Sat.Aug 20, 2022 - Fri.Aug 26, 2022

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Safety worries spur Novartis to suspend drug dosing in Huntington’s trial

Bio Pharma Dive

Researchers reported signs of nerve damage in patients treated with the drug branaplam, which is among the most advanced candidates now in testing.

Drugs 299
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Gilead’s Sunlenca receives EC approval to treat HIV

Pharmaceutical Technology

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.

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What should DTC do?

World of DTC Marketing

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).

Branding 243
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New study use musical tests for early detection of cognitive decline

Pharma Times

Researchers at Tel Aviv University used a portable brain activity-measuring device to detect cognitive decline in older people

Research 147
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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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Pfizer follows GSK with positive Phase 3 results for RSV vaccine

Bio Pharma Dive

In a pre-planned interim data analysis, Pfizer said its shot was strongly protective against severe disease and plans to submit the results to regulators this fall.

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EC grants approval for BioMarin’s gene therapy to treat Hemophilia A

Pharmaceutical Technology

The European Commission (EC) has granted conditional marketing authorisation (CMA) for BioMarin Pharmaceutical ’s gene therapy, Roctavian (valoctocogene roxaparvovec), to treat adults with severe haemophilia A (congenital Factor VIII deficiency). The treatment is indicated for patients with no history of Factor VIII inhibitors and any detectable antibodies to adeno-associated virus serotype 5 (AAV5).

More Trending

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Children's hospitals are the latest target of anti-LGBTQ harassment

NPR Health - Shots

The harassment campaigns are organized online, raising questions about what role social media platforms should play in preventing abuse.

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Next-generation RNA technologies: making longer-lasting drugs with a broader reach

Bio Pharma Dive

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.

RNA 336
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PAN-TB’s Phase II trials take a shot at shorter TB regimens

Pharmaceutical Technology

The Project to Accelerate New Treatments for Tuberculosis (PAN-TB) is banking on a collaborative approach to scientific innovation to address the growing problem of drug resistance in tuberculosis (TB). Last week, the collaborative announced that it is executing a joint development agreement (JDA) to advance two novel drug regimens to Phase II clinical trials by 2023.

Trials 246
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What is pharma’s responsibility for online health information?

World of DTC Marketing

Research has shown that 74% of all U.S. adults use the Internet, and 61% have looked for health or medical information on the Internet. Additionally, 49% have accessed a website that provides information about a specific medical condition or problem. Many people get health information from the Internet but are left on their own to determine if it’s credible.

Doctor 227
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Released during COVID, some people are sent back to prison with little or no warning

NPR Health - Shots

"Where is the fairness?" One mother was sent back after a single failed drug test, and her family's life has now been turned upside down for more than a year.

Drugs 145
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Backed by $40M, a biotech startup targets cancer with help from the immune system

Bio Pharma Dive

After several years in stealth, 3T Biosciences is launching publicly with plans to develop newer types of T cell receptor-based treatments.

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ElevateBio and Pittsburgh University to establish biomanufacturing centre

Pharmaceutical Technology

ElevateBio has signed a long-term strategic collaboration with the University of Pittsburgh, US, to establish a biomanufacturing centre for expediting cell and gene therapy development. Under the 30-year deal, ElevateBio will set up its next BaseCamp process development and Good Manufacturing Practice (GMP) manufacturing facility in Pittsburgh. This centre will be equipped with its supporting technologies, such as gene editing induced pluripotent stem cell (iPSC) and cell, vector and protein eng

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Jazz Pharmaceuticals’ epilepsy drug advances into phase 3 trial

Pharma Times

Epidiolex may ease symptoms associated with Doose syndrome, a rarer type of childhood-onset epilepsy

Trials 141
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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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Kid Cudi says he had a stroke at 32. Hailey Bieber was 25. How common are they?

NPR Health - Shots

Strokes in adults under 45 are on the rise. Now artist Kid Cudi — long considered an ambassador for mental health issues — and model Hailey Bieber have opened up about their experiences.

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Merck backs radiopharmaceutical startup Aktis, joining other high-profile backers

Bio Pharma Dive

The pharma contributed to an $84 million round for the new cancer drugmaker, which attracted Novartis and Bristol Myers Squibb in an earlier fundraise.

