| Today's Big NewsMar 10, 2023 |
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Production of these particles, which can protect and deliver medicines and vaccines where they need to go in the body, is increasing. Learn more about how collaborating with a CDMO could be invaluable in developing nano-based systems. Learn more.
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| By Annalee Armstrong,Max Bayer,Gabrielle Masson Silicon Valley Bank’s capital raise of $2 billion has sent shockwaves across the biotech industry and spurred a panic among some top venture capital firms that are urging their companies to withdraw deposits. |
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By Nick Paul Taylor Olema Oncology is betting the farm on its oral selective estrogen receptor degrader. After a year in which rivals dropped out of the race, the biotech reaffirmed its faith in the mechanism by narrowing its focus on a phase 3 breast cancer program—and put 25% of its people out of work in the process. |
By Nick Paul Taylor Vyne Therapeutics is putting its mash-up of Pfizer’s Xeljanz and Novartis’ Gilenya on the back burner. After sifting through the data from a failed midphase eczema trial, the biotech has begun searching for a partner for the program to free up its own cash for development of its BET inhibitors. |
Sponsored by Syneos Health This story centers on the benefits of implementing a full service commercial model to improve launch success for customers who lack the necessary infrastructure. Watch how Syneos Health expertise in Medical Affairs acted as a bridge to forge this full service commercial partnership, which helped meet critical deadlines for patients. |
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Thursday, March 23, 2023 | 10am ET / 7am PT In this webinar, we will discuss customer-centric digital innovations that are improving overall process, product quality and performance, as well as transforming CDMO relationships. Register now to learn more!
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By James Waldron Applied Molecular Transport has already sacrificed a lot to keep its chronic pouchitis treatment on track—including 40% of its staff and early-stage pipeline activities. But despite shedding the extra weight, the company is still searching for a partner to finally get the candidate into phase 3 trials. |
By Helen Floersh A new study suggests that hormone fluctuations don’t affect the behavior of female mice to the degree that it could influence study results—and that, in fact, they may be more stable than their male counterparts. |
By Kevin Dunleavy The key prize in Pfizer’s $11.6 billion acquisition of Biohaven Pharmaceuticals was blockbuster-to-be migraine pill Nurtec OTC. Now, five months after competing the purchase, Pfizer has taken a nasal spray version of the treatment across the FDA finish line. On Friday, the regulator signed off on Zavzpret (zavegepant) for both the treatment and prevention of migraine headaches in adults. |
By Andrea Park Laura Perryman, the former CEO of neurostimulation device maker Stimwave, was arrested in Florida on Thursday after being accused of running a yearslong scheme to defraud insurers. |
By Angus Liu Merck & Co. refuses to give Bristol Myers Squibb the comfort of an immunotherapy monopoly in a rare type of lung cancer. Merck's Keytruda has data that could allow it to go after BMS' Opdivo and Yervoy in mesothelioma. |
By Eric Sagonowsky Novartis may be in the process of spinning out its generics and biosimilar outfit, Sandoz, but that doesn't mean the latter company is pausing manufacturing investments. The generics and biosimilar player revealed plans for a $400 million plant in Slovenia. |
By Teresa Carey This week on "The Top Line," we take on AI and machine learning in the pharma and healthcare universe. The expectation is that these tools will speed up innovation and open up new markets, helping the sector stay ahead of the curve. Plus, this week's headlines. |
By Angus Liu The FDA has set a decision date for Eisai and Biogen's Leqembi. AstraZeneca and Daiichi Sankyo's Enhertu may be nearing a tumor-agnostic indication. A Cipla manufacturing facility received a 23-page Form 483. And more. |
By Gabrielle Masson,Max Bayer Less than a month after longtime Biogen chairman Stelios Papadopoulos, Ph.D., announced his planned retirement, the company has found a successor, naming Caroline Dorsa for the job. |
Fierce podcastsDon't miss an episode |
| | This week on "The Top Line," we take on AI and machine learning in the pharma and healthcare universe. The expectation is that these tools will speed up innovation and open up new markets, helping the sector stay ahead of the curve. Plus, this week's headlines. |
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May 1-3, 2023 | Jersey City, NJ
Examine how the current changes to field medical will affect the role moving forward. Last chance to save on Early Bird Rates, Register Today!
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| Executive SummaryRead about the latest survey results from over 200 biopharma executives and the changing approaches to building biologic drug development pipelines. Sponsored by: Twist Bioscience |
| WhitepaperHave you had your questions about mRNA/saRNA manufacturing unanswered during a webinar; have no fear, we have you covered here. Sponsored by: Aldevron |
| ResearchLike many top 10 and global pharma companies, an H1 client needed to diversify both its patient outreach and site investigator profiles for upcoming trials. Sponsored by: H1 |
| Whitepaper Discover the Power of Small with NanoplasmidTM – the next-generation plasmid for manufacturing today’s cell and gene therapies. Sponsored by: Aldevron |
| WhitepaperLearn more about critical success factors for your next launch based on the experience of 100+ pharma product launches. Sponsored by: Herspiegel Consulting |
| 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 |
| WhitepaperWhat are key considerations for intranasal delivery in the treatment of acute and chronic conditions? Sponsored By: Catalent |
| Research Learn more on Catalent’s step-wise approach for the definition and execution of Process Characterization for the production of a monoclonal antibody for late phase process characterization and development. Sponsored by: Catalent |
| WhitepaperExplore 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 As sponsors increasingly look to CROs to support their clinical studies, making and addressing certain clinical supply considerations at the outset of the relationship can reduce the risk of potentially unforeseen impact to budget and time later. Discover key issues sponsors should consider to help their CRO or partner of choice better understand their clinical supply needs. Sponsored by: Catalent |
| WhitepaperFor sponsors, cost is a key concern when it comes to managing the supply of their clinical trials. A financial project analyst (FPA) is a specialized expert who can help control clinical supply costs and keep the project within budget. Explore the critical role that a Financial Project Analyst plays in clinical trial supply and budget management. 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 |
| WhitepaperDiscover key considerations that every trial sponsor should know when navigating the complex clinical supply distribution landscape across Asia-Pacific. Sponsored by: Catalent |
| WhitepaperHow can specialized expertise help you optimize your clinical supply chain? Learn about the roles and responsibilities of unique experts such as clinical supply management, project management, and financial project analysis. Sponsored by: Catalent Clinical Supply |
| Research 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 |
| 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 |
| WhitepaperPlanning 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 |
| 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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