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What the Fed’s rate cut means for biotech
Industry insiders hope the Fed’s decision to cut rates for the first time in years will boost biotech investment. But the long-awaited move won’t cure all that ails the sector, others cautioned.
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After epilepsy setback, Ovid charges confidently ahead in CNS
A promising epilepsy drug Ovid sold to Takeda recently missed the mark in late-stage trials. But Ovid believes it has other novel mechanisms that could deliver a CNS win.
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At J&J, oncology R&D meets commercial strategy in a quest for new standards of care
The disparate teams of research and commercial at J&J work closely together from the get-go.
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FDA inspection backlog overseas threatens new drug approvals
The FDA’s backlog of overseas drug manufacturer inspections is still mounting — and new drugs could be delayed as a result.
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Getting IND ready — how companies can avoid common traps
Overpromising, overcommitting and neglecting CMC are a few of the pitfalls that cause sponsors to stumble when submitting a new drug application.
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How a radiopharma up-and-comer builds momentum in a surging space
Big Pharma is embracing the radiopharmaceuticals boom that was a long time in the making.
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Biopharma prepares to pivot from China as Biosecure Act advances
After the House of Representatives passed the Biosecure Act last week, U.S. biotechs could be forced to cut ties with five Chinese contract partners.
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The hunt for game-changers against the deadliest form of brain cancer
Treatments for glioblastoma have fallen short in the face of difficult challenges, but the pipeline is full of renewed attempts.
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Who’s winning in biotech’s tight market?
Three of the largest fundraising rounds in 2024 show where investors are willing to place their bets in biotech.
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Q&A
How Lilly’s sustainability goals come face to face with massive growth
Eli Lilly’s head of ESG is maintaining a focus on sustainability even as the company’s expansion plans in weight loss drive a larger footprint and more social scrutiny.
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Why pharma should redefine ‘women’s health’
A broader approach recognizes the challenges disproportionately impacting women and could lead to better outcomes, according to Organon.
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3 FDA approval dates to watch in the year’s final push
A handful of potential blockbusters are marching toward FDA review.
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Deep Dive
A decade of cancer immunotherapy: Keytruda, Opdivo and the drugs that changed oncology
Over the past 10 years, PD1-blocking medicines have transformed cancer care. But the steady expansion of their use has slowed and, despite much trying, pharmaceutical companies have largely failed to top the drugs’ successes.
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A new way of determining a drug’s value — with health equity in mind
Quality-adjusted life years are an important tool to frame a drug’s cost effectiveness, but they leave out other determinants of health.
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Lilly lays down $1B to be ‘first in biology’ with obesity gene therapies
The deal, which targets metabolic diseases, is one of a few by Big Pharma to develop lncRNA therapies.
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Huntington’s disease R&D is regaining ground after several disappointments
Setbacks haven’t stopped advances by biotechs and pharmas working on new drugs for the inherited brain disorder.
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What 3 layoff stories reveal about pharma’s troubles
The factors driving the industry’s layoffs — and what could help turn the tide.
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Big Pharma is often media shy. Merck’s chief comms officer is hoping to change that.
Cristal Downing is helping Merck & Co. buck pharma’s zipped-lip status quo and usher in a “new era” of openness, transparency and “overt communication.”
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Pharma’s ‘it’ therapy — a new drug class gaining steam
More companies are investing in protein degraders, which leverage a unique approach to harnessing the immune system in cancer, neurological diseases and more.
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A plucky biotech threatening Pfizer’s grip on the Prevnar vaccine market
Results from Vaxcyte’s clinical pneumococcal vaccine study showed the smaller company could take on Pfizer’s legendary blockbuster.
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FDA adcomm reform talks heat up
As the agency considers eliminating adcomm votes from the approval process, members vie to have their voices heard.
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Is anyone taking the world’s priciest drugs?
A slew of breakthrough gene therapies won FDA approval in recent years — but high price tags haven’t always yielded big returns.
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Their Alzheimer’s treatment worked — but shares fell anyway
Cognition Therapeutics touted what the C-suite saw as a promising mid-stage study in Alzheimer’s, but investors read a different story.
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After an FDA rejection, here’s what’s next in the psychedelics pipeline
By rejecting the first MDMA therapy earlier this month, the FDA signaled to the psychedelic drug sector that the road to approval isn’t clear cut.
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As pharma’s AI revolution gets underway, ‘hallucinations’ pose a great risk
While AI, machine learning and large language models can distill huge amounts of information, they sometimes make mistakes. New technologies could rebuild that trust.