Policy & Regulation: Page 5
-
Stock via Getty Images
Will the ‘anti-woke’ movement derail DEI efforts in pharma?
Amid the DEI backlash in corporate America, pharma leaders are quietly adjusting tactics.
By Meagan Parrish • Dec. 13, 2024 -
Courtesy of Eli Lilly
GLP-1 compounding is still in limbo. Will the FDA leave it for the next administration?
The agency has yet to make a decision about keeping tirzepatide on or off of its shortage list — letting compound pharmacies continue their lucrative operations for now.
By Amy Baxter • Dec. 11, 2024 -
Explore the Trendline➔
Stock via Getty Images
TrendlineCommercialization, marketing and social media
As the pharma industry stares down a historic patent cliff, macroeconomic headwinds and challenging R&D costs for increasingly complex medicines, nailing the launch of new medicines has become increasingly critical.
By PharmaVoice staff -
Stock via Getty Images
Psychedelics haven’t fulfilled clinical expectations, but new trial strategies could turn the tide
Leading companies in the psychedelics space have had trouble crossing the regulatory threshold. Here’s where they’re going wrong — and how to fix it.
By Kelly Bilodeau • Dec. 9, 2024 -
Stock via Getty Images
Trump’s tariffs could put more pressure on the U.S. to produce generic drugs. Are we ready?
The push to bring generic drug production back home has failed to reach a critical mass.
By Meagan Parrish • Dec. 6, 2024 -
Noam Galai via Getty Images
With Makary set to face FDA commissioner hearings, how deep do his industry ties run?
Dr. Marty Makary’s conflicts of interest could come into question before he is confirmed as the next FDA commissioner.
By Amy Baxter • Dec. 4, 2024 -
Kevin Dietsch / Staff via Getty Images
How the incoming administration could impact FTC’s approach to pharma M&A
Pharma companies looking to get a break from the FTC under a new administration may be out of luck.
By Kelly Bilodeau • Nov. 26, 2024 -
Noam Galai via Getty Images
Johns Hopkins surgeon Makary is Trump’s pick to lead FDA
A prolific medical research and author, Martin Makary criticized the FDA and CDC for their decision-making during the pandemic, although he describes himself as pro-vaccine.
By Jonathan Gardner , Ned Pagliarulo • Nov. 25, 2024 -
Win McNamee via Getty Images
Trump nominees want to slash and burn agencies. Will RFK Jr. and Oz do the same in healthcare?
Both Trump appointees have promised to bring sweeping changes to several healthcare agencies.
By Amy Baxter • Nov. 25, 2024 -
Chip Somodevilla via Getty Images
What might a Trump administration mean for the Biosecure Act?
It’s still likely U.S. biotechs and pharmas will have to cut ties with key Chinese partners — it’s just a matter of when.
By Amy Baxter • Nov. 20, 2024 -
Rebecca Noble via Getty Images
Trump names RFK Jr. as his pick to lead HHS
If confirmed to the role, Robert F. Kennedy Jr. would oversee the country's top health agencies, including the Food and Drug Administration and the Centers for Disease Control and Prevention.
By Ned Pagliarulo • Updated Nov. 14, 2024 -
Permission granted by Pfizer
Pfizer and Lilly’s telehealth prescribing platforms draw Senate scrutiny for ‘potential fraud’
As Big Pharma embraces telehealth to sell medicines directly to patients, lawmakers wonder whether the programs skirt anti-kickback rules.
By Kelly Bilodeau • Nov. 12, 2024 -
Michael M. Santiago via Getty Images
What RFK Jr.’s influence could mean for pharma
Past comments hint at the changes Robert F. Kennedy Jr. could make across the various sectors of healthcare.
By Amy Baxter • Nov. 8, 2024 -
Chip Somodevilla via Getty Images
With Trump victorious, biotech industry’s focus turns to his plans for FDA, FTC
Speculation around pharma dealmaking and the next FDA commissioner has begun.
By Ned Pagliarulo , Ben Fidler • Nov. 8, 2024 -
Stock via Getty Images
A diabetes drug, twice rejected, stumbles again — but its developer persists
After multiple rejections, Lexicon Pharmaceuticals is inching toward an FDA decision date next month for its adjunct type 1 diabetes therapy.
By Amy Baxter • Nov. 6, 2024 -
hapabapa via Getty Images
Backlash builds against Novo’s Catalent takeover
Roche recently joined naysayers who argue the deal threatens competition in the burgeoning weight loss and diabetes drug market.
By Amy Baxter • Oct. 30, 2024 -
Mario Tama via Getty Images
Where Big Pharma’s campaign cash is flowing in this election
Big Pharma CEOs are hedging all bets by supporting both sides of the aisle in the 2024 election.
By Amy Baxter • Oct. 28, 2024 -
Stock via Getty Images
On the front lines of the superbug war, new treatments can’t arrive soon enough
As antimicrobial resistance rises, researchers are running out of time to fight each new wave of superbugs. And the funding isn’t enough.
By Kelly Bilodeau • Oct. 28, 2024 -
Buda Mendes via Getty Images
Dengue is spreading and Sanofi is pulling the U.S. market’s only vaccine. What’s next?
As Sanofi prepares to halt production on its dengue vaccine in 2026, locally acquired infections in the U.S. are raising the alarm.
By Alexandra Pecci • Oct. 23, 2024 -
Douglas Cliff via Getty Images
FDA’s GLP-1 decision kicks off ‘unprecedented’ tussle over shortage
After initially declaring the shortage of Eli Lilly’s diabetes and weight loss drugs over, the FDA changed its mind and re-opened the door for GLP-1 compounders.
By Amy Baxter • Oct. 21, 2024 -
Win McNamee via Getty Images
As election day nears, Trump and Harris veer in different directions on pharma
The two presidential candidates have developed diverging policies related to healthcare and pharma.
By Amy Baxter • Oct. 14, 2024 -
Permission granted by DeepWell
Will a Medicare boost propel digital therapeutics to the mainstream?
Digital therapeutics have languished in the background of traditional medicines for years, but a recent reimbursement push may have gotten the ball rolling.
By Kelly Bilodeau • Oct. 14, 2024 -
Stock via Getty Images
BMS’ next act for Cobenfy — and other highs and lows in Alzheimer’s
The Alzheimer’s space is booming, from a new use for a schizophrenia drug to discovered pathways linked to the disease — but there’s been stumbles too.
By Meagan Parrish • Oct. 11, 2024 -
Courtesy of Madrigal
How Madrigal plans to win on the market with the first MASH drug
Despite the drug’s wide patient pool, Madrigal is taking a targeted approach with its first launch.
By Amy Baxter • Oct. 10, 2024 -
Permission granted by Katelyn Jetelina
Q&A‘It’s been hard to watch.’ A noted epidemiologist talks H5N1 and the U.S.’s fragmented response.
Katelyn Jetelina, well known for her newsletter “Your Local Epidemiologist,” digs into the H5N1 outbreak, the public health response and what’s next for vaccinations.
By Alexandra Pecci • Oct. 9, 2024 -
Stock via Getty Images
An Alzheimer’s drugmaker is accused of data ‘manipulation.’ Should its trials be stopped?
Cassava Sciences’ beleaguered investigational Alzheimer’s therapy is in two phase 3 studies.
By Meagan Parrish • Oct. 4, 2024
Previous
