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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The Pharma Data

MAY 18, 2021

In line with plans announced with the Austrian government in July 2020, Sandoz confirms that in a first step it will proceed to invest more than €100 million to introduce new manufacturing technology for the production of oral amoxicillin, an active pharmaceutical ingredient (API) for its leading penicillin product. About Sandoz.

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FDA Law Blog: Biosimilars

DECEMBER 21, 2023

When asked what excites FDLI the most about 2024 and the 75th anniversary, Simmon was quick to say, “FDLI has a front-row seat to the ever-changing and intriguing legal and regulatory developments impacting FDA-regulated products. The story of Rudolph overcoming obstacles resonated with May’s personal struggles during that time.

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The Pharma Data

AUGUST 31, 2020

Portfolio of 15 generic and over-the-counter (OTC) medicines from Sandoz division will be sold at zero- profit to governments through Africa Medical Supplies Platform (AMSP) to 55 African and 15 Caricom eligible countries . The collaboration aims to help alleviate supply and logistical constraints in the African Union member states .

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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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The Pharma Data

SEPTEMBER 17, 2020

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.” This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

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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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FDA Law Blog: Biosimilars

JUNE 27, 2024

The Government alleged that Coconut Grove violated numerous federal and state controlled substance laws. The regulation requires that pharmacists “ensure that a reasonable effort is made to obtain” this information. 21 U.S.C. § 823(g)(1)(B), (D). at 50,376. “A 21 C.F.R. §§ 1306.04(a), 21 C.F.R. §§ 1306.04(a), a), 1306.06.

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The Pharma Data

MAY 15, 2023

In total, 4 out of 10 members of the new Sandoz Board of Directors will be female, resulting in an above average 40% female-to-male ratio for this important governance body. “I We deliver high-value medicines that alleviate society’s greatest disease burdens through technology leadership in R&D and novel access approaches.

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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. Dr. Reddy’s operates in markets across the globe.

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The Pharma Data

AUGUST 13, 2020

person” (as defined in Rule 902 of Regulation S under the Securities Act), outside the United States not purchasing for the account or benefit of a U.S. person, (B) acquiring the New Notes in an offshore transaction in accordance with Regulation S under the Securities Act and (C) otherwise a Non- U.S.

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The Pharma Data

FEBRUARY 8, 2021

IBRANCE is an oral inhibitor of CDKs 4 and 6, 1 which are key regulators of the cell cycle that trigger cellular progression. IBRANCE is an oral inhibitor of CDKs 4 and 6, 1 which are key regulators of the cell cycle that trigger cellular progression. This extension does not include potential pediatric exclusivity. 2,3 In the U.S.,

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The Pharma Data

AUGUST 13, 2020

person” (as defined in Rule 902 of Regulation S under the Securities Act), outside the United States not purchasing for the account or benefit of a U.S. person, (B) acquiring the New Notes in an offshore transaction in accordance with Regulation S under the Securities Act and (C) otherwise a Non- U.S.

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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.

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FDA Law Blog: Biosimilars

DECEMBER 4, 2023

But in addition to imposing civil penalties for alleged failure to comply with their obligations under the federal Controlled Substances Act and DEA regulations, the courts mandated how those registrants must handle controlled substances going forward. The government asserted additional allegations that are outside our scope.

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The Pharma Data

AUGUST 3, 2021

The company announced plans to submit donanemab for Alzheimer’s disease and tirzepatide for type 2 diabetes to regulatory authorities by the end of 2021. and international governments, Lilly invested in large-scale manufacturing of COVID-19 antibodies at risk, in order to ensure rapid access to patients around the world.

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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.

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Agency IQ

DECEMBER 1, 2023

What We Expect the FDA to do in December 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. Government shutdown: At present, the FDA has appropriated funding through January 19.

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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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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. Government shutdown: At present, the U.S.

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The Pharma Data

APRIL 30, 2021

percent on an operational basis, due to biosimilar competition. The applications are supported by two Phase 3 studies in which Skyrizi demonstrated improved skin and joint symptoms and physical function, with a greater proportion of patients achieving minimal disease activity versus placebo. percent on a reported basis, or 12.6

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FDA Law Blog: Biosimilars

JUNE 2, 2023

Kirschenbaum — Last Friday, May 26, CMS published in the Federal Register an assortment of proposals to change the regulations governing the Medicaid Drug Rebate Program. The CMS regulation (unlike the statute) would expansively define a “misclassification” to include, not only misclassifying the drug category (e.g.,

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The Pharma Data

NOVEMBER 9, 2020

All aspects of the collaboration are under the oversight of joint governing bodies. 1,2 Expression of TSLP is increased in the airways of patients with asthma and has been correlated with disease severity. About Severe Asthma Asthma is a complex and heterogeneous disease affecting an estimated 339 million people worldwide.

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The Pharma Data

SEPTEMBER 16, 2020

Eligible patients were heavily pretreated with at least two or more prior lines of treatment, consistent with their tumor type and stage of disease. Our research drives us to understand the disease in the context of the patient’s life – not just their cancer journey – so they can take control of their lives.

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

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The Pharma Data

DECEMBER 21, 2020

Severe asthma is a complex, heterogenous disease and many patients continue to face debilitating symptoms despite receiving standard of care inhaled medicines and currently approved biologics. All aspects of the collaboration are under the oversight of joint governing bodies. Amgen will record sales in the U.S.

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FDA Law Blog: Biosimilars

OCTOBER 17, 2023

The new guidance also presents an opportunity for device manufacturers working for patient populations affected by rare life-threatening or irreversibly debilitating diseases or conditions, such as sickle cell disease. By Philip Won & Lisa M.

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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

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. Rare Disease. The vaccine was 100% effective against severe disease as defined by the U.S. Centers for Disease Control and Prevention (CDC), and 95.3%

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Agency IQ

JULY 28, 2023

BY ALEXANDER GAFFNEY, MS, RAC JUN 27, 2023 11:49 AM CDT Big-picture things to watch in Q3 A rush of things for FDA to do as we approach the end of the fiscal year: The government operates on a Fiscal Year that begins on October 1 each year and ends on September 30. government by October 1.

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Drug Discovery World

JULY 26, 2024

This, coupled with looming patent expirations, the impact of new drug pricing regulations, and tighter universal regulation of medical devices presents a complex environment for both large and small life science companies. Conversely, Trump champions free market competition and biosimilars. A new direction for the UK?

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The Pharma Data

MAY 17, 2021

US Supreme Court denies Sandoz petition to review biosimilar Erelzi case ( Press ). ACC 2021: J&J, Bayer pad case for Xarelto in post-surgery artery disease patients ( Fierce ). ACC 2021: J&J, Bayer pad case for Xarelto in post-surgery artery disease patients ( Fierce ).

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