are also looking for a way into the ring with candidates boasting fewer side effects, better muscle mass preservation and more.
FDA’s new mission to speed drug reviews
This audio is auto-generated. Please let us know if you have feedback. Between a 20% reduction in workforce in April and the departure of several top officials across departments, the FDA is undergoing a major transition. The job cuts have heightened concerns about potential delays and raised questions about how the federal regulator will keep up with its workload.
After myriad failures, a new wave of ALS drugs approaches
This audio is auto-generated. Please let us know if you have feedback. Few diseases have suffered more drug development disappointment than amyotrophic lateral sclerosis. Earlier this year, an experimental drug from Denali Therapeutics, and a candidate from Calico Life Sciences and AbbVie, failed in the clinic.
Megablockbusters are the holy grail. Here’s how drugmakers are getting there.
This audio is auto-generated. Please let us know if you have feedback. Megablockbusters are on the rise in pharma. More drugs are surpassing the $10 billion sales threshold than ever before, according to a recent analysis by PharmCube, and 12 reached or maintained that status last year alone. Once dominated by oncology and immunology drugs, the megablockbuster club has recently expanded to include super-selling cardiometabolic medications like GLP-1s.
Is DTC pharma advertising coming to an end?
This audio is auto-generated. Please let us know if you have feedback. A ban on pharma’s TV ads may finally be on the way. Sens. Bernie Sanders, I-Vt., and Angus King, I-Maine, introduced the End Prescription Drug Ads Now Act last week that would end pharma’s ability to advertise directly to consumers. If enacted, the bill would fulfill a goal of HHS Secretary Robert F.
Locked in a federal stalemate, states take PBM reform into their own hands
This audio is auto-generated. Please let us know if you have feedback. Pharma’s middlemen are under fire. Known as the negotiators between health plans, pharmacies and drug companies, pharmacy benefit managers are currently entangled in a national conversation about reform. The pharma industry has long blamed PBMs for rising drug prices, pointing to opaque rebate and profit structures, and proposed policy shifts could take them to task.
Pharma’s wins and losses in the budget bill
The budget bill currently under consideration in Congress is big — and it’s complicated. The 1,000-plus page document is full of tax and spending cuts, including some significant changes that will impact pharma and the larger healthcare industry. The legislation, which was narrowly approved in the House last month and is now in the hands of the Senate, includes reforms to pharmacy benefit managers and the Inflation Reduction Act. But the bill’s path forward is uncertain.
Pharma’s wins and losses in the budget bill
This audio is auto-generated. Please let us know if you have feedback. The budget bill currently under consideration in Congress is big — and it’s complicated. The 1,000-plus page document is full of tax and spending cuts, including some significant changes that will impact pharma and the larger healthcare industry. The legislation, which was narrowly approved in the House last month and is now in the hands of the Senate, includes reforms to pharmacy benefit managers and the Inflation Reduction Act.
The biggest obesity deals of 2025 so far
This audio is auto-generated. Please let us know if you have feedback. Two industry leaders currently define the obesity market: Novo Nordisk and Eli Lilly — the only companies with approved GLP-1s. But dozens of hopefuls are advancing candidates through the clinic with the goal of edging better drugs to the market. Not all new obesity assets will create a gold mine.
FDA’s AI tool ‘Elsa’ is here, and the industry has questions
The Food and Drug Administration aims to roll out its new AI tool, called Elsa, “ahead of schedule and under budget,” according to Commissioner Marty Makary, who offered up the most information to date about the agency’s new tool and AI goals this week. After completing a pilot program of AI-assisted scientific reviews last month, the FDA announced it was taking an “aggressive” approach to scale up the use of Elsa agency-wide by June 30. That timeline moved up this week.
FDA’s Elsa AI is here, and the industry has questions
This audio is auto-generated. Please let us know if you have feedback. The FDA plans to roll out its new AI tool, called Elsa, “ahead of schedule and under budget,” according to Commissioner Dr. Marty Makary, who offered up the most information to date about the agency’s new tool and AI goals this week. But questions remain.
The MAHA agenda won’t include expanding GLP-1 coverage - for now
This audio is auto-generated. Please let us know if you have feedback. The GLP-1 boom isn’t slowing down anytime soon. Prescriptions for overweight or obese adults jumped almost 587% from 2019 to 2024, Healthcare Dive reported, and there’s still a huge untapped patient population representing more market upside. As pharma’s pipeline explodes with more than 100 new drugs in various stages of development, one barrier to access has yet to be toppled.
