Alta Sciences

JULY 3, 2025

Altasciences At CPHI Americas 2025 pmjackson Thu, 07/03/2025 - 13:41 In the ever-changing drug development world, staying agile is essential to enabling more informed decisions, faster. It’s a challenge that affects a large percentage of new drug candidates—one we’re passionate about helping to solve.

Small Molecule

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

Drug Target Review

JUNE 5, 2025

Despite recent advances in gene therapy for sickle cell disease (SCD) , automated red blood cell exchange (aRBCX) remains a cornerstone therapy that plays a vital yet underutilised role in managing complications and enhancing quality of life for millions living with this devastating condition worldwide.

Disease

SugarCone Biotech

MARCH 24, 2025

Consequently, these drugs have limited ability to keep patients disease-free and limited impact on patient survival. When we look at how TCEs interact with targeted cancer cells we can quickly see how cancers respond to T Cell-based therapies. Other mechanisms that cancer cells use to escape from TCE treatment are less expected.

Immune Response

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]

FDA

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) 2020, 117, 24285−24293. (75)

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

LifeSciVC

JULY 8, 2025

The core claim was structural: the future of biotech depends as much on what supports the drug as what is in it. Introduction At this year’s Guggenheim biotech investor conference in Boston, the keynote wasn’t about drug pipelines, IPO windows, or FDA guidance. It was about special operations warfare.

Hospitals

New Drug Approvals

AUGUST 14, 2025

2] It is the first approval of a systemic therapy for H3 K27M-mutant diffuse midline glioma by the US Food and Drug Administration. [2] 2] It is the first approval of a systemic therapy for H3 K27M-mutant diffuse midline glioma by the US Food and Drug Administration. [2] Food and Drug Administration (FDA).

Clinical Trials

The Pharma Data

JULY 3, 2025

(NASDAQ: SBFM), a pharmaceutical company focused on developing and commercializing life-saving medicines across oncology, antiviral therapies, and other therapeutic areas, has announced the commercial launch of its first biosimilar drug, NIOPEG® , in Canada. The global market for NEULASTA® and its biosimilars is substantial.

Marketing

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 led her to found Condor Software in 2020, a company focused on providing cloud-based solutions that integrate financial operations with clinical trials.

Clinical Trials

Codon

NOVEMBER 3, 2024

As an undergraduate biology student, I spent some time in a TB lab working on antibiotic resistance — a growing concern for drug developers. Antibiotics From the Ground Up Researchers unearthed the first TB drug from the ground. We need better vaccines — and medicines — to quash TB.

Vaccine

LifeSciVC

JUNE 12, 2025

Building medicines by activating biological pathways As I joined the Company in Q4 2020 as its CEO, I had a vision of creating protein variants to activate biological pathways. This meant focusing on clinical benefit for patients with AATD and build a drug candidate profile that was meaningful for patients.

RNA

Codon

JUNE 5, 2025

The treatment, now known as Casgevy, became the first CRISPR-based therapy to gain FDA approval, in 2023. Such off-target cuts are obviously a big concern when developing human therapies, because they can cause mutations that lead to cancer or other diseases.

DNA

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

New Drug Approvals

JUNE 29, 2025

2020/0062765) was dissolved in ethanol (604 mL) at 50℃. 3] The US Food and Drug Administration (FDA) granted the application for taletrectinib priority review , breakthrough therapy , and orphan drug designations. [3] Food and Drug Administration. Food and Drug Administration (FDA). Sodium hydroxide (68.1

International

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

Codon

NOVEMBER 1, 2024

A 200x drop in price over twenty-five years is impressive, but these costs have now flatlined — or have even risen — since 2020. Today, a single injection of an FDA-approved gene therapy, called Hemgenix , cures this disease. growing drugs in 1,000-liter bioreactors), regulatory limits, and ethical quandaries.

DNA

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. Food and Drug Administration headquarters in Silver Spring, Md., You can unsubscribe at anytime.

Therapies

Drug Patent Watch

JANUARY 13, 2025

The Rise of Biosimilars: A Healthcare Revolution Biosimilars, often referred to as the “generic equivalents” of biologic drugs, have been making waves in the pharmaceutical industry for over a decade. from 2020 to 2025[1]. billion by 2025, growing at a CAGR of 34.2% billion by 2025, growing at a CAGR of 34.2%

Biosimilars

New Drug Approvals

JULY 8, 2025

1428321-10-1 Pritelivir mesylate is an antiviral drug currently under development, specifically targeting herpes simplex virus types 1 and 2 (HSV-1 and HSV-2). Pritelivir (development codes AIC316 or BAY 57-1293 ) is a direct-acting antiviral drug in development for the treatment of herpes simplex virus infections (HSV).

