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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 NewsNov 3, 2022 |
| By Max Bayer With COVID vaccine uptake slated to become more seasonal, Moderna is touting new horizons to keep investors chomping. The phase 2 data from the company's personalized cancer vaccine, slated for the fourth quarter, are top of mind. |
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By Gabrielle Masson The cat’s out of the bag: Regeneron is leaving two drugs behind, including an NGF inhibitor targeting chronic pain and a cat allergy therapy. |
By Annalee Armstrong Sprinting in an “urgent race against a brutal disease,” just like patients, Sarepta has raised a $1.2 billion war chest to prepare for a launch of the Duchenne muscular dystrophy gene therapy SRP-9001, which was filed for accelerated approval with the FDA during the third quarter. |
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 GSK has halted two phase 3 trials of its uncomplicated urinary tract infection treatment early after the antibody hit its goals, teeing up the Big Pharma to submit the candidate for FDA approval next year. |
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 Annalee Armstrong Gilead and Arcus are slimming down a phase 3 TIGIT trial to compare the lung cancer combo therapy to just Merck’s Keytruda, ditching a chemotherapy arm. |
By James Waldron Biotechs announcing a strategic review has become a depressingly common sight in these straightened times, and that’s certainly the case for Rubius Therapeutics and Tricida. |
By Gabrielle Masson While few companies are willing to put their money down on "exceptionally difficult" neurological conditions like Tourette syndrome, Emalex Biosciences is now ready for the challenge thanks to a massive $250 million series D fundraising. |
By Gabrielle Masson Kura Oncology plans to sign a $25 million equity investment deal with Bristol Myers Squibb and a term loan up to $125 million from Hercules Capital—two transactions that, in combination with the biotech’s existing cash, are expected to fund current operations into 2026. |
By Max Bayer J.P. Morgan has launched a new wing of its private equity division focused on life science investments. The firm has yet to disclose its financing plans but is slated to start making bets within the first half of 2023. |
By Joseph Keenan Norstella completed its acquisition of clinical trial intelligence specialist Citeline as part of the pharma solutions group’s goal to become a global leader in end-to-end consultancy services for the industry. |
By Joseph Keenan The National Institutes of Health has awarded a five-year, $147 million grant to the Northern California Institute for Research and Education to expand diversity among participants in the Alzheimer’s Disease Neuroimaging Initiative. |
By Joseph Keenan First Wave Biopharma has inked a deal for Rho to run a phase 2 trial for the biopharma’s treatment for exocrine pancreatic insufficiency. |
By Andrea Park As Tandem dips even further into the red, it has taken a hatchet to previous sales estimates. |
By Fraiser Kansteiner ICER’s assessment found CSL’s gene therapy—up for an FDA priority review decision at the end of November—would be fairly priced at upwards of $2.9 million. BioMarin’s Roctavian, which the company resubmitted to the U.S. FDA in late September, would be acceptable at a cost of approximately $1.9 million. |
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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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 |
Whitepaper Read through this library of resources to find out how you can strengthen innovation and efficiency, improve safety and quality, and prioritize resources to support your long-term goals. Sponsored by: JLL |
Research Learn more about adaptive ascending dose escalation designs and considerations for determining the optimal approach to meet your drug development objectives Sponsored by: Allucent |
eBook In this free guide, explore how Cloud Computing is enabling emerging biopharma organizations to decrease time-to-discovery in pursuit of breakthrough treatment modalities. Sponsored by: RCH Solutions |
Whitepaper This 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 |
Video Revolutionize your monoclonal antibody (mAb) manufacturing process with the Gibco™️ Efficient-Pro™️ Medium and Feed System. Watch our how-to video. Sponsored by: Thermo Fisher Scientific |
Whitepaper What is the most suitable dosage form technology for the Oral Delivery of Lipid-Based Formulations? Sponsored by: Catalent |
Research Learn more about how the versatility of Softgel Technology helped a customer with a volatile compound. Sponsored by: Catalent |
Whitepaper How can Lipid-Based Drug Delivery System help bring poorly soluble drugs to market? Sponsored by: Catalent |
Whitepaper Learn how formulation development for a PFS affects manufacturing to drive the industry toward optimizing delivery of injectable products and, ultimately, improving patient care. Sponsored by: Catalent Biologics |
Webinar Ypsomed and Catalent Biologics experts discuss strategies for integrated PFS manufacturing and auto-injector assembly to accelerate timelines and more in this webinar. Sponsored by: Catalent Biologics |
Whitepaper Clarus Therapeutics (Clarus) is a men’s specialty pharmaceutical company that partnered with Catalent to develop a unique and convenient drug delivery form for their hormone replacement therapy. Sponsored by: Catalent |
Whitepaper Learn more about how the transition from early to late phase of a small molecule program plays a pivotal role in a program’s ultimate success. Sponsored by: Catalent |
eBook Orally Inhaled & Nasal Drug Delivery: A Pipeline of Opportunities Sponsored By: Catalent |
Whitepaper Did you know Catalent has newly expanded in-house capabilities spanning clinical and commercial scale manufacturing for DPIs, unit-dose, bi-dose and preserved multi-dose nasal sprays? Sponsored By: Catalent |
Whitepaper What are key considerations for intranasal delivery in the treatment of acute and chronic conditions? Sponsored By: Catalent |
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