Sat.Mar 06, 2021 - Fri.Mar 12, 2021

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The top drugs that could be impacted by an obscure provision in the pandemic relief law

Bio Pharma Dive

Elimination of the so-called penny rule in Medicaid could force drugmakers to pay larger rebates on a number of top medicines, including some HIV, diabetes and anti-inflammatory drugs.

Drugs 336
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America’s healthcare costs are in deep crisis

World of DTC Marketing

SUMMARY: The media loves to blame pharma companies for high healthcare costs, but unless we start to invest in healthy lifestyles, we’re headed for a healthcare crisis the likes of which we have never experienced. The media have targeted pharmaceutical companies for a long time because sensational headlines lead to clicks. Forget the fact that prescription drugs only account for $.10 of every healthcare dollar spent and that hospital chains are raking in cash with PBM’s and insurers

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The drug Fenbendazole can make tumors sensitive to radiotherapy just like agents of chemotherapy

Pharma Mirror

Likewise, it was demonstrated by actualizing high throughput screening in-vitro framework that the drug fenbendazole is successful, not just against standard non-small cell lung cancer, NSCLC, yet in addition against the KRAS-mutant malignancy which seems, by all accounts, aggressive, barely accessible by chemotherapy and very normal (thirty percent of total cases of NSCLS) in people. [1] It became continually challenging in targeting KRAS transformation bearing tumors in view of the unclear con

In-Vitro 246
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In the News: February 2021 Regulatory and Development Updates

Camargo

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. FDA: Sponsors Seldom Disclose RTF Letters’ Existence or Contents and Often Ignore Agency Advice. The FDA revealed that pharma companies are not forthcoming when they publicly disclose the reasons behind a refuse-to-file (RTF) letter from the Agency.

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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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Crucial data on AstraZeneca's vaccine are coming. Here's what we may learn.

Bio Pharma Dive

Results from previous trials have raised questions about the vaccine and how well it works. Data from a large U.S. study could help clear up the confusion.

Vaccine 336
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Why hasn’t pharma embraced email marketing?

World of DTC Marketing

SUMMARY : DTC marketers are spending tens of millions of dollars on programmatic ads that are full of fraud and have low click-through rates but they have yet to embrace email marketing which has an average click-through rate of 3.43%. There is no doubt that more people are using the Internet for online health searches, but the downside is that there is a lot of bad/false health information online. eMail represents an opportunity for pharmaceutical companies to get closer to their customers w

Marketing 289

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Valneva and Pfizer start new Phase 2 study for Lyme disease vaccine candidate

BioPharma Reporter

Valneva and Pfizer have initiated a Phase 2 study for their Lyme disease vaccine candidate: which is the only active Lyme disease vaccine in clinical development today.

Vaccine 138
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Vertex begins human testing for diabetes cell therapy

Bio Pharma Dive

While Vertex is confident in the therapy, which came via the $1 billion acquisition of Semma Therapeutics, it will still be a few years before the company has a good read on its effects in Type 1 diabetes patients.

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Is it time for DTC marketers to use a CMP?

World of DTC Marketing

SUMMARY: In its simplest form, a creative management platform , or CMP, is a cloud-based software that allows marketing teams to create, distribute, and measure the performance of digital advertising. The advantage is that marketing teams can create online ads without relying on an agency but it requires a digital marketer who fully understands the brand’s target customer.

Marketing 190
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EU approval for J&J’s single-shot COVID-19 vaccine

Pharma Times

Conditional marketing authorisation closely follows positive opinion from CHMP

Vaccine 137
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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MPs slam £37bn NHS Test and Trace as UK endures third lockdown

pharmaphorum

There is no clear evidence that the UK’s £37 billion NHS Test and Trace programme (NHST&T) has an impact on the pandemic, according to a withering report from an influential committee of MPs. In its report the Public Accounts Committee (PAC) noted that Department of Health and Social Care justified the scale of the investment in part on the basis that an effective test and trace system would help avoid a second national lockdown.

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How Rocket Pharma quietly became one of gene therapy's high flyers

Bio Pharma Dive

An unconventional strategy is behind the rise of Rocket, a New Jersey biotech whose executives boldly talk of turning into the "Genentech of gene therapy.

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Telehealth concerns rise

World of DTC Marketing

SUMMARY: Once again, the “hype” may be bigger than the reality around telehealth. First, people aren’t always completely honest with their doctors. A recent study published in the journal JAMA Network Open found that 60 to 80 percent of patients have been less than fully forthright with their doctors at some point which can be worse with telehealth.

Doctor 180
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Technology Transfer: What Is It, and How Is It Done?

Camargo

Technology transfer is a critical step in any drug development program, occurring for various reasons and at different development stages. A sponsor may be looking for a contract development and manufacturing organization (CDMO) for clinical trial manufacturing; to transfer a manufacturing process to a larger, commercial-scale CDMO; or to replace a CDMO that has quality issues.

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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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Machine Learning Model Predicts Innovation’s Brilacidin Highly Effective Against COVID-19

BioSpace

A machine learning model that screened 1,482 compounds potentially effective for treating coronavirus disease 2019 (COVID-19) has ranked Innovation Pharma’s COVID-19 candidate brilacidin in the top 3% of compounds predicted to be most effective against the novel coronavirus.

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FDA sets meeting to review 6 speedy cancer drug approvals as evaluation widens

Bio Pharma Dive

At a public hearing in April, the agency will ask a panel of experts whether three immunotherapies should remain on the market for certain cancer types, the latest step in an industrywide review.

