AstraZeneca's Bydureon BCise (exenatide extended-release) Receives the US FDA's Approval for the Treatment of Type2 Diabetes

Published: July 23, 2021 | Tags: AstraZeneca, Bydureon BCise, exenatide extended-release, US, FDA, Approval, Type2 Diabetes

ImaginAb Signs a Multi-Year Non-Exclusive License Agreement with Boehringer Ingelheim for CD8 ImmunoPET Technology

Published: July 23, 2021 | Tags: ImaginAb, Non-Exclusive License Agreement, Boehringer Ingelheim, CD8 ImmunoPET Technology

Meiji and Dong-A ST Sign an Exclusive License Agreement with Intas to Commercialize DMB-3115, Proposed Biosimilar to Ustekinumab

Published: July 23, 2021 | Tags: Meiji, Dong-A ST, Intas, Commercialize, DMB-3115, Ustekinumab

Celltrion Collaborates with Inhalon to Develop Regdanvimab (CT-P59) for the Treatment of COVID-19 at Home

Published: July 23, 2021 | Tags: Celltrion, Inhalon, Regdanvimab, CT-P59, COVID-19

NGM Reports Completion of Patient Enrollment in P-II CATALINA Study of NGM621 in Patients with Geographic Atrophy Secondary to Age-Related Macular Degeneration

Published: July 23, 2021 | Tags: NGM, P-II, CATALINA Study, NGM621, Geographic Atrophy, Age-Related Macular Degeneration

Synaffix Signs a License Agreement with ProfoundBio for ADC Technologies

Published: July 23, 2021 | Tags: Synaffix, License Agreement, ProfoundBio, ADC Technologies

Merck and Eisai's Keytruda (pembrolizumab) + Lenvima (lenvatinib) Receive the US FDA's Approval for the Treatment of Advanced Endometrial Carcinoma

Published: July 22, 2021 | Tags: Merck, Eisai, Keytruda, pembrolizumab, Lenvima, Lenvatinib, US, FDA, Approval, Advanced Endometrial Carcinoma

Bluebird Bio's Skysona (elivaldogene autotemcel) Receives EC's Approval for the Treatment of Cerebral Adrenoleukodystrophy

Published: July 22, 2021 | Tags: bluebird bio, Skysona, elivaldogene autotemcel, Lenti-D, EC, Approval, Cerebral Adrenoleukodystrophy

Mabpharm's Biobetter (CMAB008) for Infliximab Receives NMPA's Approval in China

Published: July 22, 2021 | Tags: Sorrento, Mabpharm, Infliximab Biobetter, Marketing Approval, China

IM Reports Results of IMT-002 in P-Ib MAD Trial for the Treatment of Type 1 Diabetes

Published: July 22, 2021 | Tags: IM, IMT-002, P-Ib, MAD Trial, Type 1 Diabetes, T1D

Bayer and Merck's Verquvo (vericiguat) Receives the EC's Approval for the Treatment of Chronic Heart Failure

Published: July 22, 2021 | Tags: Bayer, Merck, Verquvo, vericiguat, EC, Approval, Chronic Heart Failure

Lexeo Acquires Stelios to Expands its Gene Therapy Pipeline for Rare Cardiovascular Diseases

Published: July 22, 2021 | Tags: Lexeo, Stelios, Gene Therapy Pipeline, Programs, Rare Cardiovascular Diseases

Calliditas Signs a License Agreement with STADA to Commercialize Specialty Therapy for the Treatment of IgA Nephropathy in EU

Published: July 21, 2021 | Tags: Calliditas, STADA, Commercialize, Specialty Therapy, Chronic Autoimmune Kidney Disease IgAN, EU

Genentech's Venclexta (venetoclax) + Azacitidine Receives Breakthrough Therapy Designation for the Treatment of Myelodysplastic Syndromes

Published: July 21, 2021 | Tags: Genentech, Venclexta, venetoclax, Azacitidine, Breakthrough Therapy Designation, Myelodysplastic Syndromes

Scilex Reports Completion of Patient Enrollment in P-III C.L.E.A.R. Program for Semdexa (SP-102) to Treat Sciatica Pain Management

Published: July 21, 2021 | Tags: Scilex, P-III, C.L.E.A.R. Program, Semdexa, SP-102, Sciatica Pain Management

