February, 2024

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Clinical research is about trial and error

pharmaphorum

Clinical research involves trial and error as part of the drug development process. Learn more about how to optimise drug trials and the important role of participants in clinical research.

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At risk patients with rare diseases need a higher level of support - and the process must change

Outsourcing Pharma

February will see the 16th annual Rare Disease Day which raises awareness of the more than 7,000 identified rare diseases worldwide.

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The Path for Prescription Drug Sales

Pharmaceutical Commerce

A dive into this market reveals that the latest numbers yield promising results—a global value of a worldwide $1.6 trillion—but it will continue to be attributed to past, present, and future healthcare spending.

Sales 116
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'The Top Line': Gene editing's next act

Fierce Pharma

Gene editing’s therapeutic application has transitioned from hypothetical to reality, marked by the recent approval of a CRISPR-based therapy for sickle cell and beta thalassemia. | This week on "The Top Line," Max Bayer from Fierce Biotech explores the future of gene editing in an interview with the CEO of Verve Therapeutics.

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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Initiative by Innovative Trials to boost patient retention inspired by boy's love of collecting

BioPharma Reporter

The father of a boy diagnosed with acute lymphoblastic leukemia at the age of nine, inspired by his son's love of collecting, has created patches of positivity for children going through cancer treatment to collect.

Trials 88
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Joining a clinical trial: Helpful hints for discussions with loved ones

Antidote

Individuals living with an illness are likely well-versed in the art of discussing difficult topics with their family and friends. However, for those who are considering taking part in a clinical trial, there may be extra questions to consider when sharing their intent to enroll.

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Novo Nordisk and Catalent deal: net positive or negative for industry?

BioPharma Reporter

Novo Nordisk recently acquired three manufacturing facilities from contract development and manufacturing organization Catalent, in a bold move that has sparked a great deal of debate and some backlash.

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Looking to the future of clinical trials: Gene therapy, precision medicine, and the ongoing quest for rare disease solutions

pharmaphorum

Looking to the future of clinical trials: Gene therapy, precision medicine, and the ongoing quest for rare disease solutions Mike.

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India’s Tata Institute develops tablet for cancer recurrence prevention

Pharmaceutical Technology

India’s Tata Institute has developed a tablet combining resveratrol and copper that has the potential to prevent the recurrence of cancer.

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Brain drug developer Alto Neuroscience prices $129M IPO

Bio Pharma Dive

The California biotech is the third this year to go public, following stock offerings from CG Oncology and Arrivent Biopharma.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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California Man Free of HIV And Cancer in Astonishing Medical Recovery

AuroBlog - Aurous Healthcare Clinical Trials blog

On the list of illnesses that nobody wants, cancer and HIV both rank pretty high, and Californian man Paul Edmonds had both. But ever since one particular treatment five years ago, he’s been free of both cancer and HIV.

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Why Proactive AME Studies are Critical to Accelerating Your Approval Journey

Worldwide Clinical Trials

During clinical development, new chemical entities (NCEs) require an absorption, metabolism, and excretion (AME) study. Also known as a human radiolabeled mass balanced study, the AME study aims to determine the overall metabolism and excretion pathways of the NCE, as well as to identify and quantify circulating metabolites relative to parent or total drug-related exposure.

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Positive results for MAIA’s SCLC treatment published in Nature Communications

Pharma Times

The aggressive type of cancer accounts for 13% of all lung cancer cases worldwide

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February 14, 2024: In This Friday’s PCT Grand Rounds, Clinical Implications of the MINT Trial

Rethinking Clinical Trials

Dr. Jeffrey Carson In this Friday’s PCT Grand Rounds, Jeffrey Carson of Rutgers Biomedical and Health Sciences will present “Clinical Implications of the MINT Trial: p=0.07.” The Grand Rounds session will be held on Friday, February 16, 2024, at 1:00 pm eastern. Carson is provost-New Brunswick for Rutgers Biomedical and Health Sciences and the Distinguished Professor of Medicine and Richard C.

Trials 162
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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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MHRA agrees licence change for Pfizer-BioNTech’s Comirnaty vaccine

Pharmaceutical Technology

The UK MHRA has granted approval for a variation in licence of Pfizer-BioNTech’s Comirnaty XBB.1.5 vaccine targeting Omicron variant.

Vaccine 357
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Alnylam change to heart drug trial sparks doubts, sinking shares

Bio Pharma Dive

Analysts pressed Alnylam executives on the reasons for the changes to HELIOS-B, a Phase 3 study in ATTR amyloidosis with cardiomyopathy that is important to the company’s future.

