Sat.Jan 09, 2021 - Fri.Jan 15, 2021

article thumbnail

Ten key clinical trials to watch in the first half of 2021

Bio Pharma Dive

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

article thumbnail

Neurology’s Growing Need for Disposable Technologies

Pharma Mirror

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.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Pharma agency babble

World of DTC Marketing

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,

article thumbnail

Boehringer Ingelheim announces partnership with Google

Pharma Times

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

Research 165
article thumbnail

Bridging Innovation & Patient Care: The Growing Role of AI

Speaker: Simran Kaur, Co-founder & CEO at Tattva Health Inc.

AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!

article thumbnail

5 trends in biotech dealmaking to watch in 2021

Bio Pharma Dive

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.

Drugs 353
article thumbnail

In the News: December 2020 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 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

More Trending

article thumbnail

Synairgen begins large-scale trial of inhaled COVID-19 treatment

Pharma Times

First patient in global trial dosed in the UK

Trials 150
article thumbnail

BioMarin tries to get hemophilia gene therapy back on track with positive data

Bio Pharma Dive

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

article thumbnail

A new approach to COVID-19 treatment

pharmaphorum

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

Vaccine 145
article thumbnail

A huge online health opportunity

World of DTC Marketing

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.

Marketing 180
article thumbnail

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

article thumbnail

Alzheimer’s Drug Shows Promise in Small Trial

NY Times

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

Trials 144
article thumbnail

JPM21: Biogen faces make-or-break year, Vertex mulls deals and Sarepta pitches a silver lining

Bio Pharma Dive

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.

article thumbnail

NeuroRx on the Move: An Interview with Founder and CEO Jonathan Javitt

BioSpace

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

132
132
article thumbnail

DTC for small, older, patient populations

World of DTC Marketing

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.

Marketing 155
article thumbnail

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

article thumbnail

Things to Consider When You are Making Your Own Scrubs

Pharma Mirror

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.

Nurses 130
article thumbnail

US to pay up to $2.6B for more doses of Regeneron's COVID-19 antibody drug

Bio Pharma Dive

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.

Antibody 313
article thumbnail

Needle-free COVID-19 vaccine COVI-VAC enters Phase 1 trials

BioPharma Reporter

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

Vaccine 128
article thumbnail

Eli Lilly announces mid-stage trial success for donanemab in Alzheimer’s

Pharma Times

Investigational antibody targets a modified form of beta amyloid called N3pG

Antibody 124
article thumbnail

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

article thumbnail

Health professions ask public to take concrete actions to help safeguard underfunded COVID-affected health systems

Pharma Mirror

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.

Nurses 130
article thumbnail

5 questions facing the FDA in 2021

Bio Pharma Dive

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

article thumbnail

Oral COVID-19 vaccine beckons, as ImmunityBio licenses iosBio tech

pharmaphorum

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.

Licensing 119
article thumbnail

ICR researchers identify potential new treatment for drug-resistant prostate cancer

Pharma Times

CCS1477 has a novel mechanism of action compared to existing treatments

Research 124
article thumbnail

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.

article thumbnail

Pleio and Medisafe Showcase Human-to-Digital Patient Engagement Future

Pharma Mirror

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.

Drugs 130
article thumbnail

JPM21: Vaccines soar, antibodies struggle as COVID-19 drugs become a business

Bio Pharma Dive

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.

Antibody 309
article thumbnail

J&J single-shot COVID-19 vaccine shows early promise

pharmaphorum

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.

Vaccine 119
article thumbnail

NHS England selects supermarket Asda to operate COVID-19 vaccination centre

Pharma Times

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

Vaccine 122
article thumbnail

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.

article thumbnail

New Study Shows COVID-19 Immunity Can Last at Least Eight Months After Infection

BioSpace

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.

article thumbnail

Dana-Farber launches venture fund targeting incurable cancers

Bio Pharma Dive

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.

article thumbnail

UCB backs epilepsy-focused digital heath startup Nile AI

pharmaphorum

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.

Sales 110
article thumbnail

Diurnal seeks marketing authorisation for Chronocort in the UK

Pharma Times

MHRA submission is based on same application filed with the EMA

Marketing 120
article thumbnail

European Clinical Supply Planning: Balancing Cost, Flexibility and Time