Mon.Jan 30, 2023

article thumbnail

FDA approves cancer drugs from Lilly, Menarini

Bio Pharma Dive

The agency’s clearance of Jaypirca gives Lilly another win from its Loxo buyout, while Menarini Group’s bet on Radius Health’s oral SERD has now paid off with Orserdu’s OK.

article thumbnail

Babies May Not Be Born With a Microbiome After All, Scientists Say

AuroBlog - Aurous Healthcare Clinical Trials blog

For more than a century, the womb has been largely considered a sterile environment. Yet even today, with advanced medical technology at hand, researchers cannot come to a consensus over whether the placenta and the amniotic fluid that bathes a fetus are truly germ-free or not.

Scientist 187
Insiders

Sign Up for our Newsletter

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

article thumbnail

Biotech CFOs eye research cuts, partnerships amid sector retrenchment: report

Bio Pharma Dive

The report, a yearly poll of 100 financing executives by accounting and consulting firm BDO, revealed the many levers young drugmakers are pulling to conserve cash.

Research 340
article thumbnail

EC approves Regeneron-Sanofi’s Dupixent for eosinophilic esophagitis

Pharmaceutical Technology

The European Commission (EC) has granted marketing authorisation for Regeneron Pharmaceuticals and Sanofi ’s Dupixent (dupilumab) to treat eosinophilic esophagitis (EoE). Dupixent’s expanded authorisation in the European Union (EU) is intended to treat 12 years and older patients with EoE, who are inadequately controlled by, are not tolerant to, or people who are not candidates for conventional medicinal treatments.

Medicine 162
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

How are digital biomarkers reshaping Parkinson’s disease research?

Bio Pharma Dive

Your Parkinson’s disease trials need better data. Hear how digital biomarkers change the game.

Research 246
article thumbnail

Lilly’s Jaypirca received FDA approval to treat MCL

Pharmaceutical Technology

Eli Lilly and Company ’s (Lilly) oncology unit Loxo@Lilly has secured the US Food and Drug Administration (FDA) approval for Jaypirca (pirtobrutinib) to treat relapsed or refractory mantle cell lymphoma (MCL). Jaypirca has been approved to treat MCL in adult patients who had previously received a minimum of two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor.

More Trending

article thumbnail

January 30, 2023: NIH Pragmatic Trials Collaboratory Begins 2023 With New Cores in Health Equity and Implementation Science

Rethinking Clinical Trials

Dr. Rosa Gonzalez-Guarda (left) and Dr. Cherise Harrington (right) The NIH Pragmatic Trials Collaboratory began 2023 with 2 new Core Working Groups focused on health equity and implementation science. The membership of both Cores draws from across the program to support the design and implementation of the NIH Collaboratory Demonstration Projects. “By launching these 2 new Core Working Groups, the NIH Pragmatic Trials Collaboratory is reaffirming its commitment to generating knowledge that suppo

Trials 130
article thumbnail

Experts advise European SME packaging firms to expand or seek acquisition prior to Pharmapack Europe

Pharma Mirror

2023 will see continued packaging consolidation, increased device viscosity capabilities and a more forgiving MDR runway Paris – Ahead of next week’s returning Pharmapack Europe 2023 (February 1-2) the event’s panel of experts predict increased consolidations in 2023 – driven by supply chain concerns and big pharma preferences – a relaxation of MDR deadlines and high viscosity delivery as the biggest area of device innovation.

Packaging 130
article thumbnail

Decline of novel drug approvals means less business for cutting-edge CMOs

Pharmaceutical Technology

The FDA approved fewer innovative drugs, New Molecular Entities (NMEs), in 2022 than it did in 2021: only 42 drugs compared to 59 drugs. This is due to generally more stringent criteria on approvals in the wake of the Aduhelm scandal. However, non-NME and biosimilar approvals increased in 2022. This is mixed news for contract manufacturing organisations (CMOs), as large CMOs such as Thermo Fisher Scientific (Waltham, MA, US) and Catalent Inc (Somerset, NJ, US) are typically involved in the manuf

Drugs 130
article thumbnail

India should adopt ANAC usage of IAF CertSearch for verifying certificates of medical devices for QA: Experts

AuroBlog - Aurous Healthcare Clinical Trials blog

India should adopt the Italian Anticorruption Authority (ANAC) usage of the International Accreditation Forum (IAF) CertSearch for verifying certificates of medical devices for quality assurance (QA), according to experts.

