Tue.Aug 09, 2022

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New Binding Mechanism Science Driving Therapeutic Insight in Immune-Mediated Diseases

Pharmacy Times

The ability of an anti-interleukin-23 antibody to bind to key immune system components may help neutralize a key driver of inflammation right at its cellular source.

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Health Canada accepts Paladin’s NDS for epilepsy-linked seizure therapy

Pharmaceutical Technology

Health Canada has accepted the New Drug Submission (NDS) of Endo International subsidiary Paladin Labs for cenobamate tablets as an adjunctive treatment to manage partial-onset seizures in adult epilepsy patients. The treatment is intended for such patients who are not well-controlled with standard therapy. The regulatory agency is anticipated to provide a decision on whether cenobamate tablets can be commercialised and sold in Canada under this NDS in the middle of next year.

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Plasmapheresis is Viable Treatment Option for Patients with Hashimoto’s Encephalopathy Nonresponsive to Steroids

Pharmacy Times

Researchers recommend having a low clinical threshold for the diagnosis of Hashimoto’s encephalopathy in patients who reveal no apparent cause for their altered mental status, given the heterogenous nature of the condition’s presentation.

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FDA okays ProstatID software for detecting prostate cancer in MRI

pharmaphorum

Magnetic resonance imaging (MRI) technology specialist Bot Image has won FDA approval for its artificial intelligence-powered software ProstatID, used for the detection and diagnosis of prostate cancer. The software is combined with traditional MRI scanning to improve the “accuracy and speed” of prostate cancer diagnosis by improving the diagnostic resolution of images, according to the company, which makes it available as a software-as-a-service (SaaS) to radiology departments.

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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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The Renaissance of Small Molecule Drug Discovery

Pharmacy Times

Last year, the majority of new drug approvals were for small molecules, including treatments for HIV, cancer, infections, heart and kidney disease, and neurological disorders.

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Alzheimer’s research data questioned by Department of Justice

Outsourcing Pharma

After scientists and reporters raised red flags about a study, Cassava Sciences is being accused of falsifying data in pursuit of an Alzheimerâs treatment.

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Big Pharma deal-making primed for acceleration

European Pharmaceutical Review

After a prolonged period of scepticism towards major moves in the mergers and acquisitions (M&A) market, leading biopharmaceutical multinationals are returning to big deal-making. The M&A data for the second quarter of 2022 shows that while both the number of pharma deals signed and their overall value are still low compared to 2021, there are signs of a revival.

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Case Study: Review of ACE Inhibitor-Induced Bowel Angioedema

Pharmacy Times

Globally, more than 40 million patients are currently taking an ACE inhibitor, primarily for the treatment of high blood pressure and heart failure.

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Pfizer to acquire Global Blood Therapeutics in $5.4bn deal

European Pharmaceutical Review

Pfizer has entered into a definitive agreement to acquire Global Blood Therapeutics (GBT) , a biopharmaceutical company dedicated to the discovery, development and delivery of life-changing treatments for underserved patient communities, such as those with sickle cell disease (SCD). According to Pfizer, the acquisition complements and further enhances its more than 30-year heritage in rare haematology, reinforcing the company’s commitment to SCD “by bringing expertise and a leading portfolio and

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Recombinant Zoster Vaccine Cost Effective for Prevention of Shingles

Pharmacy Times

A systemic review found that recombinant zoster vaccination is more cost effective than no vaccine or the previously available zoster vaccine live.

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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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Turning harp seal contraceptives into a ‘new genre’ of cancer treatments

PharmaVoice

With Andrew Hall at its helm, IMV has evolved an animal contraceptive into a unique drug delivery platform aimed at creating targeted cancer immunotherapies for humans.

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Using Immunoinformatics to Create a Clostridium Difficile Vaccine

Pharmacy Times

Immunoinformatics allows researchers to develop vaccines without microbial culturing, thus saving time and money.

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MCI OneHealth, MDClone team up to use synthetic data to accelerate research

Outsourcing Pharma

The two companies are collaborating to generate subject data sets designed to help users find insights that can speed up research and improve patient care.

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Clinical Overview: Treatments for Tardive Dyskinesia

Pharmacy Times

Tardive dyskinesia is often caused by the use of dopamine receptor blocking agents, most commonly antipsychotics, for at least a few months.

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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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5 Free Certified Pediatric Nurse Exam Practice Questions 

Board Vitals - Pharmacist

Gearing up for the CPN Exam? See where you stand and try your hand at these 5 free Certified Pediatric Nurse Exam practice questions from the all-new BoardVitals Certified Pediatric Nurse Exam Question Bank. . . How did you do? Practice makes perfect! If you struggled with some of these questions, you’re not alone. The CPN Exam is relatively difficult with a first-time pass rate of 78.47% in 2020.

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Pharmacy Focus: On The Shelf - Healthy Work-Life Balance

Pharmacy Times

On this week's episode, Joanna continues her conversation with Allyson Brennan, Founder of Emogene & Co, PharmD, about skincare, the importance of a healthy skin barrier, Vitamin C, and work-life balance.

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FDI drivers in 2022: ESG

Pharmaceutical Technology

Embracing environmental, social and governance (ESG) criteria is rising in importance as a driver of foreign direct investment (FDI) , with investors increasingly taking into account such criteria as part of their site selection decision. However, when it comes to responsible investing, there is more to it than simply ticking off the 'E', 'S' and 'G'.

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Behind the Creative….Inspiring Award Winning Creative with Halen Dang and Carrie Morris

PharmExec

Proximyl Health’s Halen Dang, VP, Creative Director of Art and Carrie Morris, VP, Creative Director of Copy discuss remote teamwork and how to successfully lead agency creative teams with hybrid schedules.

