Wed.Aug 31, 2022

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Biotech startup Ocean pivots from IPO to SPAC merger

Bio Pharma Dive

The blank-check deal gives Ocean another route to public markets after it struggled to price an initial public offering it revealed back in June 2021.

Marketing 339
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Life expectancy declines again

World of DTC Marketing

According to STAT News, “Americans born in 2021 can expect to live for just 76.1 years — the lowest life expectancy has been since 1996, according to a new government analysis published Wednesday. This is the biggest two-year decline — 2.7 years in total — in almost 100 years.” It’s only going to get worse too. The Covid-19 pandemic is the primary cause of the decline, but we are ignoring another statistic.

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Amgen says KRAS drug beat chemo in lung cancer study

Bio Pharma Dive

But the company offered no details on the closely watched trial, which is meant to confirm the effectiveness of Lumakras in non-small cell lung cancer.

Drugs 278
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Costa Rica’s commitment to developing talent in industry 4.0

Pharmaceutical Technology

Availability of labour is an important factor for foreign investors, with the education and skill sets found within that labour force being a decisive driver when it comes to FDI site selection. Data from the UN Conference on Trade and Development’s World Investment Report 2020 and the World Economic Forum’s Global Competitiveness Report 2019 indicates that countries with a higher-skilled and better-educated workforce attract more greenfield FDI projects, but how does a country ensure its workfo

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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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Beam details reasons for FDA hold on base editing cancer therapy

Bio Pharma Dive

The regulator has asked Beam for a range of technical data before it can start testing the blood cancer treatment in humans.

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Wearables: managing complexities in data privacy and consent in healthcare tech

Pharmaceutical Technology

Over the last few years, the trend for wearables has shown the potential benefits of transforming healthcare through digital technologies. Alongside fitness trackers and smartwatches, there are also medical devices used to monitor a patient’s vitals and some even contain SIM cards to enable two-way communication. Devices such as insulin pumps, heart pacemakers, and inhalers can track patient data in real-time and transmit to the user’s phone, an app, or their doctor, making the data immediately

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Whatever happened to the new no-patent COVID vaccine touted as a global game changer?

NPR Health - Shots

The inventors of Corbevax said it was cheap, easy to make, effective and safe. They hoped it could bring vaccine equity to countries that can't access costlier shots. Has it lived up to its promise?

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Pfizer lures first chief marketing officer from Verily

Bio Pharma Dive

Drew Panayiotou led marketing efforts at Alphabet’s life sciences arm Verily, and his appointment is Pfizer’s third senior-level hire this year.

Marketing 152
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The U.S. diet is deadly. Here are 7 ideas to get Americans eating healthier

NPR Health - Shots

The way many Americans eat is fueling chronic disease. Here are seven big ideas from the White House's upcoming nutrition conference for how to improve Americans' diets. (Image credit: FREDERIC J.

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Funds for free COVID-19 vaccines could run out as early as January, HHS says

Bio Pharma Dive

The commercial market for COVID-19 vaccinations could be similar to that for seasonal flu shots and other vaccines, an official with the department said.

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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

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FDA authorizes first revamp of COVID vaccines to target omicron

NPR Health - Shots

The new shots from Moderna and Pfizer-BioNTech target both the original strain of the coronavirus and the omicron BA.4/BA.5 subvariants that most people are catching now. (Image credit: Pfizer Inc.

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August 31, 2022: New Section of Living Textbook Addresses Evaluating Fitness for Use of Real-World Data Sources

Rethinking Clinical Trials

A new section of the NIH Pragmatic Trials Collaboratory’s Living Textbook of Pragmatic Clinical Trials discusses challenges associated with Evaluating Fitness for Use of real-world data for trials. The section uses a case study from the Harmony Outcomes EHR Ancillary Study (eHARMONY) to describe lessons learned and to provide recommendations for studies considering incorporating real-word data as a data source.

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This Mexican clinic is offering discreet abortions to Americans just over the border

NPR Health - Shots

In May, Americans made up 25% of patients receiving abortions at one clinic in Tijuana. By July, it was an estimated 50%. The director believes it's due to cost, privacy and convenience.

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Novartis extends Kaiku digital patient monitoring partnership

pharmaphorum

Kaiku Health’s year-old alliance with Novartis to develop a digital patient monitoring and management (DPPM) system for patients with melanoma is being extended, according to the two partners. The original agreement last year focused on melanoma patients who are receiving BRAF/MEK combination therapies – specifically Novartis’ Tafinlar (dabrafenib) and Mekinist (trametinib) drugs – and has resulted in the development of a digital module tailored to their needs.

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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.

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STAT+: Once a small player among biotech VCs, Mubadala Capital Ventures is punching above its weight

STAT News

At the start of 2021, blue-chip biotech investor ARCH Venture Partners and a relatively unknown sovereign wealth fund were in the middle of building a new biotech startup when the unthinkable happened. Alaa Halawa, executive director at United Arab Emirates’ state-owned Mubadala Capital Ventures, was waiting for a phone call from ARCH Managing Director Paul Thurk to go over their latest to-do list.

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How to Start a Pharma Company with a Low Budget in India?