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

H2 2022 to see the decline of Covid-19 vaccines as forecasts decrease

Pharmaceutical Technology

Despite the continued success of prophylactic vaccines such as Pfizer /BioNTech’s messenger RNA (mRNA) vaccine Comirnaty and spikes in COVID-19 case numbers over the winter, prophylactic COVID-19 vaccines sales forecasts have seen an average decline between H1 2022 and H2 2022 of 7% in their predicted total forecast sales between 2022 and 2028, according to GlobalData’s Coronavirus Disease 2019 (COVID-19) Sector Forecast: H2 2022 Global Analyst Consensus Sales Forecast report.

article thumbnail

STAT+: Medicare Advantage insurers to repay billions under final federal audit rule

STAT News

The federal government will audit Medicare Advantage insurers aggressively under a rule finalized Monday, which is expected to result in billions of dollars in overpayments going back toward Medicare’s trust fund and patients over the next decade. However, federal officials watered down one of the auditing policies by giving insurers seven years of immunity from having the samples of their diagnosis coding errors extrapolated to their broader Medicare Advantage membership.

145
145
article thumbnail

A baby spent 36 days at an in-network hospital. Why did her parents get a huge bill?

NPR Health - Shots

A family had more than $12,000 in medical bills they couldn't explain after their baby was delivered early. It turns out the doctors who cared for her worked at a different, out-of-network hospital.

Doctors 136
article thumbnail

STAT+: FDA may not always require post-approval trials to be enrolled before accelerated approvals

STAT News

WASHINGTON — A Food and Drug Administration official on Monday gave more clues for how the agency plans to wield new authority to make drug companies enroll post-market clinical trials before granting speedy drug approvals.  That new power is part of reforms to the FDA’s accelerated approval path that Congress recently passed. Accelerated approvals allow the agency to provide fast access to drugs for serious and life-threatening diseases by approving them based on test results

Trials 126
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

QUIZ: Test your knowledge of spillover viruses, starting with. what are they?

NPR Health - Shots

As we launch a series about spillover viruses — like SARS-CoV-2, which triggered a global pandemic, you may have a lot of questions. So do we — 7, to be exact, in the quiz below.

124
124
article thumbnail

STAT+: ‘Everybody has blood on their hands’: A decade-long battle over Medicare Advantage audits is coming to a head

STAT News

The federal government and health insurance companies have been clashing for more than a decade over how Medicare Advantage plans should be audited and how the well-documented overpayments to those plans should be clawed back. That fight is about to hit an inflection point this week, when Medicare makes a final determination about how aggressively it will probe the industry.

124
124
article thumbnail

The White House plans to end COVID emergency declarations in May

NPR Health - Shots

The declarations have been extended several times since they were first enacted back in 2020. The plan could have implications for several COVID-related policies, such as funds for tests and vaccines.

article thumbnail

STAT+: No more ‘playing God’: How the longevity field is trying to recast its work as serious science

STAT News

SAN FRANCISCO — “Why is it in popular culture, if you want to live forever, you are evil and you want to kill babies on the side?” says Martin Borch Jensen. It’s fast approaching 10 p.m. on the first night of the J.P. Morgan Healthcare Conference , and among a couple stragglers at a dinner for longevity CEOs, scientists, and investors, the conversation has turned from the practical or merely social to the philosophical.

Scientist 122
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

After cancer diagnosis, a neurosurgeon sees life, death and his career in a new way

NPR Health - Shots

Dr. Henry Marsh felt comfortable in hospitals — until he was diagnosed with advanced prostate cancer. "I was much less self-assured now that I was a patient myself," he says. His book is And Finally.

