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.

Science 40

Science Biosimilars FDA Production 40

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.

Therapies 52

Therapies Production Government Disease 52

Agency IQ

AUGUST 2, 2024

What We Expect the FDA to do in August and September 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA 40

FDA Science Regulations Biosimilars 40

The Pharma Data

MARCH 28, 2022

The adverse events (AEs) were mostly mild to moderate in severity and occurred at a similar rate across BIIB078 and placebo groups. While these were not the results we were hoping for, they are clear and will inform future research across our broad pipeline of investigational ALS therapies. Biogen Inc.

RNA 52

RNA Therapies Disease Biosimilars 52

Agency IQ

MARCH 1, 2024

What we expect European regulators to do in March 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more. and national regulators.

Regulations 40

Regulations Biosimilars Clinical Trials Production 40

Agency IQ

DECEMBER 1, 2023

What we expect European regulators to do in December 2023 In this new recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more. Upcoming E.U.

Regulations 40

Regulations Clinical Trials Production Biosimilars 40

Agency IQ

MAY 3, 2024

What we expect European regulators to do in May 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more. and national regulators.

Regulations 40

Regulations Clinical Trials Production Biosimilars 40

Agency IQ

JULY 8, 2024

What We Expect the FDA to do in July and August 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA 40

FDA Science Regulations Production 40

Agency IQ

MARCH 29, 2024

What we expect European regulators to do in April 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more. and national regulators.

Regulations 40

Regulations Production Clinical Trials Biosimilars 40

The Pharma Data

APRIL 11, 2021

The adverse event (AE) profile of the combination was generally consistent with previously published data on the individual components of the combination and no new safety signals were identified. Patients must have relapsed after the last rituximab-, rituximab biosimilars-, or anti-CD20 monoclonal antibody (e.g., Abstract: CT001.

Treatment 52

Treatment Therapies Trials Disease 52

The Pharma Data

NOVEMBER 17, 2021

There were no serious events of flushing or expirations due to flushing in the study. The most common adverse events, attained using data from dimethyl fumarate (which has the same active metabolite as VUMERITY), were flushing, abdominal pain, diarrhea and nausea. The difference in the termination rates due to GI tolerability was0.8

Treatment 52

Treatment Marketing Clinical Trials Biosimilars 52

Agency IQ

JUNE 9, 2023

High-priced cell and gene therapies are being increasingly developed for rare diseases. For example, a comparison of some gene therapy reimbursement shows that the single-treatment CAR-T cell therapy Kymriah (tisagenlecleucel) is reimbursed at 320,000 euros (based on outcome) in Italy, Germany, Spain and France.

Marketing 40

Marketing Regulations Biosimilars Drugs 40

The Pharma Data

MAY 2, 2022

AUSTEDO is also contraindicated in: patients with hepatic impairment; patients taking reserpine or within 20 days of discontinuing reserpine; patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of discontinuing MAOI therapy; and patients taking tetrabenazine (Xenazine ® ) or valbenazine (Ingrezza ® ).

Pharmaceuticals 52

Pharmaceuticals Production Treatment Disease 52

The Pharma Data

MARCH 5, 2021

Novartis has also announced a collaboration with Molecular Partners to develop two DARPin® therapies designed for potential use against COVID-19. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties.

Vaccine 52

Vaccine Production Biosimilars Hospitals 52

The Pharma Data

JUNE 1, 2022

In women in both treatment groups who experienced treatment emergent adverse events (TEAEs), the majority were mild to moderate in severity. Zuranolone has been granted Fast Track and Breakthrough Therapy Designation for MDD and Fast Track Designation for PPD by the U.S. Food & Drug Administration.

Biosimilars 52

Biosimilars Treatment Therapies Disease 52

The Pharma Data

OCTOBER 27, 2020

The companies will work together to scale-up manufacturing capacity, in collaboration with Sandoz, the generics and biosimilar Novartis division, to provide worldwide supply.

Therapies 52

Therapies Virus Treatment Clinical Trials 52

The Pharma Data

SEPTEMBER 10, 2020

(NYSE:PFE) announced today that more than 50 abstracts representing data from nine approved and investigational Pfizer medicines, including several biomarker-driven and immuno-therapies, will be presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 being held from September 19-21, 2020. Mayer E. . Pfizer Inc.:

Therapies 52

Therapies Clinical Trials Production Trials 52

Agency IQ

JULY 8, 2024

What we expect European regulators to do in July 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more. and national regulators.

Regulations 40

Regulations Pharmaceuticals Production Vaccine 40

Agency IQ

MAY 3, 2024

What We Expect the FDA to do in May and June 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA 40

FDA Science Regulations Clinical Trials 40

Agency IQ

MARCH 1, 2024

What happens to FDA staff in the event of a shutdown? That means that at least some of FDA’s work can continue – for a time – while the government is shut down. Notably, however, a key aspect of FDA’s ability to manage drug shortages comes from its authority to accept and fast-track applications (i.e., The longest shutdown in U.S.

