The Pharma Data

JUNE 24, 2025

The partnership represents a major financial and strategic milestone for Revolution Medicines, which has built a robust pipeline of targeted therapies aimed at cancers driven by mutations in the RAS family of genes—some of the most prevalent and historically difficult-to-drug oncogenes in human cancer.

Drug Development

BioPharma Drive: Drug Pricing

JULY 8, 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. Drugmakers are working to coopt this process with targeted therapies. Several have drugs in or near clinical testing.

Targeted Protein Degradation

Broad Institute

OCTOBER 29, 2024

New drug triggers rapid cell death in cancer models By Karen Zusi-Tran October 29, 2024 Breadcrumb Home New drug triggers rapid cell death in cancer models BRD-810 inhibits the MCL1 protein and reactivates apoptosis in tumor cells, displaying therapeutic potential in animal models. The result was the compound named BRD-810.

Drugs

BioPharma Drive: Drug Pricing

JULY 14, 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. Its drug could achieve $3 billion in peak yearly sales in narcolepsy Type 1 alone, he added.

Drugs

The Pharma Data

JUNE 6, 2025

Otsuka Unveils Promising Phase 3 Results for Sibeprenlimab in IgA Nephropathy, Marking Significant Proteinuria Reduction and Advancing a Novel APRIL-Targeted Therapy Otsuka Pharmaceutical Development & Commercialization, Inc., in those receiving placebo—further underscoring the tolerability of this investigational therapy.

Trials

Drug Target Review

APRIL 14, 2025

A deep interest in political science and the political economy of drugs led him to focus on how drugs are priced and distributed across different jurisdictions. Preventative drugs, unlike antibiotics used to treat infections, are taken proactively, which opens a broader market.

Therapies

The Pharma Data

JUNE 26, 2025

These findings point to MR-141’s potential utility as a convenient and practical therapy for real-world scenarios that challenge presbyopic individuals. Safety and Tolerability The safety profile of MR-141 in VEGA-3 was consistent with earlier clinical trials of the drug.

Trials

New Drug Approvals

MAY 17, 2025

4] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [7] gmol 1 References ^ “Register of Innovative Drugs” Health Canada. 4] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [7] Food and Drug Administration (FDA). 25 April 2023.

FDA Approval

New Drug Approvals

APRIL 25, 2025

3] Primary endocrine resistance was defined as relapse while on the first two years of adjuvant endocrine therapy (ET) and secondary endocrine resistance was defined as relapse while on adjuvant ET after at least two years or relapse within twelve months of completing adjuvant ET. [3] 3 November 2006. 3 November 2006. Retrieved 17 April 2025.

FDA

New Drug Approvals

MAY 9, 2025

Eligible participants had experienced disease progression on one or two prior lines of endocrine therapy , including one line with a CDK4/6 inhibitor , and could have received up to one prior line of chemotherapy in the advanced or metastatic setting. [2] Food and Drug Administration (FDA). 1] [4] It is taken by mouth. [1] PMC 4560273.

FDA

The Pharma Data

JUNE 24, 2025

In just three years, nine promising research projects have received funding under the program, setting the stage for innovative breakthroughs in drug discovery. Oncology remains a core priority, reflecting the rising global burden of cancer and the need for more effective, targeted therapies. Source link

Pharma R&D

New Drug Approvals

APRIL 2, 2025

2] [6] Suzetrigine is the first medication to be approved by the US Food and Drug Administration (FDA) in this new class of pain management medicines. [2] 2] [6] Suzetrigine is the first medication to be approved by the US Food and Drug Administration (FDA) in this new class of pain management medicines. [2] under nitrogen.

FDA

DrugBank

JUNE 18, 2025

Drug development is a complex and highly regulated process. Before a therapy can be approved for patient use, it must undergo extensive clinical testing and strictly adhere to regulatory guidelines. One of the most significant challenges in drug development is global regulatory variability. Regulatory agencies, such as the U.S.

Drug Development

Drug Target Review

MARCH 17, 2025

However, a deeper understanding of brain function particularly the role of synaptic plasticity is now opening the door to innovative therapies. Advancing drug candidates across key therapeutic areas Dr John Donello brings over 25 years of experience in pharmaceutical drug discovery, development and collaborations.

Treatment

The Pharma Data

JULY 2, 2025

A Groundbreaking Step in HER2-Targeted Therapy for BTC The EC’s decision was primarily driven by results from the Phase 2b HERIZON-BTC-01 trial , the largest of its kind in this population. Food and Drug Administration (FDA) granted accelerated approval for Ziihera for previously treated HER2-positive BTC. formerly BeiGene, Ltd.)

Therapies

New Drug Approvals

JULY 25, 2025

Corticosteroid therapy is the current standard of care for DMD despite relatively high rates of adverse effects. The distinction between it and traditional corticosteroid drugs lies in its capacity to specifically activate particular signaling pathways of corticosteroids. Drugs 2024, 84, 111− 117. (71) 70) Keam, S. Damsker, J.;

FDA

Drug Target Review

JULY 29, 2025

Effective financial management is a cornerstone in the success of clinical trials, which are integral to the advancement of drug discovery. ” This is why financial oversight is so important – without it, the success of a trial is jeopardised and the progress of drug development can be significantly hindered.

