Pharma: Page 4
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FDA ‘stuck to its corner’ with AI draft guidance, leaving plenty of questions unanswered
The first draft guidance provides an initial framework for how the agency will assess AI models in drug development, but the industry is still looking for more.
By Amy Baxter • Jan. 13, 2025 -
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Opinion // Year in PreviewPharmaVoice’s Crystal Ball: Industry shifts in R&D, policy and clinical trials
Coming changes that could impact pharma from drug development to launch.
By Meagan Parrish • Jan. 10, 2025 -
Explore the Trendline➔
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TrendlineClinical trial diversity
As pharma wises up to the fact that the current playbook for improving clinical trial diversity has yet to make a meaningful impact, the quest is on to refine that approach.
By PharmaVoice staff -
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3 trial readouts that could shake up the obesity market this year
A wave of new weight loss treatments is on the way, and drugmakers are scrambling for a foot in the door.
By Amy Baxter • Jan. 8, 2025 -
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Subcutaneous options offer convenience for patients — and a valuable window for drugmakers
New formulations for under-the-skin application of drugs give pharmas another opening in a crowded market.
By Kelly Bilodeau • Jan. 7, 2025 -
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Opinion // Year in PreviewPharmaVoice’s Crystal Ball: The industry’s AI future
How AI will further transform the business of drug discovery and development in 2025.
By Meagan Parrish • Jan. 7, 2025 -
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4 closely watched FDA approval dates in 2025 from J&J, Novo and more
A first-in-class pain med and blockbusters with new indications are just a few of the possible approvals to keep an eye on in the new year.
By Alexandra Pecci • Jan. 6, 2025 -
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PBMs have evaded lawmakers’ reform attempts so far. Could 2025 turn the tide?
How regulators could hit PBMs from multiple sides in the coming year.
By Amy Baxter • Jan. 6, 2025 -
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FDA approves drugs from Vertex, Novo, Bristol Myers to wrap 2024
The agency’s main drug review office cleared 50 novel medicines last year, short of 2018’s record total but on the higher end of recent annual tallies.
By Ben Fidler • Jan. 3, 2025 -
Permission granted by Merck Archives
How pharma was instrumental in President Jimmy Carter’s global health efforts
Pharma companies stepped up to support The Carter Center and provide access to life-saving treatments.
By Michael Gibney • Jan. 3, 2025 -
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10 of our most read articles of 2024
The high drama of an election year, industry layoffs, patent cliff strategies and other key trends that shaped pharma in 2024.
By Meagan Parrish • Dec. 20, 2024 -
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Zepbound, Mounjaro shortages are resolved, FDA confirms
The FDA’s decision will close a lucrative market opportunity for compounding pharmacies, although the agency will give a limited grace period before taking any enforcement actions.
By Ned Pagliarulo • Dec. 20, 2024 -
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Merck’s RSV antibody could soon paddle into the rough waters of a crowded market
A new antibody from Merck would join a market teeming with new entries, but plenty of regulatory and financial uncertainty.
By Michael Gibney • Dec. 19, 2024 -
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Big Pharma’s new DTC play: partnering with digital health providers
The pharma giant is looking for another edge in the competitive weight loss market through DTC expansion.
By Amy Baxter • Dec. 18, 2024 -
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Maternal mortality trends remain dire — and researchers face an uphill battle to solve them
Rising maternal mortality, particularly among vulnerable populations, stems in part from a lack of research in pregnant women.
By Michael Gibney • Dec. 17, 2024 -
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A biotech’s race to tackle the most severe hepatitis
Bluejay Therapeutics is one of just a handful of companies developing treatments for hepatitis D.
By Alexandra Pecci • Dec. 17, 2024 -
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3 closely watched drugs that failed in the clinic
How recent setbacks and scattered successes could impact various sectors of the industry.
By Kelly Bilodeau • Dec. 16, 2024 -
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Oncology, obesity and more: Where pharma R&D is headed in 2025
With a little more certainty coming to the market, the R&D environment in 2025 will be about pipeline prioritization and accelerating M&A.
By Amy Baxter • Dec. 16, 2024 -
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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 -
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Q&ARegeneron’s R&D approach scores dual wins against Alexion’s Ultomiris and in lymphoma
At this year’s ASH conference, Regeneron posted results for treatments that could disrupt the standards of care in two blood-related diseases.
By Michael Gibney • Dec. 12, 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 -
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Deep DiveEndometriosis drug research, long underfunded, confronts familiar problems in women’s health
Despite the disease’s prevalence, endometriosis remains misunderstood, and research into drugs that might treat it draws scant funding — problems that have deep roots.
By Delilah Alvarado • Dec. 11, 2024 -
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What’s next for 23andMe?
Amid its plummeting stock value, layoffs and cuts to its drug R&D program, the battered company is carrying on.
By Alexandra Pecci • Dec. 10, 2024 -
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GSK’s multiple myeloma ADC Blenrep was pulled from the market. Now, it’s poised for a comeback.
GSK’s cancer drug failed a confirmatory trial two years after an accelerated approval, but impressive new survival data could change the tide.
By Michael Gibney • Dec. 10, 2024 -
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A drug for fewer than 1,000 patients? Awareness and diagnosis are key.
Zevra Therapeutics is building a commercial strategy for an ultra-small patient pool.
By Amy Baxter • Dec. 9, 2024 -
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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
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