The Pharma Data

AUGUST 21, 2020

RELATED: Roche pens $2B biobucks pact with Innovent Biologics for bispecific and cell therapies. Lilly first licensed Tyvyt from Innovent in 2015. The original deal included rights outside of China, but in 2017, Lilly licensed back those rights while retaining downstream economics, Taylor said. Source link.

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The Pharma Data

DECEMBER 17, 2020

Partnering with Merck, a world leader in immuno-oncology, provides us with important expertise and resources in developing next-generation T cell engager therapies that will make immunotherapy work for more cancer patients.”. Janux, which was founded in 2017, is still largely a preclinical company. million per target, the company said.

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The Pharma Data

NOVEMBER 29, 2020

1 Meanwhile, these MDM2 inhibitors present some challenges, including dose-limiting hematological toxicities, thus the urgent need to develop new generation of MDM2-targeting therapies in the treatment of cancer. 2017, 16 , 101-114. SUZHOU, China and ROCKVILLE, Md. , 29, 2020 /PRNewswire/ — Ascentage Pharma (6855.HK),

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Advarra

AUGUST 10, 2023

Rapid growth in gene therapy is expected to receive additional support as the Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) prepares to launch Operation Warp Speed for Rare Diseases. Peter Marks, head of FDA’s CBER – the organization responsible for regulating gene therapies.

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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. Our mission is to create breakthrough therapies that change lives. Financial terms of the new agreement are not disclosed.

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PLOS: DNA Science

SEPTEMBER 7, 2023

Now, college tuition includes a fee to license an e-textbook for a limited time. ChatGPT accurately distinguishes gene therapy from gene editing. The patent application is 52 pages, filed in 2017 following years of published research. Tomes were split into shorter versions, like calving icebergs. ChatGPT couldn’t find any?

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The Pharma Data

MARCH 22, 2021

Tominersen, previously IONIS-HTTRx or RG6042, is an investigational antisense therapy designed to reduce the production of all forms of the huntingtin protein (HTT), including its mutated variant, mHTT. In December 2017, Roche licensed the investigational molecule from Ionis Pharmaceuticals. About Roche in Neuroscience.

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The Pharma Data

DECEMBER 8, 2020

Since partnering with Eli Lilly to produce the first monoclonal antibody therapy approved for mild-to-moderate COVID-19 patients, antibody discovery company AbCellera is going big on the Nasdaq. CEO and founder Min Li knows a thing or two from his time running GSK’s neuro R&D group before the company shuttered the program in 2017.

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The Pharma Data

MARCH 1, 2022

“There is a major unmet need for new therapies that can help improve cognitive function in patients suffering from difficult-to-treat neurologic diseases,” said Tom Hudson, M.D., The lead molecule, SDI-118, was discovered by UCB before being out-licensed to Syndesi as of 2018. About Syndesi Therapeutics.

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The Pharma Data

OCTOBER 26, 2020

(Nasdaq: PRVL), a biotechnology company developing potentially disease-modifying AAV-based gene therapies for patients with neurodegenerative diseases, today announced that the U.S. It may also allow for priority or rolling review of a company’s Biologics License Application (BLA). Founder and Chief Executive Officer of Prevail.

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New Drug Approvals

OCTOBER 24, 2023

“Etrasimod as induction and maintenance therapy for ulcerative colitis (ELEVATE): two randomised, double-blind, placebo-controlled, phase 3 studies” Lancet. Peyrin-Biroulet L, Christopher R, Behan D, Lassen C (May 2017). Retrieved 13 October 2023. ^ [link] ^ World Health Organization (2017). 401 (10383): 1132–1133.

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The Pharma Data

APRIL 4, 2022

FDA granted Breakthrough Therapy designation to Dupixent for the treatment of patients aged 12 years and older with EoE. Dupixent was also granted Orphan Drug designation for the potential treatment of EoE in 2017. If approved, Dupixent would be the first medicine available in the U.S. In September 2020, the U.S.

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The Pharma Data

JANUARY 10, 2021

About MorphoSys MorphoSys is a commercial-stage biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies for patients suffering from cancer and autoimmune diseases. In 2017, Tremfya (R) , developed by Janssen Research & Development, LLC and marketed by Janssen Biotech, Inc.,

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The Pharma Data

MARCH 4, 2021

Under the 2017 collaboration agreement, Takeda received equity in Ovid and was eligible to receive up to $85 million in payments for regulatory milestones, including the initiation of Phase 3 clinical trials. We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines.

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The Pharma Data

DECEMBER 30, 2020

NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced positive results from the long-term, open-label Phase 3 MOVEMENT trial of AXS-07, Axsome’s novel, oral, multi-mechanistic investigational medicine in the acute treatment of migraine. Ann Neurol.

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FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

FDA-2017-E-5106 ), and concerns FDA’s October 19, 2016 Accelerated Approval of BLA 761038 for LARTRUVO (olaratumab). 156 or case law that would support extension of the ‘929 patent that claims the product despite revocation of the biologics license application. 8,128,929 [] for [PTE] request under 35 U.S.C. §

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The Pharma Data

DECEMBER 15, 2020

The clinical responses were sustained by maintenance therapy with belimumab, an antibody to B-cell activating factor. In October, Johnson & Johnson successfully completed its acquisition of Momenta Pharmaceuticals , which develops therapies for immune-mediated diseases, in an all cash transaction for approximately $6.5

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The Pharma Data

NOVEMBER 30, 2020

I n-licensing of four clinical-stage product candidates to treat orphan neurological disorders. From the outset, Noema has been leveraging the latest scientific discoveries in neuroscience to identify and pursue promising new indications, and to elaborate a strategy around the four product candidates it licensed from Roche.

