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. .

Vaccine 303
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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.

Vaccine 145
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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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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.

Vaccine 347
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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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mRNA Tech Used in COVID-19 Vaccines Could be Used to Cure HIV, Cancer and More

BioSpace

Researchers are leveraging the messenger RNA (mRNA) technology used to develop the Pfizer-BioNTech and Moderna COVID-19 vaccines for possible treatments for a range of other diseases, including HIV and cancer.

Vaccine 142
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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.

Vaccine 345
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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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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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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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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 340
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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.

Vaccine 203
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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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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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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 334
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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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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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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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New subcutaneous formulation of Tysabri approved in UK

Pharma Times

Multiple sclerosis treatment can now be administered subcutaneously or intravenously

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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.

Vaccine 329
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And so pharma profiteers again

World of DTC Marketing

QUICK READ: Pfizer has already announced a price increase to the EU for their Covid Vaccine. With a CEO who earns more than $20 million annually and the potential for billions in profit Pfizer is reminding us that Wall Street is once again their primary customer. Bulgarian Prime Minister Bokyo Borissov this morning said the US pharmaceutical giant has increased the cost of future orders sold to the EU from €12 per dose to €19.50.

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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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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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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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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 328
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Amylyx Pharma plans to file ALS therapy with the EMA this year

Pharma Times

The previously-reported CENTAUR study of AMX0035 in 137 participants with ALS met its primary endpoint of slowing ALS progression

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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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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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The power of communication: engaging diverse groups in healthcare

pharmaphorum

Humans are diverse and communications to engage us need to be inclusive. It’s no longer about talking to a group, a cohort or an imagined section of society – especially in healthcare. Page & Page’s Lisa Jane Lishman outlines why communication and the strategies behind it need to be more personal to ensure that people – whoever they are – feel valued and respected.

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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 325
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Pfizer, Myovant begin dosing in relugolix contraceptive study

Pharma Times

Dosing has begun in a Phase III study evaluating the contraceptive efficacy of relugolix combination tablet

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ATMPS and Ori Biotech Collaborate on an Integrated Digital Platform for Cell and Gene Therapy Developers

Pharma Mirror

ATMPS Ltd, a leader in blockchain-based “vein to vein” cell orchestration platforms for advanced therapies, and Ori Biotech, an innovator in cell and gene therapy (CGT) manufacturing platforms, today announce a global collaboration to create seamless integration between their respective data platforms to support the development of Advanced Therapies.

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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.