Scienmag

JULY 11, 2021

They identify LAPAS1 as a novel E2F-regulated lncRNA that has a potential role in human cancer and regulates cell-cycle progression and cell proliferation Credit: Correspondence to – Doron Ginsberg – doron.ginsberg@biu.ac.il Oncotarget published “A novel E2F1-regulated lncRNA, LAPAS1, is required for S phase progression and cell proliferation” which reported that long non-coding RNAs are major […].

Regulation 98

Regulation Medicine 98

BioSpace

JULY 11, 2021

Sana Biotechnology, a gene and cell therapy hybrid whose mission is to create and deliver engineered cells as medicines for patients, puts the “I” first in Inclusion, Diversity and Equity (IDE).

Engineer 95

Engineer Gene Medicine 95

Scienmag

JULY 11, 2021

Credit: Fisk University FUTURE-MINDS-QB, a bridge program streamlining a path from a master’s degree at Fisk University, a historically Black university in Nashville, to a doctoral degree at University of Illinois Urbana-Champaign, has received a T32 training grant from the National Institute of General Medical Sciences (NIGMS) of the National Institutes of Health (NIH).

Doctors 87

Doctors Doctor 87

BioSpace

JULY 11, 2021

Morgan had determined that adding one dose of the Moderna or Pfizer-BioNTech mRNA vaccine to one of Oxford-AstraZeneca’s viral vector technology would equal stronger immunity.

Vaccination 93

Vaccination Vaccine 93

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

Clinical Research

Scienmag

JULY 11, 2021

Credit: Image: Marika Gugole/Chalmers University of Technology Imagine sitting out in the sun, reading a digital screen as thin as paper, but seeing the same image quality as if you were indoors. Thanks to research from Chalmers University of Technology, Sweden, it could soon be a reality. A new type of reflective screen – sometimes […].

Research 84

Research Engineer Development 84

BioSpace

JULY 11, 2021

?The company said that it values the FDA's feedback and is happy that the agency has accepted its request to provide insights on its Hepatitis B development program.

RNA 85

RNA Development 85

BioSpace

JULY 11, 2021

While the drug showed significant improvement in patients on a 200mg daily dose of filgotinib, it may not be promoted in the states any time soon.

Drugs 89

Drugs 89

Scienmag

JULY 11, 2021

These Oncotarget findings demonstrate that Tomivosertib exhibits potent anti-leukemic properties on AML cells and support the development of clinical translational efforts involving the use of this drug Credit: Correspondence to – Leonidas C. Platanias – l-platanias@northwestern.edu Oncotarget published “Inhibitory effects of Tomivosertib in acute myeloid leukemia” which reported that the authors evaluated the therapeutic potential […].

Development 73

Development Drugs Medicine 73

BioSpace

JULY 11, 2021

?HHS issued their announcement, saying, “Americans who have been fully vaccinated do not need a booster shot at this time.

Vaccination 93

Vaccination Vaccine 93

Scienmag

JULY 11, 2021

Care homes need to be vigilant for outbreaks of COVID-19, even after residents have received two doses of the vaccine, according to new research being presented at the European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) held online this year. Long-term care facilities, such as care homes with elderly residents with multiple underlying conditions, […].

Vaccination 75

Vaccination Vaccine Research Medicine 75

Advertisement

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

BioSpace

JULY 11, 2021

The first nonsteroidal mineralocorticoid receptor antagonist (MRA) is approved for adults with chronic kidney disease associated with type 2 diabetes.

Drugs 83

Drugs 83

Scienmag

JULY 11, 2021

COVID-19 outbreaks in French nursing homes almost certainly started in staff – and none of measures put in place stopped the virus from taking hold, new research being presented at the European Congress of Clinical Microbiology & Infectious Diseases (ECCMID), held online this year, shows. Residents of long-term care facilities represent a small fraction of […].

Nurses 75

Nurses Research Medicine 75

BioSpace

JULY 11, 2021

Adulhelm's proposed price tag of $56,000 per patient per year is hardly the most expensive drug on the market, but controversy regarding packaging and pricing continues.

Packaging 77

Packaging Packaging Marketing Drugs 77

Scienmag

JULY 11, 2021

New research published by the open access publisher Frontiers inventories greenhouse gas emissions of 167 globally distributed cities. The study shows that just 25 mega-cities produce 52% of the greenhouse gas emissions from the studied cities. In 2015, 170 countries worldwide adopted the Paris Agreement, with the goal limiting the average global temperature increase to […].

Research 75

Research Engineer Development 75

Advertisement

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.

Clinical Supply

BioSpace

JULY 11, 2021

Approximately 100 preliminary reports of GBS have been identified out of 12.8 million doses of the J&J vaccine in the U.S., according to the Centers for Disease Control and Prevention.

Vaccination 75

Vaccination Vaccine 75

Scienmag

JULY 11, 2021

A new study published by Wiley early online in CANCER, a peer-reviewed journal of the American Cancer Society, has identified unmet social needs in women with gynecologic cancer that could be addressed to improve care for patients and lessen disparities. For example, identifying patients who reported needing help with reading hospital materials resulted in the […].

Medicine 74

Medicine 74

BioSpace

JULY 11, 2021

Last week presented a fair number of clinical trial news. Read on for more information.

