FDA Law Blog: Biosimilars

NOVEMBER 1, 2023

FDA recognizes that the FD&C Act exempts licensed healthcare practitioners from certain device regulations if they manufacture devices solely for use in the course of their professional practice. For example, FDA’s regulations have exempted from certain regulatory requirements (e.g.,

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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. The report also updates our annual analyses of the strategies, market positions, and executive compensation of the three largest companies: AmerisourceBergen (Cencora), Cardinal Health, and McKesson. d/b/a Drug Channels Institute.

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The Pharma Data

OCTOBER 19, 2020

The designation provides Berubicin with certain benefits during the product’s development to treat malignant gliomas and provides CNS with the potential for market exclusivity upon the drug’s approval for that use. About CNS Pharmaceuticals, Inc.

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The Pharma Data

JANUARY 18, 2021

OKYO has been developing the chemerin molecule as a promising anti-inflammatory treatment for dry-eye disease (“DED”) licensed from researchers at On Target Therapeutics LLC. When Lucentis ® (Ranibizumab) received FDA approval in late June 2006, the new macular degeneration drug was celebrated as a major medical breakthrough.

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The Pharma Data

DECEMBER 21, 2020

The length of time that it takes for Amgen to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and Amgen expects similar variability in the future. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. Eur Respir J.

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Agency IQ

AUGUST 2, 2024

While generic drugs technically pre-dated the law (look up “Paper NDAs” if you’re interested), the law turbocharged the ability of generics to come to market. We expect the FDA to mark the occasion, especially since drug pricing continues to be such a potent issue in the Presidential election. and the E.C.

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Drug Channels

FEBRUARY 22, 2022

As always, we have updated all market and industry data with the most current information available, including our annual analyses of the market positions of the largest pharmacies, specialty pharmacies, and PBMs. If you have any questions before purchasing a license to the report, please email me. Click to Enlarge].

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FDA Law Blog: Biosimilars

AUGUST 29, 2024

That bill, addressing drug (and later biological product) patent settlement agreements (pejoratively referred to as “reverse payment agreements” by their opponents), was first introduced by Senator Herb Kohl (D-WI) in June 2006 as S.

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The Pharma Data

NOVEMBER 22, 2020

The company will be conducting market research to gain additional feedback from physicians and payors to inform the potential path forward. SOUTH SAN FRANCISCO, Calif., Cytokinetics will have no trailing royalty payment obligations to Amgen for either omecamtiv mecarbil or AMG 594. Conference Call and Webcast Information.

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Drug Channels

OCTOBER 10, 2023

No other report on the market today offers the depth, insight and analysis into these channels This 2023-24 edition contains the most current financial and industry data along with detailed information about the strategies and market positions of the largest companies: AmerisourceBergen, Cardinal Health, and McKesson.

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Drug Channels

OCTOBER 19, 2020

Channel Strategy for First Medical Product – A Look at Channel Considerations for Pharmacy vs. Medical Plus – Tailored Track Options Based on Company Size : Emerging/Small Companies – Infrastructure Set-Up, License Procurement and 3PL Contracting Mid-Large Companies – How Do I Think About My Portfolio Differently Based on Product Type?

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Drug Channels

OCTOBER 13, 2020

The 2020–21 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors —our 11th edition—remains the most comprehensive resource for analyzing the pharmaceutical distribution industry’s economics, market structure, growth rates, forces of change, and interactions with the U.S. Copyright © 2006-2020 Pembroke Consulting, Inc.

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Agency IQ

JULY 28, 2023

On March 27, the FDA finalized a transition guidance document covering products that had been marketed under enforcement discretion policies during the PHE. First, by March 2021, manufacturers were expected to conclude a risk assessment of their approved or marketed products to assess the risk of nitrosamines.

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The Pharma Data

JUNE 18, 2021

On February 26, 2021, the European Medicines Agency (EMA) accepted for review Pfizer’s Marketing Authorization Application (MAA) for the 20-valent pneumococcal conjugate vaccine candidate, as submitted for the prevention of invasive disease and pneumonia caused by S. pneumoniae serotypes in the vaccine in adults ages 18 years and older.

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Agency IQ

JUNE 16, 2023

Following the EPA’s January 4, 2006, publication of a final rule that revised 40 CFR part 16 to comply with federal mandates associated with the Privacy Act (5 U.S.C. EPA then conducted a residual risk and technology review on July 27, 2006 (71 FR 42724). This action will address Louisiana Environmental Action Network v.

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Agency IQ

JULY 12, 2024

Proposed Rule Pediatric Study Plan Requirements for New Drug and Biologics License Applications October 2024 FDA is proposing to amend its existing regulations and add new regulations pertaining to submission of required initial pediatric study plans (iPSPs) under the Federal Food, Drug, and Cosmetic Act (FD&C Act). and the E.C.

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Drug & Device Law

MAY 30, 2022

The law presumes that licensed doctors know what they are doing. W]e believe that a drug manufacturer cannot be required legally to foresee that a licensed physician will disregard express warnings regarding a drug’s use. . . . There’s a reason why prescribing physicians and implanting surgeons are called “learned” intermediaries.

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Drug & Device Law

JULY 31, 2023

no[r] a marketing product” under Lanham Act). 2006 WL 2595944, at *23 (N.D. 11, 2006) (same), aff’d in pertinent part , 291 F. 2006) (video game “clearly qualifies as an ‘artistic work’ entitled to First Amendment protection”). 2006), aff’d , 279 F. Leading Market Technologies, Inc. , Paragon 28, Inc.

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Drug & Device Law

FEBRUARY 20, 2023

In product liability litigation generally, plaintiffs have been allowed to invent all kinds of “alternative” designs as long as some “expert” opines that the design (even if never before marketed) is “feasible.” 2006), app. 2006), app. For physicians to prescribe such a safer drug, it must reach the market. 2d at 401.

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Drug & Device Law

FEBRUARY 2, 2023

1974) (applying Texas law), the Fifth Circuit had held: [T]o conclude that the maker of an unavoidably unsafe product did not act unreasonably in placing it on the market is not to relieve him of the responsibility to market it in such a way as to prevent unreasonable danger. 2006) (reversal concerned warning issues); Blackmon v.

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Drug & Device Law

JUNE 2, 2022

This was in contrast to state authority to regulate physicians licensed by the state, as in Planned Parenthood of Cincinnati Region v. Plan B, which utilizes the progestin levonorgestrel that is also used in a number of oral contraceptives, received FDA approval for over-the-counter use in 2006. the state action would be preempted.

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New Drug Approvals

APRIL 27, 2025

6] It was first approved in the US in 2004, and an extended release version was brought to market in 2007. 15] :13 Madaus licensed the US rights to trospium chloride to Interneuron in 1999 and Interneuron ran clinical trials in the US to win FDA approval. [17] Fischer J, Ganellin CR (2006). billion in 2004. [23] 4 (6): 43640.

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New Drug Approvals

MAY 11, 2025

2] [5] In December 2023, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Skyclarys, intended for the treatment of Friedreich’s ataxia. [3] 3 November 2006. 3 November 2006.

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Codon

FEBRUARY 23, 2025

By 1987, the FDA licensed zidovudine after trials showed it increased survival rates. All the participants in the study received PrEP because it would have been unethical to deprive them of an existing, licensed preventative. They’ve created voluntary licensing agreements with six other pharmaceutical manufacturers (Dr.

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