The Pharma Data

MARCH 5, 2021

Biogen (Nasdaq: BIIB) today announced it will host webcasts of its pre-recorded presentations and live discussions related to its Alzheimer’s disease investigational therapy, aducanumab, at the upcoming AD/PDTM 2021 Virtual Conference. AD/PD Webcast Schedule Details: Wednesday, March 10, 2021, 6:45 a.m. Wednesday, March 10, 2021, 11:00 a.m.

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New Drug Approvals

SEPTEMBER 29, 2024

gingivalis has been called a risk factor for Alzheimer’s disease ( Kanagasingam et al., 2017 ; Ilievski et al., gingivalis is associated with cardiovascular disease. In aged dogs with periodontal disease, ninety days of COR388 reduced oral bacterial load and gum pathology ( Arastu-Kapur et al., 2018 ; Ding et al.,

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The Pharma Data

NOVEMBER 6, 2020

The Advisory Committee also voted 0 yes, 7 no and 4 uncertain on the question, “Does Study 103 (PRIME) provide supportive evidence of the effectiveness of aducanumab for the treatment of Alzheimer’s disease?”, Aducanumab (BIIB037) is an investigational human monoclonal antibody studied for the treatment of Alzheimer’s disease.

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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. In addition, the FDA has granted Fast Track designation for PR001 for the treatment of Parkinson’s disease with GBA1 mutations.

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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

JANUARY 4, 2021

Collaboration with Biogen to develop gene therapy for an undisclosed target to treat inherited eye disease, plus option for additional target. 05, 2021 (GLOBE NEWSWIRE) — ViGeneron GmbH , a gene therapy company, today announced a global collaboration and licensing agreement with Biogen Inc. MUNICH, Germany, Jan.

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Drug Target Review

FEBRUARY 28, 2024

Prior to the founding of IN8bio, from 2014 to 2017, Mr Ho was the Founder and Managing Partner at AlephPoint Capital, a private healthcare investment fund. Human γδ TCR repertoires in health and disease. Normality sensing licenses local T cells for innate-like tissue surveillance. References Fichtner A, Ravens S, Prinz I.

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The Pharma Data

JANUARY 12, 2021

Marianne De Backer, Head of Business Development & Licensing in Bayer’s Pharmaceuticals Division, pictured above. The roots of Bayer’s platform began in 2014, when the company stepped into the gene therapy space through a collaboration for hemophilia A with Dimension Therapeutics, which was later acquired by Ultragenyx in 2017.

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New Drug Approvals

OCTOBER 24, 2023

1 Therefore, S1P receptor modulators like etrasimod were investigated in treating immune-mediated diseases like ulcerative colitis where a high level of inflammatory T cells is present in the gastrointestinal tract, thus causing diffuse mucosal inflammation. Peyrin-Biroulet L, Christopher R, Behan D, Lassen C (May 2017). July 2022).

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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. Senior Vice President and Global Head of Cardiometabolic Diseases Research, Boehringer Ingelheim. population will have obesity.

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The Pharma Data

NOVEMBER 29, 2020

2017, 16 , 101-114. HK) is a globally, clinical-stage biotechnology company engaged in developing novel therapies for cancers, CHB, and age-related diseases. SUZHOU, China and ROCKVILLE, Md. , 29, 2020 /PRNewswire/ — Ascentage Pharma (6855.HK), 2015, 58 , 1038?1052. Lai, A. Drug Discov. Ryan P.

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The Pharma Data

MARCH 1, 2022

The mechanism is currently being evaluated for the potential treatment of cognitive impairment and other symptoms associated with a range of neuropsychiatric and neurodegenerative disorders, such as Alzheimer’s disease and major depressive disorder. senior vice president, R&D, chief scientific officer, AbbVie.

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Drug Target Review

NOVEMBER 25, 2024

As the CEO of iOnctura, an innovative oncology biopharmaceutical company she co-founded in 2017, Catherine has played a key role in advancing the development of highly targeted small molecules aimed at revolutionising cancer treatment. So, with a huge amount of courage and commitment, I co-founded iOnctura in 2017.

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The Pharma Data

APRIL 4, 2022

Dupixent was also granted Orphan Drug designation for the potential treatment of EoE in 2017. EoE is a chronic, progressive type 2 inflammatory disease that damages the esophagus and prevents it from working properly. The target action date for the FDA decision on this investigational use is August 3, 2022. In the U.S.,

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The Pharma Data

DECEMBER 8, 2020

Some of the funds will be used for the development of therapeutics for oncology and other serious diseases through its proprietary ImmunoTAC technology platform. The ImmunoTAC platform pairs proprietary payloads that modulate key disease modifying pathways with monoclonal antibodies directed at specific disease sites.

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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. About the Janssen Pharmaceutical Companies of Johnson & Johnson At Janssen, we’re creating a future where disease is a thing of the past. Source link: [link].

