Policy & Regulation: Page 4
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Q&A
A leading Democrat reveals how his mental health struggles shape his policy approach
Seattle Congressman Adam Smith's journey with anxiety and chronic health has influenced his perspective on healthcare and pharmaceutical policy.
By Karissa Waddick • Aug. 17, 2023 -
Pharma’s rare disease rush
Biogen’s acquisition of Reata Pharmaceuticals is the latest in a string of high-dollar rare disease deals over the last few months. What does it mean for industry?
By Meagan Parrish , Karissa Waddick • Aug. 14, 2023 -
Trendline
Artificial intelligence & machine learning
After years of excited buzz around the potential of artificial intelligence and machine learning, pharma has begun to realize the true implications and potential value of these technologies.
By PharmaVoice staff -
PBMs could soon feel the regulatory sting
From Congress to the FTC to state legislatures, regulators are cracking the whip against PBMs.
By Karissa Waddick • Aug. 4, 2023 -
Big Pharma CEOs get candid about pricing and M&A
Head honchos at the biggest pharma companies reporting second-quarter earnings dig into the topics du jour.
By Michael Gibney • July 28, 2023 -
Biosimilar makers split strategies in bid to take on top-selling Humira
In challenging AbbVie for share of a $19 billion drug market, competitors are testing whether high upfront discounts or behind-the-scenes rebates can win them an advantage.
By Jonathan Gardner • July 26, 2023 -
Q&A
With OTC birth control approved, access battles have just begun
Perrigo received the first FDA approval for an OTC birth control pill. Now, its global VP of women’s health says the company is working on the next challenge — affordability.
By Karissa Waddick • July 26, 2023 -
For Merck, understanding maternal mortality is the first step toward equity
Merck has invested for more than a decade in reducing maternal death rates in the U.S. and globally. Now for the next chapter.
By Michael Gibney • July 25, 2023 -
4 controversial measures in Congress’ pandemic preparedness bill
Efforts to tackle drug pricing, shortages, the speed of FDA approvals and more have been mixed into Congress’ efforts to reauthorize the Pandemic and All Hazards Preparedness Act.
By Karissa Waddick • July 20, 2023 -
DCTs create fresh privacy challenges for review boards. Now there are guidelines.
A new toolkit developed by industry stakeholders paves the way for faster reviews.
By Kelly Bilodeau • July 17, 2023 -
FDA’s upcoming psychedelic review looms large for a budding industry
A new psychedelic guidance from the agency gives a clue into how it could analyze drugs in the space, but industry leaders are eager for more.
By Karissa Waddick • July 12, 2023 -
Following FDA’s full approval of Leqembi, here’s what else is in the Alzheimer’s pipeline
Leqembi’s U.S. approval is a milestone in Alzheimer’s research and medicine — and there are a few other late-stage biologic drugs that could follow.
By Michael Gibney • July 7, 2023 -
Pharma’s strike-from-all-sides attack on the IRA could be decided by the Supreme Court
New lawsuits challenging the Inflation Reduction Act’s price negotiation program hit the government with multiple Constitution-based challenges.
By Alexandra Pecci • July 6, 2023 -
Q&A // First 90 Days
A BMS exec’s journey around the world in 90 days
As BMS grapples with upcoming patent cliffs, Emma Charles, the new SVP of intercontinental markets, is focused on expanding its footprint.
By Karissa Waddick • July 5, 2023 -
The stories you’ve read the most in 2023 (so far)
From staff shortages to presidential candidates and the M&A outlook, here are our most-read stories from the first half of the year.
By PharmaVoice Staff • July 3, 2023 -
Intercept’s NASH retreat is the latest setback for a challenging liver disease
Intercept Pharmaceuticals has stepped out of the race to the first U.S. approved treatment for the complicated liver disease NASH, leaving room for other pharmas to get their foot in the door.
By Michael Gibney • June 27, 2023 -
The spotlight is on accelerated approvals — now FDA could run a tighter ship
As the fallout of the Aduhelm approval continues, scrutiny of the speedier pathway has increased and the pressure is on to close a key gap in the regulation.
By Kelly Bilodeau • June 20, 2023 -
How pharma execs are approaching drug pricing and other quandaries
From implementation of the Inflation Reduction Act, to the looming patent cliff and more, pharma leaders have a lot on their plates.
By Karissa Waddick • June 16, 2023 -
Opinion
Shaking up pharma: Change that leaders would like to see
Industry execs give voice to the “game changers” they believe would have the greatest impact on the healthcare ecosystem for all.
By Taren Grom • June 16, 2023 -
Why cancer could be the ideal realm for psychedelic treatments
The CEO of Sunstone Therapies said the results of a recent trial testing psilocybin in cancer patients with depression were “remarkable.”
By Meagan Parrish • June 9, 2023 -
FDA’s decentralized trials guidance leaves slate of fresh questions for industry
Recent FDA guidance aims to bolster DCT adoption but provides little clarity on the patchwork of telemedicine laws that pose an obstacle to the approach.
By Karissa Waddick • June 8, 2023 -
Yes, biopharma still has a reputation problem. These leaders are looking for solutions.
Negative news is breaking down the public’s perception of the biopharma industry — but leaders around the industry have some ideas to fix it.
By Michael Gibney • June 8, 2023 -
Opinion
A key to ‘winning’ in today’s market — and other trends pharma leaders are tracking
Healthcare pros share the market drivers they believe are having the biggest impact on the industry.
By Taren Grom • June 2, 2023 -
Lawmakers look to crack down on Big Pharma tax breaks
As lawmakers shine a light on Big Pharma tax cuts, the industry’s business moves are coming under attack from multiple angles.
By Alexandra Pecci • May 31, 2023 -
3 FDA decisions that could be delayed if the U.S. defaults on its debt
If federal lawmakers don’t vote to raise the debt limit by early June, these FDA actions could be impacted.
By Karissa Waddick • May 30, 2023 -
From FTC to SCOTUS, Amgen’s woes are potential ‘game changers’ for the industry
The two institutional battles offer a glimpse into the tension between pharma innovation and regulation that could reverberate across the industry.
By Michael Gibney • May 25, 2023