| Editor's Note: Fierce Biotech will not publish on Monday due to the Juneteenth federal holiday. We'll be back in your inboxes on Tuesday, June 20. |
|
While relying solely on your nonclinical laboratory can be tempting when conducting IND-enabling studies, it’s important to provide significant input and oversight to ensure regulatory compliance. Watch our on-demand webinar to learn how to prepare so that your studies meet FDA guidelines. Premier Consulting. Built for Biotech℠. _updated+(1).png)
|
|
Today's Big NewsJun 16, 2023 |
| By Nick Paul Taylor GSK is going to have to wait a little longer to start delivering a return on its $1.9 billion cancer bet. The FDA has delayed its ruling on the blood cancer candidate momelotinib by three months to provide time to review recently submitted data. |
|
|
|
| Free Virtual Event |  |
|
|
By Nick Paul Taylor Bavarian Nordic has identified a “concern” with its investigational COVID-19 vaccine. With phase 3 data imminent, the Danish drugmaker has reported weakened immune responses against the omicron variant XBB.1.1 in a midstage study. |
By Max Bayer Coherus is doubling down on its immuno-oncology pipeline with a $65 million deal to buy Surface Oncology. |
Sponsored by YPrime Michael Hughes, Chief Product Officer at YPrime discusses the benefits and challenges of eConsent implementation and how to circumvent the biggest barriers to adoption. |
By James Waldron Nine months after dumping an Ionis-partnered hypercholesterolemia asset, AstraZeneca has teamed up with a self-described “young” Chinese biotech to work on new drugs to target the condition. |
Sponsored by Sanyou Biopharmaceuticals Co., Ltd. On June 12th, 2023 local time, Sanyou Biopharmaceuticals Co., Ltd. officially announced the launch of "Sanyou Super Trillion Common Light Chain Antibody Discovery Platform" (the "platform"). As one of the nine trillion antibody discovery platforms of Sanyou, the platform features a library capacity of up to 1.12E+12 CFU. For a single target, the platform can generate hundreds of lead antibodies with diverse sequences, which can be further designed into bispecific antibodies with good drug developability, providing a feasible solution for obtaining bispecific antibodies with structures similar to the natural monoclonal antibodies |
By James Waldron Attempting to surf in Biogen’s slipstream, Clene has pointed to data for the same biomarker that got Qalsody approved as a sign that the biotech’s own amyotrophic lateral sclerosis (ALS) drug is on the right track. |
Sponsored by The Janssen Pharmaceutical Companies of Johnson & Johnson The creation of collaborative partnerships continues to be essential to delivering transformational therapies to address critical healthcare needs. |
By Gabrielle Masson,Max Bayer After nearly 20 years away, Paul Burton, M.D., Ph.D., is set to return to Amgen. Francis deSouza cedes control of Illumina after Carl Icahn proxy battle. A new nomination to Biogen's board stirs up controversy. |
By Teresa Carey This week on "The Top Line," we discuss the the top news from this year's annual BIO meeting, plus a COVID lawsuit, an FDA-approved app and the rest of the week's headlines. |
By Ben Adams Oncologists in the U.S. see pricing as the largest hurdle for patients when it comes to accessing new cancer therapies, while many are also struggling to keep up with the pace of new cell and gene therapies. |
By Andrea Park While many wearable devices currently available to people with Parkinson’s disease focus mainly on tracking the condition, the latest iteration of Cala Health’s externally worn technology is aiming to effectively treat the tremors associated with the disease. |
By Annie Burky The former manager of a morgue at Harvard Medical School is up against federal charges for allegedly stealing, selling and shipping human body parts, federal prosecutors said on Wednesday. |
By Kevin Dunleavy An announcement early this month by Mark Cuban’s deep discount drug company that it would sell Coherus Biosciences’ biosimilar version of AbbVie’s Humira has the Illinois drugmaker calling foul. In a regulatory filing, AbbVie claims that Coherus has violated a licensing agreement, which governs the commercializing of the biosimilar. |
By Angus Liu Astellas' new CEO Naoki Okamura discussed the company's business plans. Eisai and Biogen's Leqembi won backing from the FDA's external advisers. AbbVie has brought a BTK patent infringement lawsuit against BeiGene. And more. |
Fierce podcasts Don't miss an episode |
| This week on "The Top Line," we discuss the the top news from this year's annual BIO meeting, plus a COVID lawsuit, an FDA-approved app and the rest of the week's headlines. |
|
|---|
|
|
|
July 18-19, 2023 | Jersey City, NJ This is the only communications event for peer learning and networking exclusively for the life science community. Save $300 when you Register Today! .png)
|
|
Whitepaper Autoantibody screening is promising for early cancer detection with the potential to improve the whole treatment decision tree, providing a less invasive, powerful approach. Sponsored by: Sengenics |
Whitepaper Discover key considerations that every trial sponsor should know when navigating the complex clinical supply distribution landscape across Asia-Pacific. Sponsored by: Catalent |
Whitepaper Explore how clinical supply can be scaled up as decentralized programs progress, and how technological solutions can accelerate trial deployment. Sponsored by: Catalent Clinical Supply |
Whitepaper Planning on using a CRO to support your next clinical study? This infographic outlines critical areas to address at the start of the relationship in order to ensure that budget and timelines keep on track for the duration of the trial. Sponsored by: Catalent |
eBook See how clinical trial sponsors can build stronger strategies to address challenges across the patient enrollment funnel, starting with four necessary steps. Sponsored by: OneStudyTeam |
Whitepaper This paper outlines various market archetypes and key considerations leaders must address when prioritizing new potential markets for gene therapies. Sponsored by: Blue Matter, strategic consultants in the life sciences |
Research What role do the Library and Legal teams play in the drug development pipeline at Lilly? An import one – find out how. Sponsored by: CCC |
| July 18-19, 2023 | Jersey City, NJ |
|
|
| |
|
