Bio Pharma Dive

NOVEMBER 27, 2020

By teaming up with Sage, Biogen gets its hands on two drugs in mid- to late-stage testing for multiple types of depression and essential tremor.

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Drugs 297

World of DTC Marketing

NOVEMBER 27, 2020

SUMMARY: Business by press release has made pharma executives a lot of money but we still haven’t seen any over reviewed data on COVID 19 vaccines. A report released Thursday by the University of California at Los Angeles researchers said that 66 percent of Los Angeles health-care workers who responded to an online questionnaire (not a randomized sample) said they would delay taking a vaccine.

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Vaccination Vaccine Pharma Companies Trials 208

NY Times

NOVEMBER 27, 2020

Court filings reveal consultants’ talk of a records purge during the opioid crisis, and shed new light on sales advice given to the billionaire Sackler family and their drug company, Purdue Pharma.

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Pharmacy Sales Drugs 145

pharmaphorum

NOVEMBER 27, 2020

A new EMA approval has expanded the use of Vertex Pharma’s exon-skipping cystic fibrosis therapy Symkevi to children as young as six if they have specific gene mutations. The regulator has given a green light to use of Symkevi (tezacaftor/ivacaftor) with Vertex’ Kalydeco (ivacaftor) in patients ages six years and older who have two copies of the F508del mutation in the CFTR gene, or one F508del copy and one of 14 other so-called “minimal function” mutations in CFTR.

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Gene Genetic Disease FDA Approval Genetics 134

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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

Clinical Research

Pharma Times

NOVEMBER 27, 2020

It is hoped that the test will help detect cancer at a much earlier stage

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Trials 155

pharmaphorum

NOVEMBER 27, 2020

Amanda Barrell explores how a perfect storm of changing economics, advances in technology, and the increasing volume of the patient voice is stoking change in the rare disease space. New models of drug development are fuelling life-changing advantages in the rare disease space, previously an economic no-go area for pharma and biotech companies. That was among the discussion points during Fighting Rare Diseases – The Science, Economics and the Patients , a webinar hosted by o2h Group.

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Development Clinical Trials Clinical Trials Drugs 132

Drug Patent Watch

NOVEMBER 27, 2020

Annual Drug Patent Expirations for KORLYM Korlym is a drug marketed by Corcept Therap and is included in one NDA. There are fourteen patents protecting this drug and one Paragraph…. The post New patent for Corcept Therap drug KORLYM appeared first on DrugPatentWatch - Make Better Decisions.

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Pharma Times

NOVEMBER 27, 2020

The combination is the first available to treat the underlying cause of CF in this patient group.

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Scienmag

NOVEMBER 27, 2020

Credit: © 2020 KAUST A material that mimics human skin in ?strength, stretchability and sensitivity could be used to collect biological data in real time. Electronic skin, or e-skin, may play an important role in next-generation prosthetics, personalized medicine, soft robotics and artificial intelligence. “The ideal e-skin will mimic the many natural functions of human […].

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Medicine Engineer 98

Pharma Times

NOVEMBER 27, 2020

Trial results and cost-effectiveness are too uncertain for NHS use, the Institute said

Trials 101

Trials 101

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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

Scienmag

NOVEMBER 27, 2020

Serotonin keeps mice waiting longer for food, depending on where in the brain it’s released Credit: OIST We’ve all been there. Whether we’re stuck in traffic at the end of a long day, or eagerly anticipating the release of a new book, film or album, there are times when we need to be patient. Learning […].

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Scientist Genetics 69

pharmaphorum

NOVEMBER 27, 2020

AstraZeneca is to run an additional global trial to test its COVID-19 vaccine at a lower dosage, as the UK regulator begins to review trial data. The shot, known as AZD-1222, developed in partnership with Oxford University, has dominated the pharma news agenda this week after it hit efficacy targets but appeared short of rivals from Pfizer and BioNTech.