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China NMPA grants IND clearance for Ascletis’ Covid-19 therapy

Pharmaceutical Technology

The China National Medical Products Administration (NMPA) has granted clearance for Ascletis Pharma’s Investigational New Drug (IND) application of its drug candidate, ASC10, for Covid-19. An RNA-dependent RNA polymerase (RdRp) inhibitor, ASC10 is an oral double prodrug. Compared to molnupiravir, a single prodrug, ASC10 has a varied chemical structure.

In-Vivo 162
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Opinion: Surgeons fold against Medicare’s stacked deck

STAT News

Casinos dazzle you with flashing lights, high-stakes tables, and the chance to win millions of dollars. The house always wins, but casinos still trick people into thinking they will make money. Substitute Medicare for casinos and you can see what physicians who take risks with the country’s largest health payer are up against. I’m an orthopedic surgeon, so I’ll focus here on this specialty.

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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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Young adults are using marijuana and hallucinogens at the highest rates on record

NPR Health - Shots

The National Institutes of Health annually surveys substance abuse among young adults in its Monitoring the Future study.

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Ovid turns to gene therapy startup to restock drug pipeline

Bio Pharma Dive

The New York biotech will invest in and develop up to three drugs with Gensaic, an emerging startup aiming to use the viruses that infect bacteria to deliver genetic medicines.

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Novartis announces plans to spin off Sandoz business

Pharmaceutical Technology

Novartis has announced plans to completely spin off its generics and biosimilars division, Sandoz, to create a new publicly traded standalone firm. The latest development is intended to increase shareholder value by establishing a top European generics firm and a leader in biosimilars internationally. This will aid shareholders of Novartis to entirely take part in possible upside for Sandoz and Novartis Innovative Medicines businesses in the future.

Medicine 147
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MIT’s AI model can detect Parkinson’s by tracking breathing patterns

Pharma Times

The tool uses a series of connected algorithms that can assess if someone has PD from their nocturnal breathing

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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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It's definitely not a good year to be a motorcycle taxi driver in Nigeria

NPR Health - Shots

They've been banned in many districts in bustling Lagos. Commuters who rely on the taxis are in a pickle. And the drivers can't earn a living. What's behind this prohibition?

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Novartis begins plans to spin off generic drug business

Bio Pharma Dive

After reviewing multiple options including a possible sale, the Swiss drugmaker said spinning off Sandoz would give the division “greater freedom to operate” and capitalize on newly growing sales.

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Opinion: To improve children’s health in low-income countries, put pediatric surgery on par with preventing malaria or HIV

STAT News

The devastation caused by malnutrition, HIV, tuberculosis, and malaria in low income countries is well known in the U.S. and other high-income countries, due in part to masterful marketing that has elevated these diseases into the collective consciousness — and convinced many people to open their wallets. But this narrow focus on fundraising and aid limits the public good that comes from investing in child health.

Marketing 137
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Long COVID but short on treatment options

pharmaphorum

With COVID-19 vaccines and therapeutics developed in rapid time, Ben Hargreaves investigates why this has not been the case with the creation of a treatment for Long COVID. The condition is more common than might be thought and presents a significant burden to patients, and yet the pipeline of potential therapies remains relatively sparse. When the pandemic first struck, the gravity of the situation did not take long to set in.

Vaccine 134
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Why stinky sweat is good for you

NPR Health - Shots

So sweat doesn't really smell bad at all. But when bacteria eat the sweat — nostrils, look out! Only it turns out that these sweat-eating critters are responsible for a big health benefit.

Bacteria 143
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Aerie’s glaucoma drug journey ends in $770M sale to Alcon

Bio Pharma Dive

The biotech successfully brought two medicines to market, but shares have lost most of their value amid sluggish sales.

Sales 290
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In early research, an AI model detects signs of Parkinson’s using breathing patterns

STAT News

James Parkinson first flagged a link between changes in breathing patterns and the debilitating disease that now bears his name. But since his work in the early 19th century, only minimal progress has been made in treating a condition that has become alarmingly prevalent. A study published Monday offers a glimmer of new hope.

Research 137
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PathAI expands AI-driven partnership with BMS

Pharmaceutical Technology

PathAI has expanded a multi-year partnership agreement with Bristol Myers Squibb (BMS) to leverage artificial intelligence (AI)-powered pathology in translational research and clinical trials. In the initial stage, the deal will focus on key translational research in oncology, fibrosis and immunology areas to advance the work into clinical development.

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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.