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BioPharma Dive
Online Audio and Video Media
Washington, District of Columbia 15,102 followers
We provide business journalism and in-depth insight into the most impactful news and trends shaping biotech and pharma
About us
BioPharma Dive provides in-depth journalism and insight into the most impactful news and trends shaping biotech and pharma. The newsletter and website cover topics ranging from clinical readouts to FDA approvals, gene therapy to drug pricing and M&A to research partnerships. BioPharma Dive is a leading industry publication operated by Industry Dive. Our business journalists spark ideas and shape agendas for 13+ million decision-makers in the most competitive industries.
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http://www.biopharmadive.com
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Updates
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Even with another mid-stage setback, Roche believes there were enough positive signs to “merit further exploration” of the drug, which it’s been developing with Prothena for more than a decade. #biopharma
Roche sticks with Parkinson’s drug despite second study failure
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Novo shares lost nearly a fifth of their value after an experimental combination treatment called cagrisema fell short of the bar set by executives. #biopharma
Novo’s next-gen obesity drug misses expectations in closely watched trial
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BioPharma Dive reposted this
By mid-day Thursday, Vertex Pharmaceuticals had lost about $15 billion in market value. The reason: investors weren't impressed with the latest data on the company's closely watched, non-opioid pain drug. The drug technically succeeded in a mid-stage clinical trial evaluating it in patients with a common condition that causes sharp pain in the lower back and legs. However, the experiment also had a “reference arm” wherein participants received a placebo. And there, patients reported pain reductions similar to what was seen in the drug arm. Vertex offered up some explanations for why the trial shook out like it did. The company also said it intends to push the drug forward in this condition, using learnings from the mid-stage study to design a larger, hopefully better trial. But Thursday's stock drop suggests investors aren’t sold on Vertex's reasoning or plans. “We continue to be confused by management’s strong defense” of the data, which look “very messy,” wrote Paul Matteis, an analyst at Stifel Financial Corp., in a note to clients. Vertex's medication is meant to be a non-addictive alternative to opioids, and has shown in multiple clinical trials the ability to alleviate acute pain as well as a form of chronic nerve pain. The company asked for approval in the acute setting earlier this year and anticipates a verdict from the Food and Drug Administration before the end of January. To at least one analyst, the fresh data affirm that Wall Street's expectations, which forecast the drug generating billions of dollars each year at its peak, are overblown. “We continue to believe that the reality of [the drug] is significantly different than the lofty expectations attributed to it,” writes Baird analyst Brian Skorney, CFA Skorney. “Even considering a pivotal study based on this data strains credulity.” My latest for BioPharma Dive: #biotech #pain #research #pharmaceuticals #neuroscience
Vertex ‘ends the year in pain’ as latest non-opioid drug data disappoint
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Mixed results from a study focused on lower back pain left analysts wanting as well as confused about Vertex Pharmaceuticals's plans to forge ahead in the indication. #biopharma
Vertex ‘ends the year in pain’ as latest non-opioid drug data disappoint
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The FDA’s decision will close a lucrative market opportunity for compounding #pharmacies, although the agency will give a limited grace period before taking any enforcement actions.
Zepbound, Mounjaro shortages are resolved, FDA confirms
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“Pain has really been out of favor in the industry up until very recently,” said John Mulcahy, SiteOne Therapeutics, Inc.’s CEO. The company plans to use its new funds to get to “proof of concept” for its medicines. #biopharma
A Vertex partner — and potential rival — secures $100M to develop non-opioid pain drugs
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BioPharma Dive reposted this
Almost 15 years ago, in the midst of an opioid epidemic that would kill more than half a million people in the U.S., a startup formed with the aim of creating new, non-addictive pain drugs. This goal could have been seen as noble. But for most investors, it was far too risky. Pain research was known to be exceedingly difficult and, even if successful, any resulting products would have to compete in a healthcare system that opioid makers had already gamed. Yet, in a major reversal of fortune, this small company recently began to receive a huge influx of investment. On Wednesday, SiteOne Therapeutics, Inc. announced the closing of a $100 million fundraising round, and plans to put the cash toward human studies designed to show its drugs work as intended. The round was led by Novo Holdings, the controlling stakeholder of Ozempic-maker Novo Nordisk. According to Ken Harrison, a senior partner at the firm, the decision to invest was partially based on promising early data from SiteOne, but also because Vertex Pharmaceuticals had recently established a pathway to successfully develop these kinds of drugs. You can read more about Novo's investment thesis, the complex relationship between SiteOne and Vertex, and the commercial challenges facing both drugmakers in my latest for BioPharma Dive: #pain #medicine #biotech #startup #research #pharmaceuticals #science https://lnkd.in/erx7rqwY
A Vertex partner — and potential rival — secures $100M to develop non-opioid pain drugs
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News of Merck’s licensing of Hansoh’s preclinical medicine pressured shares in Viking and other #obesity drug developers seen as likely buyout targets. #biopharma
Merck moves into obesity with deal for Hansoh’s GLP-1 pill
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Phase 2 results in inflammatory bowel disease hinted the therapy could be more potent than similar medicines from Merck and Roche, each of which were acquired in multibillion-dollar deals. #biopharma
Sanofi, Teva say study results show gut disease drug could be ‘best in class’
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