Fri.Aug 05, 2022

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Most people with opioid use disorder don’t get meds for it, but these 3 changes could help

MedCity News

Medications that treat opioid use disorder (OUD) — such as methadone, buprenorphine and extended-release naltrexone — are proven to save lives. However, a new study revealed that less than 15% of Americans with OUD receive these medications. Its lead author laid out three actions the U.S. should prioritize to increase access.

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Bayer tops pharma rankings for diversity, inclusivity

pharmaphorum

The largest pharma companies have all set themselves ambitious targets in recent years to improve representation for women and minority communities in their businesses, but are they meeting those diversity objectives? On the whole, yes, says a new study by reputation intelligence and media monitoring specialist alva , which delves through millions of content items across online and traditional media and other source materials to give a score on their diversity, equity and inclusion (DE&I) ef

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Why we need to achieve a full continuum of care in maternal and infant health

MedCity News

By applying a more comprehensive maternity journey, we are able to address social determinants of health that vary by population, geography, and community – and are estimated to impact 80% of an individual’s overall, long-term health.

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Amgen to acquire biopharma firm ChemoCentryx for $3.7bn

Pharmaceutical Technology

Amgen has signed a definitive agreement to acquire biopharmaceutical company ChemoCentryx for $52 for each share in cash or a total enterprise cost of nearly $3.7bn. ChemoCentryx focuses on orally administered therapeutics for the treatment of inflammatory disorders, autoimmune ailments and cancer. For discovering, developing and marketing such treatments, the company targets the chemokine and chemoattractant systems.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

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

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Homeward secures $50M, partners with Priority Health for rural value-based care

MedCity News

Homeward is working to fill in the gap of primary and specialty care in rural areas. Currently working in Michigan, it hopes to use the funding to expand into other markets.

Marketing 111
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UK recall of Clinigen’s Mexiletine hydrochloride hard capsules

European Pharmaceutical Review

Clinigen Healthcare is recalling three batches of Mexiletine hydrochloride hard capsules, indicated for the treatment of documented arrhythmias, due to a potential risk of under- or overdose, which could have consequences for the safety of patients. The Class 1 Medicines Recall Notification was published by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).

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Gilead snaps up MiroBio and its checkpoint agonists for $405m

pharmaphorum

Less than three years after being spun out of Oxford University, privately-held biotech MiroBio is heading for a takeover by Gilead Sciences in a $405 million deal. MiroBio was formed in 2019 to develop checkpoint agonist antibodies for autoimmune and inflammatory disorders that can be used to apply the “natural brakes” of the immune system.

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Weathering the good and the bad: Why good business practices work

MedCity News

For most companies and medtech, in particular, good business practices (GBP) happens on multiple levels. On the micro level, it’s more prescriptive (i.e., regulatory best practices or good manufacturing practices). On the macro level, it’s expressed as a set of ethics and principles that govern a company’s conduct.

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Sanofi looks east with €300m Innovent cancer alliance

pharmaphorum

Sanofi is making a €300 million investment in Chinese biotech Innovent as part of a collaboration to bring two new cancer therapies as quickly as possible to patients in the world’s second-largest pharma market. The deal – which includes an option on a second €400 million investment – will see the two companies jointly develop tusamitamab ravtansine (SAR408701), a CEACAM5-targeting antibody-drug conjugate (ADC), as well as a pegylated formulation of interleukin-2 codenamed SAR444245 in Chi

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Vaping cessation programs are becoming critical for today’s workers

MedCity News

Helping your employees quit vaping increases workplace productivity and reduces the overall impact on your business’s bottom line. The sooner you implement an effective vaping cessation program, the better it will be for your employees and organization.

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How Machine Learning Drives Clinical Trial Efficiency

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.

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Q&A With Court Horncastle, Vice President and Business Unit Head, Respiratory, US Commercial for GSK

PharmExec

Court Horncastle discusses how his career led him to work with treating COPD and asthma.

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FDA approval of AstraZeneca drug is first for a new group of breast cancer patients

MedCity News

Enhertu, a breast cancer drug from AstraZeneca and Daiichi Sankyo, is now FDA approved for treating patients whose tumors express low levels of the protein HER2. The decision makes the infused therapy the first targeted treatment for this new category of breast cancer patients.

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Publishing “Trial of the Century” Opens

Copyright Clearance Center

The post Publishing “Trial of the Century” Opens appeared first on Copyright Clearance Center.

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StartUPDATES: New developments from healthcare startups

MedCity News

Check out new developments from Carrum Health, Equiva, Carefeed, Brain Check, and Atropos Health.

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Roles and Responsibilities of Specialized Clinical Supply Experts

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.

