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.

Vaccines 363

Vaccines Immunity Immunization 363

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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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.

Documentation 131

Documentation 131

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 122

Hospitals 122

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.

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

Vaccines 354

Vaccines 354

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 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 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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Pharmacy Management

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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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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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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Pharma Times

SEPTEMBER 29, 2022

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

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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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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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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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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

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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STAT

SEPTEMBER 30, 2022

Every day, pregnant people across the United States get the news that the futures they imagined for their babies are at risk due to a fetal condition. It may be something relatively minor, like a small benign growth on a lung, or something major, like a life-threatening heart or developmental problem. Some of these problems can be mediated by maternal-fetal surgery.

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Pharma Times

SEPTEMBER 26, 2022

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

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Drug Patent Watch

SEPTEMBER 24, 2022

Annual Drug Patent Expirations for IMBRUVICA Imbruvica is a drug marketed by Pharmacyclics Inc and is included in two NDAs. It is available from one supplier. There are forty patents…. The post New patent for Pharmacyclics Inc drug IMBRUVICA appeared first on DrugPatentWatch - Make Better Decisions.

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PharmExec

SEPTEMBER 28, 2022

Wednesday, September 28, 2022, 11 am ET Join this webinar to hear industry thought leaders discuss issues that impede cell and gene therapy development. They will cover new approaches for expanding viral vector manufacturing capacity with appropriate quality, share recommendations for streamlining clinical trial design and process development, explore opportunities for adapting the regulatory framework for cell and gene therapy technologies, and examine innovative pricing and contracting models.

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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 275

Vaccines 275

pharmaphorum

SEPTEMBER 30, 2022

Dr. Houda Hachad is vice president of clinical operations at AccessDx Laboratory, where she focuses on expanding the use of pharmacogenomic testing, a major piece of the puzzle for precision medicine. Genetic testing has become vastly more accessible in the last 20 years and has opened all kinds of doors in medicine, from pharmacogenetics and better understanding drug interactions and adverse events to tremendous advances in oncology: understanding the underlying genetics of cancer cells has all

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Pharma Times

SEPTEMBER 28, 2022

Phase 1b study evaluates effects of sevuparin on the symptoms of volunteer participants

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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 27, 2022

At the Los Angeles LGBT Center’s sexual health clinic, patients are normally seen within 24 hours. Recently, amid the monkeypox outbreak , it’s been a five-day wait. At Open Door Health, an LGBTQ+ community clinic in Providence, R.I., a standard test for a sexually transmitted infection might take 15 minutes. Testing for monkeypox — between authorizing the test and donning and doffing PPE — has dragged up to an hour.

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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 95

Pharma Times

SEPTEMBER 29, 2022

Positive results in COVID-19 therapy phase 3 trials show effectiveness against five symptoms

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pharmaphorum

SEPTEMBER 26, 2022

Pfizer and Sangamo have restarted recruitment of patients into their registration trial for haemophilia A gene therapy giroctocogene fitelparvovec, after the FDA lifted a clinical hold on the study. The phase 3 AFFINE trial was paused voluntarily by the two partners almost a year ago, and subsequently placed on hold by the FDA, after patients treated with the therapy produced higher than expected levels of Factor VIII – the clotting factor that giroctocogene fitelparvovec is designed to produce

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STAT

SEPTEMBER 29, 2022

The news Tuesday night that a clinical trial of an experimental Alzheimer’s therapy had succeeded hit like a blast — at last, a rare win in a disease devastating nearly 6 million Americans and countless more caregivers. The trumpeting from the companies Eisai and Biogen relied on data that showed that people receiving the therapy, lecanemab, saw a slower decline versus those on a placebo.

Drug Development 264

Drug Development 264

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 94

Pharma Pathway

SEPTEMBER 24, 2022

Alkem Laboratories Ltd-Walk-In Interviews for Quality Control/ Quality Assurance/ Production On 1st Oct’ 2022. Job Description. Alkem Laboratories Ltd Conducting Walk-In Interview for Our Formulation Manufacturing Facility based at Daman. Department: Quality Control/ Quality Assurance/ Production. Position : Officer/ Executive/ Sr. Officer/ Technician.

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Documentation 93

pharmaphorum

SEPTEMBER 26, 2022

Japan’s Daiichi Sankyo has claimed its first worldwide approval for Ezharmia, a first-in-class dual EZH1 and EZH2 inhibitor for the treatment of patients with relapsed or refractory adult T-cell leukaemia/lymphoma (ATL). The Ministry of Health, Labour and Welfare (MHLW) in Japan has cleared Ezharmia (valemetostat tosylate) based on the results of an open-label phase 2 trial which revealed a 48% overall response rate with the drug in previously-treated ATL patients.

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Chemotherapy Labelling 93