STAT

SEPTEMBER 30, 2022

For a while, scientists thought the trillions of microbes on our bodies lived in landscapes connected to the outside world — our skin, hair, and gut — but research in the last few years has shown that’s not so. When Ravid Straussman, a cancer biologist at the Weizmann Institute of Science in Israel, looked deeper, he and several other research groups around the world found bacteria in the milieu of tumors.

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PharmaVoice

SEPTEMBER 26, 2022

There is no question about the incredible clinical impact cell therapies can have on the lives of patients. However, this impact is the result of innovation that does not equate to a simple, straightforward commercialization process.

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European Pharmaceutical Review

SEPTEMBER 30, 2022

Professor Hongsoo Choi’s team at The Department of Robotics and Mechatronics Engineering at the Daegu Gyeongbuk Institute of Science & Technology (DGIST), Korea, developed revolutionary technology that produces over 100 microrobots per minute. The collaboration with Professor Sung-Won Kim’s team at Seoul St. Mary’s Hospital, Catholic University of Korea and Professor Bradley J.

Hospitals 136

Hospitals 136

pharmaphorum

SEPTEMBER 28, 2022

The US FDA’s Center for Devices and Radiological Health (CDRH) dropped a bevy of new digital health guidances and reports today and yesterday, providing some long-awaited clarity and peeks into the agency’s future plans. . The Pre-Cert pilot report. The push started yesterday with the 31-page key findings report from the FDA Pre-Certification Program pilot.

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Documentation 135

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

Communication

STAT

SEPTEMBER 27, 2022

The California State Legislature has sent a bill to Gov. Gavin Newsom that strengthens discipline for doctors who knowingly spread Covid-19 misinformation. Legislation like this is sorely needed across the country. More than two years into the pandemic, Covid-19 misinformation still runs rampant. Some comes from doctors spreading lies about unproven — and actually harmful — “treatments” for Covid-19 and promoting anti-vaccine conspiracy theories.

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Vaccines Immunization Immunity 363

PharmaVoice

SEPTEMBER 28, 2022

Swiss-based Stalicla is banking on an AI-driven precision medicine discovery platform to deliver needed therapies in the autism space.

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European Pharmaceutical Review

SEPTEMBER 29, 2022

According to a new report , implementing a Transferable Exclusivity Extension (TEE) system could solve the “broken economic model” for researching and developing new antibiotics in Europe. As the threat of antimicrobial resistance (AMR), sometimes called the hidden or silent pandemic , grows, new and novel antibiotics are needed to combat infections becoming more resistant to current treatments.

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STAT

SEPTEMBER 29, 2022

A clinical trial of one or perhaps two experimental vaccines designed to protect against the Ebola Sudan virus could soon begin in Uganda, as long as the country agrees to allow the research to take place, an official of the World Health Organization said Wednesday. The trial could get underway within a couple of weeks and definitely before the end of October, said Ana Maria Henao-Restrepo, who heads WHO’s R&D Blueprint effort to develop drugs, diagnostics, and vaccines to respon

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Vaccines 362

PharmaVoice

SEPTEMBER 29, 2022

The co-founder of Pepper Bio entered the biotech world three years ago with the goal of transforming drug discovery through the emerging discipline of transomics.

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pharmaphorum

SEPTEMBER 29, 2022

Biogen and Eisai have resurrected hopes that amyloid-targeting drugs could have a benefit in Alzheimer’s disease with a claim that their new drug lecanemab showed a “highly statistically significant” reduction in clinical decline in a phase 3 trial. The highly-anticipated readout from the Clarity AD has shown that lecanemab met primary and secondary endpoints in patients with early-stage Alzheimer’s, said the two companies in a joint statement – although for now only the

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European Pharmaceutical Review

SEPTEMBER 29, 2022

Brii Biosciences , a multi-national drug development company, has published top-line results from a Phase I study evaluating its long-acting, single-dose, intramuscularly injected drug BRII-296 in postpartum depression (PPD). “We are encouraged by the possibility of providing a novel treatment option to the 900,000 people in the US affected by postpartum depression each year in which the current standard of care is suboptimal, often requiring hospitalisation, repeat therapy and daily doses of tr

