Fri.Sep 17, 2021

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FDA advisers support booster dose of Pfizer vaccine in older or high-risk adults

Bio Pharma Dive

In a back-and-forth meeting Friday, the committee opposed clearing a third shot widely for use in people older than 16, but agreed the benefits outweighed the risks for adults over 65 or those at risk of severe COVID-19.

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Here’s the Story Behind World Patient Safety Day 2021

XTalks

World Patient Safety Day 2021 is celebrated on September 17 worldwide. This day raises global awareness about patient safety and calls for solidarity from all counties to reduce patient harm. September 17 is an official global public health campaign marked by the World Health Organization (WHO). World Patient Safety Day joins the ranks of ten other global public health campaigns that include World Tuberculosis Day, World Health Day, World Malaria Day and more.

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Biogen says experimental pain drug helps neuropathy patients in mid-stage trial

Bio Pharma Dive

With Aduhelm approved but struggling to gain traction, Biogen is talking up its pipeline. Mixed trial results, however, may make it challenging to design a larger study that can persuade regulators to approve the pain drug.

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ALS Association Pressures FDA to Approve Amylyx Drug as Agency Cuts Phase III Trial Requirement

XTalks

The ALS Association is pushing for rapid FDA approval of Amylyx Pharmaceuticals Inc.’s candidate drug AMX0035 (sodium phenylbutyrate/taurursodiol) for the treatment of amyotrophic lateral sclerosis, or ALS. The advocacy group is well known for its Ice Bucket Challenge fundraising that garnered international attention several years ago. This time, the group is backing a drug that they believe will greatly benefit ALS patients.

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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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Lilly's COVID-19 antibody cleared by FDA for post-exposure prevention

Bio Pharma Dive

The expanded authorization comes amid surging demand for antibody treatments, particularly in states with lower rates of coronavirus vaccination.

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Infants exposed to domestic violence have poorer cognitive development

Scienmag

COLUMBIA, Mo. – While assessing a pregnant woman with premature labor in 1983, Linda Bullock noticed bruises on the woman. When she asked what happened, the woman told Bullock a refrigerator had fallen on her while cleaning the kitchen. Credit: MU COLUMBIA, Mo. – While assessing a pregnant woman with premature labor in 1983, Linda […].

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Novartis says its radioligand therapy boosts health-related quality of life

Pharma Times

177Lu-PSMA-617 is being evaluated for the treatment of metastatic castration-resistant prostate cancer

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Luminopia’s digital therapy for lazy eye aces clinical trial

pharmaphorum

A digital therapeutic (DTx) for amblyopia – sometimes known as lazy eye – has been shown to improve vision correction over standard therapy in a phase 3 trial, according to its developer Luminopia. The DTx – called Luminopia One – treats amblyopia by getting people with the condition to watch specially modified TV shows and movies using a virtual reality headset designed to promote use of the weaker eye.

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Keytruda made available on the NHS for certain oesophageal cancer patients

Pharma Times

Approximately 1,000 people will be eligible for the treatment in England

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Connected Solutions Are Simplifying Specialty Medication Access

Drug Channels

Today’s guest post comes from Vicki Muscarella, Vice President of Specialty at CoverMyMeds. Vicki discusses the advantages of integrated technology solutions in enhancing specialty patients' access to therapy, affordability, and adherence. CoverMyMeds now includes RelayHealth, RxCrossroads by McKesson, and McKesson Prescription automation. Click here to sign up for complimentary early access to the specialty edition of the CoverMyMeds 2021 Medication Access Report.

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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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Novavax joins Oxford mix-and-match COVID-19 vaccine study in adolescents

Pharma Times

The Phase II clinical trial will include at least 360 adolescents aged 12-16 years old

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New patent for Veloxis Pharms drug ENVARSUS XR

Drug Patent Watch

Annual Drug Patent Expirations for ENVARSUS+XR Envarsus Xr is a drug marketed by Veloxis Pharms Inc and is included in one NDA. It is available from one supplier. There are…. The post New patent for Veloxis Pharms drug ENVARSUS XR appeared first on DrugPatentWatch - Make Better Decisions.

