Tue.Oct 24, 2023

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CDC recommends rationing of RSV shot due to shortages

STAT

The Centers for Disease Control and Prevention has recommended rationing an important monoclonal antibody product to protect young infants from RSV due to strained supply of the new product, Sanofi’s Beyfortus. In a health alert issued Monday, the CDC said clinicians should prioritize available doses for babies at highest risk from respiratory syncytial virus, reserving 100-milligram doses for infants under the age of 6 months and those with underlying health conditions that put them at h

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Pfizer’s new shot approval adds to a growing vaccine prowess

PharmaVoice

Pfizer brought in a new approval for a five-in-one shot for meningococcal disease, and the company has built a sizable vaccine business over time.

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The official definition of infertility now includes LGBTQ+ and single people

STAT

Infertility has a new definition in the U.S. — one that could make a big difference to would-be parents who are single or LGBTQ+. Last week, the American Society for Reproductive Medicine (ASRM) issued an expanded description of the condition, stating that infertility involves “the need for medical intervention, including, but not limited to, the use of donor gametes or donor embryos in order to achieve a successful pregnancy either as an individual or with a partner.

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Nearly half of Covid vaccinations this year delivered by community pharmacists

The Pharmacist

Community pharmacies have provided more than two million Covid vaccines in England so far in 2023 – representing almost half (46%) of all Covid vaccinations administered this year. The analysis by the Company Chemists’ Association (CCA), also show that to date, community pharmacies have provided almost a quarter (24%) of all Covid vaccinations in England […] The post Nearly half of Covid vaccinations this year delivered by community pharmacists appeared first on The Pharmacist.

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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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STAT+: For Parkinson’s disease, advances spurred by Apple Watch offer a glimmer of hope

STAT

Since the Apple Watch was unveiled in 2014, it has been trumpeted not only as a high tech fashion accessory, but also as a way for people to track their own health and fitness. It has evolved as a popular cardio tool for such uses as heart rate monitoring, recording your ECG, and measuring the oxygen saturation of your blood. But now, after nearly a decade of development, the Apple Watch is being leveraged on an entirely new health frontier: Parkinson’s disease, the degenerative brain dis

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PulmCrit Blogitorial – New IDSA/SCCM guidelines on fever evaluation in ICU

EMCrit Project

More guidelines! Today we'll walk through some interesting bits of the new IDSA/SCCM guideline on evaluation of new fever in the adult ICU patient (available free here). how should temperature be evaluated? This is frankly a mess. Bladder catheter or esophageal probe are best, but usually not used. Rectal temperature is 2nd best, but unwieldy […] EMCrit Project by Josh Farkas.

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Bolus + basal NAPLEX prep: Building a novel NAPLEX review program when time is of the essence

Pulses

By: Amy Dawson, PharmD and Sarah Raake, PharmD, MSEd, BCACP, LDE Bad Timing Sullivan University College of Pharmacy and Health Sciences (SUCOPHS) offers a 3-year accelerated Doctor of Pharmacy degree. The year-round curriculum focuses the first two years on didactic and introductory experiential education and the third year on advanced experiential learning.

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AstraZeneca, maker of FluMist, seeks to allow at-home administration of vaccine

STAT

People eligible to use the only needle-free flu vaccine available in the United States may be able, next year, to give it to themselves or to eligible children at home. AstraZeneca, which makes the vaccine FluMist, announced Tuesday it has submitted to the Food and Drug Administration a supplemental biologics license application that would allow for self-administration of the vaccine by people ages 18 through 49, and would allow people 18 and older to give the vaccine to eligible children.

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Almost half of ARRS funding spent on pharmacists

The Pharmacist

Nearly half (46%) of Additional Roles Reimbursement Scheme (ARRS) funding between 2019 and 2022 was spent on the recruitment of clinical pharmacists, health minister Neil O’Brien has revealed. In total, £839m was spent on ARRS roles between 2019 and 2022 – £387m of which was spent on clinical pharmacists. The news comes within a written […] The post Almost half of ARRS funding spent on pharmacists appeared first on The Pharmacist.

