Drug Discovery World

MARCH 29, 2023

What of the increased possibilities for ‘replacement pharmacy compounding’ for weekly hospital supplies, and for routine manufacturing of cell and gene therapies without a marketing authorisation? He pointed out that Europe was the first region to approve biosimilars. You can compare timelines.

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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. government, we could become subject to significant sanctions.

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The Pharma Data

MARCH 13, 2022

NYSE: PFE) announced today the completion of its acquisition of Arena Pharmaceuticals, a clinical stage company developing innovative potential therapies for the treatment of several immuno-inflammatory diseases. Pfizer Inc. The root cause of many immunological diseases is immuno-inflammation, which requires specifically designed agents.

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Agency IQ

AUGUST 2, 2024

For various reasons, that currently seems unlikely, but it is perhaps more likely that Congress will pass a short-term continuing resolution to fund the federal government for a few months, as it often does. use of RWE, registries) for capturing post-approval safety and efficacy data for cell and gene therapy products.

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The Pharma Data

MARCH 29, 2022

The global Phase 3 multi-center, randomized, double-blind, placebo-controlled study enrolled 433 UC patients who had previously failed or were intolerant to at least one conventional, biologic, or Janus kinase (JAK) inhibitor therapy. Participants received etrasimod 2 mg or placebo once-daily. Pfizer Inc.:

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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 revenue, the largest CRO in the US was Thermo Fisher Scientific Inc., of total revenue).

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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. The company is separately supporting COVID-19-related clinical investigations of several Novartis medicines.

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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.:

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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. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities.

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Agency IQ

JULY 8, 2024

The court’s decision on June 28 is going to cause a frantic re-evaluation at every regulatory agency in the federal government and in every court in the country. We’re about to find out. Read AgencyIQ’s analysis of the Loper Bright decision ] Unified Agenda: What regulations is the FDA expecting to release through the end of the year?

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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.

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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

Shorter exclusivity periods, driven by patent challenges and the introduction of generic or biosimilar competitors, significantly contribute to declining ROI. When a drug loses patent protection, generic or biosimilar versions can enter the market, leading to a rapid decline in sales for the original brand-name drug.

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FDA Law Blog: Biosimilars

JULY 24, 2023

More specific to the facts of this case than the governing statute, Jazz argues that OOPD’s determination that Lumryz is clinically superior to Xywav is inconsistent with FDA’s regulations. Jazz argues, essentially, that the change in position was the product of a pressure campaign within the Agency.

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FDA Law Blog: Biosimilars

DECEMBER 4, 2023

The government asserted additional allegations that are outside our scope. Prescribing Red Flags The government alleged that from at least 2017 to April 2021 Defendants knowingly filled controlled substance prescriptions “that raised obvious ’red flags’ of potential abuse or diversion.” Zarzamora Press Release. Complaint ¶ 55.

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Agency IQ

OCTOBER 6, 2023

As such, it doesn’t review things like vaccines, blood products or gene therapies – those products are instead reviewed by CBER. government fiscal year runs from October 1 – September 30. As AgencyIQ has previously discussed , developing biosimilars is an expensive process. As a reminder, the U.S.

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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. The increase in U.S. Revenue outside the U.S.

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The Pharma Data

APRIL 30, 2021

percent on an operational basis, due to biosimilar competition. The EC is expected to deliver its final decision on Venclyxto combination therapy for use in AML in 2Q 2021. Humira net revenues were $3.907 billion , an increase of 6.9 Internationally, Humira net revenues were $960 million , a decrease of 8.3 Full-Year 2021 Outlook.

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The Pharma Data

JULY 15, 2021

Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. About Biogen.

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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. million doses of MP0420, if it is approved in Switzerland. About DARPin® therapeutics.

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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.,

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The Pharma Data

DECEMBER 21, 2020

In September 2018 , the US Food and Drug Administration granted Breakthrough Therapy Designation for tezepelumab in patients with severe asthma, without an eosinophilic phenotype. All aspects of the collaboration are under the oversight of joint governing bodies. It’s a commitment that extends beyond introducing novel therapies.

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The Pharma Data

NOVEMBER 9, 2020

Food and Drug Administration Breakthrough Therapy Designation granted to tezepelumab in Sept. All aspects of the collaboration are under the oversight of joint governing bodies. Amgen Inflammation Amgen brings therapies to millions of people with inflammatory diseases, with a focus on serving unmet patient needs.

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The Pharma Data

JULY 8, 2021

Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. About Biogen.

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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). Eligible patients must have received a prior line of systemic anticancer therapy, consistent with their tumor type and stage of disease. Reese , M.D.,

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Agency IQ

SEPTEMBER 29, 2023

What we expect to be talking about in October: Government shutdown: The odds of a government shutdown happening in October are, we think, rather high absent a last-minute breakthrough in Congressional negotiations. Of note: A government shutdown would likely delay or cancel some of the events listed below.

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The Pharma Data

APRIL 7, 2023

BRAFTOVI is also approved, in combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy. Integrating biomarkers and targeted therapy into colorectal cancer management. American Lung Association.

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Agency IQ

OCTOBER 27, 2023

Government shutdown: At present, the U.S. federal government has appropriated funding through November 17. That means at 12:01 on November 18, the government will shut down unless Congress is able to pass either a full budget (unlikely) or a continuing resolution (more likely). the drug and device) of the combination product.

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FDA Law Blog: Biosimilars

OCTOBER 17, 2023

FDA selected and posted eight challenge participants, which included monitoring, OUD therapy, pain therapy, medication dispensing, overdose therapy, and diagnostic devices.

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The Pharma Data

FEBRUARY 8, 2021

In Japan, sales were €58 million (up 30.4%), where strong demand was moderated by the government price decrease implemented in April 2020. At the end of 2020, Dupixent ® was launched in 47 countries with approximately 230 000 patients on therapy. In Europe, fourth-quarter Dupixent ® sales grew 76.9% Net sales (€ million).

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The Pharma Data

FEBRUARY 4, 2021

In Japan, sales were €58 million (up 30.4%), where strong demand was moderated by the government price decrease implemented in April 2020. At the end of 2020, Dupixent ® was launched in 47 countries with approximately 230 000 patients on therapy. In Europe, fourth-quarter Dupixent ® sales grew 76.9% Net sales (€ million).

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Agency IQ

DECEMBER 1, 2023

Government shutdown: At present, the FDA has appropriated funding through January 19. While the FDA previously published a similar version of this document, Congress gave FDA new authority to require these plans. Expect nearly every company to be closely reading this document when it’s eventually published.

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The Pharma Data

OCTOBER 29, 2020

. “Our foundation for the future is stronger than ever, and by maintaining our focus on serving patients and delivering for shareholders, I am confident that we will continue to build on our success to date and further advance our mission of delivering life-changing therapies to people with rare diseases and devastating conditions.”

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The Pharma Data

APRIL 27, 2021

In Japan, sales were €59 million (up 53.7%), where strong demand was moderated by the government price decrease implemented in April 2020. At the end of the first quarter, Dupixent ® was launched in 49 countries with approximately 260 000 patients on therapy. . In Europe, first-quarter Dupixent ® sales grew 52.2% Net sales (€ million).

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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

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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. government exercised its option for an additional 100 million doses of BNT162b2, bringing the total number of doses to be supplied by the companies to the U.S.

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The Pharma Data

AUGUST 21, 2020

Novavax and Janssen commit 90 million COVID-19 vaccine doses to UK Government with two new deals. The UK Government has signed a new deal with Johnson & Johnson and Novavax to secure 90 million orders of their vaccine candidates to protect against COVID-19 infection. .

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