pharmaphorum

FEBRUARY 21, 2022

Already making inroads as a treatment for HER2-positive breast cancer, AstraZeneca and Daiichi Sankyo’s Enhertu has now shown efficacy in tumours that express lower levels of HER2 – potentially making it an option for a much broader group of patients. It’s a key moment for the two companies, as expansion into HER2-low breast cancer has been held up as a key requirement for Enhertu (trastuzumab deruxtecan) if it is to achieve its multibillion-dollar sales expectations.

Chemotherapy 132

Chemotherapy Labelling 132

Outsourcing Pharma

FEBRUARY 21, 2022

On February 23, five days ahead of the day of rare-disease awareness, OSPâs Rare and Orphan Diseases webinar will share insights from top industry experts.

59

59

pharmaphorum

FEBRUARY 21, 2022

Bayer has claimed EU approval for Kerendia, its new drug for chronic kidney disease (CKD) in people with type 2 diabetes, as the company tries to build a role of the drug alongside rival therapies from AstraZeneca and Johnson & Johnson. The approval is based on the phase 3 FIDELIO-DKD trial, in which Kerendia (finerenone) reduced the risk of kidney disease progression or renal death by 18% when added to the highest tolerated dose of standard therapy.

FDA 121

FDA 121

Roots Analysis

FEBRUARY 21, 2022

Since the introduction of a gene sequencing method by Frederick Sanger in 1977, the field of genomic data collection and analysis has evolved significantly. Advancement in DNA sequencing technologies have resulted in noteworthy developments in various healthcare-related research fields, such as diagnostics and personalized medicine. However, the conventional nucleotide library preparation process has several challenges, including requirement of huge amount of starting materials, inadequate throu

Immunization 52

Immunization 52

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

FEBRUARY 21, 2022

The clinical research industry has long struggled with participant diversity. One study found that only 5% of Black or Asian United Kingdom residents had ever participated in a clinical trial. A study of FDA-approved vaccine trials from 2011-2020 showed that 78% of participants were white, even though only 60% of the U.S. population was. . And then came COVID-19.

Vaccines 110

Vaccines FDA Hospitals 110

Outsourcing Pharma

FEBRUARY 21, 2022

The CRO is helping out on a project exploring the effects of the virus in children; other members of the research team include experts from Duke University.

52

52

Outsourcing Pharma

FEBRUARY 21, 2022

The two companies, which have been collaborating for 15 years, reportedly will focus on elevating decentralized trial solutions to develop new therapies.

52

52

pharmaphorum

FEBRUARY 21, 2022

An online doctor’s service operating in the UK has been fined after pleading guilty to providing online consultation and prescription services without being registered with the Care Quality Commission (CQC). The service – which provided powerful prescription medicines including high strength co-codamol, pregabalin and gabapentin to patients – exposed patients to “a significant risk of harm,” according to the CQC.

Communication 59

Communication 59

Pharma Times

FEBRUARY 21, 2022

The UK government is urged to be more mindful of children and young people who have mental health issues, following the publication of the NHS Elective Recovery Plan

43

43

pharmaphorum

FEBRUARY 21, 2022

Eli Lilly has reported phase 3 results with its ulcerative colitis challenger mirikizumab, as it waits for the readout of a second trial in the coming weeks that will allow it to file for regulatory approvals. The new data comes from the 1,162-subject LUCENT-1 trial – first unveiled last year – which compared induction treatment with the anti-IL-23p19 antibody to placebo in patients with moderately-to-severely active ulcerative colitis who had not tried a biologic therapy before.

59

59

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

FEBRUARY 21, 2022

Study reveals that many with an increased risk of cancer were excluded from the potential for monitoring

45

45