The Pharma Data

JUNE 26, 2025

FDA Approves Streamlined Monitoring Requirements and REMS Program Removal for Bristol Myers Squibb’s CAR T Cell Therapies Breyanzi and Abecma, Marking Milestone Toward Expanding Access to Cancer Treatment In a significant regulatory development, Bristol Myers Squibb announced that the U.S.

FDA Approval

Crown Bioscience

JULY 17, 2025

Oncology drug approvals in H1 2025 In the first half of 2025, the FDA’s Center for Drug Evaluation and Research (CDER) approved a total of 16 novel drugs , with half of these drugs related to the treatment of cancer.

FDA Approval

The Premier Consulting Blog

APRIL 13, 2025

On April 10, 2025, the US FDA announced that it has a long-term plan to eliminate conventional animal testing in drug development, starting with monoclonal antibodies (mAbs).[ 2] An overview of the 3Rs The FDA and other global regulatory health authorities have long embraced the 3Rs of animal research (replace, reduce, and refine).

Animal Testing

The Pharma Data

JUNE 25, 2025

FDA Approves Label Update for Lilly’s Amyvid, Expanding Its Role in Alzheimer’s Disease Diagnosis and Therapy Guidance In a major development for Alzheimer’s diagnostics, Eli Lilly and Company (NYSE: LLY) announced that the U.S. At the time, its use was primarily restricted to supporting the diagnostic process.

FDA

Drug Patent Watch

DECEMBER 10, 2024

The pharmaceutical industry has undergone significant changes over the past decade, with a growing trend towards outsourcing key aspects of research, development, and manufacturing to third-party vendors. The Rise of Integrated CDMOs The global biotechnology and pharmaceutical services outsourcing market size was valued at $70.48

Drug Development

PPD

JULY 8, 2025

Generative artificial intelligence (AI) has captured global attention for its transformative potential across industries, and nowhere is the promise greater — or more fraught — than in health care and clinical research. These domains are ripe for innovation. Errors jeopardize patient safety, regulatory compliance and trust.

Clinical Research

LifeSciVC

MAY 14, 2025

Merck, Bristol-Myers Squibb, Amgen, Eli Lilly, and Gilead have all conducted microgravity research in orbit. With respect to the latter, Mercks microgravity research on Keytruda is an informative case study. Despite the progress made, microgravity research projects to date have been exploratory, small-scale one-offs.

Science

Broad Institute

AUGUST 1, 2025

Food and Drug Administration (FDA)-approved inhibitors that broadly block FGFR. The work opens the door to potential targeted therapy for these tumors, particularly for pediatric low-grade gliomas (pLGG), though more research is needed to improve the efficacy of these treatments and to test them in pediatric clinical trials.

Treatment

Drug Target Review

JULY 3, 2025

Leveraging the extensive breadth of available data to identify entities and relationships across data sources, clinical research experts, therapeutic specialists, machine learning (ML) engineers and others can collectively evaluate areas of interest that may create new opportunities for the asset and a broader clinical strategy.

Drug Development

Drug Target Review

APRIL 7, 2025

While biomarkers are increasingly being adopted as surrogate endpoints by the US Food and Drug Administration (FDA), advances in biomarker detection also present a variety of regulatory challenges related to the complexities in their selection, implementation and clinical interpretation. References FDA-NIH Biomarker Working Group.

Clinical Development

Drug Target Review

JULY 30, 2025

Two technologies, one goal: advancing precision oncology With a background in biochemistry and biology, Julien oversees Orano Med’s internal and external research programmes. By bringing our respective expertise together, we were able to screen and rapidly identify suitable candidates for RLT.”

Clinical Trials

The Premier Consulting Blog

NOVEMBER 6, 2024

Combination products are regulated by multiple divisions within the FDA, including: Drug/Device combination products are subject to the requirements of both the FDA’s Center for Drug Evaluation and Research (CDER) and the Center for Devices and Radiological Health (CDRH).

