STAT

MARCH 30, 2023

New evidence of the spillover of the avian flu virus, known as H5N1, to some mammals is again raising alarm bells, though for experts familiar with the virus, “ none of them ever stopped worrying about H5N1.” The recent death of a Cambodian girl from bird flu is a reminder that much is at stake. If H5N1 were to cross over to humans and ignite another pandemic, could the United States do it all over again?

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Vaccines 364

ALiEM - Pharm Pearls

MARCH 29, 2023

Can you trust a febrile infant? “No” has been, and continues to be, the resounding answer over the last 40 years as researchers and clinicians work to determine the optimal evaluation and management of the well-appearing young febrile infant [1]. The goal remains to identify infants with bacterial infections in this at-risk cohort of patients while also considering the balance of cost-effectiveness on a population scale and the potential for iatrogenic harm with evaluation such as unnecessary lu

Hospitals 360

Hospitals Documentation Inpatient Immunity 360

PharmaVoice

MARCH 28, 2023

The Supreme Court will now decide whether Amgen can protect Repatha as a whole class of drugs or whether Sanofi’s rival product Praluent can retain a place in the market.

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BioPharma Dive

MARCH 30, 2023

The veteran pharmaceutical executive was J&J’s head of R&D until his departure last August. He’s agreed to run FogPharma, a richly funded startup, and take over for founder Greg Verdine.

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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.

STAT

MARCH 29, 2023

The Marburg outbreak in Equatorial Guinea continues to grow, the World Health Organization said Wednesday, as the global health agency stated that it knows of confirmed cases that the country has not yet reported. To date Equatorial Guinea has acknowledged nine laboratory-confirmed cases, seven of whom have died. In addition, 20 other people with links to the confirmed cases died without being tested; they are considered probable cases.

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ALiEM - Pharm Pearls

MARCH 31, 2023

You have a pulseless hypothermic patient requiring aggressive internal rewarming. ECMO is not available, and you’ve made the decision to initiate thoracic lavage. After placing your chest tubes, you step back triumphantly, but in short order, the nurse hands you large diameter IV tubing with warmed fluids so that you can connect it to the chest tube.

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BioPharma Dive

MARCH 27, 2023

A closely watched meeting showed the FDA’s own external advisers think that effects on this protein, known as neurofilament, could be enough to warrant conditional approval of certain drugs.

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STAT

MARCH 28, 2023

A panel of experts that advises the World Health Organization on vaccine use suggested Tuesday that countries no longer need to consider offering additional Covid-19 boosters to people at medium or low risk of becoming seriously ill if they contract the SARS-CoV-2 virus. The Strategic Advisory Group of Experts on Immunization — which is known as the SAGE — said some countries may continue to offer boosters to people at medium and low risk, but those decisions should be made ba

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Vaccines Immunity Immunization 326

PhRMA

MARCH 29, 2023

The Patient Experience Survey (PES) series continues to reveal how health insurance is not working as it should for too many Americans — especially vulnerable groups. This series – including surveys of 5,000 Americans conducted with Ipsos, a leading research company in the United States — documents a consistent trend in reports of insurer- and middlemen-imposed practices that can keep patients from the medicines and treatments that they need.

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Documentation 115

PharmaVoice

MARCH 29, 2023

Experts weigh in on how companies can design better trials that merge two phases into one.

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Pharmacy Management

BioPharma Dive

MARCH 27, 2023

The medicine, a personalized stem cell treatment, will be reviewed by an FDA advisory committee sometime in the future, the company said.

