Sat.Apr 10, 2021 - Fri.Apr 16, 2021

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5 takeaways from AACR, one of the year's top meetings on cancer drugs

Bio Pharma Dive

The American Association for Cancer Research's virtual conference featured new data on an emerging immunotherapy target, a new kind of cell therapy and a KRAS reboot.

Drugs 358
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COVID-19: Some ignored facts

World of DTC Marketing

QUICK THOUGHT: People believe the COVID-19 vaccine was developed in less than a year but that’s not true. Coronaviruses were first encountered in April 1930, when a strange respiratory disease ravaged poultry farms across North Dakota and Minnesota, killing tens of thousands of baby birds. Further scientific research into the virus and recognition that it was not like influenza A, a flu virus known to cause bronchitis, would transpire over the next 30 years. .

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2020 505(b)(2) NDA Approvals: A Year in Review, and What a Year It Was!

Camargo

In 2020, CDER approved 68 NDAs that used the 505(b)(2) pathway, representing important advances in patient care across a wide range of therapeutic areas. 505(b)(2) Drug Improvement Approvals by Year. In spite of an unusual year due to the COVID-19 pandemic, NDA approvals via the 505(b)(2) pathway increased 6% from 64 in 2019 to 68* in 2020 (Figure 1).

Drugs 176
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Moderna to take mRNA flu and HIV vaccines into Phase 1 trials this year

BioPharma Reporter

Moderna will take mRNA flu and HIV vaccines into Phase 1 trials this year, as well as beginning a pivotal Phase 3 study for its cytomegalovirus (CMV) vaccine candidate.

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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!

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CDC panel delays decision on J&J vaccine, extending pause over rare side effect

Bio Pharma Dive

Advisers to the agency agreed to wait for more data before recommending new guidance, but aim to reconvene quickly to decide on whether vaccinations with J&J's should be resumed, and for whom.

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Reaching HCPs online

World of DTC Marketing

QUICK READ: Recent research from Zoom Rx saying that digital interactions with HCPs are myopic and don’t apply to the heavily segmented HCP audience. The future of reaching HCPS is both on and off-line depending on the product, health condition, and specialty. Zoom Rx recently polled HCPs and found 78% of physicians want to maintain some contact with pharma reps.

Doctor 286

More Trending

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Apple, Google block NHS contact tracing app update on privacy grounds

pharmaphorum

A scheduled update to the NHS COVID-19 app has been blocked because it allows location tracking – something prohibited by Apple and Google, which developed some of the code it uses. . The new version of the app used in England and Wales was due to become available today to coincide with the relaxation of lockdown rules, with the public now able to attend venues such as non-essential shops, pub beer garden, gyms and hairdressers.

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US calls for pause in J&J coronavirus vaccine rollout after rare blood clotting cases

Bio Pharma Dive

The FDA and CDC recommended halting vaccinations while they investigate six cases of unusual blood clots in women given the company's shot.

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Pharma agency challenges and opportunities

World of DTC Marketing

QUICK READ: According to Setup 30% of Brand marketers say they’re likely/somewhat likely to switch Agencies in the next 6 months. While the consolidation of agencies may be a priority for some pharma companies a good digital agency can add a lot of value. There is a lot of downside to letting your main ad agency do your digital work. Setup also found that one third of brand marketers want their agencies to better understand their business + seek greater transparency and communication between Age

Branding 203
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US approval for first AI device to help detect colon cancer

Pharma Times

Device designed to help clinicians detect lesions in the colon during a colonoscopy

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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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Large-Scale Study Finds One-Third of COVID-19 Patients Suffer Neurological Damage

BioSpace

Six months after a COVID-19 diagnosis, more than 33% of people exhibited some form of brain damage, according to a study appearing in Lancet Psychiatry.

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Lilly asks FDA to revoke clearance of first COVID-19 antibody drug

Bio Pharma Dive

The request comes less than six months after the FDA authorized Lilly's bamlanivimab, reflecting the spread of virus variants that can elude the drug.

Antibody 339
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The internet enables misinformation on COVID

World of DTC Marketing

QUICK READ: Some deaths will occur during the COVID-19 vaccination rollout, but these deaths would have happened for other reasons and are unrelated to the vaccine. Vaccine-hesitant groups are peddling misinformation online and conspiracy theories aimed at eroding trust in the COVID-19 vaccine are everywhere forcing people to conduct more research. In some instances, vaccine-hesitant activists are manufacturing stories of deaths related to the vaccine that never happened.

