Sat.Feb 03, 2024 - Fri.Feb 09, 2024

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STAT+: Government warns Medicare Advantage insurers not to deny care based on AI

STAT

In recent months, the federal government has repeatedly told Medicare Advantage insurers that they cannot use artificial intelligence or algorithms to deny medical services the government routinely covers. But in finalizing a rule to that effect, it also stepped into a thicket of questions from insurers about a technology that is especially difficult to pin down: What is AI?

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Astellas’ science chief on the leap into new technologies

PharmaVoice

After a big 2023, Yoshi Shitaka said the company is banking on gene therapies, KRAS degraders and more to keep the momentum.

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ALiEM AIR Series | Toxicology Module

ALiEM - Pharm Pearls

Welcome to the AIR Toxicology Module! After carefully reviewing all relevant posts in the past 12 months from the top 50 sites of the Digital Impact Factor [1], the ALiEM AIR Team is proud to present the highest quality online content related to related to toxicology in the Emergency Department. 8 blog posts met our standard of online excellence and were approved for residency training by the AIR Series Board.

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Adding GPs to ARRS not the way forward, says pharmacist partner

The Pharmacist

Using Additional Roles Reimbursement Scheme (ARRS) funding for GPs would be ‘ridiculous’ given the difficulty of recruiting doctors and the efficiency of utilising other roles within the surgery, a pharmacist partner in a south coast general practice has said. Shilpa Patel, lead prescribing pharmacist and partner at WellBN health centre in Brighton and Hove, spoke […] The post Adding GPs to ARRS not the way forward, says pharmacist partner 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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‘Where you live shouldn’t determine how you get cancer’: An oncologist on global disparities

STAT

The prediction is dire: Cancer cases around the world are expected to surge 77% by 2050, a new report from the World Health Organization estimates. That attention-grabbing statistic, based on an analysis of 185 countries, cites a growing, aging population and factors including tobacco, alcohol, obesity, and pollution. Perhaps the most damning part of the report reveals the disparities determined by income.

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Why a former BMS exec calls her new CEO role ‘unfinished business’ in cancer care

PharmaVoice

With a focus on her “three pillars” of being a CEO, Caroline Loew explains how she’s building a new company culture at an Alkermes spinoff — and a pipeline that offers a next-gen approach to oncology.

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Seven in 10 back data sharing between clinicians

The Pharmacist

Nearly 70% of the public would be happy for their medical records to be shared between clinicians, a YouGov poll for The Times Health Commission has found. Its report, published this week, proposed patient record sharing through digital ‘patient passports’ and incentivising pharmacists ‘to do more prescribing, consultations and community care’ to relieve pressure on […] The post Seven in 10 back data sharing between clinicians appeared first on The Pharmacist.

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STAT+: Juul spent big to court Black leaders to promote its e-cigarettes, new documents show

STAT

Documents released this week shed new light on an aggressive strategy from vape maker Juul to court Black leaders, including the Rev. Al Sharpton, to publicly support its e-cigarettes. Beginning in 2018, Juul executives, including the company’s CEO, discussed six- and seven-figure partnerships with civil rights organizations, one of which would have seen it send as much as $7 million to Sharpton’s group, according to internal emails and documents that were released this week as par

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‘Beginning of the end’ for small molecules? VCs brace for Medicare investment gap

PharmaVoice

The "small molecule penalty" becomes even riskier for investors as the IRA negotiates prices, and VCs and lawmakers are looking to get a jump on those headwinds.

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Alternative therapies are needed to combat the impending threat of AMR

Pharmaceutical Technology

The potentially disastrous consequences of antimicrobial resistance (AMR) were highlighted at the recent World Economic Forum Meeting 2024.

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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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Call for patient records access as new Scottish ministers appointed

The Pharmacist

Pharmacist access to patient records is ‘more urgent than ever’, Royal Pharmaceutical Society (RPS) director for Scotland Laura Wilson will tell new health secretary Neil Gray. This comes as Mr Gray replaces former cabinet secretary for NHS recovery, health and social care Michael Matheson, who resigned yesterday following an investigation into data roaming charges he […] The post Call for patient records access as new Scottish ministers appointed appeared first on The Pharmacist.

