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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DrugBank

AUGUST 9, 2024

Investment Trends in Pharmaceutical Research and Development Investing in the pharmaceutical sector presents a unique set of challenges and opportunities; let’s examine them in more detail.  reported in 2021. Pharmaceutical Market Analysis The global pharmaceutical market revenue in 2024 is projected to be 1.15

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The Pharma Data

OCTOBER 26, 2021

Commencing a strategic review of Sandoz to maximize shareholder value , options range from retaining the business to separation 2021 Group guidance² unchanged. Sandoz is a global leader in generic pharmaceuticals and biosimilars. billion) and Entresto (at least USD 5.0 billion) and Entresto (at least USD 5.0

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Vial

MARCH 1, 2024

Introduction Contract research organizations (CROs) are essential in pharmaceutical research and development (R&D). By 2021, the number of PPD employees exceeded 30,000 globally, and Thermo Fisher Scientific Inc. By geographical region, the global CRO services market in 2023 was dominated by North America. of total revenue).

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The Pharma Data

MARCH 5, 2021

Following final agreement, Novartis plans to start production in the second quarter of 2021. First deliveries of the bulk drug product to CureVac are expected in the summer 2021. At the Kundl site, Novartis is a pioneer and has decades of experience in pharmaceutical production of proteins and in more recent years of nucleic acids.

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Drug Channels

DECEMBER 1, 2020

During 2020, the COVID-19 pandemic disrupted every aspect of the pharmaceutical channel—and our lives. If all goes well, 2021 will begin our return to normalcy, as vaccines roll out across the country. Pharmaceutical wholesalers have maintained shipments and operational capacity. distribution channels for prescription drugs.

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The Pharma Data

JANUARY 26, 2021

27, 2021 10:02 UTC. The full data analysis on 353 subjects would be available by the end of February 2021. BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is an integrated pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives.

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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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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

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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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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The Pharma Data

JULY 8, 2021

Information about the population studied has been previously communicated by Biogen and Eisai, including in the companies’ statement of June 23, 2021. Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies.

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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. is a leading global pharmaceutical company headquartered in Japan. About Eisai Co., Eisai Co.,

Clinical Trials 40

Clinical Trials Drugs Disease Licensing 40

Agency IQ

OCTOBER 6, 2023

CDER is the FDA office in charge of reviewing pharmaceuticals and therapeutic biologics. As such, it doesn’t review things like vaccines, blood products or gene therapies – those products are instead reviewed by CBER. As AgencyIQ has previously discussed , developing biosimilars is an expensive process.

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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. . is a leading global pharmaceutical company headquartered in Japan. About Aducanumab. About Biogen. About Eisai Co.,

Disease 40

Disease FDA Clinical Trials Licensing 40

Agency IQ

JUNE 9, 2023

Just over a month ago, the European Commission released its proposal for the new pharmaceutical directive and regulation. In the proposed revision to the European pharmaceutical legislation, both the regulation and directive introduce two very similar though distinct concepts: unmet medical need, and high unmet medical need.

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Marketing Biosimilars Regulations Drugs 40

FDA Law Blog: Biosimilars

DECEMBER 4, 2023

Federal Court Orders Puerto Rico Pharmaceutical Distributor to Pay $12 Million in Connection with Alleged Failure to Report Suspicious Orders of Pharmaceutical Drugs and Other Controlled Substance Violations, Nov. 6, 2023 ( DOJ Press Release ). If the pharmacist can resolve it, they must make a record of the resolution. Complaint ¶ 55.

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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% Pharmaceuticals. percentage points to 27.1%.

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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% Pharmaceuticals. percentage points to 27.1%.

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Vaccine Production FDA Pharmaceuticals 52

The Pharma Data

OCTOBER 29, 2020

29, 2020– Alexion Pharmaceuticals, Inc. Alexion plans to initiate a Phase 3 study of SOLIRIS in GBS in Japan in 2021, pending regulatory feedback. and EU for the ULTOMIRIS SC formulation and device combination in PNH and aHUS in the third quarter of 2021. Study results are expected in the first half of 2021.

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Agency IQ

FEBRUARY 15, 2024

We have tried to sort guidance documents by topic area.

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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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Agency IQ

OCTOBER 27, 2023

WUSF / AgencyIQ November 1 Initial deadline for NDSRIs Under a 2023 guidance document, the FDA has recommended that pharmaceutical companies assess Nitrosamine Drug-Related Substance Impurities for their products by November 1, 2023, with confirmatory testing due by August 1, 2025.

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Agency IQ

DECEMBER 1, 2023

Circuit vacated the final rule in 2021. The guidance will include FDORA, Section recommendations FDORA, Section on the inclusion of the “the longest feasible expiration date supported by such data” in a drug’s label. ” The report will also cover Federal agency roles in addressing vulnerabilities and statutory limitations.

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Agency IQ

SEPTEMBER 1, 2023

pharmaceutical law ceased to apply to the U.K. excluding Northern Ireland) as of January 1, 2021. The Medicines and Healthcare products Regulatory Agency (MHRA) has been releasing guidance for the pharmaceutical and medical device industry to aid product development and approval after the separation. from the E.U. or E.A.A.

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Agency IQ

JULY 28, 2023

A big nitrosamine deadline approaches : Unless you’ve been hiding under a rock for the last few years, you’ve probably heard about major issues that the pharmaceutical industry has been having with nitrosamine contamination. That would leave 19% of staff affected by furloughs. But despite the law’s age, it is not yet fully operational.

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