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2021 PM Society Digital Awards winners announced

Pharma Times

Leading the agency side, Havas Life Medicom came out on top with three Gold award wins

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New patent for Gw Res drug EPIDIOLEX

Drug Patent Watch

Annual Drug Patent Expirations for EPIDIOLEX Epidiolex is a drug marketed by Gw Res Ltd and is included in one NDA. It is available from one supplier. There are sixteen…. The post New patent for Gw Res drug EPIDIOLEX appeared first on DrugPatentWatch - Make Better Decisions.

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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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Study: Ignoring black peers leads whites to poor decisions

Scienmag

A study by a University of Texas at Dallas researcher published Sept. 17 in the journal Science Advances identifies a pattern of racial attention deficit, shedding light on why diversity efforts in organizations often fail. It also suggests a remedy: When white workers can witness the accomplishments of Black peers — rather than being told about them — the […].

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ICER says Amgen’s tezepelumab ‘likely to be too expensive’

pharmaphorum

Amgen and AstraZeneca haven’t won approval or announced a price for their severe asthma therapy tezepelumab should it reach the market, but ICER in the US maintains it will probably not be cost-effective. The cost effectiveness organisation has published a draft evidence report on the first-in-class TSLP inhibitor – which is currently under FDA review for severe asthma – and has used a “placeholder” price of $28,000 per year to run its numbers of the drug.

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New nano particles suppress resistance to cancer immunotherapy

Scienmag

A specially designed lipid nanoparticle could deliver immune-signaling molecules into liver macrophage cells to overcome resistance to anti-tumor immunotherapy. Credit: Takashi Nakamura, et al. Journal for ImmunoTherapy of Cancer. July 2, 2021. A specially designed lipid nanoparticle could deliver immune-signaling molecules into liver macrophage cells to overcome resistance to anti-tumor immunotherapy.

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ESMO21: First combo data with Amgen’s Lumakras hit the mark in CRC

pharmaphorum

Amgen has made progress with its plans to expand the use of its first-in-class KRAS inhibitor Lumakras, reporting encouraging results when the drug is used alongside its EGFR drug Vectibix in colorectal cancer (CRC). The phase 2 study due to be reported at the ESMO cancer meeting – in patients KRAS G12c-mutated CRC – is the first combination data for Lumakras (sotorasib).

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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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5 Henry Ford Hospitals earn top quality recognition for stroke care excellence

Scienmag

DETROIT – All of Henry Ford Health System’s five hospitals that are equipped to treat stroke earned Gold Plus and Honor Roll status for stroke care excellence from the American Heart Association and American Stroke Association. This top quality achievement recognizes the hospitals’ commitment to ensuring patients with stroke receive the most appropriate and timely treatment […].

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Keytruda backed by NICE for late-stage oesophageal cancer

pharmaphorum

MSD’s Keytruda has become the first immunotherapy cleared by NICE for previously-untreated patients with advanced oesophageal cancer, making it an option for routine NHS treatment. Keytruda (pembrolizumab) has been given the green light for use alongside platinum- and fluoropyrimidine-based chemotherapy in patients with locally advanced or metastatic oesophageal cancer that cannot be treated with surgery.

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UTA developing sensor network to monitor climate change effects in coastal Texas town

Scienmag

A University of Texas at Arlington civil engineer is working with a Texas coastal town to develop a low-cost sensor network that will help the community monitor climate change effects. Credit: UT Arlington A University of Texas at Arlington civil engineer is working with a Texas coastal town to develop a low-cost sensor network that […].

