New Drug Approvals

APRIL 25, 2025

8] Therefore, it may serve as a new addition to combination therapy with conventional cancer treatment, such as chemotherapy. Combining inavolisib with palbociclib and fulvestrant might improve treatment of breast cancer. [14] 2] [3] It is an inhibitor and degrader of mutant phosphatidylinositol 3-kinase (PI3K) alpha. [4] Hz, 1H), 5.02-4.89

FDA 57

FDA FDA Approval Therapies Trials 57

New Drug Approvals

JUNE 8, 2025

link] Ibuzatrelvir (1) was recently disclosed and patented by Pfizer for the treatment of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). It has received fast-track status from the USA Food and Drug Administration (FDA) and has entered phase III clinical trials as a possible replacement for Paxlovid. 2021-12-16. [2].

Metabolic Stability 62

Metabolic Stability Treatment Clinical Trials Drugs 62

New Drug Approvals

JUNE 15, 2025

Its sodium salt is used for the treatment of generalised myasthenia gravis (a disease that leads to muscle weakness and tiredness) in adults whose immune system produces antibodies against acetylcholine receptors. Retrieved 24 June 2021. 6] [9] [10] It is a complement inhibitor that is injected subcutaneously (under the skin). [6]

FDA 57

FDA Treatment Clinical Trials Production 57

New Drug Approvals

JULY 14, 2025

The mode of action of NYX-2925 seems to be distinct from that of all existing and emerging drugs that are indicated for the treatment of neuropathic pain. NYX-2925 is under investigation in clinical trial NCT04146896 (Efficacy and Safety of NYX-2925 in Subjects With Neuropathic Pain Associated With Diabetic Peripheral Neuropathy (DPN)).

Disease 62

Disease Clinical Trials Trials Treatment 62

New Drug Approvals

JUNE 29, 2025

Medical uses Taletrectinib is indicated for the treatment of adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer. [1] Medical uses Taletrectinib is indicated for the treatment of adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer. [1] World Health Organization (2021).

International 62

International FDA Clinical Trials Treatment 62

The Pharma Data

JUNE 13, 2025

Turning growing demand into a sustainable enterprise While there’s a growing market opportunity for mRNA vaccines and therapeutics — ranging from vaccines against seasonal flu and human papillomavirus (HPV) to innovative treatments for cancer — structural barriers remain. mRNA Technology Transfer Programme Moves Into Phase 2.0,

Vaccine 40

Vaccine Production Clinical Trials Science 40

New Drug Approvals

MAY 8, 2025

1] [11] In December 2023, the US Food and Drug Administration (FDA) expanded the indication for pirtobrutinib to include the treatment of adults with chronic lymphocytic leukemia or small lymphocytic leukemia. [7] 7] [12] In the European Union, pirtobrutinib is indicated for the treatment of mantle cell lymphoma. [2] 27 January 2023.

FDA Approval 52

FDA Approval FDA Therapies Trials 52

New Drug Approvals

JUNE 28, 2025

2] [5] [6] Clinical trials In September 2023, the drug’s developer, Sorrento Therapeutics, announced top-line data that olgotrelvir had met its primary endpoints in a phase III clinical trial that enrolled 1,212 patients with mild or moderate COVID-19. Berdowska I, Matusiewicz M (October 2021). mmol) at 0° C. 2023.12.004.

Clinical Trials 57

Clinical Trials Production Treatment Trials 57

New Drug Approvals

APRIL 18, 2025

Formula C 27 H 29 Cl 2 FN 2 OS Crinecerfont , sold under the brand name Crenessity , is a medication used for the treatment of congenital adrenal hyperplasia. [1] 2] In the first trial, 122 adults received crinecerfont twice daily and 60 received placebo twice daily for 24 weeks. [2] 321839-75-2 Molecular Weight 519.50 1 December 2024.

FDA 62

FDA FDA Approval Drugs Trials 62

New Drug Approvals

APRIL 19, 2025

This has a positive impact on the treatment of patients when reduction of heart rate without decrease in arterial blood pressure is desired. [9] Treatment of phenol 143 with bromo epoxide 144 in the present of K2CO3 afforded ether 145 in 76% yield. 9] It is used as landiolol hydrochloride. IV -Blocker max.

FDA 62

FDA Clinical Trials Treatment Trials 62

BioPharma Drive: Drug Pricing

JUNE 26, 2025

Progress developing a treatment for leukemia led the company in 2021 to price a $177 million initial public offering. Data from that trial is expected in 2027. “I I am absolutely thrilled to be leading Vor Bio as we transform the company to become a major player in autoimmune disease treatment,” Kress said in a statement.

Disease 109

Disease Licensing Licensing Therapies 109

Codon

NOVEMBER 1, 2024

Amodei also imagines the ways AI could accelerate biological research and yield miraculous cures in the 21st century; everything from the prevention and treatment of nearly all infectious and inherited diseases to the elimination of most cancers. Human constraints also play a role at a later stage, when clinical trials are involved.”