Production

The Pharma Data

JUNE 25, 2025

FDA Orphan Drug Designation for Antibody-Mediated Rejection in Solid Organ Transplantation The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to riliprubart , an investigational immunology therapy developed by Sanofi, for the treatment of antibody-mediated rejection (AMR) in solid organ transplantation.

FDA

The Pharma Data

JUNE 9, 2025

FDA Approves Merck’s ENFLONSIA™ to Protect Infants from Severe RSV Illness Merck operating as MSD outside the United States and Canada, has received a significant regulatory milestone with the U.S. Food and Drug Administration (FDA) granting approval for ENFLONSIA™ (clesrovimab-cfor). A New Era in Infant RSV Protection Dr. Dean Y.

FDA Approval

Broad Institute

JULY 21, 2025

There is no cure or effective treatment for this rare genetic disease, but new research suggests a potential path to one.& & Researchers at the Broad Institute and The Jackson Laboratory have used prime editing, a precise and versatile form of gene editing, to correct the root cause of AHC in mice.

Disease

BioPharma Drive: Drug Pricing

JULY 8, 2025

The result of their research is what’s now described as targeted protein degradation, which conceptually is a bit like ordering a junk hauling service for the cell. For years, researchers struggled to develop an effective method for directing the E3 ligase. You can unsubscribe at anytime.

Targeted Protein Degradation

The Pharma Data

JUNE 16, 2025

FDA Approves ANDEMBRY (garadacimab-gxii) The First Once-Monthly Prophylactic HAE Therapy Targeting Factor XIIa CSL a leading biotechnology company with a strong track record of developing innovative medicines for patients with rare and serious disorders, today announced that the U.S.

FDA Approval

Conversations in Drug Development Trends

OCTOBER 29, 2024

By: Juliane Mills, Senior Director, Therapeutic Strategy Lead, Rare Disease The rise of patient-led clinical research, particularly in rare disease, represents a significant shift in the clinical trial landscape. Why Is There an Increase in Patient-Led Rare Disease Research?

Clinical Research

The Pharma Data

JUNE 9, 2025

Xywav: A Low-Sodium Alternative with FDA Approval Xywav is a uniquely formulated, low-sodium oxybate therapy, and remains the only product of its kind approved by the U.S. Food and Drug Administration (FDA) for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients aged seven years and older with narcolepsy.

FDA Approval

Alta Sciences

FEBRUARY 19, 2025

Researchers must characterize the anti-drug-antibody (ADA) response in preclinical and clinical studies and report any ADA-positive samples as a risk-based approach. The FDA's draft guidance on nonclinical safety assessment calls for tailored toxicology studies to address these potential risks.

Drug Development

The Pharma Data

JUNE 24, 2025

These standards are widely recognized by regulatory agencies such as the FDA and EMA for use in analytical method development, validation, and quality control. Researchers can efficiently assess critical quality attributes such as vector integrity, purity, and size distribution throughout the development and manufacturing lifecycle.

Therapies

The Pharma Data

JUNE 12, 2025

This design was meant to enable clinician-researchers to gauge the ability of rilzabrutinib to control disease activity after the withdrawal of standard therapy. Fast Track and Orphan Drug Designations from FDA The U.S. Subsequently, rilzabrutinib was continued as monotherapy for the rest of the 52-week study period.

Disease

The Pharma Data

JUNE 25, 2025

The interim data, presented at the SMA Research & Clinical Care Meeting hosted by Cure SMA in Anaheim, California, offer a strong signal of therapeutic potential. Under the terms of the agreement, Biogen holds the exclusive worldwide rights to develop, manufacture, and commercialize salanersen.

Therapies

Alta Sciences

MARCH 4, 2025

This was in 2006, at a time when the FDA guidances on these topics had not yet been published. Over time, this group of professionals evolved and grew, having regular stakeholder interactions with the FDA and Controlled Substances staff to discuss requirements for drug developers. corticosteroids, beta-blockers, antidepressants).

