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Clinical Trials & Development1 month agoBeacon edges ahead in XLRP gene therapy race with Phase III hit
BIOCENTURY | PRODUCT DEVELOPMENTBEACON EDGES AHEAD IN XLRP GENE THERAPY RACE WITH PHASE III HITBioCentury’s Clinical Report Sept. 15-21
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Capital, M&A & Industry Strategy1 month agoTelix-ITM merger aims to create radiopharma juggernaut: Deals Report
BIOCENTURY | DEALSTELIX-ITM MERGER AIMS TO CREATE RADIOPHARMA JUGGERNAUT: DEALS REPORTPlus: GSK-Chimagen; Novartis-Sironax; Roche-Dualitas; and more
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Synthetic Biology, Genomics & Advanced Therapeutics1 month agoBiotech IPOs, CAR T safety, and pharma tariffs — a BioCentury podcast
BIOCENTURY | FINANCEBIOTECH IPOS, CAR T SAFETY, AND PHARMA TARIFFS — A BIOCENTURY PODCASTThe path to NASDAQ: Electra, ADARx and reverse mergers
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Drug Discovery & Therapeutics1 month agoChugai’s Lasker winners aim to beat their own blockbuster
BIOCENTURY | PRODUCT DEVELOPMENTCHUGAI’S LASKER WINNERS AIM TO BEAT THEIR OWN BLOCKBUSTERDevelopers of hemophilia A bispecific Hemlibra detail next-gen product
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Regulatory Intelligence & Drug Approvals1 month agoPDUFA VIII aims to remove CMC bottlenecks, shore up FDA staffing
BIOCENTURY | POLITICS, POLICY & LAWPDUFA VIII AIMS TO REMOVE CMC BOTTLENECKS, SHORE UP FDA STAFFINGFDA, industry agree on incremental steps to improve reviews, largely symbolic...
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Synthetic Biology, Genomics & Advanced Therapeutics1 month agoFatal toxicities test autoimmune CAR T’s safety thesis
BIOCENTURY | PRODUCT DEVELOPMENTFATAL TOXICITIES TEST AUTOIMMUNE CAR T’S SAFETY THESISAutoimmune CAR T developers point to rapid manufacturing, construct design, and patient biology as potential determinants...
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Regulatory Intelligence & Drug Approvals1 month agoUltragenyx wins first approval for MPS IIIA, closing a bumpy four-year path
BIOCENTURY | REGULATIONULTRAGENYX WINS FIRST APPROVAL FOR MPS IIIA, CLOSING A BUMPY FOUR-YEAR PATHTraditional approval shows flexibility on external controls while leaving CBER’s biomarker stance unresolved
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Regulatory Intelligence & Drug Approvals1 month agoEMA’s CHMP backs eight new medicines in September
BIOCENTURY | REGULATIONEMA’S CHMP BACKS EIGHT NEW MEDICINES IN SEPTEMBERRecommendations include two new ovarian cancer therapies, potential first oral drug for hidradenitis suppurativa, and more
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Capital, M&A & Industry Strategy1 month agoElectra dips after pricing upsized IPO, bucking trend: Public Equity Report
BIOCENTURY | FINANCEELECTRA DIPS AFTER PRICING UPSIZED IPO, BUCKING TREND: PUBLIC EQUITY REPORTPlus: Two more companies line up PIPEs to accompany mergers; Tyra’s follow-on; and more
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Capital, M&A & Industry Strategy1 month agoScale as strategy: Blackstone’s Galakatos on funding the hardest mile
BIOCENTURY | FINANCESCALE AS STRATEGY: BLACKSTONE’S GALAKATOS ON FUNDING THE HARDEST MILENick Galakatos joins The BioCentury Show to discuss the path from Clarus to a $6.3B...
Widespread atropine use fails to sway FDA advisors on Sydnexis data
At least 11 PDUFAs on FDA’s November docket
FDA Grants Accelerated Approval to Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd) for Recurrent Respiratory Papillomatosis
Novartis buys Synnovation’s PI3Kα inhibitors for $3 billion
Novartis to pay $2B upfront to take next-gen PI3Kα inhibitor from Synnovation
