Impact Therapeutics Entered into a License and Collaboration Agreement with Eikon Therapeutics to Develop and Commercialize IMP1734

Date: June 02, 2023 | Tags: Impact Therapeutics, Eikon Therapeutics, IMP1734, Pharma, China, Hong Kong, Macau, Taiwan

BMS’ Mavacamten Receives the NICE Recommendation for the Treatment of Obstructive Hypertrophic Cardiomyopathy

Date: June 02, 2023 | Tags: BMS, Camzyos, Mavacamten, Obstructive Hypertrophic Cardiomyopathy, Regulatory, NICE 

Pfizer Reports P-III Study Results of Antibiotic Aztreonam-Avibactam for Serious Bacterial Infections

Date: June 02, 2023 | Tags: Pfizer, Aztreonam-Avibactam, Bacterial Infections, Clinical Trial, P-III, REVISIT, ASSEMBLE Study

Innovent Entered into Clinical Trial Collaboration and Supply Agreement with Merck KGaA to Evaluate IBI351 + Erbitux (cetuximab) for KRASG12C-Mutated NSCLC in China

Date: June 02, 2023 | Tags: Innovent, Merck KGaA, IBI351, Erbitux, cetuximab, NSCLC, Regulatory, KRASG12C, China

TG Therapeutics’ Briumvi (ublituximab-xiiy) Receives EC’s Approval for the Treatment of Relapsing Forms of Multiple Sclerosis

Date: June 02, 2023 | Tags: TG Therapeutics, Briumvi, ublituximab-xiiy, Multiple Sclerosis, Regulatory, EC, Approval 

Bayer Entered into an Exclusive License Agreement with Cedilla Therapeutics to Develop and Commercialize CyclinE1/CDK2 Complex Inhibitors

Date: June 02, 2023 | Tags: Bayer, Cedilla Therapeutics, CyclinE1/CDK2, Complex Inhibitors, Biotech

Ionis Reports Two-Year P-II OLE Study Results of Donidalorsen for the Treatment of Hereditary Angioedema

Date: June 01, 2023 | Tags: Ionis, Donidalorsen, Hereditary Angioedema, Clinical Trial, P-II, OLE Study, OASIS-HAE Study 

Nykode Therapeutics Expands its Clinical Collaboration and Supply Agreement with Roche to Evaluate VB10.16 for Advanced Cervical Cancer

Date: June 01, 2023 | Tags Nykode Therapeutics, Roche, VB10.16, atezolizumab, Advanced Cervical Cancer, Pharma

Precigen Receives the US FDA’s IND Clearance of PRGN-2009 + Pembrolizumab for the Treatment of Recurrent or Metastatic Cervical Cancer

Date: June 01, 2023 | Tags: Precigen, PRGN-2009, Pembrolizumab, Cervical Cancer, Regulatory, US, FDA, IND 

C4 Therapeutics Entered into an Exclusive License Agreement with Betta to Develop and Commercialize CFT8919 for Non-Small Cell Lung Cancer

Date: June 01, 2023 | Tags: C4 Therapeutics, Betta, CFT8919, Non-Small Cell Lung Cancer, Pharma

Pfizer’s Vydura (rimegepant) Receives the NICE Recommendation for the Prevention of Migraine Attacks

Date: June 01, 2023 | Tags: Pfizer, Vydura, Rimegepant, erenumab, fremanezumab, galcanezumab, Migraine, Regulatory, NICE 

InDex Pharmaceuticals Entered into a License Agreement with Viatris to Develop and Commercialize Cobitolimod for Ulcerative Colitis in Japan

Date: June 01, 2023 | Tags: InDex Pharmaceuticals, Viatris, Ulcerative Colitis, Cobitolimod, Pharma, Japan, CONCLUDE program

Janssen Reports the NDA Submission of Macitentan and Tadalafil to the US FDA for Pulmonary Arterial Hypertension

Date: May 31, 2023 | Tags: Janssen, Macitentan, Tadalafil, Pulmonary Arterial Hypertension, Regulatory, US, FDA, NDA 

XtalPi Collaborated with Eli Lilly on AI Drug Discovery for ~$250M

Date: May 31, 2023 | Tags: XtalPi, Eli Lilly, AI Drug Discover, ~$250M, ID4Inno small-molecule drug discovery platform, Biotech

AbbVie Presents P-II Study (SLEek) Results of Rinvoq (upadacitinib) for the Treatment of Systemic Lupus Erythematosus at EULAR 2023

Date: May 31, 2023 | Tags: Abbvie, Rinvoq, upadacitinib, Systemic Lupus Erythematosus, Clinical Trial, P-II, SLEek Study 

Sanofi Reports P-II Study Results of Frexalimab for the Treatment of Relapsing Multiple Sclerosis

