Bio Pharma Dive
MARCH 29, 2021
A long-awaited reckoning for Biogen’s Alzheimer’s drug and the review of AstraZeneca’s coronavirus vaccine are among the top FDA decisions expected before the end of June.
World of DTC Marketing
MARCH 28, 2021
IN BRIEF: Doctors are not required to treat obese patients who won’t do anything to lose weight but the problem is more than reminding patients they need to get exercise and drop pounds. One study found that only 50 percent of patients follow the instructions associated with taking their medication, and even fewer implement necessary lifestyle changes suggested by their doctor.
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BioPharma Reporter
MARCH 31, 2021
Pfizer and BioNTech expect to expand COVID-19 vaccine manufacturing capacity to up to 2.5 billion doses by the end of 2021, thanks to the optimization of production processes and the recent initiation of production in Marburg, Germany.
BioSpace
MARCH 30, 2021
Vaccine passports are an interim step that can speed the return of some semblance of normality by allowing the rapidly growing numbers of vaccinated people to travel more easily and to attend typically crowded sporting events, concerts and religious services.
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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
MARCH 30, 2021
Two drugs developed by Wave Life Sciences didn't appear to have an effect on disease-causing proteins, another setback for Huntington's research after disappointing results last week from Roche and Ionis.
World of DTC Marketing
MARCH 29, 2021
TEASER: What DTC marketers and consumers do as the result of seeing a relevant DTC ad differs by a wide margin. DTC marketers would like to think that patients ask for the advertised drug when visiting their doctor, but that’s largely untrue. Online searches for health information remain brisk, according to Google. Many people are going online for health information as the Internet has become cluttered with misinformation.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioPharma Reporter
MARCH 29, 2021
Cytiva has opened a new diagnostics design lab in Tonglu, its manufacturing site close to Shanghai in East China, where it has been making filtration products for many years.
Bio Pharma Dive
MARCH 27, 2021
Approval of Bristol Myers Squibb and Bluebird bio's Abecma expands use of CAR-T treatment beyond leukemia and lymphoma.
World of DTC Marketing
APRIL 1, 2021
IN BRIEF: At some point, we need to realize that good health is our personal responsibility. All prescription drugs don’t make us healthy; they just mask a potentially unhealthy lifestyle that eventually will cost patients and our healthcare system a lot of money, time, and pain. Responsibility for health should be a collaborative effort among individuals and the societies in which they live.
pharmaphorum
MARCH 30, 2021
The government has continued its shake-up of UK health authorities with the creation of the Office of Health Promotion (OHP), which will focus on issues like obesity, mental and sexual health, and promoting physical activity. . The OHP will take over the health improvement remit currently the responsibility of Public Health England (PHE), and will “lead national efforts to improve and level up the public’s health,” according to the government.
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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
XTalks
APRIL 1, 2021
There is no shortage of post-workout drinks on the market, including innovative new additions to the category, like high-protein chocolate milk to sports drinks made with upcycled dairy byproducts. But could an electrolyte beer be just the thing to quench consumers’ thirst after a session at the gym? A few breweries in the US are trying to make that a reality with low alcohol by volume (ABV) beers infused with electrolytes and other nutrients.
Bio Pharma Dive
APRIL 1, 2021
Updated Phase 3 study results could position Pfizer to file for full approval of its vaccine and might have implications for its plans to develop a booster shot.
BioSpace
APRIL 2, 2021
A current Phase III trial of the Pfizer-BioNTech COVID-19 vaccine has confirmed the protection remains high for at least six months after the second dose. In a statement, Pfizer and BioNTech reported the vaccine was 91.3% effective against the disease.
pharmaphorum
MARCH 29, 2021
Akili has published data backing the efficacy of its childhood attention-deficit hyperactivity disorder (ADHD) video game therapy EndeavorRx in the peer-review journal Nature Digital Medicine. . The results come from the STARS-Adjunct trial, an open-label study of EndeavorRx (AKL-T01) that supported approval of the app and video game combination in the US and Europe last year.
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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.
Druggist
APRIL 1, 2021
Amlodipine is one of the most commonly prescribed drugs in the UK and the most prescribed high blood pressure ( BP ) medication. When patients are diagnosed with high blood pressure and a drug is recommended, amlodipine may be the first choice, but not always. Taking any drugs comes with a risk of side effects, with amlodipine associated with few common side effects.
