Wed.May 24, 2023

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Sulbactam-Durlobactam for Bacterial Pneumonia Gets FDA Approval

Drug Topics

The antibiotic, marketed as Xacduro, is indicated for hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by susceptible strains of bacteria called Acinetobacter baumannii.

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Biopharmaceutical manufacturing companies continue to expand their economic footprint across the United States

PhRMA

Before 2020, the importance of robust and resilient supply chains and how they can affect access to life-saving treatments probably wasn’t top of mind for many outside the biopharmaceutical industry. Then, in a sudden and very real way, the COVID-19 pandemic showed just how critical it is to have manufacturing facilities capable of scaling up quickly to meet an urgent public health demand.

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Trending Sources

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Fourth Dose of COVID Vaccine Produced Milder Symptoms In Patients With IBD

Drug Topics

Data presented at Digestive Disease Week show that patients with IBD had less intense post-vaccination symptoms after a fourth dose.

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STAT+: Addiction treatment center founder indicted in sprawling fraud scheme

STAT

Over the last few years, Daniel Cleggett Jr. appeared to be living a charmed life. The founder of a small Boston-area   addiction treatment empire knew he was under scrutiny; the Globe and STAT News  published investigations  in 2017 and 2019 into his questionable business dealings, and the Massachusetts attorney general’s office announced   shortly after that   it was examining alleged scams involving addiction treatment.

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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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What Is The Link Between Antidepressants and Hospital-Acquired Clostridium Difficile Infection?

Drug Topics

Researchers found an increased occurrence of CDI in individuals who were prescribed antidepressants.

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Pharmacists are Overworked, Frustrated, and Unintentionally Absent from Patient Care: It’s Time to Rightsize the Role

Pharmacy Times

Specialty pharmacists—those caring for patients with serious, sometimes life-threatening conditions such as cancer or rheumatologic disease—are not immune from the ongoing labor crisis.

More Trending

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Physicians, Staff Express Negative Attitudes Toward Emergency Department-Initiated Buprenorphine Use

Pharmacy Times

The attitudes of community-based opioid use disorder treatment center staff toward the emergency department as a site of initiation were varied, with some feeling that emergency department-initiated buprenorphine may attract patients who were not experiencing life-threatening emergencies.

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Opinion: What if we’re talking about teens’ mental health too much?

STAT

Every day, it seems, is mental health awareness day. In the U.S., there’s Eating Disorders Awareness Week in February. May is National Mental Health Awareness Month, which includes National Children’s Mental Health Awareness Day. September is Suicide Prevention Awareness Month and in October we go global, with  World Mental Health Day.

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FDA Approves Braeburn’s Brixadi Injection to Treat Moderate-to-Severe Opioid Use Disorder

Pharmacy Times

The drug is available in 2 formulations, including a weekly injection with a lower dose than previously available as well as a monthly injection.

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Startup Florence acquires Zipnosis from Bright Health to build out telehealth services

Fierce Healthcare

Startup Florence acquires Zipnosis from Bright Health to build out telehealth services hlandi Wed, 05/24/2023 - 06:15

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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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Ketamine is comparable to ECT for patients with treatment-resistant depression, study shows

STAT

When seriously depressed patients don’t respond to antidepressants, the alternatives are limited. Now a new study has found that ketamine performs at least as well as the current gold standard for such patients, electroconvulsive therapy (ECT), suggesting it deserves consideration as a frontline response for people with treatment-resistant depression.

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Linked Immunization Information System, Claims Data Captured COVID-19 Vaccination Status Better Than Claims Data Alone

Pharmacy Times

Reporting vaccination data to Immunization Information Systems databases can support public health surveillance activities.

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We’ll soon have tools to protect infants against RSV. Can we put them to good use?

STAT

When scientists, physicians, and public health officials discuss RSV, the talk almost always turns to babies. This ubiquitous infection can leave small children, especially infants, struggling to breathe. It petrifies parents. When RSV season hits, children’s hospitals are slammed by a surge in sick baby admissions.

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Comprehensive Review Suggests Cranberry Juice, Supplements Can Prevent Repeat UTIs

Pharmacy Times

The preventive effect is believed to be a result of compounds unique to cranberries called proanthocyanidins.

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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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STAT+: Immunotherapy turned brain cancers from ‘cold’ to ‘hot’ in mouse study, as clinical trials advance

STAT

LONDON — The promise of immunotherapies to treat cancer has yet to reach brain tumors. It’s difficult to deliver medicines into the brain for a host of reasons. In particular, brain tumors are able to suppress the body’s immune activity and have comparably few genetic vulnerabilities that cancer drugs can target. They’re considered immunologically “cold.

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Dupilumab found to reduce exacerbations in COPD patients with type 2 inflammation

Hospital Pharmacy Europe

The rate of exacerbations in COPD patients with type 2 inflammation is lowered by treatment with dupilumab, according to the findings of a recent randomised, placebo trial. Patients with chronic obstructive pulmonary disease (COPD) and type 2 inflammation experience a lower annualised rate of moderate to severe disease exacerbations when dupilumab is added to standard triple therapy, the BOREAS clinical trial group found.

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STAT+: FDA delays decision on Sarepta’s gene therapy for Duchenne muscular dystrophy

STAT

The Food and Drug Administration is delaying by one month a decision on the approval of a gene therapy for Duchenne muscular dystrophy, the treatment’s maker, Sarepta Therapeutics, said Wednesday. Sarepta said the FDA expects to complete the review of its gene therapy called SRP-9001 by June 22. A decision had been expected on or before May 29.

