PharmaShots Weekly Snapshots (August 23 – 27, 2021)

Ascendis’ Skytrofa (lonapegsomatropin-tcgd) Receives the US FDA’s Approval for Pediatric Growth Hormone Deficiency

Published: Aug 27, 2021 | Tags: Ascendis, Skytrofa, lonapegsomatropin-tcgd, US, FDA, Approval, Pediatric Growth Hormone Deficiency

Amgen Presents Results of Repatha (evolocumab) in P-III HUYGENS Study for the Treatment of Acute Coronary Syndrome at ESC 2021

Published: Aug 27, 2021 | Tags: Amgen, Repatha, evolocumab, P-III, HUYGENS Study, Acute Coronary Syndrome, ESC 2021

Innovent Collaborates with Bolt to Develop Three Oncology Boltbody ISAC Programs

Published: Aug 27, 2021 | Tags: Innovent, Bolt, Develop, Boltbody ISAC Programs

BeyondSpring Signs an Exclusive Agreement with Jiangsu Hengrui to Co- Develop & Commercialize Plinabulin in Greater China

Published: Aug 27, 2021 | Tags: BeyondSpring, Commercialization Agreement, Jiangsu Hengrui, Co- Develop, Commercialize, Plinabulin, Greater China

MorphoSys and Incyte’s Minjuvi (tafasitamab) + Lenalidomide Receive EC’s Approval for the Treatment of R/R DLBCL

Published: Aug 27, 2021 | Tags: MorphoSys, Incyte, Minjuvi, tafasitamab, Lenalidomide, EC, Approval, R/R DLBCL

NovaRock Signs an Exclusive License Agreement with Flame to Co-Develop and Commercialize NBL-015

Published: Aug 27, 2021 | Tags: NovaRock, Flame, Co-Develop, Commercialize, NBL-015

AstraZeneca’s ALXN1840 Meets its Primary Endpoint in P-III FoCus Trial for the Treatment of Wilson Disease

Published: Aug 26, 2021 | Tags: AstraZeneca, ALXN1840, P-III, FoCus Trial, Wilson Disease

Pfizer and BioNTech Initiate Rolling Submission of sBLA for the US FDA’s Approval of Comirnaty’s Booster Dose in Individuals Aged 16 Years and Older

Published: Aug 26, 2021 | Tags: Pfizer, BioNTech, Rolling Submission, sBLA, US, FDA, Approval, Comirnaty Booster Dose

AstraZeneca’s Forxiga (dapagliflozin) Receives MHLW’s Approval for the Treatment of Chronic Kidney Disease in Patients with and without T2D

Published: Aug 26, 2021 | Tags: AstraZeneca, Forxiga, dapagliflozin, MHLW, Approval, Chronic Kidney Disease

Merck Reports Results of Vaxneuvance (pneumococcal 15-valent conjugate vaccine) in P-III PNEU-PED Study for the Prevention of Invasive Pneumococcal Disease

Published: Aug 26, 2021 | Tags: Merck, Vaxneuvance, pneumococcal 15-valent conjugate vaccine, P-III, PNEU-PED Study, Invasive Pneumococcal Disease

Thermo Fisher’s Oncomine Dx Target Test Receives the US FDA’s Approval as a CDx for the Treatment of IDH1-Mutated Cholangiocarcinoma

Published: Aug 26, 2021 | Tags: Thermo Fisher, Oncomine Dx Target Test, US, FDA, Approval, CDx, IDH1-Mutated Cholangiocarcinoma

Lilly Signs a License Agreement with Lycia to Develop Novel LYTAC Degraders

Published: Aug 26, 2021 | Tags: Lilly, Lycia, LYTAC Degraders

Cara and Vifor’s Korsuva (difelikefalin) Receive the US FDA’s Approval for the Treatment of Moderate-to-Severe Pruritus Due to CKD in Patients with Hemodialysis

Published: Aug 25, 2021 | Tags: Cara, Vifor, Korsuva, difelikefalin, US, FDA, Approval, Pruritus, Hemodialysis

Argenx Reports EMA’s Validation of MAA for Efgartigimod to Treat Generalized Myasthenia Gravis

Published: Aug 25, 2021 | Tags: Argenx, EMA, MAA, Efgartigimod, Generalized Myasthenia Gravis

Takeda and Ono’s Opdivo (nivolumab) + Cabometyx (cabozantinib) Receive MHLW’s Approval for the Treatment of Unresectable or Metastatic Renal Cell Carcinoma

