Drug Channels

FEBRUARY 21, 2023

Pharmacies and Pharmacy Benefit Managers is a definitive, nonpartisan resource that includes the most current information about pharmacy dispensing channels, third-party payers, pharmacy benefit managers (PBMs), patients’ financial contributions, government regulations, and much more. Click to Enlarge] Thank you for your interest in our work.

Pharmacy 97

Pharmacy Specialty Pharmacies Licensing Licensing 97

FDA Law Blog: Biosimilars

JUNE 27, 2024

The Government alleged that Coconut Grove violated numerous federal and state controlled substance laws. It also states that “[t]he pharmacist shall record any related information indicated by a licensed health care practitioner.” Id. 21 U.S.C. § 823(g)(1)(B), (D). at 50,376. “A 21 C.F.R. §§ 1306.04(a), a), 1306.06.

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Pharmacy Drugs Regulations Compliance 52

FDA Law Blog: Biosimilars

MARCH 13, 2024

The PTE application states “[u]nder the terms of the AMENDED AND RESTATED DEVELOPMENT AND COMMERCIALIZATION LICENSE AGREEMENT between Pfizer Inc. exclusively licensed U.S. However, an exclusive license is not an authorization to rely on the activities of the marketing applicant for a PTE application. and OPKO Ireland Ltd.

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FDA FDA Approval Production Marketing 59

The Pharma Data

JULY 27, 2021

We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities.

Production 52

Production Clinical Trials Government Disease 52

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). 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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FDA Biosimilars Science Production 52

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. a leading clinical-stage CRISPR genome editing biotechnology company, announced that they have entered into a collaboration and license agreement for the research and development of chimeric antigen receptor (CAR)-T cell therapeutics. percent on a reported basis, or 12.6

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Drug Target Review

JULY 6, 2023

History behind animal testing In December 2022, the US Government approved the ground-breaking US Food and Drug Association (FDA) Modernization Act 2.0, History behind animal testing In December 2022, the US Government approved the ground-breaking US Food and Drug Association (FDA) Modernization Act 2.0, In Britain, 2.88

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Animal Testing Drugs Clinical Trials Clinical Research 105

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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FDA Science Regulations Production 40

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. Most are new or revised definitions and administrative changes, but several proposals represent new policies that should be of concern to drug manufacturers.

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Drugs Regulations Government Vaccine 59

The Pharma Data

SEPTEMBER 16, 2020

We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities.

Clinical Trials 52

Clinical Trials Production Trials Government 52

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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FDA Science Regulations Production 40

The Pharma Data

NOVEMBER 9, 2020

All aspects of the collaboration are under the oversight of joint governing bodies. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. Amgen’s business may be impacted by government investigations, litigation and product liability claims.

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Trials Production Clinical Trials Government 52

The Pharma Data

SEPTEMBER 20, 2020

We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities.

Production 52

Production Clinical Trials Trials Government 52

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).

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FDA Science Regulations Production 40

The Pharma Data

DECEMBER 21, 2020

All aspects of the collaboration are under the oversight of joint governing bodies. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. Amgen’s business may be impacted by government investigations, litigation and product liability claims.

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Trials Production Clinical Trials Government 40

The Pharma Data

OCTOBER 27, 2020

Novartis has been granted an option to in-license global rights of MP0420 and MP0423 – multi-targeted direct-acting antiviral therapeutic candidates demonstrating potential efficacy against COVID-19. During the clinical development stage, Molecular Partners will provide clinical supply. About DARPin® therapeutics.

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Therapies Virus Treatment Clinical Trials 52

The Pharma Data

OCTOBER 29, 2020

ALXN2060 (AG10) – Eidos: Alexion holds an exclusive license to develop and commercialize ALXN2060 (AG10) in Japan. Enrollment is underway in two parallel Phase 3 studies – one in patients with Mayo stage IIIa disease and one in patients with Mayo stage IIIb disease. Eidos is currently evaluating AG10 in a Phase 3 study in the U.S.

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Agency IQ

JUNE 29, 2023

6/27/2023 Notification FDORA, Section 3201 Within 180 days of the passage of FDORA, all biologics and biosimilars sponsors must submit a written notice to the FDA of all actively marketed products (i.e., The following PDUFA dates were obtained from publicly available sources. not discontinued) and are available for sale.

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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

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. Full-year 2020 Fabrazyme ® sales were up 3.2%, reflecting new patient accruals in Europe partially offset by COVID-19 impact and lower sales in Japan due to government price decrease in April 2020.

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Vaccine Production FDA Pharmaceuticals 52

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. Full-year 2020 Fabrazyme ® sales were up 3.2%, reflecting new patient accruals in Europe partially offset by COVID-19 impact and lower sales in Japan due to government price decrease in April 2020.

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Vaccine Production FDA Pharmaceuticals 52

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. net price, increasing usage of Toujeo ® , biosimilar glargine competition and lower sales in Europe (patient stockpilling in the first quarter of 2020). In the U.S., Plavix ® sales were down 4.0%

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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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Vaccine Production FDA Biosimilars 40

Agency IQ

SEPTEMBER 1, 2023

government is providing 10 million pounds to support the development of the new recognition route. The MHRA notes that the new pathway will be parallel to its innovation pathway (the Innovative Licensing and Access Pathway , or ILAP), which integrates “early regulatory advice with health technology assessment advice.” or E.A.A.

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International Regulations Production Marketing 40

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.

FDA 40

FDA Science Biosimilars Regulations 40

FDA Law Blog: Biosimilars

JANUARY 9, 2024

This must be a Health Canada-licensed wholesaler that is registered with FDA as a foreign seller. based entity licensed as a wholesale distributor or a pharmacist that will import the drugs. The government would require at least another 30 days to examine the shipment at the U.S. This must be a U.S.-based

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FDA Approval FDA Drugs Compliance 59

FDA Law Blog: Biosimilars

FEBRUARY 11, 2024

The regulated cannabis marketplace brings in billions of dollars in revenue into state and federal governments, with predictions that cannabis sales will exceed $53 billion by 2027.

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