Pharmaceuticals
Genomics
Bioinformatics

Microbiotica raises £36m Series C to fund Phase 2 UC trial of MB310

The Cambridge microbiome biotech closed its Series C, led by British Business Bank, to advance oral candidate MB310 into a Phase 2 ulcerative colitis study.
The Cambridge microbiome biotech closed its Series C, led by British Business Bank, to advance oral candidate MB310 into a Phase 2 ulcerative colitis study.
Biologics
Pharmaceuticals
Cell & Gene Therapy

J&J talquetamab combo wins CHMP nod for second-line myeloma

The CHMP has recommended talquetamab plus daratumumab for relapsed/refractory myeloma from second line, backed by Phase 3 MonumenTAL-3 data.
The CHMP has recommended talquetamab plus daratumumab for relapsed/refractory myeloma from second line, backed by Phase 3 MonumenTAL-3 data.
Pharmaceuticals
Biologics
Bioprocessing

IBA and Framatome launch Ekalia JV to scale Astatine-211 supply

The joint venture will build an international network of industrial At-211 production sites, starting in Nantes in 2028, to supply targeted alpha therapy programmes.
The joint venture will build an international network of industrial At-211 production sites, starting in Nantes in 2028, to supply targeted alpha therapy programmes.
Digital Health

Samsung Health cuts sleep coaching setup to three nights of data

Samsung Health's October update lowers the sleep coaching activation threshold and adds weekly adaptive guidance, plus expanded running levels and Strava route
Samsung Health's October update lowers the sleep coaching activation threshold and adds weekly adaptive guidance, plus expanded running levels and Strava route
Cell & Gene Therapy
Biologics

Legend Biotech wins FDA IND clearance for dual-target in vivo CAR-T

LB2501, designed to generate CD19/CD20 CAR-T cells inside the patient without lymphodepletion, is the first dual-targeting in vivo CAR-T to clear
LB2501, designed to generate CD19/CD20 CAR-T cells inside the patient without lymphodepletion, is the first dual-targeting in vivo CAR-T to clear
Biologics
Regulatory Science

Roche wins FDA approval for Enspryng in thyroid eye disease

Satralizumab becomes the first subcutaneous at-home treatment for TED, backed by Phase III data showing significant reductions in proptosis and diplopia.
Satralizumab becomes the first subcutaneous at-home treatment for TED, backed by Phase III data showing significant reductions in proptosis and diplopia.
Diagnostics
Medical Devices
Pharmaceuticals

IBA wins 12-cyclotron US order from major radiopharmaceutical producer

IBA secured a 12-unit Cyclone KIUBE 300 order to build a national PET radioisotope network in the US, with capacity configured for fluorine-18
IBA secured a 12-unit Cyclone KIUBE 300 order to build a national PET radioisotope network in the US, with capacity configured for fluorine-18
Biologics
Pharmaceuticals

Edesa Biotech wins FDA IND clearance for Phase 2 vitiligo study

Edesa's anti-CXCL10 antibody EB06 can now enrol US patients, with topline data from the 80-person trial expected in Q4 2027.
Edesa's anti-CXCL10 antibody EB06 can now enrol US patients, with topline data from the 80-person trial expected in Q4 2027.
Pharmaceuticals
Biologics

Eclipse Life Sciences' EC-104 implant beats Ozurdex in Phase 2 DME trial

Eclipse Life Sciences said its biodegradable intravitreal implant met its primary safety endpoint and showed superior visual and anatomical outcomes versus Ozurdex at 24
Eclipse Life Sciences said its biodegradable intravitreal implant met its primary safety endpoint and showed superior visual and anatomical outcomes versus Ozurdex at 24
Pharmaceuticals
Regulatory Science

Aquestive Therapeutics gets FDA PDUFA date for Anaphylm NDA

The FDA has accepted Aquestive's resubmitted NDA for sublingual anaphylaxis film Anaphylm, setting a review deadline of 16 March 2027.
The FDA has accepted Aquestive's resubmitted NDA for sublingual anaphylaxis film Anaphylm, setting a review deadline of 16 March 2027.
Pharmaceuticals
Biologics

Cellectar's iopofosine I 131 shows 87.5% ORR in post-BTKi WM subset

Phase 2b subset data in 24 relapsed/refractory Waldenström patients showed deep, durable responses, with a Phase 3 trial and FDA NDA filing both targeted
Phase 2b subset data in 24 relapsed/refractory Waldenström patients showed deep, durable responses, with a Phase 3 trial and FDA NDA filing both targeted
Pharmaceuticals
Genomics

Anavex wins FDA IND clearance for blarcamesine in Fragile X

Anavex Life Sciences can now open a Phase 2a trial of blarcamesine in Fragile X syndrome, giving it open INDs across all three core CNS
Anavex Life Sciences can now open a Phase 2a trial of blarcamesine in Fragile X syndrome, giving it open INDs across all three core CNS
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