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Successful drug development requires a deep understanding of the disease of interest. In rare diseases, however, much of the information may be unknown. Patient populations are small and historical data are collected inconsistently. Patient registries and natural history studies are valuable sources of rare disease information for sponsors seeking to design reliable clinical trials - read our blog to explore their distinctions.
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Today's Big NewsJan 30, 2023 |
| By James Waldron,Annalee Armstrong,Nick Paul Taylor After a slow 2022, will we see a return to form for biopharma M&A? And, if so, which biotechs does Big Pharma have in its sight? Here are our predictions. |
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By Max Bayer The regulatory sprint toward the first FDA-approved RSV vaccine in older adults continues apace, with Moderna tacking breakthrough designation onto its candidate. The MRNA company's announcement follows competitive phase 3 data released earlier this month, rivaling similar readouts from GSK and Pfizer. |
By Max Bayer Goldfinch Bio, a 2020 Fierce Biotech Fierce 15 winner, is closing its doors after seven years. Federal records show that both of the company's ongoing clinical trials have wrapped up. |
By James Waldron If we’re looking for green shoots in 2023, then the steady trickle of IPOs in recent weeks is a good place to start. Mineralys Therapeutics announced an $100 million IPO earlier in the month, and now Structure Therapeutics has put the finishing touches to its own nine figure Nasdaq offering. |
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April 3 - 4, 2023 | San Diego, CA Connect with leading communications professionals and have honest, open discussions about how to develop your career in the industry. Early Bird Rate Ends February 10th.
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By Gabrielle Masson Though medicines designed to treat psychiatric conditions have a lower chance of succeeding in drug development than other disease areas, biopharma’s pipeline currently boasts at least 163 medicines targeting mental illness. |
By Nick Paul Taylor Weeks after annoying analysts with a “half-baked” data drop, CureVac is back with more clinical trial results on its GSK-partnered mRNA vaccines against influenza and COVID-19. The update fills a key hole in the earlier release by providing an early look at how the vaccines perform in older adults. |
By Helen Floersh Scientists found that melanoma cells can grow or shrink in response to therapy, paving the way for treatments that target them based on size. |
By Gabrielle Masson,Max Bayer,Annalee Armstrong Alongside the new year, we've launched a new Fierce Biotech Fundraising Tracker to keep the pulse on the industry's financing. |
By Helen Floersh A new study illuminates how low levels of the amino acid serine can lead to neuropathy in mouse models of Type 2 diabetes. |
By Fraiser Kansteiner Amgen is cutting around 300 jobs in the U.S.—mainly along commercial lines—a company spokesperson said in an email confirming “recently announced organizational changes.” |
By Conor Hale Researchers at King’s College London have found that a blood test can help predict a person’s risks of Alzheimer’s disease years before a clinical diagnosis, by evaluating the body’s ability to form new brain cells. |
By Paige Minemyer Cigna has filed a lawsuit against CVS Health and Amy Bricker, a former executive, to prevent her from taking a job with the rival company. |
By Andrea Park Another 6,000 jobs are on the chopping block at Philips as the devicemaker continues to grapple with the negative impacts of a still-suffocated supply chain, the ongoing recall of 5.5 million of its respiratory devices and a handful of other global issues. |
By Eric Sagonowsky,Kevin Dunleavy,Fraiser Kansteiner,Angus Liu,Zoey Becker Heading into 2022, top drugmakers had $1.7 trillion in dealmaking firepower, fueling expectations among analysts that the industry was due for a gangbusters M&A year. Well, that didn’t quite pan out. |
Fierce podcastsDon't miss an episode |
| This week on "The Top Line," we hear from Stacie Dusetzina, Ph.D., a professor at Vanderbilt University's Department of Health Policy, about what the IRA means for the pharma industry. We'll also discuss what we can expect from the biotech industry in 2023. |
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May 1 - 3, 2023 | Jersey City, NJ Connect on current challenges and opportunities found within your medical affairs role to become better equipped in developing a unified scientific voice. Take advantage of the Early Bird Rates, Register Today!
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WhitepaperExploring the biology of G Protein-Coupled Receptors (GPCRs) and outlining a novel approach for developing therapeutics against previously undruggable GPCRs Sponsored by: Orion Biotechnology |
WhitepaperLearn more about critical success factors for your next launch based on the experience of 100+ pharma product launches. Sponsored by: Herspiegel Consulting |
WhitepaperRCTs with digital twins require fewer control patients and shorten trial timelines for Alzheimer's disease. Sponsored by: Unlearn AI |
Whitepaper What makes nucleotides suitable for current good manufacturing practices? Sponsored by: Thermo Fisher Scientific |
WhitepaperThis paper explores how Medical Affairs is adapting medical communications to meet the demands of a new environment (part 5 in a series). Sponsored by: Blue Matter, strategic consultants in the life sciences |
On-Demand Webinar See how high-throughput DNA synthesis combined with antibody engineering expertise provides end-to-end antibody discovery solutions. Sponsored by: Twist Bioscience |
Whitepaper Download this paper to learn considerations on how to move a biologic through clinical trials faster, advantages of Parallel Processing, and more. Sponsored by: Catalent |
WhitepaperWhat are key considerations for intranasal delivery in the treatment of acute and chronic conditions? Sponsored By: Catalent |
WhitepaperLearn how Catalent’s extensive network across APAC can meet a wide range of clinical supply needs for sponsors conducting trials within the region. Sponsored by: Catalent |
WhitepaperExplore Catalent’s newest clinical supply facility in Japan, including the comprehensive services & solutions it offers to help support trials both in-country & around the world. Sponsored by: Catalent |
Case Study Learn more on an approach for process characterization for the production of a monoclonal antibody, which will improve the efficiency and effectiveness of the process by targeting the right design and number of experiments. Sponsored by: Catalent |
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