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In 505(b)(2) development, programs are often derailed when sponsors lack experience with the specific processes and requirements of the approval pathway. These mistakes can lead to unnecessary trials being conducted, clinical holds, or the needless discontinuation of development. Download our guide to learn how to rectify past missteps and avoid future ones in 505(b)(2) product development. Premier Consulting. Built for Biotech℠.
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Today's Big NewsJan 18, 2023 |
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Tuesday, January 24, 2023 | 11am ET / 8am PT Your CRO is a finalist in a project bid and clinical supplies are one of the aspects that you will manage on behalf of the client via a partner. Register now.
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| By Max Bayer J&J is packing up a global phase 3 trial of its HIV vaccine after failing to prevent infections compared to placebo. The news comes a year and a half after a different regimen of the vaccine failed a separate phase 2 trial in Africa. |
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By Gabrielle Masson After a brutal year of biotechs slashing programs and culling staff, the hottest topic at last week’s J.P. Morgan Healthcare conference was whether the frosty market is likely to thaw in 2023. But while some companies are counting every dollar, Fierce Biotech caught up with two CEOs about riding the rocky market waves and why they think their biotech is well positioned for the next few years. |
By Max Bayer A top-line readout from COVID-19 vaccine maker Moderna for a respiratory syncytial virus vaccine seems to keep pace with leading competitors GSK and Pfizer as the three gear up for what is expected to be a very tight commercial market. |
Sponsored by Evidation Health Traditional real-world data isn’t truly from the real world – it’s from the clinical world, and it’s missing a big part of neuro patients’ stories. |
By Nick Paul Taylor Horizon Therapeutics has chalked up another win for its CD40 drug candidate dazodalibep, linking the molecule to improved outcomes in a second Sjögren’s syndrome study before it sells up to Amgen in a $28 billion deal. |
By James Waldron Irlab’s shares have cratered after the Swedish biotech reported that its Ipsen-partnered Parkinson’s therapy mesdopetam failed to reduce involuntary body movements in a phase 2b trial. |
By Nick Paul Taylor The wave of pipeline prioritization initiatives implemented last year has shown up in the data, with Phesi tracking a jump in terminations of phase 2 clinical trials and a fall in activity in certain major therapeutic areas. |
By Helen Floersh Experiments in mice, primates and human cells showed that Tessera's technology could edit and engineer genes to restore enzyme function, produce healthy hemoglobin and create CAR T cells. For their next trick, they'll do it all without ever removing cells from the body. |
By Angus Liu With a recent acquisition, Ipsen joined a growing list of drugmakers doubling down in rare diseases. Despite increasing Big Pharma investments in the area, Ipsen CEO David Loew believes his company can hold its own as a midsize player. But there's one field he doesn't want to enter just yet. |
By Andrea Park In interviews with Fierce Medtech during the J.P. Morgan Healthcare Conference in San Francisco last week, leaders from several medtech companies shared the industry trends they’re keeping an eye on in 2023 and beyond. |
By Jacqueline Renfrow Safe Pharmacy has released its first PSA aimed at counterfeit medication. |
By Robert King CMS leadership held a roundtable with providers Tuesday aimed at getting feedback on proposed reforms to prior authorization, including new measures to adopt electronic processes. |
By Conor Hale After collaborating with the developer of artificial intelligence-powered medical imaging programs for just over two years, Bayer has sealed the deal to acquire Blackford Analysis. |
Fierce podcastsDon't miss an episode |
| This week on “The Top Line,” we discuss the biotech industry’s rotten tomatoes. Plus, we cover the drug approvals of last year, a congressional report on Biogen's "inappropriate" communications with the FDA and other top headlines from this week. |
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Tuesday, January 31, 2023 | 11:00am ET This Webinar will highlight the comprehensive set of tools that Aldevron developed to support advancing mRNA projects to clinic. In addition, an overview of the technology transfer program, analytical and process characterization, release, and stability will be discussed with an insight into Aldevron’s integrated CMC capabilities ranging from transcript design and product profile definition through encapsulation and fill/finish. Register now.
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| 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 |
| Executive Summary Readers will learn manufacturing by Design Builds on Quality by Design, De-risking the Tech Transfer Process, and more. Sponsored by: Catalent |
| WhitepaperHow can Lipid-Based Drug Delivery System help bring poorly soluble drugs to market? Sponsored by: Catalent |
| 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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