Sat.May 15, 2021 - Fri.May 21, 2021

article thumbnail

FDA seeking more consistency from cell, gene therapy developers, top official says

Bio Pharma Dive

A number of drugmakers have recently faced development delays after the FDA's asked for more information on how they measure the potency of their products.

article thumbnail

Three ways to combat stress in a remote working healthcare team

World of DTC Marketing

The pandemic has been uniquely stressful for healthcare teams. With some parts of the sector shifting to remote work, that stress tended to build, having a real impact on mental health. It can be hard to manage a remote team, even more so to take care of their mental health, but there are a few steps that every employer can take. #1 Set up a Digital Helpdesk.

257
257
Insiders

Sign Up for our Newsletter

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

article thumbnail

Rashedi Hassan takes over Sales & Marketing management of Telstar’s subsidiary in Bangladesh

Pharma Mirror

Terrassa (Barcelona). Azbil Telstar announces the appointment of Rashedi Hassan as a Sales & Marketing Manager of the subsidiary of the company in Dhaka, Bangladesh. From 14th February 2021, Rashedi Hassan focuses his responsibility on developing extensive marketing and sales plan to strengthen the Telstar brand position in the local pharmaceutical market and to promote the presence and distribution of Telstar branded Life Sciences service & product solutions in the region, particularly

Sales 246
article thumbnail

EMA, MHRA to review Vertex' Kaftrio for children with CF

Pharma Times

If approved, up to 2,000 children with CF would be eligible for treatment with the drug

Drugs 146
article thumbnail

From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

article thumbnail

Sarepta's Duchenne gene therapy clears study hurdle, although questions linger

Bio Pharma Dive

A version of the treatment made at commercial scale looks similar to what Sarepta used in early testing. But the findings are no longer the last step before an approval filing, as the company once hoped.

article thumbnail

AbbVie CEO looks like a fool before Congress

World of DTC Marketing

SUMMARY: “You’re spending all this money to make sure you make money rather than spending money to… help patients,” the California congresswoman told AbbVie’s, Richard Gonzalez. “ That was pretty brutal, but to was right on target by Rep Katie Porter. While AbbVie is a poster for everything wrong with pharma, what they have done doesn’t apply to ALL pharma companies.

More Trending

article thumbnail

NICE turns down Janssen's Erleada

Pharma Times

Cost-effectiveness estimates have fallen above the threshold because of uncertain trial evidence

Trials 130
article thumbnail

Bristol Myers pays Agenus $200M for drug aimed at top immunotherapy target

Bio Pharma Dive

The pharma acquired rights to an experimental antibody medicine that blocks a protein, called TIGIT, that's become a focus for several cancer drugmakers.

Protein 340
article thumbnail

Time to rethink the objective of DTC marketing

World of DTC Marketing

QUICK READ: Only someone who is fooling themselves believes that life will go back to normal after the pandemic. The pandemic has affected healthcare dramatically as searches for health information beyond COVID, have skyrocketed and patients have become used to virtual health visits. DTC marketing needs to evolve if it’s to remain relevant as part of the brand objectives.

Marketing 155
article thumbnail

Experts state contract services sector the big winner of pandemic at CPhI Discover

Pharma Mirror

Contract services experts at this week’s CPhI Discover – (17-28th May, 2021) – the largest ever online pharma event featuring content in the opening week and networking in week two – point to pandemic contracts delivering a significant boon to the CDMO sector, but forewarn of exacerbated shortages for viral vector manufacturing. In a dedicated session three experts – Peter Shapiro Senior Director of Drugs and Business Fundamentals, PharmSource, a GlobalData Company; Eric Langer, President and Ma

article thumbnail

Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

article thumbnail

Annovis Bio Shows Alzheimer’s Reversal in Humans in Phase II Study

BioSpace

Preliminary data from Annovis Bio’s Phase II study of ANVS401 shows significant cognitive improvements in Alzheimer’s patients after only one month of treatment.

126
126
article thumbnail

Bluebird's next gene therapy gets backing from European regulator

Bio Pharma Dive

The treatment, for a progressive, often deadly brain disease, could soon become Bluebird's third approved product and one of only a handful of marketed gene therapies in the world.

article thumbnail

Janssen inks inflammatory disease collaboration with Mestag Therapeutics

Pharma Times

Collaboration will utilise Mestag’s specialist fibroblast subpopulation biology platform to identify novel therapeutic targets

