April, 2021

article thumbnail

Positive data in hand, TG Therapeutics readies MS drug for FDA review

Bio Pharma Dive

If approved, TG's drug would join Roche's fast-selling Ocrevus and Novartis' newer entrant Kesimpta as one of a newer class of multiple sclerosis therapies.

Drugs 363
article thumbnail

COVID-19: Some ignored facts

World of DTC Marketing

QUICK THOUGHT: People believe the COVID-19 vaccine was developed in less than a year but that’s not true. Coronaviruses were first encountered in April 1930, when a strange respiratory disease ravaged poultry farms across North Dakota and Minnesota, killing tens of thousands of baby birds. Further scientific research into the virus and recognition that it was not like influenza A, a flu virus known to cause bronchitis, would transpire over the next 30 years. .

Insiders

Sign Up for our Newsletter

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

article thumbnail

Plant-based COVID-19 vaccine candidate starts rolling review with Health Canada

BioPharma Reporter

Medicago has started a rolling submission with Health Canada for its plant-derived adjuvanted COVID-19 vaccine candidate: championing a unique and versatile platform that can also be scaled up easily.

article thumbnail

University of Oxford-Novavax Malaria Vaccine Demonstrates 77% Efficacy in Children

BioSpace

The same group at the University of Oxford and the Jenner Institute that developed the AstraZeneca-Oxford COVID-19 vaccine reported that their investigational malaria vaccine, R21/Matrix-M, demonstrated 77% efficacy in children over 12 months of follow-up.

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

GDPR represents an “urgent threat” to the EU’s research leadership role

pharmaphorum

More than 5,000 collaborative studies were thwarted by GDPR rules in 2019 – but is there a way to protect sensitive data while still allowing international health research to thrive? . A coalition of European academy networks has called upon European Union (EU) leaders to rethink how General Data Protection Regulation (GDPR) rules are applied to health data.

Research 145
article thumbnail

Millions Are Skipping Their Second Doses of Covid Vaccines

NY Times

Nearly 8 percent of those who got initial Pfizer or Moderna shots missed their second doses. State officials want to prevent the numbers from rising.

More Trending

article thumbnail

Social media and prescription drugs: A study

World of DTC Marketing

QUICK READ: A two-month analysis of social media and prescription drugs found the number one reason online health seekers use social media is to share and ask questions about medication side effects. I also found an abundance of medication misinformation based on personal experiences and hearsay. In conjunction with leading consumer magazine I worked on a study to determine why people were using social media for information on prescription drugs and to examine and quantify what they were sharing

Drugs 294
article thumbnail

Moderna to take mRNA flu and HIV vaccines into Phase 1 trials this year

BioPharma Reporter

Moderna will take mRNA flu and HIV vaccines into Phase 1 trials this year, as well as beginning a pivotal Phase 3 study for its cytomegalovirus (CMV) vaccine candidate.

article thumbnail

Death, Disability Among Side Effects of Chinese COVID-19 Vaccines, Leaked Documents Reveal

BioSpace

Leaked documents from provincial and municipal governments in China reveal a slew of previously unreported severe adverse events related to COVID-19 vaccines made and administered in China.

article thumbnail

UK Vaccine Taskforce head lifts lid on Novavax deal

pharmaphorum

The UK’s unique offering as a life sciences research hub helped convince US biotech Novavax to develop its COVID-19 jab there, according to the head of the country’s Vaccines Taskforce. . Last August the UK government finalised a deal with Novavax to purchase 60 million doses of the NVX-CoV2373 vaccine, which will also be manufactured in the country at a plant owned by FUJIFILM Diosynth Biotechnologies in Stockton-on-Tees.

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

Vaccines Won’t Protect Millions of Patients With Weakened Immune Systems

NY Times

Many cannot produce enough infection-fighting cells to fend off the coronavirus. But researchers are testing one therapy that may help: monoclonal antibodies.

Antibody 130
article thumbnail

The next 2 months in biotech and pharma will be busy. Here's what to watch.

Bio Pharma Dive

New developments could come soon for two coronavirus vaccines while, a bit further off, the fate of Biogen's Alzheimer's drug hangs in the balance. Important data are expected, too, for Vertex and Sarepta.

article thumbnail

Reaching HCPs online

World of DTC Marketing

QUICK READ: Recent research from Zoom Rx saying that digital interactions with HCPs are myopic and don’t apply to the heavily segmented HCP audience. The future of reaching HCPS is both on and off-line depending on the product, health condition, and specialty. Zoom Rx recently polled HCPs and found 78% of physicians want to maintain some contact with pharma reps.

Doctors 286
article thumbnail

Take the next step into CROY 2021

Pharma Times

The 2021 Clinical Researcher of the Year – The Americas competition is reaching out to the very best in the industry to take the next step and claim gold.

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

mRNA Tech Used in COVID-19 Vaccines Could be Used to Cure HIV, Cancer and More

BioSpace

Researchers are leveraging the messenger RNA (mRNA) technology used to develop the Pfizer-BioNTech and Moderna COVID-19 vaccines for possible treatments for a range of other diseases, including HIV and cancer.

article thumbnail

Apple, Google block NHS contact tracing app update on privacy grounds

pharmaphorum

A scheduled update to the NHS COVID-19 app has been blocked because it allows location tracking – something prohibited by Apple and Google, which developed some of the code it uses. . The new version of the app used in England and Wales was due to become available today to coincide with the relaxation of lockdown rules, with the public now able to attend venues such as non-essential shops, pub beer garden, gyms and hairdressers.

article thumbnail

What Ever Happened to Coke with Stevia?

