Wed.Oct 19, 2022

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Lilly agrees to acquire gene therapy developer Akouos for $610m

Pharmaceutical Technology

Eli Lilly and Company has signed a definitive agreement for the acquisition of all outstanding shares of precision genetic medicine firm Akouos for a total deal value of up to nearly $610m or up to $15.50 for each share in cash. The deal comprises an acquisition value of $12.50 for each share in cash payable at closing along with one non-tradeable contingent value right per share (CVR) of up to another $3 in cash.

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Carrum Health, GRAIL strike up partnership to offer cancer test to employers

MedCity News

Through the new collaboration, Carrum Health is offering GRAIL’s cancer test called Galleri as a benefit option for employers. It is an early-detection test for more than 50 types of cancer.

Biopharma 118
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Alzheimer’s Diagnostic Test Spots Amyloid ? Exosomes in Blood

Medgadget

Researchers at Hokkaido University in Japan have developed a biomarker test for Alzheimer’s disease that detects amyloid ? binding exosomes in a blood sample. While amyloid ? plaques in the brain are characteristic of Alzheimer’s, these researchers have previously reported that amyloid ? build-up in the brain is associated with an increase in amyloid ?

Patients 107
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6 ways to defeat physician fatigue

MedCity News

The pandemic placed an unfathomable burden on the country’s doctors. For years to come, we’ll be dissecting its implications. Here are six ways healthcare providers can lighten the physician’s burden.

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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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Frontiers Health 2022 – day 1

pharmaphorum

Frontiers Health 2022 in Milan is LIVE! Opening Day One will be Healthware Group’s CEO and founder Roberto Ascione and WTF Health’s founder and host Jessica DaMassa. The day’s keynote addresses will include ‘The H is for humanity’ by MD of Taliossa Tony Estrella and founder and trustee of Rachel’s House Lynna Chandra, as well as ‘Creative disruption in delivering novel VR solutions in pain: evidence, teamwork, and delivery’ by Christopher Eccleston, professor of medical psychology at the U

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Jazz Pharma joins the bispecific cancer drug chase via Zymeworks licensing deal

MedCity News

Jazz Pharmaceuticals is paying Zymeworks $50 million up front for rights to develop zanidatamab, a bispecific antibody cancer currently in two pivotal clinical trials. It’s the second bispecific antibody pact of the week, following Gilead Sciences’ deal to secure an option on a MacroGenics drug in early clinical development.

Pharma 112

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Endpoint security: The medicine required to cure healthcare’s cybersecurity woes

MedCity News

The healthcare industry has been reported as the second most targeted industry from cyberattacks. Following the business […].

Medicine 130
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How the Digital Patient Experience is Shaping the Future of Pharma

pharmaphorum

From diagnosis to treatment and ongoing condition management, the patient journey is becoming an increasingly digitised one – a process which has been massively accelerated by the Covid pandemic and has significant implications for pharma & their patients vs. their customers. Join us on Monday 7 th November at 12:30 GMT / 13:30 CET / 7:30 am EDT as panellists focus on how this new paradigm is shaping both the industry’s omnichannel engagement and the patient care journey, from patient identi

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Investors pour $70M into Prenuvo’s speedy whole-body MRI machine

MedCity News

Prenuvo — a company that makes an MRI machine that performs quick whole-body scans — closed a $70 million Series A equity and debt funding round. It will use the money to open more clinics throughout the country, as well as find ways to make its price point more accessible.

Medical 108
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$38 million will fund rare disease research over four-year period

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has awarded a total of $38 million in the form of 19 new grants and two new contracts, to facilitate the upcoming four years of clinical trials and regulatory tools for rare diseases. Sandra Retzky, Director of the FDA’s Office of Orphan Products Development (OOPD) explained: “The contracts aim to help inform regulatory decision making and promote diversity, equity and inclusion in clinical research.”.

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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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FDA authorizes Novavax’s Covid-19 booster, a first for a protein-based vaccine

MedCity News

Novavax’s Covid-19 vaccine is now authorized as a booster shot for adults. The regulatory decision, which comes three months after the shot was first granted FDA emergency authorization, introduces a booster shot alternative to messenger RNA vaccines.

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Lilly will acquire Akouos to accelerate hearing loss therapies

European Pharmaceutical Review

Eli Lilly is set to acquire Akouos, Inc, a precision genetic medicine company developing first-in-class adeno-associated viral gene therapies for treating inner ear conditions like sensorineural hearing loss. . Akouos’s lead product candidate AK-OTOF , is a gene therapy that treats hearing loss caused by mutations in the otoferlin gene (OTOF). .

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How Ochsner Health’s RPM pilot improved outcomes for patients with diabetes, hypertension

MedCity News

Ochsner Health recently released the results of its digital health pilot program for Medicaid patients with hypertension and type 2 diabetes. The program, which combines remote patient monitoring with personalized care teams, did an efficient job at bringing down patients’ blood pressure and hemoglobin A1c levels.

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Every scientific message has a story. Medical communications must adapt to effectively bring these to life.

pharmaphorum

Medical communications are in a state of transition. Due to the combined impact of emerging technologies, changing provider preferences, and an evolving post-pandemic world, pharma must navigate new ways to engage providers with relevant, science-driven, digital content. Delivering these materials in the proper format, however, requires a keen understanding of providers’ educational needs, learning science, and creative storytelling.