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Medical devices with screens aren’t accessible to the blind. Congress has chance to change that

STAT

Katie Keim was diagnosed with type 1 diabetes in 1967 when she was eight, well before the era of insulin pumps or even reliable home testing. The condition started eating away at her vision 20 years later. By the time she was 36, her sight was completely gone.  Keim had lived an independent life as a child despite her illness. Her summers were spent exploring oceans with her family, not at diabetic summer camps.

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RxP expands life sciences real estate portfolio in Mumbai with $150+mn investment

Express Pharma

Rx Propellant (RxP), a platform focused on providing real estate solutions, including research and development (R&D) laboratories and associated facilities for the life sciences and associated sectors in India, has announced an initial investment of $75 million in phase 1 of the Navi Mumbai Research (NMR) District, as part of its continued regional expansion strategy across India.

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Stop the Presses! DEA and DOJ Fine eBay for not Reporting Sales of Tableting and Pill Press Machines

FDA Law Blog: Biosimilars

By John A. Gilbert — Last week, DEA and DOJ announced a $59 million civil penalty settlement with eBay related to the failure to comply with Controlled Substances Act (CSA) requirements for identifying purchasers, maintaining records, and filing reports of individuals selling/purchasing pill presses and encapsulating machines. As stated in the press release , this was the fourth largest civil penalty settlement under the CSA and, ironically, did not involve the sale or distribution of any contr

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Pharmacists report rise in patients unable to collect prescriptions due to cost

The Pharmacist

The last 12 months have seen a marked increase in patients declining prescription medication because of cost, according to new research. The findings have subsequently sparked fresh calls for prescription charges to be reviewed or abolished. A survey of 1,357 pharmacists in England found that 97% had encountered patients foregoing some of the medicines on […] The post Pharmacists report rise in patients unable to collect prescriptions due to cost appeared first on The Pharmacist.

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Higher naloxone doses have no impact on overdose survival, study shows

STAT

People receiving a double dose of naloxone are no more likely to survive an opioid overdose than people receiving a standard, 4-milligram nasal spray, according to a new study. The new paper , published Thursday in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report, showed no significant difference in survival rates between people who were revived using 4- and 8-milligram sprays of naloxone, commonly known by the brand name Narcan.

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Inside the NCVR evolution in the UK

pharmaphorum

Explore the commercial research landscape in the UK and the evolution of the National Institute for Health Research (NIHR) through an informative webinar.

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J&J says top drug prospect works across autoimmune disorders

BioPharma Dive

The pharma disclosed positive results from two studies testing its antibody drug nipocalimab in generalized myasthenia gravis or Sjögren's disease.

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Covid-19 vaccine contract extensions to carry added spring payment

The Pharmacist

Pharmacies currently providing the Covid-19 vaccine are being asked by NHS England (NHSE) to extend their service provision contracts until 31 August 2024. The extension covers a potential spring booster programme, with the Joint Committee on Vaccination and Immunisation (JCVI) set to publish their guidance soon. While the fee for the extension period remains at […] The post Covid-19 vaccine contract extensions to carry added spring payment appeared first on The Pharmacist.

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Texas Medicaid agrees to fully cover gene therapy for Afghan refugees’ infant

STAT

After a months-long fight with Texas Medicaid over coverage of a gene therapy, Afghan refugees now have a chance to save their infant son. After initially balking , Texas officials have agreed to pay for the costly treatment, the boy’s family and his doctor told STAT. At the end of last week, N. Pashai’s cell phone rang. It was from a Minnesota area code.

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Data science in healthcare

pharmaphorum

Data science in healthcare is transforming the industry, from drug discovery to patient care. Learn about the role of data, artificial intelligence (AI), and the impact of initiatives like the NHS Datastore in revolutionising healthcare outcomes.

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BioNTech partners with Autolus to boost cell therapy manufacturing

BioPharma Dive

The German biotech will invest $200 million in Autolus — funds that, along with a $50 million fee, will give it licensing opportunities and access to supply infrastructure.

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More than 15.5 million doses of illegal medicines seized in 2023

The Pharmacist

Illegally traded medicines with a street value of more than £30m were seized by the Medicines and Healthcare products Regulatory Agency (MHRA) in 2023. The seizures were made as part of an international initiative called Operation Pangea and accounted for more than 15.5 million doses. Among the illegally traded medicines were prescription-only anti-anxiety medication, opioids […] The post More than 15.5 million doses of illegal medicines seized in 2023 appeared first on The Pharmacist.