Drugs 325
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Patient involvement in trial design: looking to the future

pharmaphorum

COVID-19 has transformed the way we think about patient participation in trial design – but there are still many barriers to overcome in improving engagement. Speakers at the NIHR’s recent virtual event for the pharma industry discussed best practices for bringing patient insights into research. The pandemic has forced the industry to embrace virtual patient engagement to an extent that would have seemed unachievable little more than a year ago, but there is much more the industry needs to do to

Trials 132
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Gilead’s HIV therapy Biktarvy demonstrates long-term sustained efficacy

Pharma Times

Data from two Phase III studies demonstrated durable viral suppression in HIV-1 patients

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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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Avance Clinical Client Atossa Therapeutics Announces Final Results from Phase 1 Clinical Study Showing Safety and Tolerability of AT-301 Nasal Spray Being Developed for COVID-19

Pharma Mirror

The leading Australian CRO for biotechs and Frost & Sullivan Asia-Pacific CRO Market Leadership Award winner Avance Clinical congratulated Atossa Therapeutics on the announcement of their Phase 1 final results for the AT-301 nasal spray being developed for COVID-19. Atossa Therapeutics, Inc. (Nasdaq: ATOS) is a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need with a current focus on breast cancer and COVI

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Merck gives an early peek at COVID-19 drug results

Bio Pharma Dive

Initial results from a mid-stage study indicate the antiviral drug, molnupiravir, is safe. But whether it's hitting the study's main goal remains unclear.

Drugs 325
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EU regulators probe safety of AstraZeneca vaccine batch after blood clot reports

pharmaphorum

European safety regulators have launched an investigation into the safety of a batch of the Oxford University/AstraZeneca COVID-19 vaccine, as countries including Denmark suspended its use as a precaution following reports of blood clots. Initial findings showed no issue with the shots suspended by Austrian authorities after a person was diagnosed with severe blood clotting and died 10 days after vaccination.

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CQC publishes new agreement with Equality and Human Rights Commission

Pharma Times

Agreement aims to safeguard rights of people receiving health and social care in England

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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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CPhI Report forecasts explosion of contract services growth due to surging INDs and 75 FDA approvals by 2025

Pharma Mirror

A post-pandemic pharma report from CPhI predicts the next few years will deliver strong growth in pharma innovation, with oncology and rare diseases potentially the biggest beneficiaries of positive covid legacies – including accelerated development timelines, remote trials and new technologies in genetic and target screening. The report anticipates breakthroughs in multi-modal disease therapies within five years, mRNA platforms to transform many new non-infectious disease treatment options, and

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Spurred by FDA review, Roche pulls Tecentriq for bladder cancer use

Bio Pharma Dive

Four years after negative study results, the pharma withdrew the indication as the FDA's "industry-wide evaluation" of accelerated approvals progresses.

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Why pharma isn’t yet achieving digital excellence, and how it can get there

pharmaphorum

Nearly 70% of HCPs are now digital natives, with no interest in going back to pre-COVID sales engagement methods. To thrive in this environment, pharma needs to move from ad-hoc and reactionary digital transformation to long-term ‘digital excellence’, says Veeva’s Sebastien Noel. COVID has seen pharma sales experience three years’ worth of digital transformation in the space of just a few months – but while the industry has embraced digital tools and techniques, most companies are still far from

Sales 131
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VirTrial and uMotif Partner to Further Expand Decentralized Clinical Trial Capabilities

VirTrial

Scottsdale, AZ – (March 9, 2021) – VirTrial , the leading provider of telemedicine technology, and uMotif , the patient-centric data capture platform provider, are joining forces to combine their Decentralized Clinical Trial (DCT) technologies in one seamlessly integrated solution. VirTrial’s telemedicine platform provides robust and compliant video consultation capabilities to effortlessly connect site and patient.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Syngenta and Botanical Solution Inc. (BSI) team up for a new botanical-based biofungicde rollout !

Pharma Mirror

Davis, CA: Botanical Solution Inc. (BSI) and Syngenta, two companies which are closely aligned in their commitment to innovation and sustainability in agriculture, announce that they have reached an agreement to commercialize BSI’s first product in Peru and Mexico. The two companies have already commercialized successfully the product in Chile under the trade name BotristopÒ.

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Taking a page from Celgene, Takeda builds and buys a cancer biotech

Bio Pharma Dive

An agreement to acquire Maverick Therapeutics for up to $525 million has roots in a plan hatched by Takeda to emulate elements of Celgene's dealmaking strategy.

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Cambridge Sleep Sciences’ device is trialled in Parkinson’s

pharmaphorum

Sleep disturbances are a common feature for people with Parkinson’s disease, and a device developed to help people with insomnia is now being trialled to see if it can improve their sleep quality. . The SleepHub device – developed by Barkby group company Cambridge Sleep Sciences – is on the face of it a box and speakers that plays relaxing noises to help you fall asleep more easily, but is underpinned by a sound wave technology that its developer claims prompt the brain into the activity pattern

Nurses 126
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New Drug Approval Could Be on Horizon for Alzheimer’s after 17-Year Drought

BioSpace

A drug to halt the progression of Alzheimer’s disease will likely be approved within the next three years, and Alzheon’s ALZ-801 might be the leading candidate.

Drugs 125
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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.