Brand Logo A message from Premier Research IMMUNE CHECKPOINT INHIBITOR THERAPY: OPTIMIZE DOSE AND PATIENT SELECTION TO MAXIMIZE EFFICACY AND ACCESS Immune checkpoint inhibitors offer significant survival benefit, yet many patients do not respond to these treatments. Dosing optimization offers hope. Learn how to maximize therapeutic efficacy and minimize toxicity of ICIs in our guide. TODAY’S BIG NEWS Sep 30, 2024 Roche celebrates Pharma Day by buying Regor's CDK inhibitors, regenerative med-focused AntlerA   - BMS pays $110M to form T-cell therapy pact, helping Prime buy time to advance prioritized pipeline - Kezar halts dosing and enrollment in key lupus study following 4 patient deaths - Rivus reveals data to back up muscle-sparing claims of phase 2 obesity drug  - Radiopharma biotech Aktis sees Big Pharma backers return for $175M series B  - Cereno's HDAC inhibitor reduces risks from pulmonary arterial hypertension in phase 2 trial - With post hoc analysis, BridgeBio touts case for acoramidis as FDA decision date draws near - Fierce Biotech Layoff Tracker 2024: Inventprise trims 7% of staff; About 100 bluebird employees laid off - Tampa's Moffitt Cancer Center forms cancer trial partnership with Japan's largest CRO  The Top Line Podcast: Don’t miss out on the newest episode. Listen now. A message from Fierce CRO Awards FIERCE CRO AWARDS These awards honor CROs that excel in innovation, quality, and leadership, highlighting their crucial role in advancing life sciences and improving patient outcomes. Enter now! FEATURED ROCHE CELEBRATES PHARMA DAY BY BUYING REGOR'S CDK INHIBITORS, REGENERATIVE MED-FOCUSED ANTLERA By Nick Paul Taylor Genentech is paying $850 million upfront for Regor Pharmaceuticals’ portfolio of CDK inhibitors, taking ownership of a breast cancer candidate that has shown signs of single-agent efficacy in patients failed by existing options. Roche, Genentech’s parent company, also disclosed the acquisition of AntlerA. TOP STORIES BMS PAYS $110M TO FORM T-CELL THERAPY PACT, HELPING PRIME BUY TIME TO ADVANCE PRIORITIZED PIPELINE By Nick Paul Taylor Bristol Myers Squibb is paying Prime Medicine $110 million upfront to develop reagents for ex vivo T-cell therapies. Prime, which could receive a whopping $3.5 billion in milestones, disclosed the deal alongside details of a pipeline prioritization intended to extend its cash runway into the first half of 2026. KEZAR HALTS DOSING AND ENROLLMENT IN KEY LUPUS STUDY AFTER 4 PATIENT DEATHS By Zoey Becker The voluntary hold comes after Kezar restructured last year to in a bid to support its lupus and hepatitis candidate zetomipzomib. RIVUS REVEALS DATA TO BACK UP MUSCLE-SPARING CLAIMS OF PHASE 2 OBESITY DRUG By James Waldron Rivus Pharmaceuticals has unveiled the data behind its phase 2 obesity win in heart failure patients, showing that the candidate can indeed help patients reduce weight while they retain muscle. A message from Lonza AN INTEGRATED END-TO-END APPROACH TO ADC DEVELOPMENT AND MANUFACTURING This white paper delves into key challenges in ADC development and explores new drug product capabilities in cytotoxic drug development and manufacturing, accelerating timelines to IND filing and beyond. RADIOPHARMA BIOTECH AKTIS SEES BIG PHARMA BACKERS RETURN FOR $175M SERIES B By James Waldron Having banked $60 million from Eli Lilly in the spring, Aktis Oncology has now closed an upsized $175 million series B that saw the U.S. Big Pharma rejoin a range of big-name investors in the radiopharma biotech. CERENO'S HDAC INHIBITOR REDUCES RISKS FROM PULMONARY ARTERIAL HYPERTENSION IN PHASE 2 TRIAL By James Waldron Cereno Scientific’s hypertension drug was shown to improve the risk score of 43% of patients in a phase 2 study. WITH POST HOC ANALYSIS, BRIDGEBIO TOUTS CASE FOR ACORAMIDIS AS FDA DECISION DATE DRAWS NEAR By Darren Incorvaia BridgeBio Pharma has been on the road to redemption ever since its treatment for a rare and fatal heart condition, acoramidis, flopped in an early readout of phase 3 data. Three years since tripping over that hurdle, the Bay Area company is now revealing that at the end of that trial, acoramidis had reduced combined all-cause mortality and recurrent cardiovascular-related hospitalizations compared to placebo in patients with transthyretin amyloid cardiomyopathy. FIERCE BIOTECH LAYOFF TRACKER 2024: INVENTPRISE TRIMS 7% OF STAFF; ABOUT 100 BLUEBIRD EMPLOYEES LAID OFF By Gabrielle Masson,Darren Incorvaia,Max Bayer We really didn't want to have to create another Layoff Tracker this year. But here we are, launching the third annual iteration tracking biopharma layoffs.  