Tue.Dec 06, 2022

article thumbnail

Biotech veteran Jeff Jonas on leaving Sage, guiding new biotechs and his ‘personal odyssey’

Bio Pharma Dive

In an interview with BioPharma Dive, the longtime industry executive discussed becoming a biotech investor and his plans for Abio-X, a new incubator with $150 million to spend on startups.

348
348
article thumbnail

Monoclonal antibodies challenge marketed small-molecule Alzheimer’s dominance

Pharmaceutical Technology

The three leading Alzheimer’s disease (AD) drugs currently in development are all monoclonal antibodies—donanemab by Eli Lilly , lecanemab by Eisai and Biogen , and gantenerumab by Roche. The rise of these monoclonal antibodies may change the dominance of small molecules within Alzheimer’s drugs, which account for 78% of all approved innovator drugs.

Antibody 147
Insiders

Sign Up for our Newsletter

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

article thumbnail

Star Therapeutics launches Vega, growing its galaxy of drug startups

Bio Pharma Dive

The second startup to emerge from Star’s “hub-and-spoke” model aims to develop a Hemlibra-like antibody drug for the blood clotting disorder von Willebrand disease.

Drugs 297
article thumbnail

Evaxion and ExpreS²ion partner to develop new CMV vaccine

Pharmaceutical Technology

Evaxion Biotech and ExpreS 2 ion Biotechnologies have entered a vaccine discovery collaboration agreement to co-develop a new cytomegalovirus (CMV) vaccine candidate. In the partnership’s discovery phase, RAVEN, an artificial intelligence (AI) platform of Evaxion will be leveraged for designing a next-generation vaccine candidate that induces cellular as well as humoral/antibody responses.

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

Gene therapy approvals bring validation as field closes year on high

Bio Pharma Dive

It’s been a busy fall in gene therapy, with FDA nods for new treatments from CSL and Bluebird as well as a few deals. Catch up on our best stories here.

article thumbnail

Opinion: Victims of domestic abuse should get the same top-notch concussion care as athletes

STAT News

Two vastly different experiences — serving as a “guest coach” on the sidelines for a Division I football team and volunteering in a busy emergency department — showed me just how unequal and damaging the lack of care provided for women who are victims of domestic violence can be. In the first decade of the 2000s, one of the benefits of being a professor at Wake Forest University was the opportunity I received nearly every year to serve as a guest coach.

143
143

More Trending

article thumbnail

China lends billions to poor countries. Is that a burden. or a blessing?

NPR Health - Shots

China doles out much cash for infrastructure. It must be repaid. Is that frustrating for recipients? A new survey has a surprising answer. But skeptics wonder: How honest were the participants?

143
143
article thumbnail

With $81M, Entact Bio takes a new approach to fixing helpful proteins

Bio Pharma Dive

Entact Bio aims to develop medicines that can enhance helpful proteins, rather than block harmful ones, a twist on the usual drugmaking playbook.

Protein 204
article thumbnail

Grand Rounds December 2, 2022: A Randomized Controlled Trial of Mobile Health Intervention in Heart Failure and Diabetes: Lessons Learned (G. Michael Felker, MD, MHS)

Rethinking Clinical Trials

                                          . Speakers. Michael Felker, MD, MHS. Professor of Medicine. Director, Cardiovascular and Metabolism Research, DCRI. Slides. Keywords. Pragmatic Clinical Trials, Heart Failure, Diabetes. Key Points. Making lifestyle changes is difficult especially for people living with chronic diseases, where healthy behaviors could make a big difference.

Trials 130
article thumbnail

MEI, Kyowa stop lymphoma drug trials after FDA meeting

Bio Pharma Dive

The decision not to run a Phase 3 trial of their medicine is the latest fallout from U.S. regulators’ recent moves to closely evaluate a class of drugs known as PI3 kinase inhibitors.

