Bio Pharma Dive
OCTOBER 31, 2021
Through high-stakes litigation, aggressive patenting practices and a bit of luck, Amgen will likely stretch Enbrel's monopoly until 2029, more than 30 years after it was approved.
World of DTC Marketing
NOVEMBER 5, 2021
SUMMARY: Wegovy is selling so well that it’s hard to get at pharmacies. It’s being positioned as an anti-obesity drug, but one study by Novo Nordisk has shown that people who stop taking Wegovy after a few months tend to regain much of their lost weight within a year. In addition, people who lost weight on Wegovy in clinical trials had nutritional counseling and had to stay on a strict diet.
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Scienmag
NOVEMBER 4, 2021
Since the first reported pangolin seizure in Nigeria in 2010, the country has seen an explosion in the black market for the world’s most trafficked mammal – becoming Africa’s hub for the criminal export of pangolin products to East Asia. Credit: Charles Emogor Since the first reported pangolin seizure in Nigeria in 2010, the country […].
pharmaphorum
NOVEMBER 3, 2021
A real-world study of digital therapeutic (DTx) for opioid use disorder has found that patient show used it had 46% fewer hospital stays than a control group, saving more than $2,700 over a nine-month period. The study of Pear Therapeutics’ reSET-O found that the total cost of hospital and clinician costs were $11,141 among 64 patients who were prescribed the DTx but didn’t use it, but fell to $8,733 among active users of the 12-week course.
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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
NOVEMBER 5, 2021
The drugmaker, which last week won FDA clearance of its vaccine in younger children, plans to quickly ask the agency for emergency authorization of the drug in high-risk patients.
World of DTC Marketing
NOVEMBER 1, 2021
SUMMARY: According to eMarketer, “in 2020, spending on digital advertising in the healthcare and pharma industry will grow by 14.2% to reach $9.53 billion, making it the fastest-growing sector after computing products and consumer electronics (which will grow 18.0% this year). How reliable is this estimate? eMarketer has been wrong more times than I can count.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
NOVEMBER 5, 2021
An oral antiviral drug developed by Pfizer has been shown to dramatically cut the risk of hospitalisation or death from COVID-19 when given in the early stages of infection. The phase 3 trial found that Paxlovid – which combines new protease inhibitor PF-07321332 with already-approved HIV drug ritonavir – reduced the risk of hospitalisation or death by 89% when given to newly-diagnosed adults who were at risk of developing severe COVID-19 in the EPIC-HR trial.
Bio Pharma Dive
NOVEMBER 3, 2021
With an initial investment of $20 million, the collaboration will use technologies from various Flagship-backed companies to discover and develop new therapies for the disease.
Scienmag
NOVEMBER 2, 2021
Increased mortality risk among current alcohol abstainers might largely be explained by other factors, including previous alcohol or drug problems, daily smoking, and overall poor health, according to a new study publishing November 2nd in PLOS Medicine by Ulrich John of University Medicine Greifswald, Germany, and colleagues. Credit: Alexas_Fotos, CCO ([link] Increased mortality risk among […].
BioSpace
NOVEMBER 4, 2021
Pfizer plans to seek Emergency Use Authorization for an antiviral COVID-19 treatment following an interim analysis of Phase II/III data that show statistically and clinically meaningful results.
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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
NOVEMBER 1, 2021
Novartis has claimed FDA approval for one of its ‘wild card’ drugs – Scemblix – a first-in-class STAMP inhibitor for patients with previously-treated chronic myeloid leukaemia (CML). Scemblix (asciminib) was one of a clutch of high risk, high reward drug candidates for a range of diseases that Novartis chief executive Vas Narasimhan said last year were flying under-the-radar of industry watchers, but could potentially develop into blockbusters.
Bio Pharma Dive
NOVEMBER 1, 2021
The FDA wants to better understand the risk of vaccine-associated myocarditis in 12- to 17-year-olds based on real-world use overseas, which will set back Moderna’s authorization plans in the U.S.
Scienmag
NOVEMBER 3, 2021
Clinicians and the wider research community involved in treating advanced breast cancer (ABC) need to do more to help and encourage patients to join clinical trials, according to a patient advocate who is leading a study that shows only 14% of ABC patients in the UK have been recruited to a trial. Credit: Lesley Stephen […].
BioPharma Reporter
NOVEMBER 4, 2021
Lonza has been investing in developing exosome manufacturing and characterization technologies for the past five years, and this week it ramped up its focus on that category by acquiring two sites.
