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We explain what types of agency meetings can be sought in the EU, US, Japan, China, and Canada, and provide details to guide requesting and preparing for agency interactions. Learn more. 
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Today’s Big NewsAug 11, 2023 |
| By Nick Paul Taylor The dream of using anti-CD47 drugs to boost chemotherapy in blood cancer patients is unraveling fast. Weeks after Gilead Sciences stopped its phase 3 trial for futility, ALX Oncology has called a halt to a pair of studies for a rival therapy. |
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By Nick Paul Taylor Atreca is taking drastic action to keep the show on the road into next year. With its cash running low and share price in the basement, the biotech has decided to stop work on its lead candidate, switch its focus to preclinical antibody-drug conjugates and lay off 40% of its staff. |
By Max Bayer,Gabrielle Masson A topsy turvy year for Mirati has taken its latest turn, with CEO David Meek stepping down this week effective immediately. |
By Fraiser Kansteiner Less than a month after the family of Henrietta Lacks reached a settlement with Thermo Fisher over its use of Lacks’ cells, another drugmaker stands accused of profiting from a racist medical system. |
By Andrea Park Not to be outdone by the FDA, regulators in Europe have given the all-clear to a new indication for Theranica’s neuromodulation armband for migraine treatment. |
By Fraiser Kansteiner Frank Han, Pfizer's former director of global compliance analytics, has filed a civil complaint against the drugmaker. Han claims he was terminated for identifying potential issues relating to the Foreign Corrupt Practices Act. |
By Dave Muoio Over half of health system pharmacists say they've been at least moderately impacted by drug shortages, and nearly all say they've had to get creative with dispensing and purchasing. |
By Noah Tong A report from AARP broke down how popular brand-name drugs have continued to rise in price and exceed inflation. |
By Teresa Carey This week on "The Top Line," we discuss left-handedness and its significance in neurodevelopmental and psychiatric disorder research. |
By Angus Liu Astellas has won an FDA nod for a geographic atrophy therapy from its acquisition of Iveric Bio. A Fierce Biotech report examined Singapore's search for its big biotech success story. AstraZeneca signed an mRNA vaccine manufacturing deal with China's CanSino Biologics. And more. |
Fierce podcasts Don’t miss an episode |
| This week on "The Top Line," we discuss left-handedness and its significance in neurodevelopmental and psychiatric disorder research. |
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