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.

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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.

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The Pharma Data

DECEMBER 3, 2021

In the zuranolone 50 mg cohort, the majority of patients who responded to an initial 14-day course received only one two-week course of treatment during the study and nearly 80% received only one or two treatment courses in total. of patients discontinuing study drug due to adverse events. 10) and HAMD-17 (? About Zuranolone.

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The Pharma Data

MAY 2, 2022

AUSTEDO is the first and only FDA-approved product to treat both tardive dyskinesia in adults and chorea associated with Huntingdon’s disease. Food and Drug Administration in adults for the treatment of tardive dyskinesia and for the treatment of chorea associated with Huntington’s disease. On March 9, 2022, the U.S.

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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.

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The Pharma Data

NOVEMBER 10, 2020

The event was held in one Chinese session and one English session, with more than 700 investors and analysts watched the webcast and communicated with management team about R&D and other business updates through Q&A.

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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. We remain focused on pioneering new treatments that will positively impact people living with this debilitating disease.”. Biogen Inc. Nasdaq: BIIB) and Ionis Pharmaceuticals, Inc.

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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.

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The Pharma Data

JUNE 1, 2022

The CGI-S is a clinician-administered 7-point scale that rates the severity of a person’s disease at the time of assessment. . In women in both treatment groups who experienced treatment emergent adverse events (TEAEs), the majority were mild to moderate in severity. vs. placebo -1.6, p= 0.0052).

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The Pharma Data

JULY 8, 2021

ADUHELM should be initiated in patients with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s dementia. 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).

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Agency IQ

AUGUST 2, 2024

What we expect European regulators to do in August and September 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.

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The Pharma Data

MARCH 5, 2021

To sustain access, the Novartis generics and biosimilars division Sandoz became the first company to commit to keeping stable prices for a basket of essential medicines that may help in the treatment of COVID-19 and entered into a partnership with US-based Civica Rx to support stable supply of essential generic hospital medicines.

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The Pharma Data

JULY 27, 2021

The acquisition includes Teneobio’s proprietary bispecific and multispecific antibody technologies, which will enable significant acceleration and efficiency in the discovery and development of new molecules that have the potential to treat a wide range of important diseases across Amgen’s core therapeutic areas. Reese, M.D.,

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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.

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The Pharma Data

FEBRUARY 1, 2021

Food and Drug Administration (FDA) has approved a new intramuscular (IM) injection route of administration for Plegridy ® ( peginterferon beta-1a ) for the treatment of relapsing forms of multiple sclerosis (MS). Access to and availability of treatment options have become increasingly important in the current COVID-19 environment.

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The Pharma Data

JANUARY 26, 2021

The PRESECO study aims to determine the efficacy of Avigan as an early treatment for COVID-19 patients with mild-to-moderate symptoms, with the goal of alleviating symptoms and preventing disease progression before the infection requires hospitalizations or other intensive interventions. For more information: www.aipharmalab.com.

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The Pharma Data

AUGUST 31, 2020

It was developed under the leadership of the AU Special Envoy, Strive Masiyiwa and powered by Janngo, on behalf of Africa Centres for Disease Control and Prevention (Africa CDC). This is because they did not have access to essential medicines needed for treatment. With AMSP, countries don’t have to search the market for supplies.

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The Pharma Data

DECEMBER 9, 2020

If approved, aducanumab would become the first treatment to meaningfully change the course of Alzheimer’s disease. 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.

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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

SEPTEMBER 17, 2020

Lilly is currently studying several potential neutralizing antibodies for the prevention and/or treatment of COVID-19 as either monotherapy or in combination. This is yet another example of the ways our industry is closely collaborating to combat this devastating disease and help patients around the world access new therapies.”

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The Pharma Data

DECEMBER 27, 2020

To Our Shareholders, As we reach the end of an eventful 2020, we are inspired by the many healthcare providers and biopharmaceutical companies that worked to combat the COVID-19 pandemic. Finally, we seek to generate compelling clinical data to support moving into late-stage clinical trials and eventual marketing authorizations.

