| 06.28.24 | Merck gears up to challenge Pfizer's Prevnar; Daiichi prevails over Seagen in ADC arbitration - Questex (2024)

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Brand LogoA message from BonterraTRANSFORM YOUR MEDICAL GRANTMAKING PROCESSExplore how Bonterra's medical grants software can simplify grantmaking complexities and reduce your regulatory risk.TODAY’S BIG NEWSJun 28, 2024Merck's Capvaxive gears up to challenge Pfizer's dominant Prevnar with CDC panel backing----------------------------------------------------------------------------------------------------------------------------------Without Pfizer appeal, Daiichi Sankyo closes long-running ADC patent arbitration with $47M win----------------------------------------------------------------------------------------------------------------------------------Billionaire Sackler family can't get legal immunity as part of Purdue bankruptcy deal, Supreme Court rules----------------------------------------------------------------------------------------------------------------------------------EU's drug regulator again rejects Apellis' eye med and PTC's Translarna in busy week of up-and-down decisions----------------------------------------------------------------------------------------------------------------------------------Rocket gene therapy’s flight to approval delayed by FDA rejection over manufacturing questions----------------------------------------------------------------------------------------------------------------------------------Regulatory tracker: CSL Behring's gene therapy Hemgenix secures new coverage in England, Denmark----------------------------------------------------------------------------------------------------------------------------------Spain's Rovi receives offers for potential sale of €2B-plus CDMO group----------------------------------------------------------------------------------------------------------------------------------SK Bioscience begins 'globalization' push, paying $244M for majority stake in contract manufacturer IDT Biologika----------------------------------------------------------------------------------------------------------------------------------In boost to Amgen, analysts predict osteoporosis market share shiftThe Top Line Podcast: Don’t miss out on the newest episode. Listen now.A message from LEXISNEXIS®️ RISK SOLUTIONSUse medical claims data and insights to optimize sales strategies. Healthcare Provider e Targeting Best Practices~ @ LexisNexis ‘Healthcare RSKSOLUTIONSFEATUREDMERCK'S CAPVAXIVE GEARS UP TO CHALLENGE PFIZER'S DOMINANT PREVNAR WITH CDC PANEL BACKINGBy Zoey BeckerThe recommendation sets up Merck's new pneumococcal disease vaccine to potentially capture some of Pfizer's market share.TOP STORIESWITHOUT PFIZER APPEAL, DAIICHI SANKYO CLOSES LONG-RUNNING ADC PATENT ARBITRATION WITH $47M WINBy Angus LiuAn antibody-drug conjugate patent arbitration fight that Seagen waged against Daiichi Sankyo has officially ended in a win for theJapanese company.BILLIONAIRE SACKLER FAMILY CAN'T GET LEGAL IMMUNITY AS PART OF PURDUE BANKRUPTCY DEAL, SUPREME COURT RULESBy Eric SagonowskyYears of negotiations and legal proceedings surrounding a high-dollar opioid settlement for Purdue Pharma havereached a dead endat the U.S. Supreme Court.SponsoredTHREE WAYS TO SOLVE THE ‘PATIENT SUPPORT PARADOX’Sponsored by IQVIAIn a curious twist, patient support programs — often designed to alleviate the burden on patients — sometimes create unintendedchallenges. These large, intricate, and costly initiatives can paradoxically complicate the lives of the very individuals