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STAT

MARCH 28, 2023

In the doctor’s offices of the future, artificial intelligence will be a fly on the wall, listening in and logging the sensitive conversations that happen every day between patients and their doctors. Gone will be the distracted doctor hunched over a keyboard, tapping, clicking, constantly playing catch-up with hours of extra work. That’s the vision pitched by a spate of new startups and major tech companies like Microsoft, which one year ago spent over $19 billion to acquire Nuanc

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Documentation Hospitals Communication 323

Pharmaceutical Technology

MARCH 31, 2023

The European Medicines Agency (EMA) has recommended HIPRA’s Covid-19 vaccine , Bimervax, as a Covid-19 booster. Available to people ages 16 years and above who have been vaccinated with a Covid-19 mRNA vaccine, EMA’s Human Medicines Committee concluded the vaccine is ready for marketing authorization in the EU, on 30 March. Bimervax is a recombinant protein subunit vaccine, marketed by the Girona, Spain-based Hipra.

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Vaccines Immunity Immunization 110

PharmaVoice

MARCH 30, 2023

Phages, bacteria’s natural predator, could help combat the growing threat of superbugs. But can these therapies rise above antibiotic market woes?

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BioPharma Dive

MARCH 31, 2023

After revising its calculations, CMS removed Gilead’s cancer cell therapies Yescarta and Tecartus, as well as 5 other medicines, from the first set of drugs subject to rebates under a provision of the IRA.

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STAT

MARCH 29, 2023

A growing shortage of monkeys used for early-stage pharmaceutical research is causing concern that many companies will soon face costly delays starting clinical trials — leading to a slowdown in drug development. In recent weeks, the U.S Fish & Wildlife Service began denying company requests to import long-tailed macaques from Cambodia in the wake of a federal investigation into a smuggling ring.

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Drug Development 319

Pharmaceutical Technology

MARCH 28, 2023

Following on from its Covid-19 vaccine programmes, BioNTech has set its sights on a range of infectious diseases for vaccine development. In its FY 2022 report, BioNTech has identified herpes simplex virus (HSV), malaria, and shingles as disease targets. The company saw major successes with its Covid-19 vaccine, developed in collaboration with Pfizer.

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Vaccines 110

PharmaVoice

MARCH 28, 2023

Ahead of turbulent market conditions, EY analyst Arda Ural encourages companies to rethink their sales strategy.

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BioPharma Dive

MARCH 28, 2023

The biotech will work with Sonoma, a well-funded startup run by prominent immunologist Jeffrey Bluestone, to develop cell-based medicines for ulcerative colitis and Crohn’s disease.

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STAT

MARCH 28, 2023

As the U.S. drug crisis has accelerated, the pharmaceutical industry has jumped into action — particularly when it comes to naloxone, the drug used to reverse opioid overdoses. In recent years, companies have introduced a dizzying array of ambitious new naloxone products. They include a mechanized injector that gives robotic voice commands , a prefilled syringe pen, an ultra-high-dose nasal spray, and an autoinjector that the Pentagon has purchased for use in the event of a terrorist atta

Drug Pricing 316

Drug Pricing 316

European Pharmaceutical Review

MARCH 27, 2023

A report has predicted the rapid microbiology testing market size is estimated to grow at a compound annual growth rate (CAGR) of 9.31 percent between 2022 and 2027. According to the data, the market is forecasted to increase by $2,487.91 million. The research includes historic market data from 2017 to 2021, using 2022 as the base year. It covers various testing methods such as growth-based, nucleic-acid-based and viability-based.

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Compounding Vaccines 106

PharmaVoice

MARCH 31, 2023

The major challenges pharma leaders would solve with a quick flick of an imaginary wand.

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BioPharma Dive

MARCH 27, 2023

Analysts had speculated Pfizer might divest its Bavencio interest to help close its Seagen buyout. A Pfizer spokesperson said the move was “conceived independently” of any other deal, however.

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STAT

MARCH 29, 2023

Hidden in this year’s federal spending bill, among major changes to Medicare payments to doctors and post-pandemic Medicaid , lies a little-noticed change with big implications: a mandate to protect medical devices connected to the internet from hacks or ransomware attacks. The law, which goes into effect Wednesday, explicitly states that companies cannot sell their connected medical devices without first showing the Food and Drug Administration a solid cybersecurity plan.

