Sat.Jun 25, 2022 - Fri.Jul 01, 2022

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The Pathway to Ambulatory Care Pharmacy

Pharmacy Is Right For Me

There are so many different types of careers within the field of pharmacy—from research and drug development to pharmacy informatics! To highlight some of the more unique career settings in the industry, we’re introducing a new page on our website— Novel Pharmacy Practice Settings —where you can explore these unique career pathways. In addition to learning more about unique pathways on our new webpage, we’ll also be featuring pharmacists who work in these unique settings on our blog.

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Why Oncology Pharmacists Should Be at the Helm of Precision Medicine in Oncology

Pharmacy Times

Andre Harvin, PharmD, MS, executive director of Pharmacy, Oncology Services at Cone Health, discusses the importance of putting precision medicine programs into oncology practices with pharmacists leading the way.

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Biotech spotlight: Twist Bioscience aims to remove limits on drug discovery with DNA synthesis platform

PharmaVoice

As ‘the Amazon of DNA,’ Twist CSO, Aaron Sato, discusses the company’s breakthrough approach to DNA production and its expansion into drug development.

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GSK hepatitis B hope bepirovirsen heads for phase 3 test

pharmaphorum

An antisense drug in development at GSK has shown further activity against hepatitis B virus (HBV) in a mid-stage trial, setting up a phase 3 assessment next year to see if it could offer a “functional cure” for the widespread disease. Interim results from the phase 2b B-Clear showed that bepirovirsen reduced levels of hepatitis B surface antigen (HBsAg) and HBV DNA after 24 weeks’ treatment to below the lower limit of detection in people with chronic hepatitis B, raising hopes

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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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Enabling the next wave of innovative drug therapies with speciality enzymes

Pharmaceutical Technology

Approximately 75,000 enzymes are thought to exist in the human body as vital catalysts for biochemical reactions or conversions. For hundreds of years, we have found myriad uses for microbial enzymes in manufacturing – from food, drink, and household products to a range of industrial applications. The pharmaceutical industry often relies on enzymes to perform a process known as biocatalysis, which facilitates the cost-effective and sustainable production of small molecule drugs at scale.

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Radius, Menarini Submit NDA for Elacestrant as Treatment of ER+/HER2- Breast Cancer

Pharmacy Times

As part of the submission, the companies have also requested priority review with the FDA for elacestrant in patients with ER+/HER2- advanced or metastatic breast cancer.

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FDA rejection of Spero’s tebipenem ‘raises resistance threat’

pharmaphorum

The FDA’s decision not to approve Spero Therapeutics’ oral antibiotic tebipenem Hbr for adults with complicated urinary tract infections (cUTI) further increases the threat of antibiotic resistance, according to a GlobalData analyst. The FDA delivered a blow to Spero’s hopes of bringing the carbapenem to market in a complete response letter (CRL) delivered this week, which said another trial would be required to support approval.

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Magazine-How delays derailed Covid-19 vaccination in Africa

Pharmaceutical Technology

The latest issue of Pharma Technology Focus is out now. Read it for free on all devices. Some months after the first Covid-19 vaccines became available, the World Health Organization (WHO) set a target of vaccinating 70% of each country’s population by the end of June 2022. Global trends indicate that initially, a slow supply did not allow African countries, in particular, to stay on pace to meet this target, and now vaccination rates have even begun to slow down.

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Study: COVID-19 Vaccination Not Associated With Increased Risk of Heart Attack, Stroke

Pharmacy Times

The study included the BNT162b2 and CoronaVac vaccines, which are the only COVID-19 vaccines authorized for emergency use in Hong Kong.

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Q&A With Anastasiia Kamenska, director of corporate strategy, Novartis

PharmExec

As director of corporate strategy for Novartis, Kamenska defines direction for the company’s overall enterprise. Here, she discusses how the pandemic and recent market events are shaping these strategies.

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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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Merck launches accelerator programme for AI startups

pharmaphorum

Merck & Co is looking for startup companies applying artificial intelligence , machine-learning and other digital approaches to drug discovery and development for a new accelerator programme. The big pharma – known as MSD outside North America – is initially offering support to 12 companies though the newly-formed Merck Digital Sciences Studio (MDSS) and is now taking applications from would-be participants.

