Sat.Jun 04, 2022 - Fri.Jun 10, 2022

FDA panel backs Bluebird gene therapy despite safety risks

Bio Pharma Dive

Advisers to the agency voted 15-0 in support of the rare disease treatment eli-cel, which was linked to a bone marrow cancer in three study participants

Monday Healthcare Headlines

World of DTC Marketing

Medicare Advantage plans are endangering the lives of older adults and people with disabilities.

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CDCDB: A large and continuously updated drug combination database

Drug Patent Watch

This article was originally published by Guy Shtar, Louise Azulay, Omer Nizri, Lior Rokach & Bracha Shapira in Scientific Data volume 9, Article number: 263 under a Creative Commons Attribution….

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Controlling Diabetes: Advances & Adherence

Pharmaceutical Commerce

Proper control of type 1 and 2 diabetes can greatly reduce the personal impact and economic burden of this pervasive public health condition.

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2022 Research: The Rapid Rise of Ocean Freight Visibility

Download this a benchmark study from FourKites and The Journal of Commerce exploring how international shippers’ usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19.

ASCO 2022: Gilead's tough weekend, bispecific progress and 'gamma delta' cell therapy

Bio Pharma Dive

The biotech's highly anticipated breast cancer data were upstaged by a rival, while presentations from Roche, J&J and Adicet Bio highlighted emerging alternatives to CAR-T treatment

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Drumming improves behaviour and brain function in autistic adolescents, scientists reveal

Scienmag

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FDA Can’t Always Get What It Wants…So It Asks Congress

FDA Law Blog

By Jeffrey N. Gibbs & Sara W. Koblitz — As the User Fee Acts move through Congress, it has been clear that FDA is using them as a vehicle to legislatively overturn some big court losses over the last few years.

Forbion raises $500M to back growing biotechs amid industry slump

Bio Pharma Dive

The European venture firm’s latest fund will open up a new source of investment at a time companies are struggling to go public or hold their value

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Decoding a key part of the cell, atom by atom

Scienmag

Whatever you are doing, whether it is driving a car, going for a jog, or even at your laziest, eating chips and watching TV on the couch, there is an entire suite of molecular machinery inside each of your cells hard at work. That machinery, far too small to see with the naked eye or […].

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Digital therapeutics gaining traction in the market

Pharma Phorum

Digital health funding has grown exponentially over the last few years and fuelled significant investment. Payers, healthcare professionals (HCPs) and patients recognise the positive impact these digital tools can have either standalone or in conjunction with therapeutic intervention.

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

Speaker: Steve Goldstein, Sales Leader

Currently in sales or involved in a business that depends on strong sales results? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC. You will absorb critical strategies to become a trusted partner in greater sales success.

Moderna takes mRNA influenza candidate into Phase 3 trials

BioPharma Reporter

Moderna has dosed the first participants in a Phase 3 study of the companyâs seasonal influenza vaccine candidate, mRNA-1010. Bio Developments

Immatics and Editas join up to bring CRISPR to 'gamma delta' cell therapy

Bio Pharma Dive

The two biotechs will use gene editing to make prospective treatments more potent, adding to a recent flurry of activity involving the fast-emerging form of cellular immunotherapy

Research reveals the science behind this plant’s blue berries

Scienmag

On a beautiful fall day in 2019, Miranda Sinnott-Armstrong was walking down Pearl Street in Boulder, Colorado when something caught her eye: a small, particularly shiny blue fruit, on a shrub known as Lantana strigocamara.

A Cancer Trial’s Unexpected Result: Remission in Every Patient

NY Times

The study was small, and experts say it needs to be replicated. But for 18 people with rectal cancer, the outcome led to “happy tears.”.

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Mandatory COVID Vaccination Policy Template

The federal government is developing a rule requiring employers with more than 100 employees ensure their workers are vaccinated or produce a negative COVID test weekly before entering the workplace. So, what can your organization do to prepare? Get Paycor’s COVID Vaccination Policy Template to help communicate important details to your employees.

How celebrity investor Mark Cuban is tackling out-of-control drug prices

Pharma Phorum

American entrepreneur and investor Mark Cuban tells us why he and his partners launched the Mark Cuban Cost Plus Drug Company (MCCPDC), a public-benefit corporation and online pharmacy that provides patients access to medications at a lower cost. .

