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Shape the Future of Life Sciences Entries for the Fierce Life Sciences Innovation Awards are coming to a close September 5th, 2024. Submit your entry & lead the charge in life sciences innovation. Enter now! 
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Today’s Big NewsAug 29, 2024 |
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September 9-12, 2024 | Philadelphia, PA Join us at Digital Pharma East, the leading event for digital innovation in the pharmaceutical industry. Dive into key topics including Digital Marketing, Data & Analytics, and Patient Engagement. Learn from industry experts, network with peers, and explore cutting-edge strategies to drive your digital initiatives forward. The clock is TICKING! Secure Your Pass! .png)
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| By Conor Hale In an email to staff, CDER Director Patrizia Cavazzoni said the council would replace its AI-related steering committee and policy working groups. |
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By Nick Paul Taylor Johnson & Johnson has taken another step toward realizing a return on its $6.5 billion nipocalimab bet, filing for FDA approval to challenge argenx and UCB for the generalized myasthenia gravis (gMG) market. |
By Zoey Becker The Inflation Reduction Act features a five-year boost in Medicare Part B reimbursement rates for biosimilars. The measure was intended to boost uptake, but has it worked so far? Drug development consultancy Certara sought to find out in its recent "Boost or Bust?" report. |
By James Waldron Repare Therapeutics is laying off a quarter of its workforce as the oncology biotech scales back its preclinical work to focus on more advanced candidates such as a synthetic lethal drug handed back by Roche earlier this year. |
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Thursday, September 12, 2024 | 10am ET / 7am PT Nitrosamines, potent carcinogens, have prompted stringent regulations for their detection and control in various products. With regulatory bodies demanding robust analytical methods and risk assessments, pharmaceutical and medical devices manufacturers must stay on top of the current regulatory landscape and compliance strategies. Register now for access to the key insights you need to know. 
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By Conor Hale Their goal is to offer a quick companion diagnostic that could be turned around while a patient is undergoing a routine exam. |
By Angus Liu The rightsizing at BioMarin continues to take its toll as CEO Alexander Hardy devises a new corporate strategy for the rare disease biotech. |
By Angus Liu A Merck & Co. effort to move its PD-1 behemoth Keytruda into early treatment of lung cancer has reached a dead end, along with another bid to expand into a type of early-stage skin cancer. |
By Andrea Park Silence Therapeutics isn’t staying mum about the need for broader awareness of the risks associated with heightened levels of lipoprotein(a), or Lp(a). A new campaign launched by the drugmaker this week aims to improve education around Lp(a) and encourage more widespread testing. |
By James Waldron Gain Therapeutics has set its sights on proving the effectiveness of its Parkinson’s therapy next year after the brain-penetrant small molecule demonstrated “peripheral target engagement” in a phase 1 trial. |
By Andrea Park The newly FDA-authorized updated vaccines for COVID-19 offer protection not only against serious illness but also, according to Moderna, against the loneliness that can come with a loved one’s infection with the virus. |
By Darren Incorvaia In 2022, on the alpine shores of Lake Maggiore in northern Italy, longtime friends Samuel Bakhoum, M.D., Ph.D., and Stefano Santaguida, Ph.D., were catching up. Pandemic restrictions had prevented the two from seeing each other for years, but, at a small conference in the lakeside town of Stresa, they seized the opportunity to share what they’d been working on recently—the collapse of micronuclei in cancer cells. |
By Andrea Park Five years and nearly 50 episodes in, the CDC Foundation has given its “Contagious Conversations” podcast a makeover. |
Fierce podcasts Don’t miss an episode |
| This week on "The Top Line," we look at the potential effects of the Chevron overturn on the biopharma industry. |
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Wednesday, September 24, 2024 |11am ET / 8am PT In this webinar, we will explore how real-world healthcare data and artificial intelligence can provide key insights into the hidden aspects of patient journeys. Register now. 
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Whitepaper Finding an effective epilepsy treatment can be arduous. Download this brochure to delve into how IQVIA's expertise and innovative strategic approach can streamline the clinical trial process, helping to get new therapies to patients who need them sooner. Sponsored by: IQVIA |
Whitepaper This paper explores the costs of setting up a supply chain in Europe for a new biopharma therapy. It outlines key cost drivers & the various levers decision makers can use to affect those costs. Sponsored by: AIM |
On Helix Date: 4 July 2024 - Location: Babraham Research Campus, Cambridge UK |
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