Sat.May 11, 2024 - Fri.May 17, 2024

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My rendezvous with the raw milk black market: quick, easy, and unchecked by the FDA

STAT

WASHINGTON — It’s Friday May 10, and I’m on my way to what feels like the world’s weirdest drug deal. I received a text the day before from a man named Karl. My order would be arriving from Maryland between 2 and 4 p.m. at the northwest D.C. drop site. It’ll be safely wrapped in ice packs, he assured me.

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PEM POCUS Series: Soft Tissue Ultrasound

ALiEM - Pharm Pearls

Read this tutorial on the use of point of care ultrasonography (POCUS) for pediatric soft tissue ultrasonography. Then test your skills on the ALiEMU course page to receive your PEM POCUS badge worth 2 hours of ALiEMU course credit. Take the ALiEMU PEM POCUS: Soft Tissue Quiz Case Goals List the indications of performing a pediatric soft tissue point-of-care ultrasound (POCUS).

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As Lilly surges, headwinds against its weight loss drugs are growing

PharmaVoice

After missing analysts’ earnings expectations for Mounjaro sales in the first quarter due to overwhelming demand, Lilly is also dealing with a legal loss and incoming pricing questions from lawmakers.

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ICER raps conduct of Lykos’ psychedelic trial for PTSD

pharmaphorum

The Institute for Clinical and Economic Review (ICER) typically focuses on the cost-effectiveness of new therapies, but in an unusual move has sharply criticised the design and conduct of clinical trials of Lykos Therapeutics psychedelic therapy for post-traumatic stress disorder (PTSD).

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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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USDA, FDA turf battles hamper responses to outbreaks like H5N1 bird flu

STAT

WASHINGTON — On a bright June day in 2018, one of the nation’s top regulators waved groceries in the air, quizzing the secretary of agriculture on which agency is charged with monitoring different types of food. Scott Gottlieb, the commissioner of the Food and Drug Administration at the time, grinned widely as he held liquid egg whites and a carton of eggs.

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Ten pharmacies closing every week, NPA analysis suggests

The Pharmacist

The equivalent of 10 local pharmacies are closing their doors each week, according to analysis by the National Pharmacy Association (NPA). And the number of bricks and mortar pharmacies closing between January and April 2024 is nearly 50% higher than in the same period last year, the NPA said. The association’s analysis of NHS Business […] The post Ten pharmacies closing every week, NPA analysis suggests appeared first on The Pharmacist.

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Ajax, aiming for a better JAK drug, raises $95M to begin first tests

BioPharma Dive

Goldman Sachs and Eli Lilly are among those backing the startup, which claims its prospect could be more potent than the myelofibrosis therapies that have come to market in recent years.

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CDC launching wastewater dashboard to track bird flu virus spread

STAT

Reluctance among dairy farmers to report H5N1 bird flu outbreaks within their herds or allow testing of their workers has made it difficult to keep up with the virus’s rapid spread , prompting federal public health officials to look to wastewater to help fill in the gaps. On Monday, the Centers for Disease Control and Prevention is expected to unveil a public dashboard tracking influenza A viruses in sewage that the agency has been collecting from 600 wastewater treatment sites around the

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Bayer cutbacks start to be felt with 1,500 jobs shed in Q1

pharmaphorum

Bayer's first-quarter results update shows its headcount has shrunk by around 1,500 since the start of the year, suggesting promised job cuts are starting to take hold

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BREAKING: Government publishes hub and spoke consultation response

The Pharmacist

Hub and spoke dispensing between pharmacies owned by different legal entities will be allowed from 1 January 2025, subject to parliamentary approval, the government has announced. In its consultation response published today, the government proposed introducing two models of hub and spoke dispensing across legal entities. In one model the hub would directly supply the […] The post BREAKING: Government publishes hub and spoke consultation response appeared first on The Pharmacist.

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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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5 trends impacting drug spend in the U.S.

PharmaVoice

Key factors changing how much Americans spend on prescriptions.

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STAT+: CVS is willing to dump 10% of its Medicare Advantage members next year

STAT

CVS Health is preparing to make significant changes to its 2025 Medicare Advantage plans, which could potentially drive away 10% of its membership, the company’s chief financial officer said at an investment banking conference Tuesday. “The goal for next year is margin over membership,” CVS CFO Tom Cowhey said at the conference, hosted by Bank of America.

