Drug Channels

OCTOBER 5, 2021

Click here to download a free report overview (including a summary of industry trends, the Table of Contents, and a List of Exhibits) New Drug Channels Institute Study: Biosimilars Are Delivering Higher Profits for Drug Distributors (press release) We’re offering special discounted pricing if you order before October 15, 2021! Section 4.4.

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Drug Channels

FEBRUARY 22, 2022

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. Download a free report overview for more details.

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FDA Law Blog: Drug Discovery

FEBRUARY 2, 2023

As to biosimilars, FDORA amends the statutory language regarding criteria for the demonstration of biosimilarity for a 351(k) biologic. Alternative methods will require significant research investment to demonstrate their utility for a particular context of use and inform regulatory decision-making. 42 U.S.C. § 42 U.S.C. §

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Drug Channels

OCTOBER 10, 2023

Drug Distribution Industry Gaining from Anti-Obesity Drugs and Provider-Administered Biosimilars (press release) We’re offering special discounted pricing if you order before October 20, 2023! The exhibits appear in all license versions. The PowerPoint file option is available only with the purchase of a corporate license.)

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Agency IQ

JULY 26, 2024

FDA’s new guidance on postapproval manufacturing changes for biosimilars focuses on current practice, new dosage forms Meeting a biosimilar user fee commitment, the FDA is expanding on its recommendations for biosimilar and interchangeable product applicants asking the FDA for post-approval manufacturing changes.

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FDA Law Blog: Biosimilars

JUNE 12, 2024

With input from medical professionals, stakeholder, trade associations, and patient advocacy groups, FDA provided a pathway to market for air-conduction hearing aids without a prescription or the involvement of a licensed professional. While helpful background, it’s not new information.

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Drug Channels

SEPTEMBER 12, 2023

As always, we have updated all market and industry data with the most current information available. If you have any questions before purchasing a license to the report, please email me ( afein@drugchannels.net ). Special preorder and launch pricing discounts will be valid through October 20, 2023. d/b/a Drug Channels Institute.

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Agency IQ

APRIL 26, 2024

Updated guidance on promotional labeling for biosimilars and interchangeables emphasizes a similar approach Today, the FDA issued a revised draft guidance on the development of promotional labeling for biosimilars, reference products, and—newly—interchangeable products. regarding its administration, preparation, storage, or safety).

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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. This 2023 edition includes substantial new material.

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The Pharma Data

MARCH 5, 2021

We routinely post information that may be important to investors on our website at www.biogen.com. Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement. Since October 2017 Biogen and Eisai have collaborated on the development and commercialization of aducanumab globally.

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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.

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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.

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FDA Law Blog: Biosimilars

SEPTEMBER 18, 2024

FDA did not disclose the exact date of the IND because that information is confidential. FDA asserted that even if an NMN supplement was marketed on that date, it would still be excluded because, according to FDA, NMN was authorized for investigation as a new drug under an IND before December 3, 2020.

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Agency IQ

JANUARY 19, 2024

Seventeen products were orphan drugs, fourteen were generics and eight were biosimilars. Reviews of orphan medicines and biosimilars have remained stable over the past three years. There were eight biosimilars reviewed in 2023, which is comparable to 2021 (seven) and 2022 (eight), but lower than 2020, which saw 12 biosimilars reviewed.

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FDA Law Blog: Biosimilars

MARCH 13, 2024

[(Emphasis in original)] This brings us to a spate of recent letters from the PTO to PTE applicants we’ve seen titled “REQUIREMENT FOR INFORMATION PURSUANT TO 37 C.F.R. They all as for the same type of information: U.S. exclusively licensed U.S. 10,544,220 (October 24, 2023) Pursuant to 37 C.F.R. 10,544,220 (the ‘220 patent).

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FDA Law Blog: Biosimilars

AUGUST 9, 2023

The content and prescription information elements required by 21 C.F.R. Two licensed pharmacists must directly communicate the transfer. The transferring or receiving pharmacist must ensure that the populated information is complete and accurate. to be codified at 21 C.F.R. cannot be altered during the transmission.

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Agency IQ

JUNE 2, 2023

We’re expecting that there are a lot of companies that aren’t aware of this requirement, but we’re also expecting that this information will be hugely helpful to the FDA and its ability to even know what it regulates. government’s way of informing stakeholders of the regulations that are under active development.

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Agency IQ

AUGUST 2, 2024

FDA Regulations and guidance under OIRA review as of August The White House’s Office of Information and Regulatory Affairs (OIRA) is the regulator of regulators, tasked with ensuring that all federal policies and regulations adhere to laws, existing regulations, federal policies and the wishes of the President.

