Sat.Aug 01, 2020 - Fri.Aug 07, 2020

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Pfizer signs deal with Gilead to manufacture COVID-19 antiviral remdesivir

pharmaphorum

Pfizer has signed a multi-year agreement with Gilead to manufacture and supply the COVID-19 antiviral remdesivir, which is also being tested in combination with other drugs in an effort to fight the pandemic. Under the terms of the agreement Pfizer will become one of several external partners who manufacture the investigational treatment for the disease.

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CSafe, Cloudleaf partner on cold-chain tracking tech

Outsourcing Pharma

The firms are working to create a platform that gives the ability to monitor temperature-sensitive treatments, vaccines and other products.

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Otrivine Extra Dual Relief – 8 facts YOU must know

Druggist

Otrivine Extra Dual Relief is a pharmacy only medication and the only over the counter product containing ipratropium bromide for the management of congestion and runny nose caused by colds. This post summarises the essential information about Otrivine Extra Dual Relief nasal spray. 1. Otrivine Extra Dual Relief indicated use Otrivine Extra spray is used for the management of congestion and rhinorrhoea caused by colds. 2.

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6 Key Takeaways from HBA’s “Virtual Best Practices: Clarity, Collaboration and Connecting”

Pharma Marketing Network

Recently, the Healthcare Businesswomen’s Association (HBA) held a webinar entitled, Virtual Best Practices: Clarity, Collaboration and Connecting , which dove into the topic of “Zoom fatigue,” a new, commonly used term defined by the draining feeling you experience after a day of long, unnecessary meetings. We are all facing new challenges in the rapidly changing work environment.

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Position Your Pharmacy for Expansion

Speaker: Chris Antypas and Josh Halladay

Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.

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How does HTA for orphan drugs differ across Europe?

pharmaphorum

New research looks at the factors that speed up and slow down HTA appraisals for rare disease medicines across Europe. Rare diseases drugs have always faced challenges when it comes to HTA approvals, even as governments bring in more regulatory policies that make their path through assessment easier. Several factors make it difficult for HTA bodies often to assess orphan drugs, including a lack of robust trial data due to difficulties in finding patients, the absence of randomised controlled tri

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Senate bill proposes study of the US pharma supply chain

Outsourcing Pharma

The bipartisan bill calls for an assessment of the countryâs pharma supply chain, including potential vulnerabilities and impact of foreign manufacturing.

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Researchers says hydroxychloroquine could still prevent COVID-19

Pharma Times

Scientists from the University of Oxford say the drug is being ‘discarded prematurely’

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Fearing Brexit chaos, UK asks pharma to build six-week drug stockpile

pharmaphorum

The UK government has asked pharma companies to build a six-week stockpile of drugs and find alternative shipping routes to the congested Dover-Calais crossing as the country heads for Brexit at the end of the year. In a letter , Steve Oldfield, chief commercial officer at the Department of Health and Social Care, said the government is focused on preventing potential disruption to any categories of medical supplies.

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Research partnership delves into opioid alternatives

Outsourcing Pharma

Neurasic Therapeutics is borne from a collaborative effort intended to advance development of opioid-alternative pain relief.

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Drugs That Cause Hyperthermia – Can You Name Them?

Med Ed 101

While not incredibly common, medications can cause dysregulation of our body’s thermoregulation process and cause a rise in core temperature in the presence of normal core body temperature which leads to hyperthermia. Before we get to the drugs that cause hyperthermia, let’s review thermoregulation. Our body is able to regulate our core temperature to keep […].

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

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.

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UK increases COVID-19 vaccine manufacturing capacity

Pharma Times

New deal with Wockhardt boosts capacity at the crucial 'fill and finish' stage

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Sanofi faces possible manslaughter charges in epilepsy drug probe

pharmaphorum

Sanofi has been placed under formal investigation in France for possible charges including manslaughter relating to the epilepsy drug Depakine, following the deaths of four babies whose mothers took the drug. Depakine was found to carry a high risk of birth defects if taken by pregnant women. Sanofi , which denies wrongdoing and says it warned of the risks long ago, is already being prosecuted in France following allegations it provided misleading information about the drug.

