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IND-enabling nonclinical studies play a crucial role in bringing new medications to market. But these tests require careful coordination & meticulous execution. Read our 5-step checklist to help make sure the data is accepted by regulatory agencies. Attending ACT Nov 12-15? Schedule a meeting with our experts!
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Today’s Big NewsSep 29, 2023 |
| By Nick Paul Taylor Structure Therapeutics has shared an early look at the efficacy of its oral GLP-1 receptor agonist, linking the candidate to a 5% reduction in weight after four weeks. |
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By Helen Floersh It’s no secret that most drugs that work in mice fail to work in men (and women). Yet thousands of animal lives and taxpayer dollars are spent on preclinical research that, in the end, offers little more than false hope. A new method for conducting preclinical studies could help change that. |
By James Waldron PTC Therapeutics has announced that its layoffs will now go deeper and wider than previously announced as European regulators consider halting sales of the company’s Duchenne muscular dystrophy drug. |
Sponsored by IPM.ai IPM.ai helps brands assess a unique patient population, accelerate clinical trial recruitment, and optimize commercial outcomes |
By Max Bayer ModeX Therapeutics has won a BARDA contract worth up to $168 to develop next-gen antibodies against viral infection. The company inked a partnership with Merck earlier this year worth more than $800 million. |
Sponsored by Emulate An introduction to Organ-on-a-Chip technology and how it can improve the quality of drugs entering the clinic. |
By Nick Paul Taylor Adlai Nortye has established the financial foundation to show whether its bet on an ex-Novartis asset will pay off, securing $97.5 million through an IPO and private placement to fund a phase 3 trial in head and neck cancer. |
By Max Bayer,Gabrielle Masson New Madrigal CEO Bill Sibold has his first critical vacancy to fill, with the company's COO departing. Ex-Novartis CMO John Tsai takes the reins of a new UK biotech. Editas taps former Biogen exec to lead commercial work. |
By Ayla Ellison,Eric Sagonowsky In this episode of "The Top Line," Fierce Pharma's Eric Sagonowksy talks with Pam Cheng, the AstraZeneca executive who is playing a key role in driving the company's sustainability ambitions. |
By Zoey Becker After the Centers for Medicare & Medicaid Services revealed the list of drugs set to face the first round of pricing negotiations, the drugmakers responsible for marketing them are confronting a series of deadlines. |
By Andrea Park They say a rising tide lifts all boats, and that certainly seems to be the case with the new wave of drugs and devices for diabetes management. |
By Zoey Becker As some cancer centers struggle to secure access to key platinum-based chemotherapies, a national spotlight gives the issue newfound political importance. But will this be a turning point for the recurrent shortage issue? ASCO's Julie Gralow, M.D., certainly hopes so. |
By Dave Muoio Analyses of recent government data outlined an uptick in hiring while year-over-year growth in healthcare spending, prices and utilization somewhat slowed. |
By Angus Liu AstraZeneca and Daiichi Sankyo's TROP2-targeted antibody-drug conjugate has hits its goal in a breast cancer trial. The combination of Padcev and Keytruda also succeeded in a broad first-line bladder cancer setting. AbbVie has terminated its CD47 collaboration with I-Mab. And more. |
Fierce podcastsDon’t miss an episode |
| In this episode of "The Top Line," Fierce Pharma's Eric Sagonowksy talks with Pam Cheng, the AstraZeneca executive who is playing a key role in driving the company's sustainability ambitions. |
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October 16-18, 2023 | Boston, MA Hear from leading experts as they share their experiences and insights covering drug development from the earliest stage of research to FDA approval. Time is running out, be left out! Register today
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| Whitepaper15 biotech executives from the Cambridge area discuss the current biotech landscape, as well as challenges, opportunities, and best practices for emerging biotech companies seeking success in the UK and beyond. Sponsored by: Blue Matter, strategic consultants in the life sciences |
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