Search
40+ results for “ruxolitinib extended release bioequivalence”
- DevelopmentEndo Axiom takes oral nanoparticle insulin into first-in-human trialAustralia-based Endo Axiom Pty Ltd has dosed its first human participants with an oral nanoparticle-encapsulated insulin formulation, marking the company's...
- BusinessTeva raises USD 4.9bn to refinance higher-coupon debtTeva Pharmaceutical Industries (NYSE and TASE: TEVA) priced a multi-tranche senior notes offering totaling approximately USD 4.9 billion equivalent, with...
- Regulatory & PolicyFDA extends Exelixis' zanzalintinib review by three months, pushing decision to March 2027The US FDA has extended its review of the New Drug Application (NDA) for zanzalintinib, an oral kinase inhibitor, in combination with atezolizumab...
- Regulatory & PolicyFDA grants Fast Track Designation to Sobi's pacritinib for VEXAS syndromeSwedish Orphan Biovitrum AB (Stockholm: SOBI), operating through its North American affiliate Sobi North America, announced that the US FDA has granted Fast...
- BusinessCONNECTA raises EUR 3.1m to advance TrkB modulator into mid-stage Fragile X trialBarcelona-based CONNECTA Therapeutics has closed a EUR 3.1 million (USD 3.4 million) financing round to support the clinical development of CTH120, its...
- BusinessEthris secures EUR 30m to advance broad-spectrum nasal antiviral into Phase IIb trialsGermany-based Ethris GmbH has secured EUR 30 million to support the advance of its mRNA-based respiratory treatments into later-stage trials. The financing...
- BusinessCerenome secures USD 20m royalty-based financing to scale CNSide diagnostics platformHouston-based Cerenome, Inc. (Nasdaq: CNSY) has secured a senior secured financing facility of up to USD 20 million from 3i, LP, structured with...
- BusinessThird Arc Bio advances first masked CD3 TCE under expanded Adagene collaborationThird Arc Bio has selected its first lead candidate under an amended strategic collaboration with Adagene Inc. (Nasdaq: ADAG), triggering an expansion of...
- BusinessNeOnc raises USD 15m to advance Phase II CNS cancer programs after NEO100 efficacy readoutCalifornia-based NeOnc Technologies Holdings, Inc. (Nasdaq: NTHI) announced a USD 15 million registered direct offering on September 9, 2026, with proceeds...
- DevelopmentAbbVie's atogepant meets primary endpoint in Phase III menstrual migraine trialAtogepant (Qulipta/Aquipta) met the primary endpoint and all eight ranked secondary endpoints in the Phase III LUNA trial evaluating preventive treatment of...
- BusinessViaNautis expands into spinal cord injury with SCI Ventures backing for polyNaut platformCambridge, UK-based ViaNautis Bio has secured investment from SCI Ventures to expand its non-viral genetic medicine delivery platform into chronic spinal...
- DevelopmentNodThera rebrands as Rezera as ruvonoflast meets Phase II endpoint, eyes Phase III in PADRuvonoflast (NT-0796), an oral NLRP3 inflammasome inhibitor developed by Boston-based Rezera Inc. (formerly NodThera), met its primary endpoint in the...
- BusinessMindera Health partners with UPenn to investigate quinacrine mechanism in lupusMindera Health is collaborating with University of Pennsylvania researchers to investigate why quinacrine helps some patients with cutaneous lupus—and...
- DevelopmentDisc Medicine’s DISC-3405 reduces phlebotomy needs in Phase II polycythemia vera trialMassachusetts-based Disc Medicine (Nasdaq: IRON) released Phase II data showing that DISC-3405, an anti-TMPRSS6 monoclonal antibody, sharply reduced...
- Regulatory & PolicyRoche moves Enspryng toward first approved MOGAD therapyRoche (SIX: RO; OTCQX: RHHBY) announced a US FDA Priority Review award for a supplemental Biologics License Application (sBLA) for Enspryng (satralizumab),...
- BusinessKura launches Caspian with USD 50m to advance menin inhibition in diabetesA USD 50 million financing round has backed the launch of Caspian Therapeutics, a newly formed company spun out of San Diego-based Kura Oncology (Nasdaq:...
- BusinessHarbour Bio partner Solstice raises USD 225m to advance CTLA-4 antibody in neoadjuvant cancerBoston-based Solstice Oncology launched with a USD 225 million Series A financing to advance porustobart (HBM4003), an Fc-enhanced CTLA-4 antibody that...
- DevelopmentPrana reports prolonged Type 2 biomarker suppression with IL-4Rα/TSLP bispecificPhase I data from a placebo-controlled study in healthy adults suggest that PRA-216, a bispecific antibody that simultaneously blocks IL-4Rα and TSLP, can...
- DevelopmentLancet data show durable responses with PeproMene's BAFF-R CAR T after CD19 CAR T failurePhase I data for PMB-CT01, a B-cell activating factor receptor (BAFF-R)-targeted autologous chimeric antigen receptor (CAR) T-cell therapy, have been...
- DevelopmentPharvaris’s deucrictibant XR cuts HAE attack rate 83% in Phase III, advancing dual oral strategyPharvaris N.V. (Nasdaq: PHVS) has reported an 83% reduction in monthly hereditary angioedema (HAE) attack rate with deucrictibant extended-release (XR)...
