Mon.Aug 07, 2023

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SAEM Clinical Images Series: Back Yard Football Injury

ALiEM - Pharm Pearls

A 10-year-old male with no past medical history presents to the Emergency Department (ED) by EMS for evaluation of an injury sustained while playing tackle football. The patient was forcibly hit by another child against a tree. He complains of sharp right shoulder and chest pain that worsens with movement of his right upper extremity and he arrives wearing a sling to immobilize the arm.

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Opinion: Doctors need to pay more attention to non-physical side effects of health care

STAT

When faced with a new diagnosis, a patient knows that the necessary treatment may make her feel lousy. What she doesn’t always account for, though, is the effect that it will have on the rest of her life. It’s common for patients and physicians to decide whether a treatment is worth it by weighing the health benefits against the side effects.

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Pharma’s rocky love affair with oxytocin

PharmaVoice

Although research on using oxytocin as a drug has varied, Tonix Pharmaceuticals is banking on the “love hormone” to treat autism, anxiety and more.

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A new study put period products through the wringer. Discs came out a winner

STAT

There are many period products on the market from pads, tampons and cups to discs. Yet, there is a dearth of reliable information about how much menstrual blood they can hold — a useful metric for clinicians as well as consumers. Heavy menstrual bleeding affects up to a third of people who menstruate and that can only be diagnosed using traditional menstrual products like pads and tampons.

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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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A pioneering approach to biotherapeutic antibody discovery

PharmaVoice

Immunotherapy has revolutionized cancer treatment, yet the drug discovery process to develop new biotherapeutic antibodies remains arduous.

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Kidney doctors push to protect patients by including dialysis machines in emergency stockpile

STAT

Ariel Brigham was drowning. Hurricane Harvey had dumped over 50 inches of rain across Houston and coastal Texas, leaving the then-26-year-old Texan stranded in her flooded apartment. But what was killing Brigham wasn’t water from the hurricane. It was the excess fluid and toxins building up in her own body.

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More Trending

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Community health workers, experts in the in-between, fight for their place in the system

STAT

NEW YORK — A nurse supervisor at Montefiore Comprehensive Health Care Center in the Bronx was delivering her start-of-shift updates and mantras — “Covid is not finished with us … clean, clean, clean!”— to the clinicians and administrative staff bunched up nearby. Hawa Abraham, not one or the other, stood among them.

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Doubling Down on Drug Adherence

Pharmaceutical Commerce

Creating a user-centric approach that harnesses both digital tools and behavioral science is key to getting—and maintaining—patients on therapy, and improving clinical, financial, and, ultimately, brand-success outcomes for pharma manufacturers.

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Attacks at US medical centers show why health care is one of the nation’s most violent fields

STAT

Word spread through an Oregon hospital last month that a visitor was causing trouble in the maternity ward, and nurses were warned the man might try to abduct his partner’s newborn. Hours later, the  visitor opened fire, killing a security guard  and sending patients, nurses and doctors scrambling for cover.

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DE&I Accountability in Pharma

PharmExec

Rebekah Martin, senior VP of reward, inclusion, and talent acquisition at AstraZeneca, discusses ways companies can remain accountable for DE&I efforts in pharma in this Pharmaceutical Executive Podcast video.

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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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Opinion: Drugs alone can’t win the war against tuberculosis

STAT

Recently, after years of pressure, advocates including author and philanthropist John Green scored victory against Johnson & Johnson over a patent on a key tuberculosis drug. The campaigners hope the move will give millions of people affected by tuberculosis in low- and middle-income countries access to the lifesaving medication bedaquiline. But the drugs alone can’t win the fight against the debilitating disease.

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Insights into Shifting Dynamics: Orange Book and Biologic PTAB Trends

Drug Patent Watch

A recent update from Foley & Lardner attorney Courtenay C. Brinckerhoff discusses trends in Inter Partes Review (IPR) and Post Grant Review (PGR) proceedings involving Orange Book and biologic patents, based… The post Insights into Shifting Dynamics: Orange Book and Biologic PTAB Trends appeared first on DrugPatentWatch - Make Better Decisions.

