Bio Pharma Dive
SEPTEMBER 15, 2021
Executives at Amylyx Pharmaceuticals said that based on the agency's recent feedback, they will ask for approval of AMX0035 — likely within the next six months.
Pharma Mirror
SEPTEMBER 16, 2021
What is a health coach? A health coach is someone with expertise in wellness who assists people achieve good health by being a mentor and educator on lifestyle and nutritional changes. It is important to understand that health coaching is not only about nutrition, but instead, health coaches offer people a holistic approach to creating and sustaining healthy habits.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
World of DTC Marketing
SEPTEMBER 15, 2021
SUMMARY: With patients staying away from their doctors because of COVID, DTC messages need to add incentives and better messaging to get people to take action rather than wait. No one message will do this, however. Messages need to evolve in these special times. My doctor’s office recently sent me an email that they had plenty of telehealth appointments available for patients who didn’t want to come to the office.
BioSpace
SEPTEMBER 15, 2021
?The FDA's IND approval sets the stage for the very first Phase I/II trial to evaluate EBT-101 as a functional cure for chronic HIV based on the endpoints of safety, tolerability, and efficacy.
Bio Pharma Dive
SEPTEMBER 17, 2021
In a back-and-forth meeting Friday, the committee opposed clearing a third shot widely for use in people older than 16, but agreed the benefits outweighed the risks for adults over 65 or those at risk of severe COVID-19.
pharmaphorum
SEPTEMBER 12, 2021
Deployment of digital health technologies during the pandemic improved patient satisfaction, expanded the delivery of care and augmented training of staff at a leading neurosurgery provider in the US, according to a new study. Faced with the disruption caused by the COVID-19 crisis, Cleveland Clinic centres implemented a number telehealth and audio-visual technologies to compensate for the difficulties in having face-to-face interactions with patients.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
SEPTEMBER 13, 2021
This newfound ability to take tumor cells directly from a patient and incorporate them into a more clinically accurate glioblastoma model could lead to greater patient personalization in cancer therapeutics.
Bio Pharma Dive
SEPTEMBER 15, 2021
The move, which will affect an estimated 270 positions, follows a review by the company's board, and comes just weeks after one of its most advanced drugs failed a key test.
pharmaphorum
SEPTEMBER 15, 2021
The European Commission is reportedly in advanced discussions with French biotech Valneva about picking up the contract to supply COVID-19 vaccines that was terminated by the UK government this week. A French government source told Reuters that the EU is considering using the VLA2001 vaccine as part of its booster campaign plans, along with a shot from Sanofi and GlaxoSmithKline.
Pharma Times
SEPTEMBER 15, 2021
Researchers discovered that treating mice with broad-spectrum antibiotics increased the rate at which their breast cancer tumours grew
Advertisement
White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Drug Patent Watch
SEPTEMBER 14, 2021
Annual Drug Patent Expirations for ANORO+ELLIPTA Anoro Ellipta is a drug marketed by Glaxosmithkline and is included in one NDA. It is available from one supplier. There are fourteen patents…. The post New patent for Glaxosmithkline drug ANORO ELLIPTA appeared first on DrugPatentWatch - Make Better Decisions.
Bio Pharma Dive
SEPTEMBER 13, 2021
Marion Gruber and Philip Krause, two top FDA vaccine reviewers who are unexpectedly departing this fall, joined senior WHO officials in saying booster vaccine doses are not yet widely needed.
pharmaphorum
SEPTEMBER 15, 2021
Researchers in the UK are working on an artificial intelligence (AI) algorithm to help diagnose deep vein thrombosis (DVT) from ultrasound images – and potentially prevent patients from receiving drugs unnecessarily. The team from Oxford University, Imperial College London and the University of Sheffield are working with German tech company ThinkSono on the smartphone-based app, called AutoDVT, and estimate it could cut the cost to health services of each examination by up to $150.
Pharma Times
SEPTEMBER 16, 2021
Through Entia’s virtual oncology platform, patients are able to perform their own blood tests
Advertisement
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.
Drug Patent Watch
SEPTEMBER 14, 2021
Annual Drug Patent Expirations for ZYVOX Zyvox is a drug marketed by Pfizer and is included in three NDAs. It is available from four suppliers. There are two patents protecting…. The post New patent expiration for Pfizer drug ZYVOX appeared first on DrugPatentWatch - Make Better Decisions.
Bio Pharma Dive
SEPTEMBER 14, 2021
The study, which was suspended following three deaths last year, had been restarted in February after Astellas lowered the treatment dose used.
pharmaphorum
SEPTEMBER 15, 2021
Not enough is being done to ensure that patient voices are included in policymaking around digital health, says a new patient organisation in the UK, which aims to set that situation right. The Patient Coalition for AI, Data and Digital Tech in Health has brought together members of patient organisations, medical colleges and health charities to tackle issues such as ensuring equitable access to digital health services.
