Sat.Mar 23, 2024 - Fri.Mar 29, 2024

article thumbnail

FDA rejects Regeneron lymphoma drug, setting back company’s oncology push

Bio Pharma Dive

The agency wants Regeneron to make more progress with a confirmatory trial before clearing odronextamab, a “bispecific” antibody being developed for multiple blood cancers.

Antibody 263
article thumbnail

US FDA grants approval for Alexion’s NMOSD treatment

Pharmaceutical Technology

The US FDA has approved Alexion’s Ultomiris to treat adults with AQP4 Ab+ neuromyelitis optica spectrum disorder (NMOSD).

257
257
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

March 27, 2024: A Cluster Randomized Trial to Improve Kidney Transplant Access, in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

Drs. Amit Garg and Stephanie Dixon In this Friday’s PCT Grand Rounds, Amit Garg and Stephanie Dixon of Western University’s Schulich School of Medicine and Dentistry will present “Effect of a Multicomponent Intervention to Improve Patient Access to Kidney Transplant and Living Kidney Donation: A Pragmatic, Cluster-Randomized Trial.” The Grand Rounds session will be held on Friday, March 27, 2024, at 1:00 pm eastern.

Trials 173
article thumbnail

BioNTech hit with 'notice of default' from NIH in COVID-19 vaccine royalty dispute

Fierce Pharma

Even as Germany's BioNTech deals with ongoing declines of its revenue and share price, it's facing another serious concern: U.S. | Even as Germany's BioNTech deals with ongoing declines of its revenue and share price, it's facing another serious concern: U.S. officials are pressing the company to pay royalties linked to the commercialization of its lucrative Pfizer-partnered COVID-19 vaccine.

article thumbnail

The New Age of Decentralized Clinical Trials

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

article thumbnail

Viking stays in obesity drug race with early data for weight loss pill

Bio Pharma Dive

The results are from a small Phase 1 study, but suggest Viking’s oral GLP-1 drug may not come with high rates of gastrointestinal side effects.

Drugs 264
article thumbnail

FDA approves J&J’s OPSYNVI for pulmonary arterial hypertension

Pharmaceutical Technology

The US FDA approved Johnson & Johnson's (J&J) OPSYNVI for chronic treatment in adult patients with pulmonary arterial hypertension.

More Trending

article thumbnail

AstraZeneca’s Ultomiris Wins FDA Approval for Rare Autoimmune Disease

BioSpace

AstraZeneca’s Alexion on Monday secured the fourth indication for Ultomiris, which can now be used to treat the rare autoimmune condition neuromyelitis optica spectrum disorder.

article thumbnail

European study finds popular ALS drug ineffective

Bio Pharma Dive

The failure of a medicine known as TUDCA is yet another disappointment for ALS patients, as it comes just after Amylyx’s therapy Relyvrio proved unsuccessful in confirmatory testing.

Drugs 189
article thumbnail

Cancer Research UK and CRIS fund lung cancer vaccine research

Pharmaceutical Technology

Cancer Research UK and the CRIS Cancer Foundation have awarded a £1.7m ($2.1m) grant for developing the lung cancer vaccine LungVax.

article thumbnail

Nanoscope preps filing for retinitis pigmentosa gene therapy

pharmaphorum

Nanoscope Therapeutics is on the brink of filing for FDA approval of what could be the first gene therapy for incurable eye disease retinitis pigmentosa (RP) that can be used regardless of underlying genetic mutations.

article thumbnail

Roles and Responsibilities of Specialized Clinical Supply Experts

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.

article thumbnail

Epigenetic Editing Explodes on the Heels of Gene Editing Success

BioSpace

Ubiquitous potential, possible safety advantages and the recent growth of cell and gene therapy are driving investment in a different type of genetic editing.

article thumbnail

Stoke shares surge on updated results for Dravet drug

Bio Pharma Dive

The biotech is trying to develop a Spinraza-like drug for the condition, a form of genetic epilepsy. Fresh data appear supportive of a high dose’s effectiveness.

Drugs 169
article thumbnail

Elahere secures full approval from FDA for types of ovarian cancer

Pharmaceutical Technology

The FDA granted accelerated approval for the drug back in November 2022, and granted priority review in December 2023.

Drugs 204
article thumbnail

With Merck's key PAH approval on tap, Johnson & Johnson wins nod for combo tablet

Fierce Pharma

With the FDA expected this week to approve a first-in-class treatment from Merck for pulmonary arterial hypertension (PAH), Johnson & Johnson has beaten its New Jersey rival to the punch with a | With the FDA expected this week to approve a first-in-class treatment from Merck for pulmonary arterial hypertension (PAH), Johnson & Johnson has beaten its New Jersey rival to the punch with a nod from the U.S. regulator for its newest PAH treatment.

article thumbnail

How Machine Learning Drives Clinical Trial Efficiency

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.

article thumbnail

BioNTech Hit with NIH Notice of Default over COVID-19 Vaccine Royalties

BioSpace

The National Institutes of Health claims BioNTech is in default regarding alleged royalty payments the agency contends it is owed in connection with the company’s COVID-19 vaccine Comirnaty.

article thumbnail

Axsome drug succeeds in narcolepsy symptoms trial

Bio Pharma Dive

Despite the late-stage victory, shares of the New York-based biotech dipped more than 3%. One analyst argued that Axsome’s drug has “largely been falling under investor radars.

