2012, Biosimilars and Trials - Drug Discovery Digest

When Worlds Collide: The Theory of Real-World Evidence Meets Reality

FDA Law Blog: Biosimilars

MAY 13, 2024

FDA has even gone so far as to maintain that the “real-life clinical performance of a medical product might be more clearly demonstrated through RWD/RWE because a controlled clinical trial often cannot evaluate all applications of a product in clinical practice across the full range of potential users.”

FDA

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Silence Isn’t Golden: Two Executives Convicted in First Criminal Prosecution Under the Consumer Product Safety Act

FDA Law Blog: Biosimilars

NOVEMBER 27, 2023

According to the government, these companies knew as early as 2012 that their dehumidifiers were defective, in that they could overheat and catch fire. Gree USA’s Chief Executive Officer, Charley Loh, and the Chief Administrative Officer, Simon Chu, however, did not agree to the plea deal for the corporate entity, and elected to go to trial.

Production

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CHOICE-01 Phase III Study of Toripalimab at the Interim Analysis Met Pre-Specified Primary Endpoint of Progression-Free Survival at the First-Line Treatment of Advanced NSCLC

The Pharma Data

DECEMBER 13, 2020

About Junshi Biosciences Founded in December 2012, Junshi Biosciences (HK: 1877; SH: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics.

Treatment

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FDA Grants Toripalimab Fast Track Designation for Mucosal Melanoma

The Pharma Data

JANUARY 24, 2021

Meanwhile, the FDA has also approved the Investigational New Drug (IND) application for a global Phase III trial of Toripalimab in combination with Axitinib versus Pembrolizumab for the first-line treatment of patients with advanced mucosal melanoma (Combination Clinical Trial).

FDA

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Surely You Must be Kidding, PTO?!? “No, and Don’t Call Me Shirley!” – The Seemingly Slapstick (But Yet Unfunny) World of Recent Patent Term Extension Decisions (PART 2)

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. That did not happen.

FDA

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WORLD’S LARGEST BROWSABLE RESOURCE LINKING RARE PROTEIN-CODING GENETIC VARIANTS TO HUMAN HEALTH AND DISEASE

The Pharma Data

JULY 8, 2021

Since the UK Biobank resource was opened for research use in April 2012, over 20,000 researchers from 90+ countries have been approved to use it and more than 2,000 peer-reviewed papers that used the resource have now been published.

Disease

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Biogen Files New Drug Application for Aducanumab in Japan

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.

Clinical Trials

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Analysis Life Sciences Thank You What We Expect the FDA to do in July 2023

Agency IQ

JUNE 29, 2023

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., These inspections will be routine surveillance rather than inspections as part of an approval application.

FDA

FDA Science Regulations Production

New Sandoz Board of Directors appointed

The Pharma Data

MAY 15, 2023

Since 2012, she serves as board member and currently as chair of the Audit Committee of Tecan Group, a Swiss listed company. Find out more at [link] About Sandoz Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars. Our ambition is to be the world’s leading and most valued generics company.

Science

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Analysis Life Sciences Thank You What We Expect the FDA to do in October 2023

Agency IQ

SEPTEMBER 29, 2023

Title Type Comments Close Classification Categories for Certain Supplements Under BsUFA III Guidance October 10 Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Biosimilar User Fee Act Products Guidance October 10 QTc Information in Human Prescription Drug and Biological Product Labeling Guidance October 10 Postmarketing (..)

FDA

FDA Science Regulations Production

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Agency IQ

OCTOBER 27, 2023

12/29/2023 FDORA, Section 3602 Clinical Trials Modernization : FDA is directed to require the submission of a “diversity action plan” for all Phase 3 clinical trials of new drugs. ” These include the use of expansion cohorts, concurrent trial conduct, and other designs. .”

