pharmaphorum

DECEMBER 22, 2022

The life sciences industry is flexing towards innovation in new areas, faster than ever before, and increasing patient care in astonishing ways. Decentralised oncology trials, for example, have shown actual predictive outcome value. We can now measure patient activity, steps, and movement continuously and in real time, which serves as a new potential indicator of treatment effectiveness. 1 And, digital therapeutics have emerged as an effective treatment for chronic diseases, including mental ill

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Bio Pharma Dive

DECEMBER 19, 2022

The OK caps a long development journey for the treatment, which was previously turned back by the agency. Ferring doesn’t expect it to be available until the second half of next year, however.

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Gene Therapy FDA Approval Gene Development 353

Pharmaceutical Technology

DECEMBER 21, 2022

Moderna and the UK government have entered a ten-year strategic collaboration to build a messenger ribonucleic acid (mRNA) research, development and manufacturing facility in the country. The latest development comes after the parties announced an agreement in principle in June this year. This Moderna Innovation and Technology Centre (MITC) is expected to offer access to a locally produced future mRNA vaccine portfolio against respiratory viruses, subject to regulatory evaluation and licensure.

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AuroBlog - Aurous Healthcare Clinical Trials blog

DECEMBER 22, 2022

Athletes scaled new heights during the 2020 Tokyo Olympics with the addition of seven new sports, including karate and climbing. But while overall injuries remained comparable to previous games, some of the new sports contributed a disproportionately large portion of them. [link] To safeguard athletes’ wellbeing the International Olympic Committee (IOC) audits injuries and illnesses […].

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Clinical Trials Clinical Trials Clinical Research Trials 246

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

Medicine

NPR Health - Shots

DECEMBER 23, 2022

A team of researchers' study suggests that COVID-19 health leaders incorporate exercise into their mitigation strategies.

Research 145

Research 145

Bio Pharma Dive

DECEMBER 21, 2022

Lynparza’s authorization in first-line prostate cancer comes days after U.S. regulators delayed a decision on the same indication, a potential sign of the FDA’s concerns around PARP blockers.

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Regulation Drugs 323

AuroBlog - Aurous Healthcare Clinical Trials blog

DECEMBER 20, 2022

Restricting our food intake can result in a range of health benefits, including reducing the risk of obesity. But when the dieting stops, the weight often piles back on, and a new study in mice may have identified why. [link] Scientists from the Shanghai Institute of Nutrition and the Chinese Academy of Sciences think they […].

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Bacteria Scientist Clinical Trials Clinical Trials 245

NPR Health - Shots

DECEMBER 21, 2022

A new report shows the pandemic and the overdose crisis helped push down the average life expectancy in the U.S. for a second year in a row.

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Bio Pharma Dive

DECEMBER 20, 2022

The proposed bill would strengthen rules around confirmatory testing, help speed product withdrawals and set up a panel of agency officials to better coordinate policy.

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Production Drugs 317

Pharmaceutical Technology

DECEMBER 18, 2022

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended granting variation to the marketing authorization (MA) for Moderna ’s Spikevax bivalent Original/Omicron BA.1 (mRNA-1273.214) booster for usage in children aged six to 11 years. The 0.25mL dose of the booster vaccine could potentially be used in the European Union (EU) following authorisation in these children a minimum of three months following a previous Covid-19 vaccination.

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Gene Therapy Vaccine Vaccination Clinical Trials 304

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Clinical Supply

AuroBlog - Aurous Healthcare Clinical Trials blog

DECEMBER 19, 2022

Going outdoors more during the day might lead to slipping into sleep more easily during the night, according to a new study that found a relationship between the seasons and shifts in sleeping patterns. While the study found the number of hours of slumber banked across summer, fall, winter, and spring were similar, in the […].

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Clinical Trials Clinical Trials Trials 240

STAT News

DECEMBER 20, 2022

Lots of people struggle to get enough sleep — and the responsibility for fixing the problem tends to fall on the individual. Experts offer advice like reducing screen time, exercising more, or just going to bed earlier in the evening. But many restless nights can’t be solved with blackout curtains, ear plugs, or other typical suggestions.

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Bio Pharma Dive

DECEMBER 21, 2022

The pharma dosed the first patient in a Phase 2 study testing a treatment it hopes could compete with closely-watched weight-loss drugs from Lilly, Novo Nordisk and Amgen.

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Drugs 312

Pharmaceutical Technology

DECEMBER 22, 2022

Fentanyl is a powerful opioid (a narcotic analgesic that is at least partly synthetic) that is being trafficked in increasing quantities from Mexico to the US by cartels. The Drug Enforcement Administration (DEA) recently announced that it had seized 10,000 pounds of illicit fentanyl in 2022 and pointed out that this volume represented enough fentanyl to kill every American.

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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

Clinical Trials

AuroBlog - Aurous Healthcare Clinical Trials blog

DECEMBER 21, 2022

Scientists have found an extremely subtle twist in the genetics of aging cells, one that seems to make them increasingly less functional as time goes on. Researchers from Northwestern University have revealed animals like mice, rats, killifish, and even humans show a gradual imbalance of long and short genes in virtually every cell in their […].

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Genetics Gene Scientist Research 222

Medical Xpress

DECEMBER 20, 2022

Using machine learning and clinical data from electronic health records, researchers at the Icahn School of Medicine at Mount Sinai in New York constructed an in silico, or computer-derived, marker for coronary artery disease (CAD) to better measure clinically important characterizations of the disease.

