FDA clears Incyte’s Opzelura as first vitiligo therapy
Incyte’s Opzelura cream has become the first medical treatment approved to re-pigment the skin of people with vitiligo in the US, adding to its current […]
Incyte’s Opzelura cream has become the first medical treatment approved to re-pigment the skin of people with vitiligo in the US, adding to its current […]
Eli Lilly and Incyte’s Olumiant has secured the first FDA approval for a systemic drug to treat alopecia areata, an autoimmune condition causing patchy hair […]
Eli Lilly and Incyte’s JAK inhibitor Olumiant reduced the risk of death by 13% in hospitalised COVID-19 patients when added to other drugs, according to […]
Incyte could be a few month away from a second FDA approval for its Opzelura cream that would make it the first medical treatment to […]
Lonza Collaborates with Codiak to Acquire its Exosomes Manufacturing Facility in Lexington, Massachusetts (US) Published: Nov 3, 2021 | Tags: Lonza, Codiak, Acquire, Exosomes Manufacturing […]
In an interview with PharmaShots, Dr. Briggs W. Morrison, MD, Chief Executive Officer and Director at Syndax share his views on the license agreement for […]
Shots: The submission is based on P-II studies i.e., CITADEL-203/204/205 that evaluate parsaclisib in patients with r/r FL, MZL & MCL. The anticipated PDUFA date […]
ADC Reports EMA’s Validation of MAA for Zynlonta to Treat R/R Diffuse Large B-Cell Lymphoma Published: 29 Oct, 2021 | Tags: ADC, EMA, MAA, Zynlonta, […]
Shots: The MAA is based on the P-III TRuE-V clinical program that consists of 2 P-III studies ie., TRuE-V1 & V2 evaluating ruxolitinib cream in […]
LEO Reports 16-week Results of Tralokinumab in P-III ECZTRA 6 Trial for the Treatment of Moderate-to-Severe Atopic Dermatitis Published: 22 Oct, 2021 | Tags: LEO, […]
Shots: Incyte will lead the development, manufacture, and supply of both products. ST will be responsible for the regulatory, distribution, and local marketing related activities […]
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, […]
Everest’s SPR206 Receives the NMPA’s IND Approval for the Treatment of MDR Gram-Negative Bacterial Infections Published: Sept 24, 2021 | Tags: Everest, SPR206, NMPA, IND, […]
Shots: The approval is based on the P-III REACH3 study evaluates the safety & efficacy of Jakafi vs BAT in patients ≥12yrs. with steroid-refractory chronic […]
Atopic dermatitis patients now have a new option that comes as a topical cream. The FDA approved Incyte’s drug, Opzelura, as a treatment for the […]
The FDA has approved Incyte’s Opzelura cream for atopic dermatitis, commonly called eczema, becoming the first and only topical JAK inhibitor registered in the US. […]
Shots: The approval is based on the TRuE-AD clinical trial program which consists of two P-III studies i.e., TRuE-AD1 & 2 evaluating the safety and […]
The European Commission has approved a BioMarin Pharmaceutical drug that treats achondroplasia, a rare genetic disorder that slows bone growth and is the most common […]
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, […]
Incyte and MorphoSys’ antibody therapy tafasitamab has been approved in Europe, promising to provide a more convenient alternative to expensive and cumbersome CAR-T therapies for […]
Shots: The conditional approval is based on the P-II L-MIND study evaluating the safety and efficacy of tafasitamab + lenalidomide in patients with r/r DLBCL […]
Janssen Presents Results of Rybrevant (amivantamab-vmjw) in P-I CHRYSALIS Study for Advanced NSCLC with METex14 Mutations at WCLC Published: Aug 20, 2021 | Tags: Astellas, […]
Immunology deals with physiological functioning of the immune system in states of both health and disease as well as malfunctions of the immune system in […]
Medtronic to Acquire Intersect ENT for ~$1.1B Published: Aug 6, 2021 | Tags: Medtronic, Intersect ENT, ~$1.1B Kite Signs a License Agreement with Appia to […]
Eli Lilly and Incyte have another rival in the rear-view mirror for Olumiant in alopecia areata after Pfizer reported that its ritlecitinib improved scalp hair […]
Roche Publishes the Results of Evrysdi (risdiplam) in FIREFISH Study to Treat of Type 1 SMA at NEJM Published: July 30, 2021 | Tags: Roche, […]
An Incyte drug developed as a treatment for a rare type of anal cancer has fallen short of FDA approval. The regulator said it needs […]
Shots: The US FDA has issued a CRL to the BLA of retifanlimab. The BLA submission is based on P-II POD1UM-202 trial assessing retifanlimab in […]
Incyte’s Pemazyre has become the first targeted therapy available for NHS patients with cholangiocarcinoma or bile duct cancer, after NICE concluded it provided value for […]
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 | […]
Incyte has made further progress with its ruxolitinib cream, notching up a phase 3 trial showing it can re-pigment skin in vitiligo ahead of a […]
