Bio Pharma Dive
JUNE 27, 2022
The regulator suspended testing of Astellas’ Pompe disease treatment after one patient experienced peripheral nerve damage. Both of the pharma’s clinical-stage gene therapies are now on hold.
Pharmaceutical Technology
JUNE 29, 2022
Approximately 75,000 enzymes are thought to exist in the human body as vital catalysts for biochemical reactions or conversions. For hundreds of years, we have found myriad uses for microbial enzymes in manufacturing – from food, drink, and household products to a range of industrial applications. The pharmaceutical industry often relies on enzymes to perform a process known as biocatalysis, which facilitates the cost-effective and sustainable production of small molecule drugs at scale.
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World of DTC Marketing
JUNE 29, 2022
Suppose you’re on Facebook or Instagram, and Meta has determined you may be interested in cancer treatments. In that case, you may have seen an ad for a dangerous cancer treatment, or one of the 20 or so others recently running from the CHIPSA hospital in Mexico near the US border, all of which are publicly listed in Meta’s Ad Library. They are part of a pattern on Facebook of ads that make misleading or false health claims targeted at cancer patients.
Rethinking Clinical Trials
JUNE 30, 2022
Dr. Karen Sherman. In connection with the NIH Pragmatic Trials Collaboratory Steering Committee meeting and 10th anniversary celebration, we asked Drs. Karen Sherman and Lynn DeBar to update us on the Pragmatic Trial of Acupuncture for Chronic Low Back Pain in Older Adults (BackInAction) Demonstration Project. BackInAction is a pragmatic randomized trial to evaluate the safety and effectiveness of treatments for older adults with chronic low back pain.
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
JUNE 27, 2022
Epizyme, which was once worth more than $2 billion, agreed to be bought for $247 million upfront. The biotech has continued to lose money despite winning FDA approval for a drug for rare cancers.
Pharmaceutical Technology
JUNE 29, 2022
The European Commission (EC) has granted marketing authorisation for Gilead Sciences’ subsidiary Kite’s CAR T-cell therapy, Yescarta (axicabtagene ciloleucel), to treat adults with relapsed or refractory follicular lymphoma (FL). . A CD19-directed genetically modified autologous T cell immunotherapy, Yescarta is indicated for FL patients who have received three or more previous lines of systemic therapy.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
JUNE 27, 2022
Danish researchers published a study suggesting that COVID-19 increases the risk of neurodegenerative diseases such as Alzheimer’s and Parkinson’s disease.
Bio Pharma Dive
JUNE 29, 2022
The Swiss pharma confirmed it will cut as many as 1,400 jobs in Switzerland and thousands more globally under a reorganization plan first announced in early April.
Pharmaceutical Technology
JULY 1, 2022
The latest issue of Pharma Technology Focus is out now. Read it for free on all devices. Some months after the first Covid-19 vaccines became available, the World Health Organization (WHO) set a target of vaccinating 70% of each country’s population by the end of June 2022. Global trends indicate that initially, a slow supply did not allow African countries, in particular, to stay on pace to meet this target, and now vaccination rates have even begun to slow down.
Pharma Times
JUNE 29, 2022
AVA6000 is a novel form of doxorubicin that has been modified using Avacta’s delivery platform to improve safety
Worldwide Clinical Trials
JUNE 28, 2022
Jessica Moffitt, Associate Recruiter, Talent Acquisition. As an Associate Recruiter in Talent Acquisition, Jessica Moffitt understands how valuable the DEI&B program is to her work – day-in and day-out – and to Worldwide’s People, Strategy and Culture (PSC) program overall. Speaking personally, Jessicia says: “I have struggled to thrive in typical corporate positions that promote conformity at the expense of the individual.
Bio Pharma Dive
JUNE 30, 2022
Data compiled by BioPharma Dive show a growing gap in the frequency and size of new stock offerings compared to prior years. Some analysts believe as many as a third of public biotechs must “go away” before the sector’s slump ends.
Pharmaceutical Technology
JUNE 29, 2022
The proportion of pharmaceutical companies hiring for AI related positions kept relatively steady in May 2022 compared with the equivalent month last year, with 39.3% of the companies included in our analysis recruiting for at least one such position. This latest figure was higher than the 39% of companies who were hiring for AI related jobs a year ago but a decrease compared to the figure of 43.6% in April 2022.
