Bio Pharma Dive

APRIL 18, 2024

Analysts had low expectations for Cerevel’s drug tavapadon, which was something of an afterthought in AbbVie’s proposed buyout of the biotech.

Drugs 302

Drugs 302

BioSpace

APRIL 14, 2024

GLP-1 treatments are all the rage in this space, but they aren’t the only approach in development. The pipeline assets highlighted here offer a differentiated approach, potentially increasing efficacy or reducing side effects.

Marketing 120

Marketing Drugs Development 120

Pharmaceutical Technology

APRIL 18, 2024

Clearmind Medicine has entered into a licensing agreement with Yissum to develop Generation 3.0 psychedelic compounds for mental disorders.

Licensing 246

Licensing Licensing Medicine Development 246

Rethinking Clinical Trials

APRIL 17, 2024

Dr. Joseph Ross In this Friday’s PCT Grand Rounds, Joseph Ross of Yale University will present “The Yale Open Data Access (YODA) Project: 10 Years of Clinical Trial Data Sharing.” The Grand Rounds session will be held on Friday, April 19, 2024, at 1:00 pm eastern. The YODA Project promotes open science, research transparency, and the sharing of clinical research data to support healthcare research.

Clinical Trials 161

Clinical Trials Clinical Trials Clinical Research Trials 161

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Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

Clinical Research

Bio Pharma Dive

APRIL 18, 2024

The start of a so-called rolling review formally begins an FDA evaluation of a closely watched drug that’s important to the biotech’s future, but faces questions about its sales potential.

Sales 296

Sales Drugs 296

Pharma Mirror

APRIL 17, 2024

As an authority in radiation oncology, Dr. Khuntia joining the board of directors validates BNCT and the work TAE Life Sciences is doing to make it a mainstay of modern cancer care IRVINE, Calif.- TAE Life Sciences, a pioneer in advancing Boron Neutron Capture Therapy (BNCT) for cancer treatment, proudly announces the appointment of Dr. Deepak “Dee” Khuntia, M.D., FASTRO, to its esteemed Board of Directors.

Life Science 130

Life Science 130

Fierce Pharma

APRIL 17, 2024

One-year data continued to support a more convenient, injectable version of Roche’s blockbuster multiple sclerosis (MS) drug Ocrevus ahead of an FDA decision, the Swiss pharma said. | One-year data continued to support a more convenient, injectable version of Roche’s blockbuster multiple sclerosis drug Ocrevus ahead of an FDA decision, the Swiss pharma said.

Drugs 133

Drugs 133

Bio Pharma Dive

APRIL 15, 2024

Treatment appeared to result in functional and cognitive gains in people with the neurological disorder. Three participants experienced lower extremity weakness, however.

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300

BioSpace

APRIL 18, 2024

Following a months-long safety review, the regulator on Thursday said it is now requiring black box warnings for all commercially available CAR-T therapies to reflect the risk of secondary malignancies.

Regulation 103

Regulation 103

Pharmaceutical Technology

APRIL 19, 2024

The US Food and Drug Administration (FDA) has granted fast-track designation to Bayer subsidiary Asklepios BioPharmaceutical’s (AskBio) investigational gene therapy AB-1002, aimed at treating congestive heart failure (CHF).

Gene Therapy 245

Gene Therapy Gene Drugs 245

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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

Clinical Trials

Fierce Pharma

APRIL 18, 2024

Novo Nordisk is receiving pushback from a trio of lawmakers over its decision to discontinue its long-acting insulin product Levemir, which was due for a steep discount at the start of the new year | Novo Nordisk is receiving pushback from a trio of lawmakers on its decision to discontinue its long-acting insulin product Levemir, which was due for a steep discount at the start of the new year.

Insulin 118

Insulin Production 118

Bio Pharma Dive

APRIL 15, 2024

Because live cell and tissue products are extremely sensitive to contamination from microorganisms, viral particles or other airborne impurities, research and manufacturing involving these materials needs to be conducted in a cleanroom environment.

Contamination 258

Contamination Manufacturing Production Research 258

BioSpace

APRIL 14, 2024

Metabolic dysfunction-associated steatohepatitis experts welcomed Madrigal’s Rezdiffra as an “important first," but there are more mid- to late-stage therapies showing promising results.

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Pharmaceutical Technology

APRIL 16, 2024

The price ceiling policy has been in place for more than 20 years, but it has neither been very successful nor free of consequences for pharma companies.

Pharma Companies 277

Pharma Companies Marketing 277

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Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

Clinical Trials

Fierce Pharma

APRIL 18, 2024

During a busy period of overhaul at Sanofi, the company is restructuring its U.S. vaccine commercial group. | During a busy period of overhaul at Sanofi, the company is restructuring its U.S. vaccine commercial group. A spokesperson said the company would offer affected employees a chance to apply for new roles, plus "outplacement services.

