Agency IQ

JANUARY 19, 2024

Seventeen products were orphan drugs, fourteen were generics and eight were biosimilars. Eight products received recommendations for conditional marketing authorization and one product was reviewed “under exceptional circumstances.” This most recent year saw 80 total opinions, compared to 92 in 2022 and 97 in 2021.

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The Pharma Data

OCTOBER 29, 2020

Tokyo, Japan) today announced that the European Medicines Agency (EMA) has confirmed it has accepted for review, following a standard timetable, the Marketing Authorization Application (MAA) for aducanumab, an investigational treatment for Alzheimer’s disease. . CAMBRIDGE, Mass. and TOKYO, Oct. About Aducanumab.

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The Pharma Data

MAY 6, 2021

ENVI calls on the Commission to “revise the use of supplementary protection certificates based on technological and scientific advances to prevent generic and biosimilar medicines from becoming less competitive inside and outside the EU.”. . © 2021 Regulatory Affairs Professionals Society. The restriction will apply for two years. .

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FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

If the confirmatory trial does not show that the drug provides clinical benefit, FDA has regulatory procedures in place that could lead to removing the drug from the market. You see, Oncopeptides has has pending at the PTO since March 2021 a PTE application for U.S. 6,992,207 covering PEPAXTO (Docket No. FDA-2022-E-3124 ).

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The Pharma Data

JANUARY 24, 2021

25, 2021 (GLOBE NEWSWIRE) — Junshi Biosciences (HKEX: 1877; SSE: 688180), an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, announced today that U.S. SHANGHAI, China, Jan.

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The Pharma Data

JULY 27, 2021

” In June 2021, AbbVie Inc. The acquisition is subject to customary closing conditions, including applicable regulatory approvals and is expected to close in the second half of 2021. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. anti-HBV/CD3).

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Agency IQ

JUNE 2, 2023

In 2022 and 2021, the Spring Unified Agenda was released in early/mid June. 6/27/2023 Notification FDORA, Section 3201 Within 180 days of the passage of FDORA, all biologics and biosimilars sponsors must submit a written notice to the FDA of all actively marketed products (i.e., not discontinued) and are available for sale.

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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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The Pharma Data

DECEMBER 9, 2020

Japan is the third market where we have applied for regulatory approval for aducanumab, and the filing represents continued progress on our commitment to bring this therapy to patients around the world,” said Michel Vounatsos, Chief Executive Officer at Biogen. Since October 2017 Biogen and Eisai Co.,

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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). There were 21 NMEs added to the FDA’s Purple Book , which provides information about all biological products licensed by the FDA. Read the AgencyIQ analysis here.

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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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FDA Law Blog: Biosimilars

DECEMBER 3, 2023

Each phase-in program requires the manufacturer to have had a Coverage Gap Discount Program agreement in effect in 2021, and only covers applicable drugs that have been in the market as of August 16, 2022 (i.e., of the total expenditures for all Part D drugs in 2021. had Part D expenditures on or before August 16, 2022).

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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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FDA Law Blog: Biosimilars

DECEMBER 11, 2023

FDA’s assumption that 50% of the tests will be exempt is particularly baffling because the laboratories are ones licensed to perform high complexity tests. 12] In FY2020, 2021, and 2022, Third-Party Review 510(k)s accounted for 2.6%, 2.6%, and 2.5% 21, 2021), [link]. of 510(k) decisions, respectively. [13]

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The Pharma Data

OCTOBER 29, 2020

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. Alexion plans to initiate a Phase 3 study of SOLIRIS in GBS in Japan in 2021, pending regulatory feedback. Study results are expected in the first half of 2021.

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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 A List. Priority B List.

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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. the drug and device) of the combination product.

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The Pharma Data

FEBRUARY 8, 2021

2021 financial outlook. Sanofi expects 2021 business EPS ( 1) to grow high single digit (3) at CER, barring unforeseen major adverse events. Applying average January 2021 exchange rates, the currency impact on 2021 business EPS is estimated to be between -4.5% In Europe, fourth-quarter Dupixent ® sales grew 76.9%

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The Pharma Data

FEBRUARY 4, 2021

2021 financial outlook. Sanofi expects 2021 business EPS ( 1) to grow high single digit (3) at CER, barring unforeseen major adverse events. Applying average January 2021 exchange rates, the currency impact on 2021 business EPS is estimated to be between -4.5% In Europe, fourth-quarter Dupixent ® sales grew 76.9%

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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

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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The Pharma Data

SEPTEMBER 16, 2020

The Phase 2 CRC trial is expected to have a data readout in early 2021. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. Such product candidates are not approved by the U.S.

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The Pharma Data

SEPTEMBER 20, 2020

The Phase 2 CRC trial is expected to have a data readout in 2021. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. Such product candidates are not approved by the U.S.

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Agency IQ

DECEMBER 1, 2023

Circuit vacated the final rule in 2021. The following PDUFA dates were obtained from publicly available sources. Date Company Drug November 30 Takeda/HUTCHMED Fruquintinib December 8 Vertex / CRISPR Therapeutics Exagamglogene autotemcel December 16 Arcutis Roflumilast December 16 Optinose XHANCE December 16 Merck KEYTRUDA Delayed (Orig.

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The Pharma Data

DECEMBER 21, 2020

. “The recent results from our NAVIGATOR trial were impressive, both in terms of the overall clinical data and the reduction in exacerbation rate with tezepelumab treatment, and we continue to work with AstraZeneca on planned regulatory filings in 2021.

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Agency IQ

OCTOBER 27, 2023

and Annex 1 Conference Joel Welch December 18 RAPS RAPS Webcast: FDA Forecast: What’s Next for the FDA in 2024 AgencyIQ Speakers December 21 HL7 REMS Public Call PDUFA Dates expected in November and December PDUFA dates represent the expected date of a regulatory decision by the FDA on a New Drug Application or Biologics License Application.

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Agency IQ

SEPTEMBER 1, 2023

s MHRA unveiled details of its new International Recognition Procedure, which will allow the MHRA to rely on marketing authorizations by reference regulators from several countries for a wide range of products, including generics and those that received expedited review. excluding Northern Ireland) as of January 1, 2021. from 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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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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