New Drug Approvals

JULY 25, 2025

2] [3] Vamorolone is a novel and fully synthetic glucocorticoid developed by Santhera Pharmaceuticals. 10] Society and culture Legal status Santhera Pharmaceuticals signed an agreement with Catalyst Pharmaceuticals for the North American commercialization of vamorolone in July 2023. [20] Santhera Pharmaceuticals Holding AG.

FDA

New Drug Approvals

APRIL 25, 2025

3] Names Inavolisib is the international nonproprietary name. [22] “An Overview of Bioactive 1,3-Oxazole-Containing Alkaloids from Marine Organisms” Pharmaceuticals. “International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 84” WHO Drug Information. PMC 8706051.

FDA

DrugBank

JUNE 18, 2025

While these regulations protect public health, they also introduce significant challenges for pharmaceutical researchers. This means pharmaceutical companies must remain vigilant and adaptable to comply with evolving regulations. One of the most significant challenges in drug development is global regulatory variability.

Drug Development

New Drug Approvals

JUNE 29, 2025

The resulting mixture was stirred at an internal temperature of about 65° C. was further added thereto, and then the resulting mixture was stirred at an internal temperature of 79° C. was added dropwise at an internal temperature of 22° C. The resulting mixture was stirred at an internal temperature of 19° C. for 4 hours.

International

Drug Target Review

MARCH 17, 2025

Advancing drug candidates across key therapeutic areas Dr John Donello brings over 25 years of experience in pharmaceutical drug discovery, development and collaborations. With over 25 years of experience in the pharmaceutical industry, Donello has been instrumental in drug discovery and development.

Treatment

The Pharma Data

JULY 2, 2025

Ziihera is being jointly developed by Jazz Pharmaceuticals and BeOne Medicines Ltd. under license from Zymeworks Inc. , This binding promotes internalization and degradation of HER2 receptors on the cancer cell surface. Further approval in these regions also depends on the confirmatory Phase 3 HERIZON-BTC-302 trial. In the U.S.,

Therapies

New Drug Approvals

APRIL 11, 2025

2] [3] Names Fitusiran is the international nonproprietary name. [4] “International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 75” WHO Drug Information. The FDA granted the approval of Qfitlia to Sanofi. 4] Fitusiran is sold under the brand name Qfitlia. [1] 28 March 2025.

Clinical Trials

New Drug Approvals

APRIL 2, 2025

1] [2] It was developed by Vertex Pharmaceuticals , [5] and was approved for medical use in the United States in January 2025. [2] The FDA granted approval of Journavx to Vertex Pharmaceuticals Incorporated. 2] [11] In January 2025, the FDA granted approval of Journavx to Vertex Pharmaceuticals. [2] under nitrogen. 30 July 2024.

FDA

New Drug Approvals

JULY 10, 2025

4] Names Sebetralstat is the international nonproprietary name. [5] Retrieved 9 July 2025. ^ “KalVista Pharmaceuticals Announces FDA Approval of Ekterly (sebetralstat), First and Only Oral On-demand Treatment for Hereditary Angioedema” (Press release). . ^ “Sebetralstat Orphan Drug Designations and Approvals” U.S.

FDA

SugarCone Biotech

JULY 6, 2025

Finally, while there are clear front runners among the pharmaceutical companies developing targeted therapeutics for these antigens there are also emerging biotechs aggressively pursuing these targets. Each target and each therapeutic modality induces varying degrees of clinical efficacy, as well as causing toxicities.

Drug Development

New Drug Approvals

JUNE 15, 2025

“International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 80” WHO Drug Information. . ^ “EU/3/22/2650: Orphan designation for the treatment of myasthenia gravis” European Medicines Agency. 15 September 2023. Archived from the original on 29 January 2023. hdl : 10665/330907.

FDA

New Drug Approvals

MAY 15, 2025

“International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 76” WHO Drug Information. “International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 77” WHO Drug Information. Retrieved 20 June 2023. World Health Organization (2016).

FDA Approval

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., kg, 1 eq.)

FDA

Drug Patent Watch

DECEMBER 18, 2024

As a business professional in the pharmaceutical industry, understanding and implementing effective strategies for drug patent prosecution can be the difference between market domination and missed opportunities. Dr. Jane Smith, a patent attorney specializing in pharmaceuticals, advises: “File early and file often. billion[1].

Pharmaceuticals

New Drug Approvals

APRIL 19, 2025

0004]The synthesis of Landiolol 1 is disclosed in US 5013734 , JP 3302647 , CN 100506814 , JP 2539734 and Chemical & Pharmaceutical Bulletin 1992, 40 (6) 1462-1469. “Development of a highly cardioselective ultra short-acting beta-blocker, ONO-1101” Chemical & Pharmaceutical Bulletin. June 1992). 40 (6): 14629.

FDA

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. I am proud to retire at a time when Incyte has the strongest management team, internal R&D pipeline and commercial portfolio ever.”

Therapies

Drug Patent Watch

JANUARY 8, 2025

Drug patents are a form of intellectual property protection that grants pharmaceutical companies exclusive rights to manufacture, sell, and profit from their innovations for a set period. Types of Patents in the Pharmaceutical Industry Not all patents are created equal.

Pharmaceutical Companies

The Pharma Data

JULY 2, 2025

Genmab Announces Leadership Transition as Chief Legal Officer Birgitte Stephensen Retires, Greg Mueller Appointed Successor Genmab A/S (Nasdaq: GMAB), a leading international biotechnology company focused on antibody-based therapeutics for cancer and other serious diseases, today announced a major leadership transition within its executive team.

Compliance

Drug Channels

APRIL 15, 2025

In todays fast-moving pharmaceutical marketplace, insight is everything. Whether you're building trust with customers, launching new products, or guiding internal teams, understanding the economic forces that shape drug distribution, reimbursement, and pricing is essential. Sorry, individual licenses are not currently available.)

