Wed.Dec 08, 2021

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A high-profile gene therapy biotech takes aim at Huntington's

Bio Pharma Dive

Passage Bio and the University of Pennsylvania's Gene Therapy Program said they have begun preclinical research aimed at simultaneously developing multiple approaches to treating Huntington's.

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How much should I spend on an HCP website?

World of DTC Marketing

LEAD-IN- Recent data confirms that health care professionals are using the Internet more and spending less time with drug company reps. How much should you spend on an HCP portal, and how do you measure its success? One of the first questions I often get from potential clients is, “how much does a good HCP website cost?” There is no one answer to that question.

Branding 213
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Martin Shkreli's former company to pay $40M in settlement over drug price hikes

Bio Pharma Dive

The payment resolves the government's claims against Vyera and Phoenixus for their efforts to block competition to Daraprim, the toxoplasmosis drug Shkreli famously raised the price of by 4,000%.

Drugs 294
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Cambya Sugar Substitute Lets People Have Their Cake and Eat it Too

XTalks

B.T. Sweet, an Israeli food tech startup, recently unveiled a plant-based, one-to-one drop-in sugar substitute called Cambya. It can replace sugar in a multitude of applications in the chocolate and confectionary space, boasting the same levels of sweetness and body as real sugar. So, what is Cambya and what differentiates it from other sugar substitutes?

Branding 121
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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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Omicron cuts Pfizer vaccine's potency, but data show booster may restore protection

Bio Pharma Dive

Preliminary laboratory testing by Pfizer and partner BioNTech indicated three doses may protect against omicron as well as two doses versus the original coronavirus strain.

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New Study: Fat Cells Are a Reservoir for COVID-19 Infection

BioSpace

Researchers published a study proving that SARS-CoV-2 infects human adipose or fat tissue to multiply and elicit an inflammatory response corresponding with severe COVID-19.

Research 114

More Trending

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WHO says vaccines should be effective against Omicron variant

Pharma Times

A senior official at the World Health Organisation (WHO) has said that Omicron is ‘highly unlikely’ to fully bypass vaccine protections.

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Omicron may evade Pfizer/BioNTech COVID jab, says study

pharmaphorum

Preliminary study results from South Africa have suggested that antibodies stimulated by Pfizer and BioNTech’s Comirnaty are less effective against the new COVID-19 variant Omicron. A study by the African Health Research Institute (AHRI) has found that the less of immune protection was “extensive but incomplete,” meaning that some level of immunity was retained against the vaccine.

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Marketing authorisation acquired for first and only transdermal contraceptive patch in UK

Pharma Times

The Evra hormonal patch can be worn discreetly and according to Gedeon Richter UK Ltd, is over 99% effective at pregnancy prevention

Hormones 104
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Seizing opportunities with perfectly pitched messages

pharmaphorum

Personal relationships have been the dominant force in sales for generations but the pandemic has ripped up this conveyer belt of convenience. More than 60% of clinicians are happy to either connect solely via technology or via a hybrid arrangement and there is no going back. The pharmaceutical industry became stuck in a groove of letting doctor-rep relationships obscure the challenge of delivering complex information in perfectly pitched presentations.

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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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Catalyst technology converts methane greenhouse gas into useful, valuable chemicals

Scienmag

AMES, Iowa – Methane, which produces more warming than other greenhouse gases and is the subject of newly announced U.S. emission restrictions, is hard to break down and keep out of the atmosphere. Credit: Photo by Christopher Gannon/Iowa State University AMES, Iowa – Methane, which produces more warming than other greenhouse gases and is the […].

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HypnoVR raises €4.5m for its digital sedative for pain, anxiety

pharmaphorum

French digital health startup HypnoVR has completed a first-round financing, raising €4.5 million ($5.1 million) that will be used to roll out its virtual reality-based hypnosis therapies. The company has developed a an individually tailored immersive VR platform that it uses to deliver clinical hypnosis techniques to alleviate chronic pain, anxiety and discomfort during medical procedures like surgery.

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What Should You Post About on LinkedIn?

BioSpace

Instead of letting LinkedIn slide to the bottom of your to-do list day after day, block off an hour on your calendar once a week to create a post and engage with your connections.

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Henlius claims win for PD-1 drug in small cell lung cancer

pharmaphorum

China’s Shanghai Henlius Biotech says its experimental PD-1 inhibitor serplulimab has extended survival when added to chemotherapy in a phase 3 trial as first-line therapy for extensive stage small cell lung cancer (ES-SCLC), setting up regulatory filings. The trial compared serplulimab (formerly HLX10) plus carboplatin and etoposide chemotherapy in previously untreated patients with ES-SCLC , and showed a higher overall survival than chemo alone, according to the company.

Drugs 97
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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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You can help scientists study the Sun

Scienmag

MINNEAPOLIS / ST. PAUL (12/07/2021) — If you ever wanted to be an astronomer, now is your chance. A new citizen science project, led by researchers at the University of Minnesota with support from NASA, allows volunteers to play an important role in learning more about the Sun by using their personal computers. Credit: NASA MINNEAPOLIS […].

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F.D.A. Authorizes AstraZeneca Drug for People With Immune Problems

NY Times

The antibody drug, Evusheld, was found to be strongly effective in preventing Covid in a clinical trial that enrolled mostly those at high risk.

