PharmaShots Weekly Snapshots (Jan 18 – 22, 2021)

Takeda’s Alunbrig (brigatinib) Receives MHLW’s Approval as a 1L and 2L Treatment for ALK+ Advanced or Recurrent NSCLC

Published: Jan 22, 2020 | Tags: Takeda, Alunbrig, (brigatinib), Receives, MHLW, Approval,1L and 2L, Treatment, ALK+ Advanced or Recurrent NSCLC

MTPA and Aquestive Sign a License and Supply Agreement for Exservan (riluzole) to Treat ALS in the US

Published: Jan 22, 2020 | Tags: MTPA, Aquestive ,Sign ,License ,Supply Agreement, Exservan (riluzole) ,Treat, ALS ,US

ViiV’s Cabenuva (cabotegravir and rilpivirine) Receives the US FDA’s Approval as the First and Only Complete Long-Acting Regimen for HIV treatment

Published: Jan 22, 2020 | Tags: ViiV ,Cabenuva (cabotegravir and rilpivirine), Receives ,US, FDA Approval, First and Only Complete, Long-Acting ,Regimen, HIV, treatment

Eli Lilly Reports Results of Bamlanivimab (LY-CoV555) in P-III BLAZE-2 Study for Preventing COVID-19 at Nursing Homes

Published: Jan 22, 2020 | Tags: Eli Lilly, Reports, Results, Bamlanivimab (LY-CoV555), P-III, BLAZE-2 Study, Preventing, COVID-19, Nursing Homes

Servier and MiNA Therapeutics Collaborate to Develop saRNA Therapies for Neurological Diseases

Published: Jan 22, 2020 | Tags: Servier , MiNA Therapeutics, Collaborate ,Develop ,saRNA Therapies ,Neurological Diseases

Boston Scientific to Acquire Preventice for ~$1.2B

Published: Jan 22, 2020 | Tags: Boston, Scientific, Acquire, Preventice ,~$1.2B

Roche Reports the US FDA’s Acceptance of sNDA and Granted Priority Review for Esbriet (pirfenidone) to Treat UILD

Published: Jan 21, 2020 | Tags: Roche, Reports, US, FDA, Acceptance ,sNDA ,Granted ,Priority Review ,Esbriet (pirfenidone),Treat ,UILD

Qiagen’s PCR Tests Demonstrate Effectiveness in Detecting Mutations in SARS-CoV-2 Virus

Published: Jan 21, 2020 | Tags: Qiagen’s, PCR Tests, Demonstrate ,Effectiveness ,Detecting Mutations ,SARS-CoV-2 Virus

Haemonetics to Acquire Cardiva Medical for ~$510M

Published: Jan 21, 2020 | Tags: Haemonetics, Acquire ,Cardiva Medical,  ~$510M

Bayer and Merck’s Verquvo (vericiguat) Receives the US FDA’s Approval to Treat Chronic Heart Failure

Published: Jan 21, 2020 | Tags: Bayer, Merck, Verquvo (vericiguat) ,Receives ,US ,FDA, Approval, Treat, Chronic Heart Failure

MacroGenics’ Margenza (margetuximab-cmkb) Receives the US FDA’s Patients with Pretreated Metastatic HER2-Positive Breast

Published: Jan 21, 2020 | Tags: MacroGenics, Margenza (margetuximab-cmkb), Receives, US, FDA, Pretreated, Metastatic HER2-Positive Breast

Urovant’s Gemtesa (Vibegron) Receives the US FDA’s Approval for Overactive Bladder 

Published: Jan 21, 2020 | Tags: Urovant, Gemtesa (Vibegron) ,Receives, US, FDA, Approval, Overactive Bladder

Merck KGaA and GSK’s Bintrafusp Alfa Fails to Meet its Co-Primary Endpoints in Lung Cancer Study

Published: Jan 21, 2020 | Tags: Merck KGaA, GSK, Bintrafusp Alfa, Fails, Meet, Co-Primary Endpoints, Lung Cancer, Study

Vanda’s Hetlioz (tasimelteon) Receives the US FDA’s Approval for Nighttime Sleep Disturbances in Smith-Magenis Syndrome

Published: Jan 21, 2020 | Tags: Vanda,Hetlioz (tasimelteon) ,Receives, US, FDA, Approval, Nighttime Sleep Disturbances ,Smith-Magenis Syndrome

Ridgeback’s Ebanga (mAb114) Receives the US FDA’s Approval for the Treatment of Ebola

Published: Jan 21, 2020 | Tags: Ridgeback, Ebanga (mAb114), Receives, US, FDA, Approval , Treatment, Ebola

Sorrento Presents Preliminary Results of STI-2020 Against COVID-19

Published: Jan 20, 2020 | Tags: Sorrento, Presents, Preliminary, Results, STI-2020, COVID-19

Biohaven’s Troriluzole Fails to Meet its Co-Primary Endpoints in P-II/III Study for Alzheimer’s Disease

Published: Jan 20, 2020 | Tags: Biohaven, Troriluzole, Fails, Meet, Co-Primary Endpoints, P-II/III, Study, Alzheimer’s Disease

Daiichi Sankyo and AstraZeneca’s Enhertu (trastuzumab deruxtecan) Receives EU’s Approval for the HER2 Positive Metastatic Breast Cancer

Published: Jan 20, 2020 | Tags: Daiichi Sankyo, AstraZeneca, Enhertu (trastuzumab deruxtecan), Receives, EU, Approval, HER2 Positive, Metastatic Breast Cancer

