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Find out working with a consultant on the journey to a drug’s regulatory authorization can help smooth out potential problems, conflicts and delays. Access article.
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Special IssueDec 13, 2022 |
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Experts explain the investment interest by pointing to several trends, spanning new therapeutics, the scale-up of new modalities, and ongoing innovation. Access article.
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| By Max Bayer Editas is looking to bounce back after shelving its top asset, touting an extremely small sample size of sickle cell patients treated with its gene editing therapy. |
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By Gabrielle Masson While other biotechs are culling staff and programs to stay afloat, BigHat Biosciences has remained dry under its ever-expanding umbrella, this time inking a multiproject deal with Merck & Co. while growing its team 30% since the summer. |
By Max Bayer Gossamer bio is celebrating a phase 2 win after a series of fails, but analysts aren't popping the champagne just yet. |
By Gabrielle Masson New gene writing biotech Replay has unveiled its first product company, dubbed Eudora, with plans to launch another three players into the gene therapy arena down the line. |
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Nascent biotech’s must overcome challenges during the journey from molecule to approved drug. Find out why and when to bring a CDMO onboard. Access article.
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By Nick Paul Taylor Nimbus Therapeutics is ramping up its pursuit of Bristol Myers Squibb’s plaque psoriasis drug Sotyktu, committing to moving a rival TYK2 inhibitor into phase 3 after hitting the primary endpoint in a midstage study. |
By Nick Paul Taylor Autolus Therapeutics is almost ready to make a late play for the CD19 CAR-T cell therapy space. The biotech now has phase 2 data showing its asset hit the primary endpoint at an interim analysis and is setting out plans for further data to file for FDA approval next year and try to join Bristol Myers Squibb, Gilead and Novartis on the market. |
By Nick Paul Taylor In a statement that calls the results “implausible” four times, and “unplausible” once, Relmada made the case that its RELIANCE I study was undone by data from two high-enrolling sites. |
By Nick Paul Taylor Prometheus Biosciences has laid down a major marker in the anti-TL1A space. Days after Pfizer offloaded its rival candidate to Roivant, Prometheus has reported midphase data in ulcerative colitis and Crohn’s disease that sent its stock up 170% in premarket trading. |
By Nick Paul Taylor Neurocrine Biosciences’ $45 million rare pediatric epilepsy bet has fallen at an early clinical hurdle. Thirty months after licensing the selective T-type calcium channel inhibitor, the biotech has reported its second setback in quick succession with the failure to beat placebo in a small phase 2 clinical trial. |
By Annalee Armstrong SPAC deals are creeping back into the mainstream, with Liminatus Pharma and Iris Acquisition Corp. becoming the latest in the biotech sphere to test the waters. |
By Annalee Armstrong Four months after laying off a chunk of its staff, X4 Pharmaceuticals has some good news to share, as the biotech’s WHIM syndrome therapy improved white blood cell counts in patients during a phase 3 trial. |
By James Waldron The FDA has pumped the brakes on PTC Therapeutics’ Huntington's disease trial in the U.S. even as the studies kick into gear in other countries. |
By Max Bayer Days after PureTech confirmed speculation of a merger with Nektar, conversations between the two companies have ceased, for now. PureTech says its original statement created the impression that the talks were farther along than they were. |
By James Waldron CinCor Pharma is clinging to subgroup analysis despite its mid-stage hypertension study missing its primary endpoint in hopes of advancing the candidate to a phase 3 trial. Investors seemed less convinced, sending CinCor’s shares plummeting 43% in the opening minutes of trading on Monday to $14.80 from a Friday close of $26.53. |
By Nick Paul Taylor Pfizer’s $1 billion bet on Arvinas’ protein degradation technology has delivered phase 2 data. After a publication snafu, Arvinas posted the breast cancer results ahead of schedule—and revealed one partial response among 35 patients at its phase 3 dose. |
Fierce podcastsDon't miss an episode |
| This week on “The Top Line,” we discuss the latest from the Clinical Trials on Alzheimer’s Disease conference. Plus, we cover the week's news including an investigation into Neuralink, Google’s DeepMind and why things aren't working out for PI3Ks. |
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