The Pharma Data

AUGUST 17, 2020

DF6002 is a monovalent IL-12 immunoglobulin Fc fusion protein proposed to achieve strong anti-tumor efficacy by establishing an inflammatory tumor microenvironment necessary for productive anti-tumor responses.

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New Drug Approvals

SEPTEMBER 29, 2024

gingivalis DNA was detected in postmortem cortices from people with AD and healthy controls, and in CSF of AD patients ( Jan 2019 news on Dominy et al., Findings Two Phase 1 trials of atuzaginstat were completed by June 2019. 2019 Jan;5(1):eaau3333. Epub 2019 Jan 23 PubMed.

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The Pharma Data

NOVEMBER 30, 2020

1, 2020 /PRNewswire/ — Sosei Group Corporation (“the Company”) (TSE: 4565) announces it has entered into a global collaboration and license agreement with Biohaven Pharmaceutical Holding Company Ltd. (“Biohaven”, NYSE: BHVN). . TOKYO and CAMBRIDGE, England , Dec.

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The Pharma Data

DECEMBER 14, 2020

15, 2020 (GLOBE NEWSWIRE) — Burning Rock Biotech Limited (NASDAQ: BNR, the “Company” or “Burning Rock”) today announced that it entered into an exclusive licensing agreement with Oncocyte Corporation (NYSE American: OCX) to bring DetermaRx , a risk stratification test for early stage lung cancer patients, to China. February 2019.

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The Pharma Data

MAY 4, 2021

Lilly is offering donations of baricitinib to the Indian government through Direct Relief while simultaneously working with local Indian pharmaceutical companies to execute royalty-free voluntary licensing agreements to accelerate the manufacturing and distribution of the medicine in India during the pandemic. BA HCP ISI 09JUL2020.

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The Pharma Data

DECEMBER 16, 2020

NASDAQ: AUPH / TSX:AUP) (“Aurinia” or the “Company”) today announced it has entered into a collaboration and license agreement with Otsuka Pharmaceutical Co., The Otsuka group of companies employed 47,000 people worldwide and had consolidated sales of approximately USD 13 billion in 2019. VICTORIA, British Columbia & ROCKVILLE, Md.–(

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FDA Law Blog: Biosimilars

OCTOBER 14, 2024

Facts Defendants in this case are two licensed physicians and the stem cell clinics they founded. 588, 566 (2019)). Defendants may also seek en banc review of the decision from the full Ninth Circuit. Robbins , 519 U.S. 452 (1997); see also Kisor v. Wilkie , 588 U.S. to be regulated solely under section 361 of the PHSA.

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Perficient: Drug Development

JULY 24, 2023

SDK Visual Studio 2019/2022 Docker for Windows, with Windows Containers enabled Hyper-v After cloning a SitecoreHeadlessStarterKit repository in my local machine, the next step was to spin a Docker instance. Before running the first command, make sure that the Sitecore license is placed in the correct folder on your local machine.

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The Pharma Data

DECEMBER 21, 2020

from the University of New Hampshire in Durham, and colleagues used data from the Current Population Survey (2010 to 2019) to document the rate of nursing and long-term care workers who hold second jobs. percent of licensed practical nurses and registered nurses held second jobs. Baughman, Ph.D.,

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The Pharma Data

NOVEMBER 23, 2020

. The Company previously presented its plan of compliance to the NYSE American on December 19, 2019 in response to a notice dated November 25, 2019 that the Company was below compliance with certain NYSE American continued listing standards, as set forth in Section 1003(a)(iii) of the NYSE American Company Guide, since it reported (..)

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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

NOVEMBER 29, 2020

2019, 62 , 445?447. On October 28, 2019 , Ascentage Pharma was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 6855.HK. Targeted Degradation of MDM2 as a New Approach to Improve the Efficacy of MDM2-p53 Inhibitors. About Ascentage Pharma. Ascentage Pharma (6855.HK)

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The Pharma Data

DECEMBER 21, 2020

The FDA granted cilta-cel Breakthrough Therapy and Orphan Drug designations in 2019, and the therapy received a PRIME Priority Medicines designation from the European Commission (EC) that same year and an Orphan Drug designation from the EC in February 2020.