Date: May 31, 2023 | Tags: Sanofi, Frexalimab, Relapsing Multiple Sclerosis, Clinical Trial, P-II Study 

BMS Reports the US FDA Acceptance of NDA and Granted Priority Review of Repotrectinib for ROS1-Positive Non-Small Cell Lung Cancer

Date: May 31, 2023 | Tags: BMS, Repotrectinib, Non-Small Cell Lung Cancer, Regulatory, Priority Review, US, FDA, NDA 

Stealth BioTherapeutics Entered into an Exclusive License Agreement with Pharmanovia to Commercialize Elamipretide for Barth Syndrome

Date: May 31, 2023 | Tags: Stealth BioTherapeutics, Pharmanovia, Elamipretide, Pharma, Barth Syndrome, EU, MENA 

Pfizer Reports P-III Trial (BASIS) Results of Marstacimab for the Treatment of Hemophilia A and B

Date: May 30, 2023 | Tags: Pfizer, Marstacimab, Hemophilia A, Hemophilia B, Clinical Trial, P-III, BASIS Trial

Samsung Bioepis Receives EC’s Marketing Authorization for Epysqli (biosimilar, eculizumab) to Treat Paroxysmal Nocturnal Hemoglobinuria

Date: May 30, 2023 | Tags: Samsung Bioepis, Epysqli, biosimilar, eculizumab, Paroxysmal Nocturnal Hemoglobinuria, Regulatory, Biosimilar, EC, Marketing Authorization  

Sun Pharma Entered into a License Agreement with Philogen to Commercialize Nidlegy for Skin Cancers

Date: May 30, 2023 | Tags: Sun Pharma, Philogen, Nidlegy, Daromun, skin cancers, Pharma

Marinus Receives the EMA’s CHMP Positive Opinion of Ztalmy (ganaxolone) for the Adjunctive Treatment of Seizures Associated with CDKL5 Deficiency Disorder

Date: May 30, 2023 | Tags: Marinus, Ztalmy, ganaxolone, Seizures, CDKL5 Deficiency Disorder, Regulatory, EMA, CHMP

Novo Nordisk Receives the EMA’s CHMP Positive Opinion of Sogroya (somapacitan) for Children and Adolescents with Growth Hormone Deficiency

Date: May 30, 2023 | Tags: Novo Nordisk, Sogroya, Norditropin, somapacitan, Growth Hormone Deficiency, Regulatory, EMA, CHMP 

AstraZeneca’s Ultomiris (ravulizumab) Receives the MHLW’s Approval for the Prevention of Relapses in Patients with NMOSD

Date: May 30, 2023 | Tags: AstraZeneca, Ultomiris, ravulizumab, neuromyelitis optica spectrum disorder, Regulatory, MHLW, Approval

Harbour BioMed to Present Results from P-Ib Study of Porustobart + Toripalimab in Patients with Hepatocellular Carcinoma at ASCO 2023

Date: May 29, 2023 | Tags: Harbour BioMed, Porustobart, HBM4003, Toripalimab, Hepatocellular Carcinoma, Clinical Trial, ASCO 2023

HanAll Biopharma and Daewoong Entered into Co-Development Agreement with NurrOn to Develop Novel Therapies for Parkinson's Disease

Date: May 29, 2023 | Tags: HanAll Biopharma, Daewoong, NurrOn, HL161, HL036, Pharma, Parkinson's Disease

BMS Receives EMA’s CHMP Positive Opinion Recommending Approval of Opdivo (nivolumab) as Neoadjuvant Treatment of Resectable Non-Small Cell Lung Cancer

Date: May 29, 2023 | Tags: BMS, Opdivo, nivolumab, Resectable Non-Small Cell Lung Cancer, Regulatory, EMA, CHMP 

Iovance Biotherapeutics Reports the US FDA Acceptance of BLA for Lifileucel to Treat Advanced Melanoma

Date: May 29, 2023 | Tags: Iovance Biotherapeutics, Lifileucel, Advanced Melanoma, Regulatory, Priority Review. US, FDA, BLA 

AstraZeneca Reports P-III Trial (DUO-E) Results of Imfinzi (durvalumab) + Lynparza (olaparib) for Advanced Endometrial Cancer

Date: May 29, 2023 | Tags: AstraZeneca, Imfinzi, durvalumab, Lynparza, Olaparib, Advanced Endometrial Cancer, Clinical Trial, P-III, DUO-E Trial

BMS to Present P-III Study (COMMANDS) of Reblozyl (luspatercept-aamt) as 1L Treatment of Anemia in Adults with Lower-Risk MDS at ASCO and EHA 2023

Date: May 29, 2023 | Tags: BMS, Reblozyl, luspatercept-aamt, Anemia, MDS, ASCO, EHA, 2023, Clinical Trial, P-III, COMMANDS Study

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