they aimto assist.A message from Fierce Biotech SummitFIERCE BIOTECH SUMMITSeptember 30- October 1, 2024 | Boston, MAJoin the Fierce Biotech Summit to explore biotech's recovery and future. This two-day event features leaders discussing biotechIPOs, cell therapy, regulatory challenges, and strategic innovations. Connect with experts and gain valuable industry insights.Save $500 with Early Bird Rate Today!EU'S DRUG REGULATOR AGAIN REJECTS APELLIS' EYE MED AND PTC'S TRANSLARNA IN BUSY WEEK OF UP-AND-DOWN DECISIONSBy Kevin DunleavyEurope’s CHMP has given another thumbs down to Apellis’ eye drug Syfovre and rejected PTC’s duch*enne muscular dystrophy therapyTranslarna for a third time. The CHMP gave positive opinions to several products, including Merck's PAH drug Winrevair.ROCKET GENE THERAPY’S FLIGHT TO APPROVAL DELAYED BY FDA REJECTION OVER MANUFACTURING QUESTIONSBy James WaldronRocket Pharmaceuticals’ flight path to approval for Kresladi has been delayed again after the FDA issued a complete responseletter (CRL) requesting additional manufacturing information.REGULATORY TRACKER: CSL BEHRING'S GENE THERAPY HEMGENIX SECURES NEW COVERAGEBy Fraiser Kansteiner,Eric Sagonowsky,Angus Liu,Kevin Dunleavy,Zoey BeckerIn 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.SPAIN'S ROVI RECEIVES OFFERS FOR POTENTIAL SALE OF €2B-PLUS CDMO GROUPBy Zoey BeckerRovi's potential CDMO unit sale has attracted buyout offers, the company confirmed. The unit generated 409 million euros lastyear.SK BIOSCIENCE BEGINS 'GLOBALIZATION' PUSH, PAYING $244M FOR MAJORITY STAKE IN CONTRACT MANUFACTURER IDT BIOLOGIKABy Kevin DunleavySeventeen months after SK Bioscience introduced its global expansion push, the Korean developer and manufacturer of vaccines haspulled off a deal that lives up to its ambitions. SK has acquired a 60% stake in IDT Biologika GmbH for 339 billion won ($244million).IN BOOST TO AMGEN, ANALYSTS PREDICT OSTEOPOROSIS MARKET SHARE SHIFTBy Nick Paul TaylorChange is coming to the osteoporosis market. GlobalData analysts have tipped the market to shift from bisphosphonates toanabolics, putting Amgen and its rivals in line to capture the additional $7 billion in annual sales that are forecast by 2033.ABBVIE SWEEPS UP INFLAMMATORY-FOCUSED CELSIUS FOR $250M CASH IN SUMMER HEAT WAVEBy Gabrielle MassonAbbVie is embracing summer’s heat, cranking up the M&A dial with the acquisition of inflammatory disease-focused CelsiusTherapeutics for $250 million cash.FDA, GATES FOUNDATION TEAM UP ON BREATH-BASED DIAGNOSTIC TEST DEVELOPMENTBy Conor HaleThe TB-focused project with the FDA follows up on the Gates Foundation's interest in breath biopsy tests developed by OwlstoneMedical.WYDEN BLASTS EXPRESS SCRIPTS' PRICING TACTICS, ASKS CMS TO INTERVENEBy Noah TongSen. Ron Wyden, not letting PBMs out of his sights, is urging CMS to better enforce rules that could curb unfair practices byExpress Scripts and other major PBMs.FIERCE PHARMA ASIA—DAIICHI, MERCK'S FDA REJECTION; WEGOVY'S EXPANSION; TAKEDA CEO'S HUNT FOR CHINA DEALSBy Angus LiuThe FDA rejected Daiichi Sankyo and Merck's HER3 antibody-drug conjugate. Novo Nordisk's weight-loss star Wegovy secured approvalin China. After two largelicensing deals, Takeda's CEO is open to more partnerships with Chinese biotechs. And more.CHUTES & LADDERS—METABOLIC DISORDER BIOTECH LANDS INDUSTRY VET AS CMOBy Gabrielle Masson,Andrea ParkLongtime biopharma leader Salomon (Sam) Azoulay, M.D., has joined endocrine and metabolic disorder-focused MBX Biosciences, wherehe’ll serve as chief medical officer.Fierce podcastsDON’T MISS AN EPISODE'THE TOP LINE': THE BEST