GSK claims first positive Phase 3 result for an RSV vaccine

Bio Pharma Dive

The British drugmaker now plans to seek approval of what could be the first preventive shot for the common lung infection. However, Pfizer, Johnson & Johnson and Moderna are close behind

Long-lived things for the internet of things

Scienmag

Even the most frugal among us upgrade our cell phones and laptops every now and again. They’re relatively easy to replace. Credit: Tom Cogill/University of Virginia School of Engineering and Applied Science Even the most frugal among us upgrade our cell phones and laptops every now and again.

The Impact of War on Drug Supply Chain

Pharmaceutical Commerce

A conversation with EY life sciences leaders Jim Welch and Jay Welsh.

Four things you need to know about FDA regulations and digital health

Pharma Phorum

If you work in pharma, the chances are you’re no stranger to the United States Food and Drug Administration, or FDA, which regulates pharmaceuticals.

FTC to investigate CVS Caremark, others in probe of PBM business practices

Bio Pharma Dive

The decision to launch an inquiry reversed a vote earlier this year, when FTC commissioners had deadlocked over whether to look into the drug pricing middlemen

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For communication between brain areas, milliseconds matter

Scienmag

Understanding how brain areas communicate is one of the oldest questions in neuroscience.

Decentralized Clinical Trials: the next step towards digitalization of clinical research

Clairnes

The post Decentralized Clinical Trials: the next step towards digitalization of clinical research appeared first on Clinical Trial Recruitment & Management Services. Blog Decentralized Clinical Trials

How digital is transforming the commercial leader’s role in biopharma

Pharma Phorum

Pharma’s evolving role in patient care. The digital revolution has already reshaped the commercial engine of biopharma companies.

FDA advisers offer unanimous support to second Bluebird gene therapy

Bio Pharma Dive

By a 13-0 vote, the panel agreed the benefits of Bluebird’s beta thalassemia treatment outweigh its risks, one day after reaching a similar conclusion for another of the company’s drugs

Proteomic study of 2,002 tumors identifies 11 pan-cancer molecular subtypes across 14 types of cancer

Scienmag

BIRMINGHAM, Ala. –

Can the industry elevate the success rate of cancer trials?

Outsourcing Pharma

During the upcoming BIO International Convention, experts from CerFlux, the MD Anderson Cancer Center, and Aga Khan University will weigh in with insights. Clinical Development

Eversana aims athletes’ mental coaching at pharma sales reps

Pharma Phorum

Eversana’s suite of commercialisation tools for pharma companies will soon have a new component – cognitive behavioural training tools designed to improve the performance of sales representatives.

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'Dramatic' study results for AstraZeneca, Daiichi drug suggest new way to treat aggressive breast cancer

Bio Pharma Dive

A quarter century after Roche's Herceptin became an option for HER2-positive breast cancer, positive study results for Enhertu could push doctors to consider a new classification of "HER2 low" disease

Early, encouraging data for glioblastoma treatment reported at ASCO

Scienmag

BIRMINGHAM, Ala. – All of the newly diagnosed glioblastoma multiforme patients enrolled in a Phase 1 clinical trial at the University of Alabama at Birmingham have exceeded both their median and expected progression-free survivals. Two patients, to date, have exceeded their expected overall survival.

GSK gains FDA approval for MMR vaccine Priorix

BioPharma Reporter

The US Food and Drug Administration (FDA) has approved GSKâs Priorix (Measles, Mumps and Rubella Vaccine, Live) for active immunization for the prevention of measles, mumps and rubella (MMR) in individuals 12 months of age and older. Markets & Regulations

Praxis wields the axe as lead depression drug fails

Pharma Phorum

Shares in Praxis Precision Medicines were in freefall today after the company’s efforts to develop a new therapy for major depressive disorder (MDD) ended in failure, forcing a restructuring and staff cuts.

Roche keeps the faith in new cancer immunotherapy despite trial setbacks

Bio Pharma Dive

An ambitious development plan has so far resulted in two late-stage disappointments, but the Swiss drugmaker remains confident there's more to come from its combination treatment

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Monarch butterfly populations are thriving in North America

Scienmag

For years, scientists have warned that monarch butterflies are dying off in droves because of diminishing winter colonies. But new research from the University of Georgia shows that the summer population of monarchs has remained relatively stable over the past 25 years. Credit: U.S.

U.S. House Votes to Give FDA More Power Over Accelerated Approvals

BioSpace

The House of Representatives voted on a bill that would give the U.S. Food and Drug Administration more power to ensure biopharma companies run large follow-up trials to confirm accelerated approvals