The Latest
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Lilly’s donanemab will face an Alzheimer’s adcomm in June, setting the stage for a Leqembi showdown
The FDA announced a June advisory committee date, potentially introducing a new Alzheimer’s treatment to compete with Eisai and Biogen’s Leqembi.
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Thinking inside the box: How SmartLabs is transforming laboratories for modern science and accelerating innovation
SmartLabs offers the first integrated platform combining re-configurable lab infrastructure, operations and scientific expertise.
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Opinion
The judicial microscope on abortion meds puts FDA and industry in a precarious spot
The recent SCOTUS case involving mifepristone exposes the risk of drug safety determinations by judicial fiat.
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Q&A
AZ oncology chief says AI can help solve cancer’s ‘ZIP code lottery’ as health disparities persist
Partnerships have been key to building the company’s AI capabilities and patient-focused R&D, said AstraZeneca’s head of U.S. oncology.
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Using the body as ‘a bioreactor’ — a regenerative medicine expert on where the field is headed
The director of the University of Pittsburgh’s McGowan Institute for Regenerative Medicine believes the industry is “turning a corner.”
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As drug shortages reach record highs, regulators float next steps
With many chemo and ADHD drugs stuck in stubborn shortages, several agencies are looking for new solutions to boost supplies.
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FDA’s new diagnostic rules draw pharma criticism
Tests frequently used in clinical trials will soon be regulated like medical devices — with some exceptions.
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Takeover target? Activist investor believes Novavax tech would be in ‘better hands’ with Big Pharma
With its next earnings report looming, pushback from an investor is adding pressure on Novavax to boost performance.
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As AI proliferates in pharma, regulators look to catch up in clinical trials
The FDA’s newly launched Center for Clinical Trial Innovation potentially opens the door for more efficient and expanded AI use, but leaves pharmas wanting more guidance.
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$4M+ gene therapies? How payers can adapt to a new reality of pricey ‘cures’
Pricey gene therapies promise great benefit to patients but pose a threat to the payer landscape — ICER and a Tufts think tank are offering potential solutions.
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Profile
Now a biopharma powerhouse, Vertex’s R&D bedrock could deliver tomorrow’s blockbusters
From its landmark CRISPR approval to its potential breakthrough drug for pain, Vertex’s development approach, led by chief scientific officer Dr. David Altshuler, is paying off.
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4 offbeat biotechs making a splash in the life sciences
From resurrecting an extinct species to improving regenerative medicines with plant-based materials, these biotechs are on the leading edge of science.
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As BMS announces major cuts, its Karuna deal looks poised to drive growth
The company's schizophrenia drug picked up in its $14 billion acquisition of Karuna Therapeutics recently generated positive long-term data from its phase 3 program.
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Q&A
How a biotech exec is leveraging Big Pharma lessons to advance tRNA
Michelle Werner shares how the lessons from her resume — and personal experience — are driving her work with novel therapeutics.
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Q&A
Neuroscience has entered a new era. Now it’s time for a ‘moonshot’ approach.
Dr. Jeremy Levin, CEO of Ovid Therapeutics, explains how scientific advances have converged to create a new era of drug development potential.
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As Lilly and BMS invest in manufacturing, demand for drugs still outweighs supply
From popular weight loss drugs to lifesaving cancer therapies, recent pharma deals show the industry is doubling down on manufacturing capacity to meet demand.
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Biogen: Don’t expect any big acquisitions this year
While the company is eager to diversify, CEO Chris Viehbacher said that in the near-term any dealmaking would likely focus on collaborations and early-stage assets.
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Q&A
AbbVie and Regenxbio’s ‘multibillion-dollar opportunity’ in vision loss gene therapy
After a successful mid-stage study, the companies aim to upend traditional wet AMD treatments with a one-time gene therapy.
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Inside J&J’s strategy to de-gender clinical trials
Mark Wildgust, vice president of global medical affairs for J&J's oncology division, shares strategies for making clinical trials gender- and trans-inclusive.
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Vistagen’s on-demand nasal spray could provide a novel option for social anxiety
The fast-acting medication is one of a few new approaches being tested for the crippling condition.
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WuXi partnerships at risk as lawmakers target Chinese ties to biopharma
Why the legislation could throw a wrench into the supply chain for advanced therapies and how the industry has responded.
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Deep Dive
Ukraine was pharma’s ‘darling’ of clinical trials. As war drags on, will the industry come back?
New clinical trial starts are picking back up, but are still far below their bustling pre-war level.
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Behind the ‘encouraging’ new results for Amylyx’s beleaguered drug
Where Amylyx ultimately failed in ALS, it could prevail in a rare disease. The doctor leading this research explains why.
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Roivant spinoff tackles growing complexity of clinical trials
As precision medicine booms, all trials are starting to look like rare disease trials, the company said.
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3 patent expirations in 2024 and how companies are pivoting
As the cliffs approach, pharma companies are tackling the sales hit with diverging strategies.
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Where the GLP-1 weight loss market goes will depend on data
As GLP-1s expand into new disease categories, their impact could be enough to overtake leading cardiovascular drugs.