Bio Pharma Dive
SEPTEMBER 12, 2020
Six days after a worrisome illness in a U.K. study participant led to a worldwide pause in vaccinations, the country's drugs regulator and an independent committee allowed testing to resume.
Scienmag
SEPTEMBER 12, 2020
A new comprehensive analysis on the effect of Mozart’s music on epilepsy has confirmed that listening to his piano music can reduce the frequency of epilepsy attacks. The results of this comprehensive meta-analysis (a study of studies), which may overturn current scepticism about the effect, are presented at the ECNP congress after recent publication in […].
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Pharma Tutor
SEPTEMBER 12, 2020
About Author. Nrusingha Panda. Department of Quality Assurance, Mankind Pharma Ltd.
pharmaphorum
SEPTEMBER 12, 2020
UK cost-effectiveness watchdog NICE has changed its stance on AstraZeneca’s Tagrisso as a first-line therapy for non-small cell lung cancer (NSCLC) after an improved “commercial arrangement” with the company. NICE has turned down Tagrisso in the past in previously-untreated, EGFR-positive NSCLC but has now given its blessing to that use of the drug, as well as for second-line treatment of patients with the T790M resistance mutation subtype.
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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
Scienmag
SEPTEMBER 12, 2020
What The Study Did: Researchers compared changes from 2000 to 2017 in premature deaths in the U.S. due to drug poisonings, suicide and alcohol-induced causes by geographic areas and demographic characteristics. Authors: Meredith S. Shiels, Ph.D., of the National Cancer Institute in Rockville, Maryland, is the corresponding author. To access the embargoed study: Visit our […].
The Pharma Data
SEPTEMBER 12, 2020
Image copyright. Anna Byard-Golds. “There were days where I would have a complete meltdown and start clawing at it. I wanted to rip my skin off.” Anna Byard-Golds has had eczema all her life. “I was aware at the age of four or five. I noticed my hands looked different and I could feel different to other children,” she tells Newsbeat.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
The Pharma Data
SEPTEMBER 12, 2020
Alleged British computer hacker Lauri Love was arrested in 2013 on suspicion of stealing data from the FBI, Nasa and other US agencies. In 2018, he won his appeal against extradition to the US. The judge cited Lauri’s depression and autism as factors in the decision, saying extradition would be “oppressive by reason of his physical and mental condition” Two years on, Lauri describes daily life with his autism, and how a nice comment from someone can turn into a painful assault
Drug Patent Watch
SEPTEMBER 12, 2020
Annual Drug Patent Expirations for BENICAR Benicar is a drug marketed by Daiichi Sankyo and is included in two NDAs. It is available from three suppliers. BENICAR drug price trends.…. The post Patent delisted for Daiichi Sankyo drug BENICAR appeared first on DrugPatentWatch - Make Better Decisions.
The Pharma Data
SEPTEMBER 12, 2020
South Korea, a country held up as a model for its response to Covid-19, has been struggling to contain a new nationwide outbreak. At the forefront are a team of dedicated government contact tracers, who have the authority to isolate and test anyone who is suspected of having been in contact with the virus. BBC Korea joins South Korea’s virus detectives who battle long hours as they face their biggest challenge: gaining trust and cooperation from suspected carriers who are reluctant to provide pe
Drug Patent Watch
SEPTEMBER 12, 2020
Annual Drug Patent Expirations for XIFAXAN Xifaxan is a drug marketed by Salix Pharms and is included in two NDAs. It is available from two suppliers. There are twenty-six patents…. The post Patent delisted for Salix Pharms drug XIFAXAN appeared first on DrugPatentWatch - Make Better Decisions.
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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
The Pharma Data
SEPTEMBER 12, 2020
Image copyright. Getty Images. People in the UK must not treat this weekend as a “party” before the new “rule of six” coronavirus restrictions come into force on Monday, a police union has warned. The Police Federation said there was a “real risk” that the public would “take advantage of the current situation” The new rules limit gatherings to six people indoors and outdoors in England.
Drug Patent Watch
SEPTEMBER 12, 2020
Annual Drug Patent Expirations for ALOXI Aloxi is a drug marketed by Helsinn Hlthcare and is included in two NDAs. It is available from three suppliers. There are thirteen patents…. The post Patent delisted for Helsinn Hlthcare drug ALOXI appeared first on DrugPatentWatch - Make Better Decisions.
The Pharma Data
SEPTEMBER 12, 2020
NEW YORK & MAINZ, Germany–(BUSINESS WIRE)– Pfizer Inc. (NYSE: PFE) and BioNTech SE (NASDAQ: BNTX) announced today that they have submitted an amended protocol to the U.S. Food and Drug Administration to expand the enrollment of their Phase 3 pivotal COVID-19 vaccine trial to up to approximately 44,000 participants which also allows for the enrollment of new populations.
Drug Patent Watch
SEPTEMBER 12, 2020
Annual Drug Patent Expirations for BENICAR+HCT Benicar Hct is a drug marketed by Daiichi Sankyo and is included in one NDA. It is available from three suppliers. BENICAR HCT drug…. The post Patent delisted for Daiichi Sankyo drug BENICAR HCT appeared first on DrugPatentWatch - Make Better Decisions.
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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.
The Pharma Data
SEPTEMBER 12, 2020
Image copyright. Reuters. Trials of a Covid-19 vaccine being developed by AstraZeneca and Oxford University will resume after being paused due to a reported side effect in a patient in the UK. On Tuesday, AstraZeneca said the studies were being paused while it investigated whether the adverse reaction was linked with the vaccine. But on Saturday, the university said it had been deemed safe to continue.
