Drug Discovery World

OCTOBER 20, 2022

Japan continues to be one of the largest pharmaceutical markets in the world, despite what the International Trade Administration described as ‘a challenging business landscape due to demographics’ 1. According to the International Trade Administration’s market overview, anti-tumour agents brought in the largest sales in 2020 in Japan.

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Vial

MARCH 1, 2024

By geographical region, the global CRO services market in 2023 was dominated by North America. Growth factors for this market included the growing size of the pharmaceutical industry, the increasing number of clinical trials , substantial funds dedicated to pharma and biotech R&D, and the growing biosimilars and generics market.

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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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FDA Law Blog: Biosimilars

NOVEMBER 6, 2023

A phone call to FDA requested information about the number of Remote Interactive Evaluations (RIEs) that FDA has performed at drug manufacturing facilities since it announced in April 2021 that it would start using them as an alternative to on-site inspections. We should explain what RIEs are. Comments on the guidance are invited.

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The Pharma Data

JULY 8, 2021

The update includes an addition to the Indications and Usage section of the label (Section 1) to emphasize the disease stages studied in the clinical trials, as seen below ( italics to note updated language). Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).

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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 billion (+8%, +7% cc).

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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

NOVEMBER 17, 2021

Tokyo, Japan) blazoned moment an update on the ongoing review of the Marketing Authorization Operation for aducanumab 100 mg/ mL concentrate result for infusion for the treatment of Alzheimer’s complaint by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). and EisaiCo.,Ltd.

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Agency IQ

JULY 26, 2024

FDA’s new guidance on postapproval manufacturing changes for biosimilars focuses on current practice, new dosage forms Meeting a biosimilar user fee commitment, the FDA is expanding on its recommendations for biosimilar and interchangeable product applicants asking the FDA for post-approval manufacturing changes.

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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.”. . Denmark posts guidance on decentralizing clinical trials.

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FDA Law Blog: Biosimilars

JANUARY 1, 2024

Perhaps FDA wanted us to remember 2023 as the year FDA succeeded in uncovering critical defects in drug and device manufacturing, and in critical trials. Warning Letters, generally made public in a batch each Tuesday, are FDA’s public sanction that is most widely used to bring pressure on manufacturers and clinical trial investigators.

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FDA Law Blog: Biosimilars

NOVEMBER 27, 2023

the “Gree Companies”), an appliance manufacturer and two of its subsidiaries that were involved in the manufacturing, marketing, and sale of dehumidifiers. After a brief trial, on Friday Nov. It involved Gree Electric Appliances Inc. of Zhuhai, Hong Kong, Gree Electric Appliances Sales Co. and Gree USA Inc.

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The Pharma Data

MAY 18, 2021

Basel, May 18, 2021 — Sandoz, a Novartis division, today announces plans to further strengthen its European antibiotics manufacturing network by further expanding production capabilities in Kundl, Austria and in Palafolls, Spain. Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars. About Sandoz.

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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. The trial intends to enroll 220 patients who will be randomized at 1:1 ratio into two study arms.

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The Pharma Data

MAY 15, 2023

Huebscher , non-executive board member in companies, institutions and former CEO of Solvias Group, a Swiss contract research firm, which she led between 2014 and 2021. Before joining EMMI Group as CEO, he was a Member of the Executive Board and Head of the Marketing Department at Migros-Genossenschafts-Bund. Gallen (HSG), Switzerland.

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The Pharma Data

FEBRUARY 1, 2021

01, 2021 (GLOBE NEWSWIRE) — Biogen Inc. This approval expands Biogen’s industry-leading portfolio of MS treatments, which also includes the subcutaneous (SC) administration of Plegridy, and follows the European Commission’s marketing authorization for the IM administration in December 2020. “At CAMBRIDGE, Mass., 3 Zhao Y, et al.

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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. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints we have selected.