Government 40

Government FDA Biosimilars Regulations 40

The Pharma Data

DECEMBER 27, 2020

(NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today provided a year-end review and an outline of its plans for 2021. Although our industry has enjoyed many successes lately, those affected by the conditions we are focused on still need better choices.

Therapies 52

Therapies Clinical Trials Production Treatment 52

Agency IQ

JUNE 2, 2023

What We Expect the FDA to do in June 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. not discontinued) and are available for sale.

FDA 40

FDA Science Regulations Production 40

Agency IQ

OCTOBER 27, 2023

What we expect European regulators to do in November 2023 In this new recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

Regulations 40

Regulations Pharmaceuticals Production Packaging 40

The Pharma Data

SEPTEMBER 16, 2020

Additionally, data from Amgen ‘s bispecific T cell engager (BiTE ® ) platform will feature preliminary safety and efficacy findings from the ongoing Phase 1 study of AMG 160, an investigational half-life extended BiTE immuno-oncology therapy targeting prostate-specific membrane antigen (PSMA). 20 and AMG 160, Monday Sept. Reese , M.D.,

Clinical Trials 52

Clinical Trials Production Trials Government 52

Agency IQ

SEPTEMBER 29, 2023

What We Expect the FDA to do in October 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. Of note: A government shutdown would likely delay or cancel some of the events listed below.

FDA 40

FDA Science Regulations Production 40

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.

Biosimilars 52

Biosimilars Production Treatment FDA 52

The Pharma Data

JANUARY 26, 2021

Through its three businesses – Pharmaceutical Services & Active Ingredients, Global Generics and Proprietary Products – Dr. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Dr. Reddy’s operates in markets across the globe.

Hospitals 40

Hospitals Laboratories Pharmaceuticals Production 40

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.”. .

Pharmaceuticals 52

Pharmaceuticals Clinical Trials Trials Production 52

The Pharma Data

SEPTEMBER 20, 2020

and 91.2%, respectively, in 34 heavily pretreated patients (median of two prior lines of therapy) with NSCLC, who were treated with the 960 mg daily dose (data cutoff of June 1 , 2020). No dose-limiting toxicities were observed and there were no fatal treatment-related adverse events (TRAEs). ” Amgen Webcast Investor Call Amgen?

Clinical Trials 52

Clinical Trials Production Trials Government 52

The Pharma Data

FEBRUARY 8, 2021

IBRANCE is indicated for the treatment of adult patients with HR+, HER2- advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine based therapy in postmenopausal women or in men; or with fulvestrant in patients with disease progression following endocrine therapy. 2,3 In the U.S.,

Clinical Trials 52

Clinical Trials Treatment Therapies Production 52

FDA Law Blog: Biosimilars

FEBRUARY 27, 2024

156(c)(4) states that “in no event shall more than one patent be extended under subsection (e)(1) for the same regulatory review period for any product” (emphasis added). To that end, 35 U.S.C. § 156(c)(4) The first multiple PTE case up-to-bat concerns Gilead Sciences Inc.’s In September 2014—nearly ten years ago!

FDA Approval 57

FDA Approval FDA Production Therapies 57

The Pharma Data

AUGUST 1, 2021

Percent on an Operational Basis, Due to Biosimilar Competition; Global Skyrizi Net Revenues Were $674 Million; Global Rinvoq Net Revenues Were $378 Million – Second-Quarter Global Net Revenues from the Hematologic Oncology Portfolio Were $1.816 Billion, an Increase of 14.1 percent on an operational basis, due to biosimilar competition.

FDA 52

FDA Treatment Trials Biosimilars 52

The Pharma Data

JULY 8, 2021

AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. About Biogen.

Disease 52

Disease Clinical Trials Government Research 52

The Pharma Data

JULY 27, 2021

Each of these three investigational therapies uses a different approach to treat a highly prevalent disease for which new treatment options are very much needed. Our stock price is volatile and may be affected by a number of events. “The Teneobio team is enthusiastic about joining forces with Amgen, a pioneer of biotherapeutics.

Production 52

Production Clinical Trials Government Disease 52

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. CAMBRIDGE, Mass.

Disease 40

Disease Marketing Clinical Trials Treatment 40

Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA 40

FDA Science Regulations Production 40

The Pharma Data

DECEMBER 9, 2020

(Tokyo, Japan) announced that Biogen has submitted a Japanese New Drug Application (J-NDA) to the Ministry of Health, Labor and Welfare (MHLW) for aducanumab, an investigational therapy for Alzheimer’s disease. About Biogen At Biogen, our mission is clear: we are pioneers in neuroscience.

Clinical Trials 40

Clinical Trials Drugs Disease Licensing 40