Tue.Feb 08, 2022

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Novo Nordisk gets NICE okay for obesity drug Wegovy

pharmaphorum

Novo Nordisk’s new obesity therapy Wegovy has been recommended for routine NHS use by UK cost-effectiveness watchdog NICE, but in a narrower group of patients than is covered by its MHRA-approved label. NICE has backed use of the Wegovy (semaglutide) for people with a body mass index (BMI) of 35 kg/m2 or more and at least one weight-related ailment – such as high blood pressure, high cholesterol or diabetes – as part of a weight management programme involving exercise and a reduce-calorie

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Online event to address disparities in cancer research, care

Outsourcing Pharma

The latest in the Diversity in Oncology series, taking place February 9, will discuss ways academia and community collaboration can narrow representation gaps.

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Pfizer’s COVID boom goes on, as it eyes $22bn in Paxlovid sales this year

pharmaphorum

Pfizer reckons it will make a whopping $22 billion in sales of its oral COVID-19 antiviral Paxlovid in 2022, with another $32 billion from its BioNTech-partnered coronavirus vaccine Comirnaty. The massive windfall revenues will drive its sales up towards the $100 billion mark – it’s estimating a range of $98 to $102 billion – up from $81.3 billion in 2021, which was almost twice revenues in the prior year.

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Clinical management platform enables vendor visibility: Strategikon Pharma

Outsourcing Pharma

Vision, part of the companyâs Clinical Maestro platform of software-as-a-solution applications, enables study teams to manage clinical vendor oversight.

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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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Formedix launches Community Forum to support the clinical trial industry

pharmaphorum

Glasgow, UK (24th November, 2021) – Formedix , a leading provider of clinical trial software solutions, announces the launch of the Formedix ryze Community, to provide their customers with a location to collaborate, expand their knowledge and share information. Through a range of tools, the ryze Community will support the pharmaceutical industry to streamline and enhance clinical trial set-up and build.

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New management: Promising drug for people living with obesity

Pharma Times

NICE recommends appetite suppressing drug which can reduce a patient’s by more than 10%

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Need for Speed: Kidney cancer patients waiting three times longer

Pharma Times

Greater urgency for kidney cancer treatments as 40% of UK patients wait 84 days for a diagnosis

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Digital health: making medicine more human

pharmaphorum

Covid-19 has lit a fire under the medical industry, driving them to re-evaluate and incorporate digital engagement models. Now, healthcare companies have a unique opportunity to continue this momentum beyond the pandemic bubble as Healthware Group CEO Roberto Ascione tells Dr Paul Tunnah at the 2021 Frontiers Health conference in Milan. Digital health has undergone a dramatic transformation over the past few years.

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RedHill’s oral drug boosts Veklury efficacy in severe COVID

pharmaphorum

An oral drug developed by RedHill Biopharma has reduced mortality in severe COVID-19 patients when added to therapy with corticosteroids and Gilead Science’s intravenous antiviral Veklury, setting up regulatory filings. The phase 2/3 trial also showed that opaganib – an oral sphingosine kinase-2 (SK2) inhibitor – improved survival by 70% by day 42 compared to placebo when given on top of standard care, and improved the chances of recovery at day 14 by a third, from 27.9% to 37.4%.

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FDA won’t back Lilly’s PD-1 antibody based on Chinese data alone

pharmaphorum

The FDA has dropped a bomb on Eli Lilly’s marketing application for cancer immunotherapy sintilimab ahead of an advisory committee meeting due to take place on Thursday. In briefing documents released by the FDA reviewer, the agency has made it clear that the Chinese clinical results filed in support of the PD-1 inhibitor do not meet the criteria for foreign data fled in support of a marketing application in the US.

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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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Astellas says Pompe gene therapy clears safety hurdle

pharmaphorum

With the safety of gene therapies thrown into the spotlight by a series of FDA clinical holds, Astellas has said that an interim readout in a phase 1/2 trial of its Pompe disease candidate AT845 hasn’t found any cause for concern. The FORTIS trial is investigating whether AT845, an adeno-associated virus (AAV) therapy, can deliver a functional copy of the acid alpha-glucosidase (GAA) gene directly in muscle cells in adults with late-onset Pompe disease.

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Importance of diversity in pharma and clinical trials

pharmaphorum

“Diversity.” It’s a word that is very commonly thrown around right now, not just in pharma and healthcare but across all industries. No matter which sector you work in, diversity and inclusion should not be treated as mere buzzwords designed to help improve the perception of a company, but as must-haves. We live in a diverse world and our teams, clinical trial participants, customers, and key opinion leaders (KOLs) should reflect this.

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