Sat.Aug 07, 2021 - Fri.Aug 13, 2021

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Biotech M&A tracker: After hitting new heights, deals have slowed down. Here are the latest.

Bio Pharma Dive

Deals were few and far between last quarter. But the recent history of biopharma M&A suggests they'll return. Keep track of them as as they happen with BioPharma Dive's new database.

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HCP’s use of social media: the good and the not so good

World of DTC Marketing

SUMMARY: A survey of more than 4,000 physicians showed that virtually every physician uses social media for personal reasons, while two-thirds use it for professional reasons. 86% of diagnostic device companies, 65% of pharma marketers, and over half of biotechs use social as a critical part of their marketing mix to reach HCPs. Doximity was flagged for having anti-vaccine information.

Nurses 294
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Regulatory Strategy Considerations for Working with the FDA vs the EMA, Part 1

Camargo

As regulatory requirements become increasingly harmonized across the globe, the development and marketing of pharmaceutical products worldwide are also becoming more streamlined. However, global regulations are not one-size-fits-all, and sponsors aiming to market their products in multiple regions should be aware of the current standards and processes they may encounter during the development process.

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Gene therapy specialist bluebird exits “untenable” European market

pharmaphorum

Europe market has proved so hostile to gene therapies when it comes to pricing and reimbursement for gene therapies that bluebird bio has decided to quit the market altogether, according to Andrew Obenshain, president of its severe genetic diseases unit. On the firm’s second-quarter results call, Obenshain said the biotech will start “an orderly wind-down” of its activities in Europe and seek “strategic alternatives” to make its therapies available to patients there

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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Roche sets bar in early lymphoma treatment with Polivy study results

Bio Pharma Dive

Positive data for the Swiss pharma's antibody-based drug could be a benchmark for CAR-T therapies, which other developers aim to move into early lymphoma treatment, too.

Antibody 294
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Forget COVID, diabetes is a national emergency

World of DTC Marketing

SUMMARY: Treating Americans with diabetes now costs more than the U.S. Navy’s annual budget. And the world’s richest nation is losing this battle — even before COVID. 85 percent of people with diabetes are overweight. While not all diabetes cases are linked to weight gain, overeating and eating too much is still the main cause of type 2 diabetes.

Genetics 187

More Trending

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Mattel Introduces 6 Women in Science Barbie Dolls to Inspire Next Generation Girls

XTalks

British vaccine developer, Sarah Gilbert, has been honored with a Barbie doll. This one-of-a-kind doll looks just like her with long auburn hair, oversized black glasses and wears a pantsuit. Gilbert is a professor at Oxford University who helped lead the development of the Oxford/AstraZeneca COVID-19 vaccine. She now shares the honor of having her own Barbie doll with celebrities such as Marilyn Monroe, Eleanor Roosevelt and Beyoncé.

Scientist 116
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Merck wins approval for Keytruda combo as kidney cancer treatment

Bio Pharma Dive

Clinical testing showed a clear benefit to using Keytruda with Merck and Eisai's Lenvima in patients with previously untreated advanced renal cell carcinoma.

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A HUGE opportunity for pharma websites

World of DTC Marketing

SUMMARY : Falsehoods have been shown to spread faster and farther than accurate information, and research suggests that misinformation can have negative effects in the real world, such as amplifying controversy about vaccines and propagating unproven cancer treatments. Therefore, health misinformation on social media urgently requires greater action from those working in public health research and practice.

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Moderna to build mRNA vaccine manufacturing facility in Canada

BioPharma Reporter

Moderna has signed a Memorandum of Understanding with the government of Canada to build a mRNA vaccine manufacturing facility in the country: which could serve as a model for similar partnerships around the world.

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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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Sensyne, Oxford University deploy AI to find asthma targets

pharmaphorum

Oxford University and UK clinical artificial intelligence (AI) company Sensyne Health will partner on a project to find new drug targets for people with hard-to-treat asthma. It’s estimated that almost one in five people with asthma find it difficult to control symptoms using current therapies, while around 4% have particularly severe forms that puts them at risk of life-threatening attacks.

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FDA rejects FibroGen's kidney drug in major blow to company

Bio Pharma Dive

While the decision was expected after a negative advisory panel last month, it's a significant setback that could trigger cost-cutting at the biotech, which said it will discuss next steps with partner AstraZeneca.

Drugs 278
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The first step in a great pharma marketing organization starts with recruiting

World of DTC Marketing

SUMMARY: Pharma marketing is in a funk. Somewhere over the last decade, the passionate people who believed that helping patients was the first step in excellent marketing have been replaced with people who want to know the ROI of everything. We need to hire people who have a passion for learning, exploring, and implementing great patient-centered marketing.

Marketing 180
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Pfizer and BioNTech COVID-19 vaccine capacity to hit 4 billion doses in 2022

BioPharma Reporter

Pfizer and BioNTech are lining up orders of their COVID-19 vaccine for next year and beyond, predicting total capacity in 2022 to rise to 4 billion doses.

