Thu.Jan 19, 2023

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Extended-Release Risperidone Approved by FDA for Schizophrenia

Drug Topics

Rykindo is a bi-weekly long-acting risperidone injection to treat patients with schizophrenia and bipolar 1 in adults.

FDA 360
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ICYMI: PhRMA kicks off the year at the 2023 J.P. Morgan Health Care Conference

PhRMA

This January, PhRMA joined health care leaders, investors, R&D experts and members of the media at the 2023 J.P. Morgan Health Care Conference in San Francisco, CA. During this week, we discussed ways to improve patient outcomes, access and affordability in our health care system.

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Vitamin C Supplements for Pregnant Patients Can Improve Airway Function in Children

Drug Topics

A follow-up of a trial cohort showed that children aged 5 years born to pregnant smokers had improved airway function when vitamin C supplementation was administered during pregnancy compared to placebo.

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FDA’s 2022 drug approvals fall short of recent norms

PharmaVoice

The U.S. agency’s lower number of novel drug approvals followed several controversies surrounding a 2021 Alzheimer’s approval.

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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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How Opioid Use Disorder Can Impact Contraceptive Use

Drug Topics

Women on Medicaid with opioid use disorder (OUD) who use medications for opioid use disorder (MOUD) are more likely to use contraception and to undergo female sterilization than peers not prescribed MOUD.

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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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More Trending

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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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A new study links social media use to changes in teen brains. Is that a bad thing?

STAT

Today’s teens and tweens have never known a world without social media. There are still a lot of open questions about how sites like TikTok and Instagram may shape their development — and stories focusing on the potential negative impacts of social media tend to dominate the news. But a recent study published in JAMA Pediatrics is the latest in a growing body of research that suggests the relationship that young people have with social media is too complicated to be categorized as

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Barriers to Optimal Care for Patients Diagnosed with MDS

Pharmacy Times

Dr Mancini navigates challenges inhibiting patients to receive optimal care amid diagnosis of MDS.

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UnitedHealthcare launches behavioral health coaching program for commercial plans

Fierce Healthcare

UnitedHealthcare launches behavioral health coaching program for commercial plans pminemyer Thu, 01/19/2023 - 15:05

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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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Study: Racial, Ethnic Minority Groups More Likely to Have Delayed Cancer Treatment After COVID-19 Infection

Pharmacy Times

Older patients received cancer treatment less frequently during the pandemic, as did patients covered by Medicaid.

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Microsoft to lay off 10,000 employees to cut costs as it doubles down on artificial intelligence

Fierce Healthcare

Microsoft to lay off 10,000 employees to cut costs as it doubles down on artificial intelligence aburky Thu, 01/19/2023 - 16:35

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Pharmacies Gear Up for DSCSA Interoperability Go-Live Deadline

Pharmacy Times

November 27, 2023, marks date set by statute for full implementation of Drug Supply Chain Security Act.

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Let’s Get Social: The Ascendancy of Social Media to the Top of the Media Mix

PharmExec

Fran Pollaro talks with Amanda Powers-Han, chief marketing officer at Greater Than One, a full-experience marketing agency dedicated to healthcare, about what’s trending in early 2023 for pharma media mixes.

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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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What’s Next in Health Care: How Pharmacies Can Help Serve Their Communities Better

Pharmacy Times

Key trends such as consolidation create an opportunity for independent pharmacies with a community-based approach.

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Listen: How blockbusters get made, new vaccines for RSV, and mRNA’s Q score

STAT

Where do new drugs come from? Does science need billionaires? And do normal people care about messenger RNA? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. Journalist Nathan Vardi joins us to talk about his new book delving into the race to develop the lifesaving cancer drug now called Imbruvica, involving a Scientologist CEO and secretive investor seeking redemption after the worst trade of his life.

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BONUS: Public Health Matters - Highlighting Women of Color in Pharmacy

Pharmacy Times

This week's episode features Amina Abubakar, PharmD, AAHIVP, CEO of Avant Pharmacy & Wellness Center and president of Avant Institute, who discusses her experience in the pharmacy industry and the communities she serves.

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STAT+: For only the second time, a big drugmaker offers a warranty on a medicine

STAT

In a bid to blunt competition and address rising drug costs, Sanofi is offering a warranty that will cover the cost for any hospital if a specific medicine fails to work, marking only the second time a major pharmaceutical company has taken such a step. In this instance, Sanofi designed a warranty program for its Cablivi medication, which is used to treat aTTP, a rare, life-threatening autoimmune blood disorder that is considered a medical emergency.

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5 Reasons to Upgrade Your Pharmacy Management Software

Are you still using workarounds to manage your daily operations? To achieve peak performance, it's time to explore other options for specialty and infusion pharmacy software. Streamline pharmacy operations and improve clinical performance with automated processing, real-time data exchange, and electronic decision support. Download this helpful infographic to: Drive efficiency and patient adherence from referral receipt to delivery and ongoing care – all with our Pharmacy Cloud.

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Role of Oral Agents in MDS Treatment Strategy

Pharmacy Times

Dr Mahmoudjafari shares considerations for incorporating oral agents into MDS treatment landscape.

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STAT+: Will the European Union give vouchers to pharma to develop badly needed antibiotics?