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Pharmaceutical Technology

MARCH 31, 2023

Moderna has finalised an agreement with the government of the Republic of Kenya to establish an mRNA manufacturing facility in the country. The company will construct the new advanced mRNA facility, which is claimed to be Moderna’s first mRNA manufacturing facility in Africa and is expected to have the capacity to produce up to 500 million vaccine doses annually.

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Vaccines 105

The Thyroid Pharmacist

MARCH 31, 2023

Anxiety was one of the most challenging and disempowering symptoms I experienced when I was first diagnosed with Hashimoto’s. It changed my life dramatically and made me feel like a shell of my former self. I had always been an outspoken, level-headed and calm person, but sometime in 2005, something called “new-onset anxiety” rocked my world. I was scared.

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Immunity Immunization Dosage Documentation 105

BioPharma Dive

MARCH 27, 2023

The former venture arm of GSK had several of its portfolio companies get acquired or go public in the past year, overcoming a tough environment for young biotechs.

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STAT

MARCH 31, 2023

Clinicians know the odds tend to be stacked against Black breast cancer patients. They get more dangerous and aggressive subtypes of breast cancer more frequently than white patients. Within breast cancer subtypes, Black patients tend to have worse outcomes compared to white negative patients, too. But what biological factors contribute to these disparities – and how much – is an open question.

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Chemotherapy 273

The Pharmacist

MARCH 31, 2023

Most patients find it easier to seek health advice for common conditions at a pharmacy rather than a GP surgery, according to a recent YouGov poll conducted on behalf of the Pharmaceutical Services Negotiating Committee (PSNC). Of the 1,774 adults in England who were surveyed, 68% said that they would find it easier to ask […] The post Two-thirds of public find it easier to seek help from a pharmacy appeared first on The Pharmacist.

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FDA Law Blog: Biosimilars

MARCH 29, 2023

By Kalie E. Richardson — Early on March 29, 2023, FDA announced the landmark approval of Narcan (naloxone hydrochloride) Nasal Spray for use as a nonprescription opioid overdose reversal agent. I previously blogged on the February 15, 2023 Joint Meeting of the Nonprescription Drugs Advisory Committee (NDAC) and the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) which unanimously agreed that the benefit-risk profile of Narcan Nasal Spray (NNS) is “supportive of its use as a n

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Labelling 105

BioPharma Dive

MARCH 27, 2023

Vertex will license CRISPR technology to develop insulin-producing islet cells that are more resistant to immune rejection, adding to other efforts directed at Type 1 diabetes.

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Diabetes Immunity Immunization 112

STAT

MARCH 31, 2023

As states across the U.S. introduce anti-trans legislation , transgender and nonbinary people face increasing restrictions in their ability to access gender-affirming care. Now experts say the government’s plans to end the Covid public health emergency on May 11 could further jeopardize the health and safety of trans people across the country.

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Pharmaceutical Technology

MARCH 29, 2023

Viking Therapeutics has announced the start of a Phase I clinical study to evaluate its dual glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptor agonist VK2735. The trial, which is investigating healthy adults with a minimum body mass index of 30 kg/m2, will see VK2735 administered as an oral tablet once daily for 28 days.

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Diabetes Dosage Labelling 105

Pharmacy Joe

MARCH 29, 2023

In this episode, I’ll discuss an article about timing of amiodarone for out-of-hospital, shock-refractory cardiac arrest. Episode 804: Faster Amiodarone is Better For Survival in Shock-Refractory Out-of-Hospital Cardiac Arrest Subscribe on iTunes , Android , or Stitcher A group of authors has hypothesized that the lack of clinically significant difference between amioadrone and lidocaine for out-of-hospital shock-refractory cardiac arrest is due to delayed timing of the administration of study m

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Hospitals Inpatient 105

BioPharma Dive

MARCH 27, 2023

The Swiss drugmaker believes the findings could support an approval of Kisqali in adjuvant breast cancer and, potentially, broader use than Lilly’s rival drug Verzenio.

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