Mon.Apr 25, 2022

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Digital interventions cut heart failure mortality, study shows

pharmaphorum

An analysis of 10 clinical trials of digital health interventions targeted at patients recently hospitalised for acute heart failure has found they improve outcomes compared to standard care. The meta-analysis by researchers in the US pooled the results of the studies to assess the impact of digital approaches like telemedicine, use of monitoring sensors, Internet-based interventions, smartphone apps, or text messaging/email interactions on all-cause mortality.

Hospitals 136
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HPAPI Summit hones in on pharmaceutical manufacturing risk

Outsourcing Pharma

The 2022 edition of the Highly Potent Active Pharmaceutical Ingredients Summit (June 28 to 30 in Boston) will take on a range of topics, including safety.

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Partnering to advance digital therapeutics offerings

pharmaphorum

Aaron Gani, founder and CEO of BehaVR, and Krys Zaluski, director of business development, digital health at Sumitomo Dainippon Pharma, discuss their groundbreaking partnership to develop and commercialise digital therapeutics (DTx) products. . BehaVR and Sumitomo signed a potential $140 million deal to create virtual reality (VR) therapies to treat social anxiety disorder, generalised anxiety disorder, and major depressive disorder.

FDA 102
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Healome Therapeutics to accelerate development for ocular disease

Pharma Times

Studies have demonstrated that Healome’s formulations have anti-fibrotic activity and are augmented when combined with other therapeutics

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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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Roche’s oral SERD giredestrant fails breast cancer trial

pharmaphorum

Roche revealed in its first-quarter results statement that giredestrant missed the mark in the phase 2 acelERA trial in advanced breast cancer, in what appears to be another blow to the emerging oral selective oestrogen receptor degrader (SERD) class. The Swiss pharma said in its update that the acelERA trial comparing giredestrant to physician’s choice of endocrine therapy for previously-treated hormone receptor (HR)-positive, HER2-negative breast cancer did not meet its primary endpoint

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Novartis UK announces new charity partnerships supporting social mobility

Pharma Times

Novartis will provide vital volunteering projects, career plans for young people and financial support to local charities

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Next Generation RNA Therapeutics Summit

pharmaphorum

Are you looking to solve challenges with current RNA therapeutics, such as the degradation of RNA by RNAses, the difficulty of RNA crossing the cell membrane by diffusion and the immunogenicity elicited by exogenous RNA? Next generation RNA therapeutics can help! The Next Generation RNA Therapeutics Summit comes to Boston on May 24-26 to unite experts to discuss how novel modalities from self-replicating to circular RNAs have the potential to overcome key challenges faced by current generations.

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Implants could transform CAR-T therapy into one-day procedure

pharmaphorum

CAR-T therapies have revolutionised the treatment of some blood cancers, but are costly as well as time- and resource-intensive. Now, US researchers think one solution could be an implant that generates T cells within the body to attack the cancer. It is early days for the concept, but its developers – from North Carolina State University and the University of North Carolina – have completed a proof-of-concept study that shows it works in animal models and could start to attack the cancer in a s

Hospitals 102
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CHMP backs Roche’s lymphoma bispecific mosunetuzumab

pharmaphorum

Roche is on the brink of its first regulatory approval for what could be the first bispecific antibody targeting CD3 and CD20 – mosunetuzumab – after getting a positive opinion for the drug from the EMA’s human medicines committee. The drug has been recommended by the CHMP for approval as Lunsumio as a since-agent treatment for relapsed or refractory follicular lymphoma (FL), a form of non-Hodgkin lymphoma (NHL), after two or more prior systemic therapies.

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AZ closes on FDA verdict on tremelimumab in liver cancer

pharmaphorum

AstraZeneca’s anti-CTLA4 antibody tremelimumab is moving closer to what once looked like an extremely unlikely regulatory approval, after a string of negative trial results. The drugmaker said this morning that the FDA has started a priority review of tremelimumab alongside its PD-L1 inhibitor Imfinzi (durvalumab) or the treatment of patients with unresectable hepatocellular carcinoma (HCC), the most common form of liver cancer.

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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.