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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.
pharmaphorum
NOVEMBER 5, 2021
Novartis has chalked up another successful trial for its targeted factor B inhibitor iptacopan, an orally-active drug trying to challenge antibody-based therapies for diseases associated with the complement pathway. A phase 2 trial of iptacopan in patients with the rare kidney disease C3 glomerulopathy (C3G) – which causes progressive kidney failure and has no approved treatments – showed reductions in kidney damage with the drug that Novartis said were “clinically important.” C3G of
Bio Pharma Dive
NOVEMBER 3, 2021
Data readouts for Pfizer's hemophilia gene therapies are now expected later than previously forecast, while the company also works through modifying a trial of its Duchenne treatment.
XTalks
NOVEMBER 1, 2021
Each year, World Vegan Day falls on November 1 as a way to celebrate veganism and appreciate its benefits to humans and the environment. While veganism is far from new, it has gained mass popularity over the last few decades with the advancement of plant-based food technology and a greater push for food sustainability. So, what is the history behind World Vegan Day and how is it being celebrated in 2021?
BioPharma Reporter
NOVEMBER 5, 2021
CEPI, the Coalition for Epidemic Preparedness Innovations, has announced the first funding awards under a $200m program to advance development of vaccines against SARS-CoV-2 variants and other betacoronaviruses.
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.
pharmaphorum
NOVEMBER 4, 2021
After more than 20 years, Novartis has finally decided to sell its substantial share in fellow Swiss pharma group Roche for $20.7 billion, a decent return on its original $5 billion investment. The agreement will see Novartis lose its one-third voting share stake in Roche, after agreeing to sell 53.3 million Roche bearer shares at their average price over 20 days prior to 2 November, when the deal was agreed.
Bio Pharma Dive
NOVEMBER 2, 2021
The biotech has identified gene editing as a natural fit for the technology it uses to deliver its vaccines and drugs. A deal with Metagenomi, a startup backed by Bayer, will further those ambitions.
XTalks
NOVEMBER 4, 2021
As people get older, many often experience reading problems due to blurriness in their near vision in a condition called presbyopia. Now, instead of reaching for reading glasses, AbbVie’s eyedrop formulation Vuity could offer help in correcting far-sightedness as the US Food and Drug Administration (FDA) granted approval to it late last week. Vuity is a 1.25 percent pilocarpine HCL ophthalmic solution made by AbbVie-owned Allergan.
BioPharma Reporter
NOVEMBER 5, 2021
Biomunex Pharmaceuticals, a French company focused on the discovery and development of bi- and multi-specific antibodies, sees its BiXAb5 project receive nearly â3m (US$3.5m) in the form of a grant from the French government.
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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.
pharmaphorum
NOVEMBER 4, 2021
Routine vaccination with human papillomavirus vaccines have resulted in an 87% reduction in cervical cancer cases in England, and could even see the need for smear tests phased out in future, according to a new study. The jabs with have been offered by the NHS to girls between the ages of 12 and 13 since 2008, with more than 10 million doses administered since then, and from September 2019 was also offered to boys in the same age group.
Bio Pharma Dive
NOVEMBER 2, 2021
The three-month delay could give an advantage to Bristol Myers Squibb, which holds the first approval for a CAR-T therapy for the blood cancer.
XTalks
NOVEMBER 4, 2021
Food delivery robots are no longer the stuff of science fiction. The knee-high robots — capable of transporting around four large pizzas — are now making their way around college campuses and large cities in the US, UK and Canada. While they were in the works prior to the COVID-19 pandemic, demand for contactless delivery caused a boom in the number of food delivery robots navigating the streets.
JAMA Internal Medicine
OCTOBER 31, 2021
This case series cohort study examines the association of onset of Guillain-Barré Syndrome following vaccination with the recombinant zoster vaccine in Medicare beneficiaries.
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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.
pharmaphorum
OCTOBER 31, 2021
The FDA has approved the first and so far only pharmacological treatment for presbyopia, a sight condition that typically starts in middle age and involves difficulty in focusing on near objects. The approval has been granted to Vuity (formerly AGN-190584 ), a one-daily eyedrop formulation of muscarinic cholinergic agonist pilocarpine developed by AbbVie’s Allergen unit that is now an alternative to reading glasses, contact lenses or laser eye surgery for the disorder.
Bio Pharma Dive
NOVEMBER 2, 2021
The biotech has officially filed for an accelerated review of its closely watched ALS drug, an outcome that seemed unlikely just a few months ago.
XTalks
NOVEMBER 2, 2021
The government of Scotland has rolled out a new C-peptide test for type 1 diabetes that could help patients monitor their insulin levels with greater accuracy. The test provides information about the amount of insulin a patient has in their body, which can help determine whether they can reduce or stop taking their insulin injections. The test measures levels of C-peptide protein in the blood, which is a byproduct of insulin synthesis that is released from the pancreas along with the hormone.
NY Times
OCTOBER 30, 2021
It was the state’s first lethal injection since 2015, when it halted executions after using the wrong drug in one instance and allowing a prisoner to regain consciousness in another.
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