Drug Discovery World

FEBRUARY 22, 2024

in 2023, fuelled by the FDA approval of its CRISPR-based ex vivo cell therapy Casgevy. Regeneron’s market capitalisation growth was attributed to the FDA approval of its high-dose Eylea – a VEGF fusion protein – for eye diseases, which may likely offset standard Eylea’s expected sales decline following looming biosimilar competition.

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Vial

APRIL 24, 2024

Introduction In a landscape where many contract research organizations (CROs) are available, Vial is breaking through with its promise to deliver on its vision to empower scientists to cure all human diseases by reimagining clinical trials. Digital therapeutics is not explicitly listed as a therapeutic area of expertise for Syneos Health.

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The Pharma Data

MAY 31, 2022

BIIB122 is an inhibitor of LRRK2, a potential novel target intended to impact the underlying biology and slow the progression of Parkinson’s disease Phase 2b LUMA to enroll approximately 640 participants with early-stage Parkinson’s disease; most advanced clinical study of a LRRK2 inhibitor. Denali Therapeutics Inc.

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Conversations in Drug Development Trends

JULY 9, 2024

The discussions at the conference shed light on innovative approaches to enhance long-term outcomes for patients, focusing on combination therapies that not only aid in weight loss but also help preserve muscle mass, an essential component of healthy body composition.

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The Pharma Data

APRIL 4, 2023

The approval includes all indications covered by the reference medicine*: rheumatic diseases, Crohn’s disease, ulcerative colitis, plaque psoriasis, uveitis and hidradenitis suppurativa. 1 “Living with a chronic disease can take a significant toll on a patient’s quality of life.

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The Pharma Data

FEBRUARY 25, 2022

Food and Drug Administration (FDA) has accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) for ABRILADA™ (adalimumab-afzb) as an interchangeable biosimilar to Humira® (adalimumab). The Biosimilar User Fee Act (BsUFA) goal date for an FDA decision is in Q4 2022. “An

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The Pharma Data

MARCH 16, 2022

(Nasdaq: BIIB) announced that The Journal of Prevention of Alzheimer’s Disease (JPAD) today published a peer-reviewed manuscript detailing data from the pivotal Phase 3 EMERGE and ENGAGE trials for ADUHELM ® (aducanumab-avwa) 100 mg/mL injection for intravenous use in early Alzheimer’s disease.

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The Pharma Data

JANUARY 12, 2021

In exchange for exclusive rights to selected autoimmune programs, Amgen will make upfront and milestone payments potentially totaling more than $240 million , as well as pay royalties on sales of resulting therapies. EVOQ Therapeutics today announced a license and collaboration agreement with Amgen. www.evoqtherapeutics.com.

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Drug Channels

OCTOBER 17, 2022

Don’t miss the chance to unite with colleagues and master the complexities of pharmacy and distribution models to accelerate patient access!

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Drug Discovery World

MARCH 29, 2023

UMNs have been defined in the context of the draft as diseases where there’s a lack of good treatments, and which have a high burden 3. For rare disease drugs, a variable RDP period of five, nine, or ten years, depending on the novelty of the drug. He pointed out that Europe was the first region to approve biosimilars.

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Drug Discovery World

MAY 1, 2023

The Commission states that, currently, there are significant gaps in addressing unmet medical needs, rare diseases and antimicrobial resistance (AMR). The EC also says that earlier availability of generic and biosimilar medicines will be facilitated, and market authorisation procedures simplified.

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The Pharma Data

MARCH 16, 2022

These are meaningful findings, which further our understanding of amyloid and downstream biomarkers, such as p-tau 181, in Alzheimer’s disease and can help inform how long patients may benefit from treatment to reduce amyloid beta plaque,” said Samantha Budd Haeberlein, Ph.D., SVP, Head of Neurodegeneration Development at Biogen.

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The Pharma Data

JUNE 25, 2021

Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. About Biogen At Biogen, our mission is clear: we are pioneers in neuroscience.

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The Pharma Data

SEPTEMBER 1, 2021

Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. About Biogen. At Biogen, our mission is clear: we are pioneers in neuroscience.

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The Pharma Data

JULY 8, 2021

Biogen discovers, develops, and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. About Biogen At Biogen, our mission is clear: we are pioneers in neuroscience.

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The Pharma Data

MARCH 22, 2021

Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. About Biogen. At Biogen, our mission is clear: we are pioneers in neuroscience.

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The Pharma Data

APRIL 9, 2021

Biogen discovers, develops, and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. About Biogen. At Biogen, our mission is clear: we are pioneers in neuroscience.

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Drug Channels

JULY 11, 2022

Director, Cell Therapy Operations and Patient Services, Gamida Cell Austin Fisher, Executive Director, CART Patient Support and Distribution, Autolus Chris Boneham, Vice President Market Access U.S.,

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The Pharma Data

MAY 26, 2023

Abstracts include new data from pivotal trials supporting ongoing regulatory reviews for three potential therapies, if approved, and new clinical data for six early pipeline assets. Chief Development Officer, Oncology and Rare Disease, Pfizer Global Product Development.

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The Pharma Data

SEPTEMBER 17, 2020

17, 2020 /PRNewswire/ — Eli Lilly and Company (NYSE:LLY) and Amgen (NASDAQ:AMGN) today announced a global antibody manufacturing collaboration to significantly increase the supply capacity available for Lilly ‘s potential COVID-19 therapies. INDIANAPOLIS and THOUSAND OAKS, Calif.

