PharmaShots Weekly Snapshots (September 27 – October 01, 2021)

BMS Reports EMA’s Validation of MAA for Relatlimab and Nivolumab as 1L Treatment for Unresectable or Metastatic Melanoma

Published: Oct 1, 2021 | Tags: BMS, EMA, MAA, Relatlimab, Nivolumab, Metastatic Melanoma

Merck and Ridgeback Report Interim Results of Molnupiravir in P-III MOVe-OUT Trial for the Treatment of COVID-19

Published: Oct 1, 2021 | Tags: Merck, Ridgeback, Molnupiravir, P-III, MOVe-OUT Trial, COVID-19

Sanofi Presents Results of Amlitelimab (KY1005) in P-IIa Study for the Treatment of Moderate-To-Severe Atopic Dermatitis at EADV 2021

Published: Oct 1, 2021 | Tags: Sanofi, Amlitelimab, KY1005, P-IIa, Study, Atopic Dermatitis, EADV 2021

Dermavant Presented Long-Term Results of Tapinarof in P-III PSOARING 3 Study for the Treatment of Plaque Psoriasis at EADV

Published: Oct 1, 2021 | Tags: Dermavant, Tapinarof, P-III, PSOARING 3 Study, Plaque Psoriasis, EADV

Novartis Presented Results of Remibrutinib (LOU064) in P-IIb Study for the Treatment of Chronic Spontaneous Urticaria at EADV

Published: Oct 1, 2021 | Tags: Novartis, Remibrutinib, LOU064, P-IIb, Study, Chronic Spontaneous Urticaria, EADV

Otsuka Enters into a WW License Agreement with Sunovion and Sumitomo Dainippon to Develop and Commercialize Neuropsychiatric Candidates

Published: Oct 1, 2021 | Tags: Otsuka, Sumitomo Dainippon, Neuropsychiatric Compounds

Merck to Acquire Acceleron for ~$11.5B

Published: Sept 30, 2021 | Tags: Merck, Acquire, Acceleron, ~$11.5B

Eli Lilly Reports Results of Tirzepatide in P-III SURPASS-3 MRI Sub-Study for the Treatment of Type 2 Diabetes

Published: Sept 30, 2021 | Tags: Eli Lilly, Tirzepatide, P-III, SURPASS-3 MRI Sub-Study, Type 2 Diabetes

Takeda Signs an Exclusive License Agreement with JCR to Commercialize JR-141 for the Treatment of Hunter Syndrome

Published: Sept 30, 2021 | Tags: Takeda, JCR, JR-141, Hunter Syndrome

TransMedics’ OCS Liver System Receives the US FDA’s Approval for Liver Transplantation

Published: Sept 30, 2021 | Tags: TransMedics, OCS Liver System, US, FDA, Approval, Livers Transplantation

Janssen Initiates P-III EVERGREEN Study of RSV Vaccine for the Treatment of Lower Respiratory Tract Disease Due to Respiratory Syncytial Virus

Published: Sept 30, 2021 | Tags: Janssen, P-III, EVERGREEN Study, RSV Vaccine, Lower Respiratory Tract Disease, Respiratory Syncytial Virus

Regeneron Publishes the Results of REGEN-COV (casirivimab and imdevimab) in P-III Trial for COVID-19 in NEJM

Published: Sept 30, 2021 | Tags: Regeneron, REGEN-COV, casirivimab, imdevimab, P-III, Trial, COVID-19, NEJM

Medtronic’s Radial Artery Catheter Device Receives CE Mark Approval for the Treatment of Neurovascular Diseases

Published: Sept 29, 2021 | Tags: Medtronic, Radial Artery Catheter Device, CE Mark, Approval, Neurovascular Diseases

Novartis Reports Results of ligelizumab (QGE031) in P-IIb Study for the Treatment of Chronic Spontaneous Urticaria

Published: Sept 29, 2021 | Tags: Novartis, ligelizumab, QGE031, P-IIb, Study, Chronic Spontaneous Urticaria

ViiV Healthcare Presents Three-Year Results of Dovato (dolutegravir/lamivudine) in P-III TANGO Study for the Treatment of HIV at IDWeek 2021

Published: Sept 29, 2021 | Tags: ViiV Healthcare, Dovato, dolutegravir, lamivudine, P-III, TANGO Study, HIV, IDWeek 2021