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The Pharma Data

JANUARY 18, 2021

In total, there were 31 mostly virtual expert panel meetings in 2020, but more than a dozen of those did not involve votes on New Drug Applications (NDAs), Biologics License Applications (BLAs) or new indications, but instead focused on devices, tobacco or other topics. 9, 2020 ).

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The Pharma Data

DECEMBER 9, 2020

Under its ongoing collaboration and license agreement, Crescendo’s proprietary transgenic platform and engineering expertise is being used to build Humabody ® -based therapeutics against certain targets selected by Takeda. This is the sixth technical milestone achieved by Crescendo in its collaboration with Takeda.

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DrugBank

OCTOBER 4, 2024

This involves assessing the strength and breadth of patents, evaluating the potential for future patent challenges, and analyzing the value derived from licensing agreements and royalty streams.

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The Pharma Data

JANUARY 14, 2021

Before today’s announcement, physicians wishing to prescribe buprenorphine outside of opioid treatment programs had to take an eight-hour course and often waited 60 to 90 days to receive the waiver once the course is completed and the license application is submitted. Added Dr. Rosenberg, “This is a great day for our patients.

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The Pharma Data

NOVEMBER 8, 2020

The Series B financing will be mainly used to conduct global clinical trials, research and development, and product in-licensing activities. Focused on healthcare, deep tech and new digital economy, VVC has been named “ China’s TOP 20 Healthcare VC firms of 2019-2020″ by 36Kr. View original content: [link].

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The Pharma Data

MARCH 15, 2022

The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the supplemental Biologics License Application (sBLA) for Fasenra (benralizumab) for patients with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). Fasenra was developed by AstraZeneca and is in-licensed from BioWa, Inc.,

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The Pharma Data

AUGUST 6, 2020

Otezla® Divestiture) occurred on January 1, 2019 and exclude foreign currency hedge gains and losses. All comparisons are made versus the same period in 2019 unless otherwise stated. The increase was driven primarily by the impact of the Celgene Acquisition, which was completed on November 20, 2019. Second Quarter. . .

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The Pharma Data

JANUARY 17, 2021

. “Rolontis,” a treatment for neutropenia that had its technology licensed out to Spectrum Pharmaceuticals, Inc. and “Oraxol,” which was licensed out to Athenex, Inc. Belvarafenib (HM95573, solid tumor) , which was licensed to Genentech, Inc., Hanmi Pharmaceutical Co.,

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Perficient: Drug Development

AUGUST 14, 2023

SDK Visual Studio 2019 & above Docker for Windows (Please refer to this blog for Sitecore Containers ) PowerShell 5.1 You can follow the steps mentioned in Walkthrough: Using the Getting Started template to set up the project solution. Before installing the template, you have installed the below prerequisites,NET Core 3.1

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The Pharma Data

NOVEMBER 30, 2020

I n-licensing of four clinical-stage product candidates to treat orphan neurological disorders. Sofinnova Partners seed-financed Noema in 2019. Sofinnova Partners seed-financed Noema in 2019. A 2019 seed investment from Sofinnova Partners formed Noema. BASEL, Switzerland, Dec.

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The Pharma Data

JANUARY 25, 2021

Ambulero holds an exclusive license from the University of Miami to develop and commercialize research from the laboratories of Drs. The company is a 2019 spin-out of the University of Miami co-founded by Robert L. As part of the investment, Ambulero and Orphinic formed a Polish subsidiary (Ambulero Sp. Velazquez and Jun Zhao-Liu.

