Fri.Aug 26, 2022

article thumbnail

Moderna sues Pfizer, BioNTech over COVID-19 vaccine technology

Bio Pharma Dive

The biotech claims its rivals’ vaccine Comirnaty, one of the world’s top-selling pharmaceutical products, infringes on two patents covering its messenger RNA technology.

article thumbnail

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
Insiders

Sign Up for our Newsletter

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

article thumbnail

Takeda ends deal with Finch as bumpy ride continues for microbiome drugs

Bio Pharma Dive

The pharma company terminated a collaboration that could’ve netted the biotech about $350 million. It’s the latest in a string of recent setbacks for microbiome drug developers.

article thumbnail

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

article thumbnail

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

article thumbnail

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?

143
143
article thumbnail

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

More Trending

article thumbnail

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.

article thumbnail

Moderna sues Pfizer over COVID-19 vaccine patents

NPR Health - Shots

The vaccine maker alleges that its rivals Pfizer and BioNTech used some patented features of its mRNA technology to develop their COVID vaccines. (Image credit: Rogelio V.

article thumbnail

Monkeypox vaccine: First EUA for Bavarian Nordic amid worldwide shortages

Pharmaceutical Technology

Amid a shortage of monkeypox vaccine doses, the WHO and FDA have declared public health emergencies, and the FDA has granted its first Emergency Use Authorization (EUA) to a monkeypox vaccine and opened the door for more. On August 4, the US Department of Health and Human Services (HHS) declared monkeypox a public health emergency, a move required to grant EUAs.

article thumbnail

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.

145
145
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

Moderna sues Pfizer and BioNTech over Covid-19 vaccine

STAT News

Moderna on Friday sued Pfizer and BioNTech, its main rivals in the mRNA Covid vaccine race, for allegedly infringing on its patents, the latest and perhaps most significant in a series of intellectual property disputes over the technology behind the world-changing and astoundingly lucrative shots. In its complaint , the Cambridge, Mass.-based company said it is not seeking damages prior to March 8, 2022, before which the company said it would not enforce its patents because of the Covid-19 publi

article thumbnail

Coronavirus FAQ: Does a faint line on a self-test mean I'm barely contagious?

NPR Health - Shots

These days the world of at-home testing for COVID-19 is confusing. How often do I need to test to see if I'm really positive — or negative? Does a faint line mean I'm less contagious?

110
110
article thumbnail

There’s nothing simple about chronic conditions. A complexity researcher has some ideas to improve care

STAT News

Having a chronic disease can feel like a full-time job. There are the symptoms, the flare-ups, the medications and therapies and appointments. And there are tiny adjustments to be made all the time — to a sitting position, a meal, a plan, an expectation.  And, just like in any job, a person’s ability to do the work required of their chronic disease (or, more likely, their two or more chronic conditions) fluctuates.

Research 116
article thumbnail

At 988 call centers, crisis counselors offer empathy — and juggle limited resources

NPR Health - Shots

In a mental health crisis, a conversation with an empathetic listener can be live-saving. But when someone needs in-person help, there's a shortage of resources in many parts of the country.

110
110
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

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

133
133
article thumbnail

Opinion: Monkeypox public health response is lagging for LGBTQ+ community

STAT News

I’m a 29-year-old gay man living in New York City during the first major wave of monkeypox infections in the United States. As the CEO and co-founder of a health care startup, I am very connected to the world of public health — especially public health that impacts LGBTQ+ people. So I assumed I could get vaccinated against monkeypox fairly easily.

article thumbnail

Pfizer’s RSV vaccine candidate shows promise in older adults study

Pharma Times

It is estimated that RSV infections in older adults account for 177,000 hospitalisations and 14,000 deaths each year in the US alone

article thumbnail

STAT+: Moderna’s suing Pfizer? Wow! OK, now take a deep breath.

STAT News

It’s the stuff that headline writers’ dreams are made of: Moderna is suing Pfizer and BioNTech over their Covid vaccines. As someone who has written dozens of catchy headlines about patent suits and read hundreds more, let me offer a bit of advice: Take several deep breaths. Most likely, this is less dramatic than it seems.