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Regulation Vaccination Vaccine Trials 64

Scienmag

NOVEMBER 27, 2020

? It takes a mere 250 milliseconds for individuals to recognise their own identity compared to others A psychobiological study led by the Complutense University of Madrid (UCM) on personal identity and its modification over time in parallel with the changes that individuals experience has shown that the essence of our being remains largely stable […].

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Drug Patent Watch

NOVEMBER 27, 2020

Annual Drug Patent Expirations for FORADIL Foradil is a drug marketed by Novartis and is included in two NDAs. There is one patent protecting this drug. This drug has twenty-eight…. The post New patent expiration for Novartis drug FORADIL appeared first on DrugPatentWatch - Make Better Decisions.

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Drugs Marketing 59

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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.

Clinical Supply

Scienmag

NOVEMBER 27, 2020

Gold miners have dramatically altered the landscape of Peru’s Amazon, increasing mercury poisoning risks for humans and wildlife Credit: Melissa Marchese DURHAM, N.C. – The proliferation of pits and ponds created in recent years by miners digging for small deposits of alluvial gold in Peru’s Amazon has dramatically altered the landscape and increased the risk […].

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ECRG Media's Clinical Research Podcast

NOVEMBER 27, 2020

Why Proper Resume Formatting Is Crucial Don't forget to Subscribe for new content! Subscribe: [link] Call or Text: 910-502-3732 Email: eliteclinicalgroup@gmail.com Podcast: [link] Steemit: [link] Advertise: eliteclinicalgroup@gmail.com Watch: » Industry News: [link] » All Videos: [link] » Interview Recaps: [link] » Glassdoor Reviews: [link] We do: » Insider Interviews » Resume Reviews » Question and Answer » Discuss all things Clinical Research » News and Product Reviews » Education Send in a vo

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Clinical Research Production Research 52

Scienmag

NOVEMBER 27, 2020

Childhood experiences and environment also have an impact Credit: (Adapted from Table 3 in Asahara et al. PLOS ONE, 2020.) Research based on 5425 citizens’ responses to a questionnaire survey has illuminated that obesity causes are linked to various factors in addition to the individual’s current socioeconomic circumstances, including childhood experiences, particularly those of abuse. […].

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ECRG Media's Clinical Research Podcast

NOVEMBER 27, 2020

Why Proper Resume Formatting Is Crucial. Don't forget to Subscribe for new content! Subscribe: [link] Call or Text: 910-502-3732 Email: eliteclinicalgroup@gmail.com Podcast: [link] Steemit: [link] Advertise: eliteclinicalgroup@gmail.com Watch: » Industry News: [link] » All Videos: [link] » Interview Recaps: [link] » Glassdoor Reviews: [link] We do: » Insider Interviews » Resume Reviews » Question and Answer » Discuss all things Clinical Research » News and Product Reviews » Education.

Clinical Research 52

Clinical Research Production Research 52

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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

Drug Patent Watch

NOVEMBER 27, 2020

Annual Drug Patent Expirations for MONISTAT+1+COMBINATION+PACK Monistat 1 Combination Pack is a drug marketed by Medtech Products and is included in one NDA. It is available from one supplier. There…. The post New patent expiration for Medtech Products drug MONISTAT 1 COMBINATION PACK appeared first on DrugPatentWatch - Make Better Decisions.

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Production Drugs Marketing 52

The Pharma Data

NOVEMBER 27, 2020

FDA Approves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma. NEW YORK, Nov. 25, 2020 (GLOBE NEWSWIRE) — Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that the U.S.

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FDA Approval Production Clinical Trials Clinical Trials 52

Drug Patent Watch

NOVEMBER 27, 2020

Annual Drug Patent Expirations for TAZVERIK Tazverik is a drug marketed by Epizyme Inc and is included in one NDA. There are twenty-one patents protecting this drug. This drug has…. The post New patent for Epizyme Inc drug TAZVERIK appeared first on DrugPatentWatch - Make Better Decisions.