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STAT+: Pharmalittle: FDA OKs Sage drug for postpartum depression; major U.S. health systems to offer Alzheimer’s drug

STAT

Good morning, everyone, and welcome to another working week. We hope the weekend respite was invigorating and refreshing, because that oh-so familiar routine of online meetings, calls, and deadlines has predictably returned, But what can you do? The world, such as it is, continues to spin. So to cope, we are brewing cups of stimulation — our choice today is cinnamon hazelnut.

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How the right technology and tools can accelerate progress in rare disease clinical trials

BioPharma Dive

The need for more research into rare diseases is clear, but researchers face significant challenges. Fortunately, technology has created opportunities to innovate in clinical trials for rare diseases.

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STAT+: Sage considers ways to reduce costs following FDA rejection on drug for major depression

STAT

Sage Therapeutics said Monday that it may need to reduce costs, including through employee layoffs, following the Food and Drug Administration’s denial of its rapid-acting drug for major depressive disorder. On Friday, the agency granted market clearance for the drug , called Zurzuvae, to treat women with postpartum depression, a smaller commercial market.

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Daiichi Sankyo will remain dominant in ADC market for oncology treatments: GlobalData

Express Pharma

A promising shift towards the development of antibody-drug conjugates (ADC) for cancer treatment is taking place in the pharma industry. A recent look at the marketed and pipeline drugs shows that Daiichi Sankyo, Seagen, and Roche are three of the most important companies in this wave. Daiichi’s recent trial results suggest that the company will continue to remain dominant in the oncology ADC market, says GlobalData.

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STAT+: Nektar Therapeutics sues Lilly for ‘misconduct’ in drug development deal

STAT

A behind-the-scenes feud over a drug development program erupted into public view as Nektar Therapeutics filed a lawsuit accusing Eli Lilly of undermining a project in favor of another deal. At issue is a partnership that began in 2017 to develop and potentially market a drug, known as Rezpeg, to treat various autoimmune diseases, and in particular, eczema.

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First ever pill for postpartum depression from Biogen Inc. and Sage Therapeutics approved by FDA

Outsourcing Pharma

The first oral pill in the United States specifically for postpartum depression, a serious mental illness, has been approved by the US Food and Drug Administration (FDA).

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Marksans announces completion US FDA PADE inspection

Express Pharma

Marksans has announced that the United State Food and Drug Administration (US FDA) has completed a post-marketing adverse drug experience (PADE) inspection. The inspection closed with two observations. The inspection was conducted at its Goa, Vema manufacturing facility from July 31, 2023 to August 4, 2023. The inspection included comprehensive scrutiny of practices and procedures for reporting of adverse events of Marksans’ marketed products.

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Astellas to advance oncology CAR-T therapy

European Pharmaceutical Review

Astellas Pharma has agreed to invest a total of $50 million for the right to license P-MUC1C-ALLO1, an allogeneic CAR-T cell therapy in development for multiple solid tumour indications. Under the agreement, the company will acquire approximately 8.8 percent of Poseida Therapeutics. Astellas Pharma will receive a right of exclusive negotiation and first refusal for any potential partnering of P-MUC1C-ALLO1.

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Biopharma sector still growing despite layoff wave, Stifel report finds

BioPharma Dive

The investment bank estimates that, while many smaller biotechs are laying off staff, larger companies are still growing from early 2021 levels.

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Evox Therapeutics reaches gene therapy agreement

Pharma Times

Partnership with Icahn School of Medicine will involve developing exoAAV vectors for heart disease patients - News - PharmaTimes

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Harmony, consistency and unison amongst medical practices in India: Is the gap bridging or widening?