Clinical Trials

New Drug Approvals

APRIL 11, 2025

1] [2] Adverse effects The US Food and Drug Administration prescription label for fitusiran contains a boxed warning for thrombotic events (blood clotting) and gallbladder disease (with some recipients requiring gallbladder removal). [2] Food and Drug Administration. Fitusiran 1711.0g/mol, 1] It is given by subcutaneous injection. [1]

Clinical Trials

New Drug Approvals

MAY 8, 2025

MORE US10918622 US10695323 US10464905 US10342780 US12109193 Medical uses In the United States, pirtobrutinib is indicated to treat relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor. [1] Food and Drug Administration (FDA). 27 January 2023.

FDA Approval

New Drug Approvals

JUNE 29, 2025

3] The US Food and Drug Administration (FDA) granted the application for taletrectinib priority review , breakthrough therapy , and orphan drug designations. [3] 3] The US Food and Drug Administration (FDA) granted the application for taletrectinib priority review , breakthrough therapy , and orphan drug designations. [3]

International

BioPharma Drive: Drug Pricing

JUNE 11, 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. Among those who had gotten another such therapy, the rates were 52% and 62% in those trials.

FDA

SugarCone Biotech

JULY 6, 2025

They have interesting patterns of expression in different cancer indications; thus, diverse therapies for attacking these targets have been developed. This is an active drug development landscape with a lot of recent news. These results are notable given the poor response of NRG1 fusion driven cancers to chemo- and immuno-therapies.

Drug Development

The Pharma Data

JULY 2, 2025

Food and Drug Administration (FDA) has accepted for review a new supplemental Biologics License Application (sBLA) and granted it priority review status, seeking to update the U.S. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of October 25, 2025. risk score of 9 or greater.

Trials

New Drug Approvals

APRIL 18, 2025

2] [3] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [4] 1] [2] Adverse effects The US Food and Drug Administration prescription label for crinecerfont has a warning for acute adrenal insufficiency or adrenal crisis. [2] Food and Drug Administration (FDA) (Press release). January 2025.

FDA

New Drug Approvals

AUGUST 7, 2025

After undergoing currently approved targeted therapies, patients with tumors containing ROS1 and neurotrophic tyrosine kinase receptor (NTRK) gene fusions frequently acquire resistance mutations [88,89]. These mutations restrict the ability of drugs to bind to their targets, ultimately resulting in the advancement of tumors.

FDA

BioPharma Drive: Drug Pricing

JULY 28, 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. Please select at least one newsletter.

Clinical Trials

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. Vor Biopharma licensed a drug in June 2025 that targets proteins essential to B cell survival.

Disease

New Drug Approvals

MAY 15, 2025

5] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [9] 5] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [9] “International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 76” WHO Drug Information.

FDA Approval

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. The Food and Drug Administration’s clearance was controversial. You can unsubscribe at anytime.

Therapies

BioPharma Drive: Drug Pricing

JULY 10, 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. Editors picks Permission granted by Daiichi Sankyo ASCO25 Daiichi Sankyo struck gold with ‘ADC’ cancer drugs.

Vaccine

BioPharma Drive: Drug Pricing

JULY 18, 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. That data found similar risks including breast cancer, stroke and dementia.

Therapies

BioPharma Drive: Drug Pricing

JULY 18, 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. Published July 18, 2025 • Updated 3 hours ago Ned Pagliarulo Lead Editor post share post print email license The U.S.

Therapies

BioPharma Drive: Drug Pricing

JULY 10, 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. Since the drug’s U.S. You can unsubscribe at anytime.

Drugs

BioPharma Drive: Drug Pricing

JUNE 24, 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. By Jonathan Gardner • Sept.

RNA

New Drug Approvals

JULY 7, 2025

History In December 2023, Abbisko Therapeutics entered into a licensing agreement for pimicotinib in all indications for China rights with Merck KGaA. [2] History In December 2023, Abbisko Therapeutics entered into a licensing agreement for pimicotinib in all indications for China rights with Merck KGaA. [2] 6] The U.S. 6] The U.S.

Small Molecule

New Drug Approvals

APRIL 19, 2025

Mode of action The drug acts as an ultra-short-acting 1-selective blocking agent. Contrary to landiolol, exposure to other -blockers such as esmolol amplifies the re-expression of -receptors which explains the drug tolerance effect seen during long-term esmolol infusion. Jump up to: a b “Novel Drug Approvals for 2024” U.S.

FDA

BioPharma Drive: Drug Pricing

JULY 30, 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. Elsewhere, Apellis’ drug Empaveli gained a new indication from the FDA. You can unsubscribe at anytime.

Drugs