Clinical Trials 102

Clinical Trials Clinical Trials Trials 102

Scienmag

JULY 11, 2021

Water-jet nozzles in electric toilets–commonly used in Japan and other parts of Asia–may be reservoirs for multidrug-resistant Pseudomonas aeruginosa (MDRP) in hospitals, increasing the risk of dangerous germ transmission among patients, according to new research being presented at the European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) held online this year. “This is the […].

Research 74

Research Medicine 74

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.

Clinical Trials

BioSpace

JULY 11, 2021

It was based on data from the APOLLO trial showing the drug significantly decreased the risk of progression or death by 37% compared to dexamethasone alone.

FDA Approval 75

FDA Approval Trials Drugs 75

Scienmag

JULY 11, 2021

A vaccine to protect against infection with hepatitis C could be in use within 5 years, says Professor Sir Michael Houghton, who won the Nobel Prize for Medicine and Physiology along with three other scientists for discovering the hepatitis C virus (HCV) in 1989. Sir Michael will discuss the development of a vaccine in a […].

Vaccination 72

Vaccination Vaccine Scientist Medicine 72

BioSpace

JULY 11, 2021

A former CEO of Vyera and other activist investors are pushing a slate of new company directors who would steer control of Phoenixus and Vyera away from Shkreli.

72

72

Scienmag

JULY 11, 2021

New research presented at this year’s European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) taking place online (9-12 July) shows that covering high-touch (the most regularly touched) surfaces in hospitals with silver-impregnated foil could significantly reduce levels of contamination by clinically important bacterial pathogens.

Contamination 72

Contamination Research Medicine 72

Advertisement

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.

Clinical Supply

BioSpace

JULY 11, 2021

Novo Nordisk will take over Prothena's wholly-owned subsidiary and gain full global intellectual property rights and other related rights for the latter's ATTR amyloidosis business and pipeline.

69

69

Scienmag

JULY 11, 2021

Johns Hopkins researchers describe protein regulating key step in cancer metastasis Credit: Johns Hopkins University Researchers have identified a specialized protein that appears to help prevent tumor cells from entering the bloodstream and spreading to other parts of the body. “We have discovered that this protein, TRPM7, senses the pressure of fluid flowing in the […].

Protein 69

Protein Regulation Research Engineer 69

BioSpace

JULY 11, 2021

The 2021 IPO stampede continues with five more companies aiming to trade on a stock exchange.

88

88

Scienmag

JULY 11, 2021

EGCG, a green tea polyphenol, as a modulator of in vitro methylglyoxal-induced Tau glycation and its impact on reducing advanced glycation end products in neuroblastoma cells Credit: Correspondence to – Subashchandrabose Chinnathambi – s.chinnathambi@ncl.res.in Oncotarget published “Epigallocatechin-3-gallate modulates Tau Post-translational modifications and cytoskeletal network” which reported that the chemical modulators of Tau PTMs, such as […].

In-Vitro 52

In-Vitro Production Medicine 52

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.

Clinical Trials

The Pharma Data

JULY 11, 2021

Analysis of Safety and Efficacy for up to 2.5 years with TAKHYZRO is Consistent with Initial Period of Treatment, Building on Growing Body of Evidence on the Long-term Safety and Efficacy Final Patient Subgroup Analysis Suggests Reductions of HAE Attacks Across Range of Patient Demographics and Disease Characteristics with TAKHZYRO. Takeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK ) (“Takeda”) today announced results from two final analyses from the Phase 3 HELP (Hereditary Angioedema L

Allergies 52

Allergies Antibody Recombinant DNA Technology Production 52

Drug Patent Watch

JULY 11, 2021

Annual Drug Patent Expirations for BREVIBLOC+IN+PLASTIC+CONTAINER Brevibloc In Plastic Container is a drug marketed by Baxter Hlthcare and is included in one NDA. It is available from three suppliers. There…. The post New patent expiration for Baxter Hlthcare drug BREVIBLOC IN PLASTIC CONTAINER appeared first on DrugPatentWatch - Make Better Decisions.

Containment 52

Containment Drugs Marketing 52

The Pharma Data

JULY 11, 2021

Eli Lilly and Company (NYSE: LLY) announced new Phase 2 data showing that gene expression changes induced by mirikizumab in patients with ulcerative colitis (UC) over a 12-week induction treatment were maintained for up to one year. These gene transcript changes, which were unique among those who responded to mirikizumab compared to placebo, were associated with mucosal healing, indicating that mirikizumab affects a distinct molecular healing pathway, compared to the spontaneous healing that occ

Regulation 52

Regulation Gene Gene Expression Packaging 52

Drug Patent Watch

JULY 11, 2021

Annual Drug Patent Expirations for BREVIBLOC+DOUBLE+STRENGTH+IN+PLASTIC+CONTAINER Brevibloc Double Strength In Plastic Container is a drug marketed by Baxter Hlthcare and is included in one NDA. It is available from three…. The post New patent expiration for Baxter Hlthcare drug BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER appeared first on DrugPatentWatch - Make Better Decisions.

Containment 52

Containment Drugs Marketing 52

Advertisement

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.

Clinical Trials