Policy & Regulation: Page 2
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Breast cancer tops list of most studied diseases
The most studied diseases last year included three types of cancer as research into COVID-19 fell sharply in the post-pandemic era.
By Kelly Bilodeau • Jan. 24, 2024 -
FDA looks to execute ‘largest reorganization in history’ this year
What started as an examination of the Human Foods Program has expanded into an agencywide overhaul.
By Alexandra Pecci • Jan. 23, 2024 -
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 -
How to make 2024 a banner year for biopharma, despite the headwinds
Creative thinking is the name of the game as biopharmas seek to overcome a host of challenges — and investing with purpose, building trust and embracing tech could get them there.
By Michael Gibney • Jan. 18, 2024 -
An enduring COVID mystery: Why some do fine and others die
The infectious disease market could be shifting toward a future not only focused on the microbe, but on the unique genetic attributes of the host.
By Alexandra Pecci • Jan. 17, 2024 -
FDA chief says agency can’t manage health tech alone
FDA Commissioner Dr. Robert Califf recently spoke about the future of AI and machine learning and the need for constant vigilance to improve healthcare systems.
By Alexandra Pecci • Jan. 16, 2024 -
4 big FDA approval dates to watch in 2024
Following a year where the FDA approved 55 new drugs, the 2024 PDUFA calendar is set with a number of potentially buzzy approvals.
By Alexandra Pecci • Jan. 12, 2024 -
Opinion
Pharma execs sound off on trends and policies they’re tracking in 2024
From regulatory concerns to leadership skills, pharma leaders at JPM shared how they’re approaching the coming year.
By Meagan Parrish • Jan. 12, 2024 -
Opinion // Year in Preview
PharmaVoice’s Crystal Ball: What’s next in drug innovation and clinical trials
As advanced therapies and patient perspectives strengthen their foothold in R&D, pharma is poised to deliver impactful treatments in record time.
By Meagan Parrish • Jan. 11, 2024 -
Opinion // Year in Preview
PharmaVoice’s Crystal Ball: Perspectives on the financial future
Industry leaders predict what it will take for pharma to defeat its financial foes in 2024.
By Meagan Parrish • Jan. 9, 2024 -
Regulatory twists and turns are coming for biopharma in 2024
New FDA requirements and the IRA will create complexity in the coming year. Here’s how the industry can navigate the changes.
By Kelly Bilodeau • Jan. 8, 2024 -
10 of our most read articles in 2023
A presidential candidate, a changing biotech market and an enduring murder mystery — here are PharmaVoice’s most-read articles this year.
By Meagan Parrish • Dec. 22, 2023 -
Biopharma’s FTC headache deepens with guideline shifts years in the making
Closer scrutiny of pharma deals has made the M&A landscape trickier as a new approach seeks to expand the competitive arena.
By Michael Gibney • Dec. 21, 2023 -
Study suggests PBMs are gaming pharmacy system to overcharge for drugs
Markups for generics can be as high as 7,000%, the researchers said.
By Alexandra Pecci • Dec. 15, 2023 -
Q&A
The many ‘myths’ of clinical trial diversity, and Genentech’s fight to disrupt them
Genentech’s chief diversity officer Quita Highsmith is on a crusade to prove that much of what the industry believes about clinical trial diversity is wrong.
By Michael Gibney • Dec. 14, 2023 -
What’s being done to prepare for the next pandemic?
Will the world be ready when a new outbreak hits? Here’s a look at the efforts to combat emerging viral threats.
By Kelly Bilodeau • Dec. 13, 2023 -
Q&A
A former CDC head on key R&D areas, public trust and if we learned anything from COVID-19
Dr. Julie Gerberding, now president and CEO of the Foundation for the National Institutes of Health, shares lessons learned from a long career in academic, public health and industry.
By Meagan Parrish • Dec. 13, 2023 -
Real Chemistry’s CEO on biopharma’s outlook in 2024
Shankar Narayanan, CEO of marketing consulting firm Real Chemistry, weighs in on where the industry is headed in the New Year.
By Michael Gibney • Dec. 7, 2023 -
4 historic FDA approvals from 2023
This year’s many firsts included a vaccine for RSV and a drug that slows Alzheimer’s disease.
By Alexandra Pecci • Dec. 6, 2023 -
CRISPR eyes autoimmune disease in revamp of cell therapy plans
The gene editing biotech is shelving two of its most advanced cancer drugs, and joining a growing group of companies exploring cell-based medicines for inflammatory diseases like lupus.
By Ben Fidler • Dec. 6, 2023 -
The digital therapeutics revolution is here. Will payers play ball?
Apps, VR and more could play an increasingly vital role in the wider goals of creating value-based treatments — if the industry can get payers to sign on.
By Kelly Bilodeau • Dec. 5, 2023 -
Deep Dive
Pharma benefited from basing business overseas. An international tax effort could spur a rethink.
U.S. tax law changes six years ago slashed large pharma companies' rates and saved them billions. Now, a push for an international floor could disrupt their R&D accounting.
By Jonathan Gardner • Nov. 29, 2023 -
Top FDA official Woodcock to retire early next year
The 37-year veteran helmed the agency’s pandemic response, and was a key decision-maker in controversial calls on opioids, an Alzheimer's therapy and muscular dystrophy drugs.
By Jonathan Gardner • Nov. 16, 2023 -
Can Sarepta’s Duchenne gene therapy still deliver on its promise?
For Sarepta — and DMD patients — there’s a lot riding on the treatment’s next steps.
By Kelly Bilodeau • Nov. 14, 2023 -
How pharma leaders talk about ethics in a highly criticized industry
The maze of ethical issues in biopharma can confound even the wiliest executive. How do some leaders get by?
By Michael Gibney • Nov. 9, 2023 -
An at-home flu vaccine? If approved, it could open the door to more DIY options
A new way to administer vaccines at home could help AstraZeneca reach a wider market for FluMist, the nasal influenza vaccine.
By Kelly Bilodeau • Nov. 8, 2023