Fri.Oct 21, 2022

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Pfizer planning steep price hike for COVID-19 vaccine

Bio Pharma Dive

The company is considering charging as much as between $110 and $130 per dose — roughly four times the vaccine’s current price — once sales transition to the private market.

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AbbVie announces acquisition of DJS Antibodies for $255m

Pharmaceutical Technology

AbbVie has announced the acquisition of UK-based biotechnology firm DJS Antibodies for nearly $255m in cash at closing. DJS focuses on the discovery and development of antibody therapies that act on difficult-to-drug disease-causing proteins, such as G protein-coupled receptors (GPCRs). The company leverages its HEPTAD platform to facilitate the antibody discovery of GPCRs and other difficult targets. .

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Speedy FDA approvals in focus as agency weighs withdrawal of preterm birth drug

Bio Pharma Dive

The FDA will soon decide whether to pull Covis’ Makena from the market, more than three years after its confirmatory study failed. The delay highlights the need for reforms to the accelerated approval program, critics say.

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A game of two halves for Roche’s recently approved wet AMD assets

Pharmaceutical Technology

Of late, it seemed that all the stars had aligned well for Roche in the wet age-related macular degeneration (wAMD) space. With Susvimo (ranibizumab sustained release) winning US FDA approval last year, followed by an FDA approval for Vabysmo (faricimab) this year, Roche had all the right assets to take the game to the current market leader, Regeneron and Bayer’s Eylea (aflibercept), at an accelerated pace.

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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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Karnataka embarks on inspections to ensure quality of four cough syrups that led to death of 66 children in Gambia

AuroBlog - Aurous Healthcare Clinical Trials blog

The Karnataka drugs control department is insisting that all the cough syrup manufacturers dealing in ethylene glycol and diethylene glycol will now need to procure solvents like glycerin and propylene glycol complying to pharmacopeia standards directly from manufacturers as required under para 10 of the Schedule M of the Drugs & Cosmetics Act, 1945.

Cosmetics 159
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Health department medical detectives find 84% of U.S. maternal deaths are preventable

NPR Health - Shots

More than half of these deaths occur well after the mom leaves the hospital. To save lives, mothers need more support in the "fourth trimester, that time after the baby is born," one researcher says.

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Text message therapy for depression works in young adults

pharmaphorum

Young adults with depression have been treated effectively with a cognitive behavioural therapy (CBT) course – delivered via text message – in a pilot study conducted by researchers in the US. The trial looked at a four-week CBT course adapted from a face-to-face programme to work via text messages, followed by a four-week follow-up period, in around 100 young adults in the US with at least one symptom of moderate depression and no recent history of antidepressant therapy.

Research 112
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Opinion: Support family caregivers to improve and diversify clinical trials

STAT News

During the Covid-19 pandemic, America’s 53 million family caregivers gained some long overdue recognition for their vital role as unpaid extenders of an under-resourced health care workforce. The clinical trial enterprise, however, has yet to appreciate caregivers — and fully engage them — as critical partners in recruiting and supporting people who are older, disabled, or have Alzheimer’s disease, cancer, or other chronic medical conditions for research studies.

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GSK continues campaign for greater adult immunisation coverage

pharmaphorum

The UK company reveals the results from a partner-led survey to discover the rates of vaccination for adults, why levels are lower than expected, and what can be done to improve this. Ben Hargreaves examines the reasons supplied by the survey and why GSK is invested in the answers. The emergence of COVID-19 meant that public awareness around vaccination and its importance in fighting the spread of infectious disease has increased rapidly.

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Medicare is going to cap patients’ spending on drugs. But there’s no such limit for hospital or doctor bills

STAT News

By 2025, people on Medicare who take expensive medications will feel significant financial relief : They will not have to pay more than $2,000 in a year for all of their drugs. But the 35 million people who are enrolled in the traditional Medicare program still won’t have that same relief anytime soon for their hospital, outpatient, home health, and nursing home care, leaving them exposed to potentially unlimited costs if they become seriously ill and don’t have supplemental covera

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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.