124
124
article thumbnail

STAT+: Pharma wins a key round in a court battle with hospitals over a drug discount program

STAT News

In a victory for the pharmaceutical industry, a federal appeals court ruled drug companies have the right to limit discounts to hospitals that rely on numerous contract pharmacies as they participate in a U.S. government drug discount program. The decision was made in response to lawsuits that were originally filed by three large drugmakers — Sanofi, Novo Nordisk, and AstraZeneca — that the federal government was unlawfully interpreting key provisions in the controversial 340B drug

Drugs 119
article thumbnail

Appeals court clears the way for more lawsuits over Johnson's Baby Powder

NPR Health - Shots

A U.S. appeals court has dismissed the bankruptcy case filed by a Johnson & Johnson spinoff company. Around 40,000 cancer patients have filed suit, alleging the powder was contaminated with asbestos.

article thumbnail

Fewer known risk factors, but heightened risk of cardiovascular disease in people with celiac disease

Medical Xpress

People with celiac disease might have fewer known risk factors for cardiovascular disease, but still have a heightened risk of developing it, finds a study led by researchers from Oxford Population Health, published online in the journal BMJ Medicine.

Medicine 115
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

Wegovy works. But here's what happens if you can't afford to keep taking the drug

NPR Health - Shots

The new weight-loss drugs can be life-changing for people facing health conditions worsened by obesity, but price and spotty insurance coverage may keep them out of reach.

Drugs 115
article thumbnail

Opinion: As it turns 40, the Orphan Drug Act for rare diseases needs a refresh

STAT News

This month marks the 40th anniversary of the Orphan Drug Act. Since it was signed into law in 1983, the FDA has approved more than 1,100 treatments for rare diseases. The act also created an industry that didn’t exist in the United States before its enactment, enabling the formation of companies to develop and commercialize therapies for rare diseases.

RNA 111
article thumbnail

Evolutionary history of SARS-CoV-2 leads to a universal vaccine already being tested in animal models

Medical Xpress

By taking inspiration from the evolutionary history of SARS-CoV-2 itself, scientists in China have crafted a new vaccine that, at least in animal models, provides protection against omicron and an array of its subvariants.

article thumbnail

An older person's money management errors may be a sign of some sort of dementia

NPR Health - Shots

Alzheimer's and other forms of dementia leave seniors at risk for financial mismanagement and exploitation. With few regulatory safeguards, it falls on families to monitor the risk and intervene.

109
109
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

Understanding long-term changes in the synapses between the hypothalamus and hippocampus

Medical Xpress

The complexity of the human brain is unparalleled. Fortunately, thanks to constant progress in neuroscience over the past decades, we have started to make some sense of it. For instance, we now know that neuronal synapses can undergo long-lasting changes in response to their activity and that of nearby neurons, and it is believed this "synaptic plasticity" is one of the key mechanisms behind learning and memory.

105
105
article thumbnail

Milestone product launch for Kelso Pharma

Pharma Times

Acepiro tablets for respiratory diseases will be available across the UK prescription market

article thumbnail

'Spleen-on-a-chip' yields insight into sickle cell disease

Medical Xpress

Every day, billions of red blood cells pass through the spleen, an organ that is responsible for filtering out old or damaged blood cells. This task is made more difficult when the blood cells are misshapen, as they are in patients with sickle cell disease, which affects millions of people throughout the world. Sickled blood cells can clog the spleen's filters, leading to a potentially life-threatening situation.

Research 105
article thumbnail

President Biden to end Covid-19 emergencies on May 11

STAT News

WASHINGTON — President Joe Biden informed Congress on Monday that he will end the twin national emergencies for addressing Covid-19 on May 11, as most of the world has returned closer to normalcy nearly three years after they were first declared. The move to end the national emergency and public health emergency declarations would formally restructure the federal coronavirus response to treat the virus as an endemic threat to public health that can be managed through agencies’ norm

98
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.