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Clinical Pharmacology Drug Development 105

STAT

SEPTEMBER 28, 2022

HARLINGEN, Texas — Here in the Rio Grande Valley almost everyone knows, or cares for, someone with dementia. It’s not a surprise. The region has some of the nation’s highest rates of the disease. But what’s less appreciated is the enormity of the burden carried by the mostly Mexican American caregivers. In a culture where caregiving is a family affair, it’s almost unthinkable for children and spouses to place loved ones in nursing facilities or ask for outside

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PharmaVoice

SEPTEMBER 28, 2022

The company's CEO, Kabir Nath, discusses potential roadblocks to commecialization that await its psilocybin treatment for depression.

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pharmaphorum

SEPTEMBER 27, 2022

While a rumoured takeover by Merck & Co has yet to materialise, Seagen is getting on with its own business development, including a just-agreed licensing deal for a cancer immunotherapy developed by Dutch biotech Lava Therapeutics. Seagen is paying $50 million upfront for global rights to the programme, a bispecific T cell engager intended as a treatment for EGFR-positive solid tumours, with another $650 million at the back end in milestone payments.

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Immunization Immunity 109

Speaker: Joe Sharpe and James Carlson

Payroll optimization can be one of the most time-consuming and complex factors of small business management. Yet, organizations that crack the code on streamlining employee compensation often discover innovative avenues for growth. With the right strategies in place, outsourcing and streamlining payroll processes can result in substantial time and resource savings.

European Pharmaceutical Review

SEPTEMBER 28, 2022

In a study published in the Microchemical Journal , investigators outlined the development and validation of a HPLC-MS/MS (high-performance liquid chromatography-mass spectrometry) for the determination and quantification of N -nitrosodimethylamine (NDMA) in olmesartan medoxomil. The method was able to detect, separate and quantify NDMA in the active pharmaceutical ingredient (API), manufactured tablets and marketed tablets.

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Compounding Pharmaceutical Companies Pharmaceutical Companies 105

STAT

SEPTEMBER 28, 2022

BROWNSVILLE, Texas — Gladys Maestre is on a scouting mission. The Alzheimer’s disease researcher is driving through Southmost, a Mexican American neighborhood just north of looming sections of the border wall and a checkpoint that leads to Mexico. She passes barking dogs and “no trespassing” signs, but doesn’t see a single person outside, despite the comfortable stuffed recliners, refrigerators, and shade canopies that furnish many yards.

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PharmaVoice

SEPTEMBER 26, 2022

How pharma companies can teach physicians about mechanism of action and other medication lessons with interactive mobile games.

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PhRMA

SEPTEMBER 30, 2022

Chronic conditions impose a substantial health and economic burden that affects millions of patients, families and communities across the United States each day. While these conditions come with different origins, symptoms and treatments, they each can have a negative impact on a person’s physical and emotional well-being, quality of life and productivity.

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Speaker: Chris Antypas and Josh Halladay

Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.

Pharma Times

SEPTEMBER 29, 2022

Results show reduction of clinical decline in global study of people with Alzheimer's Disease

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STAT

SEPTEMBER 26, 2022

CAMBRIDGE, Mass. — The fluorescent orange sticker atop the white machine reads “BIOHAZARD,” but it’s a bit of a misnomer. Although Earth abounds with pathogens that can maim, kill, paralyze, and poison, the specimens inside this machine — being pipetted left and right behind glass for sequencing — are probably the most innocuous human viruses you will ever encounter.