FDA

FDA Science Regulations Production

Tezepelumab NAVIGATOR Phase 3 Trial Met Primary Endpoint Of A Statistically Significant And Clinically Meaningful Reduction In Exacerbations In A Broad Population Of Patients With Severe Asthma

The Pharma Data

NOVEMBER 9, 2020

Trial Also Met the Primary Endpoint in Patients With Low Levels of Eosinophils. In the subgroup of patients with baseline eosinophil counts less than 300 cells per microliter, the trial met the primary endpoint with tezepelumab demonstrating a statistically significant and clinically meaningful reduction in AAER.

Trials

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Update On SOURCE Phase 3 Trial For Tezepelumab In Patients With Severe, Oral Corticosteroid-Dependent Asthma

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. ,

Trials

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Amgen Reports Second Quarter 2021 Financial Results

The Pharma Data

AUGUST 3, 2021

Product sales increased 3% globally, driven by double digit volume growth across a number of our products including Prolia ® (denosumab), Repatha ® (evolocumab) and our biosimilar products MVASI ® (bevacizumab-awwb) and KANJINTI ® (trastuzumab-anns). AMGEVITA continued to be the most prescribed adalimumab biosimilar in Europe.

Biosimilars

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Article EMA Thank You MHRA introduces an expanded international recognition procedure, while planning to sunset the current EC reliance pathway

Agency IQ

SEPTEMBER 1, 2023

The MHRA just opened a public comment period on its plan to end the ECDRP by the end of 2023 Regulation 58(4C) of the Human Medicines Regulation 2012 gives the MHRA the power to rely on EC decisions for approving medicines in the U.K. [See AgencyIQ’s analysis of the announcement.] according to the consultation document. reference product.

International

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Article EMA Thank You What we expect European regulators to do in May 2024

Agency IQ

MAY 3, 2024

Two consultations on clinical trial considerations, one on advanced therapies and the other addressing non-inferiority and equivalence comparisons, are closing at the end of May. The pharma reform package remains in E.U. leaders’ eyesight as the Parliament winds down ahead of its June elections.

Regulations

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Article EMA Thank You What we expect European regulators to do in July 2024

Agency IQ

JULY 8, 2024

Device regulators have dropped important guidance recently , publishing guidance on alternative trial designs for orphan devices and updating how to carry out benefit-risk assessments on the use of toxic phthalates in medical devices. elections over, AgencyIQ is also anticipating the new European Parliament to start work again soon.

Regulations

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Article EMA Thank You What we expect European regulators to do in June 2024

Agency IQ

MAY 31, 2024

Conference ( OPEN ) European Federation of Pharmaceutical Industries and Associations (EFPIA) 6/04/2024 6/05/2024 Third listen-and-learn focus group meeting of the Quality Innovation Group Webinar/Seminar ( OPEN ) EMA Quality Innovation Group (QIG) 6/05/2024 6/05/2024 Procurement Working Party Committee Meeting ( CLOSED ) British In Vitro Diagnostics (..)

Regulations

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Article EMA Thank You What we expect European regulators to do in March 2024

Agency IQ

MARCH 1, 2024

There are also some product-specific bioequivalence guidelines open for comment, along with concept papers proposing the development of materials on the topics of biosimilar development and non-inferiority comparisons in clinical trials.

Regulations

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Article EMA Thank You What we expect European regulators to do in April 2024

Agency IQ

MARCH 29, 2024

regulatory framework Webinar/ Seminar ( OPEN ) EMA 4/17/2024 4/17/2024 CEP 2.0:

Regulations

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Article EMA Thank You What we expect European regulators to do in August and September 2024

Agency IQ

AUGUST 2, 2024

While the work on the pharma package will likely take quite some time, another deadline is coming up fast: the full transition of all clinical trials from the Clinical Trials Directive to the Clinical Trials Regulation.

Regulations

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Roche reports good half-year results

The Pharma Data

JULY 21, 2021

Pharmaceuticals Division sales decline 3%; sales grow 4% in the second quarter, following a first-quarter decrease of 9%; newly launched medicines (+30%) compensate for the continued impact from biosimilars. The ongoing impact from biosimilars, particularly in the US, resulted in a sales decrease of CHF 2.8 Outlook confirmed for 2021.