Talent and Experience On the Bow
Abie McLaughlin, age 38, had a breakout year in 2024, achieving a hat trick of North American championship wins in the J/88, Tartan 10 and S2 7.9 classes. Having quickly earned a reputation as a skilled and dedicated amateur sailor, she is now in demand as one of the best foredeck crews you’ve never heard of—until now. McLaughlin’s low-key personality has kept her under the radar.
What’s next for Trump’s ‘most favored nation’ policy?
This audio is auto-generated. Please let us know if you have feedback. Following through on President Donald Trump’s “most favored nation” policy, the HHS is about to drop a drug pricing hammer on the pharma industry. But that doesn’t mean drugmakers will comply. The policy, issued by an executive order earlier this month in an attempt to bring U.S. drug prices in line with those paid in other countries, asks drugmakers to voluntarily lower their own price tags first.
Lilly’s former small molecule head makes the leap to a rising biotech in obesity
This audio is auto-generated. Please let us know if you have feedback. Welcome to First 90 Days, a series dedicated to examining how pharma executives and other leaders are planning for success in their new roles. Today, we’re speaking to Utpal Singh, chief scientific officer at Zealand Pharma, a peptide specialist that’s caught Big Pharma’s attention. Drugmakers looking for an edge in the booming obesity market aren’t just hunting for the next potential blockbuster.
With the third round of Medicare price negotiations on the way, here’s how the policy is shifting
This audio is auto-generated. Please let us know if you have feedback. Medicare’s drug price negotiation program is progressing into its third round of selections, HHS announced last week. And as the Biden-era program moves full steam ahead, changes are in store for the next 15 drugs that will end up on the negotiating table.
Trump’s ‘most favored nation’ policy is back. Here’s why it failed the first time. Original
This audio is auto-generated. Please let us know if you have feedback. President Donald Trump is bringing back a controversial policy idea from his first term targeting drug costs. The “most favored nation” policy would bring U.S. drug prices in line with the nation that pays the lowest price “anywhere in the world,” Trump said on social media this week. Implementing such a plan would reduce drug prices 30% to 80% “almost immediately,” Trump claimed.
RFK Jr.’s autism fixation hearkens back to his stance on vaccines
This audio is auto-generated. Please let us know if you have feedback. HHS Secretary Robert F. Kennedy Jr. is ramping up a long-time focus on autism that has historically been tied to his stance on vaccines.
RFK Jr.’s autism fixation hearkens back to his stance on vaccines
This story was originally published on PharmaVoice. To receive daily news and insights, subscribe to our free daily PharmaVoice newsletter. HHS Secretary Robert F. Kennedy Jr. is ramping up a long-time focus on autism that has historically been tied to his stance on vaccines.
With TV ads under threat, here’s how pharma can leverage social media
This audio is auto-generated. Please let us know if you have feedback. The “ice bucket challenge” is back. After debuting more than 10 years ago, the viral internet trend that inspired millions of people to douse friends and family with ice water and bring awareness about ALS returned recently, this time with a focus on mental health.
With compounders out of the way, Lilly and Novo go after each other Original
This audio is auto-generated. Please let us know if you have feedback. The game is afoot in the obesity space as GLP-1 rivals Eli Lilly and Novo Nordisk take their showdown to a new level. Lilly revealed in a first-quarter earnings report last week that it now has a 53% share of the GLP-1 market, overtaking Novo for the first time. The pharma giant also reported a 45% increase in revenue during the first three months of the year, bringing in nearly $13 billion.
Is the FDA headed for a major reorganization?
This audio is auto-generated. Please let us know if you have feedback. Job cuts were just the first disruption at health agencies. Now, questions remain about how the FDA will be reshaped after commissioner Dr. Marty Makary “rejected” a proposed restructuring that was leaked this month. The proposal would have upended the agency’s organizational structure and created five new shared services offices rather than current product-based offices.
Is the FDA headed for a major reorganization?
