Tags : Novo Nordisk

PharmaShots Weekly Snapshots (July 12 – 16, 2021)

Tuba Khan July 16, 2021

Eli Lilly Signs an Agreement with Banner Alzheimer’s Institute to Evaluate Donanemab in P-III TRAILBLAZER-ALZ 3 Trial for Alzheimer’s Disease Published: July 16, 2021 | Tags: Eli Lilly, Banner Alzheimer’s Institute, Donanemab, P-III, TRAILBLAZER-ALZ 3 Trial, Alzheimer Disease AcelRx Signs a License Agreement with Aguettant to Commercialize Dzuveo in EU and for Two Pre-Filled Syringe […]Read More

Insights+

Insights+: The US FDA New Drug Approvals in June 2021

Tuba Khan July 15, 2021

The US FDA has approved 6 NDAs and 2 BLAs in 2021, leading to treatments for patients and advances in the health care industry The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 37 novel products in 2021 Additionally, last year in 2020, the US FDA […]Read More

Biotech

Novo Nordisk to Acquire Prothena’s ATTR Amyloidosis Program for ~$1.2B

Tuba Khan July 13, 2021

Shots: Prothena is eligible to receive ~$1.2B as development and commercial milestones including $100M as up front and near-term clinical milestones Novo Nordisk acquires Prothena’s subsidiary and gets WW rights to the IP and related rights of Prothena’s ATTR amyloidosis business and pipeline. Novo Nordisk will develop the P-II ready Ab PRX004 for ATTR cardiomyopathy […]Read More

Insights+

PharmaShots’ Key Highlights of Second Quarter 2021

Tuba Khan July 1, 2021

The second quarter of 2021 witnesses major acquisitions, approvals, and clinical data. There are major alliances in this quarter which include Merck signed ~$1.2B supply agreement with US Government for Molnupiravir to treat COVID-19 The big acquisition took place during the quarter including Microsoft acquired Nuance for ~$19.7B, MorphoSys acquired Constellation for ~$1.7B Our team […]Read More

Weekly Snapshot

PharmaShots Weekly Snapshots (June 07 – 11, 2021)

Tuba Khan June 11, 2021

Vertex and CRISPR Therapeutics Present New Data of CTX001 from 22 Patients with TDT and SCD at EMA 2021 Published: June 11, 2021 | Tags: Vertex, CRISPR Therapeutics, CTX001, TDT, SCD, EMA 2021 AbbVie Reports Results of Four-Year Follow-Up Analysis in P-III CLL14 Trial for Venclyxto/Venclexta to Treat Chronic Lymphocytic Leukemia Published: June 11, 2021 […]Read More

Regulatory

Novo Nordisk’s Wegovy (semaglutide, 2.4mg) Receives the US FDA’s Approval

Tuba Khan June 7, 2021

Shots: The approval is based on the results from the P-IIIa STEP clinical trial program evaluating Wegovy (2.4mg injection, qw) in ~4,500 adults with obesity or overweight with at least one weight-related comorbidity Results: the therapy showed 17-18% average weight loss in people without T2D @68wks. and has a safe and well-tolerated profile across the […]Read More

Weekly Snapshot

PharmaShots Weekly Snapshots (May 31 – June 4, 2021)

Tuba Khan June 4, 2021

Tonix Pharmaceuticals Presents Results of TNX-102 SL in P-III RELIEF study for the Management of Fibromyalgia at ASCP 2021 Published: June 4, 2021 | Tags: Tonix Pharmaceuticals, TNX-102 SL, P-III, RELIEF Study, Fibromyalgia, ASCP 2021 Dermavant Submits NDA to the US FDA for Tapinarof Cream to Treat Plaque Psoriasis Published: June 4, 2021 | Tags: […]Read More

Regulatory

Novo Nordisk Resubmits Label Expansion Application to the US FDA

Tuba Khan May 31, 2021

Shots: The company has announced the resubmission of a label expansion application to the US FDA for the existing marketing authorization for Ozempic to introduce a new dose of 2.0mg for the Treatment of T2D The resubmission follows the Refusal to File letter received by the FDA on 22 March 2021. The standard review time […]Read More