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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) b) The Prospectus stipulates that approximately 10.0%

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PLOS: DNA Science

SEPTEMBER 7, 2023

Train an algorithm on the DNA sequences of a known disease-causing gene, then search for identical or highly similar sequences in cells from other individuals to assist diagnosis. Now, college tuition includes a fee to license an e-textbook for a limited time. Tomes were split into shorter versions, like calving icebergs.

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The Pharma Data

AUGUST 22, 2021

We are very encouraged by these efficacy and safety data in high-risk people, showing our long-acting antibody combination has the potential to protect from symptomatic and severe disease, alongside vaccines. Under the terms of the licensing agreement with Vanderbilt, AstraZeneca will pay single-digit royalties on future net sales.

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The Pharma Data

JANUARY 3, 2021

Nasdaq: INZY), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases of abnormal mineralization impacting the vasculature, soft tissue and skeleton, today announced that the U.S. Inozyme Pharma was founded in 2017 by Joseph Schlessinger, Ph.D., . BOSTON, Jan.

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The Pharma Data

APRIL 8, 2022

Based on these studies, one of those drugs was licensed to Cantex Pharmaceuticals for the treatment of COVID-19 and other inflammatory lung diseases. This complexity has hindered science’s understanding of how the lungs function at the cell and tissue levels, in both healthy and diseased states. During his Ph.D.

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The Pharma Data

OCTOBER 14, 2020

In carrying out the activities contemplated under the R&D Agreement, the companies have evaluated detailed specifications for implantable medical devices focused on multiple diseases with high unmet medical needs. Through the acquisition of iota, Astellas will acquire iota’s unique bioelectronics technology and world-class talent.

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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 will advance and enrich our pipeline while continuing to build a leading company in rare diseases of the brain.

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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 Premier Consulting Blog

JANUARY 17, 2023

Pediatric requirements for molecularly targeted cancer products Originally, PREA targeted only those products developed for diseases and/or conditions that occur in both adult and pediatric populations. These investigations are based on the molecular target of the product, rather than on the disease or condition.

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The Pharma Data

DECEMBER 9, 2020

If approved, aducanumab would become the first treatment to meaningfully change the course of Alzheimer’s disease. 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.

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The Pharma Data

AUGUST 5, 2020

A separate post hoc analysis demonstrated that nearly 9 out of 10 patients experienced no evidence of disease activity in the second year of treatment 4. Ofatumumab was originally developed by Genmab and licensed to GlaxoSmithKline. ” These data were published in the August 6, 2020 issue of The New England Journal of Medicine.

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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. 24] These submissions all related to a single disease. 15, 2017), [link]. [18] 15, 2017), [link]. [18] 360(m)(a)(3). [16] 31, 2023), [link]. [17] 20] PRIA at 22. [21]

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The Pharma Data

NOVEMBER 8, 2020

In 2017 we bet on refocusing our strategy on medical dermatology to best address patients’ unmet needs. Likewise, we continue to build an R&D pipeline to make a significant difference in patients’ lives by treating a wide range of skin diseases. ” Peter Guenter , CEO. Guidance for FY 2020.

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The Pharma Data

JUNE 18, 2021

First approval of a conjugate vaccine that helps protect against 20 serotypes responsible for the majority of invasive pneumococcal disease and pneumonia, 1,2,3,4,5,6,7 including seven responsible for 40% of pneumococcal disease cases and deaths in the U.S. Following today’s FDA approval, the U.S. Jansen, Ph.D.,

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Translation

MAY 28, 2022

These R&D efforts are fundamental to solving some of the world’s most challenging problems like combating climate change and curing diseases. The company received proposals from over fifty institutions, including 40 universities and 10 government labs, surfacing licensing candidates from diverse partners.

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The Pharma Data

NOVEMBER 11, 2020

. Received Rare Pediatric Disease and Fast Track Designations for INZ-701 for the treatment of ENPP1 deficiency. ENPP1 deficiency is a systemic, progressive and continuous disease occurring over the course of a patient’s lifetime, starting as early as fetal development and spanning into adulthood. BOSTON, Nov.

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The Pharma Data

DECEMBER 30, 2020

Over 37 million Americans suffer from migraine according to the Centers for Disease Control, and it is the leading cause of disability among neurological disorders in the United States according to the American Migraine Foundation. The burden of neurological disease in the United States: A summary report and call to action. 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

SEPTEMBER 15, 2020

Major revenue contributions through 2025 anticipated from Oncology, Vaccines, Rare Disease and Inflammation and Immunology. The results demonstrated that Penta immune responses were robust and noninferior to licensed meningococcal vaccines (MenB and MenACWY) in individuals 10-25 years of age, regardless of prior MenACWY exposure.

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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

OCTOBER 28, 2020

29, 2020 (GLOBE NEWSWIRE) — Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an update on the potential pathway to marketing approval for its lead product candidate remestemcel-L. NEW YORK, Oct.

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