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STAT+: With an old approach but new energy, ADCs take center stage as promising cancer treatments

STAT

MADRID — If you had to pinpoint one subject that stood out at this year’s European Society for Medical Oncology meeting , a massive conference with thousands of people from 140-some countries and 2,500 studies presented, it would be a burgeoning type of cancer treatment called antibody-drug conjugates. The conference opened to the news that Merck had signed one of the biggest licensing deals in industry history — worth up to $22 billion — to partner on three of the co

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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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OrbiMed raises $4.3B in new funds for startup investing

BioPharma Dive

The money will be spread across three investment funds and comes at a time when investment into biotech remains shakier than in years past.

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STAT+: ‘Missed opportunities’: Why a U.K. government plan to disclose financial ties between pharma and docs may fall short

STAT

Earlier this month, the U.K. government issued a proposal to gather information and opinions about payments that drug and device makers give to the medical community. The move came amid ongoing concern over financial ties between companies and health care professionals, an issue that has largely been left to trade groups to police. In an effort to take greater control, the government plans to create what resembles the OpenPayments database in the U.S., which emerged from scandals and probes into

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NIHR awards £1.5m to fund 13 work and health research projects

Pharma Times

The funding will allow several projects to support the health of working people - News - PharmaTimes

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Opinion: Insulin is increasingly affordable in the U.S. What about the rest of the world?

STAT

In March, Eli Lilly, Novo Nordisk, and Sanofi — the world’s three largest insulin manufacturers — committed to reducing the U.S. list price of insulin, a drug that millions of people require to live. Following two decades of sharp increases for consumers, the companies vowed to cut insulin prices for some insulins by at least 70%, meaning many people could see their insulin costs capped at $35 a month in the near future.

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ADDF announces speech database to identify biomarkers for Alzheimer’s

Pharmaceutical Technology

SpeechDx will contain recorded voice samples and other data, which will be used to develop algorithms for creating new speech biomarkers.

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STAT+: A controversial new study examines traditional Chinese medicine’s potential cardiac benefits

STAT

A traditional Chinese medicine compound used for cardiac benefits might help reduce the incidence of major adverse cardiac and cerebrovascular events and even cardiac death rates, according to a new study published Tuesday in the Journal of the American Medical Association. However, some outside experts expressed skepticism about the result. Tongxinluo — which means “to open (tong) the network (luo) of the heart (xin)” in Mandarin —  is a traditional Chinese medi

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Europe’s pharmaceutical packaging market to value over $35bn by 2028

European Pharmaceutical Review

Europe’s pharmaceutical packaging and labelling market is projected to reach $35.78 billion in 2028, according to a report by Arizton. Having been valued at $27.04 billion in 2022, the pharmaceutical packaging and labelling market in Europe is expected to expand at a compound annual growth rate (CAGR) of 4.78 percent up to 2028. Europe’s position in the global pharmaceutical packaging and labelling market The authors highlighted that Europe led the worldwide market at 27 percent in 2022.

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STAT+: Startup launches with $245 million for twice yearly asthma treatment

STAT

A new biotech has raised $245 million to test a new asthma medication that could compete with one sold by Amgen and AstraZeneca. The startup, Aiolos Therapeutics, was founded by former Genentech colleagues Khurem Farooq and Tony Adamis after they stumbled upon a drug being developed by Chinese pharma company Jiangsu Hengrui Pharmaceuticals Co., Ltd.

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Aiolos Bio raises $245M on prospect of better asthma drug

BioPharma Dive

The startup is taking aim at an inflammation-linked protein known as TSLP, which is the target of an approved asthma medicine.

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Why AstraZeneca’s CEO is accusing British tabloids of ‘fake news’

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Good morning, everyone. Damian here with news of a 2021-sized biotech round that has echoes of 2011, plus an ESMO recap and a curious stock move.

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Johns Hopkins study shows potential for chemical vaccine against malaria

Pharma Times

Malaria was responsible for over 600,000 worldwide deaths in 2021 - News - PharmaTimes

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STAT+: Pharmalittle: Pharma moves closer to a pricing deal with U.K.; FDA to review AstraZeneca request for self-administered flu vax

STAT

Rise and shine, everyone, another busy day is on the way. We can tell because the official mascots are racing madly about the Pharmalot grounds and the parade of vehicles is picking up nearby. As for us, we are dutifully firing up the coffee kettle to brew another cup of needed stimulation. Our choice today is the oh-so tasty maple bourbon. Please feel free to join us.