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The Pharma Data

APRIL 1, 2021

Kite, a Gilead Company (Nasdaq: GILD), today announced that it has submitted a supplemental Biologics License Application (sBLA) to the U.S. In 2017, Tecartus was granted Breakthrough Therapy Designation by the FDA for relapsed or refractory adult B-cell precursor ALL. Tecartus is an autologous, anti-CD19 CAR T cell therapy.

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The Premier Consulting Blog

JANUARY 17, 2023

However, the FDA Reauthorization Act of 2017 (FDARA) amended PREA to require timely pediatric investigations of certain new active ingredients intended for the treatment of adult cancers, even if the indication does not occur in children and/or orphan designation has been granted.

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The Pharma Data

JANUARY 3, 2021

We are initially focused on developing a novel therapy to treat ENPP1 and ABCC6 deficiencies. Inozyme Pharma was founded in 2017 by Joseph Schlessinger, Ph.D., and Axel Bolte, MSc, MBA, with technology developed by Dr. Braddock and licensed from Yale University. Demetrios Braddock, M.D.,

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Codon

JANUARY 21, 2024

We wouldn't do a challenge trial for Ebola, because the disease is extremely severe, and there are currently no licensed treatments or vaccines. You can do a challenge trial with deadly diseases, but you need a “rescue therapy.” That's the primary way that Zika is spread. Rarely, it can be sexually transmitted.

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The Pharma Data

AUGUST 5, 2020

Ofatumumab is a targeted B-cell therapy that delivers superior efficacy with a similar safety profile when compared with teriflunomide, a commonly prescribed oral treatment for multiple sclerosis 1 . Ofatumumab was originally developed by Genmab and licensed to GlaxoSmithKline. 7. Savelieva M, Kahn J, Bagger M, et al.

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The Pharma Data

NOVEMBER 8, 2020

R&D pipeline continues to drive future value through innovation and differentiated therapies including expected upcoming approval of Tirbanibulin. In 2017 we bet on refocusing our strategy on medical dermatology to best address patients’ unmet needs. Financial highlights (€ million). .

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The Pharma Data

SEPTEMBER 15, 2020

Based on the acceptable safety profile and the favorable immune response data, including the 4th dose response data, Pfizer received Breakthrough Therapy Designation. These data represent the longest period of durability observed to date by a gene therapy for hemophilia B patients.

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The Pharma Data

OCTOBER 29, 2020

If approved, aducanumab would become the first therapy to reduce the clinical decline of Alzheimer’s disease and to meaningfully change the course of Alzheimer’s disease. If approved, aducanumab would become the first therapy to reduce the clinical decline in patients with Alzheimer’s disease. CAMBRIDGE, Mass.

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The Pharma Data

NOVEMBER 5, 2020

Velders is presently chairman of HollandBIO, the association of Dutch biotech companies, and provides years of experience, specifically in the cell and gene therapy areas. Taveras will lead all research and non-clinical development functions supporting the company’s pipeline of investigational therapies.

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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). before any other country.

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The Pharma Data

DECEMBER 9, 2020

(Tokyo, Japan) announced that Biogen has submitted a Japanese New Drug Application (J-NDA) to the Ministry of Health, Labor and Welfare (MHLW) for aducanumab, an investigational therapy for Alzheimer’s disease. Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement.

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The Pharma Data

JUNE 18, 2021

Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for PREVNAR 20 for the prevention of invasive disease and pneumonia in adults age 18 years or older. The FDA previously granted Fast Track designation for PREVNAR 20 in September 2017 for use in adults aged 18 years or older. Breakthrough Therapy [link].

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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. . Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement.

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The Pharma Data

NOVEMBER 15, 2020

This prestigious group of professionals will help lead the Company as it prepares for potential commercialization of its investigational cell therapy, MultiStem ®. Most recently, she was a senior executive at Celgene Corporation, where she led corporate strategy from 2012 to 2017. She earned a BA from Durham University, U.K.,

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Agency IQ

MARCH 25, 2024

As explained in a 2013 Government Accountability Office report, the intent of the CPG was to “identify those circumstances under which the agency believed establishments with retail pharmacy licenses were engaged in ‘manufacturing, distributing, and promoting unapproved new drugs’ in a manner outside the traditional pharmacy practice of compounding.”

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The Pharma Data

OCTOBER 18, 2020

David’s proven track record of success and deep experience with the launch and growth of new oncology therapies will play an important role in the success of our commercial strategy and team. “We are excited to welcome David to the AVEO team as we continue to prepare for the potential commercial launch of tivozanib in the U.S.,”

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The Pharma Data

OCTOBER 28, 2020

Mesoblast has formally requested a Type A meeting with the FDA to discuss a potential accelerated approval of the Biologics License Application (BLA) for remestemcel-L for the treatment of SR-aGVHD in children, with an additional randomized controlled study in patients 12 years and older as a post-approval requirement. .

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The Pharma Data

OCTOBER 28, 2020

There are no currently approved therapies for Angelman syndrome; however, several symptoms of this disorder can be reversed in adult animal models of Angelman syndrome suggesting that improvement of symptoms can potentially be achieved at any age. Angelman syndrome is often misdiagnosed as autism or cerebral palsy. About Ultragenyx.

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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.

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