Sat.Jan 30, 2021 - Fri.Feb 05, 2021

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Bristol Myers finally wins FDA approval for cancer cell therapy

Bio Pharma Dive

Delays tied to factory inspections had pushed an FDA decision on Breyanzi past a key deadline, allowing Bristol Myers to avoid paying billions of dollars in payouts to investors.

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Pharma’s horrible website metrics

World of DTC Marketing

SUMMARY: The number of visitors to your website doesn’t mean anything if you have high bounce rates and low page views/time on site. More than half of mobile users leave a website that takes more than three seconds to load, yet too many pharma sites are not optimized for mobile. Houston, we have a problem. Attention spans online are declining rapidly.

Branding 187
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White paper reveals pathway for digital therapeutics use in Italy

pharmaphorum

A white paper has outlined a pathway that could allow Italy to realise the potential of digital therapeutics (DTx). The official journal of the Smith Kline Foundation, Tendenze Nuove, has published the paper entitled “Digital Therapeutics, an Opportunity for Italy” earlier this month. The book features insights and recommendations from 40 leading experts in the field, who hope that Italy will begin to follow in the footsteps of early adopters of digital therapeutics such as Germany, France and

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In the News: January 2021 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. Approval of the Month: Previously Approved Oncology Drug Cleared for Rare Pediatric Indication. Pfizer’s Xalkori (crizotinib) was approved in 2011 for the treatment of patients with locally advanced or metastatic non-small cell lung cancer that is anaplastic lymphoma kinase (ALK)-positive.

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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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Gilead partners with a cancer biotech, seeking to develop an HIV immunotherapy

Bio Pharma Dive

Gritstone Oncology, known for its cancer research, is drawing attention in infectious disease, signing a deal with Gilead two weeks after announcing plans to develop a coronavirus vaccine.

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The biggest threat to the pharma industry

World of DTC Marketing

SUMMARY: The biggest threat to the pharma industry isn’t the coming tsunami of healthcare changes. It’s reshaping the company to once again focus on patients instead of profits. At the end of last year, I worked with a leading cancer company on a test program that involved an email program. We started with research to uncover the needs and wants of current cancer patients (NSC lung) and caregivers.

Branding 187

More Trending

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Olympus Supports Dissemination of Endoscopic Procedures for Colorectal Cancer in Russia

Pharma Mirror

Olympus Corporation (Director, Representative Executive Officer, President and CEO: Yasuo Takeuchi) announced today that it has been selected(1) by Japan’s Ministry of Health, Labour and Welfare (MHLW) to implement the Japan-Russia Medical Cooperation Promotion Project in the field of endoscopy for the fiscal year ending March, 2021. Under the project, Olympus will promulgate gastrointestinal endoscopic/laparoscopic techniques in support of a five-year oncology plan launched by the Russian

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Biogen laser-focused on Alzheimer's drug as rest of business falters

Bio Pharma Dive

While the biotech prepares to launch aducanumab, its latest earnings report shows significant hits to top-selling drugs, plus another pipeline failure.

Drugs 345
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Pharma throwing money away on digital ads

World of DTC Marketing

SUMMARY: Digital ad spend in pharmaceutical brands is up 111% so far in 2020 and 80% of that money is being thrown away by fraud and the popularity of programmatic advertising. While popular, digital advertising wasn’t an immediate hit in the pharmaceuticals arena due to the strict regulations. Pharmaceutical advertisers have traditionally been slow to join with the latest trends simply because it’s more complicated for regulated industries.

Branding 187
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Not every cough is COVID – MSD UK’s lung cancer campaign

pharmaphorum

For World Cancer Day, David Long, business unit director of Oncology at MSD UK tells pharmaphorum about the company’s ‘Do It Yourself’ campaign launched in the North East to raise awareness of lung cancer symptoms. As COVID cases surged last year, lung cancer referrals dropped in the UK, causing alarm to the UK Lung Cancer Coalition (UKLCC), an alliance of the UK’s leading lung cancer experts, senior NHS professionals, charities, and healthcare companies.

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

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Two Immigrants, One Unique Plan For A Biopharma

Pharma Mirror

The American Dream is why the United States is considered the “land of opportunity,” and why for centuries immigrants have flocked to our shores seeking their fortunes. Guo-Liang Yu, Ph.D., (China), and Sanjeev Redkar, Ph.D., (India), came to the U.S. in the 1980s. By anyone’s reasonable measure, both have achieved the American Dream.

Scientist 130
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Bayer agrees to help CureVac produce coronavirus vaccine

Bio Pharma Dive

Already a partner on the shot's development, Bayer will chip in on manufacturing too, pledging to make 160 million doses in 2022.

Vaccine 336
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Katie Porter attacks pharma

World of DTC Marketing

SUMMARY: “How big pharma takeovers destroy innovation” a report from Congresswoman Porter does make some points. Still, she is missing a lot of facts at a time when hospital and health insurance costs are soaring. I always have pointed instances in which pharma puts Wall Street first and patients second. Ms. Porter points out that R&D seems to have been replaced with mergers and acquisitions, but she misses the big picture by focusing solely on drug costs.