Weekly Snapshot

PharmaShots Weekly Snapshots (May 10 – 14, 2021)

Tuba Khan May 14, 2021

AzurRx BioPharma Reports Positive Interim P-II Data of MS1819 + PERT for Cystic Fibrosis Patients with Severe Exocrine Pancreatic Insufficiency Published: May 14, 2021 | Tags: AzurRx BioPharma, P-II, MS1819, PERT, Cystic Fibrosis, Severe, Exocrine Pancreatic Insufficiency Goldfinch Bio Initiates P-I Clinical Trial of GFB-024 for the Treatment of Severe Insulin Resistant Diabetic Nephropathy Published: […]Read More

Clinical Trials

Novo Nordisk Reports Results of Semaglutide from P-IIIa STEP 1

Tuba Khan May 14, 2021

Shots: The company reported the results from the P-IIIa STEP 1 trial of the STEP programme assessing semaglutide (2.4 mg, SC, qw) vs PBO in adults with obesity for 68 wks. The results will be presented at ECO 2021 Results: The therapy showed 14.9% weight loss, 43.8% improvement in total weight-related QoL scores, 51.2% vs […]Read More

Takeda Enters into an Exclusive License Agreement with Mirum to Develop and Commercialize Maralixibat for Rare Pediatric Liver Diseases in Japan

Amgen Collaborates with Verastem to Evaluate VS-6766 + Lumakras (Sotorasib) in P-I/II Trial for KRAS G12C-Mutant Non-Small Cell Lung Cancer

Immunic Sign a License Agreement with University Medical Center Goettingen for IMU-838 & N4-Hydroxycytidine to Treat Viral Infections

AbCellera Enters into a License Agreement with Everest to Discover Antibody Therapies

Samsung Bioepis and Biogen’s Byooviz (biosimilar, ranibizumab) Receives the US FDA’s Approval for the Treatment of Retinal Vascular Disorders

Samsung Bioepis Reports Results of Post-Hoc Analysis from P-III Study of Byooviz (biosimilar, ranibizumab) for the Treatment of nAMD

Immunic Sign a License Agreement with University Medical Center Goettingen for IMU-838 & N4-Hydroxycytidine to Treat Viral Infections

Gilead Reports Results of Veklury (remdesivir) in P-III Trial for the Treatment of COVID-19

Incyte’s Jakafi (ruxolitinib) Receives the US FDA’s Approval for the Treatment of Chronic Graft-Versus-Host Disease

Innovent Reports NMPA’s Acceptance of sNDA for Sintilimab as 1L Treatment for Esophageal Squamous Cell Carcinoma

Gilead Reports Results of Veklury (remdesivir) in P-III Trial for the Treatment of COVID-19

Vigeo Reports Completion of VT1021 in P-I/II Study for the Treatment of Recurrent Glioblastoma and Pancreatic Cancer

Tags : Novo Nordisk

PharmaShots Weekly Snapshots (July 12 – 16, 2021)

Insights+: The US FDA New Drug Approvals in June 2021

Novo Nordisk to Acquire Prothena’s ATTR Amyloidosis Program for ~$1.2B

PharmaShots’ Key Highlights of Second Quarter 2021

PharmaShots Weekly Snapshots (June 07 – 11, 2021)

Novo Nordisk’s Wegovy (semaglutide, 2.4mg) Receives the US FDA’s Approval

PharmaShots Weekly Snapshots (May 31 – June 4, 2021)

Novo Nordisk Resubmits Label Expansion Application to the US FDA

PharmaShots Weekly Snapshots (May 10 – 14, 2021)

Novo Nordisk Reports Results of Semaglutide from P-IIIa STEP 1

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ViewPoints Article: 5 Technologies That Redefines Human Medicine and Therapeutics

Immunic Sign a License Agreement with University Medical Center Goettingen for IMU-838 & N4-Hydroxycytidine to Treat Viral Infections

Gilead Reports Results of Veklury (remdesivir) in P-III Trial for the Treatment of COVID-19

Incyte’s Jakafi (ruxolitinib) Receives the US FDA’s Approval for the Treatment of Chronic Graft-Versus-Host Disease

Tags : Novo Nordisk

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