Express Pharma

Nobody is likely to have a difference of opinion that the medical system and the processes have evolved as a result of knowledge, necessity and the prevailing medicines and antidotes available in different regions. This is true for the whole world whether it is America, Japan, China, Europe, India, the Amazon or wilds of Africa. The diseases and abnormalities with the human body (animals as well) are not new.

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Taiho begins latest non-small cell lung cancer trial

Pharma Times

A combination of zipalertinib and chemotherapy will be evaluated as a treatment for adults - News - PharmaTimes

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Health Canada approves GSK’s RSV vaccine for older individuals

Pharmaceutical Technology

Health Canada has granted approval for GSK’s Arexvy vaccine to prevent RSV-caused lower respiratory tract disease in older adults.

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Antibiotic manufactured via continuous-flow for first time

European Pharmaceutical Review

For the first-time, researchers have successfully and safely produced the antibiotic cefazolin using continuous-flow manufacturing. While usually produced via batch manufacturing , this latter process is time-consuming, requires specialised equipment results in a large amount of waste. On the other hand: “The method we have developed can cover mass production within compact manufacturing facilities, does not incur huge equipment costs, and can provide a pharmaceutical-grade drug safely and secur

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Iveric Bio’s intravitreal solution to treat GA gains FDA approval

Pharmaceutical Technology

Iveric Bio, an Astellas company, has received clearance from the US Food and Drug Administration (FDA) for IZERVAY.

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First oral medicine for postpartum depression approved

European Pharmaceutical Review

The US Food and Drug Administration ( FDA ) has approved Zurzuvae ( zuranolone ), the first oral medicine to treat postpartum depression (PPD) in adults. Historically, treatment for PPD has been only available as an IV injection. “The FDA approval of Zurzuvae to treat postpartum depression is a major milestone for the hundreds of thousands of women who experience this underdiagnosed and undertreated condition,” commented Christopher Viehbacher, President and Chief Executive Officer at Biogen.

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FDA approves first oral treatment for postpartum depression

Pharmaceutical Technology

Following the approval, Biogen plans for the commercial launch Zurzuvae (zuranolone) in the last quarter of 2023.

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Breaking the Pharma Industry’s Bundled Pricing Arrangements

Pharmaceutical Commerce

How the ‘fight-for-the-dollar’ is coming and likely will impact the bundled pricing of industry stakeholders.

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Solving Prior Authorization Hurdles

assurecare

Prior authorization is a crucial process in healthcare that demands healthcare providers to acquire approval from insurance companies before a treatment, procedure, or prescription can be covered. This process is formed to ensure medical requirements are met and is essential for managing costs and providing appropriate care. Nonetheless, prior authorization can be time-consuming, complicated, and expensive for healthcare providers, as they often have to pay organizational fees to process request

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Potential treatment for inherited blindness wins FDA fast-track

Pharmaceutical Technology

HuidaGene claims its gene therapy candidate was superior to FDA-approved Luxturna in preclinical studies.

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FDA approves first oral treatment for postpartum depression

World Pharma News

The U.S. Food and Drug Administration approved Zurzuvae (zuranolone), the first oral medication indicated to treat postpartum depression (PPD) in adults. PPD is a major depressive episode that typically occurs after childbirth but can also begin during the later stages of pregnancy. Until now, treatment for PPD was only available as an IV injection given by a health care provider in certain health care facilities.

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European Commission Revokes Novartis’ Conditional Marketing Authorization for Adakveo

PharmExec

Decision comes amid recommendation from agency’s Committee for Medicinal Products for Human Use.

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CCA urges action on ‘pseudo’ distance selling pharmacies

The Pharmacist

The Company Chemists’ Association (CCA) has called for more stringent action on distance selling pharmacies that supply a predominantly local area, after new research suggested more than 70% were not following contractual requirements. Many patients choose to order their prescriptions through a distance selling pharmacy (DSP), which is required by NHS England (NHSE) to make […] The post CCA urges action on ‘pseudo’ distance selling pharmacies appeared first on The Pharmacist.

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