In-Vivo 187
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Millions could benefit from genetic screening before prescribing, new research finds

Pharma Times

Research led by the University of East Anglia in collaboration Boots UK and Leiden University

Genetics 129
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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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I Holland to Deliver a Free Tooling Maintenance Webinar Series

Pharma Mirror

Ensuring punches and dies are kept in optimum condition is essential to produce high quality tablets. As the demand for pharmaceutical tablets increases, the importance for proficient tool maintenance becomes even more important. To help companies understand the processes involved, I Holland, leaders in the manufacture of tablet tooling, will launch a free seven month webinar series, with the first presentation taking place at 2pm GMT on 25th February 2021.

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J&J asks FDA for emergency clearance of coronavirus vaccine

Bio Pharma Dive

With J&J's application filed, the FDA will start reviewing study results which the company says show its shot to be 66% effective against moderate or severe COVID-19.

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Thursday pharma headlines

World of DTC Marketing

SUMMARY: The industry is facing several challenges on several fronts. Amgen is laying off people because of their poor financial outlook. Merck’s old drugs are under more scrutiny, and anti-vaxxers are causing problems by cherry-picking unreliable information. Amgen announced that it’s laying off a significant number of people, most from the salesforce, under the guise that they’re going “digital.” Let’s be honest: this is a way to inflate a company’s st

Vaccine 180
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Kesimpta and Vazkepa among latest CHMP recommendations

Pharma Times

Bumper meeting saw 13 new medicines recommended for approval

Medicine 127
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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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Olympus Supports Dissemination of Endoscopic Procedures for Colorectal Cancer in Russia

Pharma Mirror

Olympus Corporation (Director, Representative Executive Officer, President and CEO: Yasuo Takeuchi) announced today that it has been selected(1) by Japan’s Ministry of Health, Labour and Welfare (MHLW) to implement the Japan-Russia Medical Cooperation Promotion Project in the field of endoscopy for the fiscal year ending March, 2021. Under the project, Olympus will promulgate gastrointestinal endoscopic/laparoscopic techniques in support of a five-year oncology plan launched by the Russian

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With $588M IPO, Sana leads wave of new biotechs going public

Bio Pharma Dive

Nine other drug developers are set to price initial public offerings this week, extending a record run of financing activity from last year. Sana's is one of the largest in history.

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Why can’t pharma unite to fight common complaint

World of DTC Marketing

SUMMARY: The biggest argument against pharma is the cost of prescription drugs. Pharma could do something about this by simply uniting to make it easier for patients who can’t afford their medications to get them free or at little cost. OK, I will be the first to admit that pharma has problems and has not put patients first, but the reality is that the pharmaceutical industry is a business.

Drugs 180
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McKinsey Settles for $573 Million Over Role in Opioid Crisis

NY Times

The consulting firm has reached the agreement with 47 states because of its advice to drugmakers, including Purdue Pharma, the manufacturer of OxyContin.

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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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Almirall, Happify partner on digital tool for psoriasis mental health

pharmaphorum

It’s well recognised that people with psoriasis can develop depression or anxiety, particularly in moderate or severe cases where a sizeable part of the body can have skin lesions. Now, drugmaker Almirall and digital health firm Happify are working on a tool to support mental health in these patients. Almirall is a specialist in psoriasis therapies with drugs like Skilarence (dimethyl fumarate) and Ilumetri (tildrakizumab), while Happify’s app is designed to drive away negative thoughts through

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Ken Frazier to step down as Merck CEO

Bio Pharma Dive

Frazier, who's retiring after a three-decade career at Merck, will hand the reins to CFO Robert Davis at the end of June. While Frazier's tenure was framed by the success of Keytruda, his leadership extended far beyond Merck's walls.

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Digital health exploding but dangers persist

World of DTC Marketing

SUMMARY : DigitalHealth.com, a British website, had a fascinating look at the use of health apps during the pandemic. Among their findings: Downloads of apps supporting consumers with mental health needs increased by nearly 200% from summer 2019 to summer 2020 Downloads of those supporting consumers with diets and weight loss rose by a massive 1294% from mid-2019 to mid-2020.

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NICE green light for GSK's Nucala

Pharma Times

Final guidance on the drug's use to treat patients with severe eosinophilic asthma on the NHS has now been published

Drugs 123
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Family cancer experience informs eHealth company

Outsourcing Pharma

The founder of Andaman7âs leukemia diagnosis, and his sonâs experience with bone cancer, have helped inform the firm's tech and patient-centric approach.

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Gilead sales propped up by COVID-19 drug Veklury

Bio Pharma Dive

Sales of the antiviral drug accounted for a quarter of the biotech's product revenue in the fourth quarter, disguising hits to its business elsewhere.

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Pharma Rivals Step Up to Assist with COVID-19 Vaccine Production

XTalks

As COVID-19 vaccines continue to be in short supply around the world, pharma giants such as Bayer (Nasdaq: BAYRY ) are stepping up to help fulfill the need. Bayer has agreed to assist in the manufacturing of an mRNA-based coronavirus vaccine, CVnCOV, developed by fellow German biopharma company CureVac (Nasdaq: CVAC ). In early January, Bayer also struck an agreement with the company to support the further development, supply and key territory operations of CureVac’s COVID-19 vaccine candidate.

Vaccine 116
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New analysis backs safety, efficacy of AZ/Oxford COVID-19 jab

Pharma Times

The data show 100% protection against severe disease, hospitalisation and death, greater vaccine efficacy with an inter-dose interval of 12 weeks or more, and the potential for reduced asymptomatic transmission

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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.