AstraZeneca to Acquire Caelum for ~500M

Published: Sept 29, 2021 | Tags: AstraZeneca, Acquire, Caelum, ~500M

AbbVie’s Qulipta (atogepant) Receives the US FDA’s Approval for the Treatment of Migraine

Published: Sept 29, 2021 | Tags: AbbVie, Qulipta, atogepant, US, FDA, Approval, Migraine

The US FDA Approves New Indication for Lilly’s Erbitux (cetuximab) + Braftovi (encorafenib) to Treat Metastatic Colorectal Cancer with a BRAF V600E Mutation

Published: Sept 29, 2021 | Tags: Lilly, Erbitux, cetuximab, Braftovi, encorafenib, US, FDA, Approval, Metastatic Colorectal Cancer, BRAF V600E Mutation

Boehringer Ingelheim Signs an Agreement with Invetx to Develop and Commercialize Novel Veterinary Therapies

Published: Sept 28, 2021 | Tags: Boehringer Ingelheim, Invetx, Veterinary Therapies

ViiV Healthcare Signs an Exclusive License Agreement with Shionogi to Develop S-365598 for HIV

Published: Sept 28, 2021 | Tags: ViiV Healthcare, Shionogi, S-365598, HIV

Eisai Initiates Rolling Submission of BLA to the US FDA for Lecanemab to Treat Alzheimer’s Disease

Published: Sept 28, 2021 | Tags: Eisai, BLA, US, FDA, Lecanemab, Alzheimer’s Disease

AstraZeneca’s Saphnelo (anifrolumab) Receives MHLW’s Approval for the Treatment of Systemic Lupus Erythematosus

Published: Sept 28, 2021 | Tags: AstraZeneca, Saphnelo, anifrolumab, MHLW, Approval, Systemic Lupus Erythematosus

Innovent Signs a License Agreement with Union to Develop & Commercialize Orismilast for Inflammatory Dermatology Conditions in China

Published: Sept 28, 2021 | Tags: Innovent, Union, Orismilast, Inflammatory Dermatology Conditions

Bio-Thera Signs a License Agreement with Intract for Soteria and Phloral Technologies to Develop Oral Antibody Therapies

Published: Sept 28, 2021 | Tags: Bio-Thera, Intract, Soteria, Phloral, Antibody Therapies

Incyte Enters into an Exclusive WW License Agreement with Syndax to Develop and Commercialize Axatilimab for cGVHD and Other Fibrotic Diseases

Published: Sept 27, 2021 | Tags: Incyte, Syndax, Axatilimab, cGVHD, Fibrotic Diseases

Takeda’s Alofisel (darvadstrocel) Receives MHLW’s Approval for the Treatment of Complex Perianal Fistulas with Non-active or Mildly Active Luminal CD

Published: Sept 27, 2021 | Tags: Takeda, Alofisel, darvadstrocel, MHLW, Approval, Complex Perianal Fistulas, Active Luminal CD

Astellas and Seagen’s Padcev (enfortumab vedotin) Receive MHLW’s Approval for the Treatment of Radically Unresectable Urothelial Carcinoma

Published: Sept 27, 2021 | Tags: Astellas, Seagen, Padcev, enfortumab vedotin, MHLW, Approval, Advanced Urothelial Cancer

JW Reports One-Year Follow-Up Results of Relmacabtagene Autoleucel in P-II RELIANCE Study for the Treatment of R/R LBCL at CSCO 2021

Published: Sept 27, 2021 | Tags: JW, Relmacabtagene Autoleucel, P-II, RELIANCE Study, R/R LBCL, CSCO 2021

Innovent and AnHeart Report Interim Results of Taletrectinib (AB-106) in P-II TRUST Trial for the Treatment of ROS1-Positive NSCLC at CSCO 2021

Published: Sept 27, 2021 | Tags: Innovent, AnHeart, Taletrectinib, AB-106, P-II, TRUST Trial, ROS1-Positive NSCLC, CSCO 2021

Amgen’s Repatha (evolocumab) Receives the US FDA’s Approval for the Treatment of Heterozygous Familial Hypercholesterolemia

Published: Sept 27, 2021 | Tags: Amgen, Repatha, evolocumab, US, FDA, Approval, Heterozygous Familial Hypercholesterolemia

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