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 Patent Watch

DECEMBER 12, 2024

Branded drugs, developed through extensive research and clinical trials, often enjoy patent protection for a limited period. Drugs that require extensive clinical trials for generic approval or fall under special regulatory pathways may have a lower risk of generic entry.

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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

DECEMBER 13, 2020

Amgen’s ABP 798, a Biosimilar to Genentech’s Rituxan. Amgen has a target action date of December 19 for its BLA for ABP 798, a biosimilar to Genentech’s Rituxan (rituximab). The biosimilar is a collaboration between Amgen and Allergan, which was formed when Allergan was Watson Pharmaceuticals in December 2011.

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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 29, 2022

The positive 12- and 52-week results from ELEVATE UC 52 follow the recent announcement of positive 12-week findings from the ELEVATE UC 12 trial on March 23. Etrasimod demonstrated a safety profile consistent with previous studies, including the Phase 2 OASIS trial.

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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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DrugBank

AUGUST 9, 2024

Moreover, the probability of success for a drug candidate entering clinical trials is only around 10%, highlighting the substantial risks involved. Shorter exclusivity periods, driven by patent challenges and the introduction of generic or biosimilar competitors, significantly contribute to declining ROI.

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Agency IQ

OCTOBER 6, 2023

For example, these products face a much more arduous path for development of biosimilar or interchangeable products than that of generics for small molecules. As AgencyIQ has previously discussed , developing biosimilars is an expensive process. The trend of incorporating clinical trial diversity into PMRs continued in FY 2023.

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Drug Target Review

JULY 6, 2023

1 Ethical concerns surrounding the use of animal studies is increasing, especially considering 90 percent of drug candidates fail in clinical trials. 2 Therefore, the scientific community is researching and developing efficient ways to test compounds without the use of animals, to avoid unsuccessful outcomes in clinical trials.

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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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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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Vial

APRIL 10, 2024

Positioned as a technology-centric CRO, Vial aims to revolutionize clinical research by delivering faster, superior, and more cost-effective clinical trial outcomes. It draws upon 150 years of collective experience and expert scientific advisory board members to deeply understand clinical trial requirements.

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Agency IQ

OCTOBER 20, 2023

BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions This week, FDA and its grantees briefed stakeholders on the status of research projects funded through the Biosimilar User Fee Act (BSUFA III) Regulatory Science Pilot Program. Developing biosimilars is an extensive and expensive process.

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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

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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Vial

MARCH 1, 2024

Growth factors for this market included the growing size of the pharmaceutical industry, the increasing number of clinical trials , substantial funds dedicated to pharma and biotech R&D, and the growing biosimilars and generics market. By geographical region, the global CRO services market in 2023 was dominated by North America.

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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

MAY 6, 2021

ENVI calls on the Commission to “revise the use of supplementary protection certificates based on technological and scientific advances to prevent generic and biosimilar medicines from becoming less competitive inside and outside the EU.”. . Denmark posts guidance on decentralizing clinical trials.

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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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The Pharma Data

JUNE 24, 2021

today announced that the first participant has been dosed in TALAPRO-3, a global, randomized, double-blind, placebo-controlled Phase 3 clinical trial. The TALAPRO-3 trial will enroll approximately 550 men with DDR-deficient mCSPC across 285 clinical trial sites in 28 countries. About TALAPRO-3 Trial.

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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

MARCH 13, 2022

Arena has previously indicated that it expected the results of the Phase 3 ELEVATE-UC trial of etrasimod in ulcerative colitis during the first quarter of 2022. “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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