DNA 132

DNA RNA Molecular Biology Laboratories 132

PPD

APRIL 14, 2025

Initially approved for treatment of Type 2 diabetes and later for obesity studies in GLP-1 are now expanding in other indications such as obstructive sleep apnea (OSA), heart failure with preserved ejection fraction (HFpEF) and chronic kidney disease (CKD).

Clinical Trials 52

Clinical Trials Trials Clinical Development Disease 52

BioPharma Drive: Drug Pricing

JULY 2, 2025

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from Dive Brief Organon drug for endometriosis falls short in mid-stage study Company executives had seen the drug as a potential multi-billion dollar opportunity in women’s health.

Clinical Trials 240

Clinical Trials Drugs Therapies Licensing 240

BioPharma Drive: Drug Pricing

JULY 9, 2025

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from Merck to buy Verona and its lung drug in $10B deal The New Jersey-based pharma has inked one of the biggest deals of the year in pursuit of a promising new way to treat COPD.

Clinical Trials 277

Clinical Trials Drugs Therapies Licensing 277

Drug Patent Watch

JANUARY 7, 2025

As healthcare professionals, it’s our responsibility to educate patients about generic drugs and empower them to make informed decisions about their treatment options. Trial Periods Offer patients a trial period with the generic drug, assuring them that they can switch back to the brand-name medication if they experience any issues.

Drugs 71

Drugs FDA Doctors Trials 71

The Pharma Data

JULY 3, 2025

The EIC Accelerator Programme is part of the broader Horizon Europe 2021–2027 Research and Innovation framework, which provides non-dilutive and equity funding to breakthrough, high-risk innovations with global market potential. CroíValve’s DUO™ System presents a novel approach to TR treatment. CroíValve Awarded €12.5M

Clinical Trials 40

Clinical Trials Treatment Therapies Clinical Development 40

New Drug Approvals

JULY 21, 2025

Hetrombopag olamine (6), an oral nonpeptide thrombopoietin receptor (TpoR)agonistdevelopedby JiangsuHengruiPharmaceutical, was approved in China in June2021 for treatment of adult patients with chronic primary immune thrombocytopenia (ITP) and severe aplastic anemiawhohave not responded well to other treatments.46Hetrombopag,

Small Molecule 62

Small Molecule International Production Treatment 62

New Drug Approvals

JULY 18, 2025

3] It was discovered for the treatment of hepatitis C [4] and has since been investigated for use against other viral diseases such as AIDS and COVID-19 , [2] [5] for which it was granted conditional approval in China. [6] It was approved in China in 2021 as a first-in-class treatment for human immunodeficiency virus (HIV).

RNA 62

RNA Clinical Trials Trials Virus 62

National Institute on Drug Abuse: Nora's Blog

MARCH 6, 2025

Advancing reduction of drug use as an endpoint in addiction treatment trials astewart Thu, 03/06/2025 - 09:59 Nora's Blog March 18, 2025 Image Getty Images/ SolStock This blog was also published in the American Society of Addiction Medicine (ASAM) Weekly on March 18, 2025.&

Treatment 69

Treatment Trials Clinical Trials Drugs 69

Drug Target Review

JULY 4, 2023

These therapies have broadened treatment options for patients to expand beyond the more traditional small molecule drug alternatives. ADCs have the potential to redress the poor balance between safety and efficacy seen with traditional cancer treatment options. 3D rendering of Antibody Drug Conjugate Molecules.

Small Molecule 145

Small Molecule Drugs Clinical Pharmacology Trials 145

The Pharma Data

MAY 17, 2021

The agency noted that master protocols can save drugmakers time and money in study startup and can accelerate drug development by evaluating multiple drugs at the same time and maximizing the amount of information gained during research, compared to stand-alone trials.

FDA 52

FDA Trials Therapies Treatment 52

The Pharma Data

AUGUST 1, 2021

to $6.14; Raises 2021 Adjusted Diluted EPS Guidance Range from $12.37 Based upon the momentum of our business, we are raising our full year 2021 EPS guidance and believe AbbVie is very well positioned for the long term.” ” Second-Quarter Results. Worldwide net revenues were $13.959 billion, an increase of 33.9

FDA 52

FDA Treatment Trials Disease 52

The Pharma Data

APRIL 7, 2021

today announced new data from its expansive neuroscience portfolio will be presented at the 2021 American Academy of Neurology (AAN) Annual Meeting, to be held virtually from April 17-22. . Key AbbVie abstracts and presentation details for the 2021 AAN Annual Meeting program are outlined below. Clinical Trials Plenary Session.

