New Drug Approvals

OCTOBER 24, 2023

2014, 5, 12, 1313–1317 Publication Date:November 4, 2014 [link] APD334 was discovered as part of our internal effort to identify potent, centrally available, functional antagonists of the S1P 1 receptor for use as next generation therapeutics for treating multiple sclerosis (MS) and other autoimmune diseases. . 11] SYN ACS Med.

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The Pharma Data

MAY 14, 2021

Description: Copyright © 2014 All Rights Reserved. Neither ClickBank nor the author are engaged in rendering medical or similar professional services or advice via this website or in the product, and the information provided is not intended to replace medical advice offered by a physician or other licensed healthcare provider.

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FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

. § 156 or case law that would support extension of the ‘929 patent that claims the product despite revocation of the biologics license application. Moreover, Lilly should explain how a PTE application for a withdrawn “revoked” biologics license application is in compliance with requirements of 37 C.F.R.

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The Pharma Data

NOVEMBER 13, 2020

The EUL procedure assesses the suitability of yet to be licensed health products during public health emergencies, such as polio and COVID. Type 2 cVDPVs are currently the most prevalent form of the vaccine-derived virus. The EUL procedure and how it could help to speed up access to a future COVID-19 vaccine.

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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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The Pharma Data

JANUARY 12, 2021

With the phase of the Agreement relating to the development of the antibody completed, under the Agreement, as of 11 January 2021, GlobalCo has three months to exercise an option to license the Company’s intellectual property necessary to exploit the CDX antibody on an exclusive worldwide basis (“Option”). .

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The Pharma Data

DECEMBER 15, 2020

This is an important step towards a licensing agreement for Lipidor drug candidates, AKP01 and AKP02, for the treatment of psoriasis. This disclosure contains information that Lipidor is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). Aurena Laboratories has already met the requirements of the U.S.

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The Pharma Data

NOVEMBER 24, 2020

Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed.

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The Pharma Data

JANUARY 12, 2021

As part of this role he built innovative, high-performing development teams and managed the Regeneron’s regulatory filings, interactions with regulatory agencies, product launches, and business development and licensing activities across its product portfolio. About Tiziana Life Sciences.

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The Pharma Data

JANUARY 10, 2021

Its products are intended to be licensed to players in the health sector. Created at the beginning of 2014 in La Rochelle, the Company has forged numerous partnerships with leading academic centers. The Company has established three sites in France: Périgny, La Rochelle (17) and Riom (63).

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The Pharma Data

MARCH 20, 2023

Eisai submitted a supplemental Biologics License Application (sBLA) to the FDA for approval under the traditional pathway on January 6, 2023. About the Collaboration between Eisai and Biogen for AD Eisai and Biogen have been collaborating on the joint development and commercialization of AD treatments since 2014. In the U.S.,

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Drug Discovery World

JULY 13, 2023

The rules and regulations Unlicensed drugs are drugs that have not yet been assessed by a regulator, while off-label use is when an approved medication is prescribed outside of the terms of its license, e.g., for a different disease or in a different patient group. What are the risks?

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The Pharma Data

AUGUST 17, 2021

This new indication follows an FDA priority review of the Biologics License Application and is based on the collective results from the dMMR endometrial cancer cohort A1 and the dMMR solid-tumour (non-endometrial cancer) cohort F of the ongoing GARNET trial. [vii] JEMPERLI was discovered by AnaptysBio and licensed to TESARO, Inc.,

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The Pharma Data

JANUARY 18, 2021

OKYO has been developing the chemerin molecule as a promising anti-inflammatory treatment for dry-eye disease (“DED”) licensed from researchers at On Target Therapeutics LLC. THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF REGULATION (EU) NO 596/2014. LONDON and BOSTON, Jan. Gary S. .

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The Pharma Data

DECEMBER 27, 2020

United Therapeutics is developing Tyvaso DPI under a collaboration and license agreement with MannKind Corporation. Tyvaso DPI incorporates the dry powder formulation technology and Dreamboat inhalation device technology used in MannKind’s Afrezza ® (insulin human) Inhalation Powder product, approved by the FDA in 2014.

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NIH Director's Blog: Drug Development

JUNE 14, 2016

Scott and colleagues focused on six genes that encode potential drug targets licensed or in development by GlaxoSmithKline for the treatment of obesity or diabetes. 2014 Jan;32(1):40-51. 2012 Jul 6;337(6090):100-104. [4] 4] Victoza® significantly reduced the risk of major adverse cardiovascular events in the LEADER Trial. Novo Nordisk.

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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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The Pharma Data

APRIL 23, 2021

Dostarlimab was discovered by AnaptysBio and licensed to TESARO, Inc., under a Collaboration and Exclusive License Agreement signed in March 2014. The collaboration has resulted in three monospecific antibody drugs that have progressed into the clinic.

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Agency IQ

APRIL 26, 2024

For additional advice on this topic, the guidance directs readers to FDA’s 2014 guidance on the submission of interactive promotional media for currently marketed products. Information regarding interchangeability would remain available only in the Purple Book: Database of Licensed Biological Products.