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Drugs Marketing 52

The Pharma Data

NOVEMBER 27, 2020

FDA Approves Imcivree (setmelanotide) for Chronic Weight Management in Patients with Obesity Due to POMC, PCSK1 or LEPR Deficiency. BOSTON, Nov. 27, 2020 (GLOBE NEWSWIRE) — Rhythm Pharmaceuticals, Inc. (Nasdaq:RYTM), a biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic diseases of obesity, announced today that the U.S.

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FDA Approval Genetic Disease Genetics Clinical Trials 52

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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.

Clinical Supply

Drug Patent Watch

NOVEMBER 27, 2020

Annual Drug Patent Expirations for SECUADO Secuado is a drug marketed by Hisamitsu and is included in one NDA. It is available from one supplier. There are three patents protecting…. The post New patent for Hisamitsu drug SECUADO appeared first on DrugPatentWatch - Make Better Decisions.

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Drugs Marketing 52

The Pharma Data

NOVEMBER 27, 2020

FRIDAY, Nov. 27, 2020 — Opioid overdose deaths involving more than one substance are more common among American teens and young adults than deaths caused by opioids alone, researchers report. They also found that stimulants such as cocaine and crystal methamphetamine are the non-opioid substances most commonly involved in opioid overdose deaths in young people.

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Drugs Research 52

XTalks

NOVEMBER 27, 2020

A new high-definition handheld ultrasound device can help make cardiac ultrasounds more rapid and convenient, without the need for traditional bulky ultrasound equipment. With the device, a scan of the heart can be conducted at a patient’s bedside in a hospital, or in a doctor’s office or clinic. The scan generates high-quality images with results delivered to medical providers through an app on their smartphone or tablet.

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Packaging Packaging Regulation Life Science 52

The Pharma Data

NOVEMBER 27, 2020

FRIDAY, Nov. 27, 2020 — Children born prematurely have a higher risk of hospitalization later on than those born at full term, a new study says. Health problems are common in premature babies, though the risk falls as they grow up. But researchers said it has been unclear when the risk begins to drop or how it’s affected by a child’s gestational age at birth.

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Research 52

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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

Client Pharma

NOVEMBER 27, 2020

Client-Pharma is continuing to expand and is recruiting for an Account Manager to join the Clinical Trial team. It is an exciting time and we have seen significant growth in line with our business plans, and we are looking for a passionate and talented individual to join our global organisation. Ideally we would like someone who has experience in the clinical trial supply industry, but would also be open to an individual who can demonstrate a desire to join a fast moving company and be part of o

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Clinical Trials Clinical Trials Trials 52

The Pharma Data

NOVEMBER 27, 2020

FRIDAY, Nov. 27, 2020 — Freezing their eggs or ovarian tissue before breast cancer treatment increases survivors’ chances of having children after recovery, a new study finds. Nearly 10% of breast cancer cases occur in women younger than 45 years of age, some of whom haven’t yet had children, according to researchers at the Karolinska Institute in Sweden.

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Hormones Doctors Doctor Research 52

pharmaphorum

NOVEMBER 27, 2020

Despite advances in science and technology, denovo drug development has been a costly and time-consuming process over the past decades. Given these circumstances, drug repositioning and repurposing has appeared as an alternative tool to accelerate drug development processes by seeking new indications for approved/shelved drugs rather than discovering de novo drug compounds.

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The Pharma Data

NOVEMBER 27, 2020

Vaccine development to cure coronavirus is at an all-time high after Pfizer and BioNTech announced they had success with a possible vaccine candidate. This week, another pharma company revealed a new technology device that can detect if a patient is infectious or not, while the Russian government published results of its Sputnik V vaccine, claiming it is more than 95 per cent efficient 42 days after the first dose.

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Vaccination Vaccine Immune Response Marketing 52

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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.

Clinical Trials