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Wegovy is usually taken indefinitely. Amgen wants a version that can be tapered down

STAT

Amgen is trying a unique strategy with its obesity drug candidate: testing whether it can wean patients toward lower or less frequent doses over time. Very early data hints that Amgen’s candidate, called MariTide, may provide longer-lasting weight loss than highly popular obesity drugs on the market like Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound.

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A SMART way to efficiency and cost reduction in stem cell manufacturing

pharmaphorum

Learn how implementing a SMART approach in stem cell manufacturing can lead to improved efficiency and cost reduction for the production of mesenchymal stem cells (MSCs) used in the treatment of osteoarthritic and autoimmune conditions.

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The Correlation Between a New York State Law Repeal and Vaccine Coverage in Schools

Pharmaceutical Commerce

A cohort study investigates the impact of Senate Bill 2994A and answers the question: does the repeal of school-entry nonmedical vaccination exemptions result in a rise in school vaccinations?

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Study reveals AI can predict patients’ survival in glioblastoma

Pharma Times

The aggressive brain cancer is responsible for over 3,000 cases in the UK every year

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Can exercise help treat long Covid? New study finds patients improve with self-paced approach

STAT

Fatigue leads the list of persistent problems experienced by people with long Covid — which is why patients have pushed back against treatment approaches that endorse escalating levels of exercise for a condition that researchers are still trying to understand. They fear post-exertional malaise, the debilitating price to be paid for pushing their bodies too hard.

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Gilead drops CD47 drug magrolimab for blood cancers

pharmaphorum

Gilead Sciences has said it will no longer develop its CD47-targeting antibody magrolimab in blood cancers after data suggested that patients taking the drug in clinical trials were more likely to die than those in control groups.

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Novo Holdings to buy contract drugmaker Catalent for $16.5B

BioPharma Dive

In a related deal, Novo Holdings subsidiary Novo Nordisk will buy three major Catalent factories for $11 billion as it works to keep pace with demand for its obesity and diabetes medicines.

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FDA Releases Final Guidance on Use of Digital Health Technologies for Remote Data Acquisition in Clinical Investigations

FDA Law Blog: Biosimilars

By Adrienne R. Lenz, Principal Medical Device Regulation Expert & Lisa M. Baumhardt, Senior Medical Device Regulation Expert — As an end of the year gift, FDA finalized its guidance document, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations , in late December. We previously blogged on the draft guidance ( here ) and on FDA’s broader framework for Digital Health Technologies (DHT) ( here and here ).

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STAT+: Novo Holdings to purchase drug manufacturer Catalent for $16.5 billion, a deal that could expand Wegovy production

STAT

LONDON — The investment arm of Novo Nordisk’s parent foundation is buying drug manufacturer Catalent in a $16.5 billion deal, an acquisition that will give Novo additional sites as it builds up production of its booming obesity and diabetes drugs.   Under the deal, Novo Holdings is purchasing Catalent, a major contract development and manufacturing company with more than 50 sites globally.

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Drug/software combination improves blood pressure control

pharmaphorum

The combination of drugs for hypertension and software to personalise dosing to an individual patient has been shown to deliver improved blood pressure control and adherence to therapy in a pilot study.

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Study Highlights the Value of Patient Support Programs

Pharmaceutical Commerce

Researchers explore the proportion of approved drugs in the Canadian marketplace that utilize manufacturer-sponsored patient support programs, along with the types of medications that are more likely to do so.

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Biocon Biologics Partners with Sandoz Australia for Trastuzumab and Bevacizumab

Express Pharma

Biocon Biologics announced a five-year partnership with Sandoz AG which provides Sandoz the exclusive rights to promote, sell and distribute biosimilar Trastuzumab (market value of AUD $35 million) and biosimilar Bevacizumab (market value of AUD $45 million) in Australia. Under the agreement, Sandoz will distribute the Biocon Biologics’ brands, OGIVRI (bTrastuzumab) and ABEVMY (bBevacizumab), and facilitate the sustained access of these medications that were previously distributed by another pha