Agency IQ

SEPTEMBER 15, 2023

Fees are also used for a host of other activities meant to improve the FDA’s regulatory capacity and capabilities, such as I.T. Until recently, the FDA relied on a monograph process through which firms could bring OTC drugs to market without FDA approval so long as it adhered to pre-set terms under the monograph.

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FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval. If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug. FDA-2022-E-3124 ). 6,992,207 covering PEPAXTO (Docket No.

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The Pharma Data

DECEMBER 27, 2020

(NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today provided a year-end review and an outline of its plans for 2021.

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The Pharma Data

AUGUST 1, 2021

Percent on an Operational Basis, Due to Biosimilar Competition; Global Skyrizi Net Revenues Were $674 Million; Global Rinvoq Net Revenues Were $378 Million – Second-Quarter Global Net Revenues from the Hematologic Oncology Portfolio Were $1.816 Billion, an Increase of 14.1 percent on an operational basis, due to biosimilar competition.

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The Pharma Data

APRIL 27, 2021

Paris, April 28, 2021. Strong increase in Q1 2021 business EPS ( 1) at CER. Q1 2021 sales increase of 2.4% Q1 2021 business EPS ( 1) growth at CER driven by efficiency and sales performance, supported by a one-time payment. Sanofi has become a member of the top five companies of the 2021 Access to Medicine index.

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Agency IQ

OCTOBER 6, 2023

Amanda Conti, AgencyIQ What kind of biologic products entered the market? For example, these products face a much more arduous path for development of biosimilar or interchangeable products than that of generics for small molecules. As AgencyIQ has previously discussed , developing biosimilars is an expensive process.

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FDA Law Blog: Biosimilars

FEBRUARY 27, 2024

156, a patent may be extended only once (even if it would be eligible for extension on more than one occasion because it applies to several FDA-approved products), and only one patent may be extended for each regulatory review period. FDA-2020-E-1840 (July 13, 2020). These determinations were finalized in 2021.

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The Pharma Data

MAY 4, 2021

PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS. Tue, 05/04/2021 – 06:45. Tuesday, May 04, 2021 – 06:45am. <!–*/. First-Quarter 2021 Revenues of $14.6 First-Quarter 2021 Reported Diluted EPS (1) of $0.86, Adjusted Diluted EPS (2) of $0.93. Anonymous (not verified). –*/. <!–*/.q4default.bwalignc

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Agency IQ

SEPTEMBER 29, 2023

Due to the presence of nitrosamines in certain drug products, FDA had required that drug manufacturers conduct an initial risk assessment of approved or marketed products, with an initial completion date of October 1, 2021, and then confirmatory testing due by October 1, 2023.

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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 a GAAP Basis – Provides 2021 GAAP Diluted EPS Guidance Range of $6.69 to $6.89; Provides 2021 Adjusted Diluted EPS Guidance Range of $12.32

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The Pharma Data

OCTOBER 29, 2020

approval & positive CHMP opinion for ULTOMIRIS 100 mg/mL higher concentration formulation in paroxysmal nocturnal hemoglobinuria (PNH) & aHUS. Established ULTOMIRIS as new standard of care in PNH ahead of set goal, with more than 70% patient conversion from SOLIRIS ® (eculizumab) in 3 largest markets – U.S. Received U.S.

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Agency IQ

DECEMBER 1, 2023

December 2023 Banned Devices; Electrical Stimulation Devices Intended for Self-Injurious Behavior or Aggressive Behavior (Proposed Rule) The Food and Drug Administration (FDA) is proposing to ban electrical stimulation devices (ESDs) intended for self-injurious behavior (SIB) or aggressive behavior (AB).

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Agency IQ

OCTOBER 27, 2023

December 2023 Banned Devices; Electrical Stimulation Devices Intended for Self-Injurious Behavior or Aggressive Behavior (Proposed Rule) The Food and Drug Administration (FDA) is proposing to ban electrical stimulation devices (ESDs) intended for self-injurious behavior (SIB) or aggressive behavior (AB).

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FDA Law Blog: Biosimilars

FEBRUARY 11, 2024

Potency has increased since the last scheduling review, with the average tetrahydrocannabinol (“THC”) potency of marijuana seized by DEA spiking from 3.96% in 1995 to 15.34% in 2021. The illicit marijuana market remains strong despite state laws legalizing marijuana.

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