Outsourcing Pharma
SEPTEMBER 14, 2021
The pharma tech firm has forged a four-year partnership with the foundation to develop antivirals for COVID-19 and other viruses with pandemic potential.
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.
XTalks
SEPTEMBER 17, 2021
World Patient Safety Day 2021 is celebrated on September 17 worldwide. This day raises global awareness about patient safety and calls for solidarity from all counties to reduce patient harm. September 17 is an official global public health campaign marked by the World Health Organization (WHO). World Patient Safety Day joins the ranks of ten other global public health campaigns that include World Tuberculosis Day, World Health Day, World Malaria Day and more.
Bio Pharma Dive
SEPTEMBER 15, 2021
In a briefing document released Wednesday, agency reviewers did not make a strong case either for or against the broad authorization of boosters for the general public.
pharmaphorum
SEPTEMBER 14, 2021
There has been a fourth patient fatality in Astellas’ clinical trial of its AT132 gene therapy for the rare disease X-linked myotubular myopathy (XLMTM), which has been halted twice due to safety concerns. The latest suspension came after abnormal liver function tests (LFTs) were seen in a boy receiving the gene therapy, who has since passed away, according to a statement issued today by the Japanese drugmaker.
BioPharma Reporter
SEPTEMBER 14, 2021
CureVac is streamlining its external European manufacturing network for its mRNA product pipeline; having reassessed demand for its first-generation COVID-19 vaccine candidate.
Advertisement
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
XTalks
SEPTEMBER 17, 2021
The ALS Association is pushing for rapid FDA approval of Amylyx Pharmaceuticals Inc.’s candidate drug AMX0035 (sodium phenylbutyrate/taurursodiol) for the treatment of amyotrophic lateral sclerosis, or ALS. The advocacy group is well known for its Ice Bucket Challenge fundraising that garnered international attention several years ago. This time, the group is backing a drug that they believe will greatly benefit ALS patients.
Bio Pharma Dive
SEPTEMBER 16, 2021
Combining Amen's Lumakras with its drug Vectibix appeared to work better in treating colorectal cancer than Lumakras alone, spurring the biotech to unveil plans for a new Phase 3 trial.
pharmaphorum
SEPTEMBER 16, 2021
Given the rising cost of medicines as a share of the NHS budget in England, the establishment of ICSs provides a timely opportunity to take stock on delivering medicines optimisation at local level, says NHS Gloucestershire CCG’s Ellen Rule. Medicines optimisation aims to improve health outcomes, service quality, and sustainability by ensuring patients are taking their prescribed medicines as recommended to derive the intended benefits and avoid incurring harms.
Outsourcing Pharma
SEPTEMBER 16, 2021
The US agency has given the go-ahead to Cour Pharmaceuticals to evaluate the safety and efficacy of CNP-201, a drug intended to treat peanut allergies.
Advertisement
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
SEPTEMBER 14, 2021
Teatis, a New-York based company, is the maker of superfood powders for diabetic consumers. They announced the close of their seed funding round last week, during which they raised $700,000, bringing the company’s total funding of $1 million. Hiroshi Takatoh is the entrepreneur behind this brand. Takatoh noticed that there is a need for convenient and nutritious food for critically ill consumers.
Bio Pharma Dive
SEPTEMBER 16, 2021
Exkivity follows Johnson & Johnson's Rybrevant on the market for treating lung tumors harboring specific mutations in the EGFR gene. Unlike J&J's drug, however, Takeda's is given orally.
pharmaphorum
SEPTEMBER 16, 2021
Takeda has had a run of bad luck with its Wave1 pipeline of new drug candidates of late, but can now celebrate a vestry after getting FDA approval for first-in-class lung cancer therapy Exkivity. The US regulator has cleared the tyrosine kinase inhibitor (TKI) as a second-line treatment for locally advanced or metastatic non-small-cell lung cancer (NSCLC) patients whose tumours have EGFR exon20 insertion mutations, after first-line chemotherapy.
Scienmag
SEPTEMBER 17, 2021
COLUMBIA, Mo. – While assessing a pregnant woman with premature labor in 1983, Linda Bullock noticed bruises on the woman. When she asked what happened, the woman told Bullock a refrigerator had fallen on her while cleaning the kitchen. Credit: MU COLUMBIA, Mo. – While assessing a pregnant woman with premature labor in 1983, Linda […].
Advertisement
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.
Expert insights. Personalized for you.
360 
Let's personalize your content