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

Apple scores victory in dispute over heart monitoring technologies in Apple Watch

STAT News

In a significant victory, Apple has successfully challenged patents at the center of a high-profile dispute with medical device company AliveCor. The U.S. Patent and Trademark Office’s Patent Trial and Appeal Board, or PTAB, on Tuesday ruled that three AliveCor patents covering heart monitoring technologies for wearable devices were unpatentable.

Trials 122
article thumbnail

Verve shares slide after company reveals details on FDA trial hold

Bio Pharma Dive

In a letter to the biotech, the regulator asked for more information on its gene editing medicine for heart disease as well as on its potential risks.

article thumbnail

Psychedelic therapy is moving to the next frontier: workplace perk

STAT News

Acupuncture and chiropractic care weren’t always the common fixtures of employer benefit plans they are today. It took clamoring from workers, the accumulation of evidence, and the slow realization by businesses that those perks would be popular with workers. A similar evolution could be in store for psychedelic-assisted therapy for mental health conditions.

116
116
article thumbnail

Maintaining healthy lifestyle might prevent up to 60% of inflammatory bowel disease cases, suggests new research

Medical Xpress

Adopting and maintaining a healthy lifestyle might prevent up to 60% of inflammatory bowel disease cases—Crohn's disease and ulcerative colitis—finds a large international study, published online in the journal Gut.

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

Opinion: Pediatricians and parents on the brink: This is their March 2020

STAT News

In March 2020, as the Covid-19 pandemic swept across the United States, the nation’s pediatric providers and pediatric units immediately pitched in to treat adults sickened by this then-mysterious and deadly disease. But now that the pediatric community is facing its own March 2020 with the confluence of Covid-19, influenza, and respiratory syncytial virus (RSV), the response from outside this community has been slow.

111
111
article thumbnail

Scientists uncover biological explanation for why upper respiratory infections are more common in colder temperatures

Medical Xpress

Researchers at Mass Eye and Ear and Northeastern University have discovered a previously unidentified immune response inside the nose that fights off viruses responsible for upper respiratory infections. Further testing has revealed this protective response becomes inhibited in colder temperatures, making an infection more likely to occur.

article thumbnail

A new coalition aims to close AI’s credibility gap in medicine with testing and oversight

STAT News

To read the medical literature, you might think AI is taking over medicine. It can detect cancers on images earlier, find heart issues invisible to cardiologists, and predict organ dysfunction hours before it becomes dangerous to hospitalized patients. But most of the AI models described in journals — and lionized in press releases — never make it into clinical use.

Medicine 105
article thumbnail

Common workplace fumes and dusts may heighten rheumatoid arthritis risk

Medical Xpress

Breathing in common workplace dusts and fumes from agents such as vapors, gases, and solvents may heighten the risk of developing rheumatoid arthritis, suggests research published online in the Annals of the Rheumatic Diseases.

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

STAT+: The prices of 7 drugs were hiked without proof of new benefits, costing the U.S. $805 million in 2021

STAT News

During 2021, drugmakers substantially raised prices on seven widely used medicines without any new clinical evidence to justify the increases, leading patients and health insurers in the U.S. to spend an additional $805 million last year, according to a new report. The drug for which spending increased the most due to a price increase was Xifaxan, which is used to treat both irritable bowel syndrome and a complication of cirrhosis.

Drugs 98
article thumbnail

Comprehensive new review of COVID-19 vaccines shows they are effective

Medical Xpress

A comprehensive review of all the evidence available from randomized controlled trials of COVID 19 vaccines up to November 2021 has concluded that most protect against infection and severe or critical illness caused by the virus.

article thumbnail

STAT+: Zantac lawsuits are tossed out as judge lambasts lack of evidence showing links to cancer