123
123
article thumbnail

Ashfield Engage acquires Nuvera to enhance Patient Solutions offering

Pharma Mirror

Nuvera are experts in optimizing the design and build of seamless patient and HCP treatment experiences. This expertise will enhance Ashfield Engage’s Patient Solutions capabilities and create an end-to-end strategic offering across their client’s product lifecycles. Following the acquisition, Ashfield Engage and Nuvera will offer integrated specialist support and services including late-phase clinical trial experience, implementation and post-commercialization satisfaction benchmarking and serv

article thumbnail

The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

article thumbnail

Listening to ultra-rare disease communities

pharmaphorum

When it comes to ultra-rare diseases, the smaller the patient population, the bigger the challenges. As a global commercial biopharmaceutical company pioneering therapies for ultra-rare diseases, PTC Therapeutics is familiar with the challenges. The company prides itself on a patient-centric approach to treatment but there can be significant hurdles in patients accessing potentially life-changing treatments.

article thumbnail

Humira patents take center stage as House panel targets AbbVie pricing

Bio Pharma Dive

CEO Richard Gonzalez defended the company's practices, arguing its profits help spur innovation: "The products that are on the market today pay for the products of the future," he said.

article thumbnail

UK trial tests third doses of COVID-19 vaccines

Pharma Times

Initial results trialling seven vaccines will inform plans for Autumn booster programme

Vaccine 121
article thumbnail

Pharmaceutical Development and Medical Research Supply: 5 Things You Should Know

Pharma Mirror

For researchers, the challenges are endless and the journey is anything but easy and straightforward. Every year, the pharmaceutical industry of the U.K alone plays a crucial part in developing new drugs that deliver numerous health benefits. Many aim to resolve critical diseases that threaten mankind. A vast majority of these drugs are expensive and there is no doubt what financial strain they put on the ever-increasing healthcare costs of the federal government as well as the private sector.

article thumbnail

How Machine Learning Drives Clinical Trial Efficiency

Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

article thumbnail

aptaTargets’ First-in-Human Data Shows Efficacy of Aptamers in Stroke

BioSpace

Madrid-based aptaTargets S.L. announced data from its first-in-human trial using its ApTOLL aptamer to protect patients against the deleterious effects of acute ischemic stroke.

Trials 118
article thumbnail

Off-the-shelf CAR-T, a Tagrisso rival and the next breast cancer drugs: a look ahead at ASCO

Bio Pharma Dive

Dozens of companies have released abstracts ahead of the American Society of Clinical Oncology's meeting next month. Here are three storylines to watch.

Drugs 290
article thumbnail

NHS England funds first national metastatic breast cancer audit

Pharma Times

UK-based charity Breast Cancer Now ‘proud’ of milestone after campaigning for improved data collection

121
121
article thumbnail

What is a Webcast? Learn the Differences Between Webcasts vs Webinars

XTalks

Webcast or webinar? These two terms are often used interchangeably by various organizations. Ultimately, webcasts and webinars offer the same goal — they give hosts a virtual space to present content with an audience while keeping track of webinar registrations. . When push comes to shove, webcasts and webinars can be differentiated. We will take a thorough look at the definitions of these two terms, then clarify the similarities and differences, which might often be overlooked by most.

Marketing 116
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

Answering the Call: The Healey ALS Platform Trial

BioSpace

A platform trial is also efficient in that it enables the investigators to share placebo information.

Trials 118
article thumbnail

In the midst of a 'strategic shift,' Voyager loses CEO and R&D head

Bio Pharma Dive

The shake-ups come as the biotech prepares to invest more in its technology and also begin human testing for one of its most advanced gene therapies.

article thumbnail

Sanofi’s Dupixent 'rapidly' improves lung function in children

Pharma Times

Detailed results found Dupixent improved overall asthma control in children aged six to 11 years old

114
114
article thumbnail

Artificial intelligence can elevate pharma manufacturing

Outsourcing Pharma

According to a leader from industrial AI specialist AspenTech, AI can help avoid costly maintenance interruptions by predicting when upkeep is needed.

article thumbnail

European Clinical Supply Planning: Balancing Cost, Flexibility and Time

article thumbnail

Leo Pharma’s Tralokinumab News: What You Need to Know

BioSpace

While waiting for further updates, here’s everything you need to know about this highly-anticipated atopic dermatitis treatment.

109
109
article thumbnail

FDA approval sets stage for a showdown between Alexion and Apellis

Bio Pharma Dive

Apellis' newly approved drug, known as Empaveli, will compete against the blockbuster Soliris and Ultomiris franchises in the treatment of a rare and life-threatening blood disease.

article thumbnail

Novo Nordisk’s ziltivekimab hits primary endpoint in CKD trial

Pharma Times

Investigational IL-6 inhibitor reduced inflammatory biomarkers associated with atherosclerosis in CKD patients

Trials 113
article thumbnail

Clinical Trials Day 2021: Reflecting on a Challenging Year That’s Made the Industry Stronger

XTalks

Today is Clinical Trials Day 2021 — a day for recognizing the importance of clinical research in protecting and improving global health. However, this day has taken on even greater significance this year in light of the recent one-year anniversary of the start of the COVID-19 pandemic and all of the changes the clinical trials industry has seen since early 2020.

article thumbnail

The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.