Sun.Apr 24, 2022

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How a surprise finding made an Alnylam study one of biotech's most 'polarizing' trials

Bio Pharma Dive

A study testing Alnylam's drug Onpattro in a deadly heart condition was once seen as a sure bet. Now the trial is the source of much debate, and its outcome could influence how future treatments for the disease are developed.

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Connectivity, Sustainability and User Experience to transform packaging and drug delivery in next year: Pharmapack Europe 2022

Pharma Mirror

Paris, will open in May (18-19) with connectivity, sustainability and user experience identified as the key trends in 2022 influencing innovation across pharmaceutical packaging and drug delivery. The event – which unites major players in pharmaceutical packaging, drug delivery, medical devices and machinery – returns to the Paris Expo, Porte de Versailles (Hall 7.2) and will see 5000 attendees and some 300+ companies exploring next generation technologies and looking ahead to debate the major i

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Risk of Appendicitis After mRNA COVID-19 Vaccination in a Danish Population

JAMA Internal Medicine

This cohort study used data from Danish registers to assess whether recipients of mRNA COVID-19 vaccines had a higher risk of appendicitis after receiving the shot compared with individuals who did not receive the vaccine.

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Shionogi and NEC Enter into Strategic Research Collaboration for Novel Hepatitis B Therapeutic Vaccine

Pharma Mirror

OSAKA, Japan and TOKYO, Japan. Shionogi & Co., Ltd. and NEC Corporation, today announced the execution of a strategic research collaboration agreement for the development of a novel hepatitis B therapeutic vaccine. NEC OncoImmunity, an NEC subsidiary that specializes in artificial intelligence-driven biotechnology, is also participating in this research collaboration.

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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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Unvaccinated people increase risk of SARS-CoV-2 for vaccinated people even when vaccination rates are high

Scienmag

Unvaccinated people threaten the safety of the vaccinated even when SARS-Cov-2 vaccination rates are high, according to a new modelling study published in CMAJ (Canadian Medical Association Journal) [link] “Many opponents of vaccine mandates have framed vaccine adoption as a matter of individual choice,” writes Dr. David Fisman, Dalla Lana School of Public Health, University of […].

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Leading inhalation APIs expert Inke to triple production capacity

Pharma Mirror

Barcelona, Spain, April 20, 2022 – Inke, a leading global manufacturer of inhalation APIs wholly owned by Neuraxpharm Group, announces it is investing €9 million to increase production capacity for inhalation APIs. The investment will allow Inke to triple the production capacity of chemical synthesis and the micronisation of inhalation APIs at its manufacturing plant in Castellbisbal, Barcelona, by 2024.

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NorthX Biologics signs GMP manufacturing collaboration agreement with Abera Bioscience

Pharma Mirror

Sweden-based NorthX Biologics (“NorthX”), which focuses on process development and large-scale production of advanced biological drugs, has signed a collaboration agreement with Abera Bioscience (“Abera”) for upscaling and GMP manufacturing of its vaccine candidate against pneumococcus, Ab-01.12. NorthX has recently established an innovation hub to offer support to partners in achieving their long-term drug development goals.

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Stress-Related Disorders of Family Members of Intensive Care Patients With COVID-19

JAMA Internal Medicine

This cohort study examines the prevalence of stress-related disorders in family members of patients admitted to the intensive care unit with COVID-19.

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Mayo Clinic study confirms living kidney donor surgery is low risk for most patients

Scienmag

ROCHESTER, Minn. — The risk of major complications for people who donate a kidney via laparoscopic surgery is minimal. That is the conclusion of a 20-year Mayo Clinic study of more than 3,000 living kidney donors. Only 2.5% of patients in the study experienced major complications, and all recovered completely. “The results of this study […].

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Biogen pulls EU application for Alzheimer’s drug Aduhelm

pharmaphorum

Biogen has given up on seeking approval for its Alzheimer’s disease therapy Aduhelm in the EU, saying that discussions with EU regulators had made it clear the current data for the drug is not sufficient to get it past the EMA’s Committee for Medicinal Products for Human Use (CHMP). The decision does not come as a big surprise, given that the CHMP said in December it was unconvinced by the data submitted for the drug.

Drugs 52
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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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Displacement, erasure, and the gentrification of vulnerable communities in ‘liveable’ Vancouver

Scienmag

Displacement, erasure of ties, and gentrification are all taking place in the historically working-class and low-income neighbourhoods of the City of Vancouver, a recent study shows. Considered one of the most livable cities in the world, the study by University of Waterloo researchers investigated the differing expressions of Vancouver’s commitment to the concept of livability […].

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The Perils of Legalization

NY Times

We answer a common reader question about the opioid crisis and legalizing drugs.

Drugs 57
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OIST and Corundum Systems Biology to jointly establish fully automated multi-omics & microbiome data analysis lab for large-scale human phenotype research standardization to enable cross-border discoveries in personalized medicine & health

Scienmag

Okinawa Institute of Science and Technology Graduate University (OIST) and Corundum Systems Biology Inc., headquartered in Tokyo, launched a 3-year multi-omics and microbiome research (“Project”) targeting development of a fully-integrated automated lab system by FY2024. The joint lab facility (“OIST-CSB Lab”) will enable large-scale human multi-omics research, paving way for new discoveries in human health […].

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Which pharmaceutical companies have the most lotion dosed drugs?

Drug Patent Watch

This chart shows the pharmaceutical companies with the most lotion dosed drugs. For a different perspective, see the most popular dosage types. The companies with the most lotion dosed drugs…. The post Which pharmaceutical companies have the most lotion dosed drugs? appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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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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Boss Trump, ‘the Sorest Loser of All Time’

NY Times

Readers reflect on Donald Trump as both a party boss and a sore loser. Also: Reforming the patent system.