The Pharma Data

MARCH 5, 2021

Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement. Since October 2017 Biogen and Eisai have collaborated on the development and commercialization of aducanumab globally. Source link:[link].

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The Pharma Data

DECEMBER 17, 2020

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. Janux, in exchange, will receive up to $500.5 million per target, the company said. It’s a big bet for Merck.

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The Pharma Data

AUGUST 21, 2020

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. SVB Leerink’s Berens, in a November note to clients, said the Brukinsa U.S. approval, potentially speeding time to market.”.

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The Pharma Data

NOVEMBER 29, 2020

2017, 16 , 101-114. Small-molecule inhibitors of the MDM2-p53 protein-protein interaction (MDM2 inhibitors) in clinical trials for cancer treatment. 2015, 58 , 1038?1052. Lai, A. Induced protein degradation: an emerging drug discovery paradigm. Drug Discov. Ryan P. Wurz and Victor J. 2019, 62 , 445?

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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.

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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

SEPTEMBER 29, 2024

2017 ; Ilievski et al., In August 2022, Cortexyme discontinued the gingipain inhibitor program, and offered it for external licensing ( press release ). Epub 2017 Nov 6 PubMed. In preclinical work from other labs, infection with P. 2018 ; Ding et al., For a review of the preclinical literature, see Costa et al.,

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New Drug Approvals

OCTOBER 24, 2023

Peyrin-Biroulet L, Christopher R, Behan D, Lassen C (May 2017). Retrieved 13 October 2023. ^ [link] ^ World Health Organization (2017). . | Facebook Twitter FACEBOOK join me on twitter Anthony Melvin Crasto Dr. | twitter +919321316780 call whatsaapp EMAIL. “Velsipity (etrasimod) tablets, for oral use” (PDF). . 2017.03.007.

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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. Normality sensing licenses local T cells for innate-like tissue surveillance. Mr Ho has worked in the biotechnology industry for almost 20 years. Cell Mol Immunol 17:925-939 (2020).

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The Pharma Data

MARCH 1, 2022

Founded in December 2017 and based in Belgium, Syndesi is a clinical stage biotechnology company pioneering the development of novel therapeutics that modulate synaptic function to relieve the symptoms of cognitive impairment. The lead molecule, SDI-118, was discovered by UCB before being out-licensed to Syndesi as of 2018.

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FDA Law Blog: Biosimilars

JUNE 17, 2024

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). The Quality Report includes a rundown of what the universe of FDA-registered drug manufacturing sites looks like as included in the CDER Site Catalog.

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FDA Law Blog: Drug Discovery

FEBRUARY 2, 2023

The 2017 Predictive Toxicology Roadmap laid out some of the FDA’s thinking around the need for new toxicology methods driven in part by a desire to find alternatives to animal testing. 42 U.S.C. § 262(k)(2)(A)(i)(I). However, there are signs that FDA is receptive from a policy perspective to alternative methods.

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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) The Prospectus stipulates that approximately 10.0%

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The Pharma Data

MARCH 22, 2021

In December 2017, Roche licensed the investigational molecule from Ionis Pharmaceuticals. 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.

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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.

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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.

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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. The patent application is 52 pages, filed in 2017 following years of published research. Tomes were split into shorter versions, like calving icebergs. The first E-books date from the 1990s. “E” might also stand for “ephemeral.”

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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 average life expectancy of PSP patients ranges from 5 to 7 years.

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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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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. And so, there was a lot of debate about that back in 2017 and 2018 , when they were considering these trials in the first place. That's the primary way that Zika is spread. per 10,000 donors.

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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. You can identify forward-looking statements because they contain words such as “will,” “appears,” “believes” and “expects.”

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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. to develop and commercialise cilta-cel.[1].

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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. If approved, Dupixent would be the first medicine available in the U.S. indicated to treat eosinophilic esophagitis There are approximately 160,000 patients in the U.S. Regulatory filings around the world are also planned in 2022.

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Agency IQ

MAY 28, 2024

Medical Device Regulation (MDR; Regulation (EU) 2017/745 ). which now has separate regulations for medical devices and IVDs (IVDR; Regulation (EU) 2017/746 ). Additionally, companion diagnostics and combination products that contain medicinal substances that haven’t yet been licensed in the U.K. This differs from the E.U.,

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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. 10% of its Net Sales in R&D and also invests significantly in business development and in-licensing. Guidance for FY 2020.

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Translation

MAY 28, 2022

The company received proposals from over fifty institutions, including 40 universities and 10 government labs, surfacing licensing candidates from diverse partners. The scale of what we were able to accomplish is orders of magnitude faster than we could have done it any other way.”

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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. They also identified several drugs that reduced the production of inflammatory cytokines in infected Alveolus Chips, which could be useful in treating excessive inflammation in the lung.

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The Pharma Data

OCTOBER 14, 2020

iota is a start-up company founded in 2017 by Michel Maharbiz and Jose Carmena, each of whom has demonstrated outstanding achievement in the bioelectronics field. Established in 2017, iota is a start-up company focused on building a foundation for the future of bioelectronic medicine. About iota Biosciences.

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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. 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]

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Advarra

AUGUST 10, 2023

FDA CBER began issuing approvals for gene therapies in 2015 and issued the first approval for a rare disease gene therapy in 2017, with the second rare disease approval issued in 2019. This will aid clinical development and preparation for investigational new drug (IND) and biologics license application (BLA) submissions.

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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

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. ENPP1 and ABCC6 deficiencies are estimated to occur in approximately one in 200,000 and one in 50,000 births, respectively. Demetrios Braddock, M.D.,

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The Pharma Data

DECEMBER 8, 2020

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. With an intent to develop treatment for rare neurological disease where existing therapies have not shown much success, the company has licensed four clinical stage assets from Roche.

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The Pharma Data

AUGUST 22, 2021

Discovered by Vanderbilt University Medical Center and licensed to AstraZeneca in June 2020, the human monoclonal antibodies bind to distinct sites on the SARS-CoV-2 spike protein(7) and were optimised by AstraZeneca with half-life extension and reduced Fc receptor and complement C1q binding. 2017; 61(3): e01714-16. About AstraZeneca.

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The Pharma Data

DECEMBER 15, 2020

These proinflammatory T cells promoted bacterial clearance after infection with Staphylococcus aureus and, by licensing encephalitogenic Th17 cells, played a key role in the development of autoimmune disease in the central nervous system,” the authors stated.

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The Pharma Data

JANUARY 5, 2021

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. Investor Relations Contact: Peter Schwartzman Email: investor-relations@radiuspharm.com Phone: 617-583-2017. Source link.

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The Pharma Data

OCTOBER 26, 2020

It may also allow for priority or rolling review of a company’s Biologics License Application (BLA). Prevail was founded by Dr. Asa Abeliovich in 2017, through a collaborative effort with The Silverstein Foundation for Parkinson’s with GBA and OrbiMed, and is headquartered in New York, NY.

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