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Regenxbio’s Duchenne gene therapy clears pivotal bar, aims for FDA submission
Regenxbio reported that its Duchenne muscular dystrophy gene therapy met the primary bar in a pivotal study, generating a roadmap toward an FDA submission. The result centers on sufficiently high...
Create Medicines closes $122M Series B to scale in vivo CAR-T pipeline
Create Medicines raised $122 million in a Series B financing to advance its in vivo CAR-T platform across autoimmune disease and oncology. The company, formerly known as Myeloid Therapeutics, uses...
Isomorphic Labs secures massive $2.1B Series B to scale AI drug discovery
Isomorphic Labs, the Google-backed AI drug discovery company, secured a $2.1 billion Series B round as it looks to scale its AI drug design engine and move therapeutic programs closer to clinical...
Boehringer Ingelheim pays up to $478M for Immunitas antibody program in inflammation
Boehringer Ingelheim agreed to acquire global rights to a preclinical antibody program from Immunitas Therapeutics, adding a chronic inflammatory and autoimmune asset to its immunology pipeline....
Sonomind raises €20M Series A for ultrasound neuromodulation in depression
Sonomind SAS raised €20 million (US$23 million) in a Series A round to advance its ultrasound-based neuromodulation device for treatment-resistant depression. The company will use the funds to run...
EU seals Critical Medicines Act pact to shore up drug shortages
The EU reached agreement on the Critical Medicines Act, aiming to reduce shortages by boosting European manufacturing capacity for drugs and active ingredients and enabling coordinated procurement...
ARUP launches public infectious disease testing dashboard to tighten signal detection
ARUP launched a public-facing dashboard tracking weekly positive results for selected infectious disease tests, aiming to close gaps in digital epidemiology. The system provides de-identified,...
AAV gene therapy linked to brain tumor after rare integration event reported in NEJM
A team at Children’s Hospital of Philadelphia (CHOP) reported a rare case of a neuroepithelial tumor associated with adeno-associated virus (AAV) integration following intracisternal magna vector...
FDA grants first ctDNA MRD-guided bladder cancer adjuvant approval
The FDA approved Genentech’s Tecentriq (atezolizumab) and Tecentriq Hybreza as adjuvant therapy for muscle-invasive bladder cancer patients with circulating tumor DNA after cystectomy, using...
Aardvark Therapeutics faces full FDA clinical hold on Prader-Willi drug program
Aardvark Therapeutics’ Prader-Willi syndrome program hit a major regulatory setback as the FDA placed a full clinical hold on ARD-101 and related studies. The hold follows a cardiovascular safety...
Regenxbio claims pivotal Duchenne gene therapy success and eyes FDA submission
Regenxbio reported that its Duchenne muscular dystrophy gene therapy met the bar in a pivotal study, clearing the key milestone required to move toward an FDA submission. The company says the...
CREATE Medicines raises large Series B to scale in vivo CAR-T development
CREATE Medicines closed a $122 million Series B financing to advance its in vivo CAR-T platform across autoimmune disease and oncology. The company’s mRNA-LNP approach programs T cells, NK cells,...
FDA approval expands B-cell malignancy precision medicine with BeOne’s BCL2 inhibitor
BeOne Medicines won US accelerated approval for its sonrotoclax (BCL2 inhibitor) in a rare, aggressive blood cancer setting where Venclexta is used off-label. The regulatory move establishes...
Boehringer secures up to $478m global rights for Immunitas antibody program
Boehringer Ingelheim signed a global deal worth up to $478 million for a preclinical antibody program from Immunitas Therapeutics. The antibody is designed to selectively eliminate pathogenic...
EU reaches Critical Medicines Act agreement targeting drug shortages and shared procurement
The EU reached agreement on the Critical Medicines Act, a policy package aimed at reducing drug shortages by strengthening European manufacturing capacity and enabling member states to coordinate...
Isomorphic Labs raises $2.1B to scale AI drug discovery and push pipeline toward clinic
Isomorphic Labs secured a massive $2.1 billion Series B round led by Thrive Capital to scale its AI drug discovery model and advance its therapeutics pipeline. The financing is positioned as a...
Regulatory leadership uncertainty at FDA after CDER chief Høeg expected to leave
Reuters reported that FDA CDER chief Tracy Beth Høeg is expected to leave the agency following Commissioner Marty Makary’s resignation. Høeg had been acting CDER director after the departure of...
Infectious disease diagnostics move toward more transparent outbreak signal tracking
ARUP launched a public-facing infectious disease testing dashboard showing weekly test positivity and state-level heat maps for several molecular and antigen assays. The reference laboratory said...
Regulatory actions for Prader-Willi rare disease drug candidates
The FDA has placed a full clinical hold on Aardvark Therapeutics’ ARD-101 Prader-Willi syndrome program, pausing both the ongoing Phase 3 study and the associated open-label extension. The hold...
FDA approval for oncology in mantle cell lymphoma
BeOne Medicines said the FDA granted accelerated approval for its drug Beqalzi (sonrotoclax) in relapsed or refractory mantle cell lymphoma, positioning the company to challenge incumbents...