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Forge Biologics joins BGTC for new AAV gene therapies development

Pharmaceutical Technology

Forge Biologics has joined the public-private collaboration, the Bespoke Gene Therapy Consortium (BGTC), to expedite the development and manufacture of new AAV [adeno-associated virus] gene therapies to treat patients with rare diseases. The BGTC is part of the accelerating medicines partnership (AMP) programme and is managed by the Foundation for the National Institutes of Health (FNIH).

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STAT+: Congress took on high drug prices in Medicare. Now Biden wants to take it to Medicaid

STAT

WASHINGTON — The Biden administration wants to help states control Medicaid prescription drug costs by making prices more transparent and curbing the practice of so-called spread pricing. The goal is to give states more leverage in price negotiations by forcing drugmakers to share and publish details about their pricing data. The government would collect specific drug pricing information from makers of up to 10 particularly high-cost drugs.

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LGBTQ+ dating app Grindr helps fight a COVID-related decrease in STI testing

Fierce Healthcare

LGBTQ+ dating app Grindr helps fight a COVID-related decrease in STI testing aburky Wed, 05/24/2023 - 20:08

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Opinion: How ‘screen and refer’ systems fail to help patients

STAT

We’ve all had the experience of a doctor or other health care worker staring at screen while asking us sensitive questions to fill out our electronic health records. But that frustrating experience is made even worse by a new trend in health care. As Sanjay Basu wrote in a recent First Opinion, hospitals are using so-called “screen and refer” systems to identify people with social needs, like those who are experiencing domestic violence or hunger.

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First redosable gene therapy approved

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has approved the first-ever redosable gene therapy for the rare skin disease dystrophic epidermolysis bullosa (DEB). VYJUVEK (beremagene geperpavec-svdt) is authorised for DEB patients six months of age or older. The gene therapy is a topical gel that restores functional copies of the COL7A1 gene to provide wound healing and sustained functional COL7 protein expression with redosing.

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STAT+: Battle for the soul of Illumina is also a referendum on its CEO

STAT

On Thursday Illumina, the largest and most important maker of DNA sequencing technology, whose innovations have changed medicine and have been crucial in our battles with diseases from Covid to cancer, will face a day of reckoning. A catch-up: Illumina is holding a meeting during which investors will vote on who should be on its board of directors. Carl Icahn, the embodiment of activist investing, has proposed adding three new directors to the board.

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FDA Approves Buprenorphine Extended-Release Subcutaneous Injection for OUD

Drug Topics

This treatment is the first and only long-acting buprenorphine injectable with weekly and monthly doses.

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STAT+: Matt Eyles, CEO of America’s Health Insurance Plans, to depart

STAT

Matt Eyles, CEO of America’s Health Insurance Plans, is leaving by this October, the lobbying group said Wednesday. Eyles has led AHIP for the past five years — a historically profitable time for health insurers — and his departure surprised some in the industry, according to three executives and lobbyists. In 2018, Eyles took over for Marilyn Tavenner , who became CEO of AHIP right after serving as the top administrator of Medicare and Medicaid under President Obama.

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Biopharma staffers exhausted and susceptible to burnout, report says

Fierce Pharma

Biopharma staffers exhausted and susceptible to burnout, report says kdunleavy Wed, 05/24/2023 - 16:52

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STAT+: Boston Scientific cancels $230 million deal to buy Korean device company

STAT

Boston Scientific is scrapping its $230 million plan to buy a majority stake in M.I. Tech, a Korean company that builds surgical tools, the company confirmed to STAT. Instead, it will purchase a minority stake of around 10%. That purchase will go through later this year. “Our agreement to purchase the majority stake of M.I.Tech Co., Ltd, from Synergy Innovation Co., Ltd, required global regulatory approvals that we were not able to obtain in some countries,” said Boston Scientific

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Interventions for Heart Failure Should Span Care Continuum

Pharmacy Times

Comprehensive in-hospital planning, postdischarge follow-up, ongoing support are key.

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STAT+: Annexon’s trial of an eye disease drug missed by a mile. The company saw a bull’s eye

STAT

Annexon Biosciences said Wednesday that its experimental treatment for an eye disease called geographic atrophy had no effect on the growth of retinal lesions that eventually lead people with the disease to lose their vision. The result means Annexon’s drug failed to achieve the primary goal of a mid-stage clinical trial. The company has a more optimistic view of the study results, pointing to other data showing that injections of its drug, called ANX007, preserved vision compared to sham

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Dupilumab Is the First Investigational Biologic to Significantly Improve Lung Function in Patients With COPD

Pharmacy Times

The treatment improved lung function at 12 weeks and quality of life at 4 weeks.

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NACDS commends House committee for inclusion of PBM reform bill in PATIENT Act

Drug Store News

NACDS said this action is an essential component of PBM reform in the Medicaid program and vital for patients and the pharmacies serving them.

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Innoviva subsidiary Entasis scores FDA nod for bacterial pneumonia combo drug Xacduro

Fierce Pharma

Innoviva subsidiary Entasis scores FDA nod for bacterial pneumonia combo drug Xacduro kdunleavy Wed, 05/24/2023 - 09:46

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Pharmacy orgs laud House committee hearing on PBMs

Drug Store News

Several organizations representing pharmacies and pharmacists issued a statement commending the House panel for its hearing on PBM tactics.

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How Biologic Therapy Can Help Mitigate COVID-Related Complications In Patients With IBD

Drug Topics

New data from Digestive Disease Week furthers evidence that biologics can be effective

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