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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

DECEMBER 2, 2020

ERS Genomics – Ireland’s ERS Genomics Limited, and Germany’s Vivlion GmbH, announced a non-exclusive license agreement granting Vivlion access to ERS Genomics’ CRISPR/Cas9 patent portfolio, to enhance Vivlion’s gene editing reagents and screening services. Horizon Discovery Group – U.K.-based for its cGMP-compliant CHOSOURCE platform.

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The Pharma Data

JULY 8, 2021

Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) and granted Priority Review for tezepelumab in the treatment of asthma. 2014; 43: 343-73. 2014; 40 (4): 364-372. 2014; 12; 24: 14009. 2014; 133: 388-94. Amgen (NASDAQ:AMGN) announced that the U.S. Chung KF, et al. Eur Respir J.

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The Pharma Data

OCTOBER 15, 2020

“Despite the 2014 approval of two oral antifibrotic therapies, IPF and other fibrotic lung diseases remain fatal diseases with substantial unmet need. IPF treatments are relatively new, with the first and only approvals coming in 2014: oral pirfenidone (Esbriet ® ) and oral nintedanib (Ofev ® ). About Avalyn Pharma.

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Drug Discovery World

AUGUST 4, 2022

A fundamental aspect of biopharmaceutical drug development is the need for the data submitted in an Investigational New Drug (IND) to match the data containing in the Chemistry, Manufacturing and Control (CMC) section of a Biologics License Application (BLA). link] Design_of_Liquid_Formulations. 4: Thorsten Lorenz, PhD et al.,“Developability

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Drug Discovery World

JULY 27, 2023

The scheme was launched in 2014. In a case study by the NHS on treating advanced renal cell carcinoma, Dr Balaji Venugopal, Honorary Clinical Senior Lecturer at University of Glasgow, said 5 : “EAMS offers an excellent opportunity for patients to access drugs within the NHS in areas of unmet need.

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The Pharma Data

JANUARY 25, 2021

Further to the update outlined in the Company’s results for the year ended 31 December 2019, Secura Bio, Inc. (“Secura Bio”), the licensor of panobinostat, the API component of MTX110, has twice declined an invitation to withdraw its purported termination of the license. We are well positioned for a productive 2021.”

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The Pharma Data

OCTOBER 27, 2021

The primary endpoint is complete response rate (CRR) grounded on stylish response by central review (Lugano 2014 criteria). This transnational trial has enrolled cases from over 30 spots in 12 countries worldwide. After infusion, complaint assessments were performed every three months.

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The Pharma Data

DECEMBER 30, 2020

2014 Jun 16;9(6):e98933. . Smelt AF, Louter MA, Kies DA, Blom JW, Terwindt GM, van der Heijden GJ, De Gucht V, Ferrari MD, Assendelft WJ. What do patients consider to be the most important outcomes for effectiveness studies on migraine treatment? Results of a Delphi study. Lipton RB, Stewart WF. 1999;39(suppl 2):S20-S26.

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The Pharma Data

NOVEMBER 9, 2020

Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. Eur Respir J 2014; 43: 343–73. NPJ Prim Care Respir Med 2014; 12; 24: 14009. 2014; 133: 388–94. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. EMJ Allergy Immunol.

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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. 2, 2014), [link]. [12] In seeking to justify regulation of LDTs, FDA emphasizes that many of these tests are novel. [6] 31, 2023), [link]. [10] 11] Jeffrey N. Gibbs, Allyson B.

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Agency IQ

JUNE 16, 2023

0910-AI26 September 2023 March 2023 Final Rule Stage Biologics License Applications and Master Files The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) deemed any biological product approved in a new drug application (NDA) to be a biologics license application (BLA) on March 23, 2020.

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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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Codon

MARCH 28, 2023

DARPA invested more than $200 million in support of the White House’s Brain Research through Advancing Innovative Neurotechnologies ( BRAIN ) Initiative between 2014 and 2016 alone.

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The Pharma Data

JANUARY 25, 2021

patent is part of a patent family, exclusively licensed from Ionis Pharmaceuticals, which covers modulators of DNM2 expression. Cowling et al 2014 JCI). This patent family includes one additional U.S. Nat Commun. 2017 Jun 7 ;8:15661. doi: 10.1038/ncomms15661. Proc Natl Acad Sci U S A. 2018 Oct 23;115(43):11066-11071. 1808170115.

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The Pharma Data

JUNE 18, 2021

Childhood Deaths Attributable to Invasive Pneumococcal Disease in England and Wales, 2006–2014. Clin Microbiol Infect. 2016;22(1):60. 13 Oligbu G, Collins S, Sheppard CL, et al. Clin Infect Dis. 2017;65(2):308-314. 14 van Hoek, Andrews N, Waight PA, et al.

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Agency IQ

SEPTEMBER 29, 2023

As part of the classification process, we are required to discuss the potential classification before an advisory committee and seek the committee’s recommendation on classification, which took place in October 2014. The following PDUFA dates were obtained from publicly available sources.

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Agency IQ

DECEMBER 1, 2023

As part of the classification process, we are required to discuss the potential classification before an advisory committee and seek the committee’s recommendation on classification, which took place in October 2014. The following PDUFA dates were obtained from publicly available sources.

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