Drug Patent Watch
SEPTEMBER 12, 2020
Annual Drug Patent Expirations for BYDUREON Bydureon is a drug marketed by Astrazeneca Ab and is included in two NDAs. It is available from one supplier. There are thirty patents…. The post Patent delisted for Astrazeneca Ab drug BYDUREON appeared first on DrugPatentWatch - Make Better Decisions.
The Pharma Data
SEPTEMBER 12, 2020
Image copyright. EPA. Image caption. Children are included in new social distancing regulations in England. The “Rule of Six”, the latest limits on social gatherings in England, will not be changed to exempt children under 12, Michael Gove has insisted. The new rules, which limit six people to meeting indoors and outdoors, come into effect on Monday.
Drug Patent Watch
SEPTEMBER 12, 2020
Annual Drug Patent Expirations for BYDUREON+PEN Bydureon Pen is a drug marketed by Astrazeneca Ab and is included in one NDA. It is available from one supplier. There are twenty-nine…. The post Patent delisted for Astrazeneca Ab drug BYDUREON PEN appeared first on DrugPatentWatch - Make Better Decisions.
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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.
pharmaphorum
SEPTEMBER 12, 2020
None of the immune-modulating drugs approved to treat ulcerative colitis – even biosimilars – are priced low enough to be cost-effective, says the Institute for Clinical and Economic Review (ICER). The non-profit US watchdog is carrying out a review of eight targeted immune modulator (TIM) drugs used to treat inflammatory bowel disease (IBD) and says that all provide significant health benefits.
Drug Patent Watch
SEPTEMBER 12, 2020
Annual Drug Patent Expirations for AMPYRA Ampyra is a drug marketed by Acorda and is included in one NDA. It is available from two suppliers. Drug patent litigation for AMPYRA.…. The post Patent delisted for Acorda drug AMPYRA appeared first on DrugPatentWatch - Make Better Decisions.
pharmaphorum
SEPTEMBER 12, 2020
Janssen has filed a new formulation of its Darzalex in the US for the rare and potentially fatal disease light chain (AL) amyloidosis. Johnson & Johnson’s pharmaceuticals unit said it had filed Darzalex Faspro (daratumumab+hyaluronidase), a subcutaneous formulation of the drug already approved in several blood cancers. There are currently no approved therapies for AL amyloidosis, and rival Takeda is struggling to get its Ninlaro (ixazomib) to work in the disease, which is caused by a build-u
Drug Patent Watch
SEPTEMBER 12, 2020
Annual Drug Patent Expirations for OXYCONTIN Oxycontin is a drug marketed by Purdue Pharma Lp and is included in one NDA. It is available from eight suppliers. There are twenty-three…. The post Patent delisted for Purdue Pharma drug OXYCONTIN appeared first on DrugPatentWatch - Make Better Decisions.
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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.
Pharma Tutor
SEPTEMBER 12, 2020
About Authors. Rajora Priyanka Singh*, Rathore Kamal Singh. Faculty of Pharmacy, BN University, Udaipur-Raj.313001. *singhpriyanka20355@gmail.
Drug Patent Watch
SEPTEMBER 12, 2020
Annual Drug Patent Expirations for TRADJENTA Tradjenta is a drug marketed by Boehringer Ingelheim and is included in one NDA. It is available from three suppliers. There are nine patents…. The post Patent delisted for Boehringer Ingelheim drug TRADJENTA appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
SEPTEMBER 12, 2020
Scientists have discovered that measuring brainwaves produced during REM sleep can predict whether a patient will respond to treatment from depression. This enables patients to switch to a new treatment rather than continue the ineffective treatment (and the depression) for weeks without knowing the outcome. As study leader, Dr Thorsten Mikoteit said, “In real terms […].
Drug Patent Watch
SEPTEMBER 12, 2020
Annual Drug Patent Expirations for JENTADUETO Jentadueto is a drug marketed by Boehringer Ingelheim and is included in two NDAs. It is available from one supplier. There are twelve patents…. The post Patent delisted for Boehringer Ingelheim drug JENTADUETO appeared first on DrugPatentWatch - Make Better Decisions.
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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.
BioTech 365
SEPTEMBER 12, 2020
EUR 1,00 (1 Gebot)Angebotsende: Sonntag Sep-20-2020 19:58:04 CESTJetzt bieten | Zur Liste der beobachteten Artikel hinzufügen Biotech365 : ZEISS POLARISATION MIKROSKOP CARL ZEISS JENA POL – MICROSCOPE BioMarketplace You want to propose your products or a Biotech Company, a Biotech … Continue reading →
Drug Patent Watch
SEPTEMBER 12, 2020
Annual Drug Patent Expirations for TUDORZA+PRESSAIR Tudorza Pressair is a drug marketed by Circassia and is included in one NDA. It is available from one supplier. There are nine patents…. The post Patent delisted for Circassia drug TUDORZA PRESSAIR appeared first on DrugPatentWatch - Make Better Decisions.
BioTech 365
SEPTEMBER 12, 2020
EUR 149,00 (1 Gebot)Angebotsende: Sonntag Sep-13-2020 14:00:13 CESTJetzt bieten | Zur Liste der beobachteten Artikel hinzufügen Biotech365 : AGILENT OSZILLOSCOPE U1602B 20 Mhz BioMarketplace You want to propose your products or a Biotech Company, a Biotech Tool or a Bioinformatic … Continue reading →
Drug Patent Watch
SEPTEMBER 12, 2020
Annual Drug Patent Expirations for JARDIANCE Jardiance is a drug marketed by Boehringer Ingelheim and is included in one NDA. It is available from four suppliers. There are six patents…. The post Patent delisted for Boehringer Ingelheim drug JARDIANCE appeared first on DrugPatentWatch - Make Better Decisions.
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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.
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