Bio Pharma Dive
SEPTEMBER 7, 2021
On the heels of a two-day FDA meeting in which experts debated the risks of gene therapy, the biotech said its early-stage PKU treatment was associated with cancer in mice.
Pharma Mirror
SEPTEMBER 7, 2021
The Hague, Pharmacists must be allowed to do more to manage respiratory conditions in communities if the urgent need to address the harmful effects of air pollution on health is to be met, the International Pharmaceutical Federation (FIP) said today. The expansion of pharmacists’ roles in mitigating the health threats of air pollution is among several actions described in a call to action issued by FIP, marking the United Nations International Day of Clean Air for Blue Skies.
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World of DTC Marketing
SEPTEMBER 9, 2021
SUMMARY: Allowing Medicare to negotiate drug prices is popular with voters because the media has been focused on the high price of some drugs, but this measure won’t lead to lower healthcare costs. Still, in a JAMA study, the median net income (earnings) expressed as a fraction of revenue was significantly greater for pharmaceutical companies than nonpharmaceutical companies (13.8% vs. 7.7%).
Camargo
SEPTEMBER 8, 2021
Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Some Drugs May Require Reclassification to Devices. On August 9, the FDA published a Federal Register notice requesting information and comments regarding products currently classified as drugs which may require reclassification as devices.
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
Bio Pharma Dive
SEPTEMBER 8, 2021
The company has previously said it could make up to three billion vaccine doses in 2022, depending on how booster shots are authorized.
Pharma Mirror
SEPTEMBER 7, 2021
Increasing burden of chronic diseases and rising awareness about necessity of early warning signs are fuelling the demand of remote patient monitors With the COVID-19 pandemic, health systems or hospitals rapidly adopted remote patient monitoring technology to maintain social distancing and thereby control viral spread. Patients suffering from COVID – 19 need to monitor blood oxygen level and heart rate regularly.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharma Times
SEPTEMBER 6, 2021
UK’s chief medical officers will now provide ‘further advice’ on COVID-19 vaccination in this age group
Bio Pharma Dive
SEPTEMBER 9, 2021
The French drugmaker bought Principia Biopharma last year for two therapies that block a protein called BTK. The second targets a much bigger disorder, multiple sclerosis.
pharmaphorum
SEPTEMBER 6, 2021
UK researchers have used artificial intelligence (AI) to develop a way to identify patients with heart failure who would benefit from treatment with beta blockers, by interrogating data from nine landmark clinical trials. The study applied machine learning to trial data involving 15,659 patients who were being treated for heart failure with reduced ejection fraction (HFrEF), a form of heart failure where the left side of the heart isn’t able to pump blood effectively around the body.
World of DTC Marketing
SEPTEMBER 7, 2021
SUMMARY: John F. Kennedy said, “Change is the law of life, and those who look only to the past and present are certain to miss the future”. Change is coming for one simple reason; our country can’t sustain the current costs of healthcare. Today’s pharma CEOs should prepare their organizations for the future, not wasting money with lobbying costs.
Pharma Times
SEPTEMBER 9, 2021
The trial will aim to enrol 640 healthy adults, aged 50- to 70-years-old
Bio Pharma Dive
SEPTEMBER 10, 2021
At Morgan Stanley’s healthcare conference, executives detailed how the launch of their Alzheimer’s drug has been slower than expected, due in large part to lingering questions about clinical trial data and insurance coverage.
pharmaphorum
SEPTEMBER 6, 2021
Balancing medical privacy with ease of access for healthcare professionals is a challenge, but technology could provide the solution, says Aleph Zero Foundation’s Matthew Niemerg. Most people don’t think of healthcare when they hear blockchain, and that’s understandable; the technology so far hasn’t gone much beyond financial instruments – at least, not in the eyes of the public.
World of DTC Marketing
SEPTEMBER 10, 2021
SUMMARY: Marci Hamilton, a professor at the University of Pennsylvania Constitution, said, “The Constitution is not a suicide pact guaranteeing a right to harm others. The government has the latitude to protect citizens from deadly conditions, especially when the science supporting vaccination is so clear” We, as a nation, can not allow ignorance and stupidity to endanger us all.
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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
BioPharma Reporter
SEPTEMBER 7, 2021
Moderna and the nonprofit Institute for Life Changing Medicines (ILCM) are collaborating to develop a new messenger RNA (mRNA) therapeutic (mRNA-3351) for Crigler-Najjar Syndrome Type 1 (CN-1), an ultra-rare disease.
