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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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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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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Pharmaceuticals FDA Production Drugs 59

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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Licensing Licensing FDA Therapies 52

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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Therapies Virus Disease Licensing 52

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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Therapies Licensing Licensing Pharmaceuticals 52

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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Small Molecule Licensing Licensing Disease 52

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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FDA Trials Therapies Regulations 40

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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Animal Testing Biosimilars Cell Based Assays FDA 64

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

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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Drugs Disease Clinical Trials Licensing 40

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.

Disease 52

Disease Clinical Trials Pharmacokinetics Treatment 52

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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Treatment Bioinformatics Clinical Development Therapies 52

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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FDA Treatment Disease FDA Approval 52

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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Clinical Development Clinical Trials Clinical Supply Trials 52

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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FDA Clinical Trials Treatment Pharmaceuticals 52

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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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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FDA Drugs Production Licensing 40

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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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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Biosimilars FDA Production Licensing 40

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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Treatment Clinical Trials Pharmaceutical Companies Trials 52

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

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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Disease FDA Treatment Therapies 40

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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Clinical Trials Trials Treatment FDA 52

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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RNA Therapies Disease Protein Expression 52

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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Disease FDA Clinical Trials Licensing 40

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

OCTOBER 29, 2020

Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement. Since October 2017 Biogen and Eisai Co., If approved, aducanumab would be the first treatment to meaningfully change the course of the disease for individuals living with Alzheimer’s.

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Disease Marketing Clinical Trials Treatment 40

The Pharma Data

DECEMBER 9, 2020

Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement. Since October 2017 Biogen and Eisai Co., If approved, aducanumab would be the first treatment to meaningfully change the course of the disease for individuals living with Alzheimer’s.

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Clinical Trials Drugs Disease Licensing 40

Agency IQ

JANUARY 19, 2024

However, this is actually relatively aligned with the number of new active substances seen prior to and during the first year of the pandemic: 39 in 2020 ; 30 in 2019 ; 42 in 2018 and 35 in 2017. Reviews of orphan medicines and biosimilars have remained stable over the past three years. for the years 2020 to 2022. Based on the E.U.

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Biosimilars FDA Production Treatment 40

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.

Analytical Chemistry 40

Analytical Chemistry Pharmaceuticals Small Molecule Therapies 40

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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Clinical Trials FDA Treatment Trials 52

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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Trials Treatment Disease Therapies 52

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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Clinical Trials Trials Disease FDA 40

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.

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Treatment Virus Therapies FDA 52

FDA Law Blog: Biosimilars

NOVEMBER 1, 2023

FDA recognizes that the FD&C Act exempts licensed healthcare practitioners from certain device regulations if they manufacture devices solely for use in the course of their professional practice. For example, FDA’s regulations have exempted from certain regulatory requirements (e.g.,

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Laboratories FDA Regulations Licensing 81

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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Small Molecule DNA Disease Trials 62