Rethinking Clinical Trials
JUNE 27, 2022
Dr. Ted Melnick and Dr. Gail D’Onofrio, co–principal investigators of EMBED. Implementation of a user-centered clinical decision support tool did not increase the rate of patients receiving buprenorphine for treatment of opioid use disorder in the emergency department (ED) when compared to usual care. When the tool was used, it was associated with high rates of buprenorphine initiation, and the tool increased the number of physicians who provided ED-initiated buprenorphine and naloxone pre
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pharmaphorum
JUNE 27, 2022
An antisense drug in development at GSK has shown further activity against hepatitis B virus (HBV) in a mid-stage trial, setting up a phase 3 assessment next year to see if it could offer a “functional cure” for the widespread disease. Interim results from the phase 2b B-Clear showed that bepirovirsen reduced levels of hepatitis B surface antigen (HBsAg) and HBV DNA after 24 weeks’ treatment to below the lower limit of detection in people with chronic hepatitis B, raising hopes
Bio Pharma Dive
JUNE 30, 2022
Amid a historic market downturn, the precision drug company is raising money through royalty financings with Sixth Street and Royalty Pharma.
Pharmaceutical Technology
JULY 1, 2022
Pfizer has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking approval for Paxlovid (nirmatrelvir tablets and ritonavir tablets) to treat Covid-19 patients at increased disease progression risk. An inhibitor of SARS-CoV-2 main protease (Mpro), Paxlovid is intended to be given orally. Due to the oral form, the therapy can be prescribed in the early infection stage to avert severe illness.
Pharma Times
JUNE 30, 2022
Centre will accelerate drug development and enable precision health solutions
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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
JUNE 30, 2022
The FDA’s decision not to approve Spero Therapeutics’ oral antibiotic tebipenem Hbr for adults with complicated urinary tract infections (cUTI) further increases the threat of antibiotic resistance, according to a GlobalData analyst. The FDA delivered a blow to Spero’s hopes of bringing the carbapenem to market in a complete response letter (CRL) delivered this week, which said another trial would be required to support approval.
Bio Pharma Dive
JUNE 29, 2022
Between July and September, the regulator could approve a first-of-its-kind autoimmune drug and two gene therapies as well as decide how COVID-19 vaccines should be updated.
Pharmaceutical Technology
JUNE 29, 2022
Terumo Blood and Cell Technologies and BioBridge Global subsidiary, GenCure, have entered a new partnership agreement to expand and integrate cell and gene therapy manufacturing solutions. In a bid to meet the growing demand for automated and closed smart systems across the cell and gene therapy (CGT) industry, the companies entered the deal to merge technologies and capabilities.
BioPharma Reporter
JUNE 27, 2022
Australian biotech Skin2Neuronâs new form of cell therapy reversed a dementia-like syndrome in dogs, according to results of a veterinary trial.
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
JUNE 27, 2022
Cosentyx receives expanded approvals in EU for use in childhood arthritic conditions
Bio Pharma Dive
JUNE 27, 2022
The biotech company revealed three new drug candidates for breast cancer, while laying out a path to regulators for its most advanced treatment.
Pharmaceutical Technology
JUNE 28, 2022
Astellas Pharma and Sutro Biopharma have entered a global, strategic partnership and licencing agreement to discover and develop new immunostimulatory antibody-drug conjugates (iADCs). An iADC merges an antibody with a small molecule compound that elicits immunogenic cell death, and an immune-activating molecule. It can potentially enhance the anti-cancer effect.
Rethinking Clinical Trials
JUNE 27, 2022
A special series of articles addressing pragmatic and virtual trials appears this week in the journal Contemporary Clinical Trials and offers practical approaches to the many challenges clinical trials face. The 14 articles bring together leaders, researchers, biostatisticians, and bioethicists—including members of the NIH Pragmatic Trials Collaboratory—who are rethinking key aspects of the development, conduct, and oversight of clinical trials.
pharmaphorum
JUNE 29, 2022
Bayer has stepped up the digital capabilities of its radiology business with the launch of artificial intelligence-based apps for X-ray, MRI and CT imaging. The cloud-hosted platform – called Calantic Digital Solutions – has tools to help radiologists detect and quantify disease lesions in medical images and select patients for treatment in order of priority, improving their productivity.
Bio Pharma Dive
JUNE 28, 2022
Positive results for the treatment, which was developed by U.K. biotech MeiraGTx, could rebuild expectations after another gene therapy from Biogen failed in the retinal disease.
Pharmaceutical Technology
JUNE 27, 2022
Last Friday, the World Health Organization (WHO) launched updated guidelines for the treatment of hepatitis C , calling for testing and treatment to be delivered in peripheral and community-based facilities and integrating these with available care services. While some countries are making progress in eliminating hepatitis C, many remain challenged in reaching those affected, Dr Philippa Easterbrook, Senior Scientist at WHO’s Department of Global HIV, Hepatitis and Sexually Transmitted Infection
Pharma Times
JULY 1, 2022
Xenpozyme is a treatment for ASMD and the condition’s only current enzyme replacement therapy
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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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