Clinical Trials 52

Clinical Trials Treatment Trials Disease 52

The Pharma Data

MARCH 11, 2021

Eli Lilly and Company (NYSE: LLY) today announced that data from programs across its oncology portfolio and pipeline will be presented at the 2021 American Association for Cancer Research (AACR) Annual Meeting, to be held virtually April 10-15, 2021. LY3484356, an oral SERD, is currently being studied in a Phase 1/2 clinical trial.

Research 52

Research Clinical Trials Trials FDA Approval 52

FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.

Therapies 119

Therapies FDA FDA Approval Treatment 119

The Pharma Data

MARCH 20, 2021

Precision imaging analytics technology known as radiomics will see increased adoption in 2021 and will be incorporated into drug development strategies and clinical trials management, according to Rose Higgins, CEO of HealthMyne. Source link: [link].

Clinical Trials 52

Clinical Trials Drug Development Trials Drugs 52

The Pharma Data

SEPTEMBER 29, 2021

Presentations: 535P, 536P, 534P, 104P, 1534P, 444P, 630P, LBA26, 623P, 603P, 593P, 594P, 1309P, 606P, 590P, 826O, 530P, LBA58, 1520O, 48P, 508TiP, 505TiP, 509TiP, 1438TiP Bayer will present new data from its established portfolio of approved oncology therapies at the upcoming ESMO Congress 2021 from September 16-21, 2021.

Research 52

Research Clinical Trials Therapies Trials 52

The Pharma Data

JULY 23, 2021

(Nasdaq: BIIB) today announced it will share multiple oral and poster presentations from its Alzheimer’s disease clinical development portfolio at the Alzheimer’s Association International Conference (AAIC), which will be held in Denver, Colorado and online July 26-30, 2021. ADUHELM is indicated for the treatment of Alzheimer’s disease.

International 52

International Disease Clinical Trials Trials 52

The Pharma Data

JULY 12, 2021

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the presentation of data from the company’s HIV clinical development program at the 11th International AIDS Society Conference on HIV Science (IAS 2021) from July 18-21. Week 96 Metabolic and Bone Outcomes of a Phase 2b Trial of Islatravir and Doravirine.

Pharmacokinetics 52

Pharmacokinetics Clinical Trials Trials Treatment 52

The Premier Consulting Blog

OCTOBER 21, 2024

However, accelerated approval comes with a condition: sponsors must conduct confirmatory trials to verify the drug’s anticipated clinical benefits using robust outcome measures. Concerns have arisen over delays—sometimes spanning over 7–8 years—that may expose patients to risks before confirmatory trials are completed.

Trials 52

Trials FDA Clinical Trials Disease 52

The Pharma Data

APRIL 8, 2021

today announced that new data for its approved and investigational medicines for the treatment of neurological disorders will be presented at the 73rd American Academy of Neurology (AAN) Annual Meeting being held virtually April 17-22, 2021. Multiple Sclerosis (MS). Neuromyelitis Optica Spectrum Disorder (NMOSD).

Clinical Trials 52

Clinical Trials Trials Disease Therapies 52

The Pharma Data

AUGUST 27, 2020

Moderna has announced that its coronavirus vaccine candidate has shown promise in generating an immune response in elderly patients in an early-stage clinical trial. . The company has already tested the treatment on 10 adults between the ages of 56-70, and 10 over 71. The company is set to charge between $32 and $37 per dose.

Vaccine 90

Vaccine Immune Response Clinical Trials Virus 90

The Pharma Data

JANUARY 25, 2021

Regeneron’s monoclonal antibody cocktail reduced medical visits for COVID-19 patients who had not been hospitalized by almost 50 percent, according to interim clinical trial results reported by researchers at the company.

Immune Response 52

Immune Response Treatment Clinical Trials Hospitals 52

The Pharma Data

JANUARY 17, 2021

18, 2021 /PRNewswire/ — Aruvant Sciences, a private company focused on developing gene therapies for rare diseases, and Lonza announced today their agreement in support of ARU-1801, Aruvant’s one-time investigational gene therapy for sickle cell disease (SCD). NEW YORK , Jan.

Disease 52

Disease Trials Treatment Clinical Trials 52

The Pharma Data

MARCH 8, 2021

These preliminary findings were presented today during Science Spotlights TM at the 2021 Conference on Retroviruses and Opportunistic Infections (CROI 2021). At a time where there is unmet need for antiviral treatments against SARS-CoV-2, we are encouraged by these preliminary data.”.

Trials 69

Trials Virus RNA Research Laboratories 69

Drug Target Review

SEPTEMBER 21, 2023

The findings supported the possibility put forward by Cotton et al (2016) concerning the chance of repurposing these drugs for adulticidal treatment. The available treatment for that is minor surgery -to remove the nodules. With accessible and effective treatments, this is feasible. doi: 10.1002/14651858.CD011146.pub2.

Drugs 106

Drugs Treatment Disease Research 106