Phthalimides

Global Coalition for Adaptive Research Announces the Discontinued Evaluation of Apremilast in REMAP-COVID

Retrieved on: 
Monday, July 12, 2021

Global Coalition for Adaptive Research, the U.S.

Key Points: 
  • Global Coalition for Adaptive Research, the U.S.
  • Sponsor of REMAP-COVID, announced that Amgens apremilast (Otezla) has ended evaluation in the REMAP-COVID study.
  • Apremilast was evaluated within one of two domains of the study evaluating immune modulation.
  • This vital research is being conducted in collaboration with Berry Consultants, leaders in statistical design for adaptive platform trials, and is being supported by governments and non-profits worldwide.

Investigation Report on China's Lenalidomide Market 2021-2025 - ResearchAndMarkets.com

Retrieved on: 
Monday, May 10, 2021

b'The "Investigation Report on China\'s Lenalidomide Market 2021-2025" report has been added to ResearchAndMarkets.com\'s offering.\nLenalidomide is an oral immunomodulatory drug that is mainly used to treat blood cancers such as multiple myeloma, myelodysplastic syndrome, and lymphoma.

Key Points: 
  • b'The "Investigation Report on China\'s Lenalidomide Market 2021-2025" report has been added to ResearchAndMarkets.com\'s offering.\nLenalidomide is an oral immunomodulatory drug that is mainly used to treat blood cancers such as multiple myeloma, myelodysplastic syndrome, and lymphoma.
  • Celgene\'s Lenalidomide, REVLIMID was launched in China in 2013.
  • In addition to Celgene, the other manufacturers in the Chinese Lenalidomide market are Chia Tai Tianqing Pharmaceutical, Qilu Pharmaceutical, and Beijing SL Pharmaceutical.\nSales revenue of Lenalidomide in the Chinese market has an increasing trend from 2016 to 2020.
  • Especially after Lenalidomide was included in the national medical insurance catalog in the second half of 2017, the annual growth rate in 2018 reached 547.4%.

FDA Accepts Amgen's Supplemental New Drug Application For Otezla® (apremilast) For Adults With Mild-To-Moderate Plaque Psoriasis

Retrieved on: 
Wednesday, May 5, 2021

The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of December 19, 2021.\n"Otezla has been prescribed to hundreds of thousands of patients with moderate-to-severe plaque psoriasis.

Key Points: 
  • The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of December 19, 2021.\n"Otezla has been prescribed to hundreds of thousands of patients with moderate-to-severe plaque psoriasis.
  • The study randomized 595 patients 1:1 to receive Otezla (n=297) 30 mg twice daily or placebo (n=298) for the first 16 weeks.
  • PDE4 inhibition results in increased intracellular cAMP levels, which is thought to indirectly modulate the production of inflammatory mediators.
  • Depression was reported as serious in 0.1% (1/1308) of patients exposed to Otezla, compared to none in placebo-treated patients (0/506).

NeonMind CEO Provides Update on the Progress of its Psilocybin Drug Development Research Plan and Team

Retrieved on: 
Tuesday, March 23, 2021

He has played a key role in corporate development in multiple licensing, M&A deals and capital raises.

Key Points: 
  • He has played a key role in corporate development in multiple licensing, M&A deals and capital raises.
  • Mr. Martin previously led the development and commercialization of the blockbuster drug OTEZLA, , and oversaw the development of the inflammation and immunology franchise at Celgene.
  • In its pharmaceutical division, NeonMind has two distinct psilocybin drug development programs targeting obesity.
  • Participation by Albert Garcia-Romeu as an advisor to NeonMind does not constitute or imply endorsement of NeonMind by Johns Hopkins University.

Quantum Leap Healthcare Collaborative Concludes Apremilast Not Likely to Reduce Time to Recovery or Mortality in Critically Ill Patients in I-SPY COVID Trial

Retrieved on: 
Friday, March 12, 2021

SAN FRANCISCO, March 12, 2021 /PRNewswire/ --Quantum Leap Healthcare Collaborative (QLHC), the sponsor of the I-SPY COVID Trial, announced that apremilast (Otezla), made by Amgen, has been dropped for futility.

Key Points: 
  • SAN FRANCISCO, March 12, 2021 /PRNewswire/ --Quantum Leap Healthcare Collaborative (QLHC), the sponsor of the I-SPY COVID Trial, announced that apremilast (Otezla), made by Amgen, has been dropped for futility.
  • The I-SPY COVID Trial is a phase II, open label, adaptive platform trial being conducted in critically ill COVID-19 patients who are receiving high flow oxygen or mechanical ventilation.
  • Patients assigned to the apremilast arm received backbone therapy in combination with 30 mg twice daily of apremilast for up to 14 days.
  • Under the terms of the collaboration agreement, Quantum Leap Healthcare Collaborative is the trial sponsor and manages all study operations.

