| Publisher’s Note: Join us September 11-14 in Philadelphia for Digital Pharma East! We’re excited to announce our opening keynote, none other than Dustin Garis, world-renowned brand innovator, customer experience pioneer and Chief Troublemaker. Register today for the ultimate marketing event in the life sciences industry. |
Today's Big NewsAug 3, 2023 |
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October 5-6, 2023 San Diego, CA Join us at the Fierce Medical Affairs Strategic Summit West and hear industry-leading speakers from Amgen, Abbott, Bayer, Gilead, Janssen, Otsuka, Daiichi Sankyo, and many more. Register now with early bird rates and save $200. .png) |
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| By Annalee Armstrong Intellia has patients lined up in the U.S. for a phase 2 trial of a CRISPR-based treatment in hereditary angioedema, but the FDA has thrown down a roadblock over a request for a new preclinical test of the therapy’s impact on a developing fetus. |
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By Nick Paul Taylor Regeneron is rethinking development of its prostate cancer bispecific after two patients died in a clinical trial. The deaths prompted the Big Biotech to stop enrolling patients to receive REGN5678 and a full dose of its checkpoint inhibitor, but a reshaped bispecific development program is continuing. |
By Gabrielle Masson Moderna's buzzy cancer vaccine partnership with Merck will soon take a leap into lung cancer, after recent clinical data showed the shot—alongside Merck's blockbuster Keytruda—significantly reduced risk of recurrence or death in patients with melanoma. |
By Max Bayer Novartis is adding more weight onto its Ionis-hitched saddle, tacking on a next-generation cardiovascular disease treatment meant to be the sequel to pelacarsen. |
By Nick Paul Taylor Aravive’s phase 3 ovarian cancer trial has bombed, taking another chunk out of its share price. And, with cash down to $18 million at the end of the second quarter, the biotech has a matter of months to find a way out of its predicament. |
By James Waldron Agios Pharmaceuticals is basking in the “tremendous progress” of its PK activator pipeline, but that hasn’t stopped the biotech from looking for ways to freshen up its hematology portfolio courtesy of a preclinical siRNA program from Alnylam. |
By James Waldron Vaxil Bio has offloaded its CEO and is considering a fundamental shakeup of the business to free up enough cash to get a colorectal cancer drug into the clinic. |
By Annalee Armstrong After working through a default with its creditors in July, troubled Avalo Therapeutics is looking to sell or license out its core assets, with at least three therapies already involved in buyout discussions. |
By Annalee Armstrong,Gabrielle Masson,Max Bayer We had hoped that our Layoff Tracker would stay retired for a while, but 2023 is starting to look a lot like our old friend 2022 when it comes to layoffs in biotech. |
By Angus Liu Back in 2020, a surprise manufacturing shortfall led to an import ban of Bristol Myers Squibb’s Abraxane, sold by BeiGene, in China. Legal finger-pointing ensued, and now the two companies have decided to scrap their three-drug partnership altogether. |
By Conor Hale In a brief announcement from the Federal Trade Commission, the agency said it “has learned” of the termination and described the move as “a win for patients,” adding that it came after cooperation with international antitrust regulators in Australia and the U.K. |
By Zoey Becker The company raised its forecast for COVID-19 sales to between $6 billion and $8 billion, up from a prior estimate of $5 billion. Elsewhere, an RSV clash with pharma giants nears. |
By Heather Landi CVS Health posted its second-quarter earnings Wednesday morning, where it reported $1.9 billion in profit and a 10% bump in revenue. But executives tempered profit expectations for 2023 and 2024 as the healthcare giant faces headwinds in its insurance and retail pharmacy businesses. |
Fierce podcasts Don't miss an episode |
| This week on "The Top Line," we revisit an episode on Narcan the nasal spray. It is the first naloxone product to be approved for use without a prescription. |
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