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FDA clears Roche self-collection system for HPV screening

pharmaphorum

The FDA has approved Roche's HPV self-sampling solution that the company says can tackle unequal access to screening that can put women at risk of cervical cancer

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When Worlds Collide: The Theory of Real-World Evidence Meets Reality

FDA Law Blog: Biosimilars

By Jeffrey N. Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert — FDA has long touted the use of real-world evidence ( RWE ). Extolling RWE, FDA has said “RWE can be leveraged to bring new products to market, evaluate the safety and effectiveness of existing products for new uses, and assess the continued performance and safety of products once on the market.

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AI in packaging and labelling processes

Express Pharma

Artificial Intelligence (AI) is an emerging digital technology-driven tool to support various processes from design and development to distribution and delivery of goods and services with improved quality, safety, security and punctuality, thereby helping to enhance consumer satisfaction and boost the trust-building process. Since there is no artificial or arbitrary element in it and the level of intelligence is enhanced in this programme, I call it Augmented Intelligence.

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After decades fighting Big Tobacco, Cliff Douglas now leads a foundation funded by his former adversaries

STAT

“Does it trouble you to answer that question?” one of New York’s highest paid attorneys asked Cliff Douglas, then a 36-year-old activist who had found himself at the center of a $10 billion libel lawsuit brought by the cigarette giant Philip Morris. Philip Morris’ lawyer Herbert Wachtell demanded to know: Were cigarette companies intentionally killing people?

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Takeda wagers up to $2.2bn on AC Immune Alzheimer’s shot

pharmaphorum

Takeda has made a strong play for a stake in the Alzheimer’s disease market, paying $100 million upfront for an option on AC Immune’s amyloid-targeting immunotherapy. The option fee could be followed by another up to $2.1 billion in potential milestones if Takeda takes global rights to the programme, currently headed by ACI-24.060 which is in a phase 1b/2 trial with new data due in the next few weeks.

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ARRS funding for DPPs could support community trainees

The Pharmacist

NHS England (NHSE) wants Additional Roles Reimbursement Scheme (ARRS) funding that has recently been unlocked for designated prescribing practitioners (DPPs) ‘to support trainee pharmacists across sectors of practice’, a conference has heard. Last week at the Clinical Pharmacy Congress (CPC) in London, a new opportunity to use ARRS funding for pharmacy training roles was announced. […] The post ARRS funding for DPPs could support community trainees appeared first on The Pharmacist.

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Ajit Singh, Jagjit Singh from ACG receive Lifetime Achievement Award from Hurun India

Express Pharma

Ajit Singh, Chairman, ACG and Jasjit Singh, Vice Chairman, ACG have received Lifetime Achievement Awards from Hurun India. The Singh brothers joined the ranks of previous recipients such as Cyrus and Adar Poonawala of Serum Institute of India, K Dinesh, Co-Founder, Infosys and Jalaj Dani, Co- Promoter, Asian Paints. The Singh brothers acknowledged the support received from the pharma industry, their families, the ACG Global Leadership, ACG team, ACG Cares Foundation, and their customers and supp

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Opinion: Cutting-edge insulin is good. But it’s the ‘trailing edge’ of older versions that can keep it affordable

STAT

Physicians Frederick Banting and John MacLeod declined to be listed on the patent for insulin in 1923; their co-inventors Charles Best and James Collip sold the patent to the University of Toronto for $1. But despite the discoverers’ efforts to make insulin available and cheap for everyone, it has today become the poster child for soaring pharmaceutical prices.

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Home testing devices for sleep apnoea backed for NHS use

pharmaphorum

Five home-testing devices to diagnose sleep apnoea, which can affect the health of around 2.5 million adults in the UK, have been recommended for NHS use by NICE.

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CPE 'already working with DHSC' on implications of hub and spoke changes

The Pharmacist

Community Pharmacy England (CPE) has already begun working with the Department of Health and Social Care (DHSC) on how hub and spoke arrangements will work for NHS services in England, it has told The Pharmacist. This comes as the government plans to allow models of hub and spoke dispensing across different legal entities that could supply […] The post CPE 'already working with DHSC' on implications of hub and spoke changes appeared first on The Pharmacist.

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Sartorius partners with Sanofi to commercialise biomanufacturing (ICB) platform

Express Pharma

Sartorius is collaborating with Sanofi biopharmaceutical to develop an end-to-end platform for integrated and continuous downstream bioprocessing. Selected as a preferred supplier, Sartorius will contribute its engineering and manufacturing expertise to commercialise ICB platforms based on prototypes developed by Sanofi. In return, Sanofi will grant Sartorius exclusive access to its know-how and patents related to the ICB platform.

