New Drug Approvals

JULY 8, 2025

US FDA granted fast track designation for pritelivir in 2017 and breakthrough therapy designation 2020. Salt Formation: The pritelivir free base is then reacted with methanesulfonic acid to form the mesylate salt, which is the active pharmaceutical ingredient (API). 2018 Oct 23;9:2483. Bibcode : 1989PNAS…86.2186C.

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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. Retrieved 11 September 2018.

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BioPharma Drive: Drug Pricing

JULY 16, 2025

Daily Dive M-F Commercialization Weekly Every Wednesday Gene Therapy Weekly Every Thursday Emerging Biotech Weekly Every Tuesday By signing up to receive our newsletter, you agree to our Terms of Use and Privacy Policy. You can unsubscribe at anytime. The Food and Drug Administration’s clearance was controversial.

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PPD

APRIL 14, 2025

Medical researchers and practitioners see in their own patients how these ailments interconnect and overlap, as do the pharmaceutical and biotech companies working to develop GLP-1 therapeutics. This expansion is creating opportunities for clinical trials related to a range of new therapy areas and their subpopulations.

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BioPharma Drive: Drug Pricing

JUNE 26, 2025

Daily Dive M-F Commercialization Weekly Every Wednesday Gene Therapy Weekly Every Thursday Emerging Biotech Weekly Every Tuesday By signing up to receive our newsletter, you agree to our Terms of Use and Privacy Policy. However, it flamed out in testing in 2018 and Incyte was forced to pivot research toward other candidates.

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DrugBank

OCTOBER 4, 2024

Deal Structuring Deal structuring in pharmaceutical M&A requires a balance of financial, legal, and strategic considerations. Intellectual Property Valuation Valuing intellectual property (IP) assets is a critical component of pharmaceutical M&A, as these assets often represent a significant portion of a company's value.

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Pharmaceuticals Pharmaceutical Companies Therapies Marketing 98

BioPharma Drive: Drug Pricing

JULY 22, 2025

Daily Dive M-F Commercialization Weekly Every Wednesday Gene Therapy Weekly Every Thursday Emerging Biotech Weekly Every Tuesday By signing up to receive our newsletter, you agree to our Terms of Use and Privacy Policy. JHVE Photo via Getty Images Dive Brief: French pharmaceutical giant Sanofi said Tuesday it will pay $1.15

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Drug Target Review

JUNE 19, 2024

The mission of Lineage Cell Therapeutics is to deliver on some of the early promises of cell therapy. Cell therapy as a concept is a wonderful idea, but many of the early efforts never generated the kind of clinical data that gets people excited and leads to new medicines. In some cases, cell therapy can be curative for the patient.

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Therapies Small Molecule Pharmaceutical Companies Molecular Biology 84

Antidote

JULY 29, 2022

Between 2009 and 2018, U.S. billion to bring a new therapy to market. In 2019 alone, research and development spending totaled $186 billion for the global pharmaceutical industry. The process of getting a new drug to market is an expensive one.

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Drug Target Review

OCTOBER 11, 2023

1,2 Many, however, do have dysfunctional proteins at their core, and for these diseases, a new option is being explored: autophagy-boosting therapies. Gene therapy, of course, also holds great promise. 2018 [cited 2023 Sep 5]. Most of these conditions are genetic in origin and the majority have no effective treatment.

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The Pharma Data

NOVEMBER 1, 2020

02, 2020 (GLOBE NEWSWIRE) — Telix Pharmaceuticals Limited (ASX: TLX, ‘Telix’, the ‘Company’) announces it has entered into a strategic licence and commercial partnership with China Grand Pharmaceutical and Healthcare Holdings Limited (‘China Grand Pharma’) for Telix’s portfolio of Molecularly-Targeted Radiation (‘MTR’) products.

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Drug Target Review

OCTOBER 31, 2023

Ashley Hall, CDO of Reneo Pharmaceuticals Throughout my education I was discouraged by many around me. How did that transfer into the pharmaceutical industry? This sector of the pharmaceutical industry combined both my science and law background. Reneo has been working on this since before 2018.

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Drug Target Review

SEPTEMBER 26, 2023

Early detection of neurotoxicity induced by potential new therapies is a major challenge, and hiPSC-neuronal cells may provide a solution. 2018 Mar;17(3):167–81. 2018 Dec 11;94(10):390–411. 2018;(136):56573. Morgan P, Brown DG, Lennard S, Anderton MJ, Barrett JC, Eriksson U, et al. Nat Rev Drug Discov. 2016;81:37–46.