Unlock stock picks and a broker-level newsfeed that powers Wall Street. Amy Baxter Wed, Apr 30, 2025, 3:00 AM 5 min read This story was originally published on PharmaVoice. To receive daily news and insights, subscribe to our free daily PharmaVoice newsletter. Job cuts were just the first disruption at health agencies. Now, questions remain about how the FDA will be reshaped after commissioner Dr. Marty Makary “rejected” a proposed restructuring that was leaked this month.
FDA’s job cuts paint mixed picture for drugmaker’s R&D plans
This audio is auto-generated. Please let us know if you have feedback. Consequences of the drastic reductions in workforce at the FDA are starting to emerge. After the Trump administration announced plans to lay off 3,500 FDA employees, experts warned that delays in the drug development process were likely to follow, and some companies are already experiencing setbacks as they seek new approvals for drugs and clinical studies.
Trump reveals pharma reform priorities in drug pricing executive order
This audio is auto-generated. Please let us know if you have feedback. President Donald Trump’s first swing at lowering drug prices last week has been considered a possible “win” for the pharma industry. That’s because it directly addresses an aspect of the IRA’s Medicare drug price negotiation program known as the pill penalty, a particular ire of the pharma industry.
Genetic breakthroughs could point pharma to a long COVID drug
This audio is auto-generated. Please let us know if you have feedback. Why do some people recover from COVID-19 while others can’t shake persistent symptoms like fatigue, brain fog or sleep troubles? Researchers have found new genetic clues that may finally offer answers and pave the way to new treatments. The U.K.’s LOCOME project and the Metrodora Long COVID Observational study have identified genes linked to this post-viral syndrome, which affects .
Deciphering the role of histone modifications in memory and exhausted CD8 T cells
ABSTRACT Exhausted CD8 T cells (TEX) arising during chronic infections and cancer have reduced functional capacity and limited fate flexibility that prevents optimal disease control and response to immunotherapies. Compared to memory (TMEM) cells, TEX have a unique open chromatin landscape underlying a distinct gene expression program. How TEX transcriptional and epigenetic landscapes are regulated through histone post-translational modifications (hPTMs) remains unclear.
Can anything threaten Novo and Lilly’s obesity market dominance?
This audio is auto-generated. Please let us know if you have feedback. There are two clear market leaders in the market for obesity drugs. Novo Nordisk and Eli Lilly are the only pharmaceutical companies with GLP-1 medications approved for weight loss, and the popularity of their drugs has made them household names.
Novartis scores NFL deal to tackle health outcomes
This audio is auto-generated. Please let us know if you have feedback. When Novartis announced it was teaming up with the NFL last month, the company called it the first-ever corporate pharmaceutical partnership with the league. But it wasn’t exactly the only matchup between the industry and the professional football world. The NFL has inked several deals with pharma companies, starting with a 2003 sponsorship agreement that co-promoted a Bayer and GSK drug that was under FDA review.
‘Chaos’ in the biotech market has dampened hopes of a rebound. What does that mean for dealmaking and IPOs?
This audio is auto-generated. Please let us know if you have feedback. Stock market whiplash is dampening hopes for a comeback year in the biotech arena. Roughly 25% of biotech stock values sank below their cash holdings last week amid sudden changes to U.S. trade policy, Bloomberg reported. In an economic situation that’s shifting by the day, “the only thing that's certain is uncertainty,” said David Crean, managing partner at M&A consulting firm Cardiff Advisory.
Big Pharma is rewriting the R&D playbook to account for seismic shifts in the investment landscape
This audio is auto-generated. Please let us know if you have feedback. With $16.9 billion in sales in 2024 alone, Novo Nordisk has clearly received huge R&D returns from its blockbuster obesity and diabetes drugs Ozempic and Wegovy. And it’s not alone among companies cashing in. R&D returns for 2024 rose to 5.9% for the top 20 biopharma companies, up from about 4% the year before and continuing a year-over-year upward climb, according to forecasts in a new Deloitte report.
US vs. EU: When it comes to novel Alzheimer’s drugs, regulators can’t seem to agree
This audio is auto-generated. Please let us know if you have feedback. When an Alzheimer’s drug recently gained a second chance from European regulators after an initial rejection, the decision bucked the agency’s norm. Leqembi became the first fully FDA-approved drug among the emerging class of anti-amyloid Alzheimer’s treatments in 2023. Developed by Biogen and Eisai, Leqembi was originally granted an accelerated approval by the FDA before scoring a full nod later in the year.
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