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Today’s Big NewsJul 24, 2024 Ahead of adcomm, FDA pokes holes in AZ's perioperative lung cancer filing for Imfinzi BeiGene CEO eyes biologics deals for new US innovation center in New Jersey Following Lilly's lead, Sanofi pledges discounted insulin in Minnesota after lawsuit Pfizer’s gene therapy offers alternative to 'burden' of regular infusions, but can it outlast Roctavian? PBMs defend business practices — but lawmakers aren’t convinced Regulatory tracker: Novo Nordisk's Wegovy approved to cut cardiovascular risks in the UK Surge in sales of biosimilars helps Samsung Biologics to a record-setting quarter Geron losing commercial chief shortly after first FDA approval FDA blasts Indian CDMO Brassica for 'routine' data falsification, poor hygiene and more Hikma extends recall of pain drug due to 'potential presence' of sedative, reports adverse event
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Top StoriesBeiGene CEO eyes biologics deals for new US innovation center in New JerseyBy Angus Liu A new 42-acre campus in New Jersey gives BeiGene CEO John Oyler hope that the company can strike new partnerships in biologics. Following Lilly's lead, Sanofi pledges discounted insulin in Minnesota after lawsuitBy Zoey Becker The company agreed to provide its insulin to patients in Minnesota for $35 per month, following a similar settlement the state reached with Eli Lilly. Pfizer’s gene therapy offers alternative to 'burden' of regular infusions, but can it outlast Roctavian?By James Waldron Three months after scoring FDA approval for its hemophilia B gene therapy, Pfizer has posted phase 3 data suggesting it may be able to pull off the same success with a different candidate in hemophilia A.
PBMs defend business practices — but lawmakers aren’t convincedBy Noah Tong A contentious hearing between PBM CEOs and the House Commitee on Oversight and Accountability reinforced recent federal angst toward pharmacy benefit managers, but little new ground was made. Regulatory tracker: Novo Nordisk's Wegovy approved to cut cardiovascular risks in the UKBy Fraiser Kansteiner,Eric Sagonowsky,Angus Liu,Zoey Becker,Kevin Dunleavy In this tracker, Fierce Pharma is recording the regulatory progress of in-market products, including expansions into key geographies and new indications. Some of these updates may not meet the bar for standalone stories, but we think they are still worth mentioning. Surge in sales of biosimilars helps Samsung Biologics to a record-setting quarterBy Kevin Dunleavy Korean CDMO juggernaut Samsung Biologics continued its sales surge in the second quarter, with its biosimilars unit, Samsung Bioepis, doing much of the heavy lifting. For the period, Samsung Bioepis achieved (PDF) sales of 530 South Korean won ($384 million), which was a 107% year-over-year increase and a 75% sequential boost. Geron losing commercial chief shortly after first FDA approvalBy Nick Paul Taylor Geron’s chief commercial officer is hitting the exit just as the party is getting started. Less than 50 days after the biotech won FDA approval for its first drug, the exec who played a starring role in creating its commercial strategy has announced he is leaving “to pursue other interests.” FDA blasts Indian CDMO Brassica for 'routine' data falsification, poor hygiene and moreBy Fraiser Kansteiner From flubbing data to performing aseptic processing with torn and stained gowns, Brassica Pharma’s recent warning letter from the FDA reads like a textbook example of what not to do when the U.S. regulator comes knocking at your facility. Hikma extends recall of pain drug due to 'potential presence' of sedative, reports adverse eventBy Zoey Becker So far, the company has received one report of an adverse event stemming from the "potential presence" of a sedative inside the pain med's packaging. Emergent, ex-NFL star show how to tackle opioid overdoses in new ad blitzBy Nick Paul Taylor Emergent BioSolutions is mounting another ad blitz, teaming up again with the former NFL star Emmitt Smith to get the message out about how to use Narcan to tackle opioid overdoses. GSK inks deal with CDMO Touchlight for access to its ‘doggybone DNA’ techBy Joseph Keenan Pharma giant GSK inked alicensing deal with Touchlight, giving the pharma giant non-exclusive access to the CDMO’s manufacturing tech dubbed "doggybone DNA." NIH study shows AI scores high in diagnostic quiz, but still can’t show its workBy Conor Hale Researchers quizzed an AI using four years’ worth of online image challenges from the New England Journal of Medicine—a long-running column that tests the reader’s ability to diagnose a patient, based on a series of submitted pictures and some basic clinical background information. Fierce podcasts Don’t miss an episode
