Wed.Sep 06, 2023

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How a conservative, gun-toting doctor defended abortion access in Appalachia

STAT

BRISTOL, Va. — When Wes Adams’ youngest son was little, he’d sometimes toddle over to the TV, pop in a cassette, and watch himself being born. It was a home video, filmed by his older brother. There was his mother, her belly anesthetized but her head very much awake, asking the doctors to keep the incision small, please. There was his dad’s medical partner, making the cut for the C-section.

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Why this scientist left Janssen to help ‘revolutionize’ small molecule drug discovery

PharmaVoice

Murray McKinnon, CSO of Empress Therapeutics, believes its drug discovery platform holds the key to treating and detecting many diseases.

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Opinion: I cured my ARFID with psilocybin. I shouldn’t have needed to self-treat it

STAT

For 27 years, I tried to make myself eat vegetables. Last fall, I ate my first salad. Since I was 2 years old, I had an eating disorder known as ARFID — avoidant/restrictive food intake disorder. After an infant ear surgery, I mysteriously could only tolerate bread and cheese. Every other food made me gag. A ripe orange, for example, smelled like rotting flesh.

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ASBM Experts Discuss Interchangeable Biosimilars on AI Arthritis Podcast

Safe Biologics

On September 6th, AI Arthritis released Episode 88 of its AI Arthritis 360 Talk Show , in which ASBM representatives discuss potential policy changes regarding interchangeable biosimilars and how they may undermine the patient protections currently in place. Joining AI Arthritis Executive Director and host Tiffany Westrich-Robertson were ASBM Executive Director Michael Reilly, ASBM Chairman Ralph McKibbin MD FACP FACG AGAF, and ASBM Steering Committee Member Andrew Spiegel, Executive Director of

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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+: Covid hospitalizations on the rise, Humana says

STAT

More older adults have been hospitalized for Covid-19 over the past several weeks, according to internal data reviewed by health insurance giant Humana. Humana, which mostly provides health insurance to those 65 and older and who are therefore more vulnerable to the worst effects of Covid, expected more Covid cases and hospitalizations this year. But it didn’t expect the uptick to come during the waning summer months.

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Biogen, continuing executive revamp, finds a new research head

BioPharma Dive

Jane Grogan, an industry veteran who worked at Genentech for over 15 years, will take over the role starting Oct. 2. She’ll fill a seat that's lacked a permanent replacement since the departure of Al Sandrock.

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More Trending

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Bristol Myers Squibb’s Camzyos gets NICE recommendation

Pharma Times

Therapy is used among adult patients with symptomatic obstructive hypertrophic cardiomyopathy - News - PharmaTimes

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With affirmative action off the table, medical schools plan new diversity tactics

STAT

“Lots of scrambling on the ground.” That’s how Consuelo Wilkins, the senior associate dean for health equity and inclusive excellence at Vanderbilt University Medical Center, describes medical schools’ current efforts to maintain diversity in the wake of the U.S. Supreme Court’s decision to strike down affirmative action based on race.

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Vitestro begins blood-drawing device study

Pharma Times

Technology combines AI-based, ultrasound-guided 3D reconstruction with robotic needle insertion - News - PharmaTimes

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STAT+: Cancer care appears brighter as off-the-shelf CAR-T advances

STAT

If you ask biopharma leaders what’s ahead for CAR-T cancer therapy, they say the future is bright. And that future will also look markedly different than it does today, three of them said at the STAT 2023 Future Summit on Wednesday. Now in its second decade, the cell therapy — which attacks cancer by extracting white blood cells from a patient, genetically modifying them, and then re-infusing them to fight the cancer — has made remarkable strides.

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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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HRT guidance updated amid shortages and recall

The Pharmacist

The government has clarified its guidance relating to the Hormone Replacement Therapy (HRT) pre-payment certificate (PPC), while supply of HRT products continue to be affected by shortages and a product recall this week. The updated guidance advises prescribers to make their patients aware that they can get a PPC for any listed HRT product, regardless […] The post HRT guidance updated amid shortages and recall appeared first on The Pharmacist.

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Robert Winn: Without ‘high-touch’ strategies, cancer’s breakthroughs will increase disparities

STAT

Looking at the dizzying progress in cancer medicine over the last couple of decades, it’s easy to imagine that advances in synthetic biology or immunology will soon help cure or prevent more cancers. But without a strategy to connect “these miracles” to all communities, only some will benefit and others will be left behind, said Robert Winn, the director of the Massey Cancer Center at Virginia Commonwealth University.

