January, 2023

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New Report: More than 160 medicines in development for mental illness

PhRMA

Mental illness represents a broad spectrum of health conditions affecting mood, thinking and behavior. These conditions include depression, bipolar disorder, schizophrenia, substance use disorder, anxiety disorders, eating disorders, obsessive compulsive disorder and post-traumatic stress disorder, among others. Each of these illnesses often varies in its degree of severity, ranging from mild to moderate to severe, and may occur together.

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Know Your Winter Respiratory Illness

Drug Topics

With the respiratory season in full swing and COVID-19 continuing to infect, knowing the basics of the common cold, influenza, COVID-19, and respiratory syncytial virus can help ensure patients get the right care.

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Speech Therapy May Effectively Address Long COVID Communication Issues

Pharmacy Times

In addition to the physical symptoms of long COVID, patients have reported vocal, verbal, and cognitive issues that disrupt their ability to communicate.

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STAT+: Medicare Advantage insurers to repay billions under final federal audit rule

STAT

The federal government will audit Medicare Advantage insurers aggressively under a rule finalized Monday, which is expected to result in billions of dollars in overpayments going back toward Medicare’s trust fund and patients over the next decade. However, federal officials watered down one of the auditing policies by giving insurers seven years of immunity from having the samples of their diagnosis coding errors extrapolated to their broader Medicare Advantage membership.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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5 mucus-killing foods

The Checkup by Singlecare

Whether it’s allergies, the common cold, the flu, or COVID, there are a number of reasons why you might be running to the tissue box more often than usual to handle congestion and pesky mucus (otherwise known as phlegm). If you find yourself with a stuffy nose or a phlegmy cough, there are a number of foods, at-home remedies, and over-the-counter medications that can provide some much-needed relief.

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The impact of climate change on the pharma supply chain

Pharmaceutical Technology

Pharmaceutical supply chains are extremely vulnerable to the effects of climate change and face many challenges from sourcing to distribution. Whether it’s soaring temperatures, extreme cold snaps, or devastating floods, pharmaceutical logistics providers must ensure that shipments reach their destination in their intended condition without defect or delay.

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Holistic Treatment Techniques for Managing Atopic Dermatitis

Drug Topics

Patients are finding relief in alternative therapies for this chronic skin disease.

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Study: Empagliflozin Can Slow Progression of Chronic Kidney Disease to Kidney Failure

Pharmacy Times

Data from a randomized clinical trial supports previous clinical findings on SGLT2 inhibitors and their ability to slow the progression of chronic kidney disease.

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STAT+: Pfizer is scolded by a U.K. trade group for remarks its CEO made about vaccination

STAT

After weeks of deliberation, Pfizer was scolded by a U.K. pharmaceutical industry trade group after its chief executive officer made misleading statements in a media interview about the need to vaccinate young children against Covid-19. The fracas began when the Pfizer chief, Albert Bourla, gave an interview to the BBC and discussed the idea of vaccinating children between five and 11 years old, a course of action that had not yet been approved by regulators in the U.K.

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How retail pharmacy is entering clinical trial services

Drug Store News

Retail pharmacy’s foray into clinical trial services is a no-brainer given their enhanced focus on improving patient outcomes in the communities they serve.

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Major study on DMT shows promise for depression

European Pharmaceutical Review

The first major study on the efficacy of DMT in treating any mental health condition showed a remission rate of 57 percent following a single dose, in a Phase IIa trial for major depressive disorder (MDD). “SPL026 (intravenous DMT) with supportive therapy was shown to have a significant antidepressant effect that was rapid and durable, with a remission rate of 57 percent at three months following a single dose of SPL026,” stated Dr Carol Routledge, Chief Medical and Scientific Officer at Small P

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Google and DeepMind share work on medical chatbot Med-PaLM

pharmaphorum

Google and DeepMind have developed an artificial intelligence-powered chatbot tool called Med-PaLM designed to generate “safe and helpful answers” to questions posed by healthcare professionals and patients. The tool is an example of a large language model or LLM, which are designed to understand queries and generate text responses in plain language, drawing from large and complex datasets – in this case, medical research.

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Health Canada gives approval to Enhertu for breast cancer treatment

Pharmaceutical Technology

Health Canada has granted approval to Enhertu (trastuzumab deruxtecan) to treat unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer. Enhertu has been approved to treat HER2-low breast cancer adult patients who have previously received at least one line of chemotherapy in the metastatic setting or who have seen disease recurrence during or within six months after the adjuvant chemotherapy.

