| Today's Big NewsNov 18, 2022 |
| By Andrea Park Elizabeth Holmes, founder of the once high-flying blood-testing startup Theranos, was sentenced to 11.25 years in prison Friday after being convicted of fraud. |
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By Kevin Dunleavy The FDA has approved Provention Bio’s Tzield to delay the progression of type 1 diabetes. It will be available to patients age 8 and older who are in stage 2 of the disorder. With the approval, Tzield becomes the first drug approved to delay the onset of type 1 diabetes. |
By Angus Liu The FDA's oncology department, under the leadership of Richard Pazdur, M.D., has started putting an emphasis on timely confirmatory trials as a condition for accelerated approvals. But that's not a one-size-fits-all piece of guidance, Pazdur said in an interview with Fierce Biotech. |
By Frank Diamond Reinfection with SARS-CoV-2 significantly increases death and hospitalization rates, according to a recent study. |
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Tuesday, December 6, 2022 | 12pm ET/9am PT Biopharma customers are now demanding that the vendor industry work collaboratively to connect their scientific workflows. This webinar will provide valuable insights for biopharmaceutical scientists, lab directors, IT professionals, and life science vendors. Register now.
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By Max Bayer Lysogene funds are dwindling as the company reported disappointing phase 2/3 data of its lead gene therapy. The therapy was found to be clinically significant in the youngest patients but not among the majority of trial participants. |
By Andrea Park Sema4 will shut down its reproductive health testing and services division by early next year, eliminating about a third of its workforce in the process. The company joins a handful of other developers that have slimmed down rosters amid less-than-stellar third-quarter earnings reports. |
By Angus Liu After some investor clamor, Apellis Pharmaceuticals’ blockbuster hopeful eye drug pegcetacoplan is back on the FDA’s review track. |
By James Waldron While it looks like Novavax has been late to the party when it comes to gaining COVID market share, the company's executives told Fierce Biotech that they’re playing the long game. |
By Dave Muoio A new survey of more than 9,500 international primary care physicians highlights unmet mental health needs and a looming clinician shortage should the U.S. fail to take action. |
By Angus Liu Existing cancer companion diagnostics are bundled with the specific cancer drugs they’re approved for. But the FDA is looking to get around this one-drug-one-test situation by looking at “minimal performance criteria” of tests, FDA oncology chief Richard Pazdur, M.D., said. |
By Fraiser Kansteiner The FDA has blessed Eli Lilly’s approved insulin biosimilar Rezvoglar with an interchangeability tag, which means the product can be swapped out for its brand-name counterpart right at the pharmacy counter. The nod comes as insulin costs garner public, political and even pharma industry scrutiny. |
By Dave Muoio "Bad actors" are the minority, PE leaders said this week at HLTH 2022, touting a focus on responsible growth and increasing emphasis on ESG goals. |
By Nick Paul Taylor Inovio’s Lassa fever and Middle East respiratory syndrome vaccine candidates have fallen short of the bar set by the biotech’s partner, prompting the collaborators to pull the plug on the programs after getting a look at clinical data. |
Fierce podcastsDon't miss an episode |
| This week on “The Top Line,” we share this week's headlines and discuss the 2022 honorees in our annual Fiercest Women in Life Sciences report. |
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Tuesday, November 29, 2022 | 2pm ET / 11am PT Process development of RNA-LNPs can be time consuming, cost prohibitive and require deep expertise in a field that is very dynamic and accelerating fast. Outsourcing gives you direct access to infrastructure, experience, and a team who has done this before and can quickly generate meaningful data taking the guesswork out of process development. Register now.
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| WhitepaperLearn how to develop a high-performing supply chain for GMP-manufactured chemicals used throughout your biologics workflow. Download the free whitepaper from Thermo Fisher Scientific. Sponsored by: Thermo Fisher Scientific |
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| Webinar Twist Bioscience CSO Dr. Aaron Sato shares how Twist's tools for antibody discovery have been applied to identify antibodies against diverse and challenging targets. See how high-throughput DNA synthesis combined with antibody engineering expertise provides end-to-end antibody discovery solutions. Presented by: Twist Bioscience |
| WhitepaperThis paper outlines how gene therapy supply chains are different from traditional biopharma products, as well as the factors that are essential to success. Sponsored by: Blue Matter |
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