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pharmaphorum

SEPTEMBER 26, 2022

Social health—the dynamic, real-time action people take to find meaningful connections and share information that impact the health journey—has dramatically shifted the ways in which healthcare marketers can, and should, reach their desired audiences. . Through Health Union’s unique and expansive Social Health Network of more than 100,000 patient leaders; and millions of engaged patients and caregivers across a growing portfolio of more than 40 condition specific online health communities, this

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European Pharmaceutical Review

SEPTEMBER 28, 2022

The United States Pharmacopeia (USP) has opened a 90-day review period for their proposed Cannabis Species Inflorescence monograph in the Herbal Medicines Compendium (HMC), a laboratory quality standards testing reference used internationally. The proposed cannabis monograph provides scientifically validated methods, information on physical reference standards and acceptance criteria to establish the identity of cannabis chemotypes and content of cannabinoids and terpenes, as well as setting l

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Labelling 98

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Digital Pharmacist

SEPTEMBER 29, 2022

Over the past few years, the FDA has recalled many popular drugs due to a contaminant, Nitrosamine, being found in them. Medications that have been found to include concerning amounts of nitrosamines include losartan and other ARB’s, Metformin, ranitidine, rifampin, and Chantix. Let’s talk a bit more about these recalls and what nitrosamines exactly are, what to do if a patient inquires about this recall, and the legal actions that are being taken.

Pharmacy Management 98

Pharmacy Management 98

STAT

SEPTEMBER 24, 2022

For the record, Rochelle Walensky, director of the Centers for Disease Control and Prevention, would take the job again.   “I’m a clinician, a physician at heart,” she said Friday. “And when somebody calls you for help, you run.

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pharmaphorum

SEPTEMBER 30, 2022

Sarepta Therapeutics has followed through on its promise to file for accelerated approval of its gene therapy SRP-9001 for Duchenne muscular dystrophy (DMD), as it aims for a launch in the middle of 2023. Roche-partnered SRP-9001 (delandistrogene moxeparvovec) has been submitted for approval to treat ambulatory (walking) patients with DMD, a genetic disorder characterised by progressive muscle degeneration due to alterations in a protein called dystrophin that helps keep muscle cells intact.

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Labelling 105

European Pharmaceutical Review

SEPTEMBER 27, 2022

The US Food and Drug Administration (FDA) have published initial guidance deliberating how ethical it is for children to take part in research trials. The guidance , called ‘Ethical Considerations for Clinical Investigations of Medical Products Involving Children’, offers advice to institutional review boards (IRBs) and the industry at large when deciding whether to include children in studies about drugs, biological products and medical devices.

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Labelling 98

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Pharmacy Management

The Guardian - Pharmaceutical Industry

SEPTEMBER 24, 2022

As demand for menopause drugs soars, we trace the oestrogen production line from Chinese soya bean fields to European pharmacy shelves In the centre of the factory stand 31 reactors: giant metal globes that can hold up to 10,000 litres of liquid each. Every week, gleaming stainless steel drums arrive by truck at this plant on the outskirts of Oss, in the Netherlands.

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STAT

SEPTEMBER 30, 2022

We live in a time where the rate of medical and superlative scientific advances is accelerating — by more than 1,300% since 1985, according to one recent estimate. With so many “unprecedented,” “transformative” breakthroughs happening, forecasting which one will be awarded top research honors isn’t getting any easier.

Vaccines 286

Vaccines 286

pharmaphorum

SEPTEMBER 27, 2022

Five wearable devices that monitor patients with Parkinson’s disease as they go about their lives have been given a provisional recommendation from NICE, making them available via the NHS while additional data is collected. The UK health technology assessment (HTA) organisation said the devices may be more accurate at making a clinical assessment of a patient’s symptoms and disease progression compared to intermittent, in-person appointments at the clinic.

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European Pharmaceutical Review

SEPTEMBER 26, 2022

At the 2022 European Society for Medical Oncology Congress (ESMO) conference, promising results from a Phase I trial, suggesting that a novel genetically modified (GM) herpes virus eradicated or reduced advanced cancers, were presented. The GM herpes simplex virus (RP2) successfully treated twenty five percent of patients with different advanced cancers, including skin, oesophageal and head and neck cancers.

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Immunization Immunity 98

Pharma Times

SEPTEMBER 26, 2022

The study will focus on checkpoint inhibitor refractory non-small cell lung cancer

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