Mon.Nov 27, 2023

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STAT+: With biotech in a slump, the industry’s job market is upside down

STAT

After earning her doctorate in cell biology at the University of Pennsylvania in June, Sierra Collins did what many freshly minted Ph.D.s. do — she went looking for a job at a biotech company. But what was supposed to be a straightforward search has turned into an odyssey. Collins has applied for more than 53 positions (and counting). Like a good scientist, she’s gathering data along the way and uses a spreadsheet to track each company’s size and therapeutic focus, as well a

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As alcohol-related deaths climb, new drugs could curb the urge to drink

PharmaVoice

A drug developed by Kinnov Therapeutics halved alcohol consumption in heavy drinkers in a mid-stage study

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Opinion: The next Census could undercount the number of disabled Americans by 20 million

STAT

About 20 million disabled people will be erased if the U.S. Census Bureau moves forward with changes to disability data collection methods. That is because many disabled people will no longer be counted as disabled by the new questions the Census is proposing to use starting in 2025 with the annual American Community Survey (ACS). As disabled people, and as scholars who study disability measurement and use disability data for our research, we have grave concerns about this proposed change.

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SAEM Clinical Images Series: Utility of Bedside Ultrasonography

ALiEM - Pharm Pearls

A 24-year-old G1P0010 female with a PMHx of ovarian cyst (unknown laterality) and emergency contraceptive use 3 months prior presented with sudden onset abdominal pain (upper > lower) that awoke her from sleep four hours prior to presentation with associated nausea and mild lower back pain. The pain is 10/10, sharp, stabbing, and diffuse. Additionally, she reported trace white vaginal discharge at baseline.

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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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New research supports potential link between low-level lead exposure and liver injury

STAT

Nearly a decade on, the Flint water crisis still looms large in the minds of environmental toxin researchers. It was — and continues to be — evidence that not all communities in the United States are equally affected by environmental pollutants. “It’s true that they’re sort of ubiquitous, but they aren’t uniformly distributed.

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How EMD Serono plans to hit its lofty goals in R&D

PharmaVoice

One year ago, EMD Serono — Germany-based Merck KGaA’s U.S. healthcare business — set a goal to double R&D productivity in oncology, neurology and immunology, aiming to launch a new product or in a new indication about every one-and-a-half years. Achieving that goal would.

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Studies back role of community pharmacy in solving health challenges

The Pharmacist

The importance of the community pharmacy sector in addressing England’s health service challenges has been underlined by two recently published academic studies. The two peer-reviewed papers – Pharmacy users’ perceptions, awareness and future expectations of community pharmacy in England, and Professional stakeholders’ expectations for the future of community pharmacy practice in England – are based […] The post Studies back role of community pharmacy in solving health challenges appeared

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STAT+: Springworks wins FDA approval for drug to treat desmoid tumors

STAT

The Food and Drug Administration on Monday approved the first treatment for people with desmoid tumors, a localized cancer that invades soft tissue and muscle. The new drug, called Ogsiveo, is made by Springworks Therapeutics. It’s the company’s first approved medicine. Desmoid tumors are fibrous growths that start in connective tissue and are often found in the abdomen, arms, legs, and torso.

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Service spec for Pharmacy First unveiled by NHS England

The Pharmacist

The service specification for the incoming Pharmacy First scheme has been published by NHS England. The service, due to start at the end of January 2024, will cover seven common conditions – earache, impetigo, infected insect bite, shingles, sinusitis, sore throat, and uncomplicated urinary tract infections in women – alongside the current elements of the […] The post Service spec for Pharmacy First unveiled by NHS England appeared first on The Pharmacist.

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A new algorithm unveils CRISPR ‘treasure trove’

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Hello! Hope you had a peaceful holiday. Back to biotech, we discuss the tough job market, delight in some exciting early developments in CAR-T and CRISPR, and see further validation for the blockbuster anti-inflammatory drug Dupixent.

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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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Legalized medical cannabis five years on - Releaf discusses how far the industry hasn't come

Outsourcing Pharma

It is five years this month since a ground-breaking change in UK healthcare history happened â with doctors being able to prescribe cannabis-based medicines for the first time.

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STAT+: Most clinical trials run in Canada failed to take basic steps toward transparency, analysis finds

STAT

Just 3% of more than 3,700 studies run exclusively in Canada over a recent 10-year period were registered prospectively, reported results, and published the findings, underscoring ongoing concerns about clinical trial transparency, according to a new analysis. More specifically, 47% of those trials, or more than 1,770, were registered in advance, while only 12% reported results in a registry, and only 48% published their findings.

