Policy & Regulation: Page 10
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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 -
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 -
Explore the Trendline➔
Stock via Getty ImagesTrendlineRare diseases
As drug developers find promise in the rare diseases, deals and treatments are on the rise
By PharmaVoice staff -
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 -
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 Moves
Biden’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 -
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 -
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 -
Q&A
AbbVie’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 -
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 -
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 -
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 -
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 -
Sponsored by GoodRx
A 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 -
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 -
Patient influencers are here to stay — where are the regulations?
As social media health influencers enter the world of pharma advertising, experts warn that more guardrails are needed to protect the industry and patients.
By Karissa Waddick • April 17, 2023 -
Fighting vaccine hesitancy may require a new approach from pharma
The COVID-19 pandemic highlighted an ongoing problem of vaccine hesitancy undermining public health efforts. One way pharmas can help is to change the narrative.
By Michael Gibney • April 13, 2023 -
After working at Merck during the Vioxx scandal, this former sales rep is on a mission to fix the system
The founder and CEO for the Accreditation Council for Medical Affairs is increasing accountability in pharma by emphasizing training, standards and ethics in medical affairs.
By Alexandra Pecci • April 11, 2023 -
Opinion
Leaders wave a magic wand at pharma’s thorniest issues
The major challenges pharma leaders would solve with a quick flick of an imaginary wand.
By PharmaVoice staff • March 31, 2023 -
Seamless clinical trials were created to make studies easier — instead, they’ve become more complex
Experts weigh in on how companies can design better trials that merge two phases into one.
By Meagan Parrish • March 29, 2023 -
SCOTUS to decide ‘fundamental change’ in biologics patents with fate of Amgen v. Sanofi
The Supreme Court will now decide whether Amgen can protect Repatha as a whole class of drugs or whether Sanofi’s rival product Praluent can retain a place in the market.
By Michael Gibney • March 28, 2023 -
SVB’s collapse had limited impact on biopharmas — but a broader financial crisis could change the landscape
Although many pharma and biotech companies had deposits at the failed bank, most have reported little to no exposure.
By Michael Gibney • March 21, 2023 -
Making Moves
In the fallout from Aduhelm, Biogen’s leadership shakeup continues
The recent departure of neurodegenerative development head Samantha Budd Haeberlein is just the latest sign of a changing tide among Biogen’s post-Aduhelm leadership.
By Karissa Waddick • March 16, 2023 -
Biden doubles down on drug pricing in 2024 budget — but boosts R&D
The president’s 2024 budget proposal expands on last year’s drug pricing reforms, but also dramatically increases innovation investments.
By Karissa Waddick • March 13, 2023