Medical 90
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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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Microbiology In-Depth Focus 2022

European Pharmaceutical Review

Methods for strain comparison and differentiation of environmental isolates. Identification of environmental isolates is a regular requirement in pharmaceutical manufacturing, and strain differentiation can be valuable in a variety of circumstances. There have been huge advances in the technology available for sequencing bacterial genomes, which has fed through to the analyses that are available to pharmaceutical microbiologists.

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Woman of the Week: Exscientia’s Charlotte Deane

PharmaVoice

Is the industry ready for a biologic discovery revolution? Charlotte Deane, chief scientist of biologics AI at Exscientia, thinks so.

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Chiesi joins with Aptar on digital platform for respiratory patients

pharmaphorum

Hard on the heels of the official launch of its digital disease management platform, Aptar Pharma has secured a partnership with Italian drugmaker Chiesi to deploy it in support of patients. The alliance – the first to be announced since Apar’s digital health unit unveiled the platform earlier this month – will focus on patients with respiratory diseases, including asthma and chronic obstructive pulmonary disease (COPD), and will focus initially on the European market although it may be ex

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5 impactful drug trial failures from the last year

PharmaVoice

Major recent trial flops and what they mean for companies, patients and the industry.

Patients 119
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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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Mylan Laboratories Ltd-Openings for B.Pharm/ M.Pharm/ M.Sc/ B.Sc in QA/ AQA-Apply Now

Pharma Pathway

Mylan Laboratories Ltd-Openings for B.Pharm/ M.Pharm/ M.Sc/ B.Sc in QA/ AQA-Apply Now. Job Description. Hiring B.Pharm/ M.Pharm / M.Sc/ B.Sc for Officer -QA/ AQA @ Mylan Laboratories Ltd. (Viatris). Officer -QA (Validation). Post Name: Officer -QA (Validation). Qualification: B.Pharm/ M.Pharm / M.Sc/ B.Sc. Experience: 1 to 07 years. Location: Ahmedabad.

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Amplifying HCP engagement using modular content

pharmaphorum

Emma Hyland, VP strategy, commercial content at Veeva Systems, tells us modular content is the most significant wave of innovation hitting the content world in life sciences, and rightly so because HCPs’ needs and expectations have changed. As the world moves back to a form of normality after the last couple of years, the way in which we engage with HCPs has changed.

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Transition to Open Access: Tackling Complexity and Building Trust

Copyright Clearance Center

The post Transition to Open Access: Tackling Complexity and Building Trust appeared first on Copyright Clearance Center.

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Get Real About Customer Expectations

MedReps

Although the discussion focus is mainly on sales and meeting quotas in the medical sales world, there’s something else that needs to be covered: customer expectations and experience. In order to gain repeat customers, you need to figure out what yours want and provide them with the service they need. After all, the job isn’t done at the end of the sales pitch or when the sales order is placed.

Sales 77
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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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Grifols’ Tavlesse receives NICE recommendation

PharmaTimes

Therapy treats refractory chronic immune thrombocytopenia and is available across UK

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Is a Standard by Any Other Name Still a Standard?

Copyright Clearance Center

The post Is a Standard by Any Other Name Still a Standard? appeared first on Copyright Clearance Center.

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Patents: a necessary evil?

European Pharmaceutical Review

Patents are often described as the ‘lifeblood’ of pharmaceutical companies. 1 However, patent protection for pharmaceutical products is an economic trade-off between providing monopoly rights that incentivise development of future products and permitting higher drug prices to recoup the investment. 2 Recently, the US Patent and Trademark Office (US PTO) reiterated the concern that patents have been “misused to inhibit and delay – for years and even decades – competition from generic drugs and bi

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Kaiser reaches a deal with labor union after 10-week strike 

MedCity News

As of publication, nearly 2,000 Kaiser Permanente mental health workers still had to ratify the vote, and would participate in a two-day process to do so.

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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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Apogenix’s asunercept demonstrates efficacy in COVID-19 trial

PharmaTimes

Therapy showed faster clinical recovery for combined treatment groups

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New dawn for the EU’s joint procurement crisis response

Pharmaceutical Technology

The European Union (EU) is on the cusp of approving clearer rules governing the joint procurement of medicines and medical devices by member states at the EU level. The imminent rule changes will apply to crisis-relevant supplies of medical countermeasures, including both vaccines and therapeutics, where the threshold of a 'serious cross-border threat to health' is met.

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AdTheorent Health Unveils the Industry’s First and Only Predictive Audiences for Health Advertisers

PM360

AdTheorent Health , a division of AdTheorent Holding Company, Inc. that delivers privacy-first machine learning-based advertising solutions to drive measurable outcomes for healthcare marketers, today announced the launch of AdTheorent Health Predictive Audiences. AdTheorent Health Predictive Audiences allow programmatic advertisers to target “audiences” in a more precise, data-driven, and less opaque manner than was previously possible.

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Phesi launches AI-driven trial accelerator, saving $7m per trial

pharmaphorum

Yesterday, global provider of patient-centric data analytics, Phesi launched its AI-driven Trial Accelerator Platform, an integrated SaaS solution designed to enable clinical development personnel to leverage study and control arm data, so as to accelerate product development. The platform’s methods and AI models have been created and validated over the past 15 years of Phesi’s work.

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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.