Bio Pharma Dive

JANUARY 11, 2021

Study results could come soon for several coronavirus vaccines, as well as experimental medicines from Amgen, Vertex and Sage Therapeutics.

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Clinical Trials Clinical Trials Trials Vaccine 356

Pharma Mirror

JANUARY 10, 2021

By Boris Goldstein, Co-Founder & Executive Chairman at Brain Scientific COVID-19 is known for its impacts on a patient’s respiratory system, but it has also been found to affect individuals in unique ways and with varying severity levels depending on their age, risk factors, and comorbidities. Several studies have recently shown that the development of neurological conditions and symptoms are prevalent in COVID patients.

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World of DTC Marketing

JANUARY 15, 2021

HEY NOW: If you want a great example of why pharma needs to build expertise in-house and rely less on agencies, read the newest white paper from Intouch Group. I read the whitepaper, and it was full of vague obscurities that are, frankly, embarrassing. Want a great example of agency babble? Read this. “Pharma needs to turn what was a very smart, fast patchwork of change into something that becomes sustainable, durable and scalable, and start supporting HCPs in a complete shift in paradigm,

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Pharma Companies Sales Marketing Branding 180

Camargo

JANUARY 14, 2021

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 Issues Advice on Combination Products. In December, the FDA published “ Requesting FDA Feedback on Combination Products ” to (a) discuss how combination product sponsors can obtain FDA feedback on scientific and regulatory questions and (b) describe best practices for the FDA and sponsors when interacting on

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Development Production FDA Approval Drugs 148

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

Medicine

Bio Pharma Dive

JANUARY 13, 2021

Brain drugs, private equity players and blank-check companies are just some of the things deal experts say they'll be keeping an eye on this year.

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Drugs 353

pharmaphorum

JANUARY 15, 2021

While pharma has raced to develop COVID-19 vaccines, US-based company NeuroRx is taking a different approach to treating the virus. CEO Dr. Jonathan Javitt tells pharmaphorum about the science behind the company’s Zyesami, which targets the alveolar type II cells in the lung that are critical for transmission of oxygen. Zyesami was developed in conjunction with partner Relief Therapeutics, and NeuroRx is currently awaiting results from a Phase 2b/3 trial ( COVID-AIV ) evaluating the therapeutic

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Vaccine Vaccination Trials Antibody 145

NY Times

JANUARY 11, 2021

Participants with the disease still declined, but much more slowly than those receiving a placebo, investigators say.

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Trials Drugs Clinical Trials Clinical Trials 144

Bio Pharma Dive

JANUARY 11, 2021

Full one-year results from a Phase 3 study show the therapy, known as Roctavian, sharply reduced bleeds and use of blood-clotting treatments.

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Gene Therapy Gene 345

Pharma Times

JANUARY 11, 2021

Partnership will aim to research and implement quantum computing in pharma R&D

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Research 143

World of DTC Marketing

JANUARY 11, 2021

KEY POINTS: The social media shutdown of far-right hate groups and speech is once again spotlighting freedom of speech issues. Whose responsibility is it to ensure that health information, for example, online is accurate and doesn’t lead to bad patient decisions? Pharma has an opportunity to help clarify misinformation via a content and personalization strategy.

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Marketing Branding Production Research 180

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Clinical Supply

BioSpace

JANUARY 14, 2021

Like many biopharma companies, the global COVID-19 pandemic has caused delays while also offering opportunities for NeuroRx.

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Bio Pharma Dive

JANUARY 11, 2021

Biogen faces a crucial FDA decision on its Alzheimer’s drug aducanumab, while Vertex gets used to investor pressure to do a deal. Sarepta, meanwhile, is picking up the pieces after a disappointing gene therapy readout.

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Gene Therapy Gene Drugs 329

Pharma Mirror

JANUARY 15, 2021

Whenever you see physicians, nurses, or any hospital worker, there’s a good chance that they’re wearing scrubs. This sanitary clothing or uniform was originally designed for use by surgeons and their support staff while in surgery rooms. It came to be known as scrubs because surgeons typically put them on as they sterilize or scrub themselves clean before entering the operating room.

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Nurses 130

World of DTC Marketing

JANUARY 12, 2021

SUMMARY: TV doesn’t make sense for smaller and older patient populations. DTC marketers should be thinking digital and aligning execution with their needs. BMS has been advertising Opdivo via DTC TV ads but does TV really make sense? It’s estimated that 228,820 adults (116,300 men and 112,520 women) in the United States will be diagnosed with lung cancer.

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Marketing Production Research Drugs 155

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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

Clinical Trials

Pharma Times

JANUARY 13, 2021

First patient in global trial dosed in the UK

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Trials 129

Bio Pharma Dive

JANUARY 13, 2021

The deal expands an earlier agreement between Regeneron and the U.S., though many of the issues limiting the drug's use haven't been solved.