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2021 PM Society Digital Awards – Winners Announced

pharmaphorum

Havas Life Medicom, ARK and Pharmadoctor top the agency charts AstraZeneca, klarify and Novartis Gene Therapies top the pharma leader board. The Digital Awards is in its 12th year and celebrates the best in digital communications within the pharmaceutical and healthcare sectors. Judges include experts from digital, creative and communications agencies, digital specialists and marketers from industry as well as healthcare professionals.

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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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Registration opens: IOP Publishing’s free-to-attend Environmental Research 2021 conference

Scienmag

Taking place virtually between 15 and 19 November, participants will connect with leading experts to debate the direction and effectiveness of the latest environmental scientific research and work together to inspire global action. Credit: IOP Publishing Scientists, academics and policymakers dedicated to tackling environmental threats can now register to attend IOP Publishing’s (IOPP) Environmental Research […].

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ESMO21: Roche’s giredestrant takes stage in battle of the oral SERDs

pharmaphorum

Roche has revealed the first phase 2 clinical data with giredestrant, one of a clutch of new selective oestrogen receptor degraders (SERDs) hoping to provide an oral alternative to AstraZeneca’s injectable Faslodex for breast cancer. The Swiss drugmaker presented results from its coopERA trial of giredestrant in post-menopausal women with hormone receptor (HR)-positive, HER2-negative early breast cancer at the ESMO congress today which suggest its programme is on track.

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NSF EPSCoR grant will advance manufacturing of renewable and recyclable plastics

Scienmag

Plastics are an indispensable part of today’s society. These nimble polymers help keep foods fresh, cars safe, arteries clog-free and have countless other uses. But the benefits come at a cost. Each year millions of tons of discarded plastic pollute ecosystems, harm animals and exacerbate climate change. Credit: Max Jiang, KU School of Engineering Plastics […].

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Isochoric Freezing Method + Hershey’s Oat Made Chocolate – Xtalks Food Podcast Ep. 28

XTalks

Can a new method of freezing food drastically cut down on energy and emissions? In this episode of the Xtalks Food Podcast, Sydney talks about isochoric freezing, in which foods are stored in a firm, sealed container made of hard metal or plastic, filled with a liquid like water and placed in a freezer. The team discusses why this method is a more sustainable option and reflects on the environmental impact of traditional freezing. .

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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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Better support for long-term symptoms is needed to help patients live life after cancer

Scienmag

Lugano, Switzerland, 18 September 2021 – Previous standards of cancer follow-up care and support may no longer meet current needs as improvements in screening practices, early diagnosis and treatment of cancer have put long-term survival beyond five years following diagnosis within reach for more than half of patients in Europe. (1) While beating cancer should be followed by a return to normal life, the side-effects of anticancer medicines and impacts of the illness itself that sometimes persist

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FDA Advisory Committee Votes Unanimously in Favor Of COMIRNATY® Booster for Emergency Use in People 65 and Older and Certain High-risk Populations

BioTech 365

FDA Advisory Committee Votes Unanimously in Favor Of COMIRNATY® Booster for Emergency Use in People 65 and Older and Certain High-risk Populations FDA Advisory Committee Votes Unanimously in Favor Of COMIRNATY® Booster for Emergency Use in People 65 and Older … Continue reading →

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Discovery highlights the complex lifestyles of frontline immune cells

Scienmag

WEHI researchers have made a surprise discovery about how immune ‘sentinel’ cells are maintained, which could have implications for drugs in development for treating cancer. Credit: WEHI WEHI researchers have made a surprise discovery about how immune ‘sentinel’ cells are maintained, which could have implications for drugs in development for treating cancer.

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Agra Ventures Announces Change of Auditor

BioTech 365

Agra Ventures Announces Change of Auditor Agra Ventures Announces Change of Auditor VANCOUVER, British Columbia, Sept. 17, 2021 (GLOBE NEWSWIRE) — Agra Ventures Ltd. (“AGRA” or the “Company”) (CSE: AGRA) (Frankfurt: PU30.

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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.