Drug Target Review

DECEMBER 11, 2024

Such an approach ensures reliable preclinical toxicology data and supports the transition of innovative therapies from the lab to clinical trials. For small- and medium-sized pharmaceutical companies, outsourcing represents a strategic leap forward, offering a gateway to unparalleled expertise and cutting-edge analytical technologies.

International

The Pharma Data

JUNE 24, 2025

This dual-pronged approach allows Revolution Medicines to access capital tailored to its evolving needs without relinquishing equity or ceding commercial rights to a larger pharmaceutical partner. Early data has demonstrated encouraging signs of efficacy and safety, and the company is planning to initiate pivotal trials in the near term.

Drug Development

BioPharma Drive: Drug Pricing

JULY 8, 2025

Published July 8, 2025 Gwendolyn Wu Senior reporter post share post print email license Proteasomes are cellular machines for breaking down proteins. Multiple deals have been struck by large companies such as Roche and Novartis, suggesting pharmaceutical firms believe degraders have only begun to show their promise. But hurdles remain.

Targeted Protein Degradation

The Pharma Data

JUNE 24, 2025

Bayer and Tsinghua University Deepen Strategic Alliance to Advance Pharmaceutical Innovation in China Bayer and Tsinghua University (THU), two powerhouses in global pharmaceutical innovation and academic research, have announced a renewed commitment to their long-standing partnership.

Pharma R&D

New Drug Approvals

JULY 25, 2025

2] [3] Vamorolone is a novel and fully synthetic glucocorticoid developed by Santhera Pharmaceuticals. Hoffman, Efficacy and safety of vamorolone vs placebo and prednisone among boys with duchenne muscular dystrophy: a randomized clinical trial, JAMA Neurol. 4] [5] [6] [7] [8] It is taken by mouth. [1] Shale, U.J. Reeves, E.P.

FDA

Drug Target Review

MARCH 4, 2025

The MyPhenome test has already gained traction among obesity specialists, particularly in Chicago and Florida, and Phenomix has formed strategic partnerships with multiple pharmaceutical companies to support clinical trials and further analyse obesity-related data. Obesity is rising worldwide, driven by lifestyle, diet, and genetics.

Therapies

Broad Institute

MAY 21, 2025

In the early 2000s, both teams began preparing for clinical trials. After their clinical results, their technology was licensed to Juno Therapeutics (later acquired by Bristol Myers Squibb.) After their clinical results, their technology was licensed to Juno Therapeutics (later acquired by Bristol Myers Squibb.)

Therapies

BioPharma Drive: Drug Pricing

JULY 14, 2025

Published July 14, 2025 Ben Fidler Senior Editor post share post print email license Takeda reported positive results for oveporexton, a drug being developed for narcolepsy Type 1, on July 14, 2025. You can unsubscribe at anytime. The most common adverse events reported were insomnia as well as the sudden urge to urinate. Can they keep it?

Drugs

New Drug Approvals

JUNE 11, 2025

2] Gepirone was synthesized by Bristol-Myers Squibb in 1986 and was developed and marketed by Fabre-Kramer Pharmaceuticals. [4] 5] History Gepirone was developed by Bristol-Myers Squibb in 1986, [5] but was out-licensed to Fabre-Kramer in 1993. 1] It is taken orally. [1] 1] It is taken orally. [1] 5] SYN Synthesis Ormaza, V.

FDA

New Drug Approvals

APRIL 25, 2025

19] Society and culture Legal status In October 2024, the US Food and Drug Administration (FDA) approved inavolisib for the treatment of PIK3CA -mutant breast cancer based on the results from the INAVO120 trial. [3] “An Overview of Bioactive 1,3-Oxazole-Containing Alkaloids from Marine Organisms” Pharmaceuticals.

FDA

The Pharma Data

JUNE 24, 2025

Rather than diluting ownership or yielding developmental control to a larger pharmaceutical partner, Revolution Medicines is leveraging this funding arrangement to maintain autonomy over its research, development, and eventual commercialization efforts.

Clinical Development

New Drug Approvals

APRIL 11, 2025

2] History The efficacy and safety of fitusiran were assessed in two multicenter, randomized clinical trials which enrolled a total of 177 adult and pediatric male participants with either hemophilia A or hemophilia B. [2] Fitusiran 1711.0g/mol, 1] It is an antithrombin-directed small interfering ribonucleic acid. [1] Fitusiran 1711.0g/mol,

Clinical Trials

DrugBank

JUNE 18, 2025

While these regulations protect public health, they also introduce significant challenges for pharmaceutical researchers. The failure rate in clinical trials exceeds 90%, often due to insufficient safety data, efficacy concerns, or regulatory non-compliance.

Drug Development

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 efficacy of Journavx was evaluated in two randomized, double-blind, placebo- and active-controlled trials of acute surgical pain, one following abdominoplasty and the other following bunionectomy.

FDA

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. Hopes for the Phase IIb trial Donello discusses the key outcomes he hopes to see in the Phase IIb VITALIZE study of zelquistinel for major depressive disorder (MDD).

