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. Since October 2017 Biogen and Eisai Co.,

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NIH Director's Blog: Drug Development

JUNE 14, 2016

Scott and colleagues focused on six genes that encode potential drug targets licensed or in development by GlaxoSmithKline for the treatment of obesity or diabetes. That’s critical considering that just 1 in 10 drug candidates entering human clinical trials successfully goes on to receive FDA approval [5]. Novo Nordisk. 2016 March 4.

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The Pharma Data

AUGUST 29, 2020

Basel , August 30, 2020 — Novartis today announced results from a post-hoc analysis of pooled data from the Phase III ORION-10 and -11 trials evaluating the individual responses of patients on low-density lipoprotein cholesterol (LDL-C) reduction with inclisiran, a first-in-class investigational treatment for hyperlipidemia in adults.

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The Pharma Data

JANUARY 15, 2021

Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. About Darzalex Faspro® In August 2012, Janssen Biotech, Inc. Among patients who received D-VCd, 74 percent were exposed for 6 months or longer and 32 percent were exposed for greater than one year.

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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. ,

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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.

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The Pharma Data

JULY 8, 2021

Tezepelumab is the first and only biologic to consistently and significantly reduce asthma exacerbations in a broad population across Phase II and III clinical trials. The BLA was based on results from the PATHFINDER clinical trials programme, including results from the pivotal NAVIGATOR Phase III trial.

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The Pharma Data

NOVEMBER 15, 2020

Most recently, she was a senior executive at Celgene Corporation, where she led corporate strategy from 2012 to 2017. drug development initiative from 2012 to February 2019. She earned a BA from Durham University, U.K., and an MBA from Harvard Business School. Before that, Ms.

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The Pharma Data

JULY 8, 2021

Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) and granted Priority Review for tezepelumab in the treatment of asthma. 8) There were no clinically meaningful differences in safety results between the tezepelumab and placebo groups in the NAVIGATOR trial.(8)

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The Pharma Data

AUGUST 3, 2021

Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). In July, the FDA accepted the Biologics License Application and granted Priority Review for tezepelumab for the treatment of asthma. Tezepelumab. AMG 451 / KHK4083. Tax Petition.

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The Pharma Data

MARCH 31, 2023

This is enabled by the signing of a voluntary licensing agreement for patents relating to cabotegravir LA for PrEP with MPP in July 2022. ViiV Healthcare has submitted marketing applications in a number of countries including the majority of countries where clinical trials were conducted, with further registrations planned.

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The Pharma Data

NOVEMBER 26, 2020

Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for review of the Company’s Biologics License Application (BLA) seeking accelerated approval of pegunigalsidase alfa (PRX–102) for the proposed treatment of adult patients with Fabry disease. Protalix has licensed to Pfizer Inc.

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The Pharma Data

JUNE 18, 2021

The FDA’s decision is based on evidence from Pfizer’s clinical program in adults, including Phase 1 and 2 trials, and three Phase 3 trials (NCT03760146, NCT03828617, and NCT03835975) describing the safety and evaluating the immunogenicity of the vaccine. Clin Infect Dis. 2016;62(9):1119-1125. Antimicrob Agents Chemother.

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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 (..)

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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. .”

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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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The Pharma Data

MAY 4, 2021

Long-acting cabotegravir has not been approved or licensed anywhere in the world for use in HIV prevention. . ViiV Healthcare plans to start submission of regulatory files with global regulatory authorities by the end of this year and will initially focus submissions on countries where the HPTN 083 and HPTN 084 clinical trials were conducted.

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Agency IQ

JUNE 29, 2023

The following PDUFA dates were obtained from publicly available sources.

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The Pharma Data

DECEMBER 29, 2020

Phase III BRIDGE open-label, switch-over clinical trial met key objectives for safety and efficacy. ” In May 2020 , Protalix and Chiesi Global Rare Diseases announced the submission of a Biologics License Application (BLA) to the U.S. Protalix has licensed to Pfizer Inc. CARMIEL, Israel and BOSTON , Dec.

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The Pharma Data

NOVEMBER 22, 2020

Islatravir is a promising antiviral candidate with evidence from ongoing clinical trials to support its development as a once-monthly oral PrEP agent. This grant will support ICRC’s work with experienced trial sites in sub-Saharan Africa to enroll, follow and retain the large number of women required for this research.

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The Pharma Data

DECEMBER 27, 2020

Complete approval for these indications may be contingent upon results from ongoing randomized, controlled confirmatory clinical trials. Currently, 16 potentially registration-enabling clinical trials are being conducted in China and globally, including 12 Phase 3 trials and four pivotal Phase 2 trials.

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Agency IQ

SEPTEMBER 1, 2023

The MHRA notes that the new pathway will be parallel to its innovation pathway (the Innovative Licensing and Access Pathway , or ILAP), which integrates “early regulatory advice with health technology assessment advice.” In May 2023, the MHRA revealed which regulators will be included in the scheme: Australia, Canada, the E.U.,

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Agency IQ

JULY 28, 2023

September 2023 Final Rule Stage Biologics License Applications and Master Files The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) deemed any biological product approved in a new drug application (NDA) to be a biologics license application (BLA) on March 23, 2020.

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Drug & Device Law

JULY 31, 2023

2012), computer code was not a “product” for purposes of the National Stolen Property Act, 18 U.S.C. 2012 WL 5932437 (N.D. 27, 2012), limited the undefined term “product” in an Alabama sales commission statute to tangible things, excluding franchise rights. 3d 316, 338 (Alaska 2012). 2012 WL 12886210, at *3 (C.D.

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Drug & Device Law

JUNE 2, 2022

2012), addressed a challenge to the application of Idaho’s Pain-Capable Unborn Child Protection Act to criminalize the use of an FDA-approved abortifacient medication obtained through an internet prescription and mailed to the plaintiff from out of state. As we discussed here , McCormack v. Hiedeman, 694 F.3d 3d 1004 (9th Cir. 3d 27 (Okla.

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Drug & Device Law

NOVEMBER 9, 2023

2012); Amarin Pharma, Inc. Beyond such gold-plated research: [O]ther well-designed and well-conducted trials are also able to generate scientifically sound and clinically relevant information. . . . E.g. , Sorrell v. IMS Health Inc. , 552 (2011); Thompson v. Western States Medical Center , 535 U.S. 357 (2002); United States v.

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Drug & Device Law

MARCH 7, 2022

2010), a Third Circuit panel specifically affirmed a TwIqbal dismissal of punitive damages allegations: [C]ourts do indeed dismiss claims for punitive damages in advance of trial. . . . [U]nder It does not give him license to evade the less rigid ? It does not, however, give a plaintiff “license to evade the less rigid ?

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Drug & Device Law

MAY 9, 2022

Grady involved a small plane crash, and the plaintiff sued (among others) the flight school that had provided the pilot with the “aerial practicum required prior to obtaining a private pilot license” and several individual instructors. quoting trial court). 2012); Glorvigen v. 2012), and Dallas Airmotive, Inc.

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Drug & Device Law

MARCH 16, 2022

In Arizona, a manufacturer cannot be liable for punitive damages if the product was “designed, manufactured, packaged, labeled, sold or represented in relevant and material respects according to the terms of an approval, conditional approval, clearance, license or similar determination of a government agency.” Hence, the statute applied.

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