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Study Identifies Prevalence of Cardiac Amyloidosis Among Bone Scan Patients

Pharmacy Times

Although cardiac amyloidosis was previously believed to be rare, more recent diagnostic advances and awareness have led to an increasing number of cases.

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HIV vaccine being developed by Johnson & Johnson fails clinical trial

STAT

Yet another experimental HIV vaccine has failed. The National Institute of Allergy and Infectious Diseases reported Wednesday that a Phase 3 clinical trial of a vaccine was stopped because the vaccine was ineffective at preventing HIV infection. The vaccine was being developed by Janssen, the vaccine division of Johnson & Johnson.

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How to meditate for anxiety and depression

The Checkup by Singlecare

When most people hear the word meditation, they probably imagine someone sitting perfectly still in a quiet room, legs crossed, zoned out in a state of total bliss. But meditation can be performed in many different ways, and while it does take some practice to get the hang of it, even just a few minutes a day can help reduce some symptoms of common mental health conditions like anxiety and depression.

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Pharmaceutical microbiology: key developments 2022

European Pharmaceutical Review

This Q&A covers the key developments in pharmaceutical microbiology in 2022, featuring insight from pharmaceutical microbiology experts: Dr Tim Sandle, Head of Microbiology, Bio Products Laboratory Limited. Dr Tony Cundell, PhD, Principal Consultant, Microbiological Consulting, LLC. Miriam Guest, Principal Microbiologist at AstraZeneca. Regulation, particularly Annex 1, was identified as a key focus for 2022.

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A new dawn of the genomic age: five areas set to be transformed in 2023

pharmaphorum

2022 was a banner year for genomics. In March, the collaborative T2T consortium published the first complete telomere-to-telomere sequence of the human genome, filling in the last 8% of the 3 billion base pairs that make up our DNA. And in the UK specifically, genomics remained high on the national agenda, with several significant government programmes and investments announced – including the Newborn Genomes Programme in healthcare and the Precision Breeding Bill in the agricultural sector.

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Can the FDA keep the momentum going for rare disease drug approvals?

Pharmaceutical Technology

In 2022, the FDA approved only 37 new medicines, an underwhelming number compared to 98 in 2018. However, while only around 34% of the approvals in 2018 were for orphan drugs, 54% new approvals in 2022 were for drugs to treat rare diseases. Major pharmaceutical acquisitions have taken place in recent months in the rare disease space, as the number of orphan drug approvals continues to grow.

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ADHD Traits Linked to Anxiety, Depression More Than Autistic Traits

Pharmacy Times

There is a lack of funding for attention-deficit hyperactivity disorder and coinciding psychological research compared to the funds generated for autism research.

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Routine vaccinations drop among U.S. kindergartners for the third year in a row

STAT

The percentage of U.S. kindergartners who’ve received standard childhood vaccines took a small but notable dip into the 2021-2022 school year, health officials said Thursday, amid disruptions related to Covid-19 and fears that anti-vaccine sentiment stirred up by the pandemic could be spreading to other shots. Vaccinations among children remain high, but the trend — with coverage dropping from about 95% in the 2019-2020 school year to 94% in 2020-2021 to 93% in 2021-2022, according

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Merck's Keytruda dealt another blow in prostate cancer but readies new challenge to AZ's Imfinzi

Fierce Pharma

Merck's Keytruda dealt another blow in prostate cancer but readies new challenge to AZ's Imfinzi aliu Wed, 01/25/2023 - 10:17

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Can machine learning accelerate drug formulation?

Outsourcing Pharma

Research emerging from the University of Toronto found that using machine learning models was able to guide the design of long-acting drug formulations.

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The importance of AI literacy in life sciences

pharmaphorum

The promise and value of artificial intelligence (AI) in life sciences are somewhat obscured by the over-generalisation of this technology. Indeed, a major misconception surrounding AI is that it’s just tech or some intangible software that we can’t understand, when, in fact, AI itself is a tool for understanding. For life sciences companies, who must continuously sift through copious amounts of data to decipher actionable insights to inform strategic decisions, AI maximises the time and money

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AI continues to gain momentum in the biopharmaceutical industry in 2023

Pharmaceutical Technology

While the biopharmaceutical industry has been impacted and pressured by various factors such as the Covid-19 pandemic, inflation, the Ukraine-Russia war, ongoing supply chain issues, and a challenging economic environment, collaboration between pharma companies and emerging technologies providers continues to grow, especially in the research and development (R&D) field, offering some resilience in times of geopolitical and economic disruptions.

