Sat.May 22, 2021 - Fri.May 28, 2021

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In first, FDA approves KRAS-blocking cancer drug from Amgen

Bio Pharma Dive

For decades, scientists have tried unsuccessfully to target the KRAS gene, which is often mutated in lung, colon and pancreatic cancers. Lumakras is the first drug proven effective.

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Pharma’s return on R&D is in trouble

World of DTC Marketing

SUMMARY: You can’t make people work for money alone, you starve their souls when you try it, and you can starve a company to death the same way. Yet today’s pharma CEOs are focused on one thing: shareholder return and profits. The return on R&D is declining but that’s a reason to devote more money to R&D not less. The list of pharma CEO salaries is enough to make one ill with a sickness that prescription medicine can’t cure.

Drugs 193
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Study finds Germany trails Spain and the US in digital health

pharmaphorum

Germany is lagging behind other countries in the adoption of digital health, including Spain and the US, according to a new survey carried out on behalf of drugmaker Fresenius. . The three-country poll found that Spain is way out in front, with over half of people asked responding that digital is already playing a major role in the networking of healthcare facilities, diagnosing illnesses and telemedicine.

Doctors 144
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Less is more? New take on machine learning helps us “scale up” phase transitions

Scienmag

Features of large systems yielded from tiny simulations with super-resolution techniques Credit: Tokyo Metropolitan University Tokyo, Japan – Researchers from Tokyo Metropolitan University have enhanced “super-resolution” machine learning techniques to study phase transitions. They identified key features of how large arrays of interacting “particles” behave at different temperatures by simulating tiny arrays before using a […].

Research 141
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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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'A hugely consequential decision:' How Biogen's Alzheimer's drug came to face the FDA

Bio Pharma Dive

By June 7, the FDA will decide on whether to approve aducanumab, a decision that could have far-reaching consequences for patients, Biogen and Alzheimer's research.

Drugs 342
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470% price increases

World of DTC Marketing

SUMMARY: Sometimes there are just no words to express my outrage. Here is the executive summary of the Government’s report on AbbVie. I’m disgusted, sad , and angry. Mostly I’m angry because this reflects badly on all the good people within our industry who are trying to do great work and help people. Here is the executive summary from the report.

Drugs 180

More Trending

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CVS Health broadens commitment to improving clinical trial infrastructure

Outsourcing Pharma

The owner of the pharmacy giant has announced plans to partner with various stakeholders in an effort to effect improvements across the trial ecosystem.

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Moderna, with new results, set to seek vaccine clearance for young teens

Bio Pharma Dive

The biotech's shot was strongly protective against COVID-19 in a study of 12- to 17-year-olds, a finding that could soon make it the second vaccine available for adolescents in the U.S.

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Campaigners challenge NHS England’s latest plan to share patient data

pharmaphorum

Remember the Care.data debacle? Now, a new move by NHS England to move the records of 55 million patients into a database that will be accessible by third-party companies is under fire by privacy campaigners, who claim it could be unlawful. . The new General Practice Data for Planning and Research (GPDPR) service was unveiled earlier this month by NHS Digital, which described it as a way to “improve” the collection of patient information that would allow better planning of healthcare

Research 116
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Kintor’s Proxalutamide is Bolsonaro’s Newest Answer to Brazil’s COVID-19 Crisis

BioSpace

Proxalutamide, a selective high-affinity silent antagonist of the androgen receptor, is being developed by Chinese biotech, Kintor Pharmaceutical Limited (9939.HK).

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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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Pfizer explores co-administration of pneumococcal vaccine with COVID-19 booster shot

BioPharma Reporter

Pfizer has enrolled the first subjects in a study exploring the co-administration of its 20-valent pneumococcal conjugate vaccine (20vPnC) candidate following a booster dose of the Pfizer-BioNTech COVID-19 vaccine.

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Accelerating patient care through digital transformation and decentralized clinical trials

Bio Pharma Dive

The adoption of digital health technologies (DHTs) in the industry continues to pave the way to enable decentralized clinical trials (DCTs).

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Chasing Lilly, Concert eyes 2023 filing for its JAK drug for alopecia

pharmaphorum

Concert Pharmaceuticals has started the second of two planned phase 3 trials of its drug candidate for alopecia areata (AA), a common cause of hair loss, and says it hopes to report results in the second half of 2022. The two studies – THRIVE-AA1 and THRIVE-AA2 – are testing oral JAK1/2 inhibitor CTP-543 in adults with moderate-to-severe AA, an autoimmune disease that leads to loss of hair in patches on scalp and body.

Drugs 105
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Will COVID-19 Vaccines Need a Booster? CDC Will Meet to Decide

BioSpace

Drug companies have been suggesting that booster shots will be needed. However, it is up to the CDC's recommendation if booster shots are necessary.

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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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NICE green lights Tremfya to treat active psoriatic arthritis

Pharma Times

Tremfya has already been recommended for NHS use to treat eligible patient with moderate-to-severe plaque psoriasis

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Lyell aims to follow Juno, Sana as Wall Street cools to biotech IPOs

Bio Pharma Dive

The ambitious cell therapy developer, which has already raised nearly $1 billion from investors, will test the IPO market just as the pace and performance of recent biotech offerings have slowed considerably.

