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

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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
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The clock is ticking on healthcare’s excessive profiteering

World of DTC Marketing

QUICK READ: There is so much money in healthcare that every company wants their share even if patients get hurt. The amount of money Pfizer is going to make from their vaccine borders on obscene while PBMs quietly take a cut of every Rx transaction without really adding any value. It’s going to continue until we put politics aside and say “enough.” J&J has had problems in the past, but they’re trying to be an ethical and responsible pharma company.

Vaccine 273
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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.

Vaccine 145
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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.

Vaccine 141
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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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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.

Vaccine 348
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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

More Trending

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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

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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 337
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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.

Vaccine 253
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Enhertu accepted via cancer drugs fund for HER2-positive breast cancer

Pharma Times

Decision is based on results from the Phase II DESTINY-Breast01 trial

Drugs 130
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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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.

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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.

Vaccine 334
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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.

Vaccine 190
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Novo Nordisk plans study of oral semaglutide in obesity

Pharma Times

Study will include approximately 1,000 people with obesity or overweight with comorbidities

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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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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
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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.

Vaccine 325
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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.

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BMS to invest in new cell therapy manufacturing site in Europe

Pharma Times

Construction on Leiden, Netherlands site anticipated to begin later this year

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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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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
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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 325
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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 114
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New advice on COVID-19 vaccination for pregnant women in UK

Pharma Times

JCVI advises pregnant women in the UK be offered COVID-19 vaccination at the same time as the rest of the population

Vaccine 119
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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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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
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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 317
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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

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Real-world data suggests Sputnik V vaccine is 97.6% effective, says RDIF

Pharma Times

Data comes from 3.

Vaccine 111
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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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.

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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.

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Here’s What These 3 Beverage Companies are Doing to Celebrate Earth Day

XTalks

Today is Earth Day and this year’s theme is Restore Our Earth. “At the heart of Earth Day’s 2021 theme, Restore Our Earth, is optimism, a critically needed sentiment in a world ravaged by both climate change and the pandemic,” said Kathleen Rogers, president of EarthDay.org, in a press release. This theme comes at a time when COVID-19 has claimed the lives of over three million people around the world and the effects of climate changes have manifested in the form of ragin

Packaging 105
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Looking ahead: Israel sets up 2022 COVID-19 vaccine supply with Pfizer and Moderna

BioPharma Reporter

Israel has set up COVID-19 vaccine orders with Pfizer and Moderna this week: marking deals over the longer term for the two companies.

Vaccine 105
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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.