Specialty Pharmacies

Drug Patent Watch

OCTOBER 12, 2021

International License Abstract Development of generic drug product…. The post Development of Generic Drug Products by Pharmaceutical Industries Considering Regulatory Aspects: A Review appeared first on DrugPatentWatch - Make Better Decisions. This paper was originally published by Md.

Production

Drug Channels

OCTOBER 5, 2021

I am pleased to announce our new 2021–22 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors , available for purchase and immediate download. pharmaceutical distribution industry. There are loads of internal hyperlinks to help you navigate the document and customize it to your specific interests and priorities.

Pharmaceuticals

Drug Channels

OCTOBER 11, 2022

I am pleased to announce our new 2022–23 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors , available for purchase and immediate download. pharmaceutical distribution industry. examines how the Inflation Reduction Act could ultimately impact pharmaceutical wholesalers’ customers and business outlook.

Pharmaceuticals

Drug Patent Watch

JULY 13, 2020

Mudawi in the Journal of Pharmaceutical Research International under the terms of the Creative Commons Attribution License.…. This article was originally published by Mohammed M. Alshehri and Mahmoud M. The post Common Drugs with Effective Off-Label Uses appeared first on DrugPatentWatch - Make Better Decisions.

Licensing

FDA Law Blog: Biosimilars

JANUARY 11, 2024

(HPM) Directors, Karla Palmer and Dara Levy , will present at the Puerto Rico Pharmaceutical Summit 2024, February 6, 2024, at the La Concha Renaissance San Juan Resort in San Juan, Puerto Rico.

Pharmaceuticals

The Pharma Data

JANUARY 21, 2021

–( BUSINESS WIRE )– Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced an oral presentation on updated efficacy, safety, and dosing management of poziotinib from Cohorts 1 and 2 of the ZENITH20 clinical trial. About Spectrum Pharmaceuticals, Inc.

Pharmaceuticals

Drug Channels

MARCH 15, 2022

Licenses for our DCI reports are regularly purchased by nearly every company involved in the drug channel: pharmaceutical manufacturers, wholesalers, pharmacists, pharmacy owners, hospitals, buyers, benefit managers, managed care executives, policy analysts, investors, consultants, and more.

Pharmacy

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. 1 Kratz et al.,

Licensing

The Pharma Data

JANUARY 3, 2021

03, 2021 (GLOBE NEWSWIRE) — EyePoint Pharmaceuticals, Inc. NASDAQ: EYPT), a pharmaceutical company committed to developing and commercializing innovative ophthalmic products, today announced that Ocumension Therapeutics, a China-based ophthalmic pharmaceutical company traded on the Stock Exchange of Hong Kong (1477.HK),

Pharmaceuticals

The Pharma Data

AUGUST 17, 2020

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products and the definitive agreement with Dragonfly (the “Definitive Agreement”).

Licensing

FDA Law Blog: Biosimilars

JUNE 17, 2024

Claud — FDA’s Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER) is charged with assuring that drugs marketed in the U.S. Last week, OPQ released its 6th Annual Report on the State of Pharmaceutical Quality. By Kalie E. Richardson & John W.M. Measured in raw numbers, the U.S.

Pharmaceuticals

The Pharma Data

JANUARY 27, 2021

28, 2021 /PRNewswire/ — CASI Pharmaceuticals (Formerly Known As EntreMed, Inc.). technology platform simultaneously identifies both targets and the antibodies that bind to them, generating many promising new drug candidates to fuel the Company’s own clinical development pipeline or for additional licensing and partnering.

Pharmaceuticals

The Pharma Data

OCTOBER 19, 2020

20, 2020 /PRNewswire/ — CNS PHARMACEUTICALS AG , Inc. manufacturer, Pharmaceutics International, Inc. (“Pii”), has completed the manufacturing process for Berubicin Drug Product, its lead drug candidate for the treatment of glioblastoma multiforme (GBM), an aggressive form of brain cancer currently considered incurable.

Clinical Trials

The Pharma Data

OCTOBER 14, 2020

15, 2020 (GLOBE NEWSWIRE) — Eloxx Pharmaceuticals, Inc. International Dial-in Number: (210) 874-7715. About Eloxx Pharmaceuticals. Eloxx Pharmaceuticals, Inc. SOURCE: Eloxx Pharmaceuticals, Inc. WALTHAM, Mass., Domestic Dial-in Number : (866) 913-8546. Conference ID : 9467336. Source link.

Pharmaceuticals

Policy Prescription

OCTOBER 3, 2023

That’s why, according to Salant, drug companies “[blur] the distinction between dangerous counterfeit drugs and safe drugs sold by pharmacies licensed in other high-income countries.” The theory covers four “stylized facts” of the international market in prescription drugs. First, drug prices in the U.S.

Pharmacy

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). NURTEC is a trademark of Biohaven Pharmaceutical Ireland DAC. About CGRP.

Small Molecule

New Drug Approvals

DECEMBER 24, 2023

1] It was developed to treat hereditary transthyretin amyloidosis by Ionis Pharmaceuticals and AstraZeneca. [2] 1] Society and culture Names Eplontersen is the international nonproprietary name. [9] Ionis Pharmaceuticals. 1] It is a transthyretin-directed antisense oligonucleotide. [1] twitter +919321316780 call whatsaapp EMAIL.

Clinical Trials

DrugBank

MARCH 22, 2024

Due to open source data’s accessibility, it is an appealing resource for drug research as it often enables cost-effective sources for emerging pharmaceutical companies and academic research projects.  Paid Knowledge Bases Paying for access or licensing a knowledge base can be a difficult decision to make.

Licensing