Bio Pharma Dive
MARCH 31, 2021
In a new editorial, three of the agency's advisers reiterated that they see "no persuasive evidence to support approval of aducanumab at this time.
BioSpace
MARCH 28, 2021
The company’s overarching aim is to edit and equip cells with molecular tools, through CRISPR, to eliminate certain cancers.
pharmaphorum
APRIL 1, 2021
AI simulated cell company Turbine is just one of many digital drug discovery firms on the rise in Hungary. We speak to the company’s CEO and co-founder, Szabolcs Nagy, to find out why moving beyond traditional biotech drug development is a good fit for the country’s ecosystem. Hungarian company, Turbine, is taking an alternative approach to the standard biotech drug development model with its AI-based simulated cell technology, which helps the bulk of preclinical drug discovery take place digita
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.
BioPharma Reporter
MARCH 30, 2021
A couple of new developments to report in relation to Merck, known as MSD outside the US and Canada: the first being the rejection by the US FDA of the companyâs application to use its anti-PD-1 therapy, Keytruda, in certain breast cancer patients.
Bio Pharma Dive
MARCH 30, 2021
Merck & Co.'s drug could've been the first immunotherapy approved in the so-called neoadjuvant setting. Its rejection might indicate a higher bar for others with similar ambitions.
BioSpace
MARCH 28, 2021
Servier was found guilty of manslaughter and deceptive marketing practice for its weight-loss pill Mediator. The Paris-based company was fined $3.12 million following a lawsuit that took years to wind its way through the court system.
pharmaphorum
MARCH 30, 2021
Two antibodies targeting different parts of the COVID-19 virus spike protein, from Eli Lilly and GlaxoSmithKline/Vir Biotech, can cut viral load dramatically within a week. . The BLAZE-4 trial found that co-administration of Lilly’s bamlanivimab – already granted emergency approval as a COVID-19 treatment – and GSK/Vir’s experimental antibody VIR-7831 reduced virus levels by 70% after seven days compared to placebo in people with mild or moderate COVID-19 symptoms.
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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.
XTalks
MARCH 29, 2021
Are you getting used to seeing yourself on a webcam more often lately? As most businesses shifted from the office to working from home, professionals are getting used to using webcams for work-related meetings every day. The webcam experience is paramount for professionals from all spheres. The importance of actually looking clear, professional and sharp when using a webcam is critical.
Bio Pharma Dive
APRIL 1, 2021
One vaccine batch being manufactured for J&J by Emergent Biosolutions failed quality checks, reportedly ruining material sufficient for up to 15 million doses.
BioSpace
APRIL 2, 2021
If you’re one of the 17% of Americans that have been fully vaccinated against SARS-CoV-2, you are probably feeling some level of relief. But the CDC warns not to throw your mask away just yet.
Outsourcing Pharma
MARCH 30, 2021
Artificial intelligence software company Thirona has released PRAGMA-AI, technology that automates and accelerates CT scans in cystic fibrosis analysis.
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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.
XTalks
APRIL 1, 2021
Is there arsenic in your baby food? In this week’s episode of the Xtalks Food Podcast, Sydney discusses the Baby Food Safety Act of 2021 which aims to help the FDA regulate heavy metal contamination in baby food. Also in this episode, Mira talks about Pepsi’s unique social media campaign surrounding the launch of its new flavor Pepsi Mango. The team discusses why mango Pepsi may have been chosen as the brand’s first new permanent flavor in five years, and whether Pepsi’s social media-based
Bio Pharma Dive
APRIL 1, 2021
Natalie Holles, who was appointed CEO of Audentes soon after Astellas acquired the gene therapy developer in 2019, has departed amid the company's integration.
BioSpace
MARCH 30, 2021
Lisa Stockman Mauriello was diagnosed with ALS in January and is seeking access to Biogen’s tofersen (BIIB067) through the Right to Try Act. Her case has reinvigorated the ALS community and its fight for expanded access to investigational therapies for this cruel, always fatal disease.
pharmaphorum
MARCH 31, 2021
Novartis has added to its pipeline of radiopharmaceuticals pipeline once again, licensing a series of agents from iTheranostics that can be used to show where tumours are located in the body. . The diagnostic imaging agents all target fibroblast activation protein (FAP), a molecule that is only expressed at low levels on healthy cells but is found much more abundantly in solid tumours.
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