New Drug Approvals

APRIL 18, 2025

potassium hydroxide), and water to prepare 4-(2-chloro-4-methoxy-5-methylphenyl)-N-[(1S)-2-cyclopropyl-1-(3-fluoro-4-methylphenyl)ethyl]-5-methyl-N-prop-2-ynyl-1,3-thiazol-2-amine (Compound 1) or a pharmaceutically acceptable salt thereof is provided below in Scheme VII. Br), in the presence of an alkylating-step solvent (e.g.,

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BioPharma Drive: Drug Pricing

JULY 14, 2025

Published July 14, 2025 Ben Fidler Senior Editor post share post print email license Bain Capital, Kohlberg and Mubadala joined to invest in biopharmaceutical CDMO PCI Pharma on July 14, 2025. The company has 30 sites across Australia, Canada, North America, the U.K. and Europe, and, earlier this year, acquired a facility in San Diego.

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The Pharma Data

NOVEMBER 30, 2020

Biohaven acquires exclusive global rights to a portfolio of novel, small-molecule CGRP antagonists. ” Shinichi Tamura , Chairman, President and CEO of Sosei Heptares, commented: “We are delighted to enter this collaboration and license agreement with Biohaven for our portfolio of novel CGRP receptor antagonists.

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The Pharma Data

OCTOBER 27, 2021

Small molecule candidate Anle138b targets disease modification for multiple system atrophy and other neurological disorders. Teva Pharmaceutical Industries Ltd. Due to the relatively small number of affected patients and lack of effective therapy, MSA qualifies for orphan status, allowing a shorter development path.

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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. Source link: [link].

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The Premier Consulting Blog

NOVEMBER 20, 2024

Process validation is a critical regulatory requirement in pharmaceutical manufacturing. In the case of urgent or immediate public interest, process validation may be conducted concurrently with manufacturing the commercial small molecule or biologic product to expedite product availability for patients.

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The Pharma Data

JANUARY 5, 2021

Durham, North Carolina-based Ribometrix announced a strategic collaboration deal with Genentech , a Roche company, to identify and advance novel RNA-targeted small molecule therapeutics. This is because many proteins do not have small-molecule binding sites. The first identifies the 3D RNA motifs.

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The Pharma Data

JUNE 14, 2023

Cedilla’s small molecules conditionally modulate the protein complex in its functional state resulting in highly selective inhibition. Global Head of Research and Early Development for Oncology, Pharmaceuticals Division, Bayer AG. Global Head of Research and Early Development for Oncology, Pharmaceuticals Division, Bayer AG.

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The Pharma Data

OCTOBER 15, 2020

Vertex Pharmaceuticals has decided to give up on its experimental VX-814, a small molecule drug for the rare genetic disease Alpha-1 antitrypsin deficiency (AATD), canning the drug’s development after seeing lackluster results from an early phase 2 trial. James Miessler.

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The Pharma Data

OCTOBER 14, 2020

15, 2020 (GLOBE NEWSWIRE) — Eloxx Pharmaceuticals, Inc. About Eloxx Pharmaceuticals. Eloxx Pharmaceuticals, Inc. Eloxx’s lead investigational product candidate, ELX-02, is a small molecule drug candidate designed to restore production of full-length functional proteins. SOURCE: Eloxx Pharmaceuticals, Inc.

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The Pharma Data

JUNE 28, 2021

Broadens company’s oncology platform of Targeted Alpha Therapies / Acquisition includes actinium-225 labeled differentiated PSMA small molecule for the treatment of prostate cancer. Bayer today announced that it has entered into an agreement to acquire Noria Therapeutics Inc. Noria) and PSMA Therapeutics Inc.

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The Pharma Data

OCTOBER 26, 2020

27, 2020 /PRNewswire/ — Aridis Pharmaceuticals, Inc. Dr. Hasan Jafri , Chief Medical Officer of Aridis Pharmaceuticals, will be a speaker on a panel entitled “Direct Antivirals and Other Agents Against SARS-CoV2 Virus.” About Aridis Pharmaceuticals, Inc. Aridis Pharmaceuticals, Inc. SAN JOSE, Calif. ,

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The Pharma Data

MAY 7, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules.

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New Drug Approvals

JUNE 26, 2025

“Menthol derivative WS-12 selectively activates transient receptor potential melastatin-8 (TRPM8) ion channels” Pakistan Journal of Pharmaceutical Sciences. 3] It is slightly less potent as a TRPM8 activator compared to icilin , but is a much more selective TRPM8 ligand when compared to menthol. [4] 21 (4): 370–378. PMID 18930858.

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The Pharma Data

NOVEMBER 4, 2020

–( BUSINESS WIRE )– Concert Pharmaceuticals, Inc. President and Chief Executive Officer of Concert Pharmaceuticals. Concert Pharmaceuticals, Inc. License and research and development revenue. Concert Pharmaceuticals, Inc.

