| 08.14.24 | FDA looked past missing side effect reports to approve Amgen's Imdelltra; Layoffs hit Galera, Grail, Viracta

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TODAY’S BIG NEWS Aug 14, 2024 To approve Amgen's lung cancer med Imdelltra, FDA saw past 'large number' of missing adverse events - Gone are the days of Galera: Biotech says goodbye to staffers and initiates wind down - Metagenomi axes ALS program after seeing Biogen and Ionis flounder - With FDA approval of Livdelzi, Gilead launches an inflammatory drug for the first time - Flying solo, Grail will cut 30% of staff and narrow its R&D, commercial focus - Bluebird stock plummets 18% with slow uptake of sickle cell disease gene therapy Lyfgenia A message from UBC+SymetryML WEBINAR: TRANSFORMATIVE EVIDENCE GENERATION SOLUTIONS LEVERAGING FEDERATED AI Tuesday, August 27, 2024 | 12pm ET / 9am PT Join us for a one-hour, comprehensive discussion on the importance of leveraging federated AI for innovative data collection in real-world research. Register now. FEATURED TO APPROVE AMGEN'S LUNG CANCER MED IMDELLTRA, FDA SAW PAST 'LARGE NUMBER' OF MISSING ADVERSE EVENTS By Angus Liu In granting an accelerated approval to Amgen's first-in-class DLL3 bispecific Imdelltra, the FDA had to work through a “large number” of missing adverse events from a pivotal trial. TOP STORIES GONE ARE THE DAYS OF GALERA: BIOTECH SAYS GOODBYE TO STAFFERS AND INITIATES WIND-DOWN By Gabrielle Masson Galera Therapeutics is shuttering, with the biotech’s board OK'ing a liquidation plan that whittles down the company’s workforce to just three people. METAGENOMI AXES ALS PROGRAM AFTER SEEING BIOGEN AND IONIS FLOUNDER By Nick Paul Taylor Metagenomi is editing its pipeline, choosing to seek a partner for a program Moderna dropped and axing its amyotrophic lateral sclerosis activities in response to setbacks at a competitor. WITH FDA APPROVAL OF LIVDELZI, GILEAD LAUNCHES AN INFLAMMATORY DRUG FOR THE FIRST TIME By Kevin Dunleavy The FDA has approved Gilead's primary biliary cholangitis treatment Livdelzi. The drug, which was acquired in a $4.3 billion buyout of CymaBay Therapeutics six months ago, is the first inflammatory treatment launched by Gilead. A message from Digital Pharma East DIGITAL PHARMA EAST 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. Last Chance – one month left! FLYING SOLO, GRAIL WILL CUT 30% OF STAFF AND NARROW ITS R&D, COMMERCIAL FOCUS By Conor Hale The first cut is the deepest: On its inaugural earnings call as a publicly traded company, Grail said it would reduce staff as much as 30% to focus solely on obtaining regulatory and reimbursement green lights for its Galleri multi-cancer early detection test. BLUEBIRD STOCK PLUMMETS 18% WITH SLOW UPTAKE OF SICKLE CELL DISEASE GENE THERAPY LYFGENIA By Kevin Dunleavy Bluebird Bio is making progress on the launch of its three approved gene therapies but appears to be trailing Vertex in competition to attract patients to their respective treatments for sickle cell disease. EVOTEC EYES 400 LAYOFFS, CITING 'CHALLENGING MARKET' By James Waldron Evotec has set its sights on scrapping about 400 roles as the German company continues to battle tough market conditions. VIRACTA LAYS OFF 23% OF STAFF, PAUSES PROGRAM TO SLIM DOWN FOR RACE TO FINISH LINE IN LYMPHOMA By Nick Paul Taylor Viracta Therapeutics is going all-in on its lymphoma program. The biotech responded to phase 2 data by throwing its resources behind a plan to file for a blood cancer approval in 2026, hitting pause on its solid tumor program and putting 23% of its staff out of a job in the process. J&J AND ROCHE ARE THE STRONGEST COMPANIES IN THE BIOPHARMA INDUSTRY, SAYS S&P GLOBAL By Kevin Dunleavy Johnson & Johnson and Roche are at the top of S&P Global’s pharmaceutical industry power ratings, which assess the strength of the world’s top 17 