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Capital, M&A & Industry Strategy1 month agoWith Tepezza challenge in late-stage study, Sling draws $123M series C: Venture Report
BIOCENTURY | FINANCEWITH TEPEZZA CHALLENGE IN LATE-STAGE STUDY, SLING DRAWS $123M SERIES C: VENTURE REPORTPlus: Circle draws $92.5M round after introducing second development candidate; and more
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Drug Discovery & Therapeutics2 months agoScience Spotlight: A macrophage-recruiting bispecific, plus new tactics against TCR-T escape and tumor stroma
BIOCENTURY | DISCOVERY & TRANSLATIONSCIENCE SPOTLIGHT: A MACROPHAGE-RECRUITING BISPECIFIC, PLUS NEW TACTICS AGAINST TCR-T ESCAPE AND TUMOR STROMABioCentury's translational roundup looks at three new bispecific antibody...
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Capital, M&A & Industry Strategy2 months agoSleep deals cluster in narcolepsy and sleep apnea
BIOCENTURY | DATA BYTESLEEP DEALS CLUSTER IN NARCOLEPSY AND SLEEP APNEANarcolepsy drives the biggest transactions, while venture financing across the sleep field remains sparse
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Regulatory Intelligence & Drug Approvals2 months agoFDA fills in blanks on expedited IND pilot
BIOCENTURY | POLITICS, POLICY & LAWFDA FILLS IN BLANKS ON EXPEDITED IND PILOTThe agency is accepting applications from sponsors and qualified research institutions in test of...
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Global Biotechnology & Pharmaceutical Markets2 months agoFDA signals tighter scrutiny of early-stage data from China
BIOCENTURY | POLITICS, POLICY & LAWFDA SIGNALS TIGHTER SCRUTINY OF EARLY-STAGE DATA FROM CHINAU.S. agency acknowledges concerns, steers clear of outright ban on China data advocated...
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Regulatory Intelligence & Drug Approvals2 months agoPsychedelics at FDA, Mike Davis’ CDER and translating tRNAs — a BioCentury podcast
BIOCENTURY | REGULATIONPSYCHEDELICS AT FDA, MIKE DAVIS’ CDER AND TRANSLATING TRNAS — A BIOCENTURY PODCAST FDA could approve psychedelics before redosing is resolved. Plus: Takeaways from first...
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Drug Discovery & Therapeutics2 months agoSuppressor tRNAs take two translational steps forward
BIOCENTURY | DISCOVERY & TRANSLATIONSUPPRESSOR TRNAS TAKE TWO TRANSLATIONAL STEPS FORWARDPreclinical Duchenne and cystic fibrosis studies point to ways around two of the modality’s most stubborn...
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Regulatory Intelligence & Drug Approvals2 months agoFDA could approve psychedelics before redosing is resolved
BIOCENTURY | REGULATIONFDA COULD APPROVE PSYCHEDELICS BEFORE REDOSING IS RESOLVEDAgency officials say 12-week efficacy could support initial approval while durability and maintenance regimens continue to mature
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Global Biotechnology & Pharmaceutical Markets2 months agoTakeda’s Plump, GV’s Yeshwant announce retirement plans
BIOCENTURY | MANAGEMENT TRACKSTAKEDA’S PLUMP, GV’S YESHWANT ANNOUNCE RETIREMENT PLANSAndy Plump has helped remake Japanese pharma an innovative global player
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Capital, M&A & Industry Strategy2 months agoNovartis DM1 miss raises stakes for next wave of DMPK readouts
BIOCENTURY | PRODUCT DEVELOPMENTNOVARTIS DM1 MISS RAISES STAKES FOR NEXT WAVE OF DMPK READOUTSFour upcoming readouts will test the translational potential of additional DM1 candidates as...
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