Marketing 317
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After Sanofi’s setbacks, Takeda eyes finish line with its dengue vaccine

pharmaphorum

Takeda has revealed long-term clinical trial results with its dengue vaccine that reinforce its safety and efficacy – and help to differentiate it from Sanofi’s challenged Dengvaxia shot. Updated results from the large-scale TIDES trial of TAK-003 show that three years after dosing it was 62% effective at warding off dengue symptoms and prevented more than 83% of hospitalisations due to the viral infection in children aged four to 16.

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Ocugen Closes in on Seeking EUA for India-Developed COVID-19 Vaccine

BioSpace

Ocugen submitted a “Master File” to the U.S. FDA for COVAXIN, the vaccine that has already received authorization in India for people ages 12 and above.

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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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Solving a double murder arouses international interest

Scienmag

Getting the conclusive lead with investigative genetic genealogy – A successful case study of a 16 year old double murder in Sweden Credit: Edis Portori The technology using DNA-based genealogy that solved a double murder in Linköping opens completely new possibilities in investigating serious crime. LiU researchers are now involved in spreading new knowledge about […].

DNA 98
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UniQure moves Huntington's gene therapy to next phase of key trial

Bio Pharma Dive

Safety monitors cleared the company to test a higher dose after reviewing data from 10 patients, providing some hopeful news after recent setbacks for experimental drugs targeting the genetic disease.

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Could Limitless Sparkling Water be the Next Soda Substitute?

XTalks

In the age of better-for-you beverages, Limitless Sparkling Water checks off all the boxes. With no calories, sugar or artificial sweeteners, the sparkling water has the potential to be the next soda substitute. So, what separates Limitless Sparkling Water from other sodas and where does it fit into the beverage industry? Beverage titan Keurig Dr Pepper (KDP) purchased Chicago-based Limitless Sparkling Water back in January 2020, betting on sparkling water to fill the void created by decreasing

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FDA clears Myovant’s relugolix for uterine fibroids, setting up AbbVie clash

pharmaphorum

Myovant has chalked up a second approval for its flagship drug relugolix from the FDA, becoming the first once-daily oral drug in the US to treat heavy menstrual bleeding associated with uterine fibroids. . The drug will be sold as Myfembree (relugolix) for the uterine fibroids indication, and is already available to treat prostate cancer under the Orgovyx brand name.

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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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Racemases: The hunt for drugs to neutralise these critical enzymes

Scienmag

Scientists from the University of Bath in the UK explore racemases and propose strategies for finding drugs that target these important enzymes. Credit: University of Bath Scientists from the UK’s University of Bath explore racemases – an important type of enzyme that is linked to certain cancers and other life-threatening diseases while also being critical […].

Drugs 98
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Centessa raises $330M in third largest biotech IPO this year

Bio Pharma Dive

The public offering follows just three months after Centessa, created from the merger of 10 Medicxi-backed drug startups, launched with $250 million in venture funding.

Drugs 294
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Moderna Strikes Manufacturing Deal with Samsung Biologics for COVID-19 Vaccine Production

XTalks

To help boost production of its COVID-19 vaccine, Moderna has enlisted the services of Samsung Biologics , a contract development and manufacturing organization (CDMO) based in South Korea. The companies entered a Manufacturing Services and Supply Agreement in which Samsung will provide large-scale, commercial fill-finish manufacturing for Moderna’s mRNA-based COVID-19 vaccine (mRNA-1273).

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Belgium halts dosing of J&J COVID vaccine in under 41s after death

pharmaphorum

Belgium’s Ministry of Health has paused dosing of people under the age of 41 with Johnson & Johnson’s one-shot COVID-19 vaccine, following the death of a woman from what appeared to be a blood clot-related condition. . The unnamed woman – who was under the age of 40 – died on 21 May after being admitted to hospital with severe thrombosis and low blood platelets, according to a statement from the Interministerial Conference on Public Health (CIM), which brings together national an

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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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Planetary scientist receives NASA’s Early Career Award

Scienmag

Funding will support new field-portable lab, help train next-generation analog scientists Credit: Northern Arizona University NASA has selected Northern Arizona University assistant research professor Alicia Rutledge as one of only five early-career scientists in the country to receive funding through its Planetary Science Early Career Award (ECA) program, which “supports outstanding early-career individuals and allows […].

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EQRx readies a lower-cost alternative to pricey cancer immunotherapies

Bio Pharma Dive

The biotech and its partner CStone disclosed Phase 3 results in lung cancer that support approval plans for a drug similar to treatments like Merck's Keytruda, but would be priced at a fraction of the cost.

Drugs 286
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Takis Disrupt the Salty Snack Category by Introducing Five New Products

XTalks

Takis, a chip company, known for its spicy rolled tortilla chip, announced that they are expanding their brand by introducing five new snacks with their signature Fuego flavor and a new brand look. The company is looking to disrupt the market by entering the salty snack category and placing itself as the most intense snack brand in the world. The brand came to the US in 2001 and they have been known since then to provide consumers with the spice they wanted.

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New patent for Kala Pharms drug EYSUVIS

Drug Patent Watch

Annual Drug Patent Expirations for EYSUVIS Eysuvis is a drug marketed by Kala Pharms Inc and is included in one NDA. There are eleven patents protecting this drug. EYSUVIS drug…. The post New patent for Kala Pharms drug EYSUVIS appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 97
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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.