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ICR’s new study tracks disease progression in children with rare type of cancer

Pharma Times

Researchers assessed whether measuring DNA shed by cancer cells into the bloodstream could track tumour progression

DNA 125
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STAT+: Inside Michelle McMurry-Heath’s departure from BIO: Firings, internal clashes, and a pivotal job review

STAT News

WASHINGTON — Only two years ago, Michelle McMurry-Heath was named chief executive of BIO, the world’s largest biotech trade organization. She was hailed by her predecessor as a “great leader.” So her swift and abrupt exit from the role earlier this month shocked the industry. But it was set in motion in late summer, when the Biotechnology Innovation Organization’s board of directors dispatched an outside firm to produce an “assessment” of her perf

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Remote work opened some doors to workers with disabilities. But others remain shut

NPR Health - Shots

Workplaces have generally become more accommodating for people with disabilities in the last five years, according to a new survey. But some disability rights activists say challenges persist.

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STAT+: Up and down the ladder: The latest comings and goings

STAT News

Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others.  That’s right. Send us your changes, and we’ll find a home for them.  Don’t be shy. Everyone wants to know who is coming and going. And here is our regular feature in which we highlight a different person each week.

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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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Vanderbilt's pediatric transgender care clinic is one of several under assault

NPR Health - Shots

Some clinics paused gender-affirming surgeries for minors due to pushback from critics. Conservative activists say they want to protect kids. Parents of teen patients say the care is saving lives.

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STAT+: Pharmalittle: Pfizer plans to quadruple price of its Covid-19 vaccine; pharma pushed to tie exec compensation to access to meds

STAT News

And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is rather modest so far. We plan to tidy up around the castle, visit with the Pharmalot ancestors, and promenade with the official mascot. And what about you? As we have noted previously, this is a fine time to rummage about pumpkin patches and apple orchards, or hop in your motor car to whiz through the countryside and enjo

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Kite and Refuge Biotechnologies to work together to research blood cancer

Pharma Times

The licence agreement bolsters Kite’s expertise in synthetic biology for oncology

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STAT+: This summer’s Covid surge was bad for hospital profits

STAT News

​​This summer’s Covid-19 surge put a sizable dent in hospital finances, with two large investor-owned chains reporting lower revenue and profits in the recently-ended third quarter compared to the same period a year ago. Stocks in HCA Healthcare and Tenet Healthcare shed north of 10% and 30% of their value at times, respectively, on Friday following their underwhelming reports for the quarter, which ended September 30.

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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.

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Innovation Brings Unwavering Patient Support in a New Era of Specialty Medicine

Drug Channels

Today’s guest post comes from Megan Marchal, Director of Specialty Pharmacy Strategy at CoverMyMeds. Megan discusses upcoming specialty medication launches. As she explains, patients will need extra help to overcome the challenges of access, affordability, and adherence. Learn more about CoverMyMeds’ patient-centric technology solutions by downloading their Access Report: Oncology Edition.

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Opinion: Research funding is broken. Using a lottery approach could fix it

STAT News

Thirty years ago, Katalin Karikó had what was then an outlandish idea: use messenger RNA as a medicine. But getting funding to demonstrate that might be possible was impossible, despite three decades of trying. One rejection she might now be able to laugh about was a research opportunity with funding for six scientists. It received seven applications — Karikó’s was the only one that wasn’t funded.

