-
Capital, M&A & Industry Strategy2 months agoEncoded raises $275m for Dravet therapy and other financings
Our round-up of biotech financings is headed by Encoded, which has raised $275m to advance its gene therapy for Dravet syndrome into pivotal trials.
-
Clinical Trials & Development2 months agoCould UK clinical trial revamp unlock closer ties with Canada?
Two senior figures in Canada's life science sector have said they see scope for greater collaboration with the UK following clinical trial reforms.
-
Regulatory Intelligence & Drug Approvals2 months agoReviews underway of first drug for rare disease MOGAD
Patients with rare autoimmune disease MOGAD could be months away from having a first approved therapy, as the FDA starts a review of Roche's Enspryng.
-
Regulatory Intelligence & Drug Approvals2 months agoBayer moves Hyrnuo into frontline lung cancer treatment
Bayer chases after Boehringer with an FDA approval for oral HER2 inhibitor Hyrnuo in previously untreated HER2+ lung cancer.
-
Capital, M&A & Industry Strategy2 months agoNICE says no to Gilead’s lenacapavir for HIV PrEP
NICE's decision not to recommend NHS funding of Gilead's twice-yearly injectable for prevention of HIV has drawn fierce criticism from charities.
-
Synthetic Biology, Genomics & Advanced Therapeutics2 months agoBMS eyes role for new CAR-T in post-BCMA multiple myeloma
BMS' arlo-cel has shown activity in a trial that could underpin filings in multiple myeloma settings where the four main drug classes have failed.
-
Regulatory Intelligence & Drug Approvals2 months agoFDA starts review of AZ’s COPD blockbuster hope
The FDA has started a priority review of AstraZeneca's first-in-class IL-33 inhibitor tozorakimab for COPD, setting up a decision in Q1 of 2027.
-
Regulatory Intelligence & Drug Approvals2 months agoFDA makes acting CDER, CBER chiefs permanent
Michael Davis becomes the permanent head of CDER, while Karim Mikhail is confirmed as permanent CBER director and the FDA names its first AI leader.
-
AI, Machine Learning & Computational Biology2 months agoBrainomix AI lends weight to Endeavor Bio’s IPF trial data
An AI-based imaging tool from Brainomix has been used to enrich data from a phase 2a trial of Endeavor's idiopathic pulmonary fibrosis drug taladegib.
-
Capital, M&A & Industry Strategy2 months agoPharma body sees ‘green shoots’ in UK investment
The UK is starting to benefit from a "real partnership" between pharma and government, reversing years of diminishing investment, says the ABPI.
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