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ACD/Labs: tech can overcome supply chain challenges

Outsourcing Pharma

A leader from the scientific software provider discusses the most challenging obstacles in the pharma supply chain, and solutions that can conquer them.

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Free Pharmacogenomics Exam Questions – Can You Pass the Test?

Med Ed 101

As of August 1st, 2020, pharmacogenomics has been added to the BCMTMS exam content outline. We’ve updated our material to include a review of pharmacogenomic principles and common medications that may be affected by genetic variations. In addition, we’ve added pharmacogenomics quiz questions to our quiz bank. I wanted to share a sample of our […].

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5 Reasons to Upgrade Your Pharmacy Management Software

Are you still using workarounds to manage your daily operations? To achieve peak performance, it's time to explore other options for specialty and infusion pharmacy software. Streamline pharmacy operations and improve clinical performance with automated processing, real-time data exchange, and electronic decision support. Download this helpful infographic to: Drive efficiency and patient adherence from referral receipt to delivery and ongoing care – all with our Pharmacy Cloud.

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Immodulon, Champalimaud Foundation team up on ‘difficult to treat’ cancers

Pharma Times

Collaboration will explore experimental treatment IMM-101 in combination with other therapies in advanced cancers

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Coronavirus pharma news roundup – 07/08/20

pharmaphorum

Pharma’s reputation has soared due to the COVID-19 pandemic – but coronavirus is starting to bite companies’ sales. Find out more in our roundup of the biggest R&D, market access and digital stories from the past week. The perception of pharma and medical companies has surged upward since the start of the COVID-19 pandemic, but they still lie mostly outside the top-rated firms in the FutureBrand Index.

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This week's FDA COVID-19 news

Outsourcing Pharma

The agency continues to provide resources for the life-sciences industry, approve tests, and take action against companies offering false treatments.

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A mini review on nanosuspension drug delivery system : An innovative approach for poorly aqueous soluble drugs

Pharma Tutor

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AstraZeneca forges licensing agreement with Redx Pharma

Pharma Times

AZ will pay $17m in early milestone payments for the UK biotech’s fibrotic asset

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Mental health platform helps students facing exam results during pandemic

pharmaphorum

The UK digital mental health support platform Kooth has joined with five of the UK’s well known Instagram influencers to launch a campaign to help students deal with the pressures of exam results season. The campaign encourages the hundreds of thousands of students waiting to receive their exam results, to stay mentally strong and know they have access to support, if needed.

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IBM: speed is vital with COVID-era trials

Outsourcing Pharma

A leader from IBM Watson Health talks about how its advanced EDC solution is geared toward helping studies save precious time and conserve costs.

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Biogen signs $2.1 billion Parkinson’s disease deal with Denali

pharmaphorum

Biogen has bought a licence to co-develop and co-market potential Parkinson’s disease drugs with US biotech Denali, in a deal worth more than $2.1 billion. Denali has been working on small-molecule compounds capable of crossing the blood-brain barrier and Biogen has bought a licence to co-develop and co-market compounds known as LRRK2 inhibitors in Parkinson’s disease.

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Cerner and LRVHealth invest $6m in digital health firm Xealth

pharmaphorum

Health technology firms Cerner and LRVHealth have invested $6 million in Xealth to scale up its business offering digital health tools to patients and clinicians. The companies said the new relationship aims to give patients control over their own digital data so they can be more engaged in their treatment plans. Cerner and LRVHealth join Xealth’s other investors Atrium Health, Cleveland Clinic, Froedtert and the Medical College of Wisconsin, MemorialCare Innovation Fund, Providence Ventures and

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Pharma’s rep soars on back of COVID-19, says FutureBrand

pharmaphorum

The perception of pharma and medical product companies has surged forward since the start of the COVID-19 pandemic, but they still lie mostly outside the top-rated firms in the FutureBrand Index. Roche, AstraZeneca, Novo Nordisk, and Sanofi all shot up the rankings in the first edition of the report since the start of the coronavirus crisis, but the big loser was Gilead Sciences, falling 71 places to 74 in the list since the last edition in 2018.

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Government warned over test and trace as UK schools prep to reopen

pharmaphorum

The current level of test and trace in the UK is inadequate to prevent a sharp increase in coronavirus infections when schools reopen in September and there is further relaxation of social distancing rules, according to scientists. A second wave of COVID-19 could be avoided if enough people are tested and traced, according to the team from University College London and the London School of Hygiene & Tropical Medicine.

