Quanticate

SEPTEMBER 25, 2024

In rheumatoid arthritis (RA) clinical trials, accurately measuring the effectiveness of treatments is critical for determining their value in managing this chronic and debilitating condition.

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Drug Discovery World

FEBRUARY 22, 2024

Lilly’s growth was further fuelled by Mounjaro’s FDA approval for the treatment of obesity received in Q3, with Mounjaro forecasted to reach global forecast sales of $4.7 in 2023, fuelled by the FDA approval of its CRISPR-based ex vivo cell therapy Casgevy. billion for 2023.

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The Pharma Data

OCTOBER 14, 2021

The results, which demonstrate that patients treated with Biogen’s portfolio of MS therapies mount an effective antibody response to COVID-19 vaccination, are being presented at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) virtual meeting, October 13-15, 2021.

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Vaccine Therapies Immune Response Disease 52

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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Disease Small Molecule Biosimilars Engineering 52

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. Oncology Despite significant progress in cancer research, many patients face limited treatment options.

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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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Biosimilars FDA FDA Approval Small Molecule 52

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

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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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). High prices for innovative treatments and shortages of medicines remain an important concern for patients and healthcare systems.

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The Pharma Data

MARCH 16, 2022

These findings point to the potential of continued benefit of treatment in the longer term with continued reduction of amyloid beta plaques. These data demonstrate that long-term treatment with ADUHELM continues to reduce the underlying pathologies of Alzheimer’s disease beyond two years.” Biogen Inc.

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Disease Clinical Trials Treatment Biosimilars 52

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.

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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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Licensing Licensing Biosimilars Clinical Development 52

The Pharma Data

MAY 2, 2022

The companies expect to complete submission of the NDA for treatment of MDD in the second half of 2022; associated filing for postpartum depression anticipated in the first half of 2023. Food and Drug Administration (FDA) for zuranolone in the treatment of major depressive disorder (MDD). Sage Therapeutics, Inc.

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Treatment Clinical Pharmacology Drugs Biosimilars 52

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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Biosimilars Disease Therapies Treatment 52

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.

Biosimilars 52

Biosimilars Disease Therapies Treatment 52

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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Biosimilars Disease Therapies Treatment 52

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.

Biosimilars 52

Biosimilars Disease Therapies Treatment 52

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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Biosimilars Disease Therapies Treatment 52

Agency IQ

AUGUST 2, 2024

Rare Pediatric Disease Priority Review Voucher Program Expiration Threat: The FDA’s popular voucher program for rare pediatric diseases is currently scheduled to expire as of September 30, 2024 unless it is renewed by Congress.

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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 .

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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 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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Pharmaceuticals Small Molecule Biosimilars Disease 52

The Pharma Data

DECEMBER 13, 2020

The primary endpoint of the study is progression-free survival (PFS), and secondary endpoints include overall survival (OS), objective response rate (ORR), duration of response (DOR), disease control rate (DCR) and safety. SHANGHAI, China, Dec. Both supplemental NDAs received priority review status by the NMPA in July 2020.

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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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Licensing Licensing Biosimilars Disease 52

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., Within each of the six study treatment cohorts, participants were randomized to receive BIIB078 or placebo (3:1 ratio).

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RNA Therapies Biosimilars Disease 52

The Pharma Data

APRIL 28, 2022

currently on ADUHELM avoid any treatment interruptions following the final national coverage determination by Centers for Medicare & Medicaid Services (CMS) that could result in a loss of coverage for Medicare beneficiaries. For those already on ADUHELM, this meant a potential halt in their treatment plans. Organization.

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Clinical Trials Biosimilars Treatment Disease 52

The Pharma Data

MARCH 23, 2022

(NYSE: PFE) today announced positive topline results from a Phase 3 study of etrasimod, an investigational, oral, once-a-day, selective sphingosine 1-phosphate (S1P) receptor modulator in development for the treatment of moderately to severely active ulcerative colitis (UC). Participants received etrasimod 2mg once daily. About Etrasimod.

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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

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

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

MARCH 29, 2022

(NYSE: PFE) today announced positive top-line results from a second Phase 3 study of etrasimod, an investigational, oral, once-a-day, selective sphingosine 1-phosphate (S1P) receptor modulator in development for the treatment of moderately to severely active ulcerative colitis (UC). Participants received etrasimod 2 mg or placebo once-daily.

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FDA Law Blog: Biosimilars

APRIL 10, 2023

Houck — Drugs and substances classified within schedule I of the federal Controlled Substances Act (“CSA”) by definition have a high potential for abuse, no currently accepted medical use in treatment in the United States, and lack accepted safety for use under medical supervision. 21 U.S.C. § Last month bipartisan legislation, S.

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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. . In women in both treatment groups who experienced treatment emergent adverse events (TEAEs), the majority were mild to moderate in severity. vs. placebo -1.6, p= 0.0052). Food & Drug Administration.

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The Pharma Data

JUNE 24, 2021

The prognosis for men with advanced prostate cancer has significantly improved since the introduction of novel hormone therapies, but additional therapeutic options are needed for the approximately 25 percent of men with tumors harboring DNA damage response (DDR) gene mutations, who may have poorer outcomes,” said Chris Boshoff, M.D.,

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DNA Clinical Trials Trials Biosimilars 52

Agency IQ

MARCH 1, 2024

The EMA has a number of scientific guidelines and reflection papers that are currently open for public consultation, including the development of products for the treatment of depression, Hepatitis B, and hemophilia A and B.

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Agency IQ

MAY 3, 2024

Title Type Comments Close Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards Draft Guidance April 30 Early Alzheimer’s Disease: Developing Drugs for Treatment Draft Guidance May 13 Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the (..)

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The Pharma Data

JANUARY 24, 2021

25, 2021 (GLOBE NEWSWIRE) — Junshi Biosciences (HKEX: 1877; SSE: 688180), an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, announced today that U.S. and a disease control rate (DCR) of 86.2% SHANGHAI, China, Jan.

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