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The Pharma Data

JANUARY 26, 2021

27, 2021 10:02 UTC. Reddy’s”) and Global Response Aid FZCO (GRA) today announced the termination of Avigan Trial Study conducted in Kuwait focused on moderate to severe COVID patients in a hospital setting. The full data analysis on 353 subjects would be available by the end of February 2021.

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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. Although our industry has enjoyed many successes lately, those affected by the conditions we are focused on still need better choices.

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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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FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug. 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.

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DrugBank

AUGUST 9, 2024

  The average cost of bringing a new drug to market is about $2.6 Moreover, the probability of success for a drug candidate entering clinical trials is only around 10%, highlighting the substantial risks involved. reported in 2021. The market for cardiovascular drugs, valued at 155.6 trillion by 2028.

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The Pharma Data

FEBRUARY 8, 2021

Across clinical trials (PALOMA-1, PALOMA-2, PALOMA-3), 1.0% Additional cases of ILD/pneumonitis have been observed in the post-marketing setting, with fatalities reported. DISCLOSURE NOTICE : The information contained in this release is as of February 5, 2021. of IBRANCE-treated patients had ILD/pneumonitis of any grade, 0.1%

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Agency IQ

JUNE 2, 2023

In 2022 and 2021, the Spring Unified Agenda was released in early/mid June. We’re expecting that there are a lot of companies that aren’t aware of this requirement, but we’re also expecting that this information will be hugely helpful to the FDA and its ability to even know what it regulates.

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The Pharma Data

DECEMBER 9, 2020

Aducanumab, an amyloid beta-targeting antibody, has been shown in clinical trials to remove amyloid beta in the brain and significantly slow clinical decline in patients with Mild Cognitive Impairment (MCI) due to Alzheimer’s disease and mild Alzheimer’s disease dementia.

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Agency IQ

JUNE 9, 2023

What will the orphan drug market exclusivity haircut mean for industry? provides a 10-year market exclusivity period. The sponsor must show at the time of marketing authorization application (MAA) that the orphan designation criteria are still met. Orphan designation in the E.U. countries examined between 2010 and 2017.

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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

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. . About Aducanumab. You should not place undue reliance on these statements or the scientific data presented.

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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

JANUARY 15, 2024

In 2016, FDA determined that e-cigarettes and their component parts fell under the term “new tobacco products,” requiring manufacturers of such products to submit PMTAs for FDA review before the Agency would issue a marketing order permitting the legal sale of the product. FDA also directed manufacturers to produce detailed marketing plans.

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The Pharma Data

DECEMBER 21, 2020

21, 2020 /PRNewswire/ — Amgen (NASDAQ:AMGN) and AstraZeneca today announced the SOURCE trial did not meet the primary endpoint of a statistically significant reduction in the daily oral corticosteroid (OCS) dose, without loss of asthma control, with tezepelumab compared to placebo. THOUSAND OAKS, Calif. , Reese , M.D.,

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The Pharma Data

MARCH 30, 2021

will help enable growth of the Jada ® System, including potential expansion into Europe and other developed countries, as well as in the world’s least developed markets where Organon has significant experience creating affordable access.”. Food and Drug Administration (FDA). About Alydia Health. and globally.

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The Pharma Data

SEPTEMBER 16, 2020

About CodeBreaK The CodeBreaK clinical trial program for Amgen’s investigational drug sotorasib is designed to treat patients with multiple KRAS G12C -mutant solid tumors and address the longstanding unmet medical need for these cancers. The Phase 2 CRC trial is expected to have a data readout in early 2021.

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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. The COVID-19 impact has varied by study and program, but there has been little timing impact on fully-enrolled trials. Received U.S. Germany & Japan.

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The Pharma Data

SEPTEMBER 20, 2020

About CodeBreaK The CodeBreaK clinical trial program for Amgen ‘s investigational drug sotorasib is designed to treat patients with an advanced solid tumor with the KRAS G12C mutation and address the longstanding unmet medical need for these cancers. The Phase 2 CRC trial is expected to have a data readout in 2021.

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Agency IQ

FEBRUARY 15, 2024

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

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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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