Sat.Feb 05, 2022 - Fri.Feb 11, 2022

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'The music stopped': Biotech rout leaves drug startups grounded as demand slumps for IPOs

Bio Pharma Dive

For the first time in years, biotechs no longer have an easy path onto Wall Street, a market reversal that could change what the next generation of young drugmakers looks like.

Drugs 364
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Biogen continues to sink

World of DTC Marketing

Board members and senior executives are bailing out of Biogen but will there be enough life vests? What has/is happening at Biogen is a train wreck, and the only way to correct this disaster is to tear it down and rebuild the company from the top down. According to Endpoint News” We’ve seen Biogen’s CSO exit under pressure in recent weeks, and senior marketing execs leave in an exodus as the company recoiled from a fierce backlash against the FDA’s ultra controversial app

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J.&J. Pauses Production of Its Covid Vaccine Despite Persistent Need

NY Times

A crucial Johnson & Johnson plant has stopped making its Covid vaccine, though the company says it has millions of doses in inventory.

Vaccine 143
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Simons Foundation gives $4 million to CUNY Graduate Center to diversify astrophysics education

Scienmag

NEW YORK, February 9, 2022– Astrophysics is one of the most popular science fields, igniting the imaginations of many as they learn about it from television shows or news of space exploration. Like many other STEM fields, though, it lags in attracting students of color. Studies have shown the benefits of diversity in STEM fields, […].

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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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FDA sends signal with tough questions of Lilly at cancer drug meeting

Bio Pharma Dive

The agency criticized Eli Lilly for using a trial run in China to seek approval of an immunotherapy it licensed from Innovent Biologics. Outside advisers agreed in a decisive vote that could have repercussions for several other drugmakers.

Licensing 341
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Mental health apps can be useless

World of DTC Marketing

According to the Lancet, a medical journal, the incidence of depression and anxiety has soared in the pandemic—by more than 25% globally in 2020. That, combined with more people using online services, has led to a boom in mental-health apps. But are they safe and effective? Now that big companies prioritize employees’ mental health, some apps work with them to help entire workforces.

Marketing 241

More Trending

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Cancer vaccines: providing the edge in oncology

pharmaphorum

In this article, Ben Hargreaves looks into the promise of cancer vaccines and how this treatment modality may offer advantages over existing immunotherapies in the oncology sector. According to a report by IQVIA last year, there were 3,500 oncology-focused therapeutic candidates in the pipeline, which represents a 75% increase on figures seen in 2015.

Vaccine 134
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Why the FDA is making a test case of a cancer drug from China

Bio Pharma Dive

In documents released Tuesday, FDA staff gave a cool review to an immunotherapy developed by Eli Lilly and Innovent Biologics. An advisory meeting this week to review it could have broader implications for cancer drug development in the U.S.

Drugs 321
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Does Pfizer have a conscience?

World of DTC Marketing

Pfizer has held a vaccine monopoly, blocking low-income countries from accessing its novel technology, while enriching shareholders at levels advocates for vaccine equity label “obscene.” The corporation is making as much as $1 million in profits every hour from vaccine sales, according to Oxfam, and its executives boast that revenues will expand exponentially in 2022. ( The Atlantic ).

Vaccine 212
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Your microbiome shapes your life. But where did it come from?

Scienmag

Baltimore, MD— The gut microbiome is an ecosystem of hundreds to thousands of microbial species living within the human body. These populations affect our health, fertility, and even our longevity. But how do they get there in the first place? Credit: By Navid Marvi, courtesy of the Carnegie Institution for Science. Baltimore, MD— The gut […].

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

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New management: Promising drug for people living with obesity

Pharma Times

NICE recommends appetite suppressing drug which can reduce a patient’s by more than 10%

Drugs 117
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Pfizer aims to restart late-stage trial of Duchenne gene therapy following safety setback

Bio Pharma Dive

Safety concerns, including the recent death of a patient in an early study, led the FDA to place a hold on the therapy and Pfizer to redesign its Phase 3 trial.

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Obesity is a public health problem

World of DTC Marketing

( Washington Post ) Obesity turned out to be a major risk factor for covid hospitalization and death, especially non-elderly. According to the CDC, it is linked to impaired immune function and decreased lung capacity; it can make ventilation more difficult. Once again, obesity indicates that it’s killing us. The United States might well have gotten through the pandemic at far lower cost, economic and human, without the decades-long obesity epidemic that preceded it.

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Pfizer predicts $54bn in 2022 revenue from Comirnaty and Paxlovid

BioPharma Reporter

Pfizer forecasts $32bn in revenue for COVID-19 vaccine Comirnaty, and $22bn for oral COVID-19 treatment Paxlovid, in 2022.