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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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New Drug Approvals

SEPTEMBER 8, 2024

2222514-07-8 ] Palopegteriparatide , sold under the brand name Yorvipath , is a hormone replacement therapy used for the treatment of hypoparathyroidism. [1] 5] Study drug and conventional therapy were subsequently adjusted according to the albumin-corrected serum calcium levels. [5] 48,000) consisting of 34 amino acid residues.

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FDA International Trials FDA Approval 62

The Pharma Data

JULY 15, 2021

JJIPO@Monash was originally launched in 2018 to provide crucial support to researchers and companies in the Victorian life-science sector as part of the Government’s commitment to the medical technologies and pharmaceuticals sector – one of eight priority growth sectors.

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Government Science Pharmaceuticals Pharmaceutical Companies 52

Drug Target Review

MAY 23, 2023

Therapies developed in recent decades have transformed the treatment of IBD, making hospitalisation and surgery less common. However, many patients respond poorly to corticosteroid treatment, or their immune system responds unfavourably to biological therapies, such as the development of autoimmune diseases.

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Drugs Small Molecule Production Disease 75

The Pharma Data

NOVEMBER 25, 2020

Vifor Pharma Group is a global pharmaceuticals company. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions. 12 June 2018. Last accessed: June 2018. Am J Clin Nutr.

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International Pharmaceuticals Disease Pharmaceutical Companies 52

New Drug Approvals

SEPTEMBER 13, 2024

4] [6] Aticaprant was originally developed by Eli Lilly , was under development by Cerecor for a time, and is now under development by Janssen Pharmaceuticals. [2] 19] As of 2016, aticaprant has reached phase II clinical trials as an augmentation to antidepressant therapy for treatment-resistant depression. [20] 30 January 2018.

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Treatment Clinical Trials Pharmacokinetics Pharmaceuticals 62

The Pharma Data

DECEMBER 17, 2020

Buvidal received market authorizations in EU and Australia in November 2018. Camurus’ clinical pipeline includes products for the treatment of cancer, endocrine diseases, pain and addiction, which are developed in-house and in collaboration with international pharmaceutical companies. 2018; 178(6):764-773.

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Treatment Clinical Trials International Pharmaceutical Companies 52

The Pharma Data

SEPTEMBER 9, 2020

“Andexanet alfa will give clinicians an approved therapy option and clinical strategy for the reversal of major bleeding in patients being treated with rivaroxaban and apixaban. Ondexxya was originally developed by Portola Pharmaceuticals, which was acquired by Alexion in July this year. Matt Fellows. Source link.

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The Pharma Data

DECEMBER 17, 2020

Hartfield previously served as CEO of Vitae Pharmaceuticals prior to its acquisition by Allergan. X4 Pharmaceuticals – Diego Cadavid was named chief medical officer of Boston-based X4 Pharmaceuticals. Karydas is chief financial officer at Syndax Pharmaceuticals. Previously he was CFO of Voyager Therapeutics.

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Small Molecule Clinical Development Engineering Pharmaceuticals 52

The Pharma Data

JANUARY 6, 2021

Currently, oral treatment options for plaque psoriasis are limited, and many patients with moderate-to-severe psoriasis are receiving systemic injectable therapies. UNION therapeutics A/S is a privately held, clinical stage, pharmaceutical company dedicated to the development of novel treatments for inflammatory and infectious diseases.

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DrugBank

FEBRUARY 19, 2025

The application of Artificial Intelligence (AI) in drug discovery is rapidly transforming the pharmaceutical industry, offering opportunities to accelerate the identification of novel therapeutic targets, optimize molecule design, and enhance clinical trial efficiency. billion in 2023 to $7.9

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Clinical Trials Drugs Trials Treatment 52

New Drug Approvals

SEPTEMBER 10, 2024

2] [3] It is the first approval by the US Food and Drug Administration (FDA) of a systemic therapy for people with grade 2 astrocytoma or oligodendroglioma with a susceptible isocitrate dehydrogenase-1 or isocitrate dehydrogenase-2 mutation. [2] Servier Pharmaceuticals. April 2018). mol), and potassium carbonate (0.43

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The Pharma Data

JULY 6, 2021

New research from first-in-class marketed and investigational therapies in hemophilia, immune thrombocytopenia and acquired thrombotic thrombocytopenic purpura will be presented. Sanofi’s two marketed extended half-life factor replacement therapies shifted a two-decades-old treatment paradigm when launched in 2014. ePoster.

