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PharmaShots Weekly Snapshots (May 29 - June 02, 2023)

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PharmaShots Weekly Snapshots (May 29 - June 02, 2023)

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: BMSCamzyos, 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 | TagsC4 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

Related Post: PharmaShots Weekly Snapshots (May 22 - 26, 2023)


Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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