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The Pharma Data

OCTOBER 14, 2020

15, 2020 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. President and Chief Executive Officer of Tonix Pharmaceuticals. About Tonix Pharmaceuticals Holding Corp. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions.

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The Pharma Data

OCTOBER 18, 2020

Previously he served as President, Chief Medical Officer and Board Director of Sideris Pharmaceuticals and was also Chief Medical Officer at Vedantra Pharmaceuticals, BIND Therapeutics, Inc., Inflection Biosciences Ltd is developing small molecule therapeutics for the treatment of cancer. About Inflection Biosciences.

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The Pharma Data

AUGUST 21, 2020

Fortunately, as a member of the Novartis Business Development & Licensing (BD&L) department, she was in a position to try to help. Jennifer Leeds , Head of West Coast Search and Evaluation, NIBR Business Development & Licensing. Knowing that a pandemic was likely coming made watching the crisis unfold no less heartbreaking.

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The Pharma Data

DECEMBER 15, 2020

Small Molecule Inhibitors. NMD670 is a first-in-class small molecule inhibitor of the muscle specific chloride ion channel, the ClC-1 ion channel. Oral, Small Molecules. KAN-101 is in a randomized, double-blind, placebo-controlled Phase I study, Assessment of KAN-101 in Celiac Disease.

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The Pharma Data

JANUARY 26, 2021

Food and Drug Administration’s Office of Orphan Products Development has granted Orphan Drug Designation to Uttroside-B , a small molecule chemotherapeutic for the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer. (OTCQB: QBIO), announced today that the U.S. billion by 2027.

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The Pharma Data

FEBRUARY 24, 2022

The booster schedule is based on the labeling information of the vaccine used for the primary series EUA Statement Emergency uses of the vaccine have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in individuals 5 years of age and older.

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The Pharma Data

NOVEMBER 5, 2020

X4 Pharmaceuticals – Art Taveras was named CSO of Cambridge, Mass.-based Prior to that, Taveras was vice president of Small Molecule Drug Discovery and CMC Development at Biogen Idec, and Alantos Pharmaceuticals, which was acquired by Amgen in 2007. Most recently, Holland served as Global Head of licensing at Lonza AG.

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The Pharma Data

SEPTEMBER 12, 2020

Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. For more information, please visit www.BioNTech.de.

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The Pharma Data

MAY 6, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules.

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The Pharma Data

JANUARY 10, 2021

Development of TransCon CNP is progressing as planned with the recent initiation by VISEN Pharmaceuticals of a second phase 2 trial in patients with achondroplasia, the ACcomplisH China Trial, which provides for dose expansion at an effective dose determined from the ACcomplisH Trial. . ?. .

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The Pharma Data

DECEMBER 11, 2020

Pfizer and BioNTech expect to file a Biologics License Application for possible full regulatory approval in 2021. other regulatory submissions, the anticipated timing of regulatory submissions (including the anticipated timing of filing of a Biologics License Application in the U.S.),

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The Pharma Data

NOVEMBER 5, 2020

Merger completed with Rexahn Pharmaceuticals creating a Nasdaq-listed Biopharmaceutical Company Focused on Advancing Ocuphire’s Late-Stage Clinical Pipeline of Ophthalmic Drug Candidates. Ocuphire’s pipeline currently includes two small-molecule product candidates targeting front and back of the eye indications.

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The Pharma Data

JULY 21, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules.

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Agency IQ

JULY 26, 2024

in equipment) for products that are more complex or aren’t as well-characterized, such as antibody drug conjugates or recombinant DNA products, will be considered higher risk than they would if the change was made to the production of standard, small molecule products. Any CMC changes (e.g.,

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The Pharma Data

SEPTEMBER 9, 2020

Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. For more information, please visit www.BioNTech.de.

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The Pharma Data

SEPTEMBER 9, 2020

Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. For more information, please visit www.BioNTech.de.

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The Pharma Data

DECEMBER 12, 2020

12, 2020– AstraZeneca and Alexion Pharmaceuticals, Inc. AstraZeneca has developed a broad range of technologies, initially focused on small molecules and biologics and with a growing focus in precision medicine, genomics, oligonucleotides and epigenetics. Source: Alexion Pharmaceuticals, Inc. AstraZeneca contacts.

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New Drug Approvals

APRIL 30, 2025

“International nonproprietary names for pharmaceutical substances (INN): proposed INN: list 131” WHO Drug Information. 1] [2] Levacetylleucine is a modified version of the amino acid leucine. [1] 1] It is the L -form of acetylleucine. . ^ “Novel Drug Approvals for 2024” U.S. Food and Drug Administration (FDA).

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The Pharma Data

NOVEMBER 20, 2020

Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. For more information, please visit www.BioNTech.de.

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The Pharma Data

AUGUST 20, 2020

Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. For more information, please visit www.BioNTech.de.

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The Pharma Data

NOVEMBER 9, 2020

Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. For more information, please visit www.BioNTech.de.

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The Pharma Data

DECEMBER 1, 2020

Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. For more information, please visit www.BioNTech.de.

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