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GSK cancer drug Blenrep gets surprise trial win

BioPharma Dive

One year after the U.K. drugmaker withdrew the multiple myeloma drug from the U.S. market because of negative data, new study results might crack open the door to a relaunch.

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STAT+: Pharmalittle: Bioscience job market is upside down; Sanofi and Regeneron’s blockbuster Dupixent may find bigger market

STAT

Good morning, everyone, and nice to see you again after an extended break on this side of the pond. We hope your own respite was relaxing and invigorating, because that oh-so familiar routine of online calls and meetings and deadlines has predictably returned. But you knew this would happen, did you not? So time to fire up the coffee kettle and brew another cup of stimulation.

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EVERSANA brings genAI to medical content approvals

pharmaphorum

EVERSANA’s alliance with Amazon Web Services (AWS) on the application of generative artificial intelligence (genAI) to the pharma sector has borne its first fruit – a new tool to tackle the time-consuming and error-prone task of getting medical and regulatory content approvals.

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Q&A: Building a More Resilient Medicines Supply Chain

Quality Matters

Q&A: Building a More Resilient Medicines Supply Chain In this conversation, US Pharmacopeia (USP) Director of Regulatory and Public Policy Development Amy B. Cadwallader, Ph.D. joins the Duke-Margolis Drug Supply Chain Resilience and Advanced Manufacturing Consortium to discuss the importance of multi-disciplinary, cross-functional coordination to strengthen the medicine supply chain and global public health resilience in the face of ongoing threats, like persistent drug shortages.

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MHRA launches online eligibility checker tool via the IRP

Pharma Times

The IRP will bring life-saving medicines to UK patients from 1 January 2024 - News - PharmaTimes

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Silence Isn’t Golden: Two Executives Convicted in First Criminal Prosecution Under the Consumer Product Safety Act

FDA Law Blog: Biosimilars

By Riëtte van Laack & Anne K. Walsh — Although the Consumer Product Safety Act (CPSA) has been around for over 50 years to “protect the public against unreasonable risks of injury associated with consumer products,” it was not until 2008 that the statute was amended to authorize the Consumer Product Safety Commission (“CPSC”) to impose criminal liability against individual directors, officers, or agents of a corporation for violating the CPSA.

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NHSE could suspend Pharmacy First delivery if AMR concerns emerge

The Pharmacist

Pharmacists could be suspended from delivering a Pharmacy First service if concerns over antimicrobial resistance (AMR) and patient safety emerge, NHS England (NHSE) has said. The service specification for Pharmacy First – which will roll out on 31 January 2024 – has now been published, including details of how NHSE intends to oversee the scheme. […] The post NHSE could suspend Pharmacy First delivery if AMR concerns emerge appeared first on The Pharmacist.

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First treatment recommended for infants with Wolman Disease

European Pharmaceutical Review

The National Institute for Health and Care Excellence (NICE) has recommended enzyme replacement therapy sebelipase alfa (Kanuma ® ▼) in final draft guidance. Alexion’s (AstraZeneca Rare Disease) intravenous treatment is recommended for children who have been diagnosed with Wolman Disease at two years old or younger. This ultra-rare metabolic disease occurs due to lysosomal acid lipase (LAL) enzyme deficiency.

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Steadfast Nutrition launches protein efficiency formula for protein deficiency

Express Pharma

Herbfast is a blend of 23.3 g of whey protein, natural herbs and spices, vitamin B complex, digestive enzymes, green tea extract, L-carnitine, and taurine Steadfast Nutrition has launched a protein supplement HerbFast Protein, calling it ‘India’s Protein Efficiency Formula’. HerbFast Protein is a blend of 23.3 g of whey protein, natural herbs and spices, vitamin B complex, digestive enzymes, green tea extract, L-carnitine, and taurine.

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New NPA chief exec vows to ‘deliver for members’

The Pharmacist

The new chief executive of the National Pharmacy Association (NPA), Paul Rees, has promised to ‘deliver for NPA members, for the sector and for society at large’ after officially taking up the post. Mr Rees, whose appointment was announced in September, has now replaced Mark Lyonette as NPA chief executive, although Mr Lyonette will remain […] The post New NPA chief exec vows to ‘deliver for members’ appeared first on The Pharmacist.

