Thu.Apr 07, 2022

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Cancer researcher nabbed for falsifying data in PHS-funded grants

Outsourcing Pharma

The US Department of Health and Human Serviceâs Office of Research Integrity has uncovered evidence that Toni Brand committed fraud in a number of reports.

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EU says not enough evidence to warrant fourth COVID jabs

pharmaphorum

It is too early to consider widespread use of a second COVID-19 vaccine booster dose, according to the European Centre for Disease Prevention and Control (ECDC) and EMA’s COVID-19 task force (ETF). The official word from the EU authorities is that for now a fourth dose of Pfizer/BioNTech’s Comirnaty or Moderna’s SpikeVax – the preferred booster vaccines in Europe – should only be used in adults aged 80 years and over and people with compromised immunity.

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Future of clinical development highlighted in online event

Outsourcing Pharma

Experts from the Decentralized Trials and Research Alliance and Rafael Pharmaceuticals discuss progress and possibilities during Clinical Development Advances.

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Tips for Success in Nursing Clinicals 

Board Vitals - Pharmacist

If you’re like most nursing students, your clinical experiences will be either the best or worse (or potentially both) part of nursing school. There are many factors that influence the quality of your clinical experience. Most of which are out of your control, but despite that, you hold the keys to success during your nursing school clinicals. . Be a Learner First.

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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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How to Deal with A Terminal Illness Diagnosis?

Pharma Mirror

Let’s face it, dealing with a terminal illness diagnosis will never be an easy task and there’s not much you can do to mitigate the pain. However, there are a few steps that you can take to make the whole ordeal a bit more manageable for the person diagnosed and those around them. There are a few emotional chapters you’ll need to close as well as some practical matters that you should get out of the way if you are diagnosed with a terminal illness.

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BioXcel gets first approval for agitation drug Igalmi

pharmaphorum

BioXcel Therapeutics has claimed its first product approval, getting a green light from the FDA for Igalmi as a treatment for agitation in people with schizophrenia or bipolar disorder. Igalmi (dexmedetomidine) is the first drug to be approved for this use that is formulated as an tablet that dissolves under the tongue, and the first new treatment for agitation in patients with psychosis in almost a decade.

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Sandoz, Ares extend digital alliance on antimicrobial resistance

pharmaphorum

Novartis’ generics unit Sandoz has moved on to the next stage of a collaboration with Ares Genetics, which is focusing on the use of artificial intelligence to track antimicrobial resistance (AMR), improve diagnoses and guide the most effective use of antibiotics. Sandoz and Ares – a subsidiary of OpGen – started working together in 2018, and with the extension will continue the project until the end of January 2025.

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Kynos Therapeutics targets inflammation-driven illness

Pharma Times

Spin-off company will focus on developing therapies in areas of inflammation and immunometabolism

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NICE reverses stance on Merck’s Bavencio for bladder cancer

pharmaphorum

Last year, NICE said that Merck KGaA/Pfizer’s Bavencio was too expensive for routine in NHS use as a first-line maintenance treatment for bladder cancer, even though the drug is the only cancer immunotherapy approved for this use. Now, the cost-effectiveness agency has relented – with the help of an additional discount from the company – clearing the way for Bavencio (avelumab) to be used in around 800 eligible people with locally advanced or metastatic urothelial carcinoma, the most commo

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Merck turns to cardiovascular pipeline for its post-Keytruda future

pharmaphorum

For some years industry observers have been asking what Merck & Co can do to reduce its reliance on blockbuster cancer immunotherapy Keytruda. Now, it seems a key part of that effort will come from its cardiovascular disease pipeline. During an R&D update yesterday Merck said it is hoping to claim eight new cardiovascular therapy approvals between now and 2030, for diseases like atherosclerosis, heart failure, pulmonary arterial hypertension (PAH) and thrombosis, as it hunts down $10 bil

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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Pfizer bulks up in RSV with $525m takeover of ReViral

pharmaphorum

Pfizer is looking to follow its vaccine/oral antiviral combination that has proved so profitable in COVID-19 with a similar approach in respiratory syncytial virus (RSV). The drugmaker is in the latter stages of development for its RSV vaccine with phase 3 results due shortly, and has just snapped up an oral antiviral for the disease by acquiring its developer ReViral in a $525 million deal.

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What is the solution to America’s deepening access to medicines crisis?

pharmaphorum

Last week, a bill to limit the cost of insulin in the US passed the House of Representatives, taking Democrats one step closer to fulfilling their promise of lowering drug costs. But are price caps the best way to secure access to medicines, or does America have a more systemic problem? Democrat Joe Biden was elected partly on a promise to lower drug costs, in a country with among the highest prescription drug prices in the world.