Drug Channels

OCTOBER 11, 2022

Drug Distribution Industry Expands as COVID-19 Disruption Fades and Biosimilars Boom (press release) We’re offering special discounted pricing if you order before October 21, 2022! We also update sections that were introduced in recent editions, such as our estimates of wholesalers' profits from provider-administered biosimilar drugs.

Pharmaceuticals

FDA Law Blog: Biosimilars

APRIL 25, 2024

This Revised Draft Guidance provides considerations for manufacturers, packers or distributors (dubbed “firms”) of prescription biological reference products, biosimilar products, and interchangeable biosimilar products presenting data and information about such products in promotional materials in a truthful and non-misleading way.

Biosimilars

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.

Biosimilars

Agency IQ

AUGUST 25, 2023

New FDA guidance on interchangeable biosimilar labeling heads to White House for review The FDA has submitted a draft guidance focused on the labeling of interchangeable biosimilar products to the White House for review, which would fulfill a Biosimilar User Fee Act (BsUFA III) commitment.

Biosimilars

FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

Specifically, Boehringer asked FDA to interpret “strength” for biosimilars to mean “total drug content” to the exclusion of “concentration.” mL), to be biosimilar to or interchangeable with High Concentration Humira (e.g., mL), to be biosimilar to or interchangeable with High Concentration Humira (e.g.,

FDA

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. §

Animal Testing

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.

Pharmacy

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.

FDA

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.

Licensing

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.

Pharmaceuticals

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.

Pharmaceuticals

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.

Pharmaceuticals

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.

FDA

FDA Law Blog: Biosimilars

JULY 10, 2025

where no active moiety for a drug or no active ingredient for a biological product has been approved in any other application) be posted online within 30 calendar days of approval or within 30 days of the third Freedom of Information Act (FOIA) request for that package.

FDA

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.

Production

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.

Pharmacy

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.

FDA

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.

FDA

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.

Production

The Pharma Data

SEPTEMBER 16, 2020

Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. Additional information about CodeBreaK clinical trials can be found at [link]. For more information, follow us on www.twitter.com/amgenoncology.

Clinical Trials

Agency IQ

JUNE 29, 2023

Specifically, this ANPRM seeks comments, research, information, data, and responses from certain categories of stakeholders that can inform the Agency’s modernization of FDA’s recall regulation. This proposed revision to 21 CFR 807 is for consistency with FDA’s current regulations under 21 CFR part 1271, subpart A.

FDA

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. For more information about AbbVie, please visit us at www.abbvie.com. Percent on a Reported Basis, or 12.5

Production

The Pharma Data

SEPTEMBER 20, 2020

Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. Additional information about CodeBreaK clinical trials can be found at [link]. For more information, follow us on www.twitter.com/amgenoncology.

Clinical Trials

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.

FDA

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.

FDA

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).

Pharmacy

The Pharma Data

NOVEMBER 9, 2020

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.

Trials

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

FDA

The Pharma Data

OCTOBER 29, 2020

ALXN2060 (AG10) – Eidos: Alexion holds an exclusive license to develop and commercialize ALXN2060 (AG10) in Japan. The results of this study will inform the design of a randomized controlled clinical trial to expand the label in this population. Eidos is currently evaluating AG10 in a Phase 3 study in the U.S. Eastern Time.

Clinical Trials

Agency IQ

SEPTEMBER 1, 2023

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.” Cover letters accompanying an IRP application must include specific information. market more quickly.

International

BioPharma Drive: Drug Pricing

JULY 21, 2025

Skip to main content Dont miss tomorrows biopharma industry news Let BioPharma Dives free newsletter keep you informed, straight from your inbox. Now that seven ustekinumab biosimilars are commercially available, manufacturers will be paying close attention to how the market responds—and how this biosimilar race differs from last year’s.

Biosimilars

The Pharma Data

DECEMBER 21, 2020

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.

Trials

FDA Law Blog: Biosimilars

AUGUST 29, 2024

Shumsky — As readers of this blog know ( see, e.g. , here ), the Affordable Generics (and Biosimilars) Act has been floating around in Congress for the better part of two decades. The latest iteration of the Preserve Access to Affordable Generics and Biosimilars Act making its way through Congress is Senator Amy Klobuchar’s (D-MN) S.

Biosimilars

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.

FDA

FDA Law Blog: Biosimilars

DECEMBER 3, 2023

Manufacturers must also ensure that all electronic FDA listings and all NDC listings with the electronic database vendors used to process pharmacy claims, including information about discontinued drugs, are up to date for all applicable drug and selected drug NDCs. 1395w-114c(b)(4)(B)(i). See 42 U.S.C. 1395w-114c(g)(4)(B)(ii)(II)(bb).

Compliance

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.”

Animal Testing

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.

FDA