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New patent for Ocular Therapeutix drug DEXTENZA

Drug Patent Watch

Annual Drug Patent Expirations for DEXTENZA Dextenza is a drug marketed by Ocular Therapeutix and is included in one NDA. It is available from one supplier. There are three patents…. The post New patent for Ocular Therapeutix drug DEXTENZA appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 75
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AbbVie acquires DJS for $255m cash, fortifies immunology pipeline

pharmaphorum

The acquisition of DJS Antibodies, a privately-held UK-based biotechnology company dedicated to discovering and developing antibody medicines that target difficult-to-drug disease-causing proteins – such as G protein-coupled receptors (GPCRs) – will extend AbbVie’s present discovery research capabilities, through DJS’ proprietary HEPTAD platform. The HEPTAD platform generates potential novel antibodies against difficult-to-drug protein targets in immunology, and has specific capabilities which t

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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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Movement Breaks Research Study Needs Sedentary Adults

Trialfacts

Contents. About the Study. Why Participate? Your Rights. Who Can Participate? More Study Details. About the Research Centers: Study Locations. Research Center 1 : The University of British Columbia – Okanagan Campus. Location: 3333 University Way, Kelowna, BC V1V 1V7, Canada. Research Center 2: McMaster University. Location: 1280 Main St W, Hamilton, ON L8S 4L8, Canada.

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Medicines Patent Pool, Novartis pen deal to boost access to generic leukaemia drug

pharmaphorum

The Medicines Patent Pool (MPP) and Novartis have unveiled a new voluntary licensing agreement to allow generic drugmakers in seven middle income nations to develop, manufacture, and supply generic versions of the leukaemia treatment nilotinib. Fittingly announced on the sidelines of the World Cancer Congress, this marks the first time that the MPP has signed a license for a cancer treatment, and the first time a company is licensing a patented cancer medicine through a public health-oriented vo

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Clinical Study Startup and Execution: Hidden Causes Behind Big Delays

Imperical Blog

Before you plan your next study, please read this first. Planning and conducting a clinical trial presents numerous challenges, and we find that many sponsors and CROs repeatedly miss important areas when planning their studies. These planning gaps result in: Delayed clinical study startup Missing… The post Clinical Study Startup and Execution: Hidden Causes Behind Big Delays appeared first on Imperial Clinical Research Services Blog.

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South Korean proteomics company Bertis expands to the US

Drug Discovery World

Bertis, a South Korean proteomics-based precision medicine technology company, has established a US-based wholly-owned entity to expand its global presence. The subsidiary, called Bertis Bioscience, aims to establish a San Diego-based CLIA-certified lab facility in early Q4, 2022. It will offer proteomics-based screening and diagnostic tests, as well as an analysis platform to integrate multi-omics data.

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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.

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Food Safety Best Practices: Lessons Learned from the COVID-19 Pandemic

XTalks

A recent review published in the Journal of Public Health Management and Practice revealed the challenges of conducting retail food inspections during the COVID-19 pandemic, as well as lessons learned regarding food safety best practices. The review explains how local health departments can prioritize retail food regulations if unprecedented public health emergencies occur in the future.

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Boston researchers criticised over creation of Covid-19 variant

Drug Discovery World

A research team from Boston University has caused controversy for work involving the creation of a hybrid SARS-CoV-2 virus. . Researchers from Boston University’s National Emerging Infectious Diseases Laboratories conducted a study 1 to create a chimeric virus which combined the spike protein of the Omicron variant with the initial Wuhan strain of Covid-19. .

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Roche, Hookipa Pharma agree $25 million deal for arenaviral immunotherapy

pharmaphorum

Swiss pharma giant Roche has moved to strengthen its position in the KRAS-mutated cancer space through a $25 million licensing and collaboration agreement with Austrian arenaviral technology firm Hookipa Pharma. The deal focuses on Hookipa’s HB-700 program, an investigational arenaviral immunotherapy designed to treat KRAS-mutated lung, colorectal, pancreatic, and other cancers.

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Jazz acquires rights to HER2-targeted bispecific antibody

Drug Discovery World

Under an exclusive agreement, Jazz Pharmaceuticals will acquire development and commercialisation rights to Zymeworks’ zanidatamab across all indications and all territories except for those Asia/Pacific territories previously licensed by Zymeworks. Zymeworks will receive a $50 million upfront payment, a second payment of $325 million, at Jazz’s option, and further potential regulatory and commercial milestones up to $1.76 billion, plus royalties on net sales.

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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.