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The Pharma Data

OCTOBER 20, 2020

We look forward to successful commercialization and licensing of TLC’s programs across the globe under Mr. Bliss’s leadership, as well as to creating benefit and bringing value for all of TLC’s stakeholders.”. Securities and Exchange Commission. Actual results may differ materially from these forward-looking statements.

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The Pharma Data

NOVEMBER 23, 2020

His most recent position was at Amgen as Director Global Business Development – Transactions, a position he assumed in August 2019 following the acquisition of Nuevolution, a Danish small molecule development company, at which he led the commercial and business activities as Chief Business Officer.

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Agency IQ

JULY 26, 2024

The guidance “is intended to inform prospective and current applicants of the nature and type of information that applicants should provide in support of manufacturing changes to licensed biosimilars and licensed interchangeable biosimilars in different reporting categories.”

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The Pharma Data

JANUARY 25, 2021

26, 2021 /PRNewswire/ — Asieris Pharmaceuticals announced today that the company has entered into a license agreement with Photocure ASA (Photocure, PHO: OSE) to exclusively register and commercialize Hexvix® in Mainland China and Taiwan. SHANGHAI , Jan.

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The Pharma Data

FEBRUARY 22, 2021

Under the terms of the settlement agreements, AbbVie and Medytox will release all claims against Evolus related to the alleged misappropriation of Medytox’s trade secrets and grant a license to Evolus to continue to commercialize Jeuveau® in the United States and Nuceiva in all other territories in which Evolus has licensing rights.

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The Pharma Data

AUGUST 6, 2020

AstraZeneca reached a licensing deal with Chinese firm BioKangtai to help provide its adenovirus vector-based COVID-19 vaccine candidate, created by the University of Oxford, to China, AstraZeneca said (Chinese) in a social media post on Thursday. That has changed. The vaccine was moved into phase 2/3 in May.

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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. Through a 2019 deal, Innovent also licensed China rights to Lilly’s dual GLP-1 and GCGR agonist OXM3 as a potential diabetes therapy.

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The Pharma Data

DECEMBER 13, 2020

MacroGenics , based in Rockville, Maryland, has a target action date of December 18 for its Biologics License Application (BLA) for margetuximab in combination with chemotherapy for patients with metastatic HER2+ breast cancer. Read on for this week’s. MacroGenics’ Margetuximab for Metastatic HER2+ Breast Cancer.

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The Pharma Data

OCTOBER 22, 2020

The collaboration will make trusted, public health information available under the Creative Commons Attribution-ShareAlike license at a time when countries face continuing resurgences of COVID-19 and social stability increasingly depends on the public’s shared understanding of the facts. . About the World Health Organization.

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The Pharma Data

DECEMBER 21, 2020

UBX1325 is developed from BM-962, a Bcl-xL inhibiting compound licensed to UNITY by Ascentage Pharma for the treatment of age-related diseases. This progress in clinical development qualifies Ascentage Pharma for a milestone payment according to the terms of the licensing agreement. SUZHOU, China and ROCKVILLE, Md. ,

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The Pharma Data

OCTOBER 29, 2020

million , a 26 percent increase compared to the same period in 2019. Non-GAAP diluted EPS for the third quarter of 2020 was $3.24 , a 16 percent increase versus the third quarter of 2019. million in the third quarter of 2019. million in the third quarter of 2019, representing a 5 percent increase. in the prior year.

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New Drug Approvals

DECEMBER 19, 2022

World Health Organization (2019). Further reading Liu X, Gong Y (2019). . | twitter +919321316780 call whatsaapp EMAIL. Retrieved 2 December 2022 – via PR Newswire. “International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 82” WHO Drug Information. hdl : 10665/330879.

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The Pharma Data

MARCH 16, 2021

In partnering with the Lieber Institute, Boehringer Ingelheim has in-licensed preclinical pipeline candidates, representing a first-in-class approach for targets in neuropsychiatric disorders. In 2019, Boehringer Ingelheim achieved net sales of 19 billion euros. Our significant investment of almost 3.5

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