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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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BioNTech says repeat doses may be better than modified COVID-19 jab

pharmaphorum

BioNTech has suggested that giving booster doses of its current Comirnaty (BNT162b2) COVID-19 vaccine may be a preferable strategy to modifying the Pfizer-partnered shot. The comments came on the German biotech’s second-quarter results call, during which BioNTech raised its forecasts for revenues it will book from sales of the vaccine to €15.9 billion (almost $19 billion), on the back of contracts to deliver 2.2 billion doses this year with more than 1 billion already booked in for 2022.

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Bluebird to wind down business in Europe amid gene therapy struggles

Bio Pharma Dive

Shares in the biotech sunk in value Monday as the company also announced new safety concerns for one of its leading programs.

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Key metrics or DTC marketers

World of DTC Marketing

SUMMARY: DTC metrics change by product life cycle and DTC managers usually have to justify their budgets. Never report just raw numbers. You should tell a story on the value of your marketing using metrics that senior managers understand. That which you can’t measure shouldn’t be done? That’s what most DTC marketers believe because management wants concrete results.

Marketing 143
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FDA OKs Pfizer-BioNTech, Moderna Boosters for Immunocompromised

BioSpace

The amended EUA is aimed at patients who have undergone solid organ transplants or those diagnosed with conditions that have an “equivalent level of immunocompromised.

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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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Social Health: The Future of Healthcare Marketing

pharmaphorum

With advertisers preparing to spend up to $15 billion on influencer marketing by 2022, pharmaceutical and biotech companies are increasingly (and carefully) engaging trusted health social influencers to connect more authentically with consumers. As pharma starts to leverage a multitude of high-engagement channels like influencer marketing, online communities and virtual health services, the industry finds itself in a unique position to reimagine traditional direct-to-consumer (DTC) efforts and p

Marketing 111
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Eyeing future outbreaks, Moderna partners with Canadian government on vaccine plant

Bio Pharma Dive

While Canada has already secured more COVID-19 vaccine doses than it needs, the factory to be built is geared toward combating future pandemics.

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Philip Morris acquires another inhaled-drug pharma firm

Outsourcing Pharma

The US-based company continues its move away from smoking products with the purchase of drug developer OtiTopic, as part of its Beyond Nicotine initiative.

Drugs 114
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Can COVID-19 be Eradicated? New Zealand Researchers Say “Yes”

BioSpace

COVID-19 probably can be eradicated globally, just like polio, according to research just published in BMJ Global Health. That assumes, however, that a high rate of vaccination occurs globally and that there is a quick response to emerging variants.

Research 111
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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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UK cues up more Pfizer/BioNTech vaccines as price row looms

pharmaphorum

The UK government has started ordering COVID-19 vaccines for a 2022 booster campaign, including a 32 million-dose order for the Pfizer/BioNTech shot, even before third doses for 2021 have been given the go-ahead. A report in The Times claims that the government is paying £22 a dose – up from an earlier price of £18 – for the Pfizer/BioNTech vaccine as part of a £1 billion deal for additional supplies, which is needed because existing stocks will be depleted next year.

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FDA authorizes third coronavirus vaccine dose for immunocompromised people

Bio Pharma Dive

A CDC advisory panel is expected to vote on Friday to recommend the additional dose, after which certain people with weakened immune systems can receive a third shot of Pfizer's or Moderna's vaccine.

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Mid-Day Squares: The Modern-Day Chocolate Company Dominating the Refrigerated Snack Space

XTalks

When we think of functional foods, chocolate may not be the first thing that comes to mind. But with time, innovation, a shift in perspective and creative marketing, Mid-Day Squares is turning the concept of functional foods on its head. The Montreal, Canada-based chocolate company is not only redefining what it means to eat chocolate, but also how to run a successful food business that doesn’t take itself too seriously. .

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Importance of achieving true patient centricity in clinical trials

Outsourcing Pharma

A leader from Longboat by Advarra outlines what it really means for a study to be patient centric, and how to succeed in achieving patient-centric trials.

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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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AZ gets European approvals for Forxiga in chronic kidney disease

pharmaphorum

AstraZeneca’s Forxiga has become the first SGLT2 inhibitor to be approved in Europe for use in people with chronic kidney disease, extending its lead over rival drugs in the class. The European Commission has cleared Forxiga (dapagliflozin) for CKD in adults with or without diabetes, and the drug becomes the first new drug treatment for these patients in more than two decades.

Sales 111
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CDC advisory board unanimously backs third dose of Pfizer, Moderna vaccine for immunocompromised people

Bio Pharma Dive

People with weakened immune systems could start receiving an additional shot as early as this weekend. The panel's vote followed the FDA's authorization on Thursday.

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Two Women Accuse Anti-Aging Researcher Aubrey de Grey of Sexual Harassment

BioSpace

Aubrey de Grey has been accused by two women of predatory behavior, an allegation de Grey denies. SENS has placed him on administrative leave pending further investigation.

Research 101
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UIC studying IV drug as potential COVID-19 treatment

Outsourcing Pharma

The University of Illinois at Chicago has been given $6m from the US Department of Defense to develop a potential treatment for severe cases of COVID-19.

Drugs 110
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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.