Vaccine 113
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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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Need for Speed: Kidney cancer patients waiting three times longer

Pharma Times

Greater urgency for kidney cancer treatments as 40% of UK patients wait 84 days for a diagnosis

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Pfizer forecasts $100B in sales, fueled by COVID-19 vaccine, pill

Bio Pharma Dive

The company estimated revenue from its COVID-19 vaccine and antiviral pill Paxlovid will total $54 billion this year. Curiously, its stock fell by more than 5%.

Vaccine 317
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Regenxbio expands MPS I gene therapy trial after first look at data

pharmaphorum

Data from the first patients enrolled into Regenxbio’s trial of its gene therapy for rare inherited disease mucopolysaccharidosis type I (MPS I) – also known as Hurler syndrome – has shown the first signs of clinical activity. The results come from five patients enrolled in the biotech’s ingoing phase 1/2 study of RGX-111 – which uses an adeno-associated viral vector (AAV9) to deliver a gene coding for an enzyme that is deficient in MPS I patients – plus a single subject from an earl

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Valneva and Pfizer to take Lyme disease vaccine into Phase 3 trial this year

BioPharma Reporter

Valneva and Pfizer have reported further positive Phase 2 data for their Lyme disease vaccine candidate, VLA15, with a Phase 3 trial set to start in Q3, 2022.

Vaccine 112
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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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Study shows psychosocial effects of peanut allergy

Pharma Times

Research demonstrates that people who live with peanut allergies face isolation and discrimination

Allergies 116
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ProQR eye drug comes up short in key study, surprising company and investors

Bio Pharma Dive

The biotech's treatment did not improve vision in the Phase 2/3 trial, a significant setback that sent shares down by 75%.

Trials 290
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ViiV Healthcare long-acting HIV treatment secures FDA approval

Outsourcing Pharma

The HIV-focused pharma company announced the agency has approved Cabenuva for administration as few as six times a year for adults living with the virus.

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AI Marketing for Pharma – The time to rise is Now!

pharmaphorum

The digitalisation that we all experience daily has affected the way we engage with stakeholders and patients. But how can we make Customer Engagement effective, and how can we leverage technologies like AI and Marketing Automation to their best potential? The key to success lies in implementing a digital health ecosystem , in order to support the shift from an organization-centric model to a customer-centric model by using digital platforms.

Marketing 105
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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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Not so NICE: cancer patients miss out on innovative new treatments

Pharma Times

Institute for Cancer Research highlights missed opportunity for NICE to reform its cancer drug assessment processes

Drugs 112
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FDA delays review of Pfizer's COVID-19 vaccine for young children in surprise shift

Bio Pharma Dive

The FDA pushed back plans to expedite review of the shot in children under 5, seeking more data on a third dose. An advisory meeting scheduled for next week has been postponed as a result.

Vaccine 289
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Breast cancer tops list of most studied disease in 2021: Phesi

Outsourcing Pharma

The companyâs analysis of trials conducted around the world last year shows cancers took four of the top five positions, with COVID-19 in second place.

Trials 105
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Do skills gaps and the COVID brain drain threaten digital transformation?

pharmaphorum

With staff shortages and digital skill gaps being experienced across the spectrum of healthcare, from CROs and pharma to providers, the people-led sector is facing a personnel challenge that could threaten the potential of digital transformation. The healthcare ecosystem may be the natural beneficiary of recent advances in data collection and analysis, but that’s no use without the staff to develop and implement solutions.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Let it Flow: COVID-19 LFT passes UK government assessment

Pharma Times

Sustainable lateral flow test kits developed in Birmingham reduce plastic and boost self-testing through ease of use

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US buys up supply of new Lilly antibody meant to work versus omicron

Bio Pharma Dive

Distribution of Lilly's earlier antibody treatments was halted as testing showed them ineffective against omicron. Bebtelovimab appears able to neutralize the variant, and was authorized by the FDA on Friday.

Antibody 277
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C.D.C. Proposes New Guidelines for Treating Pain, Including Opioid Use

NY Times

The agency threw out previous recommended limits on doses but encouraged “nonopioid therapies” wherever possible.

Drugs 103
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Novo Nordisk gets NICE okay for obesity drug Wegovy

pharmaphorum

Novo Nordisk’s new obesity therapy Wegovy has been recommended for routine NHS use by UK cost-effectiveness watchdog NICE, but in a narrower group of patients than is covered by its MHRA-approved label. NICE has backed use of the Wegovy (semaglutide) for people with a body mass index (BMI) of 35 kg/m2 or more and at least one weight-related ailment – such as high blood pressure, high cholesterol or diabetes – as part of a weight management programme involving exercise and a reduce-calorie

Drugs 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.