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An Orbimed-backed biotech launches with $85M and plans for a new kind of DNA medicine

BioPharma Dive

Rampart Biosciences closed a Series A round that will fund its goal to develop more potent DNA-based medicines that avoid immune responses.

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STAT+: Massachusetts biotechs seek to piggyback on weight loss drug boom

STAT

The state’s celebrated cluster of biotechs has hatched breakthrough medicines for everything from COVID and cystic fibrosis to multiple rare diseases. It has pioneered cutting-edge research in exotic fields like messenger RNA, gene editing, and gene therapies. But when it comes to what is arguably the hottest space in drug development today — controlling weight and diabetes for millions of people worldwide — the brainy innovators from Kendall Square have missed out on t

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siRNA drug delivery across the blood-brain barrier in Alzheimer’s

European Pharmaceutical Review

Alzheimer’s disease (AD) is a very common neurodegenerative disease in older people, which mainly affects the patient’s cognition, memory and independence. However, it also leads to a decline in the quality of life and the condition can be fatal. According to a report by Alzheimer’s Disease International, the number of dementia patients worldwide is expected to reach 152 million in 2050, of which about 60-70 percent will be AD patients. 1 Drugs that have been approved for marketing regarding AD

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Zydus begins Phase II trial of ZYIL1, NLRP3 inhibitor in patients with ALS

Express Pharma

Zydus Life Sciences has received permission from CDSCO, India, to initiate the Phase II clinical study of NLRP3 inhibitor ‘ZYIL1’ in patients with amyotrophic lateral sclerosis (ALS). ALS patients experience neuroinflammation and rapid neurodegeneration leading to steady loss of the ability to move, speak, eat and eventually breathe. ALS results in loss of motor neurons in the brain and spinal cord which controls voluntary muscle movement.

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FDA cracks down on off-label drug use messaging

Pharmaceutical Technology

The FDA released a draft guidance giving firms recommendations on provider-directed communication for off-label drug use.

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CQC: PCN and community pharmacists ‘improve’ continuity of care in virtual wards

The Pharmacist

Involving community pharmacists and pharmacists working in primary care networks (PCNs) in virtual wards has improved the quality of care for patients, a recent report by the Care Quality Commission (CQC) has found. And it suggested that local late-night community pharmacies could fulfil prescription needs where possible. The CQC also highlighted concerns about staffing and […] The post CQC: PCN and community pharmacists ‘improve’ continuity of care in virtual wards appeared first on The P

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Certa wins FDA orphan drug designation for scleroderma therapy

Pharmaceutical Technology

The candidate recently went through a Phase II trial, with results to be presented in mid-November.

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Creating behavioural change through incremental, small steps

pharmaphorum

Creating behavioural change through incremental, small steps Mike.

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Pear Therapeutics: a lesson for future DTx developers

Pharmaceutical Technology

Pear Therapeutics was a pioneer in developing DTx for neurological conditions traditionally treated by evidence-based behavioural or psychological management strategies.

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Researchers identify 'switch' to activate cancer cell death

World Pharma News

A research team from the UC Davis Comprehensive Cancer Center has identified a crucial epitope (a protein section that can activate the larger protein) on the CD95 receptor that can cause cells to die. This new ability to trigger programmed cell death could open the door for improved cancer treatments. The findings were published Oct. 14 in the Nature journal Cell Death & Differentiation.

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Mitigating Cancer Drug Shortages: USP-American Cancer Society Summit Issues Call to Action

Quality Matters

Mitigating Cancer Drug Shortages: USP-American Cancer Society Summit Issues Call to Action Patient access to cancer drugs can mean the difference between life and death. Persistent shortages threaten patients’ access to the lifesaving and life-sustaining therapies they need. To share insights and advance potential solutions to mitigate such shortages, a virtual summit titled “Mitigating Cancer Drug Shortages” was convened Sept. 26 by the U.S.

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From GRP to SIUU – the Evolution of FDA Guidance on Off-Label Dissemination of Scientific Information

FDA Law Blog: Biosimilars

By Dara Katcher Levy — Yesterday, FDA published a new Draft Guidance, “ Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers ” (SIUU Guidance or Draft Guidance). Previous iterations of this guidance from 2009 and 2014 (blogged on here and here ) were known as Good Reprint Practices (GRP).

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Changing the Paradigm in AI Implementation

PharmExec

How pharma companies can reduce the risk of failure with AI-based innovations.

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