The Latest
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Bringing drugs to market has ‘never been more challenging,’ and pharma is learning to adapt
As changes to the U.S. regulatory foundation take hold, pharmas need to change their strategies to keep innovation — and the bottom line — above the surface.
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Executive hiring changes reflect a broader biotech comeback
Executive hiring shifts are often indicators of wider trends in the market. Here’s how the hiring landscape for pharma leaders is changing.
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Q&A // First 90 DaysAn ALS treatment wave is approaching, and this biotech CEO is ready to surf
Coya Therapeutics is entering into a phase 2b study for its ALS, and the biotech’s CEO believes it’s on the cusp of a game changer.
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Natural killer cells, a rising alternative to CAR-T cell therapy
These innate immune cells may provide a safer, lower-cost option in cancer and autoimmune diseases.
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Gene therapies have been uneven for DMD — but these companies hope to turn the tide
Despite mixed results using gene therapies to treat Duchenne muscular dystrophy, drug developers are pushing ahead with the belief the answer could come down to delivery.
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J&J is all in on tau-targeted Alzheimer’s candidates. Will the approach lead to more effective treatments?
Anti-tau candidates haven’t crossed the regulatory threshold like their anti-amyloid counterparts, but J&J’s clinical efforts could lead in the right direction.
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After an obesity stumble, BioAge reconnects with its longevity pipeline
The company is kicking off the year with a new Novartis partnership and renewed focus on metabolic aging targets.
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Innovate or perish: Industry’s evolution leaves little room for me-too approaches
Novel drug approvals have set the stage for more breakthroughs in pharma.
Updated Jan. 22, 2025 -
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In pharma’s competitive climate, companies need evidence beyond clinical trials
Early planning and market research are crucial in an era of rising cost pressures.
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Musk’s rare disease torpedo, hospitals’ pharma fix and other policies leaders are tracking
There’s more to pharma's regulatory story in 2025 than just the IRA.
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Deep Dive‘The bar has risen’: China’s biotech gains push US companies to adapt
Pharma dealmaking for drugs invented in China is putting pressure on U.S. biotechs to compete harder.
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By the numbers: J&J, GSK lead J.P. Morgan deal announcements in 2025, the largest turnout in years
The J.P. Morgan Healthcare Conference has been a focal point for M&A year after year, and after a quiet period, the deals are back on the table.
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What to expect in the sequel to Medicare’s drug price negotiation program
CMS is expected to publish up to 15 drugs for the second cycle of the program by Feb. 1, and these are some of the drugs most likely to make the list.
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FTC releases second report slamming pharmacy benefit managers
Agency commissioners voted unanimously on Tuesday to publish the report, which makes similar allegations against the controversial drug middlemen as the agency’s first report released last summer — but relies on more data.
Updated Jan. 14, 2025 -
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Year in PreviewWill 2025 mark pharma’s pivot to bigger deals after years of lackluster M&A?
A series of uncertainties that kept dealmaking to a minimum last year could be reversing as pharma reloads pipelines ahead of the patent cliff explosion.
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Merck is broadening its pipeline as Keytruda’s patent cliff looms
Merck looks ahead with an array of cardiometabolic, immunology, neuroscience and ophthalmology pipelines.
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The ability to pivot will be ‘key’ as pharma’s tariff threat looms
Companies are looking to new countries like Vietnam for manufacturing needs, but change comes at a cost.
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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.
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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.
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Q&A // Biotech SpotlightAfter layoffs, a viral immunotherapy biotech bounced back with a late-stage prostate cancer win
Candel Therapeutics’ CEO had to prioritize a phase 3 program amid layoffs and cuts, and an end-of-year clinical success was the redemption he was looking for.
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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.
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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.
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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.
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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.
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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.