drugmakers. DENALI REPORTS NEW METHOD TO GET ANTISENSE OLIGONUCLEOTIDES ACROSS BLOOD-BRAIN BARRIER By Darren Incorvaia Antisense oligonucleotides, which bind to RNA and prevent them from being translated into proteins, have gained popularity in recent years as a way to treat neurodegenerative diseases. However, getting these drugs into the brain has been challenging, requiring invasive infusion directly into the cerebrospinal fluid. ACADIA GETS IN ON THE 'DEADPOOL' HYPE WITH PARKINSON’S CAMPAIGN STARRING RYAN REYNOLDS By Andrea Park The “Merc With a Mouth” is using his voice for good. Amid a whirlwind global press tour for “Deadpool & Wolverine,” Ryan Reynolds has stepped out of the spandex suit to join forces with Acadia Pharmaceuticals to raise awareness about lesser-known symptoms of Parkinson’s disease. MODERNA UNVEILS FREE COURSERA CURRICULUM ON MRNA MEDICINES TO BOOST STEM SKILLS By Andrea Park With analysts estimating that millions of jobs in the STEM fields are currently going unfilled in the U.S., Moderna is doing its part to strengthen the workforce and close that gap. CDMOS MUST LOOK TO LEADERSHIP DIVERSITY, RETENTION AND SPECIALIZED SKILLS TO STAY ON TOP: REPORT By Fraiser Kansteiner Facing a unique set of challenges and staring down multiple new technologies and modalities, CDMOs must work to recalibrate their leadership requirements if they hope to stay on the cutting edge, executive search advisory firm WittKieffer said in a new report. Fierce podcasts DON’T MISS AN EPISODE WHAT THE DATA SAYS ABOUT THE TELEHEALTH MARKET In this week's episode of "Podnosis," we’re discussing the challenges and opportunities for telehealth, given some notable setbacks for the industry in recent months. A CLOSER LOOK AT FIERCE BIOTECH'S FIERCE 15 NEW MANDATORY BUNDLED PAYMENT MODEL FOR HOSPITALS WHAT 'THE NEXT BERLIN PATIENT' AND A PREP’S 100% EFFICACY MEAN FOR HIV DRUG DEVELOPMENT A message from Alcami WEBINAR: NITROSAMINES IN FOCUS: REGULATORY REQUIREMENTS AND BEST PRACTICES 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. RESOURCES Whitepaper LAUNCHING A PRODUCT IN EUROPE: UNDERSTANDING SUPPLY CHAIN COST DRIVERS 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 Whitepaper EFFICIENT-PRO MEDIUM AND FEED 1 ENABLE RAPID AND SEAMLESS UPSTREAM PROCESS DEVELOPMENT AND SCALE-UP FOR CHO-K1 CELLS Download the white paper to learn how this innovative solution can help optimize your mAb production processes. The findings demonstrate the system's robust capability to sustain strong cell growth and high productivity, facilitating a smooth transition from laboratory to production scale. Sponsored by: Thermo Fisher Scientific Whitepaper 2024 LIFE SCIENCES INDUSTRY OUTLOOK The definitive report on the state of our industry.  Readers will gain an understanding of key indicators to monitor, future predictions, and guidance for investors and founders navigating the therapeutic enabling tools and services, healthtech and techbio sectors through 2024 and beyond. Sponsored by: AVANT BIO INDUSTRY EVENTS On Helix Date: 4 July 2024 - Location: Babraham Research Campus, Cambridge UK UPCOMING FIERCE EVENTS 9-12 Sep Digital Pharma East Philadelphia, PA 11 Sep Fierce Pharma Marketing Awards Gala Philadelphia, PA 17-19 Sep Digital Pharma East Virtual Event Virtual Event 25-26 Sep Medical Affairs Strategic Summit West San Diego, CA 25-27 Sep Fierce Clinical Summit Philadelphia, PA View all events Brand Logo Linkedin LogoFacebook LogoTwitter LogoYoutube Logo  Connect Advertise Contact Subscriptions Contact Support Our team Senior Editors: Ben Adams, Annalee Armstrong, Conor Hale, Heather Landi, Paige Minemyer, Eric Sagonowsky Editor-in-Chief: Ayla Ellison Publisher: Rebecca Willumson Group Sales Director: Angelique Alcover This email was sent to [email protected] as part of the Fierce Life Sciences email list. Questex Signature