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While typically required for a product’s marketing approval, in some situations conducting a randomized controlled trial is unethical or impractical. Often in these scenarios, the solution is to use an in silico method to construct a virtual patient control arm. Download our guide to learn how in silico approaches can be used to evaluate drug candidates before clinical trials or in single-arm clinical trials.
Premier Consulting. Built for Biotech℠ 
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Today's Big NewsFeb 16, 2023 |
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Learnings from three IQVIA case studies. Accelerate your trials with these strategies: contract execution to go-live in 3 months, 50% timeline reduction in study build and 95% patient compliance. On-Demand Now. 
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| By Max Bayer GSK's head of vaccine R&D, Phil Dormitzer, is confident that the company has posted pack-leading data for its RSV vaccine, as it nears the finish line of the regulatory race. But he wouldn't commit to restarting trials testing the shot in maternal women after a phase 3 study was halted a year ago. |
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By Max Bayer Hours after Arrowhead Pharmaceuticals revealed that Johnson & Johnson is returning a clinical-stage NASH asset “out of the blue," CEO Chris Anzalone says that the entire $3.7 billion collaboration between the two is done. |
By Angus Liu Prostate cancer is giving Merck & Co.’s seemingly unstoppable Keytruda a hard time. But even after three pivotal trial flops in less than a year, clinical development lead Scot Ebbinghaus still thinks Merck made the right decision to go aggressive on its phase 3 program back in 2019. |
By Gabrielle Masson A biotech led by a 20-year Alnylam vet has emerged with $193 million in hand and hopes of unlocking genetic medicine’s fullest potential. |
By Annalee Armstrong Four months after getting a phase 3 kidney transplant trial back on track, Talaris Therapeutics is stopping the momentum again—this time permanently—as part of a strategic review that has claimed a third of the biotech's workforce. |
By Nick Paul Taylor Newron Pharmaceuticals has reported deepening responses to its add-on schizophrenia therapy out to one year, triggering a further stock boost as investors reassessed the likelihood of evenamide becoming the first approval in treatment-resistant disease since 1989. |
By James Waldron In the year and a half since Erytech Pharma was blindsided by a phase 3 fail that forced a pivot from pancreatic cancer to leukemia, the company has been feeling out strategic options. Now, fellow French biotech Pherecydes has spotted an opportunity to take advantage of Erytech’s money, expertise and U.S. footprint via a merger. |
By Annalee Armstrong Theratechnologies has formed a science advisory committee to try and come up with ways to overcome an imbalance between adverse events and efficacy seen in early results from a phase 1 solid tumor trial of the Canadian biotech’s lead asset. |
By Nick Paul Taylor Merck KGaA is betting 10 million euros ($10.7 million) that Aqilion has the keys to a tough target. The Big Pharma is handing over that sum, and committing 950 million euros in milestones, for preclinical inhibitors of TAK1 that have applications in a range of autoimmune and inflammatory diseases. |
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 Eric Sagonowsky Facing tens of thousands of lawsuits over cancer risks on the popular heartburn drug Zantac, GSK has argued there's "no consistent or reliable evidence" that the medicine causes any cancer. But a new report in Bloomberg Businessweek says GSK's own scientists have long known about the risks. |
By Frank Diamond Paxlovid remains one of the medications being prescribed for individuals suffering from COVID-19. Researchers collected data as the omicron variant rose. |
By Andrea Park GE HealthCare has begun a recall of several models of its nuclear medicine imaging systems that were found to be at risk of collapsing while in use, potentially crushing or trapping a patient underneath. |
By Kevin Dunleavy Ten years after last serving as CEO at Bausch + Lomb, Brent Saunders is back at his former post. But this is not your typical meet-the-new-boss-same-as-the-old-boss story. On Wednesday, when Bausch + Lomb revealed that Saunders would succeed Joe Papa as the company’s CEO effective on March 6, it reunited a company and a wheeling-dealing executive who has been through a lot over the last decade. |
By Nick Paul Taylor Pfizer has enlisted yet another celebrity to push its flagging COVID-19 vaccine franchise. After targeting seniors with its Martha Stewart wields a samurai sword spot, the Big Pharma has swung to the opposite end of the age spectrum with an ad featuring a singer who first made their name on YouTube. |
Fierce podcasts Don't miss an episode |
| This week on "The Top Line," we discuss which companies made the list of the top 10 pharma M&A deals of 2022 and what was at stake last year. We also talk about what last year's biggest deal means for M&A activity this year. |
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Whitepaper For 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 |
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Whitepaper How 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 |
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 |
Whitepaper Planning 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 |
| May 1-3, 2023 | Jersey City, NJ |
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