Sat.Apr 17, 2021 - Fri.Apr 23, 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

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
Insiders

Sign Up for our Newsletter

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

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

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

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

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

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.

More Trending

article thumbnail

AI is having a productive time in pharma and healthcare

pharmaphorum

Two years ago the use of AI in pharma and healthcare looked to be quickly heading for what Gartner’s Hype Cycle model would term the Plateau of Productivity. After the COVID-powered digital transformations of both pharma and healthcare , there can be little doubt that artificial intelligence is already having a productive time across our sector. It could even be, as consultants GlobalData predicted back in January, this year’s most disruptive technology across the pharmaceutical industry, though

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

The danger of COVID conspiracy theorists

World of DTC Marketing

QUICK READ: At times, the public health response to coronavirus (COVID-19) has been scary, characterized by antimask behavior, antivaccine beliefs, conspiracy theories around the development of the vaccine, and a general belief that even COVID numbers are false. These people are doing more harm to others than they know, and they are generally making themselves irrelevant.

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

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

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

CDC advisers recommend resuming use of J&J vaccine

Bio Pharma Dive

While health officials have documented more cases of a rare blood clotting syndrome associated with J&J's vaccine, a CDC committee supported use of the shot with an added warning.

article thumbnail

Congratulations Manny Award winners

World of DTC Marketing

QUICK READ: The MedAd News Manny Awards were last night. Congratulations to the winners, but the bar has been set higher if pharma is to really demonstrate they care about patients. Award winners should see their awards as a head nod and understand they have a LOT more work to do. I’m not much for pharma trade magazine awards. Too much self-promotional politics in involved but still it’s great to be recognized.

article thumbnail

NICE says yes to Novartis’ multiple sclerosis therapy Kesimpta

pharmaphorum

Novartis has secured backing from NICE for its relapsing multiple sclerosis (RMS) therapy Kesimpta in the UK, just two weeks after the drug was approved by the national drugs regulator. . The cost-effectiveness agency has said that anti-CD20 antibody Kesimpta (ofatumumab) can be prescribed via the NHS in England and Wales as a treatment for adults with RMS with active disease, as either a first-line therapy or after alternative drugs have been tried.

Sales 111
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

GSK’s Dostarlimab Wins FDA Approval for dMMR Endometrial Cancer

XTalks

GSK’s immunotherapy dostarlimab-gxly (Jemperli) has been granted accelerated approval by the US Food and Drug Administration (FDA) for the treatment of recurrent or advanced mismatch repair-deficient (dMMR) endometrial cancer. The therapy is indicated for endometrial cancer that has progressed during, or following, prior treatment with a platinum-based chemotherapy, and in women with dMMR tumors as determined by an FDA-approved test. dMMR occurs when a cell is unable to repair errors made during

article thumbnail

Lilly to seek first approval of an autoimmune drug for hair loss

Bio Pharma Dive

Two Phase 3 trials have now shown that Lilly's autoimmune drug baricitinib may effectively treat alopecia areata. But the FDA's concerns with so-called JAK inhibitors could complicate a review.

Drugs 317
article thumbnail

From pollutant to resource: WVU scientists push rare earth element technologies closer to production

Scienmag

Credit: WVU Water researchers at West Virginia University hope to turn a pollutant – acid mine drainage – into a technological resource through the continuation of a $2.1 million contract from the National Energy Technology Laboratory. The West Virginia Water Research Institute, a program of the Energy Institute at WVU, earned the funding to explore […].

Scientist 104
article thumbnail

SparingVision to buy GAMUT and potential Luxturna eye gene therapy competitor

pharmaphorum

French genomic medicines firm SparingVision has agreed to buy GAMUT Therapeutics, a biotech specialising in gene therapies for inherited eye diseases such as retinitis pigmentosa (RP) that could compete against Roche/Spark’s Luxturna in a wider patient group. . GAMUT’s lead product, now SPVN20, is a novel, mutation-agnostic gene therapy, which aims at restoring the function of dormant cone cells in the retina.

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

Is Omnipan the Only Cookware Millennials Need?

