August, 2023

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No longer brushed off: A Minnesota clinic tries to rewrite medicine’s approach to miscarriage

STAT

WOODBURY, Minn. — By the time Taylor Teske came to be sitting on an exam table in an obstetrician’s office in Minnesota, her medical records marked a devastating journey: nine pregnancies, one baby, eight miscarriages. The first miscarriage happened in June 2018, almost as soon as she found out she was pregnant. Teske told her boss at the vascular clinic where she worked that she was pregnant, and he asked if she wanted to sneak a look using the clinic’s ultrasound.

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‘We need to do better:’ A biotech CEO on standing apart from the crowd

PharmaVoice

The CEO of Cullinan Oncology is taking a small biotech to the next step and believes the temporary financial barriers are smaller than scientific progress.

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Antidote dispensing drones get government funding

The Pharmacist

Antidote dispensing drones or artificial intelligence that detects an overdose could be used to prevent drugs deaths, as a result of government funding awarded to 12 technology projects. The projects are the winners of the Reducing Drug Deaths Innovation Challenge, funded by the Office for Life Sciences and support the government’s Addiction Mission.

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Sanofi appoints a venture investor to R&D head as executive team expands

BioPharma Dive

Houman Ashrafian, currently a scientific advisor at SV Health Investors, will fill the role left by John Reed, who oversaw the transformation of research and development during his five years at Sanofi.

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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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BenevolentAI doses participants in BEN-8744 study

Pharma Times

The candidate is a peripherally restricted small-molecule PDE10 inhibitor to treat ulcerative colitis - News - PharmaTimes

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Stem cell therapy delivers potential for sickle cell disease

European Pharmaceutical Review

New research published in the New England Journal of Medicine has indicated that stem cell gene therapy could provide a curative treatment for sickle cell disease (SCD). Based on new data from the Novartis Phase I/II clinical trial , which used the first therapy to target a new genetic area and use cryopreserved stem cells, trial participants reported a decrease in vaso-occlusive events.

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Finding the right flu vaccine is hard. Getting people to take it is harder.

PharmaVoice

Experts have determined the strains of this year’s flu season — now the question is whether people are too fatigued by the pandemic to be immunized.

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CPE slams 'shambolic' vaccination U-turn despite additional funding

The Pharmacist

Community pharmacies will get additional payments to deliver Covid vaccinations in September and October as the government brings forward the autumn programme in light of a new Covid variant. But the sector’s negotiator has criticised the government’s ‘shambolic start’ to the vaccination programme, which it said has a ‘seemingly endlessly changing timetable’ that leaves community […] The post CPE slams 'shambolic' vaccination U-turn despite additional funding appeared first on Th

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Bristol Myers gets key FDA approval for bone marrow disease drug

BioPharma Dive

A broadened clearance for Reblozyl in myelodysplastic syndromes should help Bristol Myers offset the looming loss of revenue from top-selling medicines set to soon lose market exclusivity.

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UCB announces approval of Bimzelx

Pharma Times

The therapy is used to treat patients with psoriatic arthritis and axial spondyloarthritis - News - PharmaTimes

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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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Researchers develop novel chemosensor-based method for rapid detection of bacterial toxin

Express Pharma

A research team from Japan developed an innovative methodology to detect Lipopolysaccharide (LPS). Based on a novel fluorescent chemosensor, the proposed system detects the endotoxin in a matter of minutes, making it suitable for on-site testing in hospitals and pharma manufacturing facilities. LPS, largely known as “endotoxins”, is a molecule which is found in the outer membrane of Gram-negative bacteria, and can be very harmful to humans.

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Opinion: It’s long past time for a more comprehensive Covid treatment approach

STAT

Because Covid cases and hospitalizations are no longer front-page news, many Americans might be surprised to learn that we are in the midst of a mini-surge. The latest data from the Centers for Disease Control and Prevention, from Aug. 12, confirm a 21.6% increase in Covid-19 hospitalizations from the prior week and a 21.4% increase in Covid-related deaths, demonstrating that Covid is not over and that Latinos and Blacks have reason to be concerned.

