| 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 NewsJul 31, 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.
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| By Nick Paul Taylor Sumitomo Pharma and Otsuka’s plan to turn ulotaront into a blockbuster growth driver is on the ropes. A pair of phase 3 schizophrenia clinical trials of the candidate missed their primary endpoints, leaving the partners looking to a “high placebo response” for evidence that the asset has a future in the disease. |
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By James Waldron Okyo Pharma announced plans to sell off some of its shares on Friday, but the ophthalmology-focused biotech clearly had a change of heart over the weekend as the offer was withdrawn this morning over “changing market conditions.” |
By Nick Paul Taylor Annexon has found more to love in its failed phase 2 eye disease clinical trial. Months after framing the study as a success in its top-line results, the biotech has returned with further analyses that it pitched as evidence ANX007 is a promising, differentiated geographic atrophy candidate. |
By James Waldron MyMD Pharmaceuticals’ lead asset has hit all primary and secondary endpoints in a mid-phase study of age-related inflammation, setting the company up to begin phase 3 talks with the FDA. |
By Helen Floersh Researchers have identified another potential gene therapy for treating chronic pain, this time by indirectly targeting a key sodium ion channel. |
By Gabrielle Masson,Max Bayer,Annalee Armstrong Alongside the new year, we've launched a new Fierce Biotech Fundraising Tracker to keep the pulse on the industry's financing. |
By Andrea Park GE HealthCare warned healthcare providers that tens of thousands of TruSignal pulse oximeters may put hospitalized patients at risk of further injury. |
By Kevin Dunleavy A study of FDA advisory committee meetings between 2010 and 2021 shows that the regulator leaned heavily toward approval. When a panel recommended approval, the FDA agreed 97% of the time. When a panel recommended a thumbs-down, however, the FDA complied only 67% of the time. |
By Anastassia Gliadkovskaya The company will donate $25 to UCLA Mattel Children’s Hospital for every OB-GYN appointment booked on its platform through Aug. 21, up to $10 million total. |
By Angus Liu Takeda's targeted non-small cell lung med Exkivity has failed in a phase 3 trial in newly diagnosed patients, just days after Johnson & Johnson touted a win for its rival EGFR inhibitor. |
By Dave Muoio The American Hospital Association, American Medical Association and Blue Cross Blue Shield Association penned a joint letter highlighting "conflicting" prior authorization electronic standards and workflows they say will bring industry confusion and unnecessary burden. |
Fierce podcastsDon'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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