Recent Otezla Growth: A Result of the Amgen Acquisition or Benefiting from the Pandemic?

Retrieved on: 
Wednesday, February 10, 2021

However, Otezla became more top of mind for dermatologists when adjusting to the shifting dynamics caused by the COVID-19 pandemic.

Key Points: 
  • However, Otezla became more top of mind for dermatologists when adjusting to the shifting dynamics caused by the COVID-19 pandemic.
  • The brand continues to dominate as a first-line advanced systemic option, mainly a result of the agent's oral administration and safety.
  • Additionally, while Otezla is typically applauded for its safety profile, tolerability (namely GI issues) poses a threat for the brand.
  • Bristol Myers Squibb Announces Positive Topline Results from Second Pivotal Phase 3 Psoriasis Study Showing Superiority of Deucravacitinib Compared to Placebo and Otezla (apremilast).

Immunotherapy Veteran Robert Knight, MD, Joins NexImmune as Chief Medical Officer

Retrieved on: 
Monday, January 18, 2021

Dr. Knight is a seasoned executive with extensive experience leading early- and late-stage immunotherapy product development teams.

Key Points: 
  • Dr. Knight is a seasoned executive with extensive experience leading early- and late-stage immunotherapy product development teams.
  • During his tenure at Celgene, he helped lead the development of the companys IMiD and targeted therapy programs, including thalidomide, lenalidomide, and enasidenib.
  • We are excited to welcome Bob to the NexImmune team, said Scott Carmer, NexImmune Chief Executive Officer.
  • I am thrilled to join the NexImmune team as Chief Medical Officer at this important point in the Companys lifecycle, said Dr. Knight.

Amgen Licenses AMG 634, An Investigational Treatment For Tuberculosis And Leprosy, To Medicines Development for Global Health

Retrieved on: 
Tuesday, December 22, 2020

Amgen had acquired AMG 634 (formerly CC-11050) as part of its acquisition of Otezla(apremilast) from Celgene in 2019.

Key Points: 
  • Amgen had acquired AMG 634 (formerly CC-11050) as part of its acquisition of Otezla(apremilast) from Celgene in 2019.
  • Under the terms of the agreement, MDGH will assume full responsibility for the further development and commercialization of AMG 634.
  • "MDGH's track record and experience in product development, global health, and neglected infectious diseases makes them an ideal company to further develop AMG 634 for the benefit of patients."
  • "MDGH is dedicated to developing and delivering medicines for diseases that disproportionally affect people in low- and middle-income countries.

Updated Results from the Phase 1 Study of the BCMAxCD3 Bispecific Teclistamab Show Preliminary Efficacy in Patients with Heavily Pretreated Relapsed or Refractory Multiple Myeloma

Retrieved on: 
Saturday, December 5, 2020

We continue to identify new treatment options, particularly for patients who have relapsed or become refractory to existing therapies.

Key Points: 
  • We continue to identify new treatment options, particularly for patients who have relapsed or become refractory to existing therapies.
  • Updated Phase 1 Results of Teclistamab, a B-cell Maturation Antigen (BCMA) CD3 Bispecific Antibody, in Relapsed and/or Refractory Multiple Myeloma (RRMM).
  • Translational Approach of Using Ex Vivo Cytotoxicity and Early Clinical Data to Predict Teclistamab Efficacious Therapeutic Range in Multiple Myeloma Patients.
  • Risk of progression and survival in multiple myeloma relapsing after therapy with IMiDs and bortezomib: a multicenter international myeloma working group study.

Legend Biotech Announces Phase 1b/2 Study Data of Cilta-cel, an Investigational BCMA CAR-T, Showing Early, Deep, and Durable Responses in Heavily Pretreated Patients with Multiple Myeloma

Retrieved on: 
Saturday, December 5, 2020

Median time to first response was 1 month (range, 0.9-8.5) and responses were ongoing in 72 percent (n=70) of patients.

Key Points: 
  • Median time to first response was 1 month (range, 0.9-8.5) and responses were ongoing in 72 percent (n=70) of patients.
  • In December 2017, Legend Biotech, Inc. entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc. (Janssen) to develop and commercialize cilta-cel.
  • Cartitude-1: Phase 1b/2 Study of Ciltacabtagene Autoleucel, a B-Cell Maturation AntigenDirected Chimeric Antigen Receptor T Cell Therapy, in Relapsed/Refractory Multiple Myeloma.
  • Risk of progression and survival in multiple myeloma relapsing after therapy with IMiDs and bortezomib: a multicenter international myeloma working group study.