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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ProRelix Research

MARCH 1, 2024

Biologicals products occupy a significant place in the treatment landscape of several autoimmune diseases and cancers and are most often the only choice of treatment and management of several diseases […] The post Biosimilars and Their Growing Importance in Healthcare appeared first on ProRelix Research.

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The Pharma Data

MAY 8, 2021

Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept. The initiation of this study marks an important milestone in the development of our biosimilar aflibercept.

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FDA Law Blog: Biosimilars

SEPTEMBER 15, 2024

IPRs have become an important tool used by generic drug and biosimilar manufacturers to try and clear patent thickets covering brand-name products prior to or during the pendency of an ANDA or aBLA submission. Eliminating invalid patents under § 101 enables generic and biosimilar companies to streamline pharmaceutical litigation.

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The Pharma Data

MAY 15, 2023

Sandoz strengthens pipeline expansion through partnership to develop and manufacture multiple biosimilars Sandoz, a global leader in off-patent (generic and biosimilar) medicines, today announced a multi-year partnership with Just – Evotec Biologics, the Seattle-based subsidiary of Evotec SE.

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Drug Channels

SEPTEMBER 28, 2021

on international benchmarking goes viral Amazon is finally disrupting CVS—but not how you expected Plus, the best article ever about Elizabeth Holmes’s Theranos trial. P.S. Please join the more than 12,500 consumers of my daily commentary and links to neat stuff at @DrugChannels on Twitter.

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Agency IQ

JULY 26, 2024

FDA’s new guidance on postapproval manufacturing changes for biosimilars focuses on current practice, new dosage forms Meeting a biosimilar user fee commitment, the FDA is expanding on its recommendations for biosimilar and interchangeable product applicants asking the FDA for post-approval manufacturing changes.

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The Pharma Data

MAY 2, 2021

With eight marketed biosimilar medicines globally and 15+ molecules in pipeline, Sandoz is investing in future of biosimilars for patients and healthcare systems. Holzkirchen, May 3, 2021 – Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept.

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ProRelix Research

SEPTEMBER 24, 2024

Biostatistics involves the application of statistical techniques for the design and analysis of clinical trial data.

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FDA Law Blog: Drug Discovery

FEBRUARY 2, 2023

Since 1962, the FD&C Act has authorized FDA to require that sponsors of clinical trials submit data from “preclinical tests (including tests on animals)” in order to demonstrate that their drug is safe enough to advance to testing in humans. FDORA § 3209(a)(1). FDORA § 3209(a)(2). 42 U.S.C. § 262(k)(2)(A)(i)(I). FDORA § 3209(b).

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The Pharma Data

JULY 8, 2021

The update includes an addition to the Indications and Usage section of the label (Section 1) to emphasize the disease stages studied in the clinical trials, as seen below ( italics to note updated language). Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).

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The Pharma Data

MARCH 23, 2022

Statistically significant improvements were achieved in all key secondary endpoints in the trial as well. In the study, etrasimod patients achieved statistically significant improvements in the primary endpoint of clinical remission at week 12 as compared with placebo. The safety profile was consistent with previous Phase 2 studies.

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FDA Law Blog: Biosimilars

MAY 13, 2024

FDA has even gone so far as to maintain that the “real-life clinical performance of a medical product might be more clearly demonstrated through RWD/RWE because a controlled clinical trial often cannot evaluate all applications of a product in clinical practice across the full range of potential users.”

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The Pharma Data

NOVEMBER 10, 2020

Innovent has established a robust pipeline of 23 valuable assets, including four launched products, four products in pivotal trials, and multiple prioritized assets such as CD47, PDL1/CD47, TIGIT, VEGF/complement protein etc. that are fast progressing clinical trials. TYVYT® is the only PD-1 inhibitor included in the NRDL.

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The Pharma Data

MAY 3, 2021

DARS also greatly expanded its clinical trials operations, running three clinical trials related to streamlining biosimilars development and studying safety questions related to opioids and over-the-counter drugs,” Strauss wrote. Report. . © 2021 Regulatory Affairs Professionals Society.

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The Pharma Data

NOVEMBER 9, 2020

Trial Also Met the Primary Endpoint in Patients With Low Levels of Eosinophils. In the subgroup of patients with baseline eosinophil counts less than 300 cells per microliter, the trial met the primary endpoint with tezepelumab demonstrating a statistically significant and clinically meaningful reduction in AAER.

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Alta Sciences

JUNE 9, 2023

Altasciences has the clinical capabilities to demonstrate the biosimilarity of drug products between Asian and non-Asian populations by comparing the pharmacokinetics of the investigational drug in both ethnic groups, providing a safe strategy to save time and money. Watch the webinar.

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The Pharma Data

DECEMBER 21, 2020

21, 2020 /PRNewswire/ — Amgen (NASDAQ:AMGN) and AstraZeneca today announced the SOURCE trial did not meet the primary endpoint of a statistically significant reduction in the daily oral corticosteroid (OCS) dose, without loss of asthma control, with tezepelumab compared to placebo. THOUSAND OAKS, Calif. ,

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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.

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FDA Law Blog: Biosimilars

NOVEMBER 6, 2023

Admittedly, BiMo inspections (into items like adequacy of bioequivalence data, consistency of clinical trial data with medical records, and compliance with clinical trial protocols) lend themselves better to an RIE than assessing manufacturing compliance with regulatory requirements.