AzurRx BioPharma Reports Positive Interim P-II Data of MS1819 + PERT for Cystic Fibrosis Patients with Severe Exocrine Pancreatic Insufficiency Published: May 14, 2021 | […]
Shots: The first patient has been dosed in the P-III frontMIND study evaluating tafasitamab + lenalidomide + R-CHOP vs R-CHOP alone as a 1L treatment […]
Shots: The new analyses of the P-III BREEZE-AD5 trial and an extended safety analysis across multiple trials for Olumiant (2mg, qd) vs PBO in patients […]
BMS’ Opdivo + Yervoy and Onureg Receive EC’s CHMP Positive Opinion for MPM and AML Published: Apr 23, 2021 | Tags: BMS, Opdivo, Yervoy, Onureg, […]
Shots: The first patient has been dosed in the P-IIII inMIND study assessing the efficacy and safety of tafasitamab vs PBO in combination with lenalidomide […]
Shots: The P-III COV-BARRIER study involves assessing Baricitinib (4mg, qd) + SoC (which included 79% receiving corticosteroids and 19% receiving remdesivir, with some receiving both) […]
Evotec and Exscientia Initiate Human Clinical Trials of their Novel Immuno-Oncology Drug Published: Apr 9, 2021 | Tags: Evotec and Exscientia, Initiate, Human Clinical Trials, […]
Pfizer and BioNTech Initiate COVID-19 Vaccine Trial in Children Under 12 Published: Mar 26, 2021 | Tags: Pfizer and BioNTech, Initiate, COVID-19 Vaccine Trial, Children, […]
Shots: The approval is based on the P-II FIGHT-202 study that involves assessing Pemazyre (13.5mg, qd, on a 21-day cycle) in adults aged ≥18yrs. with […]
Eli Lilly and Incyte Report Results of Olumiant (baricitinib) in P-III BRAVE-AA2 Study for Severe Alopecia Areata Published: Mar 5, 2021 | Tags: Eli Lilly […]
Regeneron Reports IDMC Clearance of Efficacy for REGEN-COV (Casirivimab + Imdevimab) in P-III COVID-19 Outpatient Outcomes Trial Published: Feb 26, 2021 | Tags: Regeneron, Reports, […]
The FDA is to begin a fast review of Incyte’s Jakafi (ruxolitinib) for patients with chronic graft-versus-host disease (GVHD), which cannot be treated with steroids. […]
Shots: The sNDA submission is based on the P-III REACH3 study assessing ruxolitinib vs best available therapy in adult and pediatric patients ≥12yrs. with steroid-refractory […]
Shots: The NDA is based on two P-III TRuE-AD 1 & 2 assessing ruxolitinib cream (0.75%/1.5%, bid) vs vehicle (non-medicated cream) in 600 patients aged […]
The biopharma industry saw numerous deal terminations in 2020. Clinical and regulatory results, change in control limitations, and strategic reprioritizations were among the most common […]
Reistone Report Results for SHR0302 in P-II Study to Treat Ulcerative Colitis Published: Feb 5, 2020 | Tags: Reiston, Report, Result, SHR0302, P-II, Study, Treat, […]
Incyte has filed its PD-1 inhibitor retifanlimab with the FDA, seeking approval to treat a form of anal cancer associated with human papillomavirus (HPV) and […]
Shots: The EMA’s CHMP has adopted a positive opinion of pemigatinib for the treatment of adults with unresectable locally advanced or metastatic cholangiocarcinoma with documented […]
Roche Collaborate with Cambridge Quantum Computing to Develop Quantum Algorithm for Drug Discovery and Development Published: Jan 29, 2020 | Tags: Roche, Collaborate, Cambridge Quantum Computing, […]
Shots: The BLA submission is based on P-II POD1UM-202 trial involves assessing of retifanlimab (500 mg, q4w) in 94 patients with locally advanced or metastatic […]
Sinopharm’s COVID-19 Vaccine Demonstrates 79% Efficacy in P-III Study Published: Dec 30, 2020 | Tags: COVID-19, Interim Analysis, New Coronavirus Inactivated Vaccine, P-lll Study, reports, […]
Shots: The companies collaborated to evaluate ruxolitinib in combination with CK0804 in patients with MF and plan to initiate a P-Ib study. Incyte will fund […]
Novartis/Incyte’s Jakafi (ruxolitinib) looks unlikely to be added to the list of therapies that can be used against COVID-19, after it failed to cut complications […]
Shots: The EUA is based on ACCT-2 study assessing baricitinib (4mg, qd for 14 days or until hospital discharge) in combination with remdesivir vs PBO […]
Immunology is an important branch of science which deals with the study of the immune system. The immune system is a highly regulated and balanced […]
Shots: The companies shared the additional efficacy and safety data of the ACTT-2 study demonstrating baricitinib + remdesivir reduced time to recovery and improved clinical […]
The FDA approved Monjuvi for second-line diffuse large B-cell lymphoma. Though the drug has the same antigen target as approved CAR-T cell therapies, it is […]
Incyte and Morphosys’ Monjuvi antibody therapy has been approved for certain patients with lymphoma, as the companies hope to provide a more convenient alternative to […]
Novartis has axed development of its mid-stage eczema drug ZPL389, taking a $485 million hit in the process. Buried deep in the Swiss company’s Q2 […]
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