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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! .png)
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Today’s Big NewsSep 25, 2023 |
| By Annalee Armstrong “Scientifically incomplete.” “Grossly deficient.” “Lacking scientific rigor.” These are just a few of the ways the FDA has described BrainStorm Cell Therapeutics’ application for the amyotrophic lateral sclerosis treatment NurOwn—a therapy that has already been rejected twice and is now getting its day before an agency advisory committee meeting after being filed over protest. |
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By Nick Paul Taylor AbbVie has put I-Mab out of its misery. More than one year after scrapping a pair of clinical trials, the Big Pharma has cut its ties to the anti-CD47 antibody lemzoparlimab altogether and deprived I-Mab of the chance to pocket up to $1.3 billion in milestones. |
By James Waldron Novo Nordisk may be enjoying a revenue boost courtesy of its next-gen diabetes and obesity drugs, but the company isn’t kicking back and counting the cash. Instead, the Danish Big Pharma is handing over $60 million to Valo Health in the hope that the Flagship-founded company’s AI expertise can reproduce the same success in cardiovascular disease. |
Sponsored by IPM.ai IPM.ai helps brands assess a unique patient population, accelerate clinical trial recruitment, and optimize commercial outcomes |
By Nick Paul Taylor Investors have found a flaw in Morphic’s glittering EMERALD-1 trial. Months after raising $240 million on the back of top-line results that sent its stock soaring, the biotech has shared a fuller look at the data on its oral ulcerative colitis candidate and wiped out its earlier gains. |
Sponsored by Emulate An introduction to Organ-on-a-Chip technology and how it can improve the quality of drugs entering the clinic. |
By Gabrielle Masson BridgeBio Pharma has roped in $250 million via a securities purchase agreement, infusing the company with much-needed cash as it plans a potential commercial launch for heart drug acoramidis. |
By Helen Floersh There’s little question that young livers work better than old ones. But for pediatric, adolescent and young adult patients who need to take nanodrugs—formulations of medicines packaged into nanoparticles about 100,000 times smaller than a red blood cell—having optimal liver function might actually backfire. |
By Ayla Ellison,Annalee Armstrong,Gabrielle Masson,Kevin Dunleavy In this episode of "The Top Line," we shine a spotlight on some of the most promising companies in the biotech world and do a deep dive into drug commercialization strategies. |
By Conor Hale The third time held no charm for Intarcia Therapeutics, which saw its long road through the FDA potentially forced down another detour. |
By Angus Liu More than five years after an initial FDA approval, Novartis is touting positive trial results for its radiotherapy Lutathera as a first-line therapy against the rare cancer that killed Apple co-founder Steve Jobs. |
By Joseph Keenan Curavit, a virtual contract research organization, has been signed on by MedRhythms to run a study of its technology aimed at aging adults with walking impairments as a result of a stroke. |
By Zoey Becker In a critical win, the Padcev-Keyturda combo significantly reduced the risk of death in first-line bladder cancer patients who are eligible for platinum-based chemotherapy at an interim analysis of the closely watched EV-302 trial. |
By Frank Diamond The main hurdle to reaching global universal health coverage by 2030 is raising the $176 billion needed to achieve that goal, according to research by the U.S. Chamber of Commerce. |
By Andrea Park Nominations are now open for this year’s list of the fiercest women in pharma, biotech and medtech. |
Fierce podcasts Don’t miss an episode |
| In this episode of "The Top Line," we shine a spotlight on some of the most promising companies in the biotech world and do a deep dive into drug commercialization strategies. |
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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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Whitepaper 15 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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