Pharmaceutical Technology
AUGUST 23, 2022
Gilead Sciences has obtained the European Commission (EC) marketing authorisation for Sunlenca (lenacapavir) injection and tablets to treat human immunodeficiency virus (HIV) infection. The twice-yearly treatment is indicated to be administered along with other antiretroviral(s) in adult patients with multi-drug resistant HIV infection who otherwise cannot have a suppressive anti-viral regimen.
Bio Pharma Dive
AUGUST 23, 2022
At least 10 biotechnology startups are trying to use RNA molecules in new ways to make medicines. Here’s a look at where they stand.
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World of DTC Marketing
AUGUST 23, 2022
Consumers would ask their doctor about an advertised prescription drug in a perfect world. In our REAL world, that isn’t the way it happens. Is there a disconnect between what DTC marketers think will happen and what happens with DTC? The research was straightforward. Ask current patients what drove them to get an Rx for a branded product (MS drug).
Bio Pharma Dive
AUGUST 23, 2022
The biotech successfully brought two medicines to market, but shares have lost most of their value amid sluggish sales.
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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
Pharmaceutical Technology
AUGUST 23, 2022
The US Food and Drug Administration (FDA) has granted Orphan Drug Designation to Ocelot Bio’s OCE-205 to treat hepatorenal syndrome. A lead candidate of the company, OCE-205 is a peptide therapeutic. Possessing a distinguished mechanism of action (MOA), it acts on serious hemodynamic complications caused by liver fibrosis and portal hypertension in end-stage liver disease (ESLD).
Bio Pharma Dive
AUGUST 23, 2022
The five-year partnership is one of many inked between the cancer center and drugmakers like Erasca, which is targeting a cellular pathway linked to many types of tumors.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Rethinking Clinical Trials
AUGUST 23, 2022
? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ?. Speakers. Gerald Bloomfield, MD, MPH. Associate Professor with Tenure, Medicine. Associate Professor, Global Health. Duke University School of Medicine. Michelle Kelsey, MD. Assistant Professor of Medicine. Duke University School of Medicine. Slides. Keywords. Diversity, Inclusion.
STAT News
AUGUST 23, 2022
Noted biotech investment firm OrbiMed slid from first place to 14th in STAT’s latest annual ranking of venture capital firm performance. OrbiMed, which is based in New York City, is one of the most prominent players in the health care investing world. It manages $18 billion in assets, some of which the firm has invested in startups like Acceleron Pharma, which was acquired by Merck last year for $11.5 billion.
pharmaphorum
AUGUST 23, 2022
France’s BrainVectis, a subsidiary of Bayer’s Asklepios BioPharma (AskBio) unit, has been given the green light by regulators in France to start dosing patients with its gene therapy candidate for devastating neurodegenerative disorder Huntington’s disease. The phase 1/2 study is due to get underway before the end of the year and will test BrainVectis’ one-shot BV-101 gene therapy, which will be delivered using an adeno-associated virus (AAV) vector directly to areas of
NPR Health - Shots
AUGUST 23, 2022
Monkeypox is spreading primarily among gay and bisexual men, and owners of bars that serve that community feel well-positioned to share information without adding to stigma against LGBTQ people.
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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
pharmaphorum
AUGUST 23, 2022
Japan’s Takeda has secured its first regulatory approval – in Indonesia – for its dengue fever vaccine TAK-003, which has been tipped as a potential blockbuster product. Indonesia’s National Agency for Drug and Food Control (BPOM) has approved the vaccine as Qdenga to protect against the virus in people aged six to 45, on the back of data showing that it can cut dengue-related hospitalisations by 84%, with 61% protective efficacy against symptomatic illness seen up to three years aft
Outsourcing Pharma
AUGUST 23, 2022
The groupâs latest report glimpses inside the minds of pharma leaders, who are looking at a productâs full life-cycle development at the preclinical stage.
NPR Health - Shots
AUGUST 23, 2022
A hospital's cost calculator said her procedure would be $1,400 for patients without insurance. Instead, the bill was almost $18,000 and, her part was more than $5,000 — the balance of her deductible.
STAT News
AUGUST 23, 2022
As much as she tried, Judy Akin couldn’t shed the baby weight. So she’d spend hours hiking the breathtaking coast of Oahu almost every day, planning her treks around shifts as a catering manager at a local hotel. There’s a picture of her in her early forties, smiling into a camera, wearing an electric blue tank top that’s still not as blue as the water behind her.
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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.
BioPharma Reporter
AUGUST 23, 2022
The WHO has updated its advice on COVID-19 booster doses: including recommendations on which groups should receive a second booster shot and how countries should plan around the upcoming availability of variant-specific vaccines.
