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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Virtual reality technology transforming COVID-19 drug discovery

Outsourcing Pharma

Nanomeâs virtual reality tech is being put to use by Oak Ridge National Laboratory and top pharma firms to study COVID-19 and explore drug candidates.

Drugs 137
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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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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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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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FDA approval for Xywav for idiopathic hypersomnia in adults

Pharma Times

First and only FDA-approved treatment for the neurological sleep disorder

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

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NICE recommends Eli Lilly’s breast cancer drug Verzenios

Pharma Times

Cost-effectiveness watchdog initially rejected the drug in February

Drugs 130
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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 306
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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.

Vaccine 122
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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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New joint venture aims to 'open' funding opportunities for early medicines discovery

Pharma Times

Collaboration will drive medicines discovery in areas of unmet patient need

Medicine 130
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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 290
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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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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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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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UK approval for Epidyolex to treat seizures from tuberous sclerosis

Pharma Times

Approval represents a new indication for GW's cannabidiol in the UK

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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.

Vaccine 264
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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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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 115
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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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Moderna's COVID-19 vaccine maintains antibodies to six months, study shows

Pharma Times

Variants studied included Alpha, Beta, Gamma, Delta, Epsilon and Iota

Antibody 130
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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.

Vaccine 264
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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.

Vaccine 116
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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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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Enhertu improves progression-free survival in breast cancer trial

Pharma Times

Trial compared Enhertu with T-DM1 in patients with HER2-positive breast cancer

Trials 130
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VA leaves Aduhelm off coverage list, recommending against controversial Alzheimer's drug

Bio Pharma Dive

The decision, which does provide for certain exceptions, is another bump in what's become a rocky market rollout for Biogen's medicine.

Medicine 264
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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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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.

Vaccine 111
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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.