New Drug Approvals

JULY 25, 2025

Vamorolone , sold under the brand name Agamree , is a synthetic corticosteroid , which is used for the treatment of Duchenne muscular dystrophy. [4] In December 2023, it was approved in the EU for the treatment of patients ≥4 years of age. Treatment of crude 9.3 4] [5] [6] [7] [8] It is taken by mouth. [1] with peracetic acid 9.4

FDA

DrugBank

JUNE 18, 2025

Once a drug completes Phase III trials, companies prepare a New Drug Application or Biologics License Application (BLA) for final review. For example, the FDA’s Breakthrough Therapy Designation grants priority review to medicines demonstrating substantial improvement over existing treatments.

Drug Development

New Drug Approvals

APRIL 25, 2025

The difluoromethyl group can interact with the hydroxyl group presented on Ser774 (conserved) in p110, which is 3.2 8] Therefore, it may serve as a new addition to combination therapy with conventional cancer treatment, such as chemotherapy. 2] [3] It is an inhibitor and degrader of mutant phosphatidylinositol 3-kinase (PI3K) alpha. [4]

FDA

Drug Patent Watch

JANUARY 14, 2025

From mergers and acquisitions to licensing agreements and pricing discussions, these complex interactions demand a unique blend of scientific knowledge, business acumen, and interpersonal skills. The stakes are higher than ever, with billions of dollars and potentially life-saving treatments on the line.

Pharmaceuticals

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.

FDA

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] Jump up to: a b c d e f g h i j k l m n o p q “FDA Approves New Treatment for Congenital Adrenal Hyperplasia” U.S. 321839-75-2 Molecular Weight 519.50

FDA

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. Vor Biopharma licensed a drug in June 2025 that targets proteins essential to B cell survival. But a rocky few years forced Vor to change direction. and European drugmakers.

Disease

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.

FDA

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. Recent biotech company acquisitions have put emerging schizophrenia treatments in focus. By Jonathan Gardner • Sept.

RNA

BioPharma Drive: Drug Pricing

JULY 9, 2025

Published July 9, 2025 By Kristin Jensen post share post print email license Merck & Co. The Food and Drug Administration approved Verona’s Ohtuvayre in June 2024 for maintenance treatment of COPD in adults. logo displayed on the exterior of their research facility in San Francisco, Calif., Alamy Merck & Co.

Clinical Trials

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. Specifically, it removes so-called “Risk Evaluation and Mitigation Strategies” from the drugs’ labeling, which are used to help manage serious side effects of treatment.

Therapies

BioPharma Drive: Drug Pricing

JUNE 27, 2025

Published June 27, 2025 By BioPharma Dive staff post share post print email license Daniel Tadevosyan via Getty Images Today, a brief rundown of news involving Biocryst and Peter Marks, as well as updates from UCB and Altimmune that you may have missed. In the trial, 59% of people who got a 1.2 milligram shot, the company said.

Vaccine

BioPharma Drive: Drug Pricing

JUNE 23, 2025

This shift raises ethical questions around prioritizing supply for diabetes patients versus those seeking treatment for obesity or cosmetic weight loss. The balance is complex, as obesity carries its own serious health risks.

Treatment

The Pharma Data

JANUARY 6, 2021

CAMBRIDGE, England & WETHERBY, England–( BUSINESS WIRE )– Avacta Group plc (AIM: AVCT), the developer of innovative cancer therapies and diagnostics based on its proprietary Affimer ® and pre|CISION platforms, is pleased to announce that it has entered into a license agreement with POINT Biopharma Inc. million.

Licensing

The Pharma Data

SEPTEMBER 2, 2021

Novartis will present 12 abstracts at the European Respiratory Society (ERS) International Congress 2021 for Enerzair ® Breezhaler ® (IND/GLY/MF*) and Atectura ® Breezhaler ® (IND/MF**) — for patients whose asthma is uncontrolled with LABA/ICS^ and ICS, respectively 1,2. Details: Oral Presentation, 6 September, 9:30-11:00 CEST.

Licensing

The Pharma Data

MARCH 5, 2021

Biogen (Nasdaq: BIIB) today announced it will host webcasts of its pre-recorded presentations and live discussions related to its Alzheimer’s disease investigational therapy, aducanumab, at the upcoming AD/PDTM 2021 Virtual Conference. An archived version of the webinar will be available following the presentation. About Biogen.

Licensing

The Pharma Data

OCTOBER 27, 2021

NYSE and TASE: TEVA) and MODAG GmbH today announced a strategic collaboration on the exclusive worldwide licensing and development of MODAG’s lead compound anle138b and a related compound, sery433. Small molecule candidate Anle138b targets disease modification for multiple system atrophy and other neurological disorders.

Licensing

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

The Pharma Data

OCTOBER 26, 2020

(Nasdaq: ARDS), a biopharmaceutical company focused on the discovery and development of novel anti-infective therapies to treat life-threatening infections, today announced the Company will present at the ROTH Capital Partners 2020 MedTech Innovation Forum on Wednesday, October 28, 2020. About Aridis Pharmaceuticals, Inc.

Pharmaceuticals

The Pharma Data

JANUARY 14, 2021

Department of Health and Human Services’ (HHS) decision to effectively remove the “X-waiver” requirement for physicians, expanding their ability to utilize medication-assisted treatment (MAT) for patients struggling with opioid use disorder (OUD). Added Dr. Rosenberg, “This is a great day for our patients.