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The Pharma Data

NOVEMBER 17, 2021

At the recent Clinical Trials on Alzheimer’s Disease conference (CTAD), Biogen blazoned new Phase 3 findings that give farther substantiation of aducanumab’s effect on lowering amyloid beta shrine and downstream tau pathology, the two defining pathologies of Alzheimer’s complaint.

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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. In June 2021, the U.S.

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The Pharma Data

APRIL 7, 2022

For lecanemab, our partner Eisai has initiated FDA filing via the accelerated approval pathway and the readout of the Phase 3 confirmatory Clarity AD clinical trial is expected in the fall. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).

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FDA Law Blog: Biosimilars

FEBRUARY 27, 2025

They will be joined by an esteemed panel of top FDA regulatory leaders covering essential topics, including: Navigating the Approval Process for Drugs and Biologics Clarifying the Clinical Trial Process for Drugs and Biologics Understanding the Structure of the FDA and the Roles of Its Three Major Centers: CDER, CBER, and CDRH Hatch-Waxman and BPCIA (..)

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Conversations in Drug Development Trends

JULY 9, 2024

This shortage is most prevalent in the starting doses and is leading to extensive issues with patient access and delays in clinical trial start-up times as most of the obesity trials incorporate initiating GLP-1 agonist as part of the protocols.

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The Pharma Data

OCTOBER 26, 2021

Sandoz is a global leader in generic pharmaceuticals and biosimilars. Its global portfolio covers all major therapeutic areas with a global market leadership position in biosimilars, generic antibiotics and oncology medicines. billion) and Entresto (at least USD 5.0 Innovative Medicines net sales were USD 10.6 billion (+8%, +7% cc).

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The Pharma Data

MARCH 16, 2022

The data also show that in both Phase 3 trials, at 78 weeks, patients with reduced levels of plasma p-tau181 had less clinical decline than those whose plasma p-tau181 levels were not reduced. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).

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The Pharma Data

APRIL 28, 2022

On April 7, CMS issued a final national coverage determination that limited access to ADUHELM for Medicare beneficiaries to only those enrolled in FDA or National Institutes of Health (NIH) approved clinical trials. For those already on ADUHELM, this meant a potential halt in their treatment plans.

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FDA Law Blog: Biosimilars

JANUARY 15, 2024

FDA said randomized clinical trials could be used, but so could observational studies with respect to cessation data. While FDA did try to suggest that these studies were not a requirement, the Court cited a PMTA checklist in FDA’s Decisions Document that included a requirement for a randomized controlled trial or a longitudinal cohort study.

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FDA Law Blog: Biosimilars

NOVEMBER 27, 2023

Gree USA’s Chief Executive Officer, Charley Loh, and the Chief Administrative Officer, Simon Chu, however, did not agree to the plea deal for the corporate entity, and elected to go to trial. After a brief trial, on Friday Nov. The government charged these individuals with conspiracy (18 U.S.C. §

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The Pharma Data

OCTOBER 29, 2020

Importantly, the AU/EU model allows biotechs to keep their data and trial management in Australia, and take advantage of the Australian cash rebate of up to 43.5% on clinical trial costs, throughout all study phases, across both regions. “We But it was a true Eureka moment when we realized that combining Australia’s 43.5%

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DrugBank

OCTOBER 4, 2024

Gilead's assessment of the IP portfolio would have involved a detailed analysis of the patent claims, the remaining patent life, the potential for generic or biosimilar competition, and the expected revenue streams from Trodelvy in various markets. However, such acquisitions also entail significant risks for biotech firms.

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FDA Law Blog: Biosimilars

SEPTEMBER 26, 2024

In advising clients who have received Breakthrough designation, one theme seems to be emerging, which we expect is responsible for at least some of the missing authorizations-CDRH’s clinical trial expectations, especially for low-prevalence conditions, can almost guarantee that most of these Breakthrough devices never see the light of day.

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FDA Law Blog: Biosimilars

AUGUST 28, 2023

Lenz, Principal Medical Device Regulation Expert — Following up on our first post discussing Digital Health Technologies (DHTs) ( here ), this post will focus on development and qualification of DHTs for use in clinical trials for drug development. While desirable for patients, validation on multiple platforms can lead to challenges.

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PPD

FEBRUARY 22, 2023

With the imminent need for new therapies to offset the expected losses to generic formulas and biosimilars, the environment will be ripe for new partnerships to emerge. Nearly two-thirds (64%) of our survey respondents reported that they have considered clinical co-development funding.

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FDA Law Blog: Biosimilars

JULY 8, 2024

The court ruled that the Securities and Exchange Commission (SEC) may not impose fines to penalize securities in its administrative proceedings because that practice violates the Seventh Amendment “right of trial by jury” in all “suits at common law.” Here are some brief facts of the case. This did not end the analysis, however.

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The Pharma Data

JANUARY 24, 2021

Meanwhile, the FDA has also approved the Investigational New Drug (IND) application for a global Phase III trial of Toripalimab in combination with Axitinib versus Pembrolizumab for the first-line treatment of patients with advanced mucosal melanoma (Combination Clinical Trial).

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