STAT

Amid rising concern over antibiotic resistance, a battle is brewing in Europe over a proposal to offer vouchers to companies as an incentive to develop new treatments. The controversial idea has already raised objections from more than a dozen members of the European Union. The basic premise is straightforward. A company that wins regulatory approval for a novel antibiotic gets a voucher that can then be used to extend for one year the exclusive rights to the results of clinical trial data for a

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Vaxxas announces CEPI partnership to advance needle-free mRNA vaccine patches

pharmaphorum

Biotech Vaxxas has announced a partnership agreement with the 2017-established Coalition for Epidemic Preparedness Innovations (CEPI), in order to advance the development of Vaxxas’ needle-free vaccine-patch delivery technology with preclinical testing of an mRNA vaccine patch. CEPI is a partnership between public, private, philanthropic, and civil organisations to develop vaccines against future epidemics and pandemics.

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Mass Appeal: How marketers are winning the skin care game

Drug Store News

Mass market skin care sales remain a bright spot in the beauty category — outpacing gains in most other categories. DSN is investigating why shoppers think it is cool to buy mass skin care right now.

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Clinical trial-first for liver cancer immunotherapy combo

European Pharmaceutical Review

Tecentriq ® (atezolizumab) plus Avastin ® (bevacizumab) improved recurrence-free survival (RFS) when compared to active surveillance, in Genentech’s Phase III trial for early-stage hepatocellular carcinoma (HCC). “ IMbrave050 is the first Phase III study to show that a cancer immunotherapy combination reduced the risk of disease returning in people with early-stage HCC,” commented Dr Levi Garraway, PhD, Chief Medical Officer and Head of Global Product Development at Roche.

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Opinion: Upcoding: one reason Medicare Advantage companies pay clinicians to make home health checkups

STAT

At the start of 2023, an estimated 2.5 million Americans age 65 and older began using Medicare Advantage programs. Some made this choice in response to aggressive marketing campaigns. This brings the total enrollment of Medicare Advantage plans to nearly 31 million. One unexpected “benefit” of these plans is an offer by the insurance company sponsoring the plan to send a nurse or physician’s assistant, often from a startup company, to an individual’s home.

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Lloyds Pharmacy to close all 237 Sainsbury’s outlets

The Guardian - Pharmaceutical Industry

Group says move due to ‘changing market conditions’ as industry warns of insufficient government funding Lloyds Pharmacy is closing all 237 of its outlets in Sainsbury’s supermarkets amid fears of insufficient government funding for the industry. The group said it was making the closures – which are thought to affect about 2,000 jobs – “in response to changing market conditions”, adding it was “currently exploring options for each individual branch”.

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With Gates Foundation backing, a health tech company aims to speed diagnosis of some neglected tropical diseases

STAT

As it looks to curb the spread of infectious diseases, the Gates Foundation is lending its support to an effort to use artificial intelligence to make it easier for health providers in India and Nigeria to quickly diagnose certain conditions. The funding will support New York-based clinical decision support company VisualDx, which began as a collection of images to allow non-dermatologists to better identify skin conditions.

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Fierce Pharma Asia—China's reimbursement round; Sun's alopecia bet; GenScript's CDMO raise

Fierce Pharma

Fierce Pharma Asia—China's reimbursement round; Sun's alopecia bet; GenScript's CDMO raise aliu Thu, 01/19/2023 - 15:53

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Opinion: Medical school rankings need a new metric: economic mobility index

STAT

What are the attributes of a great medical school? U.S. News & World Report’s ranking system says the best American medical schools score high in areas that include the quality of the school’s curriculum (based on the opinions of deans, school administrators, and hospital residency directors); grade-point averages and standardized test scores of incoming students; student-to-faculty ratios; federal research activity; and the proportion of graduates who specialize in primary car

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Peeps’ latest collection sweetens up spring

Drug Store News

Peeps is teaming up with Mike & Ike and Dr Pepper ahead of the Easter holiday.

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STAT+: FDA rejects Lilly’s bid for accelerated approval for its Alzheimer’s drug

STAT

Eli Lilly said Thursday that U.S. regulators had rejected its application seeking accelerated approval for donanemab, a treatment for people with early stage Alzheimer’s disease. Despite the setback, Lilly said that the planned readout from an ongoing, Phase 3 study of donanemab remains on track for the middle of the year, and if positive, will form the basis of an application for full approval “shortly thereafter.

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US FDA grants Fast Track status for Avidity’s AOC 1020 to treat FSHD

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted Fast Track designation for Avidity Biosciences’ AOC 1020 to treat facioscapulohumeral muscular dystrophy (FSHD). AOC 1020 has been designed for the treatment of the underlying cause of FSHD, which is caused by the abnormal expression of a gene known as double homeobox 4 or DUX4. This DUX4 protein abnormal expression leads to modifications in gene expression in muscle cells which are associated with progressive muscle function loss in FSHD pat

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STAT+: ‘A cascade of failures’: FDA cites Indian drugmaker for numerous quality control problems

STAT

In a stunning rebuke, the Food and Drug Administration accused a drugmaker of a “cascade of failures” for a litany of quality-control problems at a manufacturing plant, the latest instance in which the regulator has castigated an Indian pharmaceutical company for such lapses. The agency cited Intas Pharmaceuticals for several violations of so-called good manufacturing practices, including problems with data integrity, standard documentation practices, accuracy, reproducing test met

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Over 25% of commercially insured ground ambulance trips could come with a surprise bill: study

Fierce Healthcare

Over 25% of commercially insured ground ambulance trips could come with a surprise bill: study dmuoio Thu, 01/19/2023 - 17:34