The Latest

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  Q&A // Biotech Spotlight

  Beyond GLP-1s? This biotech is exploring longer-term metabolic treatments

  Fractyl Health is entering pivotal studies for a procedure that aims to be an ‘off ramp’ to GLP-1s and exploring how a one-time, ‘smart GLP-1’ gene therapy can Treat type 2 diabetes.

  Biotech

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  Tariffs raise concern among generic drugmakers, and advocacy groups are seeking exemptions

  While the 10% tariff on Chinese goods won’t have too much impact on branded drugs, generics are struggling to pivot.

  Manufacturing

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  Bristol Myers gives first peek at closely watched launch of schizophrenia drug

  Cobenfy, the main asset acquired through Bristol Myers’ $14 billion purchase of Karuna, had $10 million in sales in the fourth quarter and around 1,000 prescriptions weekly by late January.

  Commercialization

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  With uncertainty roiling Big Pharma, execs are placing lower-risk bets

  The market has been no less demanding for pharma giants as 2025 begins, but last year’s strategies are paying off.

  Commercialization

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  As financial headwinds pick up, pharmas are aiming to squeeze more ROI from their R&D

  With assets under a knife and pipelines under a microscope, R&D programs are being overhauled to be more efficient and cost effective.

  Biotech

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  RFK Jr. will face these critical tests if confirmed as head of the HHS

  After a Senate committee advanced President Trump’s nominee to lead HHS, Robert F. Kennedy Jr. is poised to secure the top job at the nation’s healthcare agency.

  Leadership

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  Looming USAID shutdown threatens global health presence and a legacy of medical foreign aid

  As President Trump and his cohorts plan to shut down the U.S. Agency for International Development, here’s what that could mean for global health and the drugmaking industry.

  Leadership

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  What should pharma make of the FDA going dark on DEI?

  After a series of potent executive orders last week, the FDA removed draft guidance on diversity in clinical trials.

  Pharma

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  Drugmakers prep for bird flu outbreak, despite continued low risk

  While the virus hasn’t made a sustained leap into humans, vaccines and treatments are coming through the pipes if it does.

  Biotech

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  Deep Dive

  A new, non-opioid pain drug is here. Getting it to patients could be agony.

  After decades of research, Vertex Pharmaceuticals now has an approved pain medication. Can one of the world’s most powerful biotechs contend with a healthcare system that’s long favored opioids?

  Patient

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  Is federal funding frozen? Has it already thawed? Flip-flop leaves biopharma on edge

  NIH grants that help fund drug development were caught in the mix of confusing executive orders this week.

  Pharma

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  Year in Preview

  Pharma’s forecast for 2025: Sowing seeds of a rebound

  Despite regulatory uncertainty, pharma is bouncing back from a market slump and is being fueled by innovation. 

  Biotech

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  RFK Jr. faces reconciliation of past vaccine statements at Senate HHS hearing

  “Are you supportive of these onesies?” Sen. Bernie Sanders asked Kennedy, pointing to infant clothing stamped with anti-vaccine slogans — and more from yesterday’s confirmation hearing.

  Leadership

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  A long-awaited alternative to opioids is on the FDA doorstep. Can Vertex seal the deal?

  Vertex Pharmaceuticals’ non-opioid pain medication is up for FDA approval this week. Other drugmakers have found safer alternatives to expand the pain management landscape.

  Updated Feb. 4, 2025

  Biotech

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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.

  Leadership

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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.

  Biotech

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  Q&A // First 90 Days

  An 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.

  First 90 Days

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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.

  Biotech

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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.

  Biotech

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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.

  Biotech

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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.

  Biotech

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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

  Commercialization

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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.

  Commercialization

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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.

  Biotech

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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.

  Biotech