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AI Could Improve Blood Sugar Management in Type 1 Diabetes

Pharmacy Times

An app using AI to evaluate blood sugar data, concerning trends, and recommend management tools will be a part of a clinical trial in 2024 for further assessment.

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For most mild infections, long Covid symptoms clear after a year, large study finds

STAT

Since long Covid emerged, how best to define it, predict it, and treat it has been up for debate, but perhaps the most urgent question for patients and providers alike has been how long it lasts. A new study analyzing nearly 2 million patient records in Israel concludes that for most people, the troubling symptoms that persist after a mild Covid infection fade away after about a year.

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Personalised cancer immunotherapy granted fast track designation

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has granted fast track designation (FTD) for Evaxion Biotech’s personalised cancer immunotherapy. The FTD is for EVX-01, in combination with Keytruda ® for patients with metastatic melanoma (MM). ”We are extremely pleased that our cancer vaccine candidate EVX-01 has received the FDA fast track designation, as it enables a potentially faster approval of the vaccine,” stated Per Norlén, CEO at Denmark-based Evaxion.

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Amazon Pharmacy rolls out service for unlimited generic drug prescriptions for $5 a month

Fierce Healthcare

Amazon Pharmacy rolls out service for unlimited generic drug prescriptions for $5 a month hlandi Mon, 01/23/2023 - 22:15

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Bayer taps Google’s quantum power for drug discovery

pharmaphorum

Bayer has signed an agreement with Google aimed at using high-level processing power to handle quantum chemistry calculations used to predict the chemical and physical properties of drug molecules at the atomic scale. The deal with the tech giant’s Google Cloud unit revolves around its tensor processing units (TPUs), artificial intelligence-powered accelerators designed to run machine learning models and computationally-intensive workloads that can be customised to specific applications.

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CARsgen and Huadong Medicine to commercialise CT053 in mainland China

Pharmaceutical Technology

CARsgen Therapeutics has announced a col labor ation with Huadong Medicine to commercialise zevorcabtagene autoleucel (zevor-cel), CT053, in mainland China. The fully human, autologous BCMA CAR T-cell product candidate of CARsgen, CT053 has been developed to treat relapsed/refractory multiple myeloma (R/R MM). It comprises autologous T cells that are modified genetically with a CAR including a complete human anti-BCMA single-chain fragment variant that has a high binding affinity.

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Celebrate Your Colleagues on National Pharmacist Day 2023

Pharmacy Times

Pharmacists report a myriad of reasons for joining the profession, including the connections they can build with patients.

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Medical schools are missing the mark on artificial intelligence

STAT

Ready or not, health care is undergoing a massive transformation driven by artificial intelligence. But medical schools have barely started to teach about AI and machine learning — creating knowledge gaps that could compound the damage caused by flawed algorithms and biased decision-support systems. “We’re going to be at a point where we’re not going to be able to catch up and be able to call out the technology defects or flaws,” said Erkin Ötleş, a

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JPM23, Day 1: BMS touts new launches as patent cliff looms; Regeneron's Eylea sales disappoint

Fierce Pharma

JPM23, Day 1: BMS touts new launches as patent cliff looms; Regeneron's Eylea sales disappoint. esagonowsky. Mon, 01/09/2023 - 09:55.

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CVS, Cigna back kidney care coordination, tech startup Monogram Health's latest $375M raise

Fierce Healthcare

CVS, Cigna back kidney care coordination, tech startup Monogram Health's latest $375M raise. dmuoio. Mon, 01/09/2023 - 12:24.

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AI and the Big Data paradigm – big ambitions in novel drug discovery

pharmaphorum

Over the past few decades, data generation has veritably exploded. However, the ‘Big Data paradigm’ is not so much concerned with the volume of that data, but how businesses and, indeed, industries can derive meaningful insights from what has become a glut of information. With the currently popular approach to artificial intelligence (AI) focussing on the Big Data paradigm, also, pharmaphorum spoke with Adityo Prakash, CEO of Verseon, about the whys and wherefores, delving deeper into the proces