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Cadila Pharma launches API manufacturing plant at Dahej

Express Pharma

Equipped with Distributed Control System (DCS) automation technology, the facility has been set up with an investment of Rs 200 crore Cadila Pharmaceuticals inaugurated its state-of-the-art Active Pharmaceutical Ingredients (API) Plant at Dahej in the Bharuch district. The facility, set up with an investment of Rs 200 crore, is equipped with the latest Distributed Control System (DCS) automation technology.

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New NHS software set to improve care for millions of patients

Pharma Times

Around £330m will be invested in the software over the next seven years - News - PharmaTimes

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Novo Nordisk invests 2.1 billion euros to expand the existing production site in France

Express Pharma

The investment will significantly increase the capacity of the manufacturing site, adding aseptic production and finished production processes and an extension of the current Quality Control Laboratory Novo Nordisk has announced the investment of more than 16 billion Danish kroner (2.1 billion euros) starting in 2023 to expand the existing production site in Chartres, France, for the current and future product portfolio within serious chronic diseases.

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Is GSK’s Blenrep heading for a renaissance?

pharmaphorum

A year after GSK pulled its BCMA-targeting antibody-drug conjugate (ADC) Blenrep from the US market as a later-line therapy for multiple myeloma, there are signs that the drug may still have a role to play earlier on in the treatment pathway.

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FDA fast-tracks Genelux’s oncolytic virus-based ovarian cancer therapy

Pharmaceutical Technology

Olvi-Vec is currently being evaluated in a Phase III trial as a treatment for platinum- resistant/refractory ovarian cancer.

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AI may spare breast cancer patients unnecessary treatments

World Pharma News

A new AI (Artificial Intelligence) tool may make it possible to spare breast cancer patients unnecessary chemotherapy treatments by using a more precise method of predicting their outcomes, reports a new Northwestern Medicine study. AI evaluations of patient tissues were better at predicting the future course of a patient’s disease than evaluations performed by expert pathologists.

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Mylab and Ekincare to promote SII’s influenza nasal vaccine among corporates

Express Pharma

The joint effort between Mylab and Ekincare will enable businesses to incorporate NASOVAC-S4 into their employee wellness programs Mylab has announced a strategic partnership with Ekincare which is a corporate wellness and health benefits platform. This collaboration aims to promote NASOVAC-S4, influenza nasal vaccine developed by the Serum Institute of India (SII), among corporate entities.

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Cultivating quality excellence in the clinical trials landscape

pharmaphorum

Cultivating quality excellence in the clinical trials landscape Mike.

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IIL launches its measles and rubella vaccine

Express Pharma

This live attenuated MR vaccine has been developed by IIL in an exclusive partnership with Polyvac Institute, Vietnam Human Biologicals Institute (HBI), a division of Indian Immunologicals Limited (IIL) celebrates its silver jubilee, 25 years since its establishment in 1998. While celebrating the occasion of 25 th year of HBI with distinguished medical doctors assembled from various parts of the country, IIL launched Mebella (Measles and Rubella) vaccine for children.

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1nhaler raises £2 million to develop single-use sustainable inhaler

Outsourcing Pharma

1nhaler, a Scotland-based drug delivery device developer, has raised Â2 million to develop its single-use dry powder inhaler (DPI).

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Dupixent aces second COPD study, setting up FDA filing

pharmaphorum

Dupixent aces second COPD study, setting up FDA filing Phil.

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First treatment recommended for infants with Wolman Disease

European Pharmaceutical Review

The National Institute for Health and Care Excellence (NICE) has recommended enzyme replacement therapy sebelipase alfa (Kanuma ® ▼) in final draft guidance. Alexion’s (AstraZeneca Rare Disease) intravenous treatment is recommended for children who have been diagnosed with Wolman Disease at two years old or younger. This ultra-rare metabolic disease occurs due to lysosomal acid lipase (LAL) enzyme deficiency.

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Masterclass on Applicable Laws Regarding Promotional Materials In Pharma Marketing

PharmaState Academy

This is "not to be missed" Masterclass for Pharma Marketers, Medical, Legal, Compliance, Sales Teams! ???????????: To be awarded with 3CPhE (Continuing Pharma Education) points. Seats Booked: 25 / Seat Left: 25 Registrations Open Now Interest Form For Next Batch We limit the number of participants in a batch so that high-quality interactive learning can happen.