XTalks

In 2018 , Coke tested their Coca-Cola Stevia No Sugar product in New Zealand to see how this beverage would succeed in the market before launching it in other countries. But where is the beverage now? Is Coke Stevia Still Available? Coke with stevia was distributed worldwide until it slowly started losing sales and has now been discontinued and removed from The Coca-Cola Company’s product portfolio.

Sales 116
article thumbnail

CDC panel delays decision on J&J vaccine, extending pause over rare side effect

Bio Pharma Dive

Advisers to the agency agreed to wait for more data before recommending new guidance, but aim to reconvene quickly to decide on whether vaccinations with J&J's should be resumed, and for whom.

article thumbnail

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.

article thumbnail

DTC marketing is an oxymoron

World of DTC Marketing

QUICK READ: More TV DTC spots are airing, but DTC marketers are losing the battle between awareness and conversion because of all the noise online. Product websites are stagnant, and online health seekers are going elsewhere to learn about your medication’s side effects and cost. I’ve spent the last six months analyzing clients’ DTC marketing campaigns and they are, for most ineffective.

Marketing 265
article thumbnail

Learning about system stability from ants

Scienmag

Credit: James Herndon A new type of collective behaviour in ants has been revealed by an international team of scientists, headed by biologist Professor Iain Couzin, co-director of the Cluster of Excellence “Centre for the Advanced Study of Collective Behaviour” at the University of Konstanz and director at the co-located Max Planck Institute of Animal […].

Scientist 114
article thumbnail

CEO Salaries for the Top 20 Pharma Companies by Market Cap

BioSpace

Executives at pharmaceutical companies are known for receiving large salaries. When bonuses and stock options are factored into the picture, their annual compensation can jump into the range of tens of millions of dollars, like Pfizer’s Albert Bourla, Alex Gorsky from Johnson & Johnson, and Astra.

article thumbnail

Is disability the last bastion of the representation debate?

pharmaphorum

From #MeToo to Black Lives Matter, as a society we have been discussing the relationship between representation and equality more than ever over the last few years. . But while progress is being made in so many areas, people with disabilities are still struggling to find a voice above the accepted narrative, says Ross Lannon, the 27-year-old blogger and multi-media content creator behind A Life on Wheels.

article thumbnail

2022 Research: The Rapid Rise of Ocean Freight Visibility

A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.

article thumbnail

Organizing For The New Normal

Triage Cancer

It's spring. We're starting to emerge from, well, a lot of things. Over the past year, I've heard just about every kind of organizing/decluttering/reordering response to our pandemic isolation and work-from-home shifts. Some folks, stuck in their spaces with less to do than usual and feeling claustrophobic, jumped on the decluttering bandwagon and cleared things out with a vengeance.

article thumbnail

A startup raises $336M to make a better antibody drug for COVID-19

Bio Pharma Dive

Adagio Therapeutics, a well-financed spinout of antibody developer Adimab, could challenge Regeneron and Eli Lilly if its drug candidate proves protective in clinical tests.

Antibody 335
article thumbnail

Pharma Tuesday Stuff

World of DTC Marketing

QUICK READ: Here are some recent stories that you should all be aware of. Last month I hit 80,000 readers when accounting for email, social media, and direct traffic. I love the industry, and although I want to see some changes, I know there are many good people trying every day to make it happen. After a year of pandemic-delayed medical tr eatments, doctors are seeing more cases of advanced illnesses.

article thumbnail

Is Electrolyte Beer the Next Big Beverage Trend?

XTalks

There is no shortage of post-workout drinks on the market, including innovative new additions to the category, like high-protein chocolate milk to sports drinks made with upcycled dairy byproducts. But could an electrolyte beer be just the thing to quench consumers’ thirst after a session at the gym? A few breweries in the US are trying to make that a reality with low alcohol by volume (ABV) beers infused with electrolytes and other nutrients.

article thumbnail

An Innovative & Creative Problem Solver Approach to Selling in the Medical Device Space

Speaker: Steve Goldstein, Sales Leader

Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g

article thumbnail

FDA Approves Novel Non-Stimulant Treatment for ADHD

BioSpace

Shares of Supernus Pharmaceuticals were climbing in premarket trading this morning after Friday’s announcement the U.S. FDA approved the company’s non-stimulant treatment for ADHD in pediatric patients 6 to 17 years of age.

article thumbnail

Digital tool will be tested against COVID-19 ‘brain fog’

pharmaphorum

A digital tool used to treat attention-deficit hyperactivity disorder (ADHD) is being tested to see if it can help counter lingering, fuzzy thinking in COVID-19 survivors, a condition sometimes known as ‘brain fog’ An app called EndeavorRx – developed by PureTech Health-backed Akili Interactive – will be tested in two clinical trials to see if it can improve cognitive function in people who have recovered from COVID-19 but still show cognitive problems weeks or months later.

article thumbnail

Amylyx Pharma plans to file ALS therapy with the EMA this year

Pharma Times

The previously-reported CENTAUR study of AMX0035 in 137 participants with ALS met its primary endpoint of slowing ALS progression

123
123
article thumbnail

FDA panel largely backs speedy cancer drug approvals, forcing tough choice for agency

Bio Pharma Dive

Over three days of meetings, a group of FDA advisers discussed the tough trade-offs of accelerated immunotherapy approvals. Their decisions could escalate an already intense debate.

Drugs 328
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.