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Bio Pharma Dive

DECEMBER 22, 2022

The pharma will pay the Chinese drugmaker $175 million for access to seven preclinical antibody-drug conjugates, deepening ties established this year.

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Drugs Antibody 311

Pharmaceutical Technology

DECEMBER 19, 2022

Sanofi has extended the partnership with Innate Pharma for natural killer (NK) cell therapeutics in oncology. With the latest development, Sanofi will licence a NK cell engager programme that acts on B7H3 from the antibody-based NK cell engager therapeutics (ANKET) platform of Innate. Under the latest licence deal, Sanofi will make an upfront payment of $26.4m (€25m) to Innate.

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Development Engineer Clinical Trials Clinical Trials 264

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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.

Clinical Trials

AuroBlog - Aurous Healthcare Clinical Trials blog

DECEMBER 22, 2022

Indian drug regulators have sought pharmacovigilance (PV) for neuropathic pain drugs gabapentin and pregabalin due to cardiovascular related adverse event citing a study by American medical journal Cardiovascular Diabetology. PV is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine or vaccine related problem, according […].

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Drugs Regulation Vaccine Vaccination 203

pharmaphorum

DECEMBER 19, 2022

A collaboration between academic centres in the UK has won government funding for a digital approach to dysfunctional breathing or dyspnoea, a symptom that affects around 10% of the population. The Engineering and Physical Sciences Research Council (EPSRC) has set aside £400,000 (almost $490,000) for the project, which will help fund work at the Universities of Plymouth, Salford and Stirling, and the Glasgow School of Art.

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Bio Pharma Dive

DECEMBER 19, 2022

Removal of the partial study suspension, which the agency imposed last December after a case of persistent anemia, helps clear the way for Bluebird to submit an approval application early next year.

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Gene Therapy Gene 312

Pharmaceutical Technology

DECEMBER 20, 2022

Biotechnology firm LianBio has announced that Pfizer opted in to secure the right to develop and commercialise the respiratory syncytial virus (RSV) therapeutic candidate, sisunatovir, in Mainland China, Hong Kong, Macau, and Singapore. The deal is pursuant to the existing strategic collaboration of the companies for expanding patient access to new therapeutics in Greater China.

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Licensing Licensing Development Sales 162

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.

Clinical Research

AuroBlog - Aurous Healthcare Clinical Trials blog

DECEMBER 19, 2022

The Indian Pharmacopoeia Commission (IPC) has flagged drug safety alert to the Drugs Controller General of India (DCGI) revealing that Minoxidil is associated with adverse event known as folliculitis. IPC is the National Coordination Centre (NCC) for Pharmacovigilance Programme of India (PvPI).Minoxidil topical solution has been approved in India for the treatment of hair loss […].

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Drugs Clinical Trials Clinical Trials Clinical Research 185

Medical Xpress

DECEMBER 20, 2022

Probiotic bacteria usually found in fermented foods, such as yogurt, sourdough bread, and miso soup, might help dispel the embarrassment of persistent bad breath (halitosis), finds a pooled data analysis of the available evidence, published in the open access journal BMJ Open.

Bacteria 145

Bacteria 145

Bio Pharma Dive

DECEMBER 19, 2022

The company said its experimental drug helped patients with the fatty liver disease while also improving fibrosis. One analyst called the readout a “major win” for Madrigal and the NASH field.

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Drugs 289

Pharmaceutical Technology

DECEMBER 20, 2022

Japan has granted approval for Bristol-Myers Squibb ’s (BMS) Breyanzi (lisocabtagene maraleucel; liso-cel) as second-line therapy to treat relapsed or refractory (r/r) large B-cell lymphoma (LBCL) patients. The treatment is indicated for usage in such patients irrespective of autologous hematopoietic stem-cell transplantation status. This approval is based on clinical trial findings in subjects with r/r aggressive B-cell non-Hodgkin lymphoma following first-line therapy.

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Clinical Supply

AuroBlog - Aurous Healthcare Clinical Trials blog

DECEMBER 20, 2022

The National Accreditation Board for Hospitals & Healthcare Providers (NABH) has announced four days dental healthcare service providers’ assessors’ training programme as per second edition of Dental Healthcare Service Providers Accreditation Standards between January 17 and January 20, 2023 in New Delhi. Last Date to receive applications is December 24, 2022.

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Clinical Trials Clinical Trials Trials 184

NPR Health - Shots

DECEMBER 21, 2022

An examination of billing policies and practices at more than 500 hospitals across the country shows widespread reliance on aggressive collection tactics.

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Bio Pharma Dive

DECEMBER 19, 2022

Glofitimab, part of a long-standing collaboration between the two companies that’s resulted in Rituxan and Ocrevus, will be the responsibility of Roche, which will pay out royalties.

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Development Drugs 278

Pharmaceutical Technology

DECEMBER 20, 2022

Catalyst Pharmaceuticals has signed a definitive agreement with Eisai to acquire the US commercial rights for the latter’s anti-epileptic drug (AED), Fycompa (perampanel) CIII. Under the deal terms, Catalyst will also have an exclusive period to assess, review, and negotiate to buy a rare epilepsy asset in Eisai’s pipeline. Eisai will retain its rights to Fycompa in countries outside the US.

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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.

Clinical Trials