June, 2024

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Speaking a Second Language Has Countless Benefits in the Pharmacy Setting

Pharmacy Times

Being able to communicate in a different language can improve treatment adherence and medication efficacy outcomes

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Slideshow: Everything You Need to Know About the US Bird Flu Outbreak

Drug Topics

In a webinar conducted by the National Foundation for Infectious Diseases (NFID), experts gathered to publicly address the ongoing bird flu outbreak across many US states.

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Three months into bird flu outbreak in U.S. dairy cows, experts see deep-rooted problems in response

STAT

Three months since an outbreak of avian influenza in U.S. dairy cattle was declared, the country is failing to take the necessary steps to get in front of the virus and possibly contain its spread among cows, according to interviews with more than a dozen experts and current and former government officials. The country still does not have a sufficient testing infrastructure in place, nor a full understanding of how the virus is moving within herds and to new herds, experts say.

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Modifier gene therapy – clinical development and manufacturing considerations

European Pharmaceutical Review

Tell us about Ocugen’s lead programme, OCU400. What’s the latest and what’s next? OCU400 is a modifier gene therapy aimed at treating retinitis pigmentosa and Leber congenital amaurosis (LCA). In April 2024, Ocugen received US Food and Drug Administration (FDA) clearance to initiate the Phase III liMeliGhT clinical trial for OCU400 for retinitis pigmentosa.

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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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Supreme Court overrules Chevron deference, dealing blow to federal healthcare agencies

Fierce Healthcare

The U.S. Supreme Court, by a vote of 6-3, has overturned the Chevron deference, stripping power from federal agencies to interpret and enforce regulations. | The U.S. Supreme Court is overruling long-standing precedent. Here's how it could affect healthcare policy.

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Watch out, GSK. Gilead’s twice-yearly PrEP drug shows 100% efficacy for HIV prevention

Fierce Pharma

For the first time, an HIV PrEP drug candidate has shown zero infections in a phase 3 trial. | For the first time, an HIV PrEP drug candidate has shown zero infections in a phase 3 trial. For Gilead, it serves as one of two pieces for a potential FDA filing. For GSK, it means a major competitor could be looming around the corner.

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Novavax seeks FDA approval for updated Covid-19 vaccine

Pharmaceutical Technology

Novavax has sought US FDA approval for an updated JN.1 version of its Covid-19 vaccine, NVX-CoV2705, for individuals aged 12 years and above.

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Infant deaths increased after Texas banned abortion in early pregnancy

STAT

Since Texas’ ban on abortion went into effect, infant deaths in the state increased by nearly 13%, according to a new analysis published on Monday in JAMA Pediatrics. In the rest of the country, infant mortality increased less than 2% over the same period. “We had read the literature that was showing an association [of infant death increases] with prior abortion restrictions or states that are hostile to abortion,” said lead author Alison Gemmill, a demographer and perinatal

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Digital twins in healthcare and drug discovery: From idea to success stories

pharmaphorum

Explore how digital twins are transforming healthcare and drug discovery, with success stories showcasing their impact in the biopharma industry. Learn about their journey from concept to real-world applications.

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2024 shaping up to be a big year for healthcare AI companies. But some investors remain cautious

Fierce Healthcare

AI deal activity is dominating healthcare investment with one in four dollars invested in healthcare going toward companies leveraging AI, according to a new report. | So far, in 2024, $2.8 billion has already been invested in AI healthcare companies, with SVB projecting the sector to see $11.

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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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After 33 years, Geron finally crosses FDA finish line with blood cancer med Rytelo

Fierce Pharma

Once hailed as an anti-aging magic bullet, telomerase has failed to live up to the hype as it was profiled in a | The FDA has approved Geron Corporation's Rytelo (imetelstat) to treat a group of bone marrow disorders called myelodysplastic syndrome (MDS). The approval is the first for the 33-year-old California biotech.

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Implications for Pharmacies Navigating Shared Clinical Decision-Making in Vaccination

Pharmacy Times

The SCDM model demands more than the traditional roles assigned to pharmacists, requiring an enhanced level of patient engagement, medical knowledge, and legal authority to implement effectively

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AstraZeneca’s Tagrisso approved in Japan for lung cancer treatment

Pharmafile

AstraZeneca has announced that Tagrisso (osimertinib) in combination with pemetrexed and platinum-based chemotherapy has been approved in Japan for the first line treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) whose tumours have exon 19 deletions or exon 21 mutations.

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Surgeon general declares gun violence a public health crisis

STAT

Firearm violence is officially a public health crisis in the U.S. — Surgeon General Vivek Murthy says so. In a new advisory published on Tuesday, Murthy calls attention to the health toll of gun violence, describing the size of the crisis while laying out a roadmap of research and policy interventions to curb its effects. “My hope is that framing just the profound impact and pervasive impact of gun violence in our country … can firmly take it out of the realm of politics and

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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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Zealand Pharma rakes in $1bn in funding for obesity drugs

pharmaphorum

Fresh from reporting encouraging results with its obesity drug candidate petrelintide, Zealand Pharma has raised an impressive $1 billion from a new share offering.The Danish biotech started the fundraising process earlier this week with an expectation of raising $900 million but easily overshot that target, evidence once again of huge investor interest in companies developing a new generation of obesity drugs.

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Color Health taps OpenAI to generate screening plans for cancer patients

Fierce Healthcare

Color Health is working with OpenAI to test out computer-generated personalized care plans for cancer patients. | Color developed a new copilot app that leverages GPT-4o to identify missing diagnostics and create tailored workup plans for patients.

