Sat.Jan 21, 2023 - Fri.Jan 27, 2023

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Three VCs launch Dimension, a new firm with plans to fuel biotech’s ‘digitization’

Bio Pharma Dive

The veteran investors see the marriage of tech and life sciences as the “largest opportunity in venture today,” said co-founder and former Lux Capital general partner Adam Goulburn.

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Current and future players in the lupus market

Pharmaceutical Technology

Systemic lupus erythematosus (SLE) is a systemic, inflammatory, chronic autoimmune disease that can affect multiple organs simultaneously or sequentially, with a relapsing and remitting nature. While SLE can affect multiple major organ systems in the body, one of its most severe manifestations is renal (kidney) involvement, known as lupus nephritis (LN).

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STAT+: Pfizer is scolded by a U.K. trade group for remarks its CEO made about vaccination

STAT News

After weeks of deliberation, Pfizer was scolded by a U.K. pharmaceutical industry trade group after its chief executive officer made misleading statements in a media interview about the need to vaccinate young children against Covid-19. The fracas began when the Pfizer chief, Albert Bourla, gave an interview to the BBC and discussed the idea of vaccinating children between five and 11 years old, a course of action that had not yet been approved by regulators in the U.K.

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Anti-aging gene shown to rewind heart age by ten years

Medical Xpress

An anti-aging gene discovered in a population of centenarians has been shown to rewind the heart's biological age by 10 years. The breakthrough, published in Cardiovascular Research and led by scientists at the University of Bristol and the MultiMedica Group in Italy, offers a potential target for patients with heart failure.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Roivant’s Matt Gline on the hub-and-spoke biotech model and lessons learned from Axovant

Bio Pharma Dive

This year could stay turbulent for the biotech sector as investors look for what the Roivant CEO described in an interview with BioPharma Dive as “safe harbors in a storm.

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FDA accepts Lilly-Boehringer Ingelheim’ sNDA for Jardiance

Pharmaceutical Technology

Eli Lilly and Company and Boehringer Ingelheim have announced that the US Food and Drug Administration (FDA) accepted a supplemental New Drug Application (sNDA) for Jardiance (empagliflozin) tablets for chronic kidney disease (CKD) in adult patients. Jardiance is currently being evaluated as a potential therapy for reducing kidney disease progression and cardiovascular death risk in CKD adult patients.

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Most Americans say overturning Roe was politically motivated, NPR/Ipsos poll finds

NPR Health - Shots

An NPR/Ipsos poll finds that most Americans say Supreme Court justices are guided more by their politics than the law, and that lawmakers aren't deciding abortion policy based on public sentiment.

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Pliant shares jump on new data for lung disease drug

Bio Pharma Dive

A high dose of the company’s experimental medicine appeared potent in patients with idiopathic pulmonary fibrosis, an elusive target for drugmakers. The results are from a small and short clinical trial, however.

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Health Canada accepts Veru’s Covid-19 therapy NDS-CV for review

Pharmaceutical Technology

Health Canada has accepted for review Valeo Pharma partner Veru’s new drug submission (NDS-CV) for Covid-19 therapy sabizabulin. The new dual antiviral and anti-inflammatory agent Sabizabulin is being developed to treat hospitalised adult patients with moderate to severe Covid-19 who are at high acute respiratory distress syndrome (ARDS) and mortality risk.

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FDA scientists propose an annual Covid shot matched to current strains

STAT News

Scientists at the Food and Drug Administration propose making Covid vaccination a regular, once-a-year shot that is updated to match current strains of the SARS-CoV-2 virus, according to documents posted by the FDA on Monday. For people who are older or immunocompromised, the FDA would recommend two annual doses of the revised shot.

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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

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Scientists explain emotional 'blunting' caused by common antidepressants

Medical Xpress

Scientists have worked out why common anti-depressants cause around half of users to feel emotionally "blunted." In a study published today in Neuropsychopharmacology, they show that the drugs affect reinforcement learning, an important behavioral process that allows people to learn from their environment.

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FDA to seek outside advice on Biogen’s ALS drug

Bio Pharma Dive

The agency plans to convene a panel of experts on March 22 to discuss the approval application for tofersen, a closely watched medicine Biogen submitted to the FDA despite its failure in a key clinical trial.

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EU approves Daiichi Sankyo-AstraZeneca’s breast cancer therapy

Pharmaceutical Technology

The European Union (EU) has granted approval for Daiichi Sankyo and AstraZeneca ’s Enhertu (trastuzumab deruxtecan) as monotherapy to treat unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer adult patients. Enhertu has been approved for patients who have previously received chemotherapy in the metastatic setting or who have seen disease recurrence during or in six months after adjuvant chemotherapy.

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FDA considers major shift in COVID vaccine strategy

NPR Health - Shots

The new approach would simplify vaccination guidance so that, every fall, people would get a new shot, updated to try to match whatever variant is dominant.

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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.

