-
Helixgate Featured2 days agoWidespread atropine use fails to sway FDA advisors on Sydnexis data
BIOCENTURY | REGULATIONWIDESPREAD ATROPINE USE FAILS TO SWAY FDA ADVISORS ON SYDNEXIS DATAPanel favors another trial to establish meaningful benefit in pediatric myopia despite clinicians’ support...
-
Helixgate Featured2 days agoAt least 11 PDUFAs on FDA’s November docket
BIOCENTURY | DATA BYTEAT LEAST 11 PDUFAS ON FDA’S NOVEMBER DOCKETPD-1 x VEGF bispecific ivonescimab first on deck
-
Clinical Trials & Development2 days agoAuchincloss bill seeks to improve ‘operating system for science’
BIOCENTURY | POLITICS, POLICY & LAWAUCHINCLOSS BILL SEEKS TO IMPROVE ‘OPERATING SYSTEM FOR SCIENCE’Bill creates infrastructure to embed trials in routine care, establish Australia-style notification scheme...
-
Synthetic Biology, Genomics & Advanced Therapeutics2 days agoWhat made Estuary’s kidney gene therapy bet investable
BIOCENTURY | FINANCEWHAT MADE ESTUARY’S KIDNEY GENE THERAPY BET INVESTABLEA $93M series A backs the prospect of a one-time treatment as pharmas advance competing modalities in...
-
Capital, M&A & Industry Strategy2 days agoThe impact of Gilde’s Impact Council with Joep Muijrers
BIOCENTURY | FINANCETHE IMPACT OF GILDE’S IMPACT COUNCIL WITH JOEP MUIJRERS How Gilde’s outside expert panel and deeper patient engagement have shaped the firm’s investment strategy
-
Capital, M&A & Industry Strategy3 days agoJuvia, Lightspeed lead Dren’s $350M round as oncology program advances: Venture Report
BIOCENTURY | FINANCEJUVIA, LIGHTSPEED LEAD DREN’S $350M ROUND AS ONCOLOGY PROGRAM ADVANCES: VENTURE REPORTPlus: Formation Bio’s $600M accelerator fund; Flagship assembles three portfolio companies’ tech into...
-
Capital, M&A & Industry Strategy3 days agoTallying equity in NewCo deals as COINS raises the stakes
BIOCENTURY | DATA BYTETALLYING EQUITY IN NEWCO DEALS AS COINS RAISES THE STAKESRecent dealmaking shows how widely Treasury’s proposed COINS restrictions could reverberate across the NewCo...
-
Global Biotechnology & Pharmaceutical Markets3 days agoCo-co deals may be one casualty of the COINS Act for U.S. biotechs
BIOCENTURY | DATA BYTECO-CO DEALS MAY BE ONE CASUALTY OF THE COINS ACT FOR U.S. BIOTECHSProposed restrictions could curb U.S. participation in China co-development deals, where...
-
Capital, M&A & Industry Strategy4 days agoTreasury’s proposed COINS rule could reshape NewCo deal terms
BIOCENTURY | POLITICS, POLICY & LAWTREASURY’S PROPOSED COINS RULE COULD RESHAPE NEWCO DEAL TERMSAlternatives to equity could keep deals flowing, while some U.S. investors already favor...
-
Capital, M&A & Industry Strategy5 days agoOruka raises efficacy expectations for long-acting IL-23 inhibitors
BIOCENTURY | PRODUCT DEVELOPMENTORUKA RAISES EFFICACY EXPECTATIONS FOR LONG-ACTING IL-23 INHIBITORSBioCentury’s Clinical Report, Oct. 20–27
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