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Healthtech deals decreased significantly in the pharma industry in H1 2022

Pharmaceutical Technology

In the first half of 2022 the number of deals relating to healthtech decreased significantly by 28.7% from the same period in 2021. This marks an acceleration in growth from the 34.7% decrease in deals that occurred in H2 2021 relative to the same period a year earlier. GlobalData's deals database looks at mergers, acquisitions and venture capital and private equity investments taking place daily between thousands of companies across the world.

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Tagrisso paired with Hutchmed drug clears lung cancer test

pharmaphorum

EGFR inhibitors like AstraZeneca’s Tagrisso have been hugely successful in treating EGFR-positive lung cancer, but the durability of treatment is often reduced by resistance mutations. Now, a combination of Tagrisso with another drug looks like it may help tackle that issue. The most common biomarker among people with EGFR-mutated lung cancer who develop resistance to targeted therapy is MET, and AZ has partnered with China’s Hutchmed to combine its MET inhibitor savolitinib with Tag

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Filings buzz in pharmaceuticals: 24% decrease in artificial intelligence mentions in Q2 of 2022

Pharmaceutical Technology

Mentions of artificial intelligence within the filings of companies in the pharmaceutical industry fell 24% between the first and second quarters of 2022. In total, the frequency of sentences related to artificial intelligence between July 2021 and June 2022 was 400% higher than in 2016 when GlobalData, from whom our data for this article is taken, first began to track the key issues referred to in company filings.

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Daily Medication Pearl: Sodium Polystyrene Sulfonate (Kayexalate)

Pharmacy Times

Kayexalate is a potassium binder indicated for the treatment of hyperkalemia.

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Sartorius to acquire UK’s Albumedix for $501.5m

Pharmaceutical Technology

Life science group Sartorius has signed a definitive agreement for the acquisition of complete outstanding shares of UK-based company Albumedix from private investors in a deal valued at nearly $501.5m (£415m). Sartorius will carry out the takeover through its French-listed subgroup Sartorius Stedim Biotech. The acquisition of Albumedix is intended at bolstering the new advanced therapy solutions portfolio of Sartorius.

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How real world evidence is impacting rare disease drug development

PharmaVoice

[link]

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Pfizer signs agreement to acquire biopharma firm GBT for $5.4bn

Pharmaceutical Technology

Pfizer has signed a definitive agreement for the acquisition of all the outstanding shares of biopharmaceutical firm Global Blood Therapeutics (GBT) for a total enterprise value of nearly $5.4bn or $68.50 for each share in cash. GBT focuses on discovering, developing and delivering life-changing therapies, starting with sickle cell disease (SCD). The takeover of GBT complements and boosts Pfizer’s expertise in rare haematology.

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Daily OTC Pearl: Senokot-S

Pharmacy Times

Senokot-S is indicated for constipation relief.

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Case Study 2 – The Journey Leading to an Approved NDA

Impact Pharmaceutical Services

Download a PDF of this case study. The Journey Leading to an Approved NDA. In 2010, following a referral from another company, IMPACT (now part of Syner-G BioPharma Group) was contacted by a mid-size biopharmaceutical company to assist them with an upcoming NDA for a new chemical entity in the treatment of an orphan condition. Over the next year, IMPACT authored the following documents for the client: Pre-NDA meeting package. 5 clinical study reports.

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Verona’s ensifentrine meets primary endpoint

Pharma Times

Chronic obstructive pulmonary disease phase 3 study shows statistically significant improvements in lung function

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Case Study 6 – Regulatory Operations Department Developed and Flourishing

Impact Pharmaceutical Services

Regulatory Operations Department Developed and Flourishing. In 2013, the IMPACT (now part of Syner-G BioPharma Group) management team decided that the company needed to build a Regulatory Operations department to support their existing and future client base. The staff to manage and support this group was secured. Hosted software to publish regulatory submissions in the electronic common technical document (eCTD) format was deployed.

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Arecor granted European patents to protect Humira formulations

Pharma Times

Patents show potential of innovative Arestat technology and the development of enhanced formulations

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Case Study 5 – Regulatory Affairs Strategy and Project Team Lead

Impact Pharmaceutical Services

Regulatory Affairs Strategy and Project Team Lead. IMPACT (now part of Syner-G BioPharma Group) has been providing Regulatory Affairs support to a mid-size pharmaceutical company since 2009. Even though this company has a Regulatory Affairs Department, their rapid growth over the years has made “in-sourcing” of help a necessity. One area of particular need for the company has been identifying experienced regulatory affairs professionals to serve on their core Product Development Teams (PDT).

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Filling in the radiopharma gaps

Pharma Manufacturing

Grit and experience give a promising sector teeth

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Case Study 4 – Successful US/EU Marketing Applications for Big Pharma

Impact Pharmaceutical Services

Successful US/EU Marketing Applications for Big Pharma. As a result of repeat business, IMPACT (now part of Syner-G BioPharma Group) was contracted by a large, global pharmaceutical company to author the CSRs and accompanying submission documents to support a simultaneous US and EU submission for a combination respiratory product. This work included authoring 9 CSRs (8 Phase 3 and 1 Phase 2b) as well as the Integrated Summaries of Efficacy and Safety (ISE and ISS), Summaries of Clinical Efficac

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AI tissue analysis enables rapid discovery of drug candidates

pharmaphorum

AI could address the most significant issue in drug discovery, finds Ben Hargreaves, and also offers the potential to use tissue samples to create precision medicine for specific patient groups. The scale of the challenge. Cancer is the second leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, according to the World Health Organization.

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