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What we know about extreme heat’s health impacts after the hottest summer on record

STAT

Last summer’s heat waves demonstrated all the ways that extreme heat takes a toll on the human body. In cities across the U.S. from Phoenix to New York, people suffered from heat exhaustion, heat stroke, heat cramps, and more. In Texas, more than 300 people died from heat last year — the highest number since the state started tracking the deaths in 1989.

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Cytokinetics prepares to take on BMS’ Camzyos in HCM

pharmaphorum

Cytokinetics has revealed the results from a phase 3 trial of its hypertrophic cardiomyopathy (HCM) drug aficamten that it hopes will allow it to compete with Bristol-Myers Squibb’s first-to-market Camzyos.

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Rise of drug-resistant superbugs could make Covid pandemic look ‘minor’, expert warns

The Guardian - Pharmaceutical Industry

Common infections will kill millions if drug resistance through misuse of antibiotics is not curbed, says England’s ex-chief medical officer What is antimicrobial resistance and how big a problem is it? The Covid-19 pandemic will “look minor” compared with what humanity faces from the growing number of superbugs resistant to current drugs, Prof Dame Sally Davies, England’s former chief medical officer, has warned.

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King Charles III announced as new RPS patron

The Pharmacist

His Majesty King Charles III has become the new patron of the Royal Pharmaceutical Society (RPS), it has been announced. The news marks the first anniversary of the Coronation of His Majesty and has been welcomed by the RPS which said it was ‘grateful to the Royal family for their ongoing support’. The late Queen […] The post King Charles III announced as new RPS patron appeared first on The Pharmacist.

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STAT+: Lawmaker accuses Amgen of placing profits above patients with dosing for a cancer drug

STAT

A U.S. lawmaker is accusing Amgen of “putting profits before patients” over its decision to continue marketing a high dose of a pricey cancer treatment instead of a lower dose that is less expensive and not as toxic to patients. At issue is a medication called Lumakras, which is used to treat non-small cell lung cancer and which won conditional regulatory approval three years ago.

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Eisai, Biogen start delayed subcutaneous Leqembi filing

pharmaphorum

Eisai and Biogen have filed a rolling biologics license application in the US for a subcutaneous formulation of Alzheimer’s disease therapy Leqembi that was delayed by the FDA on procedural grounds.

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Biocon signs deal with Medix to market generic Saxenda in Mexico

Express Pharma

Biocon Biopharma announced the signing of a semi-exclusive distribution and supply agreement with Medix, a specialty pharmaceutical company in Mexico, for the commercialisation of its vertically integrated drug product, Liraglutide (gSaxenda), used in the treatment of chronic weight management. Under the terms of this agreement, Biocon will undertake the responsibility of obtaining regulatory approval, manufacturing and supply of the drug product, and Medix will be responsible for its commerci

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FDA clears IND for Verismo Therapeutics’ CAR-T therapy 

Pharmaceutical Technology

Verismo Therapeutics announced FDA clearance for a Phase I trial of its CAR-T therapy to treat non-Hodgkin lymphoma.

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Opinion: Congress: Close Medicare’s dangerous gaps in coverage for addiction treatment

STAT

While many people immediately picture young adults when thinking about the current addiction and overdose epidemic, this crisis is affecting all generations. In fact, more than 7 million older Americans struggle with substance use disorders. Opioid use disorder, in particular, has skyrocketed among Medicare beneficiaries , with opioid overdose death rates rising higher among people 65 and older than in any other age group.

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Wearable device ‘may prevent heart failure hospitalisation’

pharmaphorum

Monitoring of heart failure patients at home using a wearable developed by ADI has shown in a new study that it may be able to reduce costly hospitalisations

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Anticipation builds as Insmed bronchiectasis therapy brensocatib nears Phase III completion: GlobalData

Express Pharma

Insmed is in the spotlight over the past few years for its pipeline agent, brensocatib, which has previously shown promising Phase II results, generating anticipation within the medical community ahead of their Phase III results for the treatment of bronchiectasis. The positive outcomes could pave the way for regulatory approval, potentially transforming the therapeutic landscape for bronchiectasis, a disease that lacks the approval of any therapeutic treatment globally as of now.

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Abzena at BIO 2024: Showcasing innovation in cell line development technology

Outsourcing Pharma

Abzena, an end-to-end CDMO for biologics and bioconjugates, will be presenting its latest AbZelect and AbZelectPRO cell line development (CLD) platforms and more at BIO 2024.

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