January, 2023

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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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This biotech CEO secured two billion-dollar Big Pharma deals during the pandemic

PharmaVoice

With the industry focused on cancer and COVID-19, Marc de Garidel made deals centered on cardio.

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Scottish Medicines Consortium recommends Merck’s Tepmetko

Pharma Times

Therapy is the first oral MET inhibitor treatment option for certain advanced NSCLC adult patients

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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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Navigating Payroll Compliance: Future-Proofing Payroll in an Evolving Regulatory Landscape

Speaker: Jennifer Hill

Payroll compliance is a cornerstone of business success, yet for small and midsize businesses, it’s becoming increasingly challenging to navigate the ever-evolving landscape of federal, state, and local regulations. Mistakes can lead to costly penalties and operational disruptions, making it essential to adopt advanced solutions that ensure accuracy and efficiency.

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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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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.

Vaccines 363
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Forks in the road lead one medical expert to a ‘game changing’ liver treatment

PharmaVoice

Durect’s chief medical officer altered his retirement plans to take a leading role at the company, which is developing a treatment for severe alcohol-associated hepatitis.

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Antibody discovered by RQ Bio enters pivotal research phase

Pharma Times

AstraZeneca trial will study activity of AZD5156 which includes monoclonal antibody discovered by RQ Bio

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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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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

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

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Finding Pharmacy Solutions through Entrepreneurship

Pharmacy Is Right For Me

There are so many different types of careers within the field of pharmacy—from research and drug development to pharmacy informatics! To highlight some of the more unique career settings in the industry, we’re introducing a new page on our website— Novel Pharmacy Practice Settings —where you can explore these unique career pathways. In addition to learning more about unique pathways on our new webpage, we’ll also be featuring pharmacists who work in these unique settings on our blog.

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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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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.

Vaccines 363
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Space — the next frontier in drug development

PharmaVoice

Merck, Bristol Myers Squibb and others are taking small R&D steps in space that could lead to giant leaps for patients.

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Why Every Small Business Needs an HCM Solution: A Comprehensive Guide

Managing HR tasks like payroll, compliance, and employee data can overwhelm small businesses. That’s where a Human Capital Management (HCM) solution comes in. Our eBook, Why Every Small Business Needs an HCM Solution: A Comprehensive Guide , shows how an HCM system automates tedious processes, ensuring your business stays compliant and efficient. You’ll learn how to simplify payroll, eliminate costly errors, and empower your employees with self-service tools.

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Janssen submits marketing application for talquetamab

Pharma Times

European Medicines Agency will consider therapy for the treatment of patients with multiple myeloma

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First CAR T-cell therapy recommended on NHS

European Pharmaceutical Review

Yescarta ® ▼(axicabtagene ciloleucel; axi-cel) is now the first chimeric antigen receptor (CAR) T-cell therapy and first personalised immunotherapy to be recommended for routine use on the NHS in England. This is based on final draft guidance from the National Institute for Health and Care Excellence (NICE). The therapy by Gilead Sciences and Kite is indicated for eligible adults with diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL) who have already bee

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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

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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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Position Your Pharmacy for Expansion

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.

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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

Vaccines 363
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Boost returns from social strategies with new channels and tactics

PharmaVoice

Emerging channels offer new ways to reach key targets and improve campaign ROI.

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WTAS: Inflation Reduction Act already impacting R&D decisions

PhRMA

The Inflation Reduction Act’s (IRA’s) drug price setting provisions, as predicted, are already impacting biopharmaceutical research & development (R&D) decisions. Whether you are looking at estimates of how many fewer medicines or indications will be developed, or noting shifts away from areas of unmet patient need because the law is signaling those innovations are not valued, the IRA’s price setting provisions are a loss for patients everywhere.

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FDA approves long-acting injectable for schizophrenia and bipolar disorder

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has approved Rykindo ® (risperidone) for extended-release injectable suspension. The drug is indicated as a bi-weekly treatment for schizophrenia and as monotherapy or as adjunctive therapy to lithium or valproate for bipolar I disorder in adults. Rykindo ® is an atypical antipsychotic developed by Luye Pharmaceutical.

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Best Practices to Streamline Compensation Management: A Foundation for Growth

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.

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JP Morgan 2023 – Pre event

pharmaphorum

Before the main event at JP Morgan 2023 even kicks off, we’re checking out the Sachs Associates Neuroscience Innovation Forum on Sunday. Speakers from Lilly, Boehringer Ingelheim, Takeda, and many more pharma firms big and small will present on key trends and developments in one of the most exciting areas of pharmaceutical and digital innovation. We’ll also wander over to the UC Davis Health Future & Health CEO Summit a little later this afternoon.

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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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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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Drugstores make slow headway on staffing problems

STAT

Joan Cohrs missed her chance to grab a prescription at her usual drugstore by about 30 seconds. Cohrs walked up to the counter of an Indianapolis CVS pharmacy shortly after a metal curtain descended, closing it for lunch. She didn’t mind. The 60-year-old said she feels compassion for people in health care.

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Enhance Healthcare Efficiency With Top Payroll & HCM Services

Running a healthcare facility requires precision and care, not just for patients but also for your staff. Our guide, "A Buyer’s Guide to Payroll & HCM Services," helps healthcare providers choose the best provider. Efficient payroll management ensures timely, accurate payments, critical for maintaining staff morale and trust. Compliance support helps navigate complex healthcare regulations and avoid costly fines.

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STAT+: The health tech tracker for 2023’s first quarter: 12 industry events to watch

STAT

Continuing economic uncertainty and the threat of a recession are casting a pall over health tech in 2023 — a dramatic shift for an industry that enjoyed abundant funding in the pandemic’s early stages. Last quarter’s string of layoffs at companies like Ro, Noom and ThirtyMadison portend tight budgets and conservative contracts this year, with employers unsure about which digital offerings actually drive down health care costs for workers.

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STAT+: Oscar Health’s CEO on post-hype health insurance and finally turning a profit

STAT

Oscar Health has excelled at one thing in particular since its inception a decade ago: burning cash. The health insurance company did not plan to be profitable immediately. It was staking its future on the new Affordable Care Act marketplaces and had to grow quickly to compete with larger insurance carriers. Oscar organized its health insurance product through an app, promoted virtual care, advertised on New York subways, and then low-balled prices in certain markets to attract young, healthy pe

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Mix-it-yourself Wegovy? Some are trying risky sources for weight-loss drugs

STAT

With a few clicks, Daniel added the chemical to his online cart and ordered it. In less than a week, a vial containing white powder arrived at his house. He used a syringe to measure out sterile water and eject it into the vial to dissolve the powder. Then, with a different syringe, he drew up about a quarter of a milliliter of the solution and injected it into his lower abdomen.

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