Fossil Remedies

Do you think that India is a great place to launch a pharma business? Yes, indeed it is. In the past few decades, the Indian economy has done remarkably well. Many sectors have performed well, and the pharma sector is one of them. And the journey of growth has not ended yet. There is a great potential still, to prosper and flourish. Those, who don’t mind taking a risk in the business must reap the opportunity by launching a pharma company.

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FDA authorizes Pfizer and Moderna Covid boosters targeted against Omicron strains

STAT News

The Food and Drug Administration on Wednesday authorized new Covid booster shots from Moderna and Pfizer that more closely match the strains of the coronavirus that are currently circulating in the U.S. Pfizer’s booster, made with partner BioNTech, is being authorized for people as young as 12 years old. The Moderna booster is being authorized for people ages 18 and up.

Drugs 105
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US government provides funds to boost continuous bioprocessing

BioPharma Reporter

Despite continuous bioprocessing being talked about as the future of manufacturing in biologics for years, this has not become reality. However, in recent years, the US government has begun to dedicate funds to intensify the production of biologics.

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Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.

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Opinion: As hospitals raise their prices, U.S. workers and businesses suffer

STAT News

Despite a recent taxpayer-subsidized boon , the hospital industry spent the last several months lobbying for additional federal dollars amid warnings about the continued spread of Covid-19 and inflation’s impact on the nation’s health care system. Those efforts bore fruit: Medicare recently granted hospitals the largest price increase since 1998.

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5 ways to reduce patient burden in clinical trials

Antidote

When creating a clinical trial protocol, it’s important for sponsors to consider how each requirement impacts the patients who are taking part. While participating in a clinical trial can be beneficial for many reasons, it can also place a burden on patients who choose to participate. Complications with scheduling, transportation, and instructions can all create friction for patients — and can ultimately lead to dropouts if they are not addressed.

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The Biden administration is pushing another round of Covid boosters. Who’s listening?

STAT News

WASHINGTON — Federal health officials are starting to push new, variant-targeting vaccines that they say will curb a winter coronavirus wave and protect America’s most medically vulnerable people. The question is whether Americans feel any urgency to get them. The updated vaccines from Moderna and Pfizer and BioNTech, authorized Wednesday by the Food and Drug Administration, are tailored to fighting back the dominant BA.4 and BA.5 strains.

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‘A key way to minimalize environmental impact of manufacturing biopharmaceutical drug substance is to drive process intensification’

BioPharma Reporter

As environmental considerations move up the agenda for biopharmaceutical manufacturers, process intensification can offer a win-win situation for those looking to lower costs and improve sustainability.

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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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Opinion: The No Surprises Act: A Band-Aid protecting business as usual

STAT News

The No Surprises Act has been hailed as a major bipartisan reform aiming to eliminate most surprise out-of-network bills. For years, Americans had expected their insurance to shield them from high medical costs and cap their out-of-pocket payments at modest levels. Yet many received unexpected bills for medical services at unregulated prices when they accidentally chose out-of-network caregivers or lacked safe in-network options.

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Psyomics links up with Hertfordshire Partnership University NHS Foundation Trust

Pharma Times

Hertfordshire Trust to invest in mental health care with wide-ranging digital assessment platform

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STAT+: Pharmalittle: An emerging star in biotech investment; U.S. government expected to stop paying for Covid shots next year

STAT News

Good morning from San Diego. I’m Jonathan Wosen, STAT’s West Coast biotech reporter, and I’m picking up the baton from Allison as we continue to fill in for Ed this week. I’m not a coffee drinker, but I’ve poured myself a cup of water. No ice, though, as I find it dilutes the flavor. Jokes aside, here are some newsy items for you to peruse this morning.

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Kaiku Health enters wider partnership with Novartis

Pharma Times

Following a successful collaboration, the companies will now partner to focus on precision medicine

Medicine 105
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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.

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STAT+: One Medical founder Tom Lee on the Amazon deal and striking the right balance with virtual care

STAT News

Virtual care companies face increasing churn as telehealth visits sink below their pandemic-era peak, forcing them to cut back on staff and services or enter into bold new business agreements expanding their geographic reach. For some companies, a trend toward consolidation has led to stumbles , while others are finding new ways to sell existing services to more patients by combining customer bases.

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Life expectancy drops in the U.S. for the second year in a row

NPR Health - Shots

Life expectancy in the United States dropped for the second year in a row, according to new provisional data released by the Centers for Disease Control and Prevention.

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Phase 3 trial confirms Lumakras role in lung cancer

pharmaphorum

Amgen’s pathfinder KRAS inhibitor Lumakras has been shown to be effective in KRAS-mutated non-small cell lung cancer (NSCLC) in a phase 3 trial that should serve as a confirmation study for its earlier accelerated approval in this setting. The 345-subject CodeBreaK 200 trial of once-daily Lumakras (sotorasib) met its primary objective of improving progression-free survival (PFS) compared to chemotherapy with intravenous docetaxel in KRAS G12C-mutated NSCLC patients previously treated with

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After a decadelong spate of closures, one rural Tennessee hospital reopens

NPR Health - Shots

When rural hospitals go out of business, they're frequently gone for good. But now, some comebacks are a welcome sign for communities that have been without easy access to health care.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.