Drug Discovery World

JULY 11, 2022

As the field matures and the risks are better understood, regulators continue to streamline duplicative and burdensome oversight efforts 5. Regulatory frameworks need to be established to reduce these barriers and ensure patient safety while also facilitating expeditious development of these complex and innovative products 6.

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The Pharma Data

SEPTEMBER 9, 2020

Basel, 10 September 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) will present new ENSPRYNG® (satralizumab) data on reducing relapse severity in the treatment of neuromyelitis optica spectrum disorder (NMOSD), a rare disease of the central nervous system. Roche’s Chief Medical Officer and Head of Global Product Development.

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The Pharma Data

DECEMBER 17, 2020

Cadavid will be responsible for the strategy, direction and execution of the company’s clinical development programs. Prior to Fulcrum, Cadavid held several leadership positions at Biogen, including Senior Medical Director of the multiple sclerosis clinical development group. Immune Regulation – U.K.-based

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The Pharma Data

JANUARY 24, 2021

Sairiyo is a biotechnology company focused on repurposing and developing improved formulations of naturally derived compounds for serious, rare, and life-threatening diseases with the aim to obtain European Medicines Evaluation Agency and U.S. Research and development efforts will be led by Dr. Paul Van Slyke.

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The Pharma Data

JANUARY 25, 2021

. “ This marks our second strategic agreement with Asieris, a well-run and well-capitalized company that is executing ahead of plan on the clinical development of Cevira ®, which we licensed to them in July 2019. but with a healthcare system that is still developing. ” said Kevin Pan Ph.D.,

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The Pharma Data

JANUARY 13, 2021

Structure 3:1031-1039 (1995) 3 Waters J, Biocentury ; October 26, (2018) 4 NCT02273960; ClinicalTrials.gov ; “Study to Evaluate Safety and Efficacy in Adult Subjects With ITP (ITP)”; results posted April 1, 2019, updated July 29, 2019 and accessed Jan 11, 2021 5 Ferrant JL et al., 1 Lederman, S. International Immunol. (11):1583

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The Pharma Data

AUGUST 16, 2020

Approval supported by one of the largest clinical trial programmes undertaken for this rare disease. Chief Medical Officer and Head of Global Product Development. “We We thank the NMOSD community, including patients and investigators who participated in ENSPRYNG clinical trials.”. About Roche in neuroscience.

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The Pharma Data

DECEMBER 21, 2020

UBX1325 is developed from BM-962, a Bcl-xL inhibiting compound licensed to UNITY by Ascentage Pharma for the treatment of age-related diseases. This progress in clinical development qualifies Ascentage Pharma for a milestone payment according to the terms of the licensing agreement. SUZHOU, China and ROCKVILLE, Md. ,

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Agency IQ

SEPTEMBER 15, 2023

BY AMANDA CONTI SEP 13, 2023 1:58 PM CDT Quick background on nonprescription drug regulation Nonprescription drugs, also known as over-the-counter (OTC) drugs, are regulated differently than traditional prescription drugs. developing or amending a monograph) or sponsor-initiated operations (e.g.,

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Drug Target Review

SEPTEMBER 26, 2023

Human derived induced pluripotent stem cells (hiPSCs) have revolutionised research and are increasingly used for toxicology screening and disease modelling. 1-4 This approach saves time, money, and resources, and ultimately leads to safer medicines going forward to the clinic. Ther Innov Regul Sci. 2018 Mar;17(3):167–81.

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Agency IQ

JULY 13, 2023

December 31, 2022 [link] PDUFA 50 issue a new MAPP on approaches to address CMC challenges for CDER-regulated products (drugs, biologics) with accelerated clinical development timelines (e.g., products used to diagnose, treat, or prevent a serious disease or condition where there is unmet medical need).

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The Pharma Data

APRIL 8, 2021

OCREVUS data show its consistent benefit on slowing disease progression in relapsing multiple sclerosis (RMS) and primary progressive MS (PPMS). Data for ENSPRYNG in neuromyelitis optica spectrum disorder (NMOSD) reinforce safety and efficacy, including in patients with concomitant autoimmune diseases (CAIDs). Following U.S.

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Drug Discovery World

FEBRUARY 15, 2023

Cancer is a complex heterogenous multistep disease characterised by uncontrolled cell proliferation combined with a dysregulated immune response. The number of new cases recorded between 2016 and 2018 was 375,400, with 167,142 deaths caused by cancer between 2017 and 2019. This continues to be the standard of care.

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Agency IQ

APRIL 8, 2024

FDA updates set the stage for broader use of harmonized standards for safety reporting Though long considered a top priority by regulators, the process to standardize and harmonize the submission of individual case safety reports (ICSRs) has been slow. Periodic Benefit-Risk Evaluation Reports ). database-to-database submissions).

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The Pharma Data

MAY 18, 2021

AQP4-IgG are present in around 70-80% of people with NMOSD, who tend to experience a more severe disease course. The disease is characterised by unpredictable relapses and severe disability often occurs following the first NMOSD attack, accumulating with each subsequent relapse. Applications are under review with numerous regulators.

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The Pharma Data

SEPTEMBER 2, 2020

Initiation of Phase III clinical trial programme for fenebrutinib, an investigational medicine designed to be a highly selective and reversible Bruton’s tyrosine kinase (BTK) inhibitor, which may offer novel approach to suppress disease activity and slow disease progression in MS.

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LifeSciVC

APRIL 27, 2023

Fourteen years on, this corporate experiment has gone far beyond the initial idea, and has established an R&D engine more effective than most big pharma R&D groups at producing best-in-class small molecules against targets that matter in human disease biology. Would we wind down and exit, or chart some different path?

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The Pharma Data

OCTOBER 14, 2020

2018) PLoS One. Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. TNX-102 SL is also in development for agitation in Alzheimer’s disease and alcohol use disorder (AUD).

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The Pharma Data

NOVEMBER 22, 2020

Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. Islatravir is a promising antiviral candidate with evidence from ongoing clinical trials to support its development as a once-monthly oral PrEP agent. Forward-Looking Statement of Merck & Co.,

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The Pharma Data

DECEMBER 15, 2020

The primary endpoint of the study is the objective response rate (ORR); secondary endpoints include confirmed objective response rate (cORR), overall survival (OS), progression free survival (PFS), and disease control rate (DCR). Disease control rate (DCR). 13.2%.

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The Pharma Data

MARCH 30, 2021

Basel, 30 March 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission (EC) has approved Evrysdi (risdiplam) for the treatment of 5q spinal muscular atrophy (SMA) in patients two months of age and older, with a clinical diagnosis of SMA Type 1, Type 2 or Type 3 or with one to four SMN2 copies.

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