- BusinessAssembly Bio converts HSV program from royalty deal to 40% US profit-share with GileadAssembly Biosciences (Nasdaq: ASMB) has exercised its embedded option to co-share 40% of US development costs and profits for the herpes simplex virus (HSV)...
- DevelopmentBeam reports durable BEAM-302 AAT restoration, advances pivotal cohortUpdated Phase I/II data from Beam Therapeutics' (Nasdaq: BEAM) BEAM-302 program, presented at the European Respiratory Society Congress in Barcelona, show...
- BusinessKorsana goes public with USD 380m raise and Alzheimer's antibody poised for Phase IWaltham, Massachusetts-based Korsana Biosciences (Nasdaq: KRSA) has completed its reverse merger with Cyclerion Therapeutics and closed a USD 380 million...
- DevelopmentSemaglutide clears obesity treatment threshold in children aged 6 to under 12Phase III data from Novo Nordisk's STEP Young trial show that once-weekly semaglutide (Wegovy, Ozempic, Rybelsus) reduced body mass index (BMI) in children...
- BusinessSernova, Seraxis merge to build integrated stem cell islet replacement platform for T1DCanada-based Sernova Biotherapeutics Inc. (TSX: SVA) and Germantown, Maryland-based Seraxis Holdings, Inc. have signed a definitive merger agreement to...
- BusinessCloverleaf Bio lands USD 33m seed with Lilly, AbbVie, and Boehringer backingConnecticut-based Cloverleaf Bio has raised USD 33 million in an oversubscribed seed financing round to advance a platform of engineered transfer RNA...
- DevelopmentAirNexis’s AN01 improves lung function on top of bronchodilators in COPDA dual phosphodiesterase inhibitor delivered by dry powder inhaler met its primary endpoint in a Phase IIb randomized trial in chronic obstructive pulmonary...
- DevelopmentWindward’s TSLP mAb shows six-month asthma activity after single dosePositive Phase II interim data from SKB378/WIN378, an anti-thymic stromal lymphopoietin (TSLP) monoclonal antibody engineered for extended half-life, have...
- Regulatory & PolicyIntellia’s one-shot CRISPR therapy gets March 2027 FDA decision dateCambridge, Massachusetts-based Intellia Therapeutics, Inc. (Nasdaq: NTLA) announced that the US FDA has accepted its Biologics License Application (BLA) and...
- DevelopmentInhibrx's OX40 agonist nearly doubles response rate versus Keytruda alone in head and neck cancerA hexavalent OX40 agonist that has struggled to find clinical traction across the broader class has now produced the first randomized efficacy signal for an...
- DiscoveryGerman researchers show AI-designed protein vehicles outperform lipid nanoparticles in RNA deliveryResearchers at Helmholtz Munich and the Technical University of Munich, led by corresponding authors Christoph Gruber, Florian Giesert, and Wolfgang Wurst,...
- DevelopmentAmgen’s tarlatamab delivers Phase III OS win in first-line ES-SCLC maintenanceAdding tarlatamab to durvalumab maintenance produced a statistically significant and clinically meaningful improvement in overall survival in...
- DevelopmentNovartis’s pelacarsen misses Phase III endpoint despite deep Lp(a) loweringNovartis’s pelacarsen failed to reduce major cardiovascular events in the Phase III Lp(a)HORIZON trial despite substantially lowering lipoprotein(a)...
- BusinessBrainChild Bio raises USD 116m to advance CAR T therapy for pediatric brain cancerSeattle-based BrainChild Bio, Inc., a clinical-stage company developing CAR T cell therapies for central nervous system tumors, has closed a USD 116 million...
- BusinessIntellia secures USD 400m non-dilutive debt facility ahead of lonvo-z commercial launchMassachusetts-based Intellia Therapeutics, Inc. (Nasdaq: NTLA) announced a non-dilutive senior secured term loan facility of up to USD 400 million with...
- DevelopmentStoke, Biogen report four-year durability for Dravet therapy zorevunersenFour-year open-label extension data for zorevunersen, the antisense oligonucleotide being developed by Massachusetts-based Stoke Therapeutics (Nasdaq: STOK)...
- DevelopmentInnovent takes once-weekly oral GLP-1 into Phase IInnovent Biologics (HKEX: 01801) has registered a Phase I study of IBI3042, an oral small-molecule glucagon-like peptide-1 receptor (GLP-1R) agonist...
- DiscoveryPeking University engineers proteins that switch on in nitric oxide-rich tissuesA method for building proteins that activate only in the presence of nitric oxide (NO) — a signaling molecule produced at elevated levels at sites of...
- BusinessENA expands antiviral nasal spray INNA-051 into asthma patients with grant backingAustralia-based ENA Respiratory has received AUD 2.98 million (USD 1.9 million) from Biointelect Venturer to fund the first study of its INNA-051 antiviral...
- Regulatory & PolicyChina approves Milestone/Everest's Cardamyst nasal spray for acute PSVT China's National Medical Products Administration (NMPA) has approved Cardamyst (etripamil) nasal spray for the treatment of paroxysmal supraventricular...