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

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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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

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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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

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

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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Drug Target Review

FEBRUARY 28, 2024

Over the past 25 years, T-cell therapies have gained significant ground in the treatment of cancer. Preclinical research on γδ T cells has made great strides since the cells were first identified in the 1980s, with γδ T-cell therapies from several companies, including IN8bio, now in or nearing clinical trials for various cancers.

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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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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

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

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

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 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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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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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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Agency IQ

AUGUST 2, 2024

September 30, 2024 PDUFA Novel Approaches to Development of Cell and Gene Therapy Convene a public meeting to solicit input on methods and approaches (e.g., use of RWE, registries) for capturing post-approval safety and efficacy data for cell and gene therapy products.

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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

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

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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Agency IQ

JANUARY 19, 2024

Only one product was an advanced therapy medicinal product (ATMP), three products held PRIME designation, and three products were evaluated under accelerated assessments. approval and discussion with the FDA, the company announced in December 2023 that it intends to re-submit the biologics license application in the U.S.

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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

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

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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The Pharma Data

MAY 27, 2022

In December 2017, Janssen Biotech, Inc. Janssen) entered into an exclusive worldwide license and collaboration agreement with Legend Biotech USA, Inc. of patients with RRMM responding to therapy (98 percent overall response rate ORR ).1,6 to develop and commercialise cilta-cel.[1].

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The Pharma Data

JUNE 30, 2021

Event-free survival is defined as time from randomization to disease progression, commencement of new lymphoma therapy, or death from any cause. ZUMA-7 evaluated an one-time infusion of the CAR T-cell therapy Yescarta compared to SOC in adult patients with relapsed or refractory LBCL. View the full release here: [link].

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The Pharma Data

OCTOBER 27, 2020

License-related fees (5). License-related fees (5). Medtronic), the premarket approval application (PMA) for the ISR was approved by the FDA in December 2017. Three Months Ended September 30, . 2020.

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The Pharma Data

NOVEMBER 4, 2020

“We are excited to be nearing the EMA’s regulatory decision on VASCEPA and are busy preparing for our anticipated commercial launch in Europe, where there is a large and growing opportunity for Amarin to bring this proven effective therapy to the millions of patients at high risk for cardiovascular events. million and $8.9 million and $5.7

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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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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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Agency IQ

JULY 12, 2024

those sold under authorization from a licensed provider or other regulatory-specific situations) and is submitted as part of the medical device’s listing (general controls), and the agency may request a copy of all advertising materials for good cause ( See a Congressional Research Service explainer on this topic here ).

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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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The Pharma Data

JANUARY 5, 2021

PWS is an orphan disease with major endocrine and behavioral manifestations and no FDA-approved therapies for the treatment of hyperphagia. RAD011 was granted Fast Track Designation in 2017 and Orphan Drug Designation in August 2020 for the treatment of hyperphagia behavior and weight loss in patients with PWS. Disease Highlights.

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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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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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