STAT News
AUGUST 23, 2022
As the world continues to learn how to live with Covid-19 in the long run, scientists are testing ways to quickly tell people how well-protected they are against the virus, and whether they need another booster. A new study , published Monday in Cell Reports Methods, presents a simple test to detect neutralizing antibodies against SARS-CoV-2, using little more than a finger prick and a testing cartridge.
Drug Discovery World
AUGUST 23, 2022
A Phase I/II clinical trial targeting a treatment for Huntington’s Disease (HD) using a gene therapy has been given the clearance to go ahead in France. . The National Agency for Safety of Medicines and Health Products (ANSM) gave the go-ahead to Bayer AG to conduct the clinical trial through its subsidiary BrainVectis to investigate its gene therapy, BV-101 in the treatment for Huntington’s Disease (HD). .
STAT News
AUGUST 23, 2022
I was slouched in my lab seat during a lecture on osteopathic principles and practices, doing my best to pay attention but admittedly thinking more about lunch than the blood flow of the head. Suddenly, as I was observing a beautiful illustration of the venous drainage of the brain, a name at the bottom of the screen stunned me. Image adapted from Pernkopf’s Atlas 3 rd Edition.
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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.
FDA Law Blog
AUGUST 23, 2022
By Lisa M. Baumhardt, Senior Medical Device Regulation Expert & Richard A. Lewis, Senior Regulatory Device & Biologics Expert — We are almost three years into the public health emergency as a result of the COVID-19 pandemic, and still only have 19 rapid antigen tests authorized for at-home use in the United States. The primary barrier to bringing new antigen tests to market has been FDA’s minimum requirement of 80% sensitivity for authorization.
STAT News
AUGUST 23, 2022
Recent years have seen a surge of research into rarer forms of kidney disease, with drug companies, regulators, and researchers alike hunting for ways to help patients who have few options. Much of that progress can be traced to the early strategy of the Kidney Health Initiative, a public-private partnership.The partnership, formed in September 2012 by the American Society of Nephrology and the Food and Drug Administration, made one of its first priorities trying to help dissolve some of t
pharmaphorum
AUGUST 23, 2022
Pfizer and BioNTech have asked the FDA for emergency authorisation of an Omicron-targeted COVID-19 booster vaccine ahead of the planned autumn immunisation campaign in the US. The new version of their Comirnaty vaccine includes mRNA for the spike protein of the wild-type SARS-CoV-2 that first emerged in late 2019, as well as for the BA.4 and BA.5 subvariants of the now-dominant Omicron variant.
STAT News
AUGUST 23, 2022
Biomanufacturing has produced important materials, ingredients, therapeutics, and more for decades, yet it is still far from a mature industry. Given life’s 3.5 billion years of experimentation on Earth , it takes a lot of effort and resources to fully unleash nature’s potential for societal gain. That said, biomanufacturing is entering a new age, spurred by the growth of synthetic biology and renewed investment in bioprocess innovations and technologies.
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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.
Outsourcing Pharma
AUGUST 23, 2022
A leader suggests considering patient views and needs all along the clinical development path reaps a number of benefits, including time and cost savings.
STAT News
AUGUST 23, 2022
You’re reading the web edition of STAT Health Tech, our guide to how tech is transforming the life sciences. Sign up to get this newsletter delivered in your inbox every Tuesday and Thursday.
Pharma Times
AUGUST 23, 2022
The marketing authorisation application is supported by results from a phase 3 trial for AML
NPR Health - Shots
AUGUST 23, 2022
NPR's Mary Louise Kelly talks with Dr. Anthony Fauci about his decision to retire after nearly 40 years as the head of the National Institute of Allergy and Infectious Disease.
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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.
Pharma Times
AUGUST 23, 2022
Despite current treatments, the mortality rate for patients with invasive candidiasis remains high
NPR Health - Shots
AUGUST 23, 2022
The veterinary sedative xylazine is being mixed into illegal drugs and could be contributing to a rise in overdoses. (Story first aired on Weekend Edition Saturday on July 30, 2022.
pharmaphorum
AUGUST 23, 2022
Swiss eyecare firm Alcon has made a move to boost its position in ophthalmological medicines with a $15.25 per share offer to buy Aerie Pharmaceuticals that value the US company at around $770 million. If completed, the deal will add two commercial products to Alcon’s range – glaucoma therapies Rocklatan (netarsudil/latanoprost) and Rhopressa (netarsudil) – as well as a pipeline of clinical and preclinical drug candidates currently headed by AR-15512, in phase 3 for dry eye disease.
NPR Health - Shots
AUGUST 23, 2022
Rising temperatures can be deadly for people without air conditioning. There are a few programs to provide units for those who can't afford them, but the demand is growing.
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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.
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