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Antibody Drugs 313

Pharma Mirror

JANUARY 15, 2021

Geneva – The presidents of all five international organisations that make up the World Health Professions Alliance (WHPA) have called for continued support for health and care workers in 2021 in a joint video message released today. International Council of Nurses president Ms Annette Kennedy, said: “As health professionals, most of us have been fighting the COVID-19 pandemic.

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Nurses 130

BioPharma Reporter

JANUARY 11, 2021

Codagenixâs intranasal COVID-19 vaccine has entered Phase 1 clinical trials: with the first volunteers dosed in the UK.

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Vaccine Vaccination Trials Clinical Trials 119

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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.

Clinical Trials

pharmaphorum

JANUARY 12, 2021

ImmunityBio has licensed technology underpinning a COVID-19 vaccine that could be administered orally rather than by injection from UK biotech iosBio. Approvals for injectable vaccines for COVID-19 are starting to build, but non-injectables like oral and intranasal vaccines could be required if the pandemic is to be fought across all areas of the globe, according to Wayne Channon, the UK firm’s chairman.

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Licensing Licensing Vaccine Vaccination 119

Bio Pharma Dive

JANUARY 14, 2021

A new commissioner, high-stakes coronavirus vaccine reviews and a rising gene therapy workload will test the agency this year.

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Gene Therapy Gene Vaccine Vaccination 313

Pharma Mirror

JANUARY 11, 2021

New program combines human hello to digital embrace for long-term medication support Boston, MA – Medisafe, a leading digital drug companion company, is teaming up with Pleio to launch a new integrated digital health model with a unique combination of human and digital resources. Known as the GoodStart program, Pleio’s concierge service uses mentors to acclimate patients on their prescription therapy via live phone calls and digital nudges, meeting patients’ need for human connection.

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Drugs 130

BioSpace

JANUARY 15, 2021

Janet Lambert, CEO of the Alliance for Regenerative Medicine (ARM), painted a rosy picture despite a few challenges at the 2021 Cell & Gene State of the Industry Briefing during this year’s Biotech Showcase, held virtually January 11-15.

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Gene Therapy Gene Medicine 114

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.

Clinical Research

pharmaphorum

JANUARY 15, 2021

J&J has announced early trial results that suggest its single-shot coronavirus vaccine provides a sustained response against the virus ahead of a phase 3 trial readout due later this month. The UK has caused controversy in recent weeks by tinkering with the dosing regimens for coronavirus vaccines from AstraZeneca and Pfizer/BioNTech, which are being rolled as part of the country’s mass vaccination programme.

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Vaccine Vaccination Immune Response Antibody 119

Bio Pharma Dive

JANUARY 12, 2021

Moderna and Gilead reported billions in sales for their coronavirus treatments, but Regeneron's antibody drug cocktail hasn't gained traction. BioNTech, meanwhile, could report critical new vaccine results in days.

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Antibody Vaccine Vaccination Drugs 309

XTalks

JANUARY 15, 2021

Ortho Clinical Diagnostics received emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for its VITROS SARS-CoV-2 antigen test for detection of active COVID-19 infection. The rapid antigen test can run up to 130 tests in an hour with and can deliver same-day results, making it useful for mass-scale COVID-19 testing. The antigen test provides precise, clinically reliable results generated on the company’s high-volume VITROS systems, which are installed in more than 5,

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In-Vitro Vaccine Vaccination Drugs 105

BioSpace

JANUARY 11, 2021

Evidence continues to build for long-lasting immunity to COVID-19 following disease infection, with the publication of a new study showing a durable immune response as far as eight months after the initial onset of symptoms.

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Immune Response 113

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Clinical Supply

pharmaphorum

JANUARY 15, 2021

Belgian drugmaker UCB has been steadily building its digital health expertise for several years, and that includes nurturing new projects. One of those is now being launched as a new company – Nile AI – that aims to improve the care of people with epilepsy. UCB is bankrolling Los Angeles-based Nile with €25 million (around $29 million) in startup cash and will be a majority shareholder, with a presence on the company’s board as well as options on acquiring “data and insights” from its platform.

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Sales Medicine Production Development 110

Bio Pharma Dive

JANUARY 15, 2021

Binney Street Capital plans to invest in eight to 10 companies over the next three years. Developing new drugs will be a core focus, though investments could also go toward health services, digital health or diagnostics.

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Development Drugs 293

Pharma Times

JANUARY 14, 2021

Qualified pharmacists will administer the Pfizer/BioNTech vaccine at an in-store pharmacy

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Vaccine Vaccination Pharmacy 99

BioSpace

JANUARY 11, 2021

On Friday, the U.S. Food and Drug Administration (FDA) issued an official alert stating that it could trigger false negatives in COVID-19 tests.

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Drugs 99

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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.

Clinical Trials