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How an AstraZeneca exec is leading the charge in the next immuno-oncology era

PharmaVoice

The pharma giant’s head of immuno-oncology is now charging toward the next step in the cancer fight with long-term survival and precision.

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Number of advanced pharmacist roles in general practice doubles in a year

The Pharmacist

The number of advanced pharmacist practitioner roles in general practice in England has nearly doubled in the last year, while the number of pharmacists has remained consistent. The increase in advanced roles has brought the total number of full-time equivalent (FTE) pharmacist roles in general practice to 2,000 as of July 2023, once both roles […] The post Number of advanced pharmacist roles in general practice doubles in a year appeared first on The Pharmacist.

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Sage, reeling from depression drug decision, to lay off 40% of workforce

BioPharma Dive

Two founding executives are leaving Sage alongside a major restructuring announced weeks after the FDA approved the medicine, Zurzuvae, for much narrower use than the company had hoped.

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MTHFR, Hashimoto’s and Nutrients

The Thyroid Pharmacist

You may have heard of the term “MTHFR gene mutation” and may be wondering what it is. First, I’d like to say that I prefer the term “MTHFR gene variation” rather than “mutation.” The word mutation makes it sound like there’s something wrong with the person, while variation is more empowering – and in my opinion, also more accurate. While the word “mutation” implies an occurrence that is rare, unnatural, or flawed, the MTHFR gene variation is common.

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Clinical trials: How AI can help providers stay TMF inspection-ready

Pharmaceutical Technology

The clinical trials industry is facing a number of hurdles, but AI and digitalisation are being heralded as key to overcoming them, particularly when it comes to preparing for inspections and audits

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STAT+: Departing Stanford president retracts two widely cited papers, against lead author’s wishes

STAT

After an expansive investigation found manipulated data and other issues with papers co-authored by Stanford’s now ex-president Marc Tessier-Lavigne , the prominent neuroscientist on Thursday retracted two studies published in the journal Science in 2001 — over the objection of a former postdoctoral researcher who played a leading role in both projects.

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A rare disease research aims to tackle disability discrimination in new lawsuit

PharmaVoice

How a pediatric neurologist is advocating for herself and the disabled community in a legal battle with the Howard Hughes Medical Institute.

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Breaking: Autumn jabs brought forward amid new Covid variant

The Pharmacist

This autumn's Covid vaccination programmes in England are being brought forward to begin on 11 September following the identification of a new Covid variant, the government has announced. Eligible patients are being urged to come forward for their jab as soon as they are invited to do so, with NHS England prioritising those living in […] The post Breaking: Autumn jabs brought forward amid new Covid variant appeared first on The Pharmacist.

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Medicare names first 10 drugs for price negotiations

BioPharma Dive

The list includes the top-selling blood thinners Eliquis and Xarelto, as well as the arthritis drug Enbrel and heart failure medicine Entresto.

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Cybersecurity dominates pharma industry discussions during Q2 2023: GlobalData

Express Pharma

Amid the push for digital transformation, the pharma industry finds itself navigating a critical intersection of concerns—data protection, regulations, and the threat of data breaches. This pivotal juncture has thrust cybersecurity into the spotlight in the discussions of companies during Q2 2023, revealing its paramount significance in safeguarding sensitive information, with regulation mentions getting on par with data protection, reveals the Company Filing Analytics Database of GlobalData.

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Fourteen HP&M Attorneys Recognized by Best Lawyers® in 2024 in America

FDA Law Blog: Biosimilars

Hyman, Phelps & McNamara, P.C. (“HP&M”) is is proud to announce that 14 of the Firm’s attorneys have been selected to the 2024 edition of The Best Lawyers in America®. Newly recognized this year are attorneys Josephine M. Torrente (FDA Law), Michelle L. Butler (FDA Law), Sara W. Koblitz (FDA Law), Allyson B. Mullen (FDA Law), and Anne K. Walsh (FDA Law), as well as McKenzie E.