Drugs 169
article thumbnail

GlycoMimetics files patent for treating cancer and related conditions with compound of formula (i)

Pharmaceutical Technology

Discover GlycoMimetics Inc.'s groundbreaking patent for treating cancer and related conditions with Formula (I) compound. Learn how this method can reduce chemotherapy side effects and improve patient outcomes.

147
147
article thumbnail

In banner year, Lilly rewards CEO David Ricks with 24% boost in total pay to $26.6M

Fierce Pharma

In 2023, Eli Lilly CEO David Ricks received a 24% boost in pay from $21.4 million to $26.6 million. The increase coincides with the company's booming sales.

Sales 122
article thumbnail

What the FDA's New Dosage Guidance Means for the Future of Clinical Research

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.

article thumbnail

Brazil and Caring Cross to Produce Affordable CAR-T, Stem Cell Gene Therapies

BioSpace

Brazil’s Ministry of Health and nonprofit Caring Cross announced a collaboration Tuesday aimed at local manufacturing of CAR-T cell and stem cell gene therapies at a much lower cost than Europe and the U.S.

article thumbnail

FDA approves Merck lung disease drug acquired in $11B deal

Bio Pharma Dive

Merck is couting on Winrevair, which it acquired by buying Acceleron Pharma, to help soften the blow when Keytruda loses patent protection later this decade.

article thumbnail

Oncology in 2024: The clinical trial trends reshaping the role of CROs

Pharmaceutical Technology

CROs are fundamental to the development of cancer treatments but face multiple challenges. We analyze the biggest trends in oncology and the technological solutions available to CROs to optimize efficiencies.

article thumbnail

Novo Nordisk agrees $1.1bn takeover of RNA biotech Cardior

pharmaphorum

Novo Nordisk has agreed to buy Cardior Pharmaceuticals for $1.1 billion, adding expertise in RNA therapeutics and a heart failure therapy in mid-stage trials.

RNA 121
article thumbnail

The New Age of Decentralized Clinical Trials

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.

article thumbnail

Axsome Therapeutics’ Small Molecule Clears Phase III Trial in Narcolepsy

BioSpace

Axsome clinched a late-stage victory for its chronic sleep disorder candidate AXS-12, which demonstrated significant improvement in cataplexy—the sudden loss of muscle tone while a person is awake—after five weeks.

Trials 117
article thumbnail

Supreme Court weighs abortion opponents’ standing in mifepristone case

Bio Pharma Dive

The high court's treatment of the case, which centers on a conservative challenge to FDA decisions expanding abortion pill access, is seen as potentially consequential for the drug agency.

Drugs 152
article thumbnail

Astellas secures approval for gastric cancer antibody in Japan

Pharmaceutical Technology

The approval from Japan’s Ministry of Health, Labour, and Welfare (MHLW) is based on positive results from two studies.

Antibody 173
article thumbnail

Caring Cross, Brazil's Fiocruz team up to produce cell and gene therapies at a fraction of their cost in the US

Fierce Pharma

Maryland non-profit Caring Cross has unveiled a partnership with the Brazilian government that's designed to provide access to advanced cell and gene therapies for diseases like leukemia, lymphoma | Maryland nonprofit Caring Cross has unveiled a partnership with the Brazilian government which is designed to provide access to advanced CAR-T and gene therapies for diseases like leukemia, lymphoma and HIV infection—and in the process provide a manufacturing model that demonstrates how to reduc

article thumbnail

Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.

article thumbnail

Avenzo Closes $150M Oversubscribed Series A-1 to Advance Cancer Therapies

BioSpace

Avenzo Therapeutics on Tuesday said it will use the financing round to advance its next-generation oncology pipeline, including a potentially best-in-class CDK2 selective inhibitor.

108
108
article thumbnail

SQZ, Portal founder Armon Sharei on starting over in biotech

Bio Pharma Dive

After his first biotech startup was sold off in parts, Sharei is applying the lessons he’s learned to a new company with a different business model.

161
161
article thumbnail

Syros Pharmaceuticals files patent for treating cancer with compound of formula (i)

Pharmaceutical Technology

Discover Syros Pharmaceuticals' groundbreaking patent for treating cancer by targeting CDK7 with compounds of Formula (I). Learn about the innovative method and potential new treatment options for solid tumors.

130
130
article thumbnail

Reuters Pharma USA 2024 - Day 2

pharmaphorum

Get live coverage of the latest updates and developments from Day 2 of Reuters Pharma USA 2024. Stay informed with real-time news and insights from the event.

article thumbnail

Deliver Fast, Flexible Clinical Trial Insights with Spotfire

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.