Biosimilars

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Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

Agency IQ

DECEMBER 1, 2023

12/29/2023 FDORA, Section 3602 Clinical Trials Modernization : FDA is directed to require the submission of a “diversity action plan” for all Phase 3 clinical trials of new drugs. ” These include the use of expansion cohorts, concurrent trial conduct, and other designs. .”

FDA

FDA Science Regulations Production

Article EMA Thank You What we expect European regulators to do in December 2023

Agency IQ

DECEMBER 1, 2023

Positive *Biosimilar **Generic Notable comment periods closing in December Below are various deadlines regarding E.U. Positive January 2023 Azacitidine Kabi (azacitidine)** Fresenius Kabi Deutschland GmbH Positive January 2023 Krazati (adagrasib) Mirati Therapeutics B.V.

Regulations

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Analysis Life Sciences Thank You Everything the FDA is planning to do in Q3 2023

Agency IQ

JULY 28, 2023

September 30, 2023 PDUFA Digital Health Technologies Establish a secure cloud technology to enhance its infrastructure and analytics environment that will enable FDA to effectively receive, aggregate, store, and process large volumes of data from trials conducted using DHTs. That would leave 19% of staff affected by furloughs.

FDA

FDA Science Biosimilars Regulations

How Recent Drug Pricing Laws Impact Drug Discovery (H.R. 5376)

Drug Hunter

APRIL 24, 2023

A landmark part of the act is the requirement of Medicare to negotiate the prices for the 15 drugs with highest Medicare spend without generic and/or biosimilar substitutions across Part B (hospital drugs) and D (at-home drugs), with negotiated price implementation starting in 2026.

Small Molecule

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Drug Discovery Digest

When Worlds Collide: The Theory of Real-World Evidence Meets Reality

Silence Isn’t Golden: Two Executives Convicted in First Criminal Prosecution Under the Consumer Product Safety Act

Trending Sources

CHOICE-01 Phase III Study of Toripalimab at the Interim Analysis Met Pre-Specified Primary Endpoint of Progression-Free Survival at the First-Line Treatment of Advanced NSCLC

FDA Grants Toripalimab Fast Track Designation for Mucosal Melanoma

Surely You Must be Kidding, PTO?!? “No, and Don’t Call Me Shirley!” – The Seemingly Slapstick (But Yet Unfunny) World of Recent Patent Term Extension Decisions (PART 2)

WORLD’S LARGEST BROWSABLE RESOURCE LINKING RARE PROTEIN-CODING GENETIC VARIANTS TO HUMAN HEALTH AND DISEASE

Biogen Files New Drug Application for Aducanumab in Japan

Analysis Life Sciences Thank You What We Expect the FDA to do in July 2023

New Sandoz Board of Directors appointed

Analysis Life Sciences Thank You What We Expect the FDA to do in October 2023

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Tezepelumab NAVIGATOR Phase 3 Trial Met Primary Endpoint Of A Statistically Significant And Clinically Meaningful Reduction In Exacerbations In A Broad Population Of Patients With Severe Asthma

Update On SOURCE Phase 3 Trial For Tezepelumab In Patients With Severe, Oral Corticosteroid-Dependent Asthma

Amgen Reports Second Quarter 2021 Financial Results

Article EMA Thank You MHRA introduces an expanded international recognition procedure, while planning to sunset the current EC reliance pathway

Article EMA Thank You What we expect European regulators to do in May 2024

Article EMA Thank You What we expect European regulators to do in July 2024

Article EMA Thank You What we expect European regulators to do in June 2024

Article EMA Thank You What we expect European regulators to do in March 2024

Article EMA Thank You What we expect European regulators to do in April 2024

Article EMA Thank You What we expect European regulators to do in August and September 2024

Roche reports good half-year results

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

Article EMA Thank You What we expect European regulators to do in December 2023

Analysis Life Sciences Thank You Everything the FDA is planning to do in Q3 2023

How Recent Drug Pricing Laws Impact Drug Discovery (H.R. 5376)

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