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AI hiring levels in the pharmaceutical industry rose in May 2022

Pharmaceutical Technology

The proportion of pharmaceutical companies hiring for AI related positions kept relatively steady in May 2022 compared with the equivalent month last year, with 39.3% of the companies included in our analysis recruiting for at least one such position. This latest figure was higher than the 39% of companies who were hiring for AI related jobs a year ago but a decrease compared to the figure of 43.6% in April 2022.

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Novel C. Difficile Treatment Reduces Recurrence in Key Subgroups

Pharmacy Times

Paul Feuerstadt, MD, FACG, AGAF, discussed research into the novel C. difficile treatment RBX2660 and what investigators have found about its efficacy in key subgroup analyses.

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Overcoming Supply Chain Crises with Digitization

Pharmaceutical Commerce

Amy Shortman outlines some ways visibility technology is solving problems at a time when it’s needed most, and how digitization is the key to overcoming supply chain crises.

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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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Study exposes lack of diversity in US cancer trials

pharmaphorum

Almost half (48%) of cancer clinical trials in the US have no Hispanic or Latin American subjects, and 42% have no black patients, according to a diversity analysis focusing on thousands of studies conducted in the past 15 years. The analysis – from a dataset that spans more than half a million patients – reveals once again the lack of inclusivity in clinical research, which undermines the ability of clinical trials to generate results that reflect the real-world situation in US cancer treatmen

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Pfizer seeks approval from US FDA for Covid-19 treatment

Pharmaceutical Technology

Pfizer has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking approval for Paxlovid (nirmatrelvir tablets and ritonavir tablets) to treat Covid-19 patients at increased disease progression risk. An inhibitor of SARS-CoV-2 main protease (Mpro), Paxlovid is intended to be given orally. Due to the oral form, the therapy can be prescribed in the early infection stage to avert severe illness.

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FDA Approves Lisocabtagene Maraleucel for Second-Line Large B-cell Lymphoma

Pharmacy Times

Lisocabtagene maraleucel (liso-cel, Breyanzi; Bristol Myers Squibb) approved for the second-line treatment of patients with large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma not otherwise specified, high-grade B-cell lymphoma, primary mediastinal LBCL, and follicular lymphoma grade 3B.

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Global Blood Therapeutics: driving innovation in sickle cell disease

European Pharmaceutical Review

Sickle cell disease – a rare, yet prevalent, genetic disease in Europe. Sickle cell disease (SCD) is a devastating, lifelong blood disorder that occurs when someone inherits sickle cell genes from both parents. 1 It affects haemoglobin, a protein carried by red blood cells that delivers oxygen throughout the body. 2 SCD predominantly affects those whose ancestors are from sub-Saharan Africa but is also common in people of Hispanic, South Asian, Southern European and Middle Eastern ancestry. 3 Wh

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Bayer launches digital AI platform for radiology specialists

pharmaphorum

Bayer has stepped up the digital capabilities of its radiology business with the launch of artificial intelligence-based apps for X-ray, MRI and CT imaging. The cloud-hosted platform – called Calantic Digital Solutions – has tools to help radiologists detect and quantify disease lesions in medical images and select patients for treatment in order of priority, improving their productivity.

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Terumo and GenCure sign agreement for cell and gene therapies

Pharmaceutical Technology

Terumo Blood and Cell Technologies and BioBridge Global subsidiary, GenCure, have entered a new partnership agreement to expand and integrate cell and gene therapy manufacturing solutions. In a bid to meet the growing demand for automated and closed smart systems across the cell and gene therapy (CGT) industry, the companies entered the deal to merge technologies and capabilities.

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Pharmacists Can Help Create a Safe, Tolerant Workplace for LGBTQ+ Employees

Pharmacy Times

As we mark the second anniversary of Bostock v. Clayton County this month, let’s remember to treat each other with dignity, empathy, and respect, while we work together for a safer and more tolerant workplace.

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From vineyards to antivirals, Gilly Regev brings creative thinking to science

PharmaVoice

The CEO of SaNOtize is tapping into outside-the-box innovation to develop a nitric oxide-delivery platform to treat and prevent COVID-19.

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Ipsen beefs up in oncology, buying US biopharma Epizyme

pharmaphorum

The revamp of French drugmaker Ipsen has continued with a takeover agreement for US counterpart Epizyme and its cancer therapy Tazverik, in a deal valued at a little under $250 million. Ipsen is offering $1.45 per share for Cambridge, Massachusetts-based Epizyme – valuing the US company at around $247 million – and is also promising a further contingent value right (CVR) payment of up to $1 per share if Tazverik (tazemetostat) achieves certain development and sales targets.