Virus

New Drug Approvals

APRIL 19, 2025

4] Landiolol can be used as first-line treatment for acute ventricular rate control in patients with atrial fibrillation (Level I recommendation- 2020 Guidelines of the European Society of Cardiology [15] ). Mode of action The drug acts as an ultra-short-acting 1-selective blocking agent. Food and Drug Administration (FDA).

FDA

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. 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

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 approved Verona’s Ohtuvayre in June 2024 for maintenance treatment of COPD in adults.

Clinical Trials

Common Sense for Drug Policy Blog

AUGUST 1, 2025

Drug User Liberation Front's Compassion Club and Fulfillment Center Model "This case study underscores the feasibility of a community-based intervention in addressing the current public health crisis, revealing that drug users themselves can orchestrate a program aimed at safeguarding their communities. Int J Drug Policy.

Drugs

New Drug Approvals

AUGUST 4, 2025

Donafenib , sold under the brand name Zepsun , is a pharmaceutical drug for the treatment of cancer. Deuterium in drug discovery: progress, opportunities and challenges. Nature Reviews Drug Discovery, DOI: 10.1038/s41573-023-00703-8, published online 5 June 2023 ACS Omega 2021, 6, 5532−5547. Drugs 2021, 81, 1915−1920.

Metabolic Stability

New Drug Approvals

JULY 18, 2025

D-ARABINOFURANOSYL)- 4′-C-Azido-2′-deoxy-2′-fluoro-b-D-arabinocytidine Azvudine is an antiviral drug which acts as a reverse transcriptase inhibitor. [3] In addition to its antiviral activity, concentration of the drug in the thymus has suggested immune-targeting activity; this dual function is unique among RdRp inhibitors.8

RNA

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

Drug Target Review

FEBRUARY 28, 2024

Over the past 25 years, T-cell therapies have gained significant ground in the treatment of cancer. Preclinical research on γδ T cells has made great strides since the cells were first identified in the 1980s, with γδ T-cell therapies from several companies, including IN8bio, now in or nearing clinical trials for various cancers.

Therapies

Drug Target Review

OCTOBER 5, 2023

The research team identified 231 individuals diagnosed with relapsing-remitting MS, with 174 of them having undergone aHSCT treatment before the year 2020. Around three years following their aHSCT, 20 patients (11 percent) were administered disease-modifying drugs.

Therapies

Drug Target Review

JULY 4, 2023

Over the last two decades, an increasing number of Antibody Drug Conjugate (ADC) therapeutics have been approved for oncology indications. These therapies have broadened treatment options for patients to expand beyond the more traditional small molecule drug alternatives. 3D rendering of Antibody Drug Conjugate Molecules.

Small Molecule

The Pharma Data

DECEMBER 8, 2020

Blood disease trial participants given Vertex’s and CRISPR Therapeutics’ CRISPR/Cas9-based gene-editing therapy CTX001 demonstrated a “consistent and sustained response” to the treatment, according to new phase 1/2 trial data the companies have announced. To date, a total of 19 trial participants have been dosed with the gene therapy.

Therapies

Drug Target Review

FEBRUARY 2, 2024

The standard animal model paradigm for drug discovery does not translate well to effects in patients for a number of reasons. In summary, all these factors can affect the response to drugs and drug target manipulation. Once created, our 3D human tissue models can be manipulated and worked with in the lab.

Drugs

Drug Channels

NOVEMBER 24, 2020

In this issue: Rebate rule redux Most Favored Nation and healthcare benchmarking Amazon’s pharmacy customer opportunity Drug spending realities updated GPO consolidation Plus, I congratulate Dirk Rodgers of RxTrace on his retirement. Join me for an exclusive live webinar, Drug Channels Outlook 2021 , on December 18, 2020, from 12:00 p.m.

Pharmacy

The Pharma Data

NOVEMBER 3, 2020

4, 2020 /PRNewswire/ — Q3 2020 highlights. m (-), including US launch of the scientifically proven digital therapies deprexis® and vorvida®. Updated financial outlook 2020. 2020 Jul-Sep. 2020 Jan-Sep. m (90.9).

Therapies

Eye on FDA

AUGUST 18, 2020

But it is not likely to surprise anyone that the first half of 2020 has caused not only an increase in communication from FDA, but a focus as well. Approvals – There were 54 press statements regarding approvals so far in 2020, comparing to 42 approvals announced in 2019.

FDA

The Pharma Data

JANUARY 12, 2021

Preliminary revenue for the fourth quarter of 2020 is expected to be approximately $40.6 Preliminary revenue for the fourth quarter of 2020 is expected to be approximately $40.6 Preliminary revenue for the full year 2020 is expected to be approximately $125.4 2020 was a transformational year for Vapotherm.

Therapies