pharmaphorum

APRIL 19, 2022

GlaxoSmithKline says the FDA has started its review of daprodustat for anaemia associated with chronic kidney disease (CKD), as it strives to succeed where two other rivals in the HIF-PHI class have failed. GSK has submitted daprodustat base on its ASCEND phase 3 programme, which included five trials across both dialysis and non-dialysis patients and showed that the drug offered an oral alternative to injectable erythropoietin stimulating agents (ESAs) for anaemia, without sacrificing efficacy.

FDA 121

FDA 121

Outsourcing Pharma

APRIL 19, 2022

The one-year-old organization is giving $50m USD in grants to encourage scientists from five cancer research centers to work together on cancer solutions.

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pharmaphorum

APRIL 19, 2022

Ehab Youssef, area head of Europe North at Roche Pharmaceuticals, tells us why European countries need interoperability to ensure a more effective overall European healthcare system. COVID spotlighted the vulnerability of the healthcare system and the need for structural and technological change to help manage such as crisis. Though some regions have started to make the necessary changes, Youssef says Europe is lagging. “In general, there is a good progression in almost every country.

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Roots Analysis

APRIL 19, 2022

Over the past decade, the biopharmaceutical industry has witnessed several advancements in terms of bioprocessing. Bioprocess technology is one of the integral parts of biotechnology that deals with different biological processes involving living or competent cells to get value added products at the end of the process. Recently, an increasing demand for various efficient technology is has been observed in the biopharmaceutical industry where, single-use technology has emerged as one of the most

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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.

pharmaphorum

APRIL 19, 2022

AstraZeneca and Daiichi Sankyo should only have to wait for six months to hear from the FDA if it will approve their HER2 drug Enhertu for non-small cell lung cancer (NSCLC) and add to its current uses in breast and gastric cancer. The US regulator has kicked off a priority review of Enhertu (trastuzumab deruxtecan) as a treatment for NSCLC with HER2 mutations after prior systemic therapy, setting up a decision in the third quarter of this year.

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FDA Chemotherapy 105

Outsourcing Pharma

APRIL 19, 2022

Cryoport Inc has acquired Cell&Co BioServices, continuing its EMEA expansion efforts.

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Outsourcing Pharma

APRIL 19, 2022

The CDMO has been awarded funding from the US government to work on treatments for sarin and other substances used frequently employed in chemical attacks.

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pharmaphorum

APRIL 19, 2022

The industry has long sought the insight and advice of revered, influential figures. Typically, these key opinion leaders (KOLs) are researchers, physicians, or other healthcare providers (HCPs) that hold high levels of expertise in their respective fields. However, as the industry moves to occupy more virtual spaces, a new breed of industry influencers has emerged – digital opinion leaders (DOLs).

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Pharma Times

APRIL 19, 2022

Protein technology could dramatically improve prospects of heart attack victims by proliferating organ cells

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pharmaphorum

APRIL 19, 2022

It has long been understood that the Hippo pathway plays a critical role in the development of a wide range of diseases. Although once seen as an elusive pathway, emerging novel data and research is forging a wider and more developed mechanistic understanding of it. New avenues have been opened to evolve the landscape of targetable nodes and therapeutic interventions, from small molecule approaches to novel modalities targeting the TEAD transcription complex.

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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.

FDA

Pharma Times

APRIL 19, 2022

High unmet need in the area of hepatitis B therapies will see companies share responsibilities to develop the vaccine

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Vaccines 45

pharmaphorum

APRIL 19, 2022

In 2022, pharma is truly a global industry, and innovation can come from anywhere. But for small life sciences outside of the USA and Europe, it can still be challenging to break onto this global stage. However, with novel offerings targeted at wide-spread conditions, and with the right partnership strategies, it can be done. RudaCure is a four-year-old biotech company based in the South Korea, focusing on ocular disease and chronic pain with a pair of potentially first-in-class drugs.

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Pharmaceutical Companies Pharmaceutical Companies Communication FDA 52

pharmaphorum

APRIL 19, 2022

Join the 3rd Gamma Delta T Therapies Summit to learn and network with 120+ of the world’s leaders including ??T pioneer, Adrian Hayday, and together accelerate the development of effective, persistent, globally accessible cell therapy for solid tumors. Enhance cytotoxicity, discover novel targets, engineer stealth, and persistence, interrogate cell subsets, and scale-up manufacturing through a deep understanding of the fundamental biology and target product profile for ??

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pharmaphorum

APRIL 19, 2022

Four years after Bristol-Myers Squibb paid $1.85 billion upfront to make Nektar’s bempegaldesleukin a companion drug to its cancer immunotherapy Opdivo, the alliance is being discontinued. Things were already looking shaky for the programme last month when a phase 3 trial of pegylated IL-2 drug bempeg given in combination with PD-1 inhibitor Opdivo (nivolumab) as first-line melanoma therapy failed across the board.

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Pharmacy Management Software

pharmaphorum

APRIL 19, 2022

Getting your clinical study designed and built ready for data collection takes A LOT of work and expertise… you’ve got to do all your CRF designs; keep up with protocol changes; add the annotations; make sure everything aligns with CDISC standards. And the list goes on, and on…. But it doesn’t have to be this difficult… with the right technology you can be a clinical study pro and master clinical trial setup!

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