The Pharma Data

DECEMBER 17, 2020

Merck will fund research and development on the program, according to the collaboration. Under the terms of the agreement, Merck received an exclusive worldwide license to products and intellectual property developed from this collaboration. Janux, which was founded in 2017, is still largely a preclinical company.

Immune Response

The Pharma Data

DECEMBER 21, 2020

Legend will receive $75 million from J&J as a clinical development-based milestone payment, per a 2017 collaboration pact.

Therapies

The Pharma Data

JANUARY 4, 2021

05, 2021 (GLOBE NEWSWIRE) — ViGeneron GmbH , a gene therapy company, today announced a global collaboration and licensing agreement with Biogen Inc. . The companies will use ViGeneron’s proprietary vgAAV technology to efficiently transduce target cells via intravitreal injections. MUNICH, Germany, Jan.

Therapies

The Pharma Data

MARCH 2, 2021

Boehringer Ingelheim and Gubra today announced a new research and licensing agreement focused on the identification and validation of targets and innovative peptide compounds for the treatment of obesity. Senior Vice President and Global Head of Cardiometabolic Diseases Research, Boehringer Ingelheim. About Gubra.

Treatment

FDA Law Blog: Drug Discovery

FEBRUARY 2, 2023

Alternative methods will require significant research investment to demonstrate their utility for a particular context of use and inform regulatory decision-making. In 2019, FDA formed an agency-wide Alternative Methods Working Group indicating that it viewed the applicable scope of alternative methods to go beyond just toxicology research.

Animal Testing

The Pharma Data

NOVEMBER 17, 2020

of the Net Proceeds is originally intended to be used for the Group’s research and development of ASC21, which is an IND-approved NS5B polymerase nocleot(s)ide inhibitor licensed from Medivir AB under the exclusive licensing agreement executed in June 2017. b) The Prospectus stipulates that approximately 10.0%

Licensing

The Pharma Data

MARCH 1, 2022

“With AbbVie’s acquisition of Syndesi, we aim to advance the research of a novel, first-in-class asset for the potential treatment of cognitive impairment associated with neuropsychiatric and neurodegenerative disorders.” The lead molecule, SDI-118, was discovered by UCB before being out-licensed to Syndesi as of 2018.

Small Molecule

The Pharma Data

NOVEMBER 22, 2020

Alzprotect co-owns or has an exclusive worldwide license from the French National Institute of Health and Medical research (Inserm) and the University of Lille (France) on a total of 58 patents related to Ezeprogind in 39 countries. The company employs 8 people and is supported by BPI France, the National Research Agency and Eurasanté.

Drugs

The Pharma Data

JANUARY 10, 2021

In 2017, Tremfya (R) , developed by Janssen Research & Development, LLC and marketed by Janssen Biotech, Inc., for the treatment of plaque psoriasis, became the first drug based on MorphoSys’ antibody technology to receive regulatory approval.

Clinical Trials

FDA Law Blog: Biosimilars

JUNE 17, 2024

Claud — FDA’s Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER) is charged with assuring that drugs marketed in the U.S. Of the 4,819 facilities in the Site Catalog, 60% manufacture drugs approved under a New Drug Application (NDA), Abbreviated NDA (ANDA), or Biologics License Application (BLA).

Pharmaceuticals

The Pharma Data

MARCH 22, 2021

In December 2017, Roche licensed the investigational molecule from Ionis Pharmaceuticals. Neuroscience is a major focus of research and development at Roche. Survival ranges from approximately 10-20 years following motor onset of the disease. About Roche in Neuroscience.

Disease

Translation

MAY 28, 2022

We hear recurring pain points among R&D leaders: Companies lack a systematic way to discover researchers and technologies outside of their geography, industry and existing relationships. In two months, Halo connected Oldcastle with sixty interested researchers. We had one researcher in mind.

Testimonials

The Pharma Data

DECEMBER 15, 2020

Researchers are aware of more than 80 diseases that occur when the immune system attacks the body’s own organs, tissues and cells. The researchers regulated the abnormal immunological memory processes found in these patients. However, if the immune system malfunctions, it can attack healthy cells, tissues and organs.

Disease

The Pharma Data

JANUARY 5, 2021

director of research programs for the Foundation for Prader-Willi Research, said, “With a focus on individuals with PWS and their caregivers, our mission is to accelerate research and support the development of therapies that will eliminate the challenges of PWS.” Theresa Strong, Ph.D., ” Clinical Highlights.

Disease

The Pharma Data

OCTOBER 14, 2020

Astellas and iota previously entered into a Research and Development Agreement in August 2019 (the “R&D Agreement”) to jointly conduct research and development activities associated with iota’s ultrasonic-powered bioelectronic devices (also known as “neural dust”) in a number of indications. and Jose Carmena, Ph.D.,

Disease

The Pharma Data

JANUARY 3, 2021

With these important regulatory clearances for our first-in-human clinical trial for INZ-701 in subjects with ENPP1 deficiency, we have transitioned from a research-stage to a clinical-stage company. Inozyme Pharma was founded in 2017 by Joseph Schlessinger, Ph.D., Demetrios Braddock, M.D.,

Clinical Trials

The Pharma Data

NOVEMBER 8, 2020

In 2017 we bet on refocusing our strategy on medical dermatology to best address patients’ unmet needs. Investment in Research & Development remained at c. 10% of its Net Sales in R&D and also invests significantly in business development and in-licensing. Normalized net income was €74.2

Licensing

The Premier Consulting Blog

JANUARY 17, 2023

The Pediatric Research Equity Act (PREA) was signed into law in 2003 to increase pediatric use information in product labeling and close knowledge gaps regarding the safety, efficacy, and appropriate dosing of drugs to treat children.

