Agency IQ

JANUARY 19, 2024

Seventeen products were orphan drugs, fourteen were generics and eight were biosimilars. Only one product was an advanced therapy medicinal product (ATMP), three products held PRIME designation, and three products were evaluated under accelerated assessments. for the years 2020 to 2022. for the years 2020 to 2022.

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FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

You see, Oncopeptides has has pending at the PTO since March 2021 a PTE application for U.S. 156 or case law that would support extension of the ‘929 patent that claims the product despite revocation of the biologics license application. 6,992,207 covering PEPAXTO (Docket No. FDA-2022-E-3124 ).

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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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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

OCTOBER 29, 2020

If approved, aducanumab would become the first therapy to reduce the clinical decline of Alzheimer’s disease and to meaningfully change the course of Alzheimer’s disease. If approved, aducanumab would become the first therapy to reduce the clinical decline in patients with Alzheimer’s disease. CAMBRIDGE, Mass.

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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

DECEMBER 9, 2020

(Tokyo, Japan) announced that Biogen has submitted a Japanese New Drug Application (J-NDA) to the Ministry of Health, Labor and Welfare (MHLW) for aducanumab, an investigational therapy for Alzheimer’s disease. Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement.

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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

JULY 27, 2021

Each of these three investigational therapies uses a different approach to treat a highly prevalent disease for which new treatment options are very much needed. ” In June 2021, AbbVie Inc. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. anti-HBV/CD3).

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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

As such, it doesn’t review things like vaccines, blood products or gene therapies – those products are instead reviewed by CBER. 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). Read the AgencyIQ analysis here.

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The Pharma Data

MAY 5, 2022

Nasdaq: BIIB) and MedRhythms have entered into a license agreement to develop and commercialize MR-004, an investigational prescription digital therapeutic for the potential treatment of gait deficits in multiple sclerosis (MS). Biogen Inc. MedRhythms is headquartered in Portland, Maine. Source link: [link].

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The Pharma Data

OCTOBER 29, 2020

. “Our foundation for the future is stronger than ever, and by maintaining our focus on serving patients and delivering for shareholders, I am confident that we will continue to build on our success to date and further advance our mission of delivering life-changing therapies to people with rare diseases and devastating conditions.”

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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 2020, Dupixent ® sales reached €3,534 million, up 73.9%

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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 2020, Dupixent ® sales reached €3,534 million, up 73.9%

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Agency IQ

FEBRUARY 15, 2024

We have tried to sort guidance documents by topic area. Priority B List.

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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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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

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

Additionally, data from Amgen ‘s bispecific T cell engager (BiTE ® ) platform will feature preliminary safety and efficacy findings from the ongoing Phase 1 study of AMG 160, an investigational half-life extended BiTE immuno-oncology therapy targeting prostate-specific membrane antigen (PSMA). 20 and AMG 160, Monday Sept. Reese , M.D.,

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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. It’s a commitment that extends beyond introducing novel therapies.

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The Pharma Data

SEPTEMBER 20, 2020

and 91.2%, respectively, in 34 heavily pretreated patients (median of two prior lines of therapy) with NSCLC, who were treated with the 960 mg daily dose (data cutoff of June 1 , 2020). Eligible patients must have received a prior line of systemic anticancer therapy, consistent with their tumor type and stage of disease. Reese , M.D.,

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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

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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Agency IQ

SEPTEMBER 1, 2023

excluding Northern Ireland) as of January 1, 2021. This reliance procedure was implemented on January 1, 2021, for a planned two-year span, but last September, MHRA extended the effective period for the procedure to the end of 2023. from the E.U. on February 1, 2020 started a year-long transition period; The E.U. market more quickly.

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Agency IQ

JULY 28, 2023

First, by March 2021, manufacturers were expected to conclude a risk assessment of their approved or marketed products to assess the risk of nitrosamines. That would leave 19% of staff affected by furloughs. Some of the affected former NDAs were approved using drug master files (DMFs).

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