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

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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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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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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New Drug Approvals

APRIL 19, 2025

Dean L (2017). July 2017). PMID 26261777. “Metoprolol Therapy and CYP2D6 Genotype” In Pratt VM, McLeod HL, Rubinstein WS, et al. Medical Genetics Summaries. National Center for Biotechnology Information (NCBI). PMID 28520381. Bookshelf ID: NBK425389. Ojima T, Nakamori M, Nakamura M, Katsuda M, Hayata K, Kato T, et al.

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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

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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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

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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Perficient: Drug Development

NOVEMBER 22, 2023

Sitecore first introduced Identity Server as a feature in Sitecore 9, which was released in October 2017. Cost: While Sitecore’s Identity Server is included in the Sitecore license, Azure AD B2C is a separate service that requires a subscription.

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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. 4] [5] It is a highly selective retinoic acid receptor gamma (RARγ) agonist. [6] 6] It was approved for medical use in Canada in June 2022, [4] and in the United States in August 2023. [5] Grogan, D.

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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.

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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

AUGUST 16, 2024

The June 2023 guidance recommends that studies involve two monitors (one with graduate-level professional training and clinical experience in psychotherapy, licensed to practice independently) to observe study participants during treatment sessions. At that time, FDA flagged concerns with functional unblinding and inherent expectation bias.

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Agency IQ

AUGUST 25, 2023

BsUFA was first authorized in 2012, and BsUFA I ran from FY2013-2017. The FDA states that “certain text in the reference product labeling related to condition(s) of use for the reference product that are not licensed for the biosimilar product would generally not be included in the biosimilar product labeling.”

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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

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.

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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).

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The Pharma Data

NOVEMBER 5, 2020

Most recently, Holland served as Global Head of licensing at Lonza AG. Prior to joining Navitor, Hughes served as president and CSO of Zafgen and previously led Zafgen as CEO from 2008 to 2017. Prior to Lonza, she led External Science and Partnering across the globe for Sanofi R&D. Schijns, a former professor at N.C.

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The Pharma Data

OCTOBER 18, 2020

Following the acquisition, he continued at Takeda to successfully launch ALUNBRIG ® (brigatinib), which exceeded launch year and subsequent year forecasts nationally.

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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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