ResourcesWhitepaper Simplifying manufacturing of alphavirus self-amplifying RNA repliconsSelf-amplifying RNAs (also known as self-replicating RNAs), or saRNAs, are increasing in popularity as a platform for vaccine development. Download to learn how to make a more streamlined and efficient manufacturing of self-amplifying RNAs. Sponsored by: TriLink Whitepaper Building A Patient Support Program that Can Scale GloballyAn insider’s workbook filled with practical tips and tools for designing and scaling a global patient support program. Sponsored by: Harte Hanks Whitepaper Defining digital twins in drug discovery and developmentWhen we talk about digital twins in the context of biology andmedicine, we're inherently discussing a simplified model. These simplificationsaren't a drawback but a necessity. Sponsored by: Unlearn Industry EventsDrug Development Boot Camp® VIRTUAL | Spring 2024 April 10-11, 2024 Date: 4 July 2024 - Location: Babraham Research Campus, Cambridge UK Upcoming Fierce Events
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Brand LogoA message from Allazo HealthWEBINAR: THE EVOLUTION OF OMNI-CHANNEL MARKETING WITH DYNAMIC MODULAR CONTENTWednesday, August 7, 2024 |11am ET / 8am PTJoin usfor this one-hour, deep dive to learn more about the rise of dynamic modular content as today's leading engagementstrategy. Discover how this innovative digital design system is helping increase patient medication adherence and the length oftherapies.Register now.TODAY’S BIG NEWSJul 24, 2024Ahead of adcomm, FDA pokes holes in AZ's perioperative lung cancer filing for Imfinzi-BeiGene CEO eyes biologics deals for new US innovation center in New Jersey-Following Lilly's lead, Sanofi pledges discounted insulin in Minnesota after lawsuit-Pfizer’s gene therapy offers alternative to 'burden' of regular infusions, but can it outlast Roctavian?-PBMs defend business practices — but lawmakers aren’t convinced-Regulatory tracker: Novo Nordisk's Wegovy approved to cut cardiovascular risks in the UK-Surge in sales of biosimilars helps Samsung Biologics to a record-setting quarter-Geron losing commercial chief shortly after first FDA approval-FDA blasts Indian CDMO Brassica for 'routine' data falsification, poor hygiene and more-Hikma extends recall of pain drug due to 'potential presence' of sedative, reports adverse eventThe Top Line Podcast: Don’t miss out on the newest episode. Listen now.A message from MercalisBiosimilars Commercialization: Lessons Learned from Adalimumab and Four Necessary Approaches n_1ercalis AFEATUREDAHEAD OF ADCOMM, FDA POKES HOLES IN AZ'S PERIOPERATIVE LUNG CANCER FILING FOR IMFINZIBy Kevin DunleavyAn FDA advisory committee will discuss AstraZeneca’s application for Imfinzi in early-stage non-small cell lung cancer. The agencyis asking external experts to weigh in on whether a new trial is needed to determine the contributions of the therapy on eitherend of surgery.TOP STORIESBEIGENE CEO EYES BIOLOGICS DEALS FOR NEW US INNOVATION CENTER IN NEW JERSEYBy Angus LiuA new 42-acre campus in New Jersey gives BeiGene CEO John Oyler hope that the company can strike new partnerships in biologics.FOLLOWING LILLY'S LEAD, SANOFI PLEDGES DISCOUNTED INSULIN IN MINNESOTA AFTER LAWSUITBy Zoey BeckerThe company agreed to provide its insulin to patients in Minnesota for $35 per month, following a similar settlement the statereached with Eli Lilly.PFIZER’S GENE THERAPY OFFERS ALTERNATIVE TO 'BURDEN' OF REGULAR INFUSIONS, BUT CAN IT OUTLAST ROCTAVIAN?By James WaldronThree months after scoring FDA approval for its hemophilia B gene therapy, Pfizer has posted phase 3 data suggesting it may beable to pull off the same success with a different candidate in hemophilia A.A message from Fierce Clinical SummitFIERCE CLINICAL SUMMITSeptember 25-27, 2024 | Philadelphia, PAJoin the Fierce Clinical Summit, the premier event for clinical research and trial management. Explore topics in ClinicalOperations, Quality, and DCT & Technology. Learn, network, and connect with peers to advance industry standards and innovations inclinical trials.Secure your pass today!PBMS DEFEND BUSINESS PRACTICES — BUT LAWMAKERS AREN’T CONVINCEDBy Noah TongA contentious hearing between PBM CEOs and the House Commitee on Oversight and Accountability reinforced recent federal angsttoward pharmacy benefit managers, but little new ground was made.REGULATORY TRACKER: NOVO NORDISK'S WEGOVY APPROVED TO CUT CARDIOVASCULAR RISKS IN THE UKBy Fraiser Kansteiner,Eric Sagonowsky,Angus Liu,Zoey Becker,Kevin DunleavyIn this tracker, Fierce Pharma is recording the regulatory progress of in-market products, including expansions into keygeographies and new indications. Some of these updates may not