Tue.Apr 23, 2024

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EC approves Pfizer’s Emblaveo for multidrug-resistant infections

Pharmaceutical Technology

The European Commission (EC) has granted marketing authorisation for Pfizer’s EMBLAVEO (aztreonam-avibactam), aimed at treating adults with multidrug-resistant infections where treatment options are limited.

Marketing 253
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NABH unveils plan for 2nd Edition of Accreditation Standards for Allopathic Clinics

AuroBlog - Aurous Healthcare Clinical Trials blog

In a significant development for healthcare quality assurance in India, the National Accreditation Board for Hospitals & Healthcare Providers (NABH) has announced the implementation plan for the 2nd Edition of NABH Accreditation Standards for Allopathic Clinics.

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FDA rejects Abeona cell therapy, asks for more manufacturing data

Bio Pharma Dive

The complete response letter for Abeona’s treatment is one of several manufacturing setbacks for cell and gene therapy developers in recent years.

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Doctor Reveals What Happens When You Stop Taking Ozempic

AuroBlog - Aurous Healthcare Clinical Trials blog

Drugs like Ozempic are very effective at helping most people who take them lose weight. Semaglutide (sold as Wegovy and Ozempic) and tirzepatide (sold as Zepbound and Mounjaro) are the most well known in the class of drugs that mimic hormones to reduce feelings of hunger.

Doctors 185
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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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Novartis raises forecasts as top drug sales beat Wall Street estimates

Bio Pharma Dive

Sales of Entresto and Cosentyx grew faster in the first quarter than analysts anticipated, helping drive the quarterly beat and raise.

Sales 182
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April 23, 2024: Younger, Uninsured Patients Among Those at Greatest Risk for Missing Follow-up Assessments in Trauma Research

Rethinking Clinical Trials

In an analysis of data from the TSOS study, younger patients and patients who were publicly insured or uninsured were among several subgroups of patients who were at significant risk of missing follow-up outcome assessments. The report was published this week in Injury. Successful studies of interventions for patients with posttraumatic stress disorder (PTSD) require engaging with injured patients in long-term follow-up.

Research 162

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Novartis nominates former Bristol Myers CEO Giovanni Caforio as its new chair. Will M&A deals follow?

Fierce Pharma

Giovanni Caforio, M.D., is lining up a new gig soon after handing all his Bristol Myers Squibb leadership roles in March. | Giovanni Caforio, M.D., is lining up a new gig soon after handing all his Bristol Myers Squibb leadership roles in March. The recent Big Pharma CEO, known for steering the $74 billion acquisition of Celgene, has been proposed as the new chair at Novartis for 2025.

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Former Bristol Myers CEO tapped as Novartis’ next board chair

Bio Pharma Dive

Giovanni Caforio, who left Bristol Myers in November after eight years as CEO, is set to succeed Novartis’ longtime board chair Joerg Reinhardt next year.

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Could placenta-derived cells revolutionize age-related disease treatment?

BioPharma Reporter

Celularity, a biotech company specializing in placental-derived allogeneic cell therapies, will be showcasing data at the upcoming ASGCT Annual Meeting, showcasing the potential of their off-the-shelf natural killer (NK) cells to combat age-related diseases.

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Orphan drug market to reach $270B by 2028, led by J&J, Vertex and Roche: Evaluate

Fierce Pharma

The orphan drug sector has long been clearing growth in the larger pharmaceutical market with booming sales. | The orphan drug sector has long been clearing growth in the larger pharmaceutical market with booming sales. But thanks to blockbuster meds across wider disease areas and other challenges, the lucrative market may soon slow down for the first time in years.

Marketing 132
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Hepion shelves Phase II NASH trial amid shallow cash resources

Pharmaceutical Technology

The future of Hepion’s ASCEND-NASH study was already in the balance following cost-cutting measures last December.

Trials 130
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How do we unlock the potential of digital health?

pharmaphorum

Unlock the power of digital health through AI and clinical advancements. Learn how these technologies are shaping the future of healthcare and how to harness their potential.

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EC approves BeiGene’s tislelizumab for three NSCLC indications

Pharmaceutical Technology

Tislelizumab is greenlit as a first-line treatment in combination with certain drugs in non-small cell lung cancer.

Drugs 130
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FDA clears ImmunityBio’s bladder cancer drug at 2nd attempt

pharmaphorum

After rejecting ImmunityBio’s Anktiva last year, the FDA has now cleared the drug as a treatment for bladder cancer, making it the biotech's first commercial-stage product

Drugs 122
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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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Targeting mouth cancer with light-activated drugs

Pharmaceutical Technology

LightOx explained how light-activated drugs can be used to treat cancer on day one of the Biotrinity 2024 conference in London.

Drugs 130
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Day One takes on Novartis with FDA nod for Ojemda in broader common childhood brain tumor use

Fierce Pharma

Another drug is in town for common pediatric brain tumors. Compared with an incumbent offering from Novartis, the newcomer boasts an FDA approval covering a broader patient population. | Another drug is in town for common pediatric brain tumors. Compared with an incumbent offering from Novartis, Day One's newcomer boasts an FDA approval covering a broader patient population.

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Smaller regulators grasp innovation through international collaboration

Pharmaceutical Technology

At the Swiss Biotech Day Conference, key opinion leaders discussed ways to reduce disparities caused by reduced regulatory capacities.

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What is health literacy? Definition and resources

Antidote

Equitable access to medical care is valuable for everyone, and an important part of this equation is health literacy. Health literacy encompasses not just access to medical care, but also the ability to understand and use medical guidance. This can include anything from a doctor’s suggestions, to medication dosage information, and aftercare guidance.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Investors advocate for early biotech partnerships for later deal success

Pharmaceutical Technology

At the Swiss Biotech Day conference, key opinion leaders discussed trends in pharmaceutical partnerships.

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Trial reveals mechanisms that contribute to impact of malnutrition and HIV infection

Pharma Times

Severe acute malnutrition is responsible for nearly half of all child deaths globally and affects 17 million children annually

Trials 115
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Mallinckrodt gets grant for filter apparatus for liquid removal from gas

Pharmaceutical Technology

Discover Mallinckrodt Plc's innovative patent for a filter apparatus removing liquid from gas efficiently. Learn about the unique features and benefits of this groundbreaking technology.

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Boehringer Ingelheim and Ochre Bio partner on liver disease in deal worth over $1bn

Pharma Times

Chronic liver disease and associated cirrhosis account for one million deaths every year

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The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

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MiMedx Group gets grant for amniotic fluid compositions kit with administration device

Pharmaceutical Technology

Discover MiMedx Group Inc's patented kit for medical applications, