FDA Law Blog: Biosimilars

MARCH 5, 2024

First, AstraZeneca alleged that CMS improperly defined a “qualifying single source drug” to include all dosage forms and strengths of the drug marketed by the manufacturer with the same active moiety or ingredient—even if those different forms and strengths were approved under different NDAs. Opinion at 17.

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The Pharma Data

SEPTEMBER 27, 2021

5.500% Notes due 2027 532457 AZ1 7 0.750% due August 31, 2026 0.820% 40 bps $1,226.23 3.100% Notes due 2027 532457 BP2 13 0.750% due August 31, 2026 0.820% 35 bps $1,100.66 5.500% Notes due 2027 532457 AZ1 7 0.750% due August 31, 2026 0.820% 40 bps $1,226.23 and Citigroup Global Markets Inc. BNP Paribas Securities Corp.

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The Pharma Data

DECEMBER 14, 2020

Market researchers expect the global market for gene and cell therapy to grow at a CAGR of over 25% through 2027. c-LEcta is a world-leading biotechnology company with a focus on enzyme engineering and application in regulated markets like the food and pharma industries. 1 Allied Market Research, September 2020.

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The Pharma Data

SEPTEMBER 7, 2021

5.500% Notes due 2027. 3.100% Notes due 2027. and Citigroup Global Markets Inc. toll-free at +1 (888) 292-0070 or collect at +1 (980) 387-3907 or to Citigroup Global Markets Inc. 284,112,000. 1.750% due August 15, 2041. 5.550% Notes due 2037. 532457 BA5. 476,152,000. 1.750% due August 15, 2041. 532457 AZ1. 377,505,000.

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Vial

FEBRUARY 29, 2024

From the pre-clinical testing and lead discovery, to human testing and post-marketing surveillance, CROs offer a comprehensive array of services that sponsors now commonly seek out. There’s no doubt the market value for CROs is trending upwards; in 2022 alone, the CRO market was estimated to be worth US$56.7

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Agency IQ

JANUARY 26, 2024

Class A devices needed to be IVDR-ready on the original date (May 26, 2022), but class D had until May 2025, class C until May 2026, and class B and sterile class A until May 2027. In-house tests (in the U.S. called laboratory-developed tests manufactured and used in a single lab) had until May 26, 2024.

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FDA Law Blog: Biosimilars

JUNE 14, 2023

The striking phrase “valley of death,” is generally understood to refer to the tendency for innovative technologies to fail to reach market, whether due to reimbursement and/or physician or patient preference. up to 225 total products enrolled through FY 2026 and up to 325 total products enrolled through FY 2027).

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The Pharma Data

FEBRUARY 22, 2022

S&P Global Ratings provided the second party opinion on the Framework and reported that it is aligned with the Green Bond Principles (2021) administered by the International Capital Market Association. “This green bond will fund specific projects across our company that are intended to mitigate our impact on the environment.”

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The Pharma Data

NOVEMBER 29, 2021

The DJSI World Index recognizes the top 10% of companies in the S&P Global Broad Market Index for performance on ESG issues, which S&P Global considers critical to generating long-term stakeholder value.

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The Pharma Data

SEPTEMBER 27, 2021

and Citigroup Global Markets Inc. toll-free at +1 (888) 292-0070 or collect at +1 (980) 387-3907 or to Citigroup Global Markets Inc. As a result, tendered notes may not be withdrawn, except in certain limited circumstances where additional withdrawal rights are required by law. Lilly has retained BofA Securities, Inc.

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The Pharma Data

JANUARY 26, 2021

As an Orphan Drug, Uttroside-B may benefit from a seven-year market exclusively following marketing approval, grant funding for clinical trials that contribute to marketing approval, protocol assistance, and tax credits. billion by 2027. About Q BioMed Inc. Q BioMed Inc.

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The Pharma Data

JANUARY 25, 2021

This activity could increase (or reduce the size of any decrease in) the market price of the Company’s common stock, the notes or the Company’s 2.50% Convertible Senior Notes due 2027 at that time. per share on the Nasdaq Global Select Market on January 25, 2021.

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Vial

DECEMBER 7, 2023

This is evident in the estimated market value for AI in drug discovery, which was US$0.6 billion by 2027 , at a compound annual growth rate (CAGR) of 45.7% This acceleration of the drug discovery process could potentially save countless lives by bringing effective treatments to market more quickly. between these years.

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Advarra

JUNE 13, 2023

The accelerating gene therapy market is expected to grow globally by 16.6% between 2020-2027. Per a report from the American Society of Cell and Gene Therapy (ASGCT) , gene therapy research is an increasingly important part of an institution’s research portfolio, with over 3,500 therapies in preclinical or clinical.

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The Pharma Data

JUNE 7, 2022

Those taking up this offer will be required to hold the Shares or the corresponding FCPE units for a period of approximately five years, i.e. until 31 May 2027, except upon the occurrence of an early release event provided for under Article R. 3324-22 of the French Labour Code and authorized in the subscriber’s country.

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The Premier Consulting Blog

NOVEMBER 20, 2023

years after publication; no earlier than October 1, 2027) End of Enforcement Discretion for: Premarket review for high-risk IVDs. Our expertise gives us the ability to develop customized and tailored strategic plans, mitigate regulatory risks, and optimize marketing success. Phase 4 (3.5

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Agency IQ

MAY 17, 2024

Ultimately, industry is wagering that increased regulatory efficiency—which it pays for—will benefit its products through faster review times, more certainty and more time on the market for its products. GDUFA III), which reauthorized the program through 2027. The generic drug user fee program is currently on its third iteration (i.e.,

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Agency IQ

NOVEMBER 3, 2023

The agency further proposed a five “stage” phaseout of its current enforcement discretion, which would walk in the medical device regulatory requirements – from adverse events reporting to pre-market review – over four years. Under the proposed rule, these tests would be able to continue operating under the current status quo.