meet the bar for standalone stories, but we think they are stillworth mentioning.SURGE IN SALES OF BIOSIMILARS HELPS SAMSUNG BIOLOGICS TO A RECORD-SETTING QUARTERBy Kevin DunleavyKorean CDMO juggernaut Samsung Biologics continued its sales surge in the second quarter, with its biosimilars unit, SamsungBioepis, doing much of the heavy lifting. For the period, Samsung Bioepis achieved (PDF) sales of 530 South Korean won ($384million), which was a 107% year-over-year increase and a 75% sequential boost.GERON LOSING COMMERCIAL CHIEF SHORTLY AFTER FIRST FDA APPROVALBy Nick Paul TaylorGeron’s chief commercial officer is hitting the exit just as the party is getting started. Less than 50 days after the biotech wonFDA approval for its first drug, the exec who played a starring role in creating its commercial strategy has announced he isleaving “to pursue other interests.”FDA BLASTS INDIAN CDMO BRASSICA FOR 'ROUTINE' DATA FALSIFICATION, POOR HYGIENE AND MOREBy Fraiser KansteinerFrom flubbing data to performing aseptic processing with torn and stained gowns, Brassica Pharma’s recent warning letter from theFDA reads like a textbook example of what not to do when the U.S. regulator comes knocking at your facility.HIKMA EXTENDS RECALL OF PAIN DRUG DUE TO 'POTENTIAL PRESENCE' OF SEDATIVE, REPORTS ADVERSE EVENTBy Zoey BeckerSo far, the company has received one report of an adverse event stemming from the "potential presence" of a sedative inside thepain med's packaging.EMERGENT, EX-NFL STAR SHOW HOW TO TACKLE OPIOID OVERDOSES IN NEW AD BLITZBy Nick Paul TaylorEmergent BioSolutions is mounting another ad blitz, teaming up again with the former NFL star Emmitt Smith to get the message outabout how to use Narcan to tackle opioid overdoses.GSK INKS DEAL WITH CDMO TOUCHLIGHT FOR ACCESS TO ITS ‘DOGGYBONE DNA’ TECHBy Joseph KeenanPharma giant GSK inked alicensing deal with Touchlight, giving the pharma giant non-exclusive access to the CDMO’s manufacturingtech dubbed "doggybone DNA."NIH STUDY SHOWS AI SCORES HIGH IN DIAGNOSTIC QUIZ, BUT STILL CAN’T SHOW ITS WORKBy Conor HaleResearchers quizzed an AI using four years’ worth of online image challenges from the New England Journal of Medicine—along-running column that tests the reader’s ability to diagnose a patient, based on a series of submitted pictures and some basicclinical background information.Fierce podcastsDON’T MISS AN EPISODE'THE TOP LINE': FORMER FTC DIRECTOR WEIGHS IN ON NOVO'S $16.5B DEAL WITH CATALENTIn February, Novo Holdings announced a $16.5 billion deal to acquire Catalent, and this week on "The Top Line," we explore thecurrent state and implications of the proposed buyout.'THE TOP LINE': A LOOK AT BIG PHARMA’S TOP-PAID CEOS‘PODNOSIS’: ONC’S MICKY TRIPATHI ON CREATING A CONNECTED HEALTHCARE SYSTEMA message from Fierce PharmaFIERCE PHARMAYour Quest for Success Happens HereElevate your brand visibility with Fierce Pharma. Connect with over 1.7 million decision-makers and meet your marketing goals!Learn more now.RESOURCESWhitepaperSIMPLIFYING MANUFACTURING OF ALPHAVIRUS SELF-AMPLIFYING RNA REPLICONSSelf-amplifying RNAs (also known as self-replicating RNAs), or saRNAs, are increasing in popularity as a platform for vaccinedevelopment. Download to learn how to make a more streamlined and efficient manufacturing of self-amplifying RNAs.Sponsored by: TriLinkWhitepaperBUILDING A PATIENT SUPPORT PROGRAM THAT CAN SCALE GLOBALLYAn insider’s workbook filled with practical tips and tools for designing and scaling a global patient support program.Sponsored by: Harte HanksWhitepaperDEFINING DIGITAL TWINS IN DRUG DISCOVERY AND DEVELOPMENTWhen we talk about digital twins in the context of biology and medicine, we're inherently discussing a simplified model. Thesesimplifications aren't a drawback but a necessity.Sponsored by: UnlearnINDUSTRY EVENTSDrug Development Boot Camp® VIRTUAL | Spring 2024April 10-11, 2024On HelixDate: 4 July 2024 - Location: Babraham Research Campus, Cambridge UKUPCOMING FIERCE EVENTS9-12SepDigital Pharma EastPhiladelphia, PA11SepFierce Pharma Marketing Awards GalaPhiladelphia, PA17-19SepDigital Pharma East Virtual EventVirtual Event25-26SepMedical Affairs Strategic Summit WestSan Diego, CA25-27SepFierce Clinical SummitPhiladelphia, PAView all eventsBrand LogoLinkedin LogoFacebook LogoTwitter LogoConnectAdvertiseContactSubscriptionsContact SupportOur teamSenior Editor: Eric SagonowskyDeputy Editor: Angus LiuSenior Writer: Kevin DunleavyStaff Writers: Zoey Becker, Fraiser KansteinerEditor-in-Chief: Ayla EllisonPublisher: Rebecca WillumsonGroup Sales Director: Angelique AlcoverThis email was sent to [emailprotected] as part of the Fierce Pharma email list./\\f SRS RIS RO K/ %J&j& L\
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