Albireo's Bylvay (odevixibat) Receives the US FDA's Approval for the Treatment of Progressive Familial Intrahepatic Cholestasis

Published: July 21, 2021 | Tags: Albireo, Bylvay, odevixibat, US, FDA, Approval, Progressive Familial Intrahepatic Cholestasis

Relmada In-Licenses Psilocybin Program from Arbormentis

Published: July 21, 2021 | Tags: Relmada, In Licenses, Psilocybin Program, Arbormentis

Merck Presents Results from P-IIa Clinical Trial of Islatravir (MK-8591) for the Prevention of HIV at IAS 2021

Published: July 21, 2021 | Tags: Merck, Islatravir, MK-8591, P-IIa, Clinical Trial, HIV, IAS 2021

Myovant's Ryeqo (relugolix, estradiol, and norethindrone acetate) Receives EC's Approval for the Treatment of Women with Uterine Fibroids

Published: July 20, 2021 | Tags: Myovant, Ryeqo, relugolix, estradiol, norethindrone acetate, EC, Approval, Uterine Fibroids

BioNTech Signs a Purchase Agreement to Acquire Kite's Cell Therapy, R&D Platform and Manufacturing Facility in Gaithersburg, MD

Published: July 20, 2021 | Tags: BioNTech, Kite, Cell Therapy, R&D Platform, Manufacturing Facility, Gaithersburg, MD

Kadmon's Rezurock (belumosudil) Receives the US FDA's Approval for the Treatment of Chronic Graft Versus Host Disease

Published: July 20, 2021 | Tags: Kadmon, Rezurock, belumosudil, US, FDA, Approval, Chronic Graft Versus Host Disease

Samsung Bioepis Initiates P-III Clinical Trial of SB17 Proposed Biosimilar to Stelara (ustekinumab)

Published: July 20, 2021 | Tags: Samsung Bioepis, P-III, Clinical Trial, SB17, Proposed Biosimilar, Stelara, ustekinumab

Regeneron's Ronapreve Antibody Cocktail (casirivimab and imdevimab) Receives MHLW's Approval for the Treatment of Mild to Moderate COVID-19

Published: July 20, 2021 | Tags: Regeneron, REGEN-COV Antibody Cocktail, casirivimab, imdevimab, MHLW, Approval, COVID-19

AstraZeneca Signs an Exclusive WW License Agreement with Aridis for Suvratoxumab to Prevent Pneumonia

Published: July 20, 2021 | Tags: AstraZeneca, License Agreement, Aridis, Suvratoxumab, Pneumonia

Genentech Reports New Data of Hemlibra (emicizumab-kxwh) in P-IIIb STASEY Study to Treat Hemophilia A

Published: July 19, 2021 | Tags: Genentech, Hemlibra, emicizumab-kxwh, P-IIIb, STASEY Study, Hemophilia A

Gilead Reports New Data of Lenacapavir in P-II/III CAPELLA Trial for the Treatment of HIV

Published: July 19, 2021 | Tags: Gilead, Lenacapavir, P-II/III, CAPELLA Trial, HIV

AstraZeneca's Imfinzi (durvalumab) Receives NMPA's Approval as a 1L Treatment of Extensive-Stage Small Cell Lung Cancer

Published: July 19, 2021 | Tags: AstraZeneca, Imfinzi, durvalumab, NMPA, Approval, Extensive-Stage Small Cell Lung Cancer

Sanofi's Fexinidazole Receives the US FDA's Approval as the First Oral Treatment for Sleeping Sickness

Published: July 19, 2021 | Tags: Sanofi, Fexinidazole, US, FDA, Approval, Sleeping Sickness

Merck's Vaxneuvance (pneumococcal 15-valent conjugate vaccine) Receives the US FDA's Approval for the Prevention of Invasive Pneumococcal Disease Caused by 15 Serotypes

Published: July 19, 2021 | Tags: Merck, Vaxneuvance, Pneumococcal 15-valent Conjugate Vaccine, US, FDA, Approval, Invasive Pneumococcal Disease, 15 Serotypes

GSK Reports Results of Daprodustat in P-III ASCEND Program for the Treatment of Anemia due to Chronic Kidney Disease

Published: July 19, 2021 | Tags: GSK, Daprodustat, Five, P-III, Studies, Anaemia, Chronic Kidney Disease

Related Post: PharmaShots Weekly Snapshots (July 12 - 16, 2021)