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IndiaRF to acquire API and CRAMS business of Ind-Swift for Rs 1,650 cr

Express Pharma

India Resurgence Fund ( IndiaRF), an investment platform promoted by Piramal Enterprises and Bain Capital will acquire the active pharma ingredients (API) and contract research and manufacturing services (CRAMS) business of Ind-Swift Laboratories for a consideration of Rs 1,650 crores. The Board of Directors of Ind-Swift Laboratories on September 6 , 2023 approved a business transfer of its API and CRAMS business to Synthimed Labs, a portfolio company of IndiaRF.

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Opinion: What does ‘bona fide competition’ actually mean in the biologics market?

STAT

On Aug. 29, Medicare released its highly anticipated list of 10 therapies for which it plans to establish a price by 2026. The Inflation Reduction Act (IRA), passed in August 2022, gives Medicare pricing power over therapies that both cost Medicare lots of money and have by 2026 enjoyed market exclusivity for a certain number of years — nine for small-molecule drugs and 13 for biologics.

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My Top 5 Ciprofloxacin Clinical Pearls

Med Ed 101

Ciprofloxacin (Cipro) has historically been used on a regular basis for urinary tract infections. That frequency of use changed a few years back when the boxed warnings for serious adverse effects came out. I wanted to provide my top ciprofloxacin clinical pearls that you may see in practice as well as on your board exams! […] The post My Top 5 Ciprofloxacin Clinical Pearls appeared first on Med Ed 101.

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STAT+: Pharmalittle: Novartis is losing its chief commercial officer; vaccine experts urge more inclusivity in clinical trials

STAT

Top of the morning to you. And a steamy one, it is. In fact, there is more steam rising from the grounds of the Pharmalot campus than from our ritual cup of stimulation (which happens to be coconut rum today). But this is to be expected at this time of year, yes? In any event, there is work to be done, so as always, we have assembled a few items of interest for you.

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Strategies for Success in an Evolving Commercialization Landscape

PharmExec

A phased launch approach may ultimately be more sustainable and enable maximum market penetration and commercial success with less upfront investment than traditional “go-for-broke” strategies.

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STAT+: Nimbus Therapeutics raises $210 million in one of the larger fundraising rounds this year

STAT

Seven months after  Nimbus Therapeutics sold an experimental autoimmune disease medicine to Takeda Pharmaceuticals  for up to $6 billion, the Boston biotech said Wednesday it has raised $210 million in venture capital to advance its pipeline of drugs to combat other disorders, including cancer. The private financing round, which was led by new investor GV (Google Ventures) and existing investors SR One and Atlas Venture, is among the bigger ones in biopharma worldwide this year.

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MHRA approves Pfizer/BioNTech’s adapted COVID-19 vaccine for Omicron XBB.1.5

Express Pharma

UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved an adapted Pfizer/BioNTech COVID-19 vaccine that targets the Omicron XBB 1.5 subvariant, after it was found to meet the UK regulator’s standards of safety, quality and effectiveness. The vaccine has been approved for use in individuals from six months of age. The adapted vaccine works in the same way as the original vaccine by causing the immune system (the body’s natural defences) to produce antibodies and blood

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J&J sends blood pressure drug back to Idorsia

BioPharma Dive

The decision is the latest in a series of setbacks for the Actelion spinout and ends a lucrative partnership that began in 2017.

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Roche's Alecensa delivers unprecedented Phase III results for people with ALK-positive early-stage lung cancer

World Pharma News

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the Phase III ALINA study evaluating Alecensa® (alectinib), compared with platinum-based chemotherapy, met its primary endpoint of disease-free survival (DFS) at a prespecified interim analysis. Alecensa demonstrated a statistically significant and clinically meaningful improvement in DFS as adjuvant therapy in people with completely resected stage IB (tumour ≥4cm) to IIIA (UICC/AJCC 7th edition) anaplastic lymphoma kinase (ALK)-positive non-smal

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MHRA grants approval for Pfizer-BioNTech’s adapted vaccine for Covid-19

Pharmaceutical Technology

The UK MHRA has granted approval for Pfizer and BioNTech’s adapted Covid-19 vaccine (Comirnaty) targeting the Omicron XBB 1.5 subvariant.

