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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Agency IQ

AUGUST 2, 2024

Letter Program Tag Commitment Due Date MDUFA International Harmonization Commencing with FY 2024, publish an annual assessment of the international harmonization activities described the strategic plan due by the end of FY 2023. The following PDUFA dates were obtained from publicly available sources. and the E.C.

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Agency IQ

JUNE 2, 2023

By harmonizing with the International Electrotechnical Commission, this rule will decrease the regulatory burden on industry and allow the Agency to take advantage of the expertise of the international committees, thereby also saving resources. The following PDUFA dates were obtained from publicly available sources.

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The Pharma Data

JANUARY 24, 2021

About Combination Clinical Trial The Combination Clinical Trial is an international, multi-center, randomized Phase III study designed to evaluate the efficacy and safety of Toripalimab in combination with Axitinib versus Pembrolizumab as a first-line treatment in patients with unresectable, locally advanced or metastatic mucosal melanoma.

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Agency IQ

JULY 8, 2024

and the E.C.

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The Pharma Data

OCTOBER 29, 2020

Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement. The Alzheimer’s Disease International 2019 Alzheimer’s Yearbook estimates that approximately 10 million people in the EU suffer from dementia (excluding Mild Cognitive Impairment). Since October 2017 Biogen and Eisai Co.,

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The Pharma Data

AUGUST 3, 2021

Product sales increased 3% globally, driven by double digit volume growth across a number of our products including Prolia ® (denosumab), Repatha ® (evolocumab) and our biosimilar products MVASI ® (bevacizumab-awwb) and KANJINTI ® (trastuzumab-anns). AMGEVITA continued to be the most prescribed adalimumab biosimilar in Europe.

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The Pharma Data

JUNE 30, 2021

Agreement includes commercializing biosimilar candidate of ophthalmology drug ranibizumab (Lucentis ® ) in Europe, Canada, Israel and global markets. TEL AVIV, Israel & ZURICH–(BUSINESS WIRE)– Teva Pharmaceutical Industries Ltd. Teva and Bioeq will share revenue from the commercialization of the biosimilar.

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Agency IQ

MAY 3, 2024

The following PDUFA dates were obtained from publicly available sources.

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The Pharma Data

AUGUST 3, 2021

The company announced donanemab received Breakthrough Therapy designation for treatment of Alzheimer’s disease and its intention to submit a biologics license application (BLA) for donanemab under the accelerated approval pathway later this year based on data from TRAILBLAZER-ALZ. Gross margin as a percent of revenue was 79.3

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Drug Target Review

JULY 6, 2023

3 Furthermore, the act “removes a requirement to use animal studies as part of the process to obtain a license for a biological product that is biosimilar or interchangeable with another biological product.” A new research paper, co-authored by PETA Science Consortium International e.V., Annals of Internal Medicine.

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Drug Discovery World

NOVEMBER 9, 2023

Peter O’Callaghan, PhD, Head of Expression System Sciences, Biologics and Licensing, Lonza, on: ‘Solve bispecific heavy-light chain mispairing with bYlok technology’. Nick Pittman, Marketing Manager, Global Biopharmaceutical Business, Waters Corporation, on: ‘Robust multi-level LC-MS workflows for biosimilar comparability assessment’.

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Agency IQ

SEPTEMBER 29, 2023

October 2023 Amendments to the Final Rule Regarding the List of Bulk Substances That Can Be Used to Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act (Proposed Rule) FDA has issued a regulation creating a list of bulk drug substances (active pharmaceutical ingredients) that can be used to compound (..)

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Agency IQ

JUNE 29, 2023

June 2023 Sunlamp Products; Amendment to the Performance Standard (Final Rule) FDA is updating the performance standard for sunlamp products and ultraviolet lamps intended for use in these products to improve safety, reflect new scientific information, and work towards harmonization with international standards.

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The Pharma Data

OCTOBER 29, 2020

29, 2020– Alexion Pharmaceuticals, Inc. ALXN2060 (AG10) – Eidos: Alexion holds an exclusive license to develop and commercialize ALXN2060 (AG10) in Japan. To participate in the call, dial 866-762-3111 ( USA ) or 210-874-7712 (International), conference ID 6582445 shortly before 8:00 a.m. Eastern Time.

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Agency IQ

OCTOBER 27, 2023

WUSF / AgencyIQ November 1 Initial deadline for NDSRIs Under a 2023 guidance document, the FDA has recommended that pharmaceutical companies assess Nitrosamine Drug-Related Substance Impurities for their products by November 1, 2023, with confirmatory testing due by August 1, 2025.

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Agency IQ

FEBRUARY 15, 2024

AgencyIQ has analyzed the agency’s guidance agendas, user fee commitment letters, statutory obligations and international efforts to determine which guidance documents the agency is actively working on this year (and in some cases, in the years ahead as well). We have tried to sort guidance documents by topic area. Priority B List.

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Agency IQ

DECEMBER 1, 2023

The revisions will update the existing requirements with the specifications of an international consensus standard for medical device manufacturers, ISO 13485:2016. The following PDUFA dates were obtained from publicly available sources.

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The Pharma Data

FEBRUARY 8, 2021

Pharmaceuticals. Fourth-quarter 2020 Pharmaceutical sales increased 2.4% Fourth-quarter 2020 Pharmaceutical sales increased 2.4% In 2020, Pharmaceuticals sales increased 3.1% price, patients switching to Toujeo ® and biosimilar glargine competition. Pharmaceuticals business operating income. Specialty Care.

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The Pharma Data

FEBRUARY 4, 2021

Pharmaceuticals. Fourth-quarter 2020 Pharmaceutical sales increased 2.4% Fourth-quarter 2020 Pharmaceutical sales increased 2.4% In 2020, Pharmaceuticals sales increased 3.1% price, patients switching to Toujeo ® and biosimilar glargine competition. Pharmaceuticals business operating income. Specialty Care.

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FDA Law Blog: Biosimilars

DECEMBER 3, 2023

state pharmaceutical assistance programs). Under this rule, CMS will consider all entities, including corporations, partnerships, proprietorships, and other entities treated as a single employer under subsection (a) or (b) of section 52 of the Internal Revenue Code of 1986 as one manufacturer. Phase-in Memorandum at 2.

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Agency IQ

SEPTEMBER 1, 2023

MHRA introduces an expanded international recognition procedure, while planning to sunset the current EC reliance pathway Today, the U.K.’s pharmaceutical law ceased to apply to the U.K. from the E.U. on February 1, 2020 started a year-long transition period; The E.U. excluding Northern Ireland) as of January 1, 2021.

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The Pharma Data

APRIL 27, 2021

Pharmaceuticals. First-quarter 2021 Pharmaceutical sales increased 3.8% up 60%) driven by increase disease and product awareness as well as adoption of new ISTH (International Society on Thrombosis and Haemostasis) TTP guidelines. Pharmaceuticals business operating income. to €2,638 million. At CER, BOI increased 13.3%.

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The Pharma Data

MAY 4, 2021

Multiple innovative and biosimilar products across our portfolio delivered growth, demonstrating the strength of our business and the depth and breadth of our growth drivers. Internal Medicine. and four additional selling days in international markets. REVENUES. . . . . . ($ in millions). First-Quarter. . 1,611. . *. *.

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Agency IQ

JULY 28, 2023

A big nitrosamine deadline approaches : Unless you’ve been hiding under a rock for the last few years, you’ve probably heard about major issues that the pharmaceutical industry has been having with nitrosamine contamination. That would leave 19% of staff affected by furloughs. But despite the law’s age, it is not yet fully operational.

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