Fri.Jun 10, 2022

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Four things you need to know about FDA regulations and digital health

pharmaphorum

If you work in pharma, the chances are you’re no stranger to the United States Food and Drug Administration, or FDA, which regulates pharmaceuticals. But if you’re becoming more involved with the world of digital health, as many pharma companies are these days, you may find that your old FDA knowledge isn’t much help in knowing what will be required of you.

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Controlling Diabetes: Advances & Adherence

Pharmaceutical Commerce

Proper control of type 1 and 2 diabetes can greatly reduce the personal impact and economic burden of this pervasive public health condition. To that end, stakeholders are exploring many parallel routes to help individuals and society maintain the upper hand, as the toll of diabetes continues to skyrocket.

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How digital is transforming the commercial leader’s role in biopharma

pharmaphorum

Pharma’s evolving role in patient care. The digital revolution has already reshaped the commercial engine of biopharma companies. Pharma’s digital initiatives now routinely enable new channels that educate and market to patients, physician engagement that is more efficient and effective, and novel payment mechanisms and distribution models that improve access to therapies.

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The Impact of War on Drug Supply Chain

Pharmaceutical Commerce

A conversation with EY life sciences leaders Jim Welch and Jay Welsh.

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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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Is COVID in pregnancy linked to infant development issues?

pharmaphorum

Babies born to mothers who contracted COVID-19 during seem to be at slightly higher risk of neurodevelopmental delays, say US researchers, although they caution their findings are preliminary. Their retrospective study looked at more than 7,500 infants delivered during the pandemic, including 222 born to mothers with a positive COVID-19 test during pregnancy.

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Veeva MyInsights: Where is the value of data?

Viseven

There are tasks we, humans, can perform well with our eyes closed. Managing a successful multichannel customer engagement strategy is not on that list. Not seeing your output is about the second worst thing if you are a marketer, brand or product manager (after producing no output). In life sciences, that field of extra responsible decision making, detailed insights after each step are, of course, an especially prized possession.

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The Promise of Industry 4.0

Pharmaceutical Commerce

Pharma supply chain management will be one of the earliest beneficiaries of the Fourth Industrial Revolution, and the potential of ‘networks of networks’.

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Takeda bolsters data for dengue jab as regulatory reviews roll on

pharmaphorum

Takeda has reported positive new, long-term results in its pivotal trial of dengue fever vaccine TAK-003 that builds the case for the shot as regulators review marketing applications. The new data – coming after four-and-a-half years of follow-up – has revealed that TAK-003 cut dengue-related hospitalisations by 84%, with 61% protective efficacy against symptomatic dengue illness, with no serious safety issues.

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Dealing with Dangerous Goods

Pharmaceutical Commerce

The packaging and shipping of dangerous goods (DG) adds further challenges. to the distribution pressures brought about by the pandemic.

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NICE backs NHS use of Amarin’s Vazkepa for cardiovascular risk reduction

pharmaphorum

Around 425,000 people in England and Wales with cardiovascular disease who are at risk of a secondary stroke or heart attack, could be eligible for treatment with Amarin’s Vazkepa, following a NICE recommendation. In draft guidance, the health technology assessment (HTA) organisation has recommended Vazkepa (icosapent ethyl) as a treatment option for adult patients with high-risk cardiovascular disease and elevated levels of triglycerides in their blood who are already taking statins.

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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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Pharmaceutical Commerce - June 2022 Issue (PDF)

Pharmaceutical Commerce

Click the title above for a link to open the Pharmaceutical Commerce June 2022 issue in an interactive PDF format.

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Ziphius Vaccines and University of Antwerp begin collaboration

Pharma Times

The partnership will involve the optimised delivery of saRNA-based vaccines and therapeutics

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From Point-in-time to Real-time

Pharmaceutical Commerce

Why ‘real-time-all-the-time’ supply chain operations are fundamental to biopharma success.

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Verona Pharma’s ensifentrine heads for phase 3 chronic obstructive pulmonary disease trial

Pharma Times

The company completes its enrolment in phase 3 trial evaluating ensifentrine for treatment of COPD

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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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Food for Thought from France

Pharmaceutical Commerce

A reflection on the industry's effort to foster and facilitate sustainability.

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Relief for GSK as RSV vaccine clears phase 3 test in adults

pharmaphorum

GSK will start preparations for regulatory filings of its respiratory syncytial virus (RSV) vaccine straight away, after the shot hit the mark in the much-anticipated AReSVi 006 trial in adults aged 60 years and above. Top-line results from the study released this morning show that the RSVPreF3 OA vaccine showed “statistically significant and clinically meaningful” efficacy in this setting, with consistent activity across RSV A and B strains and in older age groups including the over