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Raman spectroscopy market expected to value $875m by 2028

European Pharmaceutical Review

A report published by Lucintel predicts that the global Raman spectroscopy market will value $875.2 million by 2028, with a CAGR of 7.3 percent from 2023 to 2028. Between 2023 to 2028, the research suggested that a greater focus on drug development, growing requirement for spectroscopy via cloud-based platforms, alongside the industry’s need for precise and effective analytical methods, will drive the market.

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AstraZeneca mulls risk strategy for Ultomiris following FDA response letter

Pharmaceutical Technology

The US FDA has requested that AstraZeneca make modifications to the Ultomiris REMS programme to approve a label expansion.

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Guidance recommending BMS cardiac myosin inhibitor published

European Pharmaceutical Review

The recommendation of Camzyos ® ▼(mavacamten) as an add-on treatment option for symptomatic obstructive hypertrophic cardiomyopathy (oHCM) in adults has been published in the National Institute for Health and Care Excellence (NICE)’s final guidance. Bristol Myers Squibb’s first-in-class treatment option is recommended for eligible oHCM patients on the NHS.

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Latest NHS community pharmacist figures ‘may be overestimated’

The Pharmacist

Latest community pharmacy workforce statistics reported by NHS England (NHSE) may have been overestimated due to a double-counting of locum pharmacists, a cross-sector group has suggested. The Community Pharmacy Workforce Development Group (CPWDG), comprised of several pharmacy bodies, has called into question NHSE’s community pharmacy workforce survey for 2022.

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HDA 2023 Traceability Seminar: A Status Update

Pharmaceutical Commerce

Stakeholders uncover the obstacles surrounding the industry onboarding process.

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Fresh off $4B deal, Nimbus gears up for ‘third chapter’ with new fundraise

BioPharma Dive

The Boston biotech has sold two experimental drugs — a liver disease medicine and a TYK2 inhibitor — to Gilead and Takeda respectively.

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New RPS policy lead to help ‘promote’ pharmacy across Scotland

The Pharmacist

The incoming policy and practice lead at the Royal Pharmaceutical Society (RPS) in Scotland has vowed to help the profession ‘reach its full potential’ and ensure pharmacy is promoted across the country. This week RPS Scotland announced that Fiona McIntyre, a hospital pharmacist by background, will be taking on the role in early October. Ms […] The post New RPS policy lead to help ‘promote’ pharmacy across Scotland appeared first on The Pharmacist.

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New Research Reveals Perceptions of the Role of AI Among Healthcare Stakeholders

Pharma Marketing Network

“Artificial Intelligence” (AI) is certainly experiencing the shiny object spotlight in 2023. In all industries, the “what if’s” around the use of AI range from massive upsides in efficiency to looming downsides of impending elimination of entire teams. At the DHC Group, our goal to help shape the future of digital health means we focus on upcoming challenges and industry advancements, and provide insights to help prepare decision makers for the evolving digital health landscape.

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FDA starts review of Roche's PNH drug crovalimab

pharmaphorum

FDA starts review of Roche's PNH drug crovalimab Phil.

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Abbott to acquire Bigfoot Biomedical

Pharmafile

Abbott and Bigfoot Biomedical have announced a definitive agreement for Abbott to acquire Bigfoot, however this transaction is still subject to customary closing conditions and is not expected to close until the third quarter of 2023. Financial details of the agreement are yet to be announced. The deal is intended to further the companies’ goals […] The post Abbott to acquire Bigfoot Biomedical appeared first on Pharmafile.

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Moderna says updated COVID shot likely to protect against worrisome variant

BioPharma Dive

The findings add to early evidence showing a heavily mutated variant called BA.2.86, which is growing in prevalence, may not be as evasive as scientists once feared.

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10 Things To Do To Lower Your Toxic Burden

The Thyroid Pharmacist

I don’t know about you, but I love the fall season… the excitement of back-to-school, the crisp change to the weather, the beautiful array of colors as leaves change, and the promise of new beginnings. There’s an inspirational energy this time of year, and I like to use it to tackle areas of my life that I want to change or address. This season, I want to bring some attention to the environments we live in, and how to make low tox living a bit more approachable.

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Why pharmacies are turning to route optimisation

pharmaphorum

Why pharmacies are turning to route optimisation Mike.

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