TAMPA'S MOFFITT CANCER CENTER FORMS CANCER TRIAL PARTNERSHIP WITH JAPAN'S LARGEST CRO By Darren Incorvaia Tampa’s Moffitt Cancer Center is forging an international partnership with Japan’s largest CRO, CMIC, to improve the ability of both organizations to run global cancer trials. J&J, LEGEND SOLIDIFY CARVYKTI'S LEAD IN EARLIER MULTIPLE MYELOMA WITH STRONG SURVIVAL SHOWING By Angus Liu After putting on a strong performance in preventing disease progression, Johnson & Johnson and Legend Biotech’s Carvykti has once again demonstrated a major benefit—this time in prolonging patients’ lives. ASTRO: RANDOMIZED PROSTATE CANCER STUDY FINDS NO MAJOR DIFFERENCES BETWEEN IMRT AND PROTON BEAM RADIATION By Conor Hale A prostate cancer trial compared two types of radiation treatments head-to-head, and found both helped control tumors with no differences in quality of life. Fierce podcasts DON’T MISS AN EPISODE THE TOP LINE ESMO, WCLC LUNG CANCER DATA SPARK HOPE—AND DEBATE In this week's "The Top Line," Fierce journalists discuss key issues from promising but debated lung cancer data at recent conferences. ACCELERATING SOLUTIONS TO CANCER THROUGH IMPACT INVESTING RECAPPING DIGITAL PHARMA EAST 2024 A message from Carr Biosystems Optimize Bioprocessing with Scalable Solutions – Achieve Higher Yields, Greater Purity, and Faster Time-to-market. RESOURCES Whitepaper ACCELERATING TIMELINES TO CLINIC WITH GPEX® LIGHTNING Unlock the Future of Biotherapeutics with Catalent Biologics! Sponsored by: Catalent Biologics Whitepaper EPILEPSY CLINICAL TRIALS 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 UNIQUE SOLUTIONS FOR DRUG DISCOVERY AND DEVELOPMENT Unique Solutions for Drug Discovery and Development Sponsored by: Cell Signaling Technology Whitepaper WHY BIOTECH SPONSORS NEED OUTSIDE SUPPORT: IRB, IBC, DMCS, AND EACS When the fate of your company hangs in the balance, you need expert guidance to navigate the complexities of biotechnology development and to make informed decisions. Sponsored by: WCG Whitepaper Power non-invasive, self-sampling solutions using the Colli-Pee™️ first-void urine collection device. Learn more. Sponsored by: DNA Genotek Whitepaper OVERCOMING DRUG DEVELOPMENT HURDLES WITH PHASE-APPROPRIATE TECHNOLOGY TRANSFERS Facing roadblocks in drug development? Uncover how phase-appropriate technology transfers can help you navigate challenges and speed up your journey to market. Sponsored by: Veranova Whitepaper BUILDING A “BEST PRACTICE” COMMERCIAL ORGANIZATION IN BIOPHARMA We interviewed dozens of biopharma leaders on the critical success factors for building a Best Practice commercial organization. This report shares what we learned. Sponsored by: Blue Matter Consulting INDUSTRY EVENTS On Helix Date: 4 July 2024 - Location: Babraham Research Campus, Cambridge UK UPCOMING FIERCE EVENTS 30-1 Sep-Oct New Product Planning Summit Boston, MA 30-1 Sep-Oct Fierce Biotech Summit Boston, MA 18-19 Nov Diversity, Equity & Inclusion Forum Free Virtual Event 20 Nov Advanced Therapies: Cell & Gene, mRNA and Beyond Free Virtual Event 27 Nov Fierce Life Sciences Innovation Awards Submissions Deadline Sept 12th View all events Brand Logo Linkedin LogoFacebook LogoTwitter LogoYoutube Logo  Connect Advertise Contact Subscriptions Contact Support Our team UK/EU Bureau Chief: James Waldron Associate Editor: Gabrielle Masson Staff Writer: Darren Incorvaia Contributing Writer: Nick Paul Taylor 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 Biotech email list. Questex Signature