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Agency IQ

AUGUST 25, 2023

The most recent reauthorization, BsUFA III, extended the program for fiscal years 2023 through 2027, and was authorized at the end of 2022. Although almost three years have passed since the last draft guidance on this topic, few additional interchangeable products have entered the market. Featuring previous research by Rachel Coe.

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Agency IQ

AUGUST 4, 2023

Article 18 of Regulation (EC) No 1223/2009 prohibits the marketing of cosmetic products that involved animal testing to meet the regulation’s requirements. That ban on placing on the market extends to products using ingredients or combinations of ingredients that were subject to animal testing.

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Agency IQ

OCTOBER 6, 2023

France In January, the French ecology ministry published a PFAS action plan enumerating six objectives for regulating forever chemicals more comprehensively by 2027. [For an in-depth analysis of this restriction proposal, read AgencyIQ’s February 10, 2023 article here.]

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Agency IQ

AUGUST 18, 2023

The registration database, EUDAMED , isn’t yet complete d, with just half of its planned modules released to production – actor registration, UDI and device registration, and Notified Bodies and certificates are live; still being worked on are the modules for clinical and performance studies, vigilance, and market surveillance.

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Agency IQ

AUGUST 2, 2024

legislation The list below includes legislation proposed by the European Commission that is yet-to-be-published.

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Agency IQ

JUNE 28, 2024

DTSC would be required to adopt regulations by January 1, 2027, to administer the bill. Product reformulation can take years, and the potential requirement to reformulate a product exclusively for a smaller market like Maine may also cause manufacturers and importers to simply stop offering those products in the state.

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Agency IQ

MARCH 29, 2024

March 2024 Greenhouse Gas Emissions Standards for Heavy-Duty Vehicles—Phase 3 (Final Rule Stage) 2060-AV50 On April 12, 2023, EPA announced a proposal for more stringent standards to reduce greenhouse gas emissions from HD vehicles beginning in model year (MY) 2027. 7521(a), starting with model year 2027.

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Agency IQ

NOVEMBER 20, 2023

Sentinel Update: PDUFA projects, ARIA sufficiency and building out a method for causal inference FDA’s Sentinel Initiative, the post-market, real-world data surveillance system, is nearing the end of its current five-year strategic plan. The Sentinel Initiative was kicked off in 2008 under the FDA Amendments Act (FDAAA).

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Agency IQ

FEBRUARY 15, 2024

CDER, CBER 9/30/2027 Revised or final guidance to be released 18 months after the public comment period ends PDUFA Commitment Letter Digital Health Technologies Publish draft guidance describing a process to evaluate a predetermined change control plan for digital health devices. Priority A List. primary and secondary).

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The Pharma Data

MAY 4, 2021

Following the completion of the spin-off of the Upjohn Business (4) in the fourth quarter of 2020, Pfizer now operates as a focused innovative biopharmaceutical company engaged in the discovery, development, manufacturing, marketing, sales and distribution of biopharmaceutical products worldwide. in December 2019; and. in December 2019; and.

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The Pharma Data

DECEMBER 30, 2020

The companies agreed to the steep price cuts in order to have their drugs made available to the world’s second-largest pharmaceutical market. The company’s product candidate is targeting the global metastatic cancer treatment market, projected to be worth $111.2 billion by 2027. billion people, Bloomberg said.

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Agency IQ

FEBRUARY 21, 2024

In sum, the aim of the organization and its stakeholders is to develop an online environment to house everything from clinical trial data to marketing applications, to product labeling, manufacturing changes, and more.

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Agency IQ

DECEMBER 15, 2023

March 2024 February 2024 Greenhouse Gas Emissions Standards for Heavy-Duty Vehicles—Phase 3 Final Rule Stage 2060-AV50 On April 12, 2023, EPA announced a proposal for more stringent standards to reduce greenhouse gas emissions from HD vehicles beginning in model year (MY) 2027. 7521(a), starting with model year 2027.

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Agency IQ

DECEMBER 1, 2023

2060-AV59 Market-Based Approaches Under the National Pollutant Discharge Elimination System (NPDES) Program (Proposed Rule Stage) EPA supports market-based mechanisms to accomplish its mission to protect human health and the environment especially regarding nutrient management. Regan, Case No: 1:16-cv-00364-CRC (D.D.C.

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Agency IQ

JUNE 16, 2023

For increased flexibility in bringing PIPs to market, a developer can also submit both. Market-based mechanisms include water quality trading under the Clean Water Act (CWA), an approach that may cost less than more traditional regulatory approaches. EPA is reviewing the comments received and is planning to issue a final rule.

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Agency IQ

FEBRUARY 2, 2024

This means that the medical device frameworks – including the pre-market pathways and evidentiary requirements, as well as post-market quality system frameworks and reporting requirements – are applied to the vast majority of all (CDRH-regulated) IVD products. IVDs used in blood donation screening/processing). In the E.U.,

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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

NOVEMBER 25, 2020

The most-favored-nation (MFN) model will be in place between January 1, 2021, and December 31, 2027, allowing time for CMS to evaluate its effect on access to therapeutics, their costs, and quality of care. This is an attempt to contain the growth in Medicare Part B spending without compromising healthcare quality.

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FDA Law Blog: Biosimilars

FEBRUARY 11, 2024

The illicit marijuana market remains strong despite state laws legalizing marijuana. As state attorneys general, they are concerned about the illicit market, unregulated intoxicating hemp-derived cannabinoids, and the proliferation of dangerous opioids.

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