pharmaphorum

MARCH 9, 2022

Sanofi and Sobi’s haemophilia partnership has been under competitive pressure from new therapies like Roche’s antibody Hemlibra, so the two companies are hoping a new long-acting drug candidate can revitalise the franchise. New phase 3 data on efanesoctocog alfa (also known as BIVV001) has met its objectives in a phase 3 study, providing protection from bleeding episodes in patients with haemophilia A with once-weekly dosing.

Labelling 98

Labelling FDA 98

The deprescribing.org Blog

MARCH 9, 2022

Hello, deprescribers! We are back again after a quiet few months with some more blog content. Today we are talking about prescribing cascades with Dr. Sameera Toenjes from University of Toronto (Canada). We hope that after this interview you will have “can this symptom be caused by a drug?” imprinted on your brain (though most of you probably already do!).

Patient Care 52

Patient Care Hospitals 52

pharmaphorum

MARCH 9, 2022

There isn’t enough evidence to support the use of Merck & Co/MSD’s Keytruda in combination with chemotherapy as a first-line treatment for advanced triple negative breast cancer, according to the UK cost effectiveness watchdog NICE. In draft guidance, the agency has said that while Keytruda (pembrolizumab) added to chemotherapy is more effective than chemo alone.

Chemotherapy 75

Chemotherapy 75

Roots Analysis

MARCH 9, 2022

Over the years, the rising popularity of biologics has led to a paradigm shift in the healthcare industry. In the last decade alone, the annual number of approvals of biopharmaceuticals (including monoclonal antibodies, recombinant proteins, vaccines, and gene therapies), by the US FDA, have steadily risen. In fact, over 8,000 biological pharmaceutical products are currently under clinical investigation worldwide. .

Vaccines 52

Vaccines Dosage Immunization FDA 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

MARCH 9, 2022

MIP, the Business School of Politecnico di Milano, the largest technical university, is partnering with Healthware Group, a digital health consultancy (and pharmaphorum’s parent company) to launch a new executive programme aimed at providing digital health literacy and education to life sciences executives, as well as to the startup community. The five-month program will begin in June of this year and is currently accepting applications.

52

52

Outsourcing Pharma

MARCH 9, 2022

A leader from the Syneos Health company explains how innovative tech can elevate patient recruitment and engagement, even with the challenges DCTs can face.

52

52

Outsourcing Pharma

MARCH 9, 2022

A leader from the VCRO shares how far the industry has come with decentralized adoption, where opportunities for improvement exist, and what lies ahead.

52

52

Tria Health Blog

MARCH 9, 2022

Sleep Awareness Week is next week from March 13th– 19th. The National Sleep Foundation created this week to reemphasize the importance of the connection of sleep and health. Their theme this year is “Best Slept Self”.

40

40

Pharmacy Friday Pearls

MARCH 9, 2022

Download PDF. Introduction . 1. Around 9,000 Americans are treated for snake bites and 5 die each year. Most are bitten by members of the Crotalinae subfamily (a.k.a. crotalids) of the pit viper family which includes copperheads, water moccasins, and rattlesnakes. 2. Crotalid envenomation’s can cause broad range of adverse effects, including local tissue, hematologic, and/or systemic effects including shock and life-threatening bleeding. 3.

Immunization 40

Immunization Packaging Labelling FDA 40

Med Ed 101

MARCH 9, 2022

Alpha-blockers (i.e., tamsulosin) are commonly seen in male patients, as they are used to treat symptoms of benign prostatic hyperplasia (BPH; the only FDA-approved indication currently). Because of this, there is no doubt a prescription sent to the pharmacy for a female may raise some speculation. In recent years, uroselective alpha-blockers have been used for […].

FDA 40

FDA Labelling 40

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

MARCH 9, 2022

Trodelvy is accepted for use in mTNBC patients who have already received two or more systemic therapies

48

48

pharmaphorum

MARCH 9, 2022

Companies can choose whether or not to submit to NICE to have their products appraised. Many do, presumably because they want market access in the UK and there are likely to be positive ripples from getting a NICE seal of approval with other payers around the world. But some companies choose not to. Leela Barham looks at what has been happening to the number of non-submissions at NICE, updating on trends last looked at in 2020.

52

52

Pharma Times

MARCH 9, 2022

Results showed a clinically meaningful prevention of bleeds in people with severe haemophilia A

41

41