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Roche’s Tecentriq flunks triple-negative breast cancer trial

pharmaphorum

Roche’s hopes of extending the use of its PD-L1 inhibitor Tecentriq in triple-negative breast cancer (TNBC) have been dashed by a late-stage trial failure looking at the drug in combination with chemotherapy. Adding Tecentriq to treatment with paclitaxel as a first-line treatment for TNBC patients whose tumours expressed the biomarker PD-L1 did not lengthen the time it took for the cancer to progress, when compared to paclitaxel plus placebo.

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Lundbeck gets cold feet, axes schizophrenia drug trial

pharmaphorum

Lundbeck has axed a phase 2 trial of a schizophrenia drug, saying that the study was unlikely to meet its efficacy target. The company said it made the decision after a futility analysis indicated that the trial was not likely to succeed, when measured against a standard scale. When Lundbeck began the trial at the beginning of last year, it said the drug could be a new approach to treating schizophrenia.

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Will new data make Pfizer’s Lorbrena a ‘no-brainer’ in early lung cancer?

pharmaphorum

Pfizer has taken a big step towards positioning Lorbrena as a worthy heir to its big-selling Xalkori drug in lung cancer, after beating its parent in a phase 3 trial. The CROWN trial pitted Lorbrena (lorlatinib) against Xalkori (crizotinib) in patients with previously-untreated ALK-positive non-small cell lung cancer (NSCLC), and showed that Lorbrena was better at staving off progression of the disease.

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Playing an Active Role in Treatment Yields More Confidence in Patients

pharmaphorum

When aiming to reach the people who will benefit most from a given medication or therapy, patients who play an active role in treatment decisions are often at the forefront of the conversation. But what does playing an active role in treatment really mean? While there is no concrete definition, a meta-analysis of Health Union’s 2019 large scale, condition-specific In America surveys uncovers certain attitudes and behaviors associated with this mindset.

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Novo Nordisk beats Q2 profit forecasts by cutting costs

pharmaphorum

Denmark’s Novo Nordisk has beaten profit forecasts in the second quarter after overcoming tough conditions in the diabetes market by improving its productivity. Novo said that COVID-19 has begun to affect sales, with fewer new starts as a result of social distancing measures. The company’s diabetes care products saw an increase in sales during the second quarter, although this was offset by lower sales of insulin.

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Ophthalmic Drug Delivery Development – Trials and Tribulations workshop

pharmaphorum

SMi reports: Brian Levy, CEO, Ocunexus Therapeutics will lead the post conference workshop on Wednesday 25 th November 2020. SMi presents the 4 th Annual Ophthalmic Drugs Conference taking place on the 23 rd -24 th November 2020, in London. SMi are also pleased to announce that they will be hosting a half-day post-conference workshop, Wednesday 25 th November 2020 at 13.30 – 17.30.

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Pre-filled Syringes San Francisco will now take place as a Virtual Conference

pharmaphorum

SMi Reports: Due to the ongoing challenges surrounding COVID-19 and large public gatherings, September’s Pre-filled Syringes San Francisco conference will now run as a virtual event. With the continued uncertainty surrounding large gatherings in the UK, SMi Group have made the decision to turn the pre-filled Syringes Conference on the 14h – 15th September 2020 into a fully interactive virtual meeting.

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Merck & Co to repurpose failed obesity drug for NASH

pharmaphorum

Merck & Co is to pay $10 million to Hanmi to repurpose an obesity drug discarded by Johnson & Johnson, into a therapy for the fatty liver disease known as NASH. Non-alcoholic steatohepatitis, as the disease is also known, has been a target for pharma for years but is proving a tough nut to crack as there are no drugs yet approved to treat it.

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DBV craters on FDA’s peanut allergy immunotherapy rejection

pharmaphorum

DBV Technologies’ long and tortuous path to an FDA verdict on its Viaskin Peanut allergy shot has led to another dead end. The France-headquartered biotech confirmed the complete response letter (CRL) from the US regulator today, adding another delay to a programme that is already falling well behind a rival therapy developed by Aimmune – Palforzia – which was approved in February.

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