Policy & Regulation: Page 7
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Courtesy of Eisai
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 -
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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 -
Explore the Trendline➔
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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 -
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Q&A // First 90 DaysA 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 -
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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 -
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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 -
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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 -
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OpinionShaking 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 -
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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 -
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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 -
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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 -
Courtesy of U.S. Food and Drug Administration
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 -
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OpinionA 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 -
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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 -
Anna Moneymaker/Staff via Getty Images
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 -
Carol Highsmith. (2005). "The Apex Building" [Photo]. Retrieved from Wikimedia Commons.
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 -
(2021). Retrieved from NCI.
Making MovesBiden’s pick to lead the NIH faces an uphill battle
Pending Senate confirmation, NCI head Monica Bertagnolli will take the helm of the collection of research organizations as it faces increasing bipartisan scrutiny.
By Karissa Waddick • May 18, 2023 -
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Major regulatory changes are coming to pharma in the EU — and industry’s weighing in
The European Union published a long-awaited proposal that could bring sweeping changes to its pharma sector last month, but the legislative fight has only just begun.
By Karissa Waddick • May 16, 2023 -
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Years into the pandemic, only a handful of clinical trials are targeting long COVID — here’s one of them
Scientists at Stanford are testing Pfizer’s Paxlovid on long COVID symptoms and their efforts could provide clues for other conditions.
By Kelly Bilodeau • May 15, 2023 -
Permission granted by Christopher Boone AbbVie
Q&AAbbVie’s Christopher Boone on RWE’s potential — and its ‘profound ethical dilemmas’
With decades of experience in public health, Boone is leveraging RWE to move the needle within clinical development.
By Taren Grom • May 10, 2023 -
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3 key FDA approval trends this year
Although approvals are off to a slow start in oncology, the agency has been living in the fast lane for neurological disorders and more.
By Kelly Bilodeau • May 8, 2023 -
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Insulin prices have dropped — will Civica still be a disrupter in the field?
The nonprofit generics maker still sees a need for low-cost insulin despite recent moves by major drugmakers to slash the prices of their popular products.
By Karissa Waddick • May 8, 2023 -
Permission granted by Neena Patil
Podcast
Woman of the Week: Jazz Pharmaceuticals’ Neena Patil
Patil’s dual interests in healthcare and law are at the intersection of her C-suite role.
By Taren Grom • May 3, 2023 -
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Taking your biotech global? Here’s how you can navigate cultural norms
What’s so different about doing pharma business in the U.K. versus Japan? One of Moderna’s top brass shares her tips for navigating choppy cultural waters.
By Alexandra Pecci • May 2, 2023 -
Permission granted by GoodRx
Sponsored by GoodRxA physician’s perspective on health equity, diversity and inclusion
Dr. Preeti Parikh sees parallels between promoting health equity and current DE&I challenges in the workplace.
By Preeti Parikh, MD, Executive Medical Director, GoodRx • April 24, 2023 -
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A new era of COVID innovation is here
With a $5 billion dollar infusion, a new White House program is helping catalyze development of next-gen treatments, from pan-coronavirus vaccines to enhanced antivirals.
By Kelly Bilodeau • April 17, 2023
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