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The Pharma Data

OCTOBER 29, 2020

If approved, aducanumab would become the first therapy to reduce the clinical decline of Alzheimer’s disease and to meaningfully change the course of Alzheimer’s disease. If approved, aducanumab would become the first therapy to reduce the clinical decline in patients with Alzheimer’s disease.

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The Pharma Data

MARCH 23, 2022

“These positive results demonstrate that etrasimod, if approved, could be a potential breakthrough option for patients with ulcerative colitis who aren’t able to experience improvement on current therapies,” said Michael Corbo, Chief Development Officer, Inflammation & Immunology, Pfizer Global Product Development. About Etrasimod.

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The Pharma Data

MARCH 13, 2022

Acquisition offers new, differentiated, and potentially best-in-class approach to address needs of a broader number of patients with immuno-inflammatory diseases. In particular, we’re hopeful that we can accelerate clinical development of etrasimod successfully to have a positive impact on those living with these debilitating diseases.”.

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The Pharma Data

MARCH 5, 2021

Biogen (Nasdaq: BIIB) today announced it will host webcasts of its pre-recorded presentations and live discussions related to its Alzheimer’s disease investigational therapy, aducanumab, at the upcoming AD/PDTM 2021 Virtual Conference. AD/PD Webcast Schedule Details: Wednesday, March 10, 2021, 6:45 a.m. About Biogen.

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The Pharma Data

NOVEMBER 6, 2020

The Advisory Committee also voted 0 yes, 7 no and 4 uncertain on the question, “Does Study 103 (PRIME) provide supportive evidence of the effectiveness of aducanumab for the treatment of Alzheimer’s disease?”, Aducanumab (BIIB037) is an investigational human monoclonal antibody studied for the treatment of Alzheimer’s disease.

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The Pharma Data

MARCH 28, 2022

We are incredibly grateful for the selfless commitment of the individuals with ALS who participated in the study, and the community’s dedication to advancing research for this devastating disease,” said Toby Ferguson, M.D., Biogen Inc. Nasdaq: BIIB) and Ionis Pharmaceuticals, Inc.

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Drug Discovery World

OCTOBER 20, 2022

Similarly, biosimilars are expected to grow. This is unsurprising – our drug discovery industry does, after all, centre itself around creating initiatives that leave no one behind, from cancer therapies to malaria vaccines. . Overview . Investment and collaboration . Eisai and Biogen’s anti-amyloid beta (A?)

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The Pharma Data

MAY 2, 2022

AUSTEDO is the first and only FDA-approved product to treat both tardive dyskinesia in adults and chorea associated with Huntingdon’s disease. Food and Drug Administration in adults for the treatment of tardive dyskinesia and for the treatment of chorea associated with Huntington’s disease. On March 9, 2022, the U.S.

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The Pharma Data

APRIL 28, 2022

One of our immediate priorities following the NCD decision is to support patients on therapy who were uncertain whether they could receive their next infusion,” said Alisha Alaimo, President of Biogen’s U.S. About ADUHELM® (aducanumab-avwa) 100 mg/mL injection for intravenous use ADUHELM is indicated for the treatment of Alzheimer’s disease.

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The Pharma Data

MARCH 29, 2022

The global Phase 3 multi-center, randomized, double-blind, placebo-controlled study enrolled 433 UC patients who had previously failed or were intolerant to at least one conventional, biologic, or Janus kinase (JAK) inhibitor therapy. Participants received etrasimod 2 mg or placebo once-daily. Pfizer Inc.:

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Vial

APRIL 10, 2024

Moreover, IQVIA offers strategic partnership opportunities, multi-year contracts, and quick access to project managers and clinical research associates1,3.

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Agency IQ

MARCH 1, 2024

There are also some product-specific bioequivalence guidelines open for comment, along with concept papers proposing the development of materials on the topics of biosimilar development and non-inferiority comparisons in clinical trials.

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Drug Discovery World

AUGUST 22, 2023

This will continue to be the case going forward, but the nature of the off-patent landscape will evolve in line with ongoing changes in the segment’s ‘pipeline’: the originator products of today, which will become the generic and biosimilar medicines of tomorrow.

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The Pharma Data

MAY 2, 2022

Zuranolone has been granted Fast Track and Breakthrough Therapy Designation for MDD and Fast Track Designation for PPD by the U.S. While antidepressants are widely used to treat MDD, large-scale studies have demonstrated the need for additional therapies with a differentiated profile. Food & Drug Administration.

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The Pharma Data

JUNE 1, 2022

The CGI-S is a clinician-administered 7-point scale that rates the severity of a person’s disease at the time of assessment. . Zuranolone has been granted Fast Track and Breakthrough Therapy Designation for MDD and Fast Track Designation for PPD by the U.S. vs. placebo -1.6, p= 0.0052). Food & Drug Administration.

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Agency IQ

MARCH 29, 2024

regulatory framework Webinar/ Seminar ( OPEN ) EMA 4/17/2024 4/17/2024 CEP 2.0: regulatory framework Webinar/ Seminar ( OPEN ) EMA 4/17/2024 4/17/2024 CEP 2.0: regulatory framework Webinar/ Seminar ( OPEN ) EMA 4/17/2024 4/17/2024 CEP 2.0: regulatory framework Webinar/ Seminar ( OPEN ) EMA 4/17/2024 4/17/2024 CEP 2.0:

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FDA Law Blog: Biosimilars

APRIL 10, 2023

Booker opined that the Act would expedite rescheduling schedule I substances that receive breakthrough therapy designation to schedule II that “with DEA oversight-will enable patient access and reduce the burden on further clinical investigation.” Booker & Paul introduce the Breakthrough Therapies Act for Veterans and Patients, Mar.

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