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Astellas and Sutro partner to develop immunostimulatory ADCs

Pharmaceutical Technology

Astellas Pharma and Sutro Biopharma have entered a global, strategic partnership and licencing agreement to discover and develop new immunostimulatory antibody-drug conjugates (iADCs). An iADC merges an antibody with a small molecule compound that elicits immunogenic cell death, and an immune-activating molecule. It can potentially enhance the anti-cancer effect.

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AbbVie Submits sNDA to FDA for Qulipta for Preventive Treatment of Chronic Migraine

Pharmacy Times

Submission is based on phase 2 study results evaluating atogepant in adults who met the primary endpoint of a statistically significant reduction from the baseline compared with a placebo.

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Pursuing new paths in targeted protein degradation drug development

European Pharmaceutical Review

DRUG DEVELOPMENT based on targeted protein degradation (TPD) has progressed rapidly since the publication in 2015 of three landmark papers 1-3 that highlighted important early-stage breakthroughs with drug-like molecules in this area of research. Since that time, the field has advanced to the point where there are now more than two dozen companies dedicated to working on the development of TPD drugs, some of which have advanced to later-stage clinical development.

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Astellas pumps $90m into Sutro immuno-oncology alliance

pharmaphorum

Astellas has agreed a $1.36 billion partnership with US biotech Sutro Biopharma for a series of antibody-drug conjugates for cancer, focusing on applications in patients who don’t respond to current immunotherapies. The alliance includes an upfront payment of $90 million, backed by $422.5 million in possible milestone payments apiece for up to three development programmes based on Sutro’s immunostimulatory antibody-drug conjugate (iADC) technology.

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WHO’s new hepatitis C guidelines a step forward in reaching those in need

Pharmaceutical Technology

Last Friday, the World Health Organization (WHO) launched updated guidelines for the treatment of hepatitis C , calling for testing and treatment to be delivered in peripheral and community-based facilities and integrating these with available care services. While some countries are making progress in eliminating hepatitis C, many remain challenged in reaching those affected, Dr Philippa Easterbrook, Senior Scientist at WHO’s Department of Global HIV, Hepatitis and Sexually Transmitted Infection

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Addressing the Mystery of Long Hauler COVID: The Time is Now

Pharmacy Times

As we learn more about inflammatory syndromes, we may get better at using laboratory tests to identify and isolate the actual cellular and chemical processes that drive them.

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Sanofi pushes to accelerate medical writing, reporting processes

Outsourcing Pharma

The pharmaceutical company has enlisted the help of the AI and NLP tech specialist to streamline clinical study report generation and submission processes.

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NHS App could offer video consultations by 2024

pharmaphorum

The NHS App will be updated over the next couple of years to include a series of new features, including the ability to offer remote video consultations between patients and GPs, according to the Department of Health and Social Care. The update to the app is part of a series of measures unveiled in the Plan for Digital Health and Social Care that describes how technologies will be used to “drive efficiency, free up hospital space and clinician time, and bust the Covid backlogs.” From

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BMS receives US FDA approval for CAR T cell therapy to treat B-cell lymphoma

Pharmaceutical Technology

Bristol Myers Squibb (BMS) has received approval from the US Food and Drug Administration (FDA) for its CD19-directed chimeric antigen receptor (CAR) T cell therapy Breyanzi (lisocabtagene maraleucel) to treat relapsed or refractory large B-cell lymphoma (LBCL) in adult patients. Breyanzi is given as a defined composition for reducing the variability of the CD8 and CD4 component dose.

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New Clinical Data for Bivalent COVID-19 Booster Candidate Shows Potent Response Against Omicron Variant

Pharmacy Times

At 1 month, a 50-µg booster dose of mRNA-1273.214 had a potent neutralizing antibody response against the Omicron variants in all individuals, regardless of prior infection.

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Healthier Together and philanthropic ventures in tropical disease

European Pharmaceutical Review

Europe’s Healthier Together initiative. The European Commission (EC) has launched the Healthier Together: EU Non-communicable diseases (NCDs) initiative to support EU Member States in reducing the burden of NCDs by addressing the leading causes of avoidable premature death in Europe and improving citizens’ health and well-being. The €156 million initiative identifies effective actions and the available legal and financial supporting tools across five main areas: cardiovascular diseases, di