Treatment

New Drug Approvals

JULY 2, 2025

1] It was discovered by Chugai Pharmaceutical Co. then was licensed to Lilly in 2018. [1] 1] [3] Clinical trials The results of Phase I safety and Phase II ascending-dose clinical trials enrolling people with obesity or type 2 diabetes were published in 2023. [4] 1] It was discovered by Chugai Pharmaceutical Co.

Small Molecule

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. The trial evaluated Ziihera as a monotherapy in 87 previously treated patients with HER2-positive BTC. under license from Zymeworks Inc. ,

Therapies

New Drug Approvals

JULY 10, 2025

Retrieved 9 July 2025. ^ “KalVista Pharmaceuticals Announces FDA Approval of Ekterly (sebetralstat), First and Only Oral On-demand Treatment for Hereditary Angioedema” (Press release). “International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 87” WHO Drug Information.

FDA

New Drug Approvals

JUNE 29, 2025

1] [3] History The efficacy of taletrectinib to treat ROS1-positive non-small cell lung cancer was evaluated in participants with locally advanced or metastatic, ROS1-positive non-small cell lung cancer enrolled in two multi-center, single-arm, open-label clinical trials, TRUST-I (NCT04395677) and TRUST-II (NCT04919811). [3]

International

BioPharma Drive: Drug Pricing

JUNE 11, 2025

Published June 11, 2025 Ben Fidler Senior Editor post share post print email license The FDA on June 11, 2025 approved Nuvation's Ibtrozi for ROS1-positive non-small cell lung cancer. Among those who had gotten another such therapy, the rates were 52% and 62% in those trials. Registered in England and Wales. TechTarget, Inc.s

FDA

New Drug Approvals

JUNE 15, 2025

“International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 80” WHO Drug Information. 6] [9] [10] It is a complement inhibitor that is injected subcutaneously (under the skin). [6] 1] Zilucoplan is a 15 amino-acid, synthetic macrocyclic peptide with formula C172H278N24O55. hdl : 10665/330907.

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

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.,

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. 2] [5] It is a kinase inhibitor [2] [6] that is taken by mouth. [2]

FDA Approval

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. IV -Blocker max. June 1992).

FDA

BioPharma Drive: Drug Pricing

JULY 16, 2025

Published July 16, 2025 • Updated 2 hours ago Ben Fidler Senior Editor post share post print email license Sarepta Therapeutics announced a workforce reduction on July 16, 2025. But the steady expansion of their use has slowed and, despite much trying, pharmaceutical companies have largely failed to top the drugs’ successes.

Therapies

BioPharma Drive: Drug Pricing

JULY 10, 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 Moderna COVID vaccine gets full approval for children The approval comes amid regulatory upheaval under HHS head Robert F. You can unsubscribe at anytime. Kennedy Jr.,

Vaccine

BioPharma Drive: Drug Pricing

JULY 10, 2025

Published July 10, 2025 Ben Fidler Senior Editor post share post print email license Soleno Therapeutics on July 10, 2025 announced preliminary sales for its new Prader-Willi Syndrome drug Vykat. This database now covers the 50 best-selling pharmaceutical products and has been updated to reflect current patent expiry expectations.

Drugs

BioPharma Drive: Drug Pricing

JUNE 24, 2025

Published June 24, 2025 Gwendolyn Wu Senior reporter post share post print email license Lexeo Therapeutics and two life sciences investors are working together to launch a startup to develop cardiac RNA therapies. You can unsubscribe at anytime. Both programs are in early human studies. By Jonathan Gardner • Sept.

RNA

BioPharma Drive: Drug Pricing

JULY 30, 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 News roundup Madrigal buys into GLP-1 from CSPC; Apellis wins expanded drug approval The Hong Kong-based CSPC will receive $120 million from Madrigal under the deal.

Drugs

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. PCI helps biopharmaceutical companies manufacture and package drug products used in clinical trials as well as commercially.

Production

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

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. Incyte expects multiple pivotal trial readouts this year, along with proof-of-concept data for several pipeline candidates. You can unsubscribe at anytime.

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

BioPharma Drive: Drug Pricing

JULY 28, 2025

By Jacob Bell • July 1, 2025 Kendall Davis/BioPharma Dive Tracker 10 clinical trials to watch the rest of 2025 Expected readouts in obesity, lung cancer and AATD headline a series of study results that could give the biotechnology sector a boost. inhibitors. inhibitors. Informa PLCs registered office is 5 Howick Place, London SW1P 1WG.

Specialty Pharmacies

BioPharma Drive: Drug Pricing

AUGUST 11, 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 Sponsored Regulatory uncertainty and access challenges changing go-to-market models, DTC, and DTP Published Aug. You can unsubscribe at anytime. The disconnect? TechTarget, Inc.s

Marketing

BioPharma Drive: Drug Pricing

JULY 22, 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 News roundup Replimune drug rejected by FDA; Omega raises $647M biotech fund The FDA raised issues that Replimune said hadn’t come up in meetings previously. and Europe.

FDA