Treatment

The Pharma Data

JANUARY 10, 2021

Chief Executive Officer of MorphoSys, will present at the 39 th Annual J.P. EST. Live audio of the presentation can be accessed from the Media and Investors section under Conferences on MorphoSys’ website, www.morphosys.com. The presentation as well as a replay of the webcast will also be available on MorphoSys’ website.

Clinical Trials

The Pharma Data

NOVEMBER 18, 2020

Presentations to highlight the OBI-833 Phase 1 clinical study results in non-small cell lung cancer (NSCLC) and the dose escalation cohort. These results will be presented by the lead investigators of OBI Pharma’s novel anti-Globo H therapeutic cancer vaccine, OBI-833. ” Presentation number: 397P / Poster: ID 680.

Vaccine

The Pharma Data

DECEMBER 13, 2020

The FDA also recommended that Gamida Cell generate additional manufacturing-related data prior to requesting a pre-Biologics License Application (BLA) meeting. During the meeting, the FDA provided encouraging feedback regarding the Phase 3 study of omidubicel pertaining to the pre-specified primary and secondary endpoints. About Omidubicel.

Licensing

Drug Hunter

APRIL 20, 2023

The 2022 winner, with the most overall votes across the ten finalist molecules , is BMS’ oral, deuterated allosteric TYK2 inhibitor, deucravacitinib, the first new treatment for plaque psoriasis in nearly a decade. We asked the global drug discovery community to nominate and vote on their favorite molecule from 2022, and the results are in.

Small Molecule

The Pharma Data

AUGUST 19, 2021

Oral presentation at the International Association for the Study of Lung Cancer’s (IASLC) 2021 World Conference on Lung Cancer (WCLC) shows evidence that the bispecific mechanism of action for RYBREVANT TM can provide anti-tumor activity against either EGFR-mutated or MET-mutated non-small cell lung cancer. 1 Treatment-related Grade ?3

Treatment

The Pharma Data

NOVEMBER 10, 2020

The poster presentation, given by Johan Sandin , CSO at AlzeCure, presents how the mechanisms in the research platform Alzstatin work and shows that the target mechanism within the platform is suitable as a new treatment for Alzheimer’s disease. . STOCKHOLM , Nov.

Pharmaceutical Companies

The Pharma Data

JANUARY 27, 2021

. “The responses observed in six out of nine patients are very encouraging and clearly suggest that BI-1206 may restore the response to rituximab in patients who have few treatment alternatives. CEO of BioInvent. Readout from two patients is still pending. CET ( 11:30 a.m.

Pharmaceuticals

The Pharma Data

DECEMBER 14, 2020

15, 2020 (GLOBE NEWSWIRE) — Burning Rock Biotech Limited (NASDAQ: BNR, the “Company” or “Burning Rock”) today announced that it entered into an exclusive licensing agreement with Oncocyte Corporation (NYSE American: OCX) to bring DetermaRx , a risk stratification test for early stage lung cancer patients, to China.

Licensing

The Pharma Data

NOVEMBER 27, 2020

FDA Approves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma. the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that the U.S. NEW YORK, Nov.

FDA Approval

The Pharma Data

NOVEMBER 11, 2020

Food and Drug Administration (FDA) clearance of an Investigational New Drug (IND) application for SLV213 for the treatment of COVID-19 and has dosed the first subjects in a Phase 1 clinical study. SLV213 was developed based on research from UC San Diego and the university exclusively licensed it to Selva Therapeutics.

Treatment

Drug Target Review

FEBRUARY 1, 2024

What challenges has the industry faced in developing and commercialising treatments for neurological diseases, including rare diseases? Part of the challenge is that patients present with very different kinds of clinical phenotypes, meaning the populations are heterogeneous.

Therapies

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). Findings from the primary efficacy and safety endpoints and additional secondary objectives will be presented at an upcoming medical meeting.

Trials

The Pharma Data

APRIL 20, 2023

A separate analysis showed that treatment with Kesimpta for up to five years was well-tolerated, with no new or increased safety risks identified 2. These data will be presented at the American Academy of Neurology (AAN) Annual Meeting held in Boston and virtually on April 22-27, 2023.

Treatment

The Pharma Data

JANUARY 13, 2021

Food and Drug Administration (FDA) has designated as a Fast Track development program the investigation of Brilacidin as a potential treatment for COVID-19. A molecular screening study of 11,552 compounds also supports Brilacidin as a promising novel coronavirus treatment. Brilacidin for UP/UPS was licensed to Alfasigma S.p.A.

Clinical Trials

The Pharma Data

OCTOBER 15, 2020

Data was presented at the International Society of Pediatric Oncology (“SIOP”) Virtual Annual Congress held October 14 through October 17, 2020 in Ottawa, Canada. Data was presented at the International Society of Pediatric Oncology (“SIOP”) Virtual Annual Congress held October 14 through October 17, 2020 in Ottawa, Canada.

Licensing

Drug Target Review

FEBRUARY 28, 2024

Over the past 25 years, T-cell therapies have gained significant ground in the treatment of cancer. 2,3 However, unlike αβ T cells, which are activated by the presentation of antigens to their TCRs, γδ T cells do not require antigen presentation to become activated. Kabelitz D, Serrano R, Kouakanou L, et al. Fisher J, Anderson.

Therapies

Conversations in Drug Development Trends

AUGUST 9, 2024

It broadens recruitment strategies, diversifies the patient population, and expands the study population, thus increasing access to potentially life-saving treatments. These trials increase the chances of success by enabling the early detection of effective treatments in defined populations and focusing efforts on the most promising options.

Trials