XTalks

Chef Avenue , a Silicon Valley-based cookware company, started a Kickstarter on April 6 for their product, Omnipan, which has made over $200,000 in just over two weeks. In fact, they were fully funded five hours after the launch of their Kickstarter. Omnipan allows consumers to prep, cook, bake and steam their meals in the same patent-pending technology pan.

article thumbnail

Coronavirus vaccine makers Oxford, Novavax follow up with a promising malaria shot

Bio Pharma Dive

A vaccine co-developed by the U.K. academic center and the Maryland biotech could be the first to meet the WHO's efficacy target for a malaria vaccine.

article thumbnail

Canine cancer research startup impacts treatment in humans

Outsourcing Pharma

One Healthâs FidoCure is using genomics and AI technology to develop precision oncological treatments, and the work is benefiting human cancer research.

Research 116
article thumbnail

Pfizer-BioNTech, Moderna Vaccines Effective Against Variants and More COVID-19 News

BioSpace

With the U.S. Food and Drug Administration’s vaccines advisory committee meeting being held today to discuss the Johnson & Johnson vaccine and blood clotting, there’s even more interest in what’s going on in the pandemic than usual. Here’s a look at some of the top stories.

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

UK regulator backs Amarin’s cardiology drug Vazkepa

pharmaphorum

Amarin’s Vazkepa cardiology drug has been backed by the UK’s drugs regulator, following approval in Europe at the end of March. . The Medicines and Healthcare products Regulatory Agency (MHRA) granted a marketing authorisation for Vazkepa (icosapent ethyl) as a treatment to reduce risk of cardiovascular events in high-risk patients. These are defined as patients who have elevated triglycerides and either established cardiovascular disease or diabetes and at least one additional cardiovascular ri

article thumbnail

Bluebird to withdraw gene therapy from Germany after dispute over price

Bio Pharma Dive

The biotech will cut staff, primarily in Europe, after negotiations with German health authorities resulted in a price lower than Bluebird had sought.

article thumbnail

Hubble captures giant star on the edge of destruction

Scienmag

Credit: NASA, ESA, STScI In celebration of the 31st anniversary of the launching of NASA’s Hubble Space Telescope, astronomers aimed the renowned observatory at a brilliant “celebrity star,” one of the brightest stars seen in our galaxy, surrounded by a glowing halo of gas and dust. The price for the monster star’s opulence is “living […].

98
article thumbnail

Egg Without the Chicken: How Clara Foods is Cracking Animal-Free Eggs

XTalks

San Francisco, California-based startup Clara Foods announced a partnership with ZX Ventures , the innovation arm of Anheuser-Busch (AB) InBev, to realize its ambition of manufacturing animal-free eggs on a industrial scale. While Clara Foods, a leader in animal-free proteins, worked for years to replicate the taste, function and proteins of eggs without the chickens, scaling the product has been difficult — until now.

Protein 98
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

Beam’s New CRISPR Base Editing Tool Targets Sickle Cell Mutation

BioSpace

Beam Therapeutics has recently unveiled a new CRISPR base editing tool to target sickle cell mutations, a promising approach that holds substantial clinical value for patients with these blood disorders.

98
article thumbnail

A look ahead at the FDA meeting that could decide the future of 6 cancer drug approvals

Bio Pharma Dive

Six accelerated approvals for immunotherapies from Merck, Bristol Myers Squibb and Roche might soon be withdrawn. Here's a detailed look at why.

Drugs 306
article thumbnail

Targeting drug-resistant breast cancer with estrogen

Scienmag

Dartmouth researchers achieve better long-term control of drug-resistant breast cancer growth in mice by switching between estrogen and anti-estrogen therapies. A new clinical trial will inform which patients may benefit from this strategy Credit: Mark Washburn LEBANON, NH – Researchers at Dartmouth’s and Dartmouth-Hitchcock’s Norris Cotton Cancer Center (NCCC) hope to make estrogen therapy a […].

Drugs 98
article thumbnail

Celebrating Medical Laboratory Professionals Week 2021

XTalks

This week marks Medical Laboratory Professionals Week (MLPW), or Lab Week, which is taking place April 18–April 24 this year. The annual event celebrates the work of professionals in the medical laboratory industry, which include medical technicians, medical technologists, lab assistants, pathologists, biologists, geneticists and a host of other specialists.

article thumbnail

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.