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FDA Law Blog: Biosimilars

MARCH 4, 2024

The draft guidance provides recommendations for applicants and manufacturers about the requirements for notifications about production changes of certain finished drugs and biological products and certain active pharmaceutical ingredients (API), and outlines information FDA would like to receive in addition to the requirements.

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The Pharma Data

MAY 2, 2022

Under the terms of the settlement agreement, the litigation between the parties in the United States District Court for the District of New Jersey will be ended, and Lupin will have a license to sell its generic product beginning April 2033, or earlier under certain circumstances. IMPORTANT SAFETY INFORMATION.

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Agency IQ

JULY 8, 2024

FDA Regulations and guidance under OIRA review as of July The White House’s Office of Information and Regulatory Affairs (OIRA) is the regulator of regulators, tasked with ensuring that all federal policies and regulations adhere to laws, existing regulations, federal policies and the wishes of the President.

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Agency IQ

MAY 3, 2024

FDA’s Diversity Action Plan guidance: The FDA’s hotly-anticipated revised draft guidance document is currently under review at the White House’s Office of Information and Regulatory Affairs (OIRA), and we anticipate that it will be published over the next two months.

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The Pharma Data

JANUARY 24, 2021

The company has established a diversified R & D pipeline comprising 27 innovative drug candidates and 2 biosimilars, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. For more information, please visit: [link]. Contact Information.

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The Pharma Data

NOVEMBER 6, 2020

With the opinions expressed at the Advisory Committee and the data presented, the FDA will continue the review process with a decision on whether to approve the aducanumab Biologics License Application by March 7, 2021. . Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement.

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FDA Law Blog: Biosimilars

JUNE 27, 2024

The regulation requires that pharmacists “ensure that a reasonable effort is made to obtain” this information. It also states that “[t]he pharmacist shall record any related information indicated by a licensed health care practitioner.” Id. at § 64B16-27.810(2). at § 64B16-27.800(2).

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The Pharma Data

OCTOBER 29, 2020

Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement. We routinely post information that may be important to investors on our website at www.biogen.com. For more information about Eisai Co., Since October 2017 Biogen and Eisai Co., please visit [link]. Biogen Safe Harbor.

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The Pharma Data

DECEMBER 9, 2020

Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement. We routinely post information that may be important to investors on our website at www.biogen.com. For more information about Eisai Co., Since October 2017 Biogen and Eisai Co., please visit [link]. Biogen Safe Harbor.

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The Pharma Data

JULY 27, 2021

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

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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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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). AgencyIQ compiled these data using information in approval letters and review packages posted to the Drugs@FDA database.

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Agency IQ

JUNE 2, 2023

FDA unveils long-awaited Patient Medication Information proposed rule Since 2017, the FDA has been working on a proposal to create a new type of patient-focused labeling for certain outpatient drug products that would be specifically targeted for patient use. The FDA recently concluded its work on a proposed rule focused on PMI.

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The Pharma Data

APRIL 30, 2021

percent on an operational basis, due to biosimilar competition. AbbVie received information requests from the FDA for an updated assessment of the benefit-risk profile for Rinvoq in both indications. For more information about AbbVie, please visit us at www.abbvie.com. Humira net revenues were $3.907 billion , an increase of 6.9

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The Pharma Data

AUGUST 3, 2021

Certain financial information for 2021 and 2020 is presented on both a reported and a non-GAAP basis. For further detail on non-GAAP measures, see the reconciliation below as well as the “Reconciliation of GAAP Reported to Selected Non-GAAP Adjusted Information” table later in this press release. 2)% EPS – Reported 1.53

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Agency IQ

SEPTEMBER 29, 2023

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED SEP 25, 2023 10:39 PM CDT Note: At the request of our subscribers, we are beginning to include information about the next two months of expected developments to make it easier for you to keep track of upcoming events. the drug and device) of the combination product.

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Agency IQ

FEBRUARY 12, 2024

to analyze data, generate summaries of certain information, or other tasks of interest to companies in the interest of efficiencies. This is a topic that the agency has been keenly aware of for years, but it’s not clear from the title if it will refer to how the FDA will use A.I.

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Agency IQ

FEBRUARY 15, 2024

In other cases, the FDA is under no obligation to release a document at any time, but is instead developing the document on its own accord. We have tried to sort guidance documents by topic area. Priority B List.

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Drug Target Review

JULY 6, 2023

3 Furthermore, the act “removes a requirement to use animal studies as part of the process to obtain a license for a biological product that is biosimilar or interchangeable with another biological product.”

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