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

Droplet-array sandwiching: Biochemical tools from droplets

Drug Discovery World

Scientists showcase how the concentration of chemicals in droplets can be efficiently controlled by running experiments in the tiniest of cell cultures. These findings could be u seful for more effective drug screening and cell-based analys is. Droplet-array sandwiching technology (DAST) lets one use droplets as tiny reaction chambers or cell culture media.

article thumbnail

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.

Reagent 98
article thumbnail

Early signs suggest monkeypox may be slowing in the U.S.

NPR Health - Shots

Rates of new cases are declining in major cities, suggesting public health campaigns are working.

124
124
article thumbnail

STAT+: Pharmalittle: Moderna sues Pfizer over Covid-19 vax patents; White House directs quick access to federally funded research

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. For now, our agenda is rather modest, since we are planning to shuttle our short person back to an institution of higher learning and sort out sundry chores on the Pharmalot campus. And what about you?

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

Your Brand Just Got Added to a Must-Have Formulary: Now What?

Drug Channels

Today’s guest post comes from Chris Dowd, Senior Vice President of Market Development at ConnectiveRx. Chris discusses the benefits of using in-electronic health record (EHR) messaging to communicate formulary information to both healthcare providers and patients during the patient encounter. Click here to learn more about ConnectiveRx’s in-EHR messaging.

article thumbnail

Moderna sues Pfizer/BioNTech over COVID-19 vaccine tech

pharmaphorum

The rivalry between Moderna and Pfizer/BioNTech in commercialising their COVID-19 vaccines has now spilled over into the courts, in the form of a patent infringement lawsuit. Moderna has filed complaints in the US and Germany claiming that the mRNA technology used to make Pfizer and BioNTech’s Comirnaty vaccine infringes multiple patents that cover its own Spikevax shot.

article thumbnail

Full Lifecycle Recruiting to Improve a Life Sciences Organization’s Recruitment Efforts

XTalks

Full lifecycle recruitment can help life science and pharma companies find the best talent to fill job postings. It differs from traditional recruiting because it is a more involved hiring process. Full lifecycle recruiting involves everything from preparing the job posting to making sure the new hire has a great onboarding and orientation. Recruiters, HR leaders and leaders in the life sciences and pharma who manage people can benefit from using full lifecycle recruiting to enhance a life scien

article thumbnail

New patent for Azurity drug NYMALIZE

Drug Patent Watch

Annual Drug Patent Expirations for NYMALIZE Nymalize is a drug marketed by Azurity and is included in one NDA. It is available from one supplier. There are five patents protecting…. The post New patent for Azurity drug NYMALIZE appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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

Checking In With Boomerang Jordan Deatherage

Intouch Solutions

Here at EVERSANA INTOUCH, we have dozens of boomerangs. No, not the wooden kind – our “boomerangs” are employees who leave, then return to work here. Why? Well, we let them tell it. Today, we’re hearing from Jordan Deatherage, Account Director, EVERSANA INTOUCH. . After having my third child, I made the decision to take time off work. I had a great boss, a fantastic team, and really enjoyed my job, but I felt as though my family’s schedule was getting out of control, with my first child e

article thumbnail

New patent for Glenmark Specialty drug RYALTRIS

Drug Patent Watch

Annual Drug Patent Expirations for RYALTRIS Ryaltris is a drug marketed by Glenmark Specialty and is included in one NDA. It is available from one supplier. There are twelve patents…. The post New patent for Glenmark Specialty drug RYALTRIS appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
article thumbnail

A life scientist’s how-to guide for organoids

Drug Discovery World

Learn best practices to consider for organoid work, as well as how to use Corning Matrigel matrix and other products to support research. Organoids have gained popularity over the years due to their ability to self-organise into “mini-organs” capable of recapitulating their respective organ-specific functions. Products such as Corning Matrigel matrix can help streamline workflows for more efficient culturing, storing and handling.

article thumbnail

Radiopharma specialist Aktis’ first-round financing swells to $156m

pharmaphorum

Aktis Oncology has gone back for another bite of the cherry in its Series A round, adding another $84 million to the $72 million raised last year to help bring its radiopharmaceuticals to market. The extension to the first round saw participation from the venture capital arm of Merck & Co plus other investors – Bristol-Myers Squibb and Novartis were already on board – and takes the total raised by the Massachusetts biotech to $161 million.

DNA 52
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.