Published: Aug 25, 2021 | Tags: Ono, Takeda, Opdivo, nivolumab, Cabometyx, cabozantinib, MHLW, Approval, Renal Cell Carcinoma, Japan

Vertex Expands its 2018 Agreement with Arbor to Develop Novel Ex Vivo Engineered Cell Therapies

Published: Aug 25, 2021 | Tags: Vertex, Arbor, Ex Vivo Engineered Cell Therapies, CRISPR Gene-Editing Technology

AbbVie’s Rinvoq (upadacitinib) Receives EC’s Approval for the Treatment of Moderate to Severe Atopic Dermatitis

Published: Aug 25, 2021 | Tags: AbbVie, Rinvoq, upadacitinib, EC, Approval, for the Treatment of Moderate to Severe Atopic Dermatitis

Roche Signs a License Agreement with Shape to Advance AAV-based RNA Editing Technology for Neuroscience and Rare Disease

Published: Aug 25, 2021 | Tags: Roche, Shape, AAV-based RNA Editing Technology, Neuroscience, Rare Disease

UCB’s Bimzelx (bimekizumab) Receives EC’s Approval for the Treatment of Moderate to Severe Plaque Psoriasis

Published: Aug 24, 2021 | Tags: UCB, Bimzelx, bimekizumab, EC, Approval, Plaque Psoriasis

Novartis’ Kymriah (tisagenlecleucel) Fails to Meet its Primary Endpoint in P-III BELINDA Study as 2L Treatment in Aggressive B-Cell Non-Hodgkin Lymphoma

Published: Aug 24, 2021 | Tags: Novartis, Kymriah, tisagenlecleucel, P-III, BELINDA Study, Aggressive B-Cell Non-Hodgkin Lymphoma

Merck KGaA and GSK Discontinue P-II INTR@PID BTC 055 Study of Bintrafusp Alfa as 1L Treatment of Biliary Tract Cancer

Published: Aug 24, 2021 | Tags: Merck KGaA, GSK, Discontinue, P-II, INTR@PID BTC 055 Study, Bintrafusp Alfa, Biliary Tract Cancer

Theravance Reports Results of Izencitinib in P-IIb Dose-Finding Induction Study for the Treatment of Ulcerative Colitis

Published: Aug 24, 2021 | Tags: Theravance, Izencitinib, P-IIb, Dose-Finding, Induction Study, Ulcerative Colitis

Takeda Signs a License Agreement with Genevant to Develop and Commercialize Novel Nonviral Gene Therapies for Liver Diseases

Published: Aug 24, 2021 | Tags: Takeda, Genevant, Novel Nonviral Gene Therapies, Liver Diseases

Pfizer and BioNTech’s Comirnaty Receive the US FDA’s Approval to Prevent COVID-19 in Individuals Aged 16 Years and Older

Published: Aug 24, 2021 | Tags: Pfizer-BioNTech, Covid-19 Vaccine, Comirnaty, US, FDA, Approval, COVID-19

Pfizer to Acquire Trillium for ~$2.26B

Published: Aug 23, 2021 | Tags: Pfizer, Acquire, Trillium, ~$2.26B

Alexion to Discontinue its P-III CHAMPION-ALS Trial of Ultomiris (ravulizumab) for Amyotrophic Lateral Sclerosis

Published: Aug 23, 2021 | Tags: Alexion, P-III, CHAMPION-ALS Trial, Ultomiris, ravulizumab, Amyotrophic Lateral Sclerosis

Zydus’ ZyCoV-D Receives the DCGI’s EUA for the Treatment of COVID-19

Published: Aug 23, 2021 | Tags: Zydus, ZyCoV-D, DCGI, EUA, COVID-19

Pfizer’s Xeljanz (tofacitinib citrate) Receives EC’s Approval for the Treatment of Active Polyarticular JIA & Juvenile PsA

Published: Aug 23, 2021 | Tags: Pfizer, Xeljanz, tofacitinib citrate, EC Approval, Active Polyarticular JIA, Juvenile PsA

BeiGene Reports NMPA’s Acceptance of sBLA for Tislelizumab (BGB-A317) to Treat Nasopharyngeal Cancer in China

Published: Aug 23, 2021 | Tags: BeiGene, NMPA, sBLA, Tislelizumab, Nasopharyngeal Cancer, China

BMS’ Opdivo(nivolumab) Receives the US FDA’s Approval for the Adjuvant Treatment of High-Risk Urothelial Carcinoma

Published: Aug 23, 2021 | Tags: BMS, Opdivo, nivolumab, US, FDA, Approval, Urothelial Carcinoma

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