| Today's Big NewsOct 28, 2022 |
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A GPS to your next blockbuster drug - Design molecules towards your desired properties through AI+Biophysics. Learn more.
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| By Kevin Dunleavy Nearly two years after shelling out $1.4 billion for MYR and its hepatitis D drug , Gilead has yet to gain sanction for bulevirtide in the U.S., and it’s not happening any time soon as the FDA has given it a thumbs down. |
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By Nick Paul Taylor The dream of taming IL-2 keeps slipping further away. After seeing Bristol Myers Squibb and Nektar Therapeutics give up on their candidate, Sanofi has reported “lower than projected” efficacy data on its prospect and rethought its plans for the molecule. |
By Conor Hale On the backs of a waning COVID-19 pandemic and global supply chain disruptions, the FDA expects that a broader slowdown in the pace of medtech innovation will result in a dip in the number of new devices approved by the agency this year. |
By Robert King MACPAC is calling on states and CMS to publicly release key progress reports on the unwinding of the COVID-19 emergency, which will spark a massive redetermination of Medicaid eligibility. |
By Zoey Becker Last quarter, Gilead Sciences said it was aiming to ramp up its oncology franchise. That goal played out nicely for the company in its latest earnings report, with third-quarter sales skyrocketing 79% year over year. Gilead aims to derive a third of its revenue from oncology products by 2030, the company announced in April. |
By Max Bayer A new STAT News investigation has found that Eisai's experimental Alzheimer's drug lecenemab may have contributed to a patient's death, according to documents obtained by the outlet. The Japanese pharma acknowledged the death but wouldn't divulge specific details citing patient privacy. |
By Fraiser Kansteiner Women worldwide who count on Ferring Pharmaceuticals' flagship fertility drug may be out of luck for the foreseeable future. Ferring Pharmaceuticals has paused global shipments of the injectable med, citing changes in the manufacturing process by its third-party supplier. |
By Dave Muoio A new review of COVID-era telehealth use highlights potential quality shortcomings resulting from virtual care. Researchers say its vital information as providers and policymakers weigh telehealth's role in post-pandemic care. |
By Kevin Dunleavy Five weeks after getting a harsh thumbs down from the FDA for its multiple myeloma treatment, Pepaxto, Oncopeptides has delivered something of a parting shot—phase 3 results that show what the company calls in its press release a “clinical benefit” for the drug. The agency halted confirmatory trials and pulled the drug off the market after negative results from one of those studies. |
By Nick Paul Taylor Vultures are circling Quantum Genomics. A high-stakes phase 3 hypertension readout has gone against the French biotech, prompting it to stop work on firibastat in cardiology and reallocate its remaining 11 million euros ($11 million) to other projects. |
By Andrea Park During a call with investors on Thursday, CEO Mick Farrell reported that snags in the supply chain are beginning to smooth out, putting ResMed on track to ramp up production in the coming months. |
By Andrea Park Months after its G7 continuous glucose monitor landed European approval in March—leading to a wide-scale rollout of the sensor across the continent earlier this month—Dexcom is zeroing in on the U.S. market. |
By Anastassia Gliadkovskaya Launched in 2016, the company develops clinically designed VR lessons that help teach life skills aimed at children with autism and other neurodevelopmental disorders. |
By Gabrielle Masson An increasingly bitter conflict between biotech and investor has come to a close, with Mereo BioPharma losing out to Rubric Capital Management and handing the activist investor four spots on its board. |
By Sharon Klahr Coey Roche’s Genentech’s Diversity and Inclusion team is not afraid to ask the hard questions when it comes to the hurdles Black women face dealing with healthcare. |
Fierce podcastsDon't miss an episode |
| | This week on “The Top Line,” we dig into rumors of a shaky relationship between Biogen and Eisai. We also chat about AZ’s ability to finally tout the approval of an asset that’s seen many failures over the years. |
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Tuesday, November 15, 2022 | 1pm ET / 10am PT In this webinar, learn how Medable is focused on improving access to clinical trials for patients, supporting the innovation of clinical trial delivery and offering greater choices for participation and engagement to patients. Register now.
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