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New FDA CMC Draft Guidance Released for Personalized Antisense Oligonucleotide Products

Many patients rely on personalized medicine like antisense oligonucleotide (ASO) products for complex or treatment-resistant conditions. Meeting the needs of these patients is a challenge for pharmaceutical companies, as the expenses involved and small patient sizes complicate the establishment of […]

more info 04/26/2022View Related Articles
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‘A new era of diagnosis for Alzheimer’s disease’: Scientists study blood tests for dementia

As pharmaceutical companies spend hundreds of millions on a potential treatment for Alzheimer’s disease, other researchers are focusing on a more elemental question. How can you tell whether a family member or loved one has Alzheimer’s or another form of dementia? These researchers say a new […]

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White Paper: Finland as a Real-World Evidence Resource

Finland has a long-running and well-established national health and social data system. This positions the nation as a rich resource for real-world evidence (RWE). In a new white paper, Business Finland explains the intricacies of the Finnish RWE ecosystem and how researchers and decision-makers […]

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UK: Life Sciences 2022 – Arnold & Porter

1. Life Sciences Regulatory Framework 1.1 Legislation and Regulation for Pharmaceuticals and Medical Devices On account of Brexit, the UK is no longer subject to EU single-market rules or the EU legislative framework. However, under the EU-UK Withdrawal Agreement's Protocol on Ireland and Northern […]

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CorEvitas, LLC Announces Executive Leadership Promotions | Nachricht

WALTHAM, Ma. and ARLINGTON, Va., April 26, 2022 /PRNewswire/ -- CorEvitas, LLC is excited to announce leadership changes for HealthiVibe, its market-leading Patient Experience business. The company continues to grow and integrate the patient voice with its real-world evidence model bringing […]

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Dr. Michael Raymont reports Albert Labs Announces The Additi

Dr. Michael Raymont reports ALBERT LABS ANNOUNCES THE ADDITION OF TWO RENOWNED SCIENTIFIC ADVISORS TO ITS SCIENTIFIC ADVISORY BOARD (SAB) Albert Labs International Corp. has strengthened its scientific advisory board with the addition of Prof. Robert Britton, a natural product chemist, and renowned […]

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Webinar: Lessons Learned from Inspections and Audits During COVID-19

While the efforts and procedures of many regulatory bodies ground to a halt during the COVID-19 pandemic, the US Food and Drug Administration (FDA) pressed on with inspection. However, the agency’s tactics shifted as it adopted remote tools to connect with pharma and digital health companies before […]

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Profit Pump: 100 years after first patient uses insulin, out-of-pocket costs continue to climb

InvestigateTV - Every day, usually multiple times a day, millions of people in the U.S. put into their bodies a substance that per milliliter is 60 times more expensive than a bottle of 2008 vintage Dom Perignon champagne. Whether it’s drawn into a syringe, dialed up by a pen or dosed by an […]

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Health Affairs Pathways Podcast: While We Wait – The emPATH Way Forward

Series 2 of the Health Affairs Pathways podcast, entitled While We Wait, covers the issues surrounding the boarding crisis facing mental healthcare patients and providers. In the latest episode, hosts, Sania Ali and Avni Kulkarni explore how emergency psychiatric assessment, treatment and healing […]

more info 04/25/2022View Related Articles
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Roche’s Oral Breast Cancer Drug Disappoints in Phase II Study

The pharma manufacturer Roche has announced discouraging results for its oral breast cancer drug giredestrant. Results show that the drug failed on the study’s primary endpoint of improving progress-free survival for ER-positive, HER2-negative patients, although investigators state that efficacy […]

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Using Artificial Intelligence to Optimize Hospital Resource Management

With rising patient volumes and staffing shortages, hospitals must find ways to optimize asset management to keep up. Unfortunately, the math and organizational strategies behind such efforts are complex. In a half-day session tomorrow at Becker’s Annual Meeting, the healthcare analytics company […]

more info 04/25/2022View Related Articles
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Tomorrow (4/26) – Health Affairs Webinar: Food Insecurity and Other Health-Related Social Needs Among Older Adults

Older adults have unique healthcare challenges and are impacted disproportionately by social determinates of health (SODH), like poor housing, transportation access, financial issues, and food insecurity. In a webinar taking place tomorrow, April 26th, speakers Brian W. Powers, Stephany M. Franklin, […]

more info 04/25/2022View Related Articles
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Call for Abstracts and Reviewers: ISPOR Europe 2022

ISPOR is seeking abstracts for its upcoming ISPOR Europe 2022 conference. ISPOR Europe 2022 is the leading health economics and outcomes research (HEOR) conference in Europe, attracting professionals from academia, industry, and regulatory bodies. Poster and podium presentations are accepted. […]

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India Unveils New Digital Health Platform and Mental Telehealth Projects

Two new digital health projects have just been announced by the Indian Government. The first is the Ayushman Bharat Digital Health Mission (ABDM), an open platform to unify the nation’s digital health ecosystem. The second project, as detailed by India’s Finance Minister Nirmala Sitharaman during […]

more info 04/22/2022View Related Articles
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Excelra Invests in Rising HEOR and RWE Consulting Firm Anlitiks

