| Today's Big NewsJan 5, 2023 |
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The National Biotechnology and Biomanufacturing Initiative, which channels more than $2 billion to America’s biotech sector, will have far-reaching implications not only for the domestic biotech space but industries at large, including life sciences. Where are the salient opportunities? What are the gravest risks? Read this in-depth white paper from Randstad for answers. 
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| By Annalee Armstrong Deaths in a clinical trial for Eisai’s Alzheimer’s drug lecanemab are once again being flagged, this time in a New England Journal of Medicine entry that highlights a potential risk for patients undergoing a certain type of emergency stroke treatment. |
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By Annalee Armstrong A day after buzzing Hummingbird Bioscience for an antibody-drug conjugate licensing pact, Synaffix is back with a substantially similar, yet bigger deal. The Singapore and U.S.-headquartered biotech will work with Amgen in a pact valued at up to $2 billion. |
By James Waldron In the wake of a bruising FDA rejection for its rare pediatric cancer drug, Y-mAbs Therapeutics has followed the increasingly common biotech trend of laying off staff and trimming back its remaining pipeline. |
By Nick Paul Taylor Takeda has pressed go on plans to seek approval for its enzyme replacement therapy in an ultra-rare disease. Citing the “totality of the evidence” seen in phase 3, the Japanese drugmaker outlined its intent to head to regulators armed with data on the ADAMTS13 replacement therapy it acquired from Shire. |
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Download this whitepaper for guidance on how to Scale your Direct-to-Consumer Microbiome Testing Company and when it makes sense to outsource microbiome sequencing to a third-party provider. 
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By Nick Paul Taylor GSK is stepping up its interest in T-cell engaging antibodies, handing WuXi Biologics $40 million upfront for an exclusive license to one preclinical bispecific and options on three additional candidates. |
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 Max Bayer Moderna is eyeing a bronze medal in the RSV race behind Pfizer and GSK with plans to readout a phase 3 trial in the first quarter. And while CEO Stéphane Bancel is bullish on his shot's competitiveness, he believes a combo vaccine will likely be where the company stands out. |
By James Waldron Renibus Therapeutics’ lead candidate for patients undergoing cardiac surgery has sailed through a phase 2 trial, setting up the Texan biotech for a late-stage study in the coming months as it also unveiled a double-dose of CEOs. |
By Annalee Armstrong Roche is making sure its peptide discovery spinout Nimble Therapeutics stays close with a revision of the companies’ development partnership valued at up to $1.1 billion. |
By Helen Floersh The new benchmark for oncology clinical trial diversity from the nonprofit behind the Good Pharma Scorecard gave one company a perfect score, but most others have work to do. |
By Conor Hale To those who've always wanted to digitally monitor their bathroom health at home: you're in luck. |
By Joseph Keenan CRO giant IQVIA has signed on to conduct the first clinical trial of Biostage’s lab-grown esophageal implant. |
By Kevin Dunleavy A federal appeals court has upheld a previous ruling that Pfizer’s Hospira did not infringe on patents in developing its generic version of Astellas' Lexiscan. The only option left for the Japanese company is an appeal with the U.S. Supreme Court. |
By Joseph Keenan Poland-based Neuca Group, the parent company of CRO Clinscience, has taken a majority stake in Florida-based OncoBay to expand its reach in the U.S. |
By Dave Muoio Shorter stays and modest labor relief helped contain costs, though hospitals' median margins still remain red for the year, per Kaufman Hall. The firm advised struggling hospitals to turn their eyes to outpatient services, which have enjoyed consistent revenue growth since last year and pre-pandemic. |
Fierce podcasts Don't miss an episode |
| In this week's episode of "Podnosis," we talk about how telehealth exacerbates health inequities. We also discuss the impact of anti-trans legislation on healthcare and what providers can do to break down barriers to care for gender-diverse populations. |
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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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Whitepaper This 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 |
Whitepaper How 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 |
Whitepaper What are key considerations for intranasal delivery in the treatment of acute and chronic conditions? 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 |
Whitepaper Learn 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 |
Whitepaper Explore 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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