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Daiichi’s lung cancer ADC rejected by FDA in blow to first project under Merck partnership

Fierce Pharma

In the second setback for the HER3 field in days, the FDA has rejected Daiichi Sankyo’s Merck & Co.-partnered antibody drug conjugate (ADC) patritumab deruxtecan. | In the second setback for the HER3 field in days, the FDA has rejected Daiichi Sankyo’s Merck & Co.-partnered antibody drug conjugate patritumab deruxtecan.

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Researchers Find Shared Multiomic Molecular Dysregulations in Brains With PTSD and MDD

Pharmacy Times

The investigators are optimistic that the data can establish stress-related pathways while revealing potential therapeutic options for patients with major depressive disorder and post-traumatic stress disorder.

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Avoiding the pharma ‘junk pile’ with launch readiness, pipeline rigor and ‘quick kills’

PharmaVoice

Drug launches have underperformed expectations at a high rate, and pharmas need to get better at thinning the pipeline to make room for the real wins, says a life sciences consultant.

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Michigan launches first effort of its kind to detect silent bird flu infections in farmworkers

STAT

Michigan has led the nation in making inroads with its farmers as it has worked to contain spread of H5N1 bird flu infections in dairy cows. Now the state’s health authorities are trying to do the same in looking for undetected infections among farmworkers. The Michigan Department of Health and Human Services is working with an undisclosed number of farms to try to assess the risk to workers of becoming infected with the virus, which has spread to at least 25 farms in the state in the pas

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Pharmacogenomics and IVDR: Overcoming transition challenges

pharmaphorum

Understanding the challenges and opportunities in transitioning to IVDR for pharmacogenomics can be complex. Learn more about how to overcome these challenges effectively.

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National Nurses United pushes back against deployment of ‘unproven’ AI in healthcare

Fierce Healthcare

The nation’s largest nurses union is demanding that artificial intelligence tools used in healthcare be proven safe and equitable before deployment. | A union organization for nurses nationwide says the deployment of AI in healthcare will push nurses out of patient rooms and compromise patient safety. A new AI Bill of Rights lays out nurse and patient protections, which are not currently being met.

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Europe taps CSL Seqirus to produce bird flu vaccines for pandemic preparedness efforts

Fierce Pharma

Right after signing on to help with bird flu pandemic preparedness efforts in the U.S., CSL Seqirus has agreed to do the same in Europe through a vaccine supply pact. | The vaccine maker will deliver 665,000 doses of its avian flu-matched pre-pandemic vaccine. Under a 4-year contract, authorities can purchase up to 40 million doses.

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During Drug Shortages, There Are Resources so Pharmacists ‘Never Need to Ration Life-Saving Drugs’

Pharmacy Times

Laura Bray, founder of Angels for Change, explains that addressing the 4 key economic causes to drug shortages can also help lead to effective solutions long-term.

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AstraZeneca’s Tagrisso receives approval in Japan for lung cancer

Pharmaceutical Technology

AstraZeneca has received Japanese approval for Tagrisso plus chemotherapy as first-line treatment for non-small cell lung cancer (NSCLC).

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Opinion: Long Covid feels like a gun to my head

STAT

I have spent my career studying infectious diseases that fall under the heading of neglected tropical diseases. Now I have a neglected disease — long Covid — an incurable (for now and for me) disease. As a medical anthropologist working in global health, I thought I understood the despair of poor health. I didn’t. I join 7% of the U.S. adult population — or about 18 million Americans — who have experienced long Covid.

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Why progress on ovarian cancer treatments is slow

pharmaphorum

Progress on ovarian cancer treatments has been slow, despite promising drugs like Keytruda and Lynparza. Learn about the obstacles and challenges in developing effective treatments for this deadly disease.

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Amazon Pharmacy expands RxPass subscription service to Medicare patients

Fierce Healthcare

Amazon Pharmacy is expanding its prescription drug subscription program, called RxPass, to Prime members on Medicare insurance. | The RxPass program, launched in January 2023, provides unlimited access to 60 eligible generic medications and will ship the medications to customers' homes for a flat monthly fee of $5.

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Kansas AG accuses Pfizer of misrepresenting COVID vaccine, hiding safety risks in lawsuit

Fierce Pharma

Kansas Attorney General is accusing Pfizer of "misrepresenting" its vaccine's safety and efficacy in a 179-page civil suit.

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Understanding the Connection Between Genetic Risk and Brain Cell Activity in Autism Spectrum Disorder

Pharmacy Times

Over the course of 15 years, epigenetic and transcriptional analysis of postmortem brain samples have revealed underlying molecular differences.

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Regenerative cell therapy biotech uses IPO to blast into human trials

PharmaVoice

Bucking conventional fundraising, FibroBiologics’ CEO Pete O’Heeron explains why the biotech company bet on themselves in the public market.

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STAT+: Gilead’s twice-yearly antiviral protected women from HIV infection in large trial

STAT

Gilead said Thursday that twice-a-year injections of a new antiviral drug, called lenacapavir, completely protected cisgender women from contracting HIV in a large Phase 3 trial. In the study, none of the 2,134 women who received lenacapavir contracted HIV. By comparison, 16 of the 1,068 women who received the long-running daily pill Truvada contracted HIV.

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Blood test could spot Parkinson’s years earlier

pharmaphorum

An AI-powered blood test that may be able to predict Parkinson’s years before symptoms develop could allow earlier treatment and guide trials of new treatments

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Google-backed startup Heyday Health banks $12.5M to scale house calls combined with telehealth

Fierce Healthcare

Heyday Health launched three years ago to provide primary care to seniors by blending traditional house calls with 21st-century innovation via telehealth visits. | Heyday Health bills itself as a "virtual-forward, value-based care provider" designed to meet patients where they are, providing care in the comfort of their homes.

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