2012, Drug Development and Licensing

What Do Patients Have to Say about Gene Therapy Trials? An Upcoming FDA Public Meeting to Hear from Patients and Caregivers

FDA Law Blog: Drug Discovery

MARCH 13, 2023

Bauer, Senior Regulatory Drug Expert & James E. Valentine — Incorporating patient and caregiver experiences into every phase of drug development has become increasingly prioritized during both development and review ( see, e.g. , previous coverage here ). By Larry J.

Therapies

Therapies Trials FDA Clinical Trials

Obesity care gets personalised: tailoring therapies with Phenomix

Drug Target Review

MARCH 4, 2025

Advancing drug development The implications of precision medicine in obesity care extend beyond selecting the right treatment for individual patients; it is also reshaping the development of next-generation obesity drugs. GenturaDxs technology is the basis of Luminexs acclaimed Aries platform.

Therapies

Therapies Treatment Clinical Trials Science

Precision Medicine: Using Genomic Data to Predict Drug Side Effects and Benefits

NIH Director's Blog: Drug Development

JUNE 14, 2016

Several years ago, the Food and Drug Administration (FDA) recommended that drug developers take special care to show that potential drugs to treat diabetes don’t adversely affect the cardiovascular system [1]. 2012 Jul 6;337(6090):100-104. [4] 5] Clinical development success rates for investigational drugs.

Drugs

Drugs Disease Drug Development Clinical Trials

The Significance of the MHRA Approval and Upcoming FDA Review of the First Gene Editing Treatment

Conversations in Drug Development Trends

NOVEMBER 27, 2023

Food and Drug Administration (FDA) announced its acceptance of the Biologics License Application (BLA) for exa-cel. The CRISPR technique was first published in 2012, outlining a method to harness the previously underappreciated bacterial immune system. In June 2023, the U.S.

Treatment

Treatment FDA Clinical Trials Therapies

FDA Grants Toripalimab Fast Track Designation for Mucosal Melanoma

The Pharma Data

JANUARY 24, 2021

The FTD will significantly accelerate the research, development, and marketing of Toripalimab in the United States. This marks another important milestone, after Toripalimab was granted the ODD and the BTD by the FDA.

FDA

FDA Clinical Trials Trials Treatment

Biogen Files New Drug Application for Aducanumab in Japan

The Pharma Data

DECEMBER 9, 2020

Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement. have collaborated on the development and commercialization of aducanumab globally. million people live with dementia and about 4 million people live with Mild Cognitive Impairment (MCI) in Japan (2012).

Clinical Trials

Clinical Trials Drugs Disease Treatment

Athersys Announces Three Appointments to Board of Directors

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. Prior to Celgene, she held leadership roles in marketing, sales and new business development from 2002 to 2011 at Johnson & Johnson. drug development initiative from 2012 to February 2019.

Clinical Trials

Clinical Trials Trials Production Therapies

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

Agency IQ

JUNE 29, 2023

The following PDUFA dates were obtained from publicly available sources.

FDA

FDA Science Regulations Production

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

Agency IQ

SEPTEMBER 29, 2023

The following legislative requirements are due within the next two months: Legislation Program Tag Requirement Due Date FDORA, Section 3202 Orphan Drug Program FDA shall publish final guidance related to the draft guidance titled, “Rare Diseases: Common Issues in Drug Development.”

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

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.

FDA

FDA Science Regulations Production

BeiGene Announces Inclusion of Three Innovative Oncology Products in China National Reimbursement Drug List (NRDL)

The Pharma Data

DECEMBER 27, 2020

Since its first approval in 2012, approximately 150,000 patients worldwide have received KYPROLIS. We also market or plan to market in China additional oncology products licensed from Amgen Inc., 2012 Aug 2;120(5):947-59. i KYPROLIS has been shown to block proteasomes, leading to an excessive build-up of proteins within cells.

Production

Production Therapies Treatment Drugs

Novartis new analysis shows high consistency in lowering LDL-C in individual response with investigational inclisiran

The Pharma Data

AUGUST 29, 2020

Global Head of Cardiovascular, Renal and Metabolic Drug Development, Novartis. Novartis has obtained global rights to develop, manufacture and commercialize inclisiran under a license and collaboration agreement with Alnylam Pharmaceuticals. Heart disease and stroke Statistics-2012 update. Circulation.

Treatment

Treatment Disease Therapies Trials

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

Agency IQ

DECEMBER 1, 2023

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. The following PDUFA dates were obtained from publicly available sources.

FDA

FDA Science Regulations Production

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

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.

FDA

FDA Science Biosimilars Regulations

Drug Discovery Digest

What Do Patients Have to Say about Gene Therapy Trials? An Upcoming FDA Public Meeting to Hear from Patients and Caregivers

Obesity care gets personalised: tailoring therapies with Phenomix

Trending Sources

Precision Medicine: Using Genomic Data to Predict Drug Side Effects and Benefits

The Significance of the MHRA Approval and Upcoming FDA Review of the First Gene Editing Treatment

FDA Grants Toripalimab Fast Track Designation for Mucosal Melanoma

Biogen Files New Drug Application for Aducanumab in Japan

Athersys Announces Three Appointments to Board of Directors

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

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

BeiGene Announces Inclusion of Three Innovative Oncology Products in China National Reimbursement Drug List (NRDL)

Novartis new analysis shows high consistency in lowering LDL-C in individual response with investigational inclisiran

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

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

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