World of DTC Marketing
FEBRUARY 28, 2021
SUMMARY: Pharma companies, like J&J, have received criticism for engaging in illegal activities, such as providing kickbacks and bribes, knowingly shipping adulterated or contaminated drugs to pharmacies, and marketing drugs for unapproved uses. Johnson & Johnson has paid $2.7 billion in penalties. Can a COVID-19 vaccine approval suddenly erase that?
Pharma Mirror
FEBRUARY 28, 2021
Novartis announced the Health Sciences Authority (HSA) has approved* Piqray®, an ?-specific class I phosphatidylinositol-3-kinase (PIK3CA) inhibitor, for the treatment of postmenopausal women, and men, with hormone receptor positive (HR+), human epidermal growth factor receptor 2 (HER2-) negative, advanced breast cancer with a PIK3CA mutation in combination with fulvestrant after disease progression following an endocrine-based regimen.
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NY Times
FEBRUARY 28, 2021
The company’s coming trials will also involve pregnant women and people whose immune systems are compromised.
Pharma Mirror
FEBRUARY 28, 2021
NLP and social graphs are effective instruments to speed up investigator recruitment and ensure timely pharmaceutical product releases. Read how NLP can leverage the power of unstructured data and help find doctors-influencers that can substantially provide assistance to a clinical trial. Igor Kruglyak is a Senior Advisor at the global IT service provider Avenga and a 35+ year veteran executive of global key development and deployment projects.
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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
BioSpace
FEBRUARY 28, 2021
To facilitate its goal of building an industry-leading gene therapy company focused on rare CNS diseases, Sio has made it a priority to interact with patient organizations to determine their primary objective, whether that be stability or a cure.
Druggist
FEBRUARY 28, 2021
Melatonin is a hormone that is released at night by the pineal gland located in the brain. Melatonin controls the sleep-wake cycle (24-hour cycle). In other words, melatonin acts as a biological clock that regulates sleep. Melatonin, therefore, can be used to promote and regulate sleep (Wagner et al., 1998). This post answers the question: Can you get melatonin over the counter in the UK?
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Scienmag
FEBRUARY 28, 2021
Astronomers accurately measure the temperature of red supergiant stars Credit: © 2021 Andrew Klinger Red supergiants are a class of star that end their lives in supernova explosions. Their lifecycles are not fully understood, partly due to difficulties in measuring their temperatures. For the first time, astronomers develop an accurate method to determine the surface […].
BioSpace
FEBRUARY 28, 2021
What percentage of a population needs to be immune in order to achieve herd immunity is a matter of debate among scientists and public health officials.
JAMA Internal Medicine
FEBRUARY 28, 2021
This randomized clinical trial examines whether mindfulness-based stress reduction and headache education improve migraine day frequency and improvements in disability, quality of life, depression scores, pain catastrophizing, and self-efficacy for people who experience migraines.
BioSpace
FEBRUARY 28, 2021
On Sunday, Reuters reported the U.K. pharma giant sold off its 7.7% stake in the company for more than $1 billion.
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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
Scienmag
FEBRUARY 28, 2021
Major changes in bereavement care have occurred during the COVID-19 pandemic, amid a flood of demand for help from bereaved people, according to new research from the University of Cambridge. The first major study of pandemic-related changes in bereavement care has found that the switch to remote working has helped some services to reach out, […].
BioSpace
FEBRUARY 28, 2021
The end of February and beginning of March is a busy time for the U.S. Food and Drug Administration, with a number of PDUFA dates on the calendar.
Scienmag
FEBRUARY 28, 2021
Offering financial incentives to hospitals shows strong potential to drive swift system and practice changes to intervene in the opioid epidemic, Penn Medicine research finds PHILADELPHIA– Hospital emergency departments (EDs) not only care for patients with overdose and other complications from opioid use, but they also serve as vital touch points to engage patients into […].
BioSpace
FEBRUARY 28, 2021
Merck KGaA, Darmstadt, Germany plunked down €188 million (about $226 million) in upfront cash to acquire exclusive global development and commercialization rights to Debiopharm’s oral Inhibitor of Apoptosis Proteins (IAP) antagonist, xevinapant.
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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.
Scienmag
FEBRUARY 28, 2021
New article and commentary from American Journal of Psychiatry Diversity, equity and inclusion (DEI) leaders in academic medicine are subject to increasing expectations with limited resources and there is an urgent need for psychiatry departments to commit to fully supporting their efforts, according to an article now available in the American Journal of Psychiatry written […].