BIOPHARMA M&A DEALSIn today’s episode of "The Top Line," Fierce Biotech’s Annalee Armstrong and James Waldron discuss what they think are the bestand smartest biopharma acquisitions in recent years.'THE TOP LINE': INSIDE THIS YEAR’S ASCO: BIGGEST DATA DROPS, TRENDS AND THE BEST EXHIBIT BOOTH‘PODNOSIS’: LGBTQ+ FERTILITY AND FAMILY BUILDINGA message from Fierce Pharma PR & Communications SummitFIERCE PHARMA PR & COMMUNICATIONS SUMMITJuly 8-9, 2024 | Jersey City, NJHear the latest industry trends from leaders in the field, and developed with input from our esteemed advisory board, to ensureyou have a sound plan for your company, brands, and yourself. Save $200 when you Register Today!Discover Drexel's Online Drug Discovery and Development Programs $§ DrexelDISCOVER DREXEL’S ONLINE DRUG DISCOVERY & DEVELOPMENT PROGRAMSSponsored by Drexel UniversityDrexel’s online drug discovery and development programs give you a unique, career-focused opportunity to evaluate and engage withthe entire drug discovery process. You’ll learn from the best, with the best – surrounded by leaders in the pharmaceutical andbiotechnology industries. Learn more today.RESOURCESWhitepaperDEFINING 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: UnlearnWhitepaperTHE ROLE OF ENVIRONMENTAL MONITORING IN A CONTAMINATION CONTROL STRATEGYThe Role of Environmental Monitoring in a Contamination Control StrategySponsored by: ThermoFisher ScientificWhitepaperTHE ECONOMICS OF SYNTHETIC MRNA CAPPING STRATEGIESThis study delved into the manufacturing costs of the three mRNA capping methods. It involved discussions with 30 subject matterexperts engaged in mRNA therapeutic development across various companies in the US and the EU.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 HanksResearchCREATING ACCURATE CLINICAL TRIAL BENCHMARKS WITH AILearn how a Top-10 Pharma company automated the extraction of oncology efficacy endpoints from scientific literature with highprecision and recall using a combination of AI technologies.Sponsored by: IQVIAWhitepaperFRESENIUS MEDICAL CARE GETS 25X FASTER KIDNEY DISEASE INSIGHTSThis detailed case study shows how Fresenius Medical Care achieved 25 times faster insights to help kidney disease patients,launching the world’s largest global database of dialysis care with fully anonymized patient data.Sponsored by: Privacy Analytics, an IQVIA companyeBookGET TO ESIGNATURE FASTER: MAXIMIZE THE VALUE OF YOUR ESIGNATURE INVESTMENT WITH TRUE FORMS AUTOMATIONThis eBook offers insights for business leaders looking to do more with reduced budgets by using the power of SmartIQ’s true formsautomation to eliminate the need to print, sign, and scan/mail physical documents, increase operational efficiency, and reducedisparate systems.Sponsored by: SmartComms LLCWhitepaperDRIVING DTC ADOPTION WITH TELEHEALTH PROGRAMSVirtual care programs represent a compelling opportunity for decision makers in life sciences companies to drive growth,innovation, and value creation. Download now to learn more.Sponsored by: WheelINDUSTRY EVENTSDrug Development Boot Camp® VIRTUAL | Spring 2024April ‌10-11, ‌2024On HelixDate: ‌4 ‌July ‌2024 ‌- ‌Location: ‌Babraham ‌Research ‌Campus, ‌Cambridge ‌UKUPCOMING FIERCE EVENTS8-9JulPharma PR & Communications Summit EastJersey City, NJ9-12SepDigital Pharma EastPhiladelphia, PA11SepFierce Pharma Marketing Awards GalaPhiladelphia, PA17-19SepDigital Pharma East Virtual EventVirtual Event25-26SepMedical Affairs Strategic Summit WestSan Diego, CAView 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.Questex Signature

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