2018, Biosimilars, Licensing and Trials

Article FDA Thank You Following a 2018 draft framework, FDA unveils long-awaited PDURS draft guidance

Agency IQ

SEPTEMBER 22, 2023

Following a 2018 draft framework, FDA unveils long-awaited PDURS draft guidance A long-awaited draft guidance on Prescription Drug Use-Related Software (PDURS) outlines when information from digital health tools could be represented on prescription drug labeling. See AgencyIQ’s full analysis of the 2018 framework, and industry response, here.]

FDA

FDA Biosimilars Production Regulations

European Commission vs Big Pharma, or profit vs access?

Drug Discovery World

MARCH 29, 2023

Moreover, an extra six months of RDP for drugs with full comparator clinical trials (rather than showing only that a drug is no worse than the standard of care). Will this be a viable solution? Clinical trials The draft outlines the requirement for clinical trials in children where a drug is approved in adults for a different disease.

Clinical Trials

Clinical Trials Biosimilars Pharma Companies Production

FDA Action Alert: MacroGenics and Amgen

The Pharma Data

DECEMBER 13, 2020

MacroGenics , based in Rockville, Maryland, has a target action date of December 18 for its Biologics License Application (BLA) for margetuximab in combination with chemotherapy for patients with metastatic HER2+ breast cancer. Amgen’s ABP 798, a Biosimilar to Genentech’s Rituxan. Read on for this week’s.

FDA

Trends in Pharmaceutical Mergers and Acquisitions

DrugBank

OCTOBER 4, 2024

This involves assessing the strength and breadth of patents, evaluating the potential for future patent challenges, and analyzing the value derived from licensing agreements and royalty streams. The Evolving Regulatory System Regulatory frameworks play a pivotal role in shaping the pharmaceutical M&A landscape.

Pharmaceuticals

Pharmaceuticals Pharmaceutical Companies Marketing Therapies

Article EMA Thank You EMA’s 2023 new medicines report suggests return to pre-pandemic volume

Agency IQ

JANUARY 19, 2024

Seventeen products were orphan drugs, fourteen were generics and eight were biosimilars. However, this is actually relatively aligned with the number of new active substances seen prior to and during the first year of the pandemic: 39 in 2020 ; 30 in 2019 ; 42 in 2018 and 35 in 2017. for the years 2020 to 2022. Based on the E.U.

Biosimilars

Biosimilars FDA Production Treatment

FDA Grants Toripalimab Fast Track Designation for Mucosal Melanoma

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).

FDA

FDA Clinical Trials Trials Treatment

Analysis Life Sciences Thank You FDA fiscal year in review: New drug approvals in the wake of the pandemic and legislative reforms

Agency IQ

OCTOBER 6, 2023

All products are received in one of two forms: A New Drug Application (or NDA, for pharmaceuticals) or a Biologics License Application (BLA, for biologics). There were 21 NMEs added to the FDA’s Purple Book , which provides information about all biological products licensed by the FDA.

FDA

FDA Biosimilars Science Production

Tezepelumab NAVIGATOR Phase 3 Trial Met Primary Endpoint Of A Statistically Significant And Clinically Meaningful Reduction In Exacerbations In A Broad Population Of Patients With Severe Asthma

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.

Trials

Trials Production Clinical Trials Government

Update On SOURCE Phase 3 Trial For Tezepelumab In Patients With Severe, Oral Corticosteroid-Dependent Asthma

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. ,

Trials

Trials Production Clinical Trials Government

AbbVie Reports Full-Year and Fourth-Quarter 2020 Financial Results

The Pharma Data

FEBRUARY 4, 2021

Percent on an Operational Basis, Due to Biosimilar Competition; Global Skyrizi Net Revenues Were $1.590 Billion; Global Rinvoq Net Revenues Were $731 Million. percent on an operational basis, due to biosimilar competition. Humira Net Revenues Were $16.112 Billion, an Increase of 8.4 Percent on a Reported Basis, or 12.5 Recorded a $4.7

Production

Production International Clinical Trials Small Molecule

Sanofi delivered close to double-digit Q4 2020

The Pharma Data

FEBRUARY 8, 2021

We continue to work in parallel on our two COVID-19 vaccine candidates, with clinical trials starting in the coming weeks. In Europe, where the product is commercially available in several countries and has a temporary license to be sold in France, sales were €12 million. Full-year 2020 franchise sales were down 4.8%

Vaccine

Vaccine Production FDA Pharmaceuticals

Sanofi delivered close to double-digit Q4 2020 business EPS(1) growth at CER

The Pharma Data

FEBRUARY 4, 2021

We continue to work in parallel on our two COVID-19 vaccine candidates, with clinical trials starting in the coming weeks. In Europe, where the product is commercially available in several countries and has a temporary license to be sold in France, sales were €12 million. Full-year 2020 franchise sales were down 4.8%

Vaccine

Vaccine Production FDA Pharmaceuticals

Sanofi continued its growth trajectory. Strong increase in Q1 2021 business EPS(1) at CER

The Pharma Data

APRIL 27, 2021

reflecting increased competition partially offset by demand growth partly related to clinical trial supply and price upside in Europe. net price, increasing usage of Toujeo ® , biosimilar glargine competition and lower sales in Europe (patient stockpilling in the first quarter of 2020). Aubagio ® sales decreased 1.1% In the U.S.,

Vaccine

Vaccine Production FDA FDA Approval

PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS

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. The FDA action converts the 2018 accelerated approval to full approval. Inlyta globally, up 34% operationally, primarily reflecting increased demand in the U.S.

Vaccine

Vaccine Production FDA Clinical Trials

Drug Discovery Digest

Article FDA Thank You Following a 2018 draft framework, FDA unveils long-awaited PDURS draft guidance

European Commission vs Big Pharma, or profit vs access?

Trending Sources

FDA Action Alert: MacroGenics and Amgen

Trends in Pharmaceutical Mergers and Acquisitions

Article EMA Thank You EMA’s 2023 new medicines report suggests return to pre-pandemic volume

FDA Grants Toripalimab Fast Track Designation for Mucosal Melanoma

Analysis Life Sciences Thank You FDA fiscal year in review: New drug approvals in the wake of the pandemic and legislative reforms

Tezepelumab NAVIGATOR Phase 3 Trial Met Primary Endpoint Of A Statistically Significant And Clinically Meaningful Reduction In Exacerbations In A Broad Population Of Patients With Severe Asthma

Update On SOURCE Phase 3 Trial For Tezepelumab In Patients With Severe, Oral Corticosteroid-Dependent Asthma

AbbVie Reports Full-Year and Fourth-Quarter 2020 Financial Results

Sanofi delivered close to double-digit Q4 2020

Sanofi delivered close to double-digit Q4 2020 business EPS(1) growth at CER

Sanofi continued its growth trajectory. Strong increase in Q1 2021 business EPS(1) at CER

PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS

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