Bio Pharma Dive
MAY 19, 2021
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.
World of DTC Marketing
MAY 19, 2021
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.
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Pharma Mirror
MAY 19, 2021
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
Camargo
MAY 19, 2021
The Camargo Blog has published a four-part blog series highlighting those designation programs available specifically for products with rare disease indications. This final installment will explain the criteria, timeline, and benefits of Humanitarian Use Device (HUD) designation. The HUD designation program is designed for medical devices and is similar to the Orphan Drug Designation (ODD) program for drugs and biological products.
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Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud
Bio Pharma Dive
MAY 18, 2021
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.
World of DTC Marketing
MAY 19, 2021
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.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
XTalks
MAY 21, 2021
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.
Bio Pharma Dive
MAY 21, 2021
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.
World of DTC Marketing
MAY 17, 2021
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.
BioSpace
MAY 20, 2021
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.
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
pharmaphorum
MAY 21, 2021
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.
Bio Pharma Dive
MAY 18, 2021
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.
Pharma Times
MAY 19, 2021
Collaboration will utilise Mestag’s specialist fibroblast subpopulation biology platform to identify novel therapeutic targets
BioPharma Reporter
MAY 21, 2021
Canadian biotechnology company, Medicago, announced positive interim Phase 2 results this week for its plant-derived COVID-19 vaccine, which has been tested in combination with GSKâs pandemic adjuvant.
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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.
XTalks
MAY 20, 2021
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.
Bio Pharma Dive
MAY 18, 2021
The pharma acquired rights to an experimental antibody medicine that blocks a protein, called TIGIT, that's become a focus for several cancer drugmakers.
pharmaphorum
MAY 19, 2021
Just over a year ago, hi.health launched an app that takes the legwork out of submitting reimbursement claims to private health insurers. Now, the startup has taken another leap forward, settling users bills immediately. . Fredrik Debong. The addition to the hi.health app acts as a digital health expense account, according to the company’s co-founder and chief scientific officer Fredrik Debong, who was a co-founder of diabetes management app mySugr.com, which was snapped up by Roche in 201
Scienmag
MAY 20, 2021
First plant found to deceive pollinators by mimicking decomposing insects Credit: Credit: T. Rupp, B. Oelschlägel, K. Rabitsch et al. The plant Aristolochia microstoma uses a unique trick: its flowers emit a fetid-musty scent that seems to mimic the smell of decomposing insects. Flies from the genus Megaselia (family Phoridae) likely get attracted to this […].
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.
Pharma Times
MAY 20, 2021
If approved, up to 2,000 children with CF would be eligible for treatment with the drug
Bio Pharma Dive
MAY 20, 2021
Dozens of companies have released abstracts ahead of the American Society of Clinical Oncology's meeting next month. Here are three storylines to watch.
BioSpace
MAY 19, 2021
“The virus will not be eradicated through vaccination alone. That means. we need our medicines. That was a failure of 2020 that doesn’t get enough emphasis,” Jake Glanville, chief executive officer of Bay Area-based Centivax, told BioSpace in an interview.
BioPharma Reporter
MAY 20, 2021
Protalix BioTherapeutics is planning to propose a virtual or record review inspection to clear the barrier to approval of its Chiesi Farmaceutici-partnered Fabry disease treatment.
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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.
Outsourcing Pharma
MAY 17, 2021
According to a leader from industrial AI specialist AspenTech, AI can help avoid costly maintenance interruptions by predicting when upkeep is needed.
Bio Pharma Dive
MAY 17, 2021
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.
XTalks
MAY 21, 2021
You’ve heard of vegetarian and pescatarian diets, but a new diet, or rather a lifestyle, has been gaining traction over the last few years: climatarian. Vegetarians stick mainly to vegetables, pescatarians add fish to the equation, but climatarians “choose what to eat according to what is least harmful to the environment,” according to Cambridge Dictionary.
BioPharma Reporter
MAY 20, 2021
Thermo Fisher Scientific Inc and the University of California, San Francisco (UCSF) have formed a alliance to accelerate the development and manufacturing of cell-based therapies.
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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.
Scienmag
MAY 20, 2021
Rice lab’s discovery of ‘magic angle’ builds on its ultrathin, highly aligned nanotube films Credit: Kono Laboratory/Rice University HOUSTON – (May 20, 2021) – It’s always good when your hard work reflects well on you. With the discovery of the giant polarization rotation of light, that is literally so. The ultrathin, highly aligned carbon nanotube […].
Bio Pharma Dive
MAY 17, 2021
As remote work continues, print is as important as ever for biopharmaceutical companies when it comes to reaching a varied audience that may include patients, doctors' offices, researchers, and internal staff.
pharmaphorum
MAY 20, 2021
NICE has rejected Johnson & Johnson’s oral prostate cancer drug Erleada (apalutamide) in patients with hormone-relapsed or hormone sensitive disease in first draft guidance. The cost-effectiveness body is assessing Erleada , plus androgen deprivation therapy (ADT), for prostate cancer in adults who have hormone-relapsed non-metastatic disease at high risk of metastasising and hormone-sensitive metastatic disease.
BioPharma Reporter
MAY 20, 2021
Data management in antibody drug conjugate (ADC) manufacturing is challenging says ADC/Labs, which is trying to help scientists in the field get around such obstacles.
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Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.
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