Mon.Sep 12, 2022

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Timely reauthorization of PDUFA and BsUFA is vital to the FDA’s review of medicines

PhRMA

As we’ve discussed on this blog before, timely reauthorization of the Prescription Drug User Fee Act (PDUFA) and the Biosimilar User Fee Act (BsUFA) is critical to sustaining the U.S. Food and Drug Administration’s (FDA) ability to keep pace with the number of innovative drugs, biologics and biosimilars entering the regulatory review pipeline.

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Addressing Burnout in Pharmacy

Drug Topics

The causes of burnout in pharmacy are multifactorial. The solutions need to be as well.

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Navigating the patient experience: Burdens and barriers standing between patients and their care

PhRMA

Health care affordability is not the only hurdle facing patients, according to PhRMA’s third Patient Experience Survey (PES). The latest PES report exposes another crucial problem: the frustration and confusion people have around how to use their coverage. Administrative hurdles and other barriers imposed by health insurers and pharmacy benefit managers (PBMs), such as time-consuming paperwork or prior authorization, are a challenge for many insured Americans, including more vulnerable communiti

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Mitigating Costs of Cancer Treatment: The Role of Pharmacists

Drug Topics

Cancer care is expensive, but pharmacists can help.

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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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With increased virus activity, providers urged to be alert for signs of rare polio-like syndrome in kids

STAT

Pediatricians and top health officials are warning about an uptick in activity of a common virus that in rare cases can cause a polio-like syndrome in young children. The virus, an enterovirus known as EV-D68, is one of the bugs that regularly circulates and infects us from time to time, typically just causing colds. But occasionally, children infected with it will develop limb weakness and a progressive form of paralysis, what’s called acute flaccid myelitis , or AFM.

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Study: Anti-Depressants May Help Avoid Severe COVID-19 Symptoms

Pharmacy Times

Although serotonin is widely associated with feelings of happiness, a study suggests it may be associated with the severity of COVID-19.

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More Trending

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Interaction Considerations for Common OTC Drug Classes

Pharmacy Times

Although OTC medications are generally considered safe when used as directed, there are some key drug interactions for pharmacists to keep in mind when helping patients choose an OTC product.

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Albertsons invests in pharmacy to support comprehensive immunization access

Drug Store News

Improvements to scheduling and pharmacy care will support co-administration of flu vaccine and new reformulated COVID-19 boosters at more than 1,700 pharmacy locations.

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FDA Grants Breakthrough Therapy Designation to Group B Streptococcus Vaccine Candidate

Pharmacy Times

Decision is based on interim analysis of Pfizer’s GBS6 in healthy pregnant woman aged 18 to 40 years, who were vaccinated during their second or early third trimesters.

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Using Digital Tools to Improve Reporting of At-Home COVID-19 Testing

Drug Topics

At-home COVID-19 testing is convenient, but impacts the number of reported cases. Could a digital tool help improve reporting to public health agencies?

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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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FDA Approves Spevigo for Treatment of Generalized Pustular Psoriasis Flares in Adults

Pharmacy Times

Boehringer Ingelheim’s monoclonal antibody inhibits interleukin-36 (IL-36) signaling and is the first treatment specifically approved for this indication.

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CVS Heath's Aetna enters insurance exchange marketplace in 12 states

Drug Store News

Aetna CVS Health individual and family plans will be available in select counties in Arizona, California, Delaware, Florida, Georgia, Illinois, Missouri, North Carolina, New Jersey, Nevada, Texas and Virginia.

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Study: Diet Change Makes Biggest Impact on Reducing CV Risk in Those With Hypertension

Pharmacy Times

Analysis presented at an American Heart Association meeting suggests that following DASH is most effective to reduce the risk of heart attacks and strokes.

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Raising a RUC-kus, Blues’ antitrust deal appealed, & a UAE deal

STAT

You’re reading the web edition of Health Care Inc., STAT’s weekly newsletter following the flow of money through the health care system.  Sign up here  to get it in your inbox. Bucking the RUC. A heavyweight group of former Medicare officials and payment experts is calling on the federal government to overhaul how Medicare pays physicians, which they say has morphed into a system that is “mind-numbingly complex and nontransparent.

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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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FDA Approves Deucravacitinib for Adults With Moderate-to-Severe Plaque Psoriasis

Pharmacy Times

Deucravacitinib (Sotyktu) may become the new standard of care oral therapy for moderate-to-severe plaque psoriasis, according to investigators.

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STAT+: Experts urge Medicare to overhaul secretive panel that helps determine doctors’ pay

STAT

A heavyweight group of former Medicare officials and payment experts are calling on the federal government to overhaul how Medicare pays physicians, which they say has morphed into a system that is “mind-numbingly complex and nontransparent.” One of the most integral components of this fee system is the American Medical Association’s Relative Value Scale Update Committee, or RUC, a group of 32 physicians that meets behind closed doors a few times every year.

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Pharmacy Students in Hawaii Get Experience With Unique Patient Populations

Pharmacy Times

Hawaii has a distinct culture, and the students said that has led them to have unique perspectives on culturally competent care.