Omeros Reports the US FDA’s Acceptance and Priority Review of BLA for Narsoplimab (OMS721) to Treat HSCT-TMA

Published: Jan 20, 2020 | Tags: Omeros, Reports, US, FDA, Acceptance ,Priority Review , BLA Narsoplimab (OMS721) ,Treat, HSCT-TMA

Thermo Fisher to Acquire Mesa Biotech for $450M

Published: Jan 20, 2020 | Tags: Thermo Fisher, Acquire, Mesa Biotech, $450M

Lilly and Merus Collaborate to Discover Novel T-Cell Re-Directing Bispecific Antibodies

Published: Jan 20, 2020 | Tags: Lilly, Merus ,Collaborate ,Discover, Novel T-Cell, Re-Directing, Bispecific Antibodies

Biocryst’s Orladeyo (berotralstat) Receives the US FDA’s Approval to Prevent Attacks of Hereditary Angioedema (HAE)

Published: Jan 20, 2020 | Tags: Biocryst, Orladeyo (berotralstat), Receives, US, FDA, Approval, Prevent ,Attacks, Hereditary Angioedema (HAE)

Myovant’s Orgovyx (relugolix) Receives the US FDA’s Approval as the First Oral GnRH Receptor Antagonist for Advanced Prostate Cancer

Published: Jan 20, 2020 | Tags: Myovant, Orgovyx (relugolix), Receives, US, FDA, Approval, First Oral, GnRH Receptor Antagonist, Advanced, Prostate Cancer

Philips to Acquire Capsule Technologies for ~$635M

Published: Jan 19, 2020 | Tags: Philips, Acquire, Capsule Technologies, ~$635M

Innovent Out Licenses Byvasda’s (biosimilar, bevacizumab) Development and Commercialization Rights to PT Etana in Indonesia

Published: Jan 19, 2020 | Tags: Innovent, Out Licenses, Byvasda’s (biosimilar, bevacizumab), Development, Commercialization Rights, PT Etana, Indonesia

Grifols to Evaluate New Immunoglobulin Therapy Against COVID-19 in Spain

Published: Jan 19, 2020 | Tags: Grifols, Evaluate, New Immunoglobulin Therapy, COVID-19, Spain

Janssen Signs a Research Agreement with TenNor to Develop Treatments for Nontuberculous Mycobacteria Diseases

Published: Jan 19, 2020 | Tags: Janssen, Signs, Research Agreement, TenNor, Develop, Treatments, Nontuberculous Mycobacteria Diseases

Tessa’s CD30 CAR-T Therapy Receives EMA’s PRIME Designation for Relapsed or Refractory Classical Hodgkin Lymphoma

Published: Jan 19, 2020 | Tags: Tessa, CD30 CAR-T Therapy, Receives, EMA, PRIME Designation, Relapsed or Refractory Classical Hodgkin Lymphoma

Boehringer Ingelheim Collaborates with Cure Genetics to Develop Next-Generation Liver-Targeted Gene Therapy

Published: Jan 19, 2020 | Tags: Boehringer Ingelheim, Collaborates, Genetics, Develop, Next-Generation, Liver-Targeted, Gene Therapy

Nanobiotix Presents Results of NBTXR3 (PEP503) in P-Ib/II Study for Rectal Cancer at ASCO-GI 2021

Published: Jan 18, 2020 | Tags: Nanobiotix, Presents, Results, NBTXR3 (PEP503), P-Ib/II , Study, Rectal Cancer, ASCO-GI 2021

Cardiff Oncology Report Results of Onvansertib in P- Ib/II Study for KRAS-Mutated Metastatic Colorectal Cancer

Published: Jan 18, 2020 | Tags: Cardiff Oncology, Report, Results, Onvansertib, P- Ib/II, Study, KRAS-Mutated, Metastatic, Colorectal Cancer

Genmab’s Darzalex Faspro (daratumumab and hyaluronidase-fihj) Receives the US FDA’s Approval for Patients with Newly Diagnosed Light-chain (AL) Amyloidosis

Published: Jan 18, 2020 | Tags: Genmab, Darzalex Faspro (daratumumab and hyaluronidase-fihj), Receives, US, FDA, Approval, Patients, Newly Diagnosed, Light-chain,(AL) Amyloidosis

Daiichi Sankyo and AstraZeneca’s Enhertu Receive the US FDA’s Approval for Previously Treated HER2-Positive Advanced Gastric Cancer

Published: Jan 18, 2020 | Tags: Daiichi Sankyo, AstraZeneca, Enhertu, Receive, US, FDA, Approval, Previously, Treated, HER2-Positive, Advanced, Gastric Cancer

AstraZeneca’s Imfinzi (durvalumab) New Dosing Option Receives Approval for NSCLC in the EU & UK

Published: Jan 18, 2020 | Tags: AstraZeneca, Imfinzi (durvalumab), New Dosing Option, Receives, Approval, NSCLC, EU, UK

GSK Presents Results of Dostarlimab in P-I GARNET Study for dMMR Solid Cancers at ASCO GI

Published: Jan 18, 2020 | Tags: GSK, Presents, Results, Dostarlimab, P-I, GARNET, Study,dMMR, Solid Cancers, ASCO GI

Related Post: PharmaShots Weekly Snapshots (Jan 11- 15, 2021)