JAMA Internal Medicine
FEBRUARY 28, 2021
This cohort study compares the associations of long-acting insulin analogs and NPH insulin with the risk of severe hypoglycemia in older patients with type 2 diabetes.
Scienmag
FEBRUARY 28, 2021
Funding will support spatially imaging the flow of photocurrents inside quantum materials Credit: Lee Pellegrini/Boston College Chestnut Hill, Mass. (3/1/2021) — Boston College Assistant Professor of Physics Brian Zhou has received a CAREER Award from the National Science Foundation, which supports junior faculty in the sciences through the Faculty Early Career Development Program.
BioSpace
FEBRUARY 28, 2021
Suzhou Medilink Therapeutics (Medilink), based in Suzhou, China, closed on a $50 million Series A financing round. An A1 series round was led by Apricot Capital and a series-A1 was co-led by Loyal Valley Capital and Qiming Venture Partners.
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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.
Drug Patent Watch
FEBRUARY 28, 2021
Annual Drug Patent Expirations for ANDROGEL Androgel is a drug marketed by Abbvie and is included in two NDAs. It is available from two suppliers. There are eleven patents protecting…. The post New patent expiration for Abbvie drug ANDROGEL appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
FEBRUARY 28, 2021
Oak Brook, IL – The March edition of SLAS Discovery features the cover article, “Therapeutic and Vaccine Options for COVID-19: Status After 6 Months of the Disease Outbreak” by Christian Ogaugwu (Federal University Oye-Ekiti, Ekiti State, Nigeria ), Dawid Maciorowski, Subba Rao Durvasula, Ph.D., Ravi Durvasula, M.D., and Adinarayana Kunamneni, Ph.D.
BioSpace
FEBRUARY 28, 2021
Beijing-based CRMO Pharmaron has accomplished impressive global growth via acquisitions over the past eight months.
Scienmag
FEBRUARY 28, 2021
BINGHAMTON, NY – Several proposals have emerged on how to distribute the COVID-19 vaccine, but they fall short in ensuring that the vaccine is distributed fairly. A team including Binghamton University professor Nicole Hassoun suggests three ways to more fairly and effectively distribute the vaccine so that people in poor countries get the vaccine as […].
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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.
BioTech 365
FEBRUARY 28, 2021
DGAP-News: Heidelberg Pharma AG / Key word(s): Personnel 01.03.2021 / 07:22 The issuer is solely responsible for the content of this announcement. PRESS RELEASE Heidelberg Pharma Expands Management Team – Dr. András Strassz promoted to Chief Medical Officer – Dr.
BioSpace
FEBRUARY 28, 2021
The company has agreed to deliver 100 million doses of the vaccines by the end of June.
BioTech 365
FEBRUARY 28, 2021
Takeda Earns the Best Place To Work Certification in Bulgaria Takeda Earns the Best Place To Work Certification in Bulgaria SOFIA, Bulgaria–(BUSINESS WIRE)–#Bulgaria–Takeda been officially recognized as one of the best places to work in Bulgaria for 2021 according to … Continue reading →
BioSpace
FEBRUARY 28, 2021
It was another busy week for clinical trial news. Here’s a look.
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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
FEBRUARY 28, 2021
Junshi Biosciences and AstraZeneca Announce Strategic Collaboration to Commercialize Toripalimab in China Junshi Biosciences and AstraZeneca Announce Strategic Collaboration to Commercialize Toripalimab in China — Junshi grants AstraZeneca exclusive promotion rights of toripalimab in mainland China for the urothelial carcinoma … Continue reading →
Drug Patent Watch
FEBRUARY 28, 2021
This chart shows the generic firms that had the most successful drug patent challenges last year. Companies that successfully challenge patents on branded drugs are granted six months of generic…. The post Most drug patent challenges last year appeared first on DrugPatentWatch - Make Better Decisions.
BioTech 365
FEBRUARY 28, 2021
Mobidiag Receives CE-IVD Marking for Amplidiag® RESP-4 for Simultaneous Detection of COVID-19, Flu A, Flu B and RSV Mobidiag Receives CE-IVD Marking for Amplidiag® RESP-4 for Simultaneous Detection of COVID-19, Flu A, Flu B and RSV – Real-time PCR-based test … Continue reading →
pharmaphorum
FEBRUARY 28, 2021
The FDA has approved emergency use of a third COVID-19 vaccine from Johnson & Johnson’s Janssen Biotech unit, the day after an advisory committee concluded it was safe and effective. Janssen’s Ad26.COV2.S vaccine has been authorised for use in people aged 18 or over after a “comprehensive evaluation of available safety, effectiveness and manufacturing quality information,” said the FDA.
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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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