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. and elsewhere in its 2025 fiscal year and plans to present detailed results at an upcoming medical meeting.

Drugs

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

JUNE 29, 2025

Taletrectinib CAS 1505514-27-1 as salt: 1505515-69-4 , Taletrectinib adipate FDA 6/11/2025, Ibtrozi, To treat locally advanced or metastatic ROS1-positive non-small cell lung cancer AB-106, DS-6051a 405.5 1] Taletrectinib was approved for medical use in the United States in June 2025. [3] Food and Drug Administration.

International

The Pharma Data

JUNE 6, 2025

Food and Drug Administration (FDA) granted the therapy Priority Review status in May 2025 following its Biologics License Application (BLA) submission in March, reflecting the agency’s recognition of its potential to address a serious condition with limited treatment options.

Trials

New Drug Approvals

APRIL 25, 2025

12] However, absorption, metabolism, and excretion data of taselisib , a molecule with a related chemical scaffold, suggest moderately slow absorption into the systemic circulation, metabolism to play a minor role in drug clearance, and biliary excretion to be the main route of excretion. [13] Retrieved 17 April 2025. January 2025.

FDA

New Drug Approvals

JULY 10, 2025

g/mol O5ZD2TU2B7 FDA 7/3/2025, Ekterly, To treat acute attacks of hereditary angioedema N -[(3-fluoro-4-methoxypyridin-2-yl)methyl]-3-(methoxymethyl)-1-[[4-[(2-oxopyridin-1-yl)methyl]phenyl]methyl]pyrazole-4-carboxamide Sebetralstat , sold under the brand name Ekterly , is a medication used for the treatment of hereditary angioedema. [1]

FDA

New Drug Approvals

JULY 2, 2025

Orforglipron ( LY-3502970 ) is an oral, non-peptide, small-molecule GLP-1 receptor agonist developed as a weight loss drug by Eli Lilly and Company. [1] then was licensed to Lilly in 2018. [1] then was licensed to Lilly in 2018. [1] April 17, 2025. Retrieved April 18, 2025. January 2025). Hz, J ＨＦ ＝6.9

Small Molecule

The Pharma Data

JULY 2, 2025

Continued authorization of Ziihera for this indication will depend on positive outcomes from the ongoing Phase 3 HERIZON-BTC-302 trial , which is evaluating the drug in combination with standard-of-care therapy in the first-line setting. under license from Zymeworks Inc. , formerly BeiGene, Ltd.) the original developer. In the U.S.,

Therapies

New Drug Approvals

JULY 25, 2025

The distinction between it and traditional corticosteroid drugs lies in its capacity to specifically activate particular signaling pathways of corticosteroids. In individuals diagnosed with DMD, the primary mechanism through which corticosteroid drugs exhibit their effectiveness is by exerting anti-inflammatory effects. Nagaraju, J.M.

FDA

New Drug Approvals

AUGUST 7, 2025

5] Repotrectinib was approved for medical use in the United States in November 2023, [5] [6] and in the European Union in January 2025. [3] These mutations restrict the ability of drugs to bind to their targets, ultimately resulting in the advancement of tumors. Retrieved 23 May 2025. 14 January 2025. in DMF (4.0

FDA

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. The company scrapped its initial drug program in 2022 and changed course two years later when a second prospect disappointed.

FDA

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] Retrieved 25 January 2025. Food and Drug Administration (FDA).

FDA

SugarCone Biotech

JULY 6, 2025

A post-ASCO update on tumor targets DLL3, B7H3 and HER3 July 2025 Paul D Rennert, SugarCone Biotech LLC Introduction: DLL3, B7H3 and HER3 are compelling tumor antigens to target with cancer therapeutics. This is an active drug development landscape with a lot of recent news. months (see [link] ).

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.

Trials

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] 16 April 2025. Retrieved 3 May 2025. Food and Drug Administration (FDA) (Press release). 29 March 2023. 24 March 2023.

FDA Approval

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. By BioPharma Dive staff • Updated June 30, 2025 Keep up with the story. inhibitors.

Clinical Trials

BioPharma Drive: Drug Pricing

JUNE 26, 2025

Published June 26, 2025 Gwendolyn Wu Senior reporter post share post print email license B cells, like those pictured above, malfunction in autoimmune disease. Published June 26, 2025 Gwendolyn Wu Senior reporter post share post print email license B cells, like those pictured above, malfunction in autoimmune disease.

Disease

Drug Channels

FEBRUARY 26, 2025

On March 18, 2025, Drug Channels Institute will release The 2025 Economic Report on U.S. drug pricing, reimbursement, and dispensing system. prescription drug channels. prescription drug channels. Special preorder and launch pricing discounts will be valid through March 31, 2025. All rights reserved.

Pharmacy

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. In a statement Monday , Sarepta said it plans to cut approximately 36% of its staff and pause research on several drug programs.

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. Kennedy Jr., Kennedy Jr.

Vaccine

BioPharma Drive: Drug Pricing

JULY 18, 2025

Published July 18, 2025 Delilah Alvarado Staff Reporter post share post print email license Food and Drug Administration Commissioner Martin Makary speaks on stage during The Semafor 2025 World Economy Summit on April 24, 2025 in Washington, DC. By Jacob Bell • July 1, 2025 Keep up with the story.

Therapies

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. Since the drug’s U.S. The disease, which affects an estimated 10,000 to 20,000 people in the U.S.,

Drugs

BioPharma Drive: Drug Pricing

JULY 18, 2025

Published July 18, 2025 • Updated 3 hours ago Ned Pagliarulo Lead Editor post share post print email license The U.S. Published July 18, 2025 • Updated 3 hours ago Ned Pagliarulo Lead Editor post share post print email license The U.S. Food and Drug Administration headquarters in Silver Spring, Md.,

Therapies

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. By Jonathan Gardner • Sept.

RNA

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

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 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

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. Published June 26, 2025 Ned Pagliarulo Lead Editor post share post print email license An Incyte researcher works in a laboratory. However, Incyte’s other drugs don’t make it much money.

Therapies

FDA Law Blog: Biosimilars

FEBRUARY 18, 2025

Lewis, , Principal Regulatory Device and Biologics Expert The FDA is currently funded through March 1st, 2025. Drugs/Biologics/Devices / Tobacco (CDER, CBER, CDRH, CTP) These centers are largely supported by user-fee programs that support their review staff (MDUFA, PDUFA, BsUFA, GDUFA). By Richard A.

Government

BioPharma Drive: Drug Pricing

JUNE 27, 2025

Published June 27, 2025 Ned Pagliarulo Lead Editor post share post print email license Bristol Myers Squibb sells two CAR-T cell therapies for cancer. Published June 27, 2025 Ned Pagliarulo Lead Editor post share post print email license Bristol Myers Squibb sells two CAR-T cell therapies for cancer.

Therapies

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. © 2025 TechTarget, Inc. inhibitors. inhibitors. or its subsidiaries.

Specialty Pharmacies

BioPharma Drive: Drug Pricing

JUNE 27, 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 Biocryst sells Europe business; Peter Marks criticizes new FDA vaccine rules Biocryst is offloading part of its business to an Italian drugmaker for $250 million upfront.

Vaccine

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. By BioPharma Dive staff • Updated July 2, 2025 Keep up with the story.

Marketing

Drug Channels

APRIL 15, 2025

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. We also offer licenses to our secure hosted learning environmentno internal setup required! Visit our eLearning page to get started.

Specialty Pharmacies

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.

FDA