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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.,

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DrugBank

AUGUST 9, 2024

Humira , AbbVie's monoclonal antibody for autoimmune diseases, generated over $20 billion in annual revenue at its peak before losing patent exclusivity in 2023.  Shorter exclusivity periods, driven by patent challenges and the introduction of generic or biosimilar competitors, significantly contribute to declining ROI.

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The Pharma Data

SEPTEMBER 10, 2020

“Meaningful innovation in cancer care requires building upon our understanding of tumor biology, leveraging cutting-edge research, and applying the knowledge we gain into new treatments that address and prevent resistance,” said Chris Boshoff, M.D., Chief Development Officer, Oncology, Pfizer Global Product Development. “We Solomon B. . .

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The Pharma Data

AUGUST 3, 2021

– Notable pipeline events included positive data readouts for tirzepatide for type 2 diabetes and Jardiance for adults, with or without diabetes, who live with heart failure with preserved ejection fraction (HFpEF). Key Events Over the Last Three Months Regulatory. on a reported basis and increased to $1.87 on a non-GAAP basis.

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The Pharma Data

JUNE 2, 2022

BYOOVIZ™ is the first FDA approved ophthalmology biosimilar BYOOVIZ, priced 40% lower than LUCENTIS®, provides an equally effective and more affordable treatment option to patients suffering from retinal disorders BYOOVIZ will be commercially available through major distributors across the U.S. on July 1, 2022. Biogen Inc.

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The Pharma Data

JULY 8, 2021

Today, access to the world’s largest browsable resource linking rare protein-coding genetic variants to human health and disease was launched through a genetic exome sequence analysis collaboration between AbbVie (NYSE: ABBV), Biogen Inc. Nasdaq: BIIB) and Pfizer (NYSE: PFE). The browser can be accessed via [link]. About AbbVie. About Biogen.

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The Pharma Data

AUGUST 13, 2020

This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.

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The Pharma Data

APRIL 30, 2021

percent on an operational basis, due to biosimilar competition. Recent Events. Food and Drug Administration (FDA) and European Medicines Agency (EMA) seeking approval for Skyrizi (risankizumab, 150 mg) for the treatment of adults with active psoriatic arthritis (PsA). Humira net revenues were $3.907 billion , an increase of 6.9

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The Pharma Data

AUGUST 13, 2020

This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.

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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.

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Agency IQ

JUNE 9, 2023

Commission Regulation (EC) No 847/2000 set the rules, defining an orphan drug as one “that it is intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition affecting not more than five in 10 thousand persons in the Community when the application is made.” Orphan designation in the E.U.

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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.

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Drug Discovery World

NOVEMBER 9, 2023

Advances in discovery and engineering of antibodies for non-cancer targets This session will feature a range of presentations which include: Joshua Tan, PhD, Chief, Antibody Biology Unit, National Institute of Allergy and Infectious Diseases, National Institutes of Health, on: ‘Discovery of broadley-neutralising antibodies against Coronaviruses’.

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The Pharma Data

SEPTEMBER 20, 2020

” Sotorasib demonstrated confirmed objective response rate (ORR) and disease control rates (DCR) of 35.3% No dose-limiting toxicities were observed and there were no fatal treatment-related adverse events (TRAEs). The webcast will be archived and available for replay for at least 90 days after the event.

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The Pharma Data

NOVEMBER 9, 2020

1,2 Expression of TSLP is increased in the airways of patients with asthma and has been correlated with disease severity. The trial comprised a five to six week screening period, a 52-week treatment period and a 12-week post-treatment follow-up period. 300 cells/µL) and low (< 300 cells/µL) blood eosinophil counts.

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Agency IQ

JUNE 29, 2023

What We Expect the FDA to do in July 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.

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