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Therapies Pharmacokinetics Treatment RNA 52

The Pharma Data

JANUARY 21, 2021

Caggiano joins Evolve Biologics after most recently serving as CEO of Dendreon Pharmaceuticals LLC. Among his earlier leadership roles in the biotech, pharmaceutical and medical device industries, Caggiano directed the divestiture of Allergan’s LAP-BAND to Apollo Endosurgery in 2013. Abbott Laboratories and TAP Pharmaceuticals.

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Laboratories Pharmaceuticals Clinical Development Engineering 52

The Pharma Data

OCTOBER 14, 2020

15, 2020 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. President and Chief Executive Officer of Tonix Pharmaceuticals. 2018) PLoS One. About Tonix Pharmaceuticals Holding Corp. Jessica Morris (corporate) Tonix Pharmaceuticals investor.relations@tonixpharma.com (212) 688-9421.

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Vaccine Pharmaceuticals Small Molecule Virus 40

New Drug Approvals

SEPTEMBER 6, 2024

2 History Efficacy was evaluated in MARIPOSA (NCT04487080), a randomized, active-controlled, multicenter trial of 1074 participants with exon 19 deletion or exon 21 L858R substitution mutation-positive locally advanced or metastatic non-small cell lung cancer and no prior systemic therapy for advanced disease. [2] hdl : 10665/330941.

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FDA Approval FDA International Treatment 48

Common Sense for Drug Policy Blog

JUNE 6, 2024

2018 ; Llewellyn and Tober 2010; Denham 2019 ). Underground labs can be defined as illicit operations where IPEDs, most commonly anabolics androgenic steroids, are produced from these imported powders outside of registered pharmaceutical manufacture. 2017 ; Greenway and Price 2018 ). 2014 ; Begley et al. 2014 ; Begley et al.

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The Pharma Data

AUGUST 31, 2020

Detects, confirms and differentiates HIV-1 and HIV-2 infections providing clinicians with critical diagnostic data for personalised management of patients with HIV – from appropriate counseling on disease differences to targeted therapy. Centers for Disease Control and Prevention (CDC) estimated in 2018 that 1.2 Clin Infect Dis.

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FDA Approval FDA Virus Disease 52

The Pharma Data

OCTOBER 26, 2020

Kala Pharmaceuticals announced today that the U.S. As the prevalence of dry eye disease increases, there is a tremendous need for new therapies to manage mild-to-moderate dry eye disease patients, many of whom currently go untreated. Roughly 16.4 million U.S. Dean of the University of Alabama at Birmingham School of Optometry. “As

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Treatment Disease FDA FDA Approval 52

The Pharma Data

AUGUST 6, 2020

Tecentriq is approved in the US, EU and countries around the world, either alone or in combination with targeted therapies and/or chemotherapies in various forms of non-small cell and small cell lung cancer, certain types of metastatic urothelial cancer and in PD-L1-positive metastatic triple-negative breast cancer. 2] Yao H et al.

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Treatment Pharmaceuticals Disease Therapies 52

Drug Target Review

APRIL 12, 2023

Brunner continued to explain that one of the biggest changes in the pharmaceutical industry is that AI has moved over from just making data predictions to also analysing data. Norman echoed these predictions, suggesting that there will be advancements in individualised personal medicine, like gene therapy and CRISPR , on a much larger level.

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Drugs DNA Disease Science 52

The Pharma Data

SEPTEMBER 2, 2020

From the success of our first-in-class B-cell MS therapy OCREVUS, we are poised to continue advancing the science in MS with our new investigational BTK inhibitor fenebrutinib, and in NMOSD with the recent FDA approval of ENSPRYNG.”. Roche’s Chief Medical Officer and Head of Global Product Development.

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Clinical Trials Disease Treatment Therapies 52

The Pharma Data

MARCH 13, 2021

Takeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK ) (“Takeda”) today announced that it has submitted a New Drug Application (NDA) to the Ministry of Health, Labour and Welfare (MHLW) in Japan for lanadelumab subcutaneous injection, a monoclonal antibody therapy for prophylaxis against attacks of hereditary angioedema (HAE).

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The Pharma Data

DECEMBER 9, 2020

The collaboration expansion gives Takeda access to a range of Crescendo’s half-life extension Humabodies for use with its two Humabody programmes, previously licensed in November 2018 and July 2019 , and Humabody programmes Takeda licenses in the future during the term of the collaboration expansion. – Ends-.

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