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STAT+: As pharmaceutical companies bemoan Medicare’s drug negotiations, hospitals and doctors stay mum

STAT

The pharmaceutical industry has been up in arms over Medicare’s first list of 10 prescription drugs that will be subject to negotiations. But other major parts of the health care industry — hospitals, doctors, and other providers — have refrained from either lending support or criticizing the government’s process. The American Hospital Association, the industry’s main lobbying group, told STAT it is “not commenting on this issue right now.

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Are weight loss drugs a win for the global economy?

PharmaVoice

As Novo Nordisk’s drug Wegovy sways Denmark’s economy, we're examining wider implications for the weight loss market.

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Slightly unhealthy middle aged traits linked with earlier heart attacks and strokes

The Pharmacist

Middle-aged people who have three or more ‘unhealthy’ traits have heart attacks and strokes two years sooner, highlighting the importance of screening and early detection, say Swedish researchers. Those classed as having metabolic syndrome – with a slightly high waist circumference, and marginally increased blood pressure, cholesterol and glucose levels – but who otherwise feel […] The post Slightly unhealthy middle aged traits linked with earlier heart attacks and strokes appeared first o

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Apellis finds faulty needles in probe of rare eye drug side effects

BioPharma Dive

The company doesn’t know if the needles have caused retinal vasculitis in some people receiving its geographic atrophy drug Syfovre, but is no longer recommending their use.

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Pfizer’s first-ever bispecific antibody Elrexfio holds promise in multiple myeloma

Pharmaceutical Technology

The US Food and Drug Administration's recent accelerated approval of Pfizer's Elrexfio for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) has made a significant impact in the oncology community.

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The Missing Link to Thyroid Fatigue

The Thyroid Pharmacist

Sometimes we can get stuck on our healing journey. We may be on a seemingly great diet, taking the right supplements, and doing everything in our power to feel better, but still feel like we’re making no progress. But, many times, we’re only one small change away from seeing a huge difference. In my case, I was well on my way to feeling better with Hashimoto’s after changing my diet and incorporating key supplements.

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STAT+: J&J cuts the price of its lifesaving TB pill by more than half for many low- and middle-income countries

STAT

Amid controversy over access to a lifesaving tuberculosis pill, a new contracting effort is expected to lower the price for the medicine by as much as 55% in dozens of low- and middle-income countries, according to a group that administers a global fund for distributing TB drugs. But advocacy groups continue to argue that Johnson & Johnson, which makes the pill, has stymied wider access.

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Brii Biosciences aims to come up big where Sage and Biogen fell short

PharmaVoice

The depression space recently got a stinging FDA rebuke — but Brii thinks it can break through with improved formulations.

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Could cytisine replace varenicline for smoking cessation?

The Pharmacist

With varenicline currently unavailable, is it possible that cytisine might serve as an alternative pharmacotherapy to help patients to stop smoking? Rod Tucker takes a closer look in our Review series. Tobacco smoking is a major cause of premature death and kills more than eight million people each year, including 1.3 million non-smokers, exposed to […] The post Could cytisine replace varenicline for smoking cessation?

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Foundery, a new biotech venture firm, sets out to speed early immune drug research

BioPharma Dive

Billing itself as both a scientific and investment partner, Foundery aims to provide research grants and drug development support to researchers developing new immunotherapies.

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Academic Pharmacy Fellowships: Is it the defined path into Academia?

Pulses

By : Victoria L. Williams, PharmD, BCCCP “Dr. Williams, what do I have to do if I want to pursue a career in academia? ” a curious student asked me after class. As a clinical faculty member with 50% of my appointment dedicated to direct patient care and the other 50% to teaching, research/scholarship, and service, my answer started off strong with tried-and-true advice on pursuing residency training to prepare for the practice component of my role.

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Industry examining FDA guidance on nitrosamines

Quality Matters

Industry examining FDA guidance on nitrosamines Nitrosamine impurities in pharmaceutical products have been making major headlines recently, as this year has marked the fifth anniversary since they were first detected at unacceptable levels in some blood pressure medications and – even more importantly – due to a flurry of new regulatory activity taking place around the globe this summer, including by the U.S.