Mon.Feb 07, 2022

article thumbnail

ViiV Healthcare long-acting HIV treatment secures FDA approval

Outsourcing Pharma

The HIV-focused pharma company announced the agency has approved Cabenuva for administration as few as six times a year for adults living with the virus.

FDA 107
article thumbnail

Clarify Health’s new offering shows one way tech can help improve clinical trial diversity

pharmaphorum

The last three years in pharma have seen a growing awareness of and dissatisfaction with a trend that has plagued the industry for its whole life: Nondiverse and unrepresentative clinical trials, which lead to incomplete data and compounded health disparity for minority populations. It’s been more than a year since the US Food and Drug Administration released its final guidance on diversifying clinical trials in November 2020.

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

Real-world evidence ‘central’ to drug development: Parexel

Outsourcing Pharma

An expert from the CRO discusses the role real-world data plays in developing therapies, with benefits ranging from speeding recruitment to decreasing costs.

52
article thumbnail

New NHS online platform will show waiting times for care

pharmaphorum

The UK government’s long-awaited plan to tackle the backlog in NHS care caused by the pandemic has been delayed, but one small part that aims to improve transparency has been revealed. Patients who need non-urgent surgery will be able to use a new platform on the NHS.UK website – called My Planned Care – to get information about waiting times for their trust.

59
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

CVS, Medable join forces to expand clinical trial access

Outsourcing Pharma

The collaboration between the trial tech company and heathcare firm is aimed at increasing study access at MinuteClinic locations using Medableâs software.

52
article thumbnail

NICE clears use of GSK’s Jemperli in endometrial cancer

pharmaphorum

Women in England with a specific type of endometrial cancer will be able to access an immunotherapy for the first time, after NICE backed use of GlaxoSmithKline’s PD-1 inhibitor Jemperli via the Cancer Drugs Fund (CDF). The health technology assessment (HTA) agency has given a temporary okay to the use of Jemperli (dostarlimab) for endometrial cancer patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) mutations, while additional evidence for the drug&#

More Trending

article thumbnail

Sanofi claims FDA okay for drug to treat rare blood disorder CAD

pharmaphorum

Sanofi has won FDA approval for its sutimlimab for cold agglutinin disease (CAD) at the second time of asking, becoming the first approved therapy for the rare blood disorder in the US. The complement C1s-targeting antibody – given the brand name Enjaymo – has been cleared decrease the need for blood transfusions in patients with CAD, an autoimmune disease which results in destruction of red blood cells (haemolysis).

FDA 52
article thumbnail

Not so NICE: cancer patients miss out on innovative new treatments

Pharma Times

Institute for Cancer Research highlights missed opportunity for NICE to reform its cancer drug assessment processes

44
article thumbnail

Bayer’s pipeline takes a hit as it drops eliapixant

pharmaphorum

Bayer has abandoned development of its investigational P2X3 receptor antagonist eliapixant, despite promising efficacy data in clinical trials, on what appears to be safety grounds. The decision comes right on the heels of the FDA’s rejection of Merck & Co’s rival oral P2X3 antagonist gefapixant, which was also attributed to concerns about the safety of the drug.

FDA 52
article thumbnail

Pandemic, practice and policymaking: European-wide review of community pharmacies

Pharma Times

Extensive research into pharmacy responses across Europe during the pandemic yields several recommendations

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.