Drugs 95
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The impact of drugs on gut microbes is greater than we thought

Scienmag

We are one of the most medicated generations of humans to live on our planet. Cardiometabolic diseases like type 2 diabetes, obesity, and coronary artery disease continue to increase in prevalence and together constitute the highest cause of mortality worldwide. Affected people often have to take multiple daily medications for months or even years. Credit: […].

Drugs 89
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1E Therapeutics Raises $120 Million in Seed Funding

BioSpace

1E Therapeutics announced $120 million seed funding, a remarkable feat for an early-stage biotech company. The funding is the largest of its kind for an Israeli biotech company.

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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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UTHealth Houston researchers uncover new findings about cluster headaches

Scienmag

Debilitating cluster headaches commonly begin in childhood, but patients are not typically diagnosed until they are adults, according to research from The University of Texas Health Science Center at Houston (UTHealth Houston). Credit: Photo courtesy of UTHealth Houston Debilitating cluster headaches commonly begin in childhood, but patients are not typically diagnosed until they are adults, […].

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China Puts Renewed Focus on Monoclonal Antibodies in COVID-19 Fight

BioSpace

Researchers in China are busy developing several treatments, combining vaccines and drugs for COVID-19, as also working on monoclonal antibody treatments.

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Schlumberger inventor Ashers Partouche recognized for technology innovation in the oil and gas industry

Scienmag

HOUSTON, TEXAS – Schlumberger Inventor Ashers Partouche is the recipient of the 2022 Edith and Peter O’Donnell Award in Technology Innovation from TAMEST (The Academy of Medicine, Engineering and Science of Texas). He was chosen for the wellbore formation testing technology platform he helped develop, Ora, which is in use globally in the energy industry. […].

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Reata Stock Takes a Blow as FDA Panel Voted Down Alport Syndrome Drug

BioSpace

Shares of Reata Pharmaceuticals have plunged nearly 40% in premarket trading after an FDA advisory panel recommended against the approval of its Alport syndrome disease treatment, bardoxolone.

Drugs 94
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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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What can 35-year-old stool samples tell scientists about HIV/AIDS?

Scienmag

PITTSBURGH, Dec. 8, 2021 – Men who contracted HIV in the early days of the HIV/AIDS pandemic harbored a greater relative abundance of pro-inflammatory vs. anti-inflammatory gut microbes before they became HIV-positive compared to their counterparts who remained HIV-negative, according to new research published today in the journal Microbiome. In addition, the men who progressed […].

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After Setbacks, CymaBay Pushes Forward with Potential Liver Disease Treatment

BioSpace

The holds were lifted by the FDA in July of 2020, but the company’s timeline had been severely set back by the miscalculation.

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Iron treatments reduce heart attacks in patients on dialysis

Scienmag

A new paper in Cardiovascular Research, published by Oxford University Press, indicates that iron treatments may reduce heart attacks in patients experiencing kidney failure undergoing dialysis. Coronary artery disease is prevalent in patients with chronic kidney disease but how often heart attacks occur in patients on maintenance hemodialysis and the appropriate treatments to try to […].

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CSL and uniQure’s Hemophilia B Gene Therapy Hits the Mark

BioSpace

CSL Behring and uniQure announced that their etranacogene dezaparvovec hit the pre-specified primary endpoint in their Phase III clinical trial in severe to moderately severe hemophilia B.

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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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Fish help control crown-of-thorns starfish numbers on Great Barrier Reef

Scienmag

Reef fish, such as emperors, tropical snappers and rockcods, help keep numbers of crown-of-thorns starfish in check on the Great Barrier Reef, according to a new study from the Australian Institute of Marine Science. Credit: Australian Institute of Marine Science Reef fish, such as emperors, tropical snappers and rockcods, help keep numbers of crown-of-thorns starfish […].

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Moderna and Pfizer Premature Statements on Omicron + FDA Approves New Hepatitis B Vaccine – Xtalks Life Science Podcast Ep. 40

XTalks

In this episode, Ayesha discussed statements from Moderna and Pfizer regarding Omicron and the need for new variant-specific boosters. Moderna’s CEO sparked concerns when he said the current vaccines likely won’t be effective against Omicron, while Pfizer’s CEO said vaccines for COVID-19 will likely be needed for many years. The editorial team discussed the impact of these comments as they were relatively premature given that not much is known about Omicron yet, such as its transmissibility and

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Preventing extreme polarization of political attitudes

Scienmag

Encouraging interactions between people on opposite ends of the political spectrum may not be the best way to foster tolerance in a polarized nation. Credit: Proceedings of the National Academy of Sciences Encouraging interactions between people on opposite ends of the political spectrum may not be the best way to foster tolerance in a polarized […].

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Frontiers Health Digital Innovators: Debiopharm Innovation Fund S.A.’s Tanja Dowe

pharmaphorum

pharmaphorum’s founder, Dr Paul Tunnah, talks with Debiopharm Innovation Fund’s CEO Tanja Dowe at Frontiers Health as part of his mini series of interviews from Frontiers Health. . Live from the conference in Milan, Tanja discusses how Debiopharm Innovation Fund concentrates on series A and series B investments, and recently released a report outlining what’s next for start-ups who’ve received series A funding.

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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.