New Drug Approvals

JUNE 15, 2025

24 September 2024.

FDA

New Drug Approvals

APRIL 18, 2025

World Health Organization (2019). . ^ “Neurocrine Biosciences Announces FDA Approval of Crenessity (crinecerfont), a First-in-Class Treatment for Children and Adults With Classic Congenital Adrenal Hyperplasia” (Press release). Neurocrine Biosciences. 13 December 2024. Retrieved 16 December 2024 via PR Newswire. 1 November 2022).

FDA

New Drug Approvals

APRIL 19, 2025

Archived from the original (PDF) on 16 June 2019. Yamashita T, Nakasu Y, Mizutani H, Sumitani K (2019). The synthesis of 3 in high yields starting from 15 and 19 is described in CN100506814. A further publication disclosing it is US5013734. . 42 (5): 373498. doi : 10.1093/eurheartj/ehaa612. hdl : 1887/3279676. PMID 32860505.

FDA

FDA Law Blog: Biosimilars

FEBRUARY 18, 2025

The answers below are based on my experience as a reviewer and compliance officer at FDA during the 5-week 2018/2019 government shutdown. During the 5-week shutdown in 2018/2019, PDUFA funding was the most robust and could have funded several months of review operations. What does it mean for FDA staff?

Government

BioPharma Drive: Drug Pricing

JUNE 26, 2025

Published June 26, 2025 Ned Pagliarulo Lead Editor post share post print email license An Incyte researcher works in a laboratory. On June 26, 2025, the company announced the replacement of longtime CEO Hervé Hoppenot with Bill Meury.

Therapies

Drug Patent Watch

DECEMBER 18, 2024

A 2019 survey by the World Intellectual Property Organization (WIPO) found that inadequate prior art searches were responsible for 32% of patent application rejections[2]. Be prepared to enforce your patents through licensing agreements or litigation if necessary.

Pharmaceuticals

BioPharma Drive: Drug Pricing

JUNE 21, 2024

A medicine Jazz acquired in 2019 missed the goal of a Phase 2 study. Elsewhere, Vanda rejected two takeover bids and Ashibio emerged from stealth with an antibody licensed from Gilead.

Drug Development

Drug Discovery Today

DECEMBER 17, 2019

December 10, 2019 — Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, gene therapies, and consumer health products, today announced that it has completed clinical production of Bridge Therapeutics Inc.’s Somerset, N.J. Birmingham, Ala.–

Production

The Pharma Data

JANUARY 6, 2021

a leading global provider of immuno-oncology imaging agents, today announced it has signed a new multi-year, non-exclusive license with Pfizer Inc. ImaginAb will receive license fees and payments for manufacturing and other support. LOS ANGELES , Jan. 7, 2021 /PRNewswire/ — ImaginAb Inc. , No other terms were disclosed.

Licensing

The Pharma Data

JULY 18, 2021

Food and Drug Administration (FDA) granted Priority Review designation for the Biologics License Application (BLA) for their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older. The Pfizer-BioNTech COVID-19 vaccine has not been approved or licensed by the U.S. Pfizer Inc.

Licensing

The Pharma Data

MAY 7, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older. AUTHORIZED USE IN THE U.S.:

Licensing

The Pharma Data

NOVEMBER 3, 2020

The Coalition for Epidemic Preparedness Innovations (CEPI) has agreed to fund development of a potential COVID-19 vaccine from China’s Clover Biopharmaceuticals with a global phase 2/3 study and through licensing and distribution. million for an initial trial of SCB-2019 in Australia that enrolled 150 participants. Jason Scott.

Vaccine

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.

Licensing

Perficient: Drug Development

AUGUST 2, 2023

SVS is designed to work with a command line in the background and also provides an interactive interface in Visual Studio 2019. SVS requires a license; we can utilize the same license as Sitecore TDS. If you don’t have a license, then you can purchase from the TDS site.

Packaging

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.

Licensing

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.

Small Molecule

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.,

Nurses

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 (..)

Compliance

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.,

Laboratories

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 ).

FDA

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.

Pharmaceuticals

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.

Therapies

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.

Licensing

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.

Treatment

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. 21] Phase III In December 2019, Ipsen issued a partial clinical hold for people under the age of 14, due to reports of early fusion of growth plates. [22] 22] Ipsen acquired Clementia in 2019.

FDA

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.

Therapies

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.

Vaccine

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.

Licensing

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.

Licensing

The Pharma Data

NOVEMBER 5, 2020

Collegium will grant Teva a license to market its generic version of Xtampza ER in the United States beginning on or after September 2, 2033 (subject to U.S. million for the quarter ended September 30, 2019 (the “2019 Quarter”) and $33.6 million for the 2019 Quarter and $44.5 million for the 2019 Quarter.

Pharmaceuticals

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].

Clinical Trials

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

Licensing

The Pharma Data

JUNE 24, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 years of age and older. AUTHORIZED USE IN THE U.S.:

Vaccine

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.

Licensing

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.

Licensing

The Pharma Data

MARCH 26, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older.

Vaccine

The Pharma Data

JANUARY 5, 2021

Under the terms of the Ribometrix-Genentech collaboration, Genentech is paying Ribometrix $25 million up front, gaining exclusive rights to several predefined targets as well as an exclusive global license for the development and commercialization of compounds that come out of the collaboration.

RNA