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Cystic fibrosis patients ask DPIIT to allow local manufacturing of CFTR modulators to bring down price

AuroBlog - Aurous Healthcare Clinical Trials blog

Patients of cystic fibrosis (CF) and their relatives have requested the Department for Promotion of Industry and Internal Trade (DPIIT) to take steps to provide CF drugs at an affordable cost using the provisions of the Patents Act, 1970, considering that the drugs at present cost anywhere from Rs. 21 lakh to Rs. 2.66 crore.

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Pfizer fleshes out oncology strategy, targeting 8 blockbuster cancer drugs by 2030

Fierce Pharma

In what CEO Albert Bourla called an update to a top priority at Pfizer, the company on Thursday systemically laid out its new oncology strategy following the $43 billion acquisition of antibody-dru | Pfizer on Thursday systemically laid out its new oncology strategy following the $43 billion acquisition of Seagen. The company aims to have at least eight blockbuster cancer drugs by 2030, with a focus on four main cancer types.

Drugs 28
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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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Study reveals SARS-CoV-2 can infect dopamine neurons causing senescence

Pharma Times

Dopamine neuron senescence is a hallmark of Parkinson’s disease

Medicine 155
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February 7, 2024: Pragmatic Recruitment of Underrepresented Groups, in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

In this Friday’s PCT Grand Rounds, Cynthia Hau of the VA Boston Health Care System will present “Pragmatic Recruitment of Underrepresented Groups: Experience From the Diuretic Comparison Project.” The Grand Rounds session will be held on Friday, February 9, 2024, at 1:00 pm eastern. Hau is a statistician for the VA Cooperative Studies Program Coordinating Center in the VA Boston Health Care System.

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Alternative therapies are needed to combat the impending threat of AMR

Pharmaceutical Technology

The potentially disastrous consequences of antimicrobial resistance (AMR) were highlighted at the recent World Economic Forum Meeting 2024.

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Venture firm Scion Life Sciences launches with $310M to back new biotechs

Bio Pharma Dive

The new firm intends to carefully select its startups and fund them for the long haul. “We're not a company formation factory,” said Aaron Kantoff, the firm’s co-founder.

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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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You May Not Need to Lose as Much Weight as You Think, Expert Reveals

AuroBlog - Aurous Healthcare Clinical Trials blog

If you’re one of the one in three people whose New Year’s resolution involved losing weight, it’s likely you’re now contemplating what weight-loss goal you should actually be working towards. But type “setting a weight loss goal” into any online search engine and you’ll likely be left with more questions than answers.

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The opportunities and challenges facing rare disease therapies developers

pharmaphorum

Explore the opportunities and challenges facing rare disease therapies developers, including the impact of Rare Disease Day, FDA regulations, and cutting-edge technologies like CRISPR gene therapy.

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Study reveals AI can predict patients’ survival in glioblastoma

Pharma Times

The aggressive brain cancer is responsible for over 3,000 cases in the UK every year

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February 28, 2024: A Randomized Trial of a Food-as-Medicine Program, in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

In this Friday’s PCT Grand Rounds, Joseph Doyle of the Massachusetts Institute of Technology (MIT) will present “Effect of an Intensive Food-as-Medicine Program on Health and Healthcare Use: Evidence From a Randomized Clinical Trial.” The Grand Rounds session will be held on Friday, March 1, 2024, at 1:00 pm eastern. Doyle is the Erwin H.

Medicine 147
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2022 Research: The Rapid Rise of Ocean Freight Visibility

A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.

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Bayer wins FDA breakthrough therapy designation for NSCLC candidate

Pharmaceutical Technology

Bayer’s oral tyrosine kinase inhibitor is currently in a Phase I trial estimated to enrol 460 patients.

Trials 331
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NEJM paper fills in details on ‘remarkable’ CAR-T result in autoimmune disease

Bio Pharma Dive

The full results spotlight cell therapy’s potential to treat lupus and other inflammatory conditions, but also the problems drug developers must solve first.

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Bipolar Disorder Linked to a Higher Risk of Early Death Than Smoking

AuroBlog - Aurous Healthcare Clinical Trials blog

People with bipolar disorder are four to six times more likely to die prematurely than those without the condition, according to a study that compared data on thousands of people with and without the disorder.

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FDA approves Iovance’s Amtagvi as first T-cell therapy for a solid tumor

Fierce Pharma

The T-cell therapy treatment class, which has transformed the treatment of certain blood cancers, has now reached the solid tumor field thanks to an FDA approval for a first-of-its-kind immunothera | The T-cell therapy treatment class, which has transformed the treatment of certain blood cancers, has now reached the solid tumor field thanks to an FDA approval for a first-of-its-kind immunotherapy developed by Iovance Biotherapeutics.

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An Innovative & Creative Problem Solver Approach to Selling in the Medical Device Space

Speaker: Steve Goldstein, Sales Leader

Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g