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ESMO: Evidence builds for BioNTech’s amplified CAR-T therapy

pharmaphorum

BioNTech has been thrust into the limelight with its mRNA-based vaccines and therapeutics – most notably its Pfizer-partnered COVID-19 shot – but the other side of its business is CAR-T therapies for cancer, and it is making progress in this area as well. At the ESMO congress the German biotech reported updated results from a phase 1/2 trial of its lead candidate BNT-211 for solid tumours, which consists of a CAR-T directed at the antigen Claudin-6 on cancer cells, coupled with an mRNA vaccine (

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Novartis to invest $300mn in European biotherapeutics

European Pharmaceutical Review

Novartis has revealed plans to invest $300 million in next-generation biotherapeutics. The multi-year investment will be implemented across existing Novartis locations in Switzerland, Slovenia and Austria to create a fully integrated, “dedicated scientific environment will bolster its capacity and capabilities for early technical development of biologics”.

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Don’t let shrill debates keep you from getting a Covid booster

STAT

Even before the new Covid booster shots arrived, the arguments about them got shrill. There’s a dizzying kaleidoscope of defensible opinions about the new Covid shots, which are designed to match the BA.5 strain of the virus that currently accounts for 9 in 10 Covid cases in the U.S.

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Happitech launches smartphone app for cardiac researchers

pharmaphorum

Mobile health specialist Happitech has launched software that it says can help researchers use photoplethysmography (PPG) technology in the development of applications for use in cardiovascular care. The FastStart Research app is designed to be used with optical PPG sensors that can measure heart rate, heart rate variability, and atrial fibrillation (AF) and are increasingly being deployed in smartphones and wearable devices such as Google’s Fitbit range and the Apple Watch.

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Products to Watch: HRG’s top 5 choices from August 2022

Drug Store News

Hamacher Resource Group’s new product team evaluated a total of 59 new products in August, choosing five that stood out.

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STAT+: Data likely support approval of Amgen’s KRAS-targeted drug, but still come with disappointments

STAT

Clinical trial results reported Monday by Amgen may be enough to confirm the U.S. approval of its KRAS-targeting lung cancer drug called Lumakras. But the new data also show lung cancer patients are not benefiting from Lumakras as much as previously hoped, and liver toxicity remains a safety concern. In the study, called CodeBreaK 200, Lumakras delayed tumor growth by a little more than one month compared to the standard chemotherapy, docetaxel — a lower-than-expected improvement that non

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US FDA grants approval for BMS’ Sotyktu to treat plaque psoriasis

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Bristol Myers Squibb ’s (BMS) Sotyktu (deucravacitinib) to treat adult patients with moderate-to-severe plaque psoriasis. The oral treatment is indicated for such patients who are candidates for systemic therapy or phototherapy. It should not be used along with other immunosuppressants.

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Pharmig’s 30th Anniversary Conference

Pharmig

The year 2022 is a significant occasion for Pharmig, as we will be hosting our 30th-anniversary conference. This exciting event marks over 30 years of Pharmig providing pharmaceutical microbiologists with a voice. The post Pharmig’s 30th Anniversary Conference appeared first on Pharmig.

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Opinion: Why do people turn down social risk assistance offered by their doctors’ offices?

STAT

After decades of research documenting the profound effects of social factors on health , such as income, education, employment, food security, and neighborhood, the health care sector has finally begun grappling with these so-called social drivers of health. The health care system’s response has included efforts to identify patients and families experiencing social risk factors.

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Phase 3 Trial Launches for Acute Migraine Treatment

Pharmacy Times

Surveys show that 70% of migraine sufferers are not satisfied with their current acute treatment regimen.

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Kroger updates ESG action plan

Drug Store News

Kroger’s signature Zero Hunger | Zero Waste social and environmental impact plan emphasizes the role it plays across the food system and its many stakeholders as an employer, food processor, retailer, healthcare provider and more.

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STAT+: Pretzel Therapeutics, eyeing diseases caused by broken mitochondria, launches with $72.5 million

STAT

In the life sciences industry, where company names derived from “biology” or “genetics” are a dime a dozen, it helps to have a brand that stands out. Pretzel Therapeutics is one of this year’s more creative gambits, launching Monday with $72.5 million in series A financing — just in time for Oktoberfest season.

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Perfect, Colgate debut AR-powered teeth whitening experience

Drug Store News

Both companies have joined forces on a tooth whitening algorithm that showcases the Colgate Optic White Overnight Teeth Whitening Pen results in an augmented reality simulation.

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STAT+: Pharmalittle: FDA approves new type of psoriasis drug; U.S. starts late-stage trial to test an antiviral against monkeypox

STAT

Good morning, everyone, and welcome to another working week. We hope the weekend respite was refreshing and invigorating, because that oh-so familiar routine of online meetings, calls, and deadlines has predictably returned. But you knew this would happen, yes? To cope, we are firing up the coffee kettle and brewing a cup of stimulation. Our choice today is salted caramel mocha.

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Albertsons invests in pharmacy to support comprehensive immunization access

Drug Store News

Improvements to scheduling and pharmacy care will support co-administration of flu vaccine and new reformulated COVID-19 boosters at more than 1,700 pharmacy locations.

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Examining What Interchangeable Means in Biosimilars

Drug Topics

Some companies are using the interchangeability designation as a marketing ploy.

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Lunchables, Frankford Candy team up on buildable gummy kits

Drug Store News

Products that are part of the partnership include Gummy Lunchables Cracker Stackers and Gummy Lunchables Pepperoni Pizza kits.

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