Production

New Drug Approvals

AUGUST 21, 2023

4] [5] History Palovarotene is a retinoic acid receptor gamma (RARγ) agonist licensed to Clementia Pharmaceuticals from Roche Pharmaceuticals. 20] Research Phase II Clementia submitted a new drug application for palovarotene for the treatment of fibrodysplasia ossificans progressiva after observing positive phase II results. [21]

FDA

Agency IQ

AUGUST 16, 2024

The road to research on psychedelic products is paved with obstacles. This means that research programs are subject to additional oversight from U.S. FDA released a draft guidance in June 2023 attempting to address many of these unique aspects of clinical research on psychedelic substances.

FDA

FDA Law Blog: Biosimilars

DECEMBER 11, 2023

FDA’s assumption that 50% of the tests will be exempt is particularly baffling because the laboratories are ones licensed to perform high complexity tests. 15, 2017), [link]. [18] 22] FDA, Financial Report to Congress: Medical Device User Fee Amendments of 2017 FY 2022, at 27, [link]. [23] 15, 2017), [link]. [18]

FDA

Agency IQ

JANUARY 12, 2024

These windows depend on whether the new drug application (NDA) or biologics license application (BLA) is a new molecular entity, and if the application has received standard review (10 months, plus 2 months of administrative time) or priority review (6 months, plus 2 months of administrative time).

FDA

The Pharma Data

DECEMBER 30, 2020

2017 Apr; 81(4):479-484. The Company may occasionally disseminate material, nonpublic information on the company website. References. Gooch CL, Pracht E, Borenstein AR. The burden of neurological disease in the United States: A summary report and call to action. Ann Neurol.

Trials

The Pharma Data

NOVEMBER 5, 2020

Horizon Therapeutics – Karin Rosén joined Ireland-based Horizon Therapeutics as executive vice president, research and development and chief scientific officer. Taveras will lead all research and non-clinical development functions supporting the company’s pipeline of investigational therapies. medical affairs at GlaxoSmithKline.

Analytical Chemistry

Agency IQ

AUGUST 25, 2023

The FDA requires extensive testing to support the approval of a biosimilar product, including comparative clinical studies and other human research. BsUFA was first authorized in 2012, and BsUFA I ran from FY2013-2017. Featuring previous research by Rachel Coe.

Biosimilars

The Pharma Data

AUGUST 5, 2020

In February, the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) accepted the company’s Supplemental Biologics License Application (sBLA) and Marketing Authorization Application (MAA), respectively, for ofatumumab for the treatment of relapsing forms of multiple sclerosis in adults. December 21, 2015. link] 9.

Trials

The Pharma Data

NOVEMBER 11, 2020

Under the FDA’s Rare Pediatric Disease Priority Review Voucher program, a sponsor who receives approval of a biologics license application (BLA) for a rare pediatric disease product application may be eligible for a voucher which can be redeemed to obtain priority review for a subsequent marketing application for a different product.

Clinical Trials

The Pharma Data

NOVEMBER 9, 2020

executive vice president of Research and Development at Amgen. We lead with science through discovery research that is disease-agnostic and biology-first, modality-second. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. 2017; 377 (10): 936-946.

Trials

The Pharma Data

OCTOBER 27, 2020

and RESEARCH TRIANGLE PARK, N.C. , Research and development expense. The table below summarizes research and development expense by major category (dollars in millions): . Research and development projects. SILVER SPRING, Md. .

FDA

The Pharma Data

DECEMBER 21, 2020

executive vice president of Research and Development at Amgen. We lead with science through discovery research that is disease-agnostic and biology-first, modality-second. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. 2017; 377 (10): 936-946.

Trials

Agency IQ

AUGUST 2, 2024

The following PDUFA dates were obtained from publicly available sources.

FDA

The Pharma Data

OCTOBER 28, 2020

GeneTx was launched by FAST, a patient advocacy organization and the largest non-governmental funder of Angelman syndrome research. GeneTx licensed the rights to antisense technology intellectual property from the Texas A&M University System in December 2017. About Ultragenyx.

Protein Expression

Agency IQ

SEPTEMBER 29, 2023

So while not specific to medical devices and diagnostics, parts of the regulations will affect healthcare products and their legislation – the European medical device (MDR; Regulation (EU) 2017/745) and diagnostics regulations (IVDR; Regulation (EU) 2017/746).

Regulations

Molecule Blog

AUGUST 6, 2021

Introduction Globally, early-stage biopharma research suffers from chronic underfunding leading to discontinued research in the early stages of the pharma development cycle. This is happening so regularly that academia has coined the phase of research up until clinical trials the “Valley of Death”.

Licensing

The Pharma Data

NOVEMBER 29, 2020

C-Founder of Ascentage Pharma and Chairman of its Scientific Advisory Board, and Warner-Lambert/Parke-Davis Professor in Medicine, Professor of Internal Medicine, Pharmacology and Medicinal Chemistry, Director of Michigan Center for Therapeutic Innovation, University of Michigan , is a leading researcher in the field. 2017, 16 , 101-114.

Licensing

The Pharma Data

AUGUST 21, 2020

At last year’s American Association for Cancer Research meeting, Richard Pazdur, director of FDA’s Oncology Center of Excellence, said the agency would consider accepting applications based on China-only clinical data. Lilly first licensed Tyvyt from Innovent in 2015. leveraging existing data where possible,” he said. Source link.

Licensing

The Pharma Data

MARCH 4, 2021

Discovered at Takeda’s Shonan, Japan research center, soticlestat is a potent, highly selective, first-in-class inhibitor of the enzyme cholesterol 24-hydroxylase (CH24H). President of Research and Development at Takeda. Under the new exclusive agreement, all global rights to soticlestat have been secured by Takeda from Ovid.

Treatment