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Are you thinking about launching a study? Or are you in the middle of managing a biopharma project? Learn more about the major risks surrounding your work and the best ways to manage your project for success. Download the App Note here. 
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Today's Big NewsOct 31, 2022 |
| By Annalee Armstrong After a fruitless search for patients with a specific type of prostate cancer, Janssen is suspending a phase 1 clinical trial that was being conducted with ESSA Pharma’s experimental small-molecule inhibitor. |
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By Nick Paul Taylor Data from a preclinical chronic toxicology study have torpedoed AbbVie’s psoriasis prospect cedirogant, leading the company to dump the midphase asset and cut off a source of cash for its partner Inventiva. |
Sponsored by Fortress Biotech With 9 marketed products and 20 clinical programs, Fortress Bio’s business model is designed to decrease risk and expense while creating a regular flow of value-creating events for shareholders. |
By James Waldron CytoDyn has withdrawn an approval application for leronlimab in a specific HIV indication, the latest installment in the troubled biotech’s ongoing saga to get the monoclonal antibody to market. |
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. |
By James Waldron Two years ago, Santhera refocused its energies on Duchenne muscular dystrophy prospect vamorolone and lung disease candidate lonodelestat. Now, the biotech has decided its lonodelestat dreams may have to die so vamorolone can fly. |
Sponsored by By: Fierce Biotech Fierce Biotech sits down with biotech and drug development leaders as they discuss the latest breakthroughs and innovations driving the life sciences industry. These videos explore what's next for the biotech industry and how companies are delivering value to patients and customers in today's evolving healthcare landscape. |
By Max Bayer Actinium is jumping off the sugar rush attained from a sweet phase 3 victory of its radiotherapy to treat elderly patients with acute myeloid leukemia. The company says it will take the data to regulators as it looks for regulatory approval. |
By Nick Paul Taylor A FDA advisory committee has blown a hole in Y-mAbs Therapeutics’ hopes of winning approval for its rare disease drug, delivering a damning 0-16 verdict on the question of whether the company showed its candidate improves overall survival. |
By Helen Floersh Researchers have designed a new molecule that increases serotonin signaling, with improvements in as little as two hours in mouse models of depression. |
By Andrea Park Fresh off reporting higher-than-expected third-quarter revenues that it attributed to a strong diagnostics division and the lasting effects of recent acquisitions, Thermo Fisher Scientific is doubling down in both areas. |
By Kevin Dunleavy China banned the import and sale of GSK’s Avodart through its national bulk-buy drug procurement program. The drug is used in combination with Boehringer Ingelheim’s Flomax for enlarged prostate. The ban begins immediately and extends through April of 2024, and was triggered by an inspection of a plant in Poznan, Poland. |
By Robert King CMS issued a final rule on Friday seeking to make it easier for beneficiaries to enroll in Medicare and to narrow any delays in the start of coverage. |
By Fraiser Kansteiner With the former leader of the company’s pharmaceutical branch now steering Fresenius overall, new CEO Michael Sen is being frank about the need for a “reset.” The move could give the German drugmaker and healthcare services outfit a shot at redemption as activist investor Elliott Management reportedly angles for a shakeup. |
By Jacqueline Renfrow GSK has launched a new television ad campaign called “Shingles is Sleeping” to promote awareness of the risks of the shingles virus. |
Fierce podcasts Don'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 8, 2022 | 12:30pm ET / 9:30am PT As a partner in the overall health ecosystem, Myriad Genetics is combining de-identified genetic data with indications, phenotypes, and outcomes to power the next generation of precision medicine advancements. Register now. 
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