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FDA pulls AZ’s Evusheld for COVID, citing lack of efficacy

pharmaphorum

AstraZeneca’s revenue boost from COVID-19 therapy Evusheld looks set to be curbed early, as the FDA withdraws authorisation for the antibody on the grounds that it is ineffective against most subvariants now circulating in the US. Evusheld (tixagevimab and cilgavimab) was cleared by the FDA towards the end of 2021, becoming the first antibody to be authorised for prevention of COVID-19 infection, and it rapidly found use among people with compromised immune systems, such as cancer chemothe

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FDA weighs shift in COVID vaccination strategy

Bio Pharma Dive

Agency scientists are proposing to update COVID shots once a year to match circulating coronavirus strains, as well as simplifying current vaccination regimens.

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Opinion: How a checklist can help decolonize global health research

STAT News

When institutions in the United States and other high-income countries embark on collaborations to improve health or the delivery of health care in low-income countries, they do it with the best of intentions. But intentions aren’t good enough. Projects conducted by trainees at schools of medicine, public health, and other health disciplines in high-income countries can often make the problems they set out to address worse.

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50 years after Roe v. Wade, many abortion providers are changing how they do business

NPR Health - Shots

The overturning of the Roe v. Wade decision just months ahead of its 50th anniversary has prompted many abortion providers to shift how they serve patients. (Image credit: Rogelio V.

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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.

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A new dawn of the genomic age: five areas set to be transformed in 2023

pharmaphorum

2022 was a banner year for genomics. In March, the collaborative T2T consortium published the first complete telomere-to-telomere sequence of the human genome, filling in the last 8% of the 3 billion base pairs that make up our DNA. And in the UK specifically, genomics remained high on the national agenda, with several significant government programmes and investments announced – including the Newborn Genomes Programme in healthcare and the Precision Breeding Bill in the agricultural sector.

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Merck gets a ‘surprise’ win for Keytruda in early lung cancer

Bio Pharma Dive

The FDA gave the top-selling immunotherapy a broad label in adjuvant lung cancer despite mixed results in the main study supporting its application, taking one Wall Street analyst by surprise.

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New test could detect Alzheimer's disease 3.5 years before clinical diagnosis

Medical Xpress

New research from the Institute of Psychiatry, Psychology & Neuroscience (IoPPN) at King's College London has established a blood-based test that could be used to predict the risk of Alzheimer's disease up to 3.5 years before clinical diagnosis.

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25 people in Florida are charged with a scheme to get fake nursing diplomas

NPR Health - Shots

The defendants allegedly took part in a scam that sold more than 7,600 fraudulent nursing degree diplomas from three Florida-based nursing schools, according to recently unsealed federal indictments. (Image credit: D.A.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

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

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After nearly 4 years of deliberation, FDA punts on how to regulate CBD

STAT News

WASHINGTON — The FDA is giving up on trying to figure out a way to regulate CBD on its own. The agency announced Thursday that it is formally calling on Congress for help — and, according to one official, looking for guidance on other hemp products like Delta 8 THC, too. For nearly four years, the Food and Drug Administration has been laboring to craft a solution that would allow CBD to be legally sold in capsules, gummy vitamins, and various foods, even though the agency also cons

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J&J puts focus on cancer drugs in push to reach 2025 sales target

Bio Pharma Dive

The drugmaker reported fourth quarter revenue that fell short of forecasts, but reiterated confidence in reaching a $60 billion pharmaceutical sales goal.

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Researchers map the effects of dietary nutrients on disease

Medical Xpress

Researchers at the Francis Crick Institute and King's College London have created a tool to predict the effects of different diets on both cancerous cells and healthy cells.

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UV nail dryers may pose cancer risks, a study says. Here are precautions you can take

NPR Health - Shots

A new study finds that UV dryers for gel nail polish can damage DNA and mutate cells, confirming dermatologists' safety concerns. There are precautions you can take and alternatives to consider.

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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.

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STAT+: A different kind of ‘RAC’ subsidized hospitals’ labor during the pandemic

STAT News

Hospitals have bemoaned rising employee expenses throughout the pandemic, as they’ve paid workers more to prevent them from jumping to competitors, pursuing traveling gigs, or leaving the profession completely. But some, like those in Texas, have been able to bring in traveling nurses and other temporary staff on the taxpayers’ dime.

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Veteran biotech leader George Scangos to step down as Vir CEO

Bio Pharma Dive

The former Biogen head is retiring after taking Vir from a small startup to a publicly traded developer of infectious disease drugs. Bayer executive Marianne De Backer will succeed him.

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It's the trendy diet method, but does intermittent fasting really work?

Medical Xpress

Diet trends come and go, but intermittent fasting, a form of dieting based around periods of non-eating followed by periods of concentrated eating, has somehow endured.

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To reignite the joy of childhood, learn to live on 'toddler time'

NPR Health - Shots

The days might seem long, but the years go by quickly, friends warned when my son was born. I wanted to savor each precious memory, but how? Living on "toddler time," showed me the way.

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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.