Excelra has announced a new majority investment in the health economics and outcomes research (HEOR) and real-world evidence (RWE) consulting firm Anlitik, located in Boston. The young company’s mission is to quickly process real-world data (RWD) into usable RWE for life sciences researchers and […]

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Telehealth Experiences Uncertainty as Cross-State Care Wavers End

The slew of emergency orders allowing cross-state healthcare during the pandemic have begun to expire, cutting telecare for millions of patients. Many patients relied on the technology because of in-person clinic closures during the initial waves of the pandemic, but greater adoption of telehealth […]

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Webinar: Empowering Caregivers in a Digitally Connected World

While digital health has helped engage patients in their own care and improved patient experiences, caregivers are still learning to adapt to the new paradigm. In a new Medisafe and Fierce Pharma Webinar on Tuesday, May 3rd, 2022, speakers will discuss how digital health has changed the game for […]

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Biogen Alzheimer’s Drug Pulled from European Application Process

Following a rocky series of setbacks in Europe and abroad, Biogen has backed out of the application process in Europe for it’s controversial Azheimer’s disease (AD) drug Aduhelm. The European Medicines Agency (EMA) had rejected the application in late 2021 based on safety concerns. In addition,  […]

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Researchers Propose New Tool for Investigating Rare Disease-Gene Relationships

Many diseases are related to genetic factors, but determining gene-disease relationships (GDRs) is tricky, especially for rare diseases with small sample sizes and limited genetic investigations. The ClinGen GDR Framework was established to help identify and catalog GDRs, but the tool may be lacking […]

more info 04/21/2022View Related Articles
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Tuesday (4-26) Webinar: Trust – The Missing Link Impacting Pharma’s Patient Services

Patients are increasingly interested in pharma support programs, but many are not taking advantage of these programs or sticking with them long-term. One factor behind this barriers is a general decline in patients’ trust in pharma companies. Pharma must work to regain this trust in order to […]

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Five Scenarios that Get Patients Engaged in Social Health

A recent analysis by Health Union shows that most patients online social networking for health-related reasons. This phenomenon, called social health, can help all health stakeholders if appropriately implemented. The analysis shows that engagement with social health occurs more frequently when […]

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ICER Will Assess Value and Effectiveness of Multiple Sclerosis Treatments

The Institute for Clinical and Economic Review (ICER) will perform value and effectiveness assessments on several drugs for multiple sclerosis. The drugs include several monoclonal antibody treatments from manufacturers like Biogen, Novartis, and Genentech and some biosimilars for Rituximab. The […]

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Ottawa scales back drug price reforms that would have cost big pharma billions

Ottawa is dramatically scaling back regulatory changes to reduce the cost of drugs, five years after heralding them as a once-in-a-generation effort to cut costs and shave billions off industry profits. The federal reprieve for pharmaceutical companies follows a series of court challenges, which the […]

more info 04/21/2022View Related Articles
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Sanofi Transfers Late-Drugs to New Neuro and Psychedelic Biotech Startup

Sanofi has partnered with Terran Biosciences, a small New York biotech, to work on two late-stage neurological and psychiatric drugs. This is the second such investment into the otherwise low profile startup, following a deal last month with Concert Pharmaceuticals. Terran, which focuses on neuro […]

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Imara reduced to six employees as the biotech, once again preclinical, explores its options

Imara will employ just six people by the end of this quarter as 83% of the staff has been shown the exit following the biotech’s Phase IIb flops earlier this month. The company will likely have to find a buyer or shut down. Imara’s main goal and likely only priority at this point — after ending […]

more info 04/21/2022View Related Articles
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US Biotech Braces for Market Adjustments that Could Lead to Layoffs and Closures

Despite the expansion of the biotech industry in recent years, many are predicting an upcoming market adjustment that could negatively impact many in the field. US biotech stocks have dropped in the past year, with some losing up to 80-90% of their value. In addition, smaller firms have turned to […]

more info 04/20/2022View Related Articles
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ISPOR 2022 Plenary Session: HTA on the Run

On May 16th, ISPOR 2022 will open with its welcome plenary session entitled, “HTA on the Run.” In the session, speakers will explain how and why health technology assessment (HTA) agencies have adopted accelerated processes. In addition, 3 case studies will be presented that demonstrate different […]

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Amgen’s Biosimilar of Stelara Shows Promising Preliminary Results

New preliminary results show that Amgen’s biosimilar ABP 654 is effective in reducing psoriasis symptoms. ABP 654 is a biosimilar of Stelara, a drug currently improved and in use in 74 countries. Patients treated with the biosimilar experienced improvement in the psoriasis area severity […]

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Europe’s Largest Pharmaceutical Firm Highlights Need for Interoperability

The COVID-19 pandemic brought inadequacies in healthcare systems worldwide to the forefront. One core problem, according to Ehab Youssef, head of Europe North at Roche Pharmaceuticals, is a lack of data interoperability. Improving the compatibility of different data sources, Youssef argues, would […]

more info 04/20/2022View Related Articles
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Call for Nominations: STAT Wunderkinds Program

STAT is seeking nominations for its Wunderkind program. The program highlights promising early career professionals who have completed their terminal degree and have taken on a new position in their field. Professionals who run their own research group or hold leadership positions are not eligible. […]

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