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EC grants approval for Merck-AstraZeneca’s Lynparza for breast cancer

Pharmaceutical Technology

The European Commission (EC) has granted approval for Merck (MSD outside the US and Canada) and AstraZeneca ’s Lynparza (olaparib) as monotherapy or along with endocrine therapy for the adjuvant treatment in adults with high-risk, early-stage breast cancer. The treatment is indicated for people with germline BRCA1/2 mutations (gBRCAm) and have human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer.

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South Tees NHS Trust reaches e-prescribing milestone by implementing Alcidion

PharmaTimes

Better Meds is already removing paper forms and manual processes from NHS Trust’s system

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Create Job Ads That’ll Attract the Most Suitable Candidates

Rep-Lite

Building a business can be a very challenging process, but it can be gratifying. It does not only produce profits for the owners, but it creates jobs and careers for a lot of people. In creating companies, one is essentially creating a multitude of opportunities. Both old and new companies need a pool of talents to remain or become functional. While it is valid for all industries, the medical and pharmaceutical companies need to be picky with who they hire.

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Gilead Sciences signs agreement to acquire MiroBio for $405m

Pharmaceutical Technology

Gilead Sciences has signed a definitive agreement for the acquisition of the complete outstanding share capital of MiroBio in a deal valued at nearly $405m in cash, subject to necessary adjustments. With the acquisition, Gilead will gain access to the discovery platform and complete line of immune inhibitory receptor agonists of MiroBio. The scientific approach of MiroBio for immune balance restoration to treat autoimmune diseases complements the inflammation research and development works of Gi

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.

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Traditional approaches to growth in biopharma are no longer sustainable

pharmaphorum

Over the past 15 years, more than 60% of asset growth among the top 30 biopharma companies came from acquisitions. Such inorganic growth is no longer viable, argues Pervaise Khan, Accenture’s UK Life Sciences Lead. The pace of innovation in biopharma has rocketed over the last two years, with vaccines, new antivirals, and therapies delivered at an unprecedented pace.

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FDA approves Coherus’ Cimerli for DME, with year-long interchangeability exclusivity

Pharmaceutical Technology

The diabetic macular oedema (DME) space recently witnessed a new approval; the US Food and Drug Administration (FDA) announced the approval of Coherus’ Cimerli (ranibizumab-eqrn; FYB201), a vascular endothelial growth factor (VEGF) inhibitor therapy. Cimerli is a biosimilar of Lucentis (ranibizumab) and has been granted 12 months of interchangeability exclusivity across five different retinal diseases: DME, diabetic retinopathy (DR), neovascular (wet) age-related macular degeneration (AMD), myop

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Intertwining Technology and Data Solutions

Pharmaceutical Commerce

A look into the effectiveness of data processing pipelines.

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Updated NCCN Breast Cancer Screening Guidelines Help Clarify Risk for Patients

Pharmacy Times

Patients can better understand the most current recommendations for breast cancer screening with the new NCCN Guidelines for Patients®: Breast Cancer Screening and Diagnosis.

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Accelerating Clinical Supply Through Integrated Drug Development

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.

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5 Ways to Tackle Patient Non-Adherence

Pharmaceutical Commerce

Five strategies to help pharma companies improve their return on investment from adherence-promoting initiatives and drive positive health outcomes for patients.

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Sanofi and Innovent Biologics enter strategic collaboration

PharmaTimes

Partnership will accelerate development of oncology medicines and expand presence in China

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FDA Approves First Therapy for New HER2-low Breast Cancer Subtype

Pharmacy Times

The FDA approved a new drug that treats unresectable and metastatic HER2-low breast cancer, giving patients with this new subtype a treatment beyond chemotherapy.

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AES Clean Technology Launches OMNI Electric Utility Raceway

PharmaTech

The OMNI Electric Utility Raceway power and data management system is designed to reduce risk and accelerate cleanroom delivery.

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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic

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Pharmacists Play Key Role in Counseling Patients About Monkeypox

Pharmacy Times

Michael Ganio, PharmD, MS, BCPS, FASHP, senior director of pharmacy practice and quality at ASHP, discussed the declaration of monkeypox as a public health emergency.

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La Jolla Institute for Immunology Acquires Carterra LSA Platform

PharmaTech

La Jolla’s acquisition of Carterra’s LSA Platform is designed to advance their immunological and infectious disease research.

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Myocarditis, Pericarditis Rare in Young Men After COVID-19 Vaccination With Moderna Vaccine

Pharmacy Times

While the vaccines continue to provide critical, evidence-based protection against the coronavirus, rare cases of myocarditis and pericarditis have been reported.

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No drugs for prions: could new approaches alleviate therapeutic scarcity?

Pharmaceutical Technology

The development of therapeutics for transmissible spongiform encephalopathies (TSEs) continues to be challenged by the complex nature of these diseases. Also referred to as prion diseases, TSEs are rare and fatal neurodegenerative conditions. As per the prevailing prion theory, a misfolded version of a normal cell-surface protein acts as the chief infectious agent.

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

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.