Vaccination 112

Vaccination Vaccine 112

Bio Pharma Dive

APRIL 15, 2024

Learn about why access to robust biomarkers such as cfHPV-DNA is pivotal in determining eligibility, assessing treatment response and detecting recurrence early to improve patient outcomes.

DNA 258

DNA Development 258

XTalks

APRIL 17, 2024

In this episode, Ayesha spoke with Howard Berman, PhD, Founder and CEO of Coya Therapeutics , a clinical-stage biotech company developing regulatory T cell (Treg) therapies targeting neurodegenerative, autoimmune and metabolic diseases. Dr. Berman founded Coya Therapeutics in 2021. Howard Berman, PhD Founder and CEO Coya Therapeutics Dr. Berman has over 18 years of entrepreneurial and industry experience working at the interplay of science and business.

Life Science 105

Life Science Production Development 105

Pharmaceutical Technology

APRIL 17, 2024

Estetrol is under clinical development by Mithra Pharmaceuticals and currently in Phase III for Genitourinary Syndrome of Menopause (GSM).

Clinical Development 246

Clinical Development Development 246

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

Clinical Research

Fierce Pharma

APRIL 19, 2024

Roche isn’t content with Alecensa being the best-selling ALK inhibitor in metastatic lung cancer. | Roche isn’t content with Alecensa being the best-selling ALK inhibitor in metastatic lung cancer. The Swiss pharma has now secured an FDA approval in the post-surgical setting as it continues to test the drug in additional patient populations.

FDA Approval 103

FDA Approval Drugs 103

Bio Pharma Dive

APRIL 18, 2024

It’s “early innings” in the obesity drug race, said Metsera CEO Clive Meanwell, whose company has acquired a portfolio of medicines it aims to test in combination.

Drugs 195

Drugs Medicine 195

pharmaphorum

APRIL 16, 2024

A smart sensor developed by Adherium has been cleared by the FDA for use with AstraZeneca's asthma inhaler Airsupra and Breztri for COPD.

Development 129

Development 129

Pharmaceutical Technology

APRIL 18, 2024

Inflammation, cell metabolism and neuronal health are current key areas of focus for dementia researchers, according to Jane Osbourn, chief scientific officer (CSO) at Alchemab.

Research 204

Research 204

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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

Clinical Supply

Fierce Pharma

APRIL 17, 2024

In addition to their acclaimed efficacy against diabetes and obesity, GLP-1 drugs are gaining traction for their potential to treat a variety of other common disorders. | In addition to their acclaimed efficacy against diabetes and obesity, GLP-1 drugs are gaining traction for their potential to treat a variety of other common disorders. Now, two trials have shown that Eli Lilly’s weight loss product Zepbound (tirzepatide) can help patients overcome obstructive sleep apnea (OSA).

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Trials Production Drugs 115

Bio Pharma Dive

APRIL 16, 2024

Joel Marcus, the longtime head of Alexandria Real Estate Equities, sees few near-term challengers to the established biotech hubs of Boston, San Diego and San Francisco.

Research 204

Research 204

BioSpace

APRIL 16, 2024

With Wednesday’s readout showing symptom improvements in obstructive sleep apnea patients, Eli Lilly is preparing to file for a label expansion for its top-selling weight-loss drug Zepbound.

Drugs 107

Drugs 107

Pharmaceutical Technology

APRIL 17, 2024

LX2006 consists of adeno-associated virus (AAV) vector carrying the frataxin gene, responsible for causing Friedreich’s ataxia.

Gene Therapy 234

Gene Therapy Gene 234

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This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

Clinical Trials

Fierce Pharma

APRIL 16, 2024

Despite a pair of clinical misfires in 2023, argenx has stuck by the thesis that its star drug Vyvgart, also known as efgartigimod, could tackle a wide array of autoimmune diseases linked to immuno | Argenx is bolstering its case for Vyvgart’s CIDP potential and preparing for a possible launch later this year—all while the company continues to prove the medication’s worth in its inaugural generalized myasthenia gravis indication.

Drugs 114

Drugs 114

Bio Pharma Dive

APRIL 19, 2024

The agreement may help Alvotech capitalize on a recent policy shift by CVS that has driven major market share declines for AbbVie’s blockbuster drug.

Marketing 177

Marketing Drugs 177

BioSpace

APRIL 17, 2024

Teva Pharmaceuticals and Alvotech got the FDA’s greenlight for their biosimilar to Johnson & Johnson’s blockbuster Stelara, which will launch in the U.S. in February 2025.

FDA Approval 101

FDA Approval 101

Pharmaceutical Technology

APRIL 19, 2024

The US Food and Drug Administration (FDA) has granted approval for Takeda’s ENTYVIO subcutaneous (SC) administration as a maintenance therapy to treat adults with moderately to severely active Crohn's disease (CD).

FDA Approval 147

FDA Approval Drugs 147

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Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.

Clinical Trials