The Latest

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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.

  Commercialization

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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.

  Biotech

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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.

  Biotech

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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.

  Biotech

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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.

  Biotech

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  Q&A // First 90 Days

  With a new oncology R&D head, Takeda revamps its strategy

  The company is using a “three-by-four” approach to sharpen its cancer R&D aims.

  First 90 Days

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  Pharmas’ IRA court losses mount. They keep pursuing them.

  The final drug prices for Medicare’s negotiation program have been published, but pharma companies continue to push their legal strategies.

  Pharma

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  As a new mpox strain gains ground, a key drug stumbles in the clinic

  Despite the disappointing results, the drug’s developer, Siga Therapeutics, said there’s more to the story.

  Biotech

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  Lessons from COVID: Tuskegee impacts still erode trust in healthcare, but hope shines through

  A long-time leader in public health and outreach to people of color, Dr. Reed Tuckson offers the lessons he learned from the COVID pandemic and how pharma can better serve those communities.

  Leadership

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  BioMarin taps Amgen, Roche vets in executive reshuffle

  Greg Friberg and James Sabry will take over, respectively, as heads of R&D and business development, less than a year after BioMarin named a new CEO.

  Biotech

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  Will the IRA squash new drugs? Those worries are likely exaggerated, studies say.

  There’s no link between revenue and R&D from smaller biotechs, and that’s where most innovation comes from, according to new studies.

  Biotech

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  Pharma’s concerns pile up months after Supreme Court’s landmark Chevron decision

  The Supreme Court case added another layer of uncertainty on the regulatory front and opened up the Inflation Reduction Act to more legal attacks.

  Pharma

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  Q&A

  23andMe inches closer to cancer immunotherapy, guided by its genetic database

  Dr. Jennifer Low, head of 23andMe’s therapeutics division, is taking the company into new territory with a potential cancer treatment that targets a unique pathway.

  Biotech

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  Novo plans new plant as it races to meet drug demand

  The new factory, which Novo is committing some $220 million to build, will supply raw materials for the company’s chronic disease medicines.

  Manufacturing

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  BMS’ KarXT nears schizophrenia approval, but AbbVie and others wait in the wings

  With fewer side effects, the new wave of upcoming drugs could improve patient adherence, and the competition for a large projected market is getting fierce.

  Pharma

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  The drugs hit hardest by Medicare price negotiations

  The final negotiations slash drug prices between 38% and 79% for Medicare’s 2026 calendar year.

  Pharma

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  Medicare reveals results of drug price negotiations

  The agency said the first round of pricing talks, which involved drugs like the blood thinners Eliquis and Xarelto, will result in $6 billion in savings for taxpayers.

  Pharma

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  Can BioNTech sustain a post-COVID mRNA pipeline? Oncology is the next hope.

  The German biotech is leveraging its mRNA platforms to develop a new class of cancer treatments that are necessary to lift the company’s flagging sales.

  Pharma

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  Q&A // Biotech Spotlight

  A biotech’s difficult journey to bring a new kind of Parkinson’s drug to patients

  A series of executive turnovers at Gain Therapeutics this year precedes important early-stage Parkinson’s results that could change how the disease is treated.

  Biotech

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  A potential MS ‘game changer’ could bring more safety to the table — even against viruses

  Immunic’s treatment has anti-inflammation, neuroprotection and antiviral effects plus a ‘benign’ safety profile that even seems to lower the risk of COVID-19 infection.

  Biotech

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  M&A is ready to explode, and that’s good news for pharma layoffs

  Deals driven by obesity meds are fueling an M&A comeback, driving the industry to take fewer cost-cutting measures.

  Commercialization

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  Pharma execs react to final drug price negotiations with Medicare

  Here’s what the leaders of the companies with the 10 drugs in the first wave of price negotiations with Medicare said about how the new prices will impact their portfolio.

  Leadership

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  Market share shakeup: Big Pharma’s bestselling drugs drive industry shifts in 2024’s first half

  The top drugs at each of the world’s most valuable pharma companies tell the story of just how much the industry has changed over the course of a few years.

  Commercialization

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  Roche licenses Sangamo’s technology for another shot at Alzheimer’s drugs

  Through a new deal, Roche has exclusive rights to Sangamo molecules designed to repress the gene that makes “tau,” a protein many scientists view as a main driver of Alzheimer’s.

  Biotech

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  Q&A

  Autobahn’s road to a breakthrough depression treatment is paved with high-profile investors

  The biotech boasts some Big Pharma backers that drove a $100 million fundraising effort in July to take its depression drug into a mid-stage study.

  Biotech