STAT News

Several big drugmakers — Sanofi, GSK, Pfizer and Boehringer Ingelheim — will not have to face thousands of lawsuits claiming the Zantac heartburn drug can cause cancer after a federal judge decided consumers’ claims were not backed by sound scientific evidence. In a 341-page ruling , U.S. District Court Judge Robin Rosenberg concluded that the consumer lawsuits relied on flawed science and were therefore unable to show legitimate links between the widely used medicine and se

article thumbnail

How antibody therapy affects the breadth of COVID mRNA vaccines

Medical Xpress

Nearly three years into the pandemic, many of us now carry antibodies against the virus—due to an infection or two, a few doses of mRNA vaccine, or a round of monoclonal-antibody treatment. But not all immune responses are created equal, and how we first developed our antibodies may influence the character of our body's response to SARS-CoV-2.

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

STAT+: ‘This is not a cure’: Consensus begins to emerge on new Alzheimer’s drug

STAT News

NEW YORK — A consensus may be emerging about how to prescribe the new Alzheimer’s drug lecanemab , according to remarks made by both a critic of other Alzheimer’s medicines and the CEO of the company that developed it. Ivan Cheung, the CEO of Eisai , the lecanemab developer, said at a STAT event Monday night that if patients carry a particular genetic variant that increases the risk of bleeding in the brain when taking the drug, they should only take the medicine if they and

Drugs 98
article thumbnail

Drug development practices to improve public health policy 

Drug Discovery World

Dr Andrew Garrett, Executive Vice President of Scientific Operations at ICON, explores the benefits of integrating some of the validation and standardisation practices already developed for PIs into the practices around NPIs and public health data; outlines some of the practices that can be implemented in order to do this; and highlights the need for interdisciplinary collaboration between pharmaceutical and non-pharmaceutical researchers and public health centres to consider the overlap between

article thumbnail

STAT+: ‘Who is the real pioneer?’: Apple and AliveCor go head-to-head over crucial heart monitoring tech for smartwatches

STAT News

Two years after it accused Apple of copying its heart monitoring technology and putting it into millions of smartwatches, a small company called AliveCor may soon notch a fresh legal victory. But if you’re going to go to war with Apple, you’d better be ready to fight to the death. The allegations, raised in federal court and before the International Trade Commission, surround technologies AliveCor released in 2017 with the KardiaBand, a high-tech watchband that used the Apple Watch

article thumbnail

Keeping high blood pressure at bay for the holidays

Medical Xpress

No matter what winter holiday traditions you celebrate, you probably won't find "think about blood pressure" on your to-do list, even after checking it twice.

104
104
article thumbnail

The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.

article thumbnail

STATUS List Spotlight: A Conversation with Otis Brawley

STAT News

Editor’s note: A livestream of the conversation will be embedded below at 2 p.m. This February, STAT published our first STATUS List. This annual project aims to be the most definitive accounting of impactful individuals in health, medicine, and science. Some are well-known as changemakers; others are largely unheralded heroes. But all have compelling stories to tell.

article thumbnail

Male professional footballers' hamstring injuries and off days has doubled over the past 20 years

Medical Xpress

The proportion of hamstring injuries and associated days away from match play among male professional European footballers has doubled over the past 20 years, finds research published online in the British Journal of Sports Medicine.

article thumbnail

STAT+: U.S. delays backing for patent waivers on Covid-19 therapies and diagnostics

STAT News

The U.S. government will not support extending a Dec. 17 deadline for waiving intellectual property protection for Covid-19 diagnostics and treatments, a move that is likely to impede the chances for a World Trade Organization agreement to bolster global access to needed medical products. Instead, the U.S. trade representative indicated the Biden administration will ask the U.S.

article thumbnail

Dapagliflozin reduces risk for hospitalization in patients with CKD with or without diabetes

Medical Xpress

Dapagliflozin, a sodium-glucose cotransporter-2 (SGLT2) inhibitor, reduced the risk for hospitalization for any cause in patients with chronic kidney disease (CKD) with and without type 2 diabetes. The findings suggest that dapagliflozin should be considered in such patients. The study is published in Annals of Internal Medicine.

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.