Thu.Feb 17, 2022

article thumbnail

Expect growth, innovation in digital health landscape: BCG Digital Ventures

Outsourcing Pharma

In its forward-looking report on digital health, the consulting outfit offers predictions on what changes are ahead and how they might impact the field.

117
117
article thumbnail

GBT claims EU approval for sickle cell drug Oxbryta

pharmaphorum

Global Blood Therapeutics’ run of positive regulatory news for its oral sickle cell disease treatment Oxbryta has continued with an approval for the drug in Europe for patients aged over 12. The green light from the European Commission comes a couple of years after Oxbryta (voxelotor) was cleared by the FDA for the treatment of haemolytic anaemia caused by SCD in the over-12s, and a few weeks after an expansion of its US label to include patients aged four and above.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

Chronic Disease Solutions: Spotlight on COVID-19 and its Impact on Heart Disease

PharmD Live

By Richard Korecky, PharmD, BCGP. COVID-19 has profoundly changed the world we live in today and will continue to leave an indelible mark long after the pandemic has ended. One area of concern for both health care providers and their patients is the long-term effect of COVID-19 infection on patients with chronic diseases. Acute cardiac injury has been a well-documented feature of infection with SARS-CoV-2, which causes COVID-19 among patients requiring hospitalization.

article thumbnail

BMS builds case for mavacamten label ahead of FDA decision

pharmaphorum

Bristol-Myers Squibb has new data backing up the value of mavacamten for obstructive hypertrophic cardiomyopathy (HCM), as it waits for a delayed verdict on its marketing application for the drug, acquired as part of its $13.1 billion takeover of MyoKardia in 2020. The phase 3 VALOR-HCM trial in adults with obstructive HCM eligible for a procedure called septal reduction therapy (SRT) met its primary endpoint, according to BMS.

article thumbnail

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.

article thumbnail

3 Exosome Services And Technologies For Skin Regeneration

Pharma Mirror

The importance of exosomes in skin cell regeneration has been extensively researched over the past few years. Functions involving the fibroblasts, forming of new blood vessels, and controlling the localized inflammatory response of the skin are all benefits of their use. Exosomes have another essential function, and that would be intercellular communication.

article thumbnail

Accelerating patient engagement in the digital health era

pharmaphorum

Understanding the person behind the patient is a crucial part of medicine, one that healthcare providers can use to improve the efficacy of treatments. At the 2021 Frontiers Health conference in Milan, Mark Duman and Paul Tunnah discuss the importance of co-creating with patients. Over the past 50-years, demand for patient and public involvement in the development of new therapeutics has soared as patients grew more aware of and informed about their health.

52

More Trending

article thumbnail

Sage, Biogen’s zuranolone looks approvable, but will it sell?

pharmaphorum

Last year, the first phase 3 trial of Sage Therapeutics and Biogen’s antidepressant hopeful zuranolone hit its efficacy targets, but raised doubts about the durability of the response. Now, a second phase 3 trial has followed the same pattern, doing nothing to quell debate about its commercial prospects. The latest study – called CORAL and involving 440 patients with major depressive disorder (MDD) – showed that zuranolone was able to achieve a modest statistically significant two-point re

FDA 52
article thumbnail

Bayer program streamlines clinical trial process, site relationships

Outsourcing Pharma

Created via a joint effort with EY, the pharmaceutical company launched ASPIREs, a program intended to improve its clinical trial processes in numerous areas.

article thumbnail

Moderna’s commercial network grows

Pharma Times

Vaccine pioneers expand presence throughout Europe with a view to leveraging technology

article thumbnail

Tech Innovations: February 2022

Outsourcing Pharma

This monthâs list of announcements about technology, funding, and more includes Medable, Clarify Health, Thermo Fisher Scientific, and other key companies.

52
article thumbnail

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.

article thumbnail

Seal of Approval: Direct-to-PCR COVID-19 test in the UK validated

Pharma Times

First direct-to-PCR test added to the CTDA register of approved UK products

41
article thumbnail

Brain activity study backs Akili’s digital therapy for ADHD

pharmaphorum

Akili Interactive’s prescription gaming app for attention deficit hyperactivity disorder (ADHD) EndeavorRx has been show to enhance neuronal activity in an area of the brain associated with attention function. The results come from a single-arm, unblinded study of the app, but add to the clinical evidence that EndeavorRx can have a positive impact on children with ADHD which led it to become the prescription game to be approved by the FDA in 2020.

FDA 138
article thumbnail

COVID jabs now offered to all children aged 5 to 11 across UK

pharmaphorum

England and Northern Ireland have followed Wales and Scotland in offering healthy children aged between five and 11 a low-dose COVID-19 vaccine, making vaccination an option for a younger age group across the UK. Health Secretary Sajid Javid says the rollout will be “non-urgent”, and parents would be able to decide whether or not the vaccination would be right for their children.

article thumbnail

New HIV variant highlights the importance of monitoring virus mutations

pharmaphorum

Researchers discovered a highly virulent variant of HIV in the Netherlands that genetic sequence analysis suggests has been circulating since the 1990s. . Approximately 38 million people currently live with HIV (human immunodeficiency virus) worldwide, and, in 2020 alone, 680,000 people died of AIDS-related illnesses. Earlier this month, the ongoing BEEHIVE (Bridging the Epidemiology and Evolution of HIV in Europe) project reported their detection of the new variant of subtype-B HIV-1, the most

article thumbnail

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.