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New subcutaneous formulation of Tysabri approved in UK

Pharma Times

Multiple sclerosis treatment can now be administered subcutaneously or intravenously

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

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Vaccines Won’t Protect Millions of Patients With Weakened Immune Systems

NY Times

Many cannot produce enough infection-fighting cells to fend off the coronavirus. But researchers are testing one therapy that may help: monoclonal antibodies.

Antibody 130
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Lilly gene-targeted drug shows potential for use across cancers

Bio Pharma Dive

Study results presented at AACR showed Retevmo shrank tumors in nine different cancers, building a case for the type of tissue-agnostic label that only three other medicines have secured.

Gene 332
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Should we be worried about pharma’s supply chain?

World of DTC Marketing

QUICK READ: Pharma supply chain issues are a concern for us all but especially patients. The goal of getting a drug to market as fast as possible so they can recoup drug development costs has the potential for mistakes that could cost lives. Coupled with all this is the continued outsourcing of raw materials and other steps in drug development. Patients should be scared.

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Gilead’s Trodelvy scores accelerated approval in advanced bladder cancer

Pharma Times

US Food and Drug Administration approved antibody drug conjugate based on Phase II trial results

Antibody 130
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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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Medical Equipment: Should You Buy, Lease, or Just Wait?

Pharma Mirror

Running a healthcare business is a tricky thing. Certain equipment is often being requested by physicians who are insisting it’s needed to improve patient diagnosis and care. Yet, it’s not always affordable. Other times, it’s preferred, but the business should be mindful of the cost and look at how best to afford it. Should medical equipment be purchased outright, leased, and then acquired or delayed until it’s more affordable?

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Moderna watches for 'waning immunity' as new data show durable vaccine protection

Bio Pharma Dive

Updated study results show Moderna's coronavirus vaccine was strongly protective against COVID-19 through six months. But executives outlined contingency plans in case those effects fade.

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Exscientia starts trials of first AI-derived cancer immunotherapy

pharmaphorum

Exscientia was the first company to start human trials of a new drug designed using artificial intelligence (AI) last year, and now says it has started testing of the first AI candidate for immuno-oncology. . Oxford, UK-based Exscientia has been working with German biotech Evotec on the adenosine A2a receptor antagonist, which is being tested as a treatment for adult patients with advanced solid tumours.

Trials 127
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Inhaled asthma drug accelerates recovery from COVID-19

Pharma Times

Self-reported recovery was three days shorter for patients receiving inhaled budesonide

Drugs 130
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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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Rising Demand for Customized Medication To Transform Compounding Pharmacies Market Outlook

Pharma Mirror

Compounding pharmacies, which involve the preparation and selling of prescribed medicines are gaining massive popularity across the healthcare sector owing to the rising awareness regarding the benefits of compounded medications. Besides, the shortfall of various drugs such as cancer medicines and other lifesaving drugs is fostering the demand for compounding pharmacy services.

Pharmacy 130
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Merck, in latest COVID-19 setback, scraps one drug and pins hopes on another

Bio Pharma Dive

The decision to end development of a medicine acquired in a $425 million deal last November is another disappointment for Merck's coronavirus effort, which once involved multiple drugs and vaccines.

Drugs 326
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Changing the paradigm: Microbiome modulation may become the next ‘pillar’ in cancer treatment

BioPharma Reporter

Insights have been gained into the role of the microbiome in disease states such as cancer, and strategies to manipulate the microbiome are quickly emerging, though optimal approaches are not yet known, said experts during an AACR 2021 event this week.

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NICE publishes new guidance on chronic pain management

Pharma Times

Guidelines recommend exercise programmes and psychological therapies rather than commonly used drugs

Drugs 130
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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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How Market Listening Can Help Drive Your Pharma Sales Funnel

Pharma Mirror

The pharmaceuticals industry is responsible for the research, development, production and of medications and generates over 1.25 trillion in revenue globally. While experiencing significant growth over the last two decades, the industry has become even more significant over the past year. The role of pharma sales reps is an incredibly important part of this lifecycle from initial research to point of sale and distribution, with reps connecting the groundbreaking research and technology of pharma

Sales 130
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FDA faces backlash after seeking more data on an experimental ALS therapy

Bio Pharma Dive

The ALS Association demanded the FDA "move with the urgency" other agencies have in reviewing a drug from Amylyx Pharmaceuticals.

Drugs 322
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Thermo Fisher Scientific snaps up PPD in $17.4b acquisition deal

Outsourcing Pharma

The science service and technologies firm plans to bring the CRO under its Laboratory Products and Services Segment umbrella after the deal is completed.

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Early promise for new immunotherapy combo in brain cancer

Pharma Times

Experimental drug plus immunotherapy demonstrated early potential in aggressive brain cancer

Drugs 127
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time