PharmaShots Weekly Snapshots (August 23 – 27, 2021)

 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

Related Post: PharmaShots Weekly Snapshots (August 16 – 20, 2021)

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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