Clinical Trials

The Pharma Data

JUNE 27, 2025

We are grateful to the patients, families, and researchers who made this progress possible, and we look forward to working with the health authorities to make treatment available as soon as possible.” Food and Drug Administration (FDA) and the European Medicines Agency (EMA) —to expedite review and potential approval for this new indication.

Trials

The Pharma Data

JULY 2, 2025

HK), a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), has announced the official launch of WuXiHigh™ 2.0 , a next-generation, high-throughput formulation development platform specifically engineered for high-concentration biologics. WuXi Biologics Launches WuXiHigh™ 2.0 WuXiHigh™ 2.0:

FDA Approval

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] 3] [6] [20] [21] The drug application was granted priority review and breakthrough therapy designations by the FDA. [3]

FDA

Pharma Manufacturing

JUNE 17, 2025

Despite the potential efficiencies and the FDA encouraging manufacturers to make the switch from batch processing, the pharmaceutical industry has been slow to adopt continuous manufacturing due in large part to general conservatism and the cost implications of such investments. “Those are through the FDA,” he said.

RNA

Drug Target Review

JULY 21, 2025

In Part 2 of our conversation with Layla Hosseini-Gerami, Chief Data Science Officer at Ignota Labs , we explore the many forms of toxicity and how AI-powered tools like omics and cell painting are transforming early prediction in pre-clinical research.

Drugs

Drug Target Review

NOVEMBER 25, 2024

I went on to complete my MBA and PhD at The Institute of Cancer Research (ICR) in drug development. This suited my personality and constant curiosity more than academic research. This pathway, called the PI3K pathway, had been largely researched and discarded. This has empowered me.

Treatment

Broad Institute

MAY 21, 2025

The Merkin Prize recognizes novel technologies that have improved human health and is administered by the Broad Institute, one of the worlds leading biomedical research institutes. Some researchers suspected that the body would attack and destroy the CAR T cells. Their work puts us on the doorstep of finding cures to help millions.

Therapies

The Pharma Data

JUNE 6, 2025

FDA Priority Review and Accelerated Development Pathway Sibeprenlimab has already drawn regulatory attention. Given the FDA’s acceptance of proteinuria reduction as a surrogate endpoint in IgAN trials, the strong Phase 3 results could support accelerated approval of sibeprenlimab pending final data.

Trials

Broad Institute

JUNE 24, 2025

Related groups Liu Group Related news New CRISPR genome editing system offers a wide range of versatility in human cells Researchers extend power of gene editing by developing a new class of DNA base editors In May 2025, researchers announced that K.J. This unprecedented feat required diagnosing K.J.’s

Treatment

Broad Institute

JULY 31, 2025

& The researchers systematically studied genes and proteins across the whole genome and proteome in lung tumors and paired noncancerous lung tissues from more than 400 patients from North America, Eastern Europe, and Asia, making it the largest “proteogenomic” study of any cancer to date.

DNA

New Drug Approvals

JULY 25, 2025

Vamorolone was approved by the FDA in October 2023 for the management of DMD in patients ≥2 years of age. 19] The US Food and Drug Administration (FDA) approved vamorolone based on evidence from a single clinical trial of 121 boys with DMD who were 4 to <7 years of age. Food and Drug Administration (FDA). 65 (9): 737–743.

FDA

ACTO

AUGUST 5, 2025

This partnership eliminates the lag and limitations of traditional market research, enabling dynamic feedback loops that power more effective engagement and smarter field execution. The KeyOps survey solution supports flexible quantitative research – from brief, on‑demand queries to in‑depth ATUs or AAUs – providing fast insights.

Science

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] The FDA has long supported development of non-opioid pain treatment. acting director of the FDA’s Center for Drug Evaluation and Research. under nitrogen.

FDA