Bio Pharma Dive
SEPTEMBER 7, 2021
Wall Street analysts expect little impact on biotech developers after an inconclusive discussion last week. Yet the FDA still appears wary, as shown by a new hold on a BioMarin rare disease treatment.
Pharma Mirror
SEPTEMBER 9, 2021
Sterling Pharma Solutions, a global contract development and manufacturing organisation, today announced the completion of the initial phase of investment at its site in Dudley, UK to create the company’s centre of excellence for research into commercial applications of continuous flow chemistry. Announcement of the investment follows the appointment of Professor Ian R.
Pharma Times
SEPTEMBER 7, 2021
New analysis from the Health Foundation's REAL Centre warns extra support and investment needed
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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
SEPTEMBER 8, 2021
An artificial intelligence algorithm was able to detect signs of lung cancer on CT scans a year earlier than with traditional methods, according to a new study. CT (computed tomography) scans are already used to spot signs of lung tumours, followed by a biopsy or surgery to confirm whether the tumour is malignant, according to Benoît Audelan, a researcher at France’s National Institute for Research in Digital Science and Technology.
Bio Pharma Dive
SEPTEMBER 7, 2021
Long a bystander in the race to develop so-called allogeneic treatments, the cancer drugmaking giant has joined the fray with a wide-ranging alliance that could be worth up to $3 billion.
Pharma Mirror
SEPTEMBER 8, 2021
Marseille, France, Provepharm Life Solutions, a private French pharmaceutical company that finds new applications for well-known molecules, today announces a €120 million ($142.3M) strategic funding. Tikehau Capital will provide the funds and joins the group’s pool of banking investors, including Société Générale, BNP Paribas, Banque Populaire Méditerranée, Crédit Agricole Alpes Provence and Bpifrance.
Pharma Times
SEPTEMBER 10, 2021
Treatment approved for adults and adolescents with moderate to severe atopic dermatitis
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
SEPTEMBER 8, 2021
Rapid creation of compliant marketing content is increasingly important and there are ways emerging pharma companies can stay ahead of the game – despite having fewer resources than bigger firms. A new pharma marketing content ebook from Veeva looks at best practices for building a content foundation that can enable long-term growth. It explains how to launch, scale faster, and improve the time to marker for localised, compliant content with cloud-based content management.
Bio Pharma Dive
SEPTEMBER 9, 2021
Formed as a diagnostics developer, Mammoth Biosciences, which Doudna started with two of her former students at the University of California, has accelerated plans to make gene editing medicines as well.
Pharma Mirror
SEPTEMBER 7, 2021
Singapore, Local family cord blood bank Cryoviva Singapore ([link] is continuing with its rapid geographic growth plans with an entry into the Bahrain market. This latest new market entry closely follows Cryoviva establishing a footprint in Dubai to serve couples in the UAE that are on the family way. “It fills the entire Cryoviva team with a great sense of pride and satisfaction to help customers in Bahrain and add another nation to the list of countries we serve from Singapore.
Pharma Times
SEPTEMBER 6, 2021
New government body will be co-led by deputy chief medical officer Jeanelle de Gruchy
pharmaphorum
SEPTEMBER 10, 2021
A digital health company focusing on neurodegenerative disorders – Neuroglee Therapeutics – has raised $10 million in first-round funding to roll out a virtual neurology clinics for people with cognitive problems caused by dementia. The Singapore startup, which is partnering with the Mayo Clinic on the clinics, said the cash injection will also go towards the development of its pipeline of digital therapeutics (DTx) for Alzheimer’s disease and other neurodegenerative conditions.
Bio Pharma Dive
SEPTEMBER 8, 2021
The acquisition, which took some analysts by surprise, will give the French pharma an approved treatment for graft-versus-host disease.
Pharma Mirror
SEPTEMBER 6, 2021
TOKYO, TANAKA Kikinzoku Kogyo K.K. (Head office: Chiyoda-ku, Tokyo; Representative Director & CEO: Koichiro Tanaka), which is a subsidiary of TANAKA Holdings Co., Ltd. and operates the TANAKA Precious Metals manufacturing business, announced today that TANAKA made an equity contribution to Ambix Life Science Fund I, L.P., a medical device venture fund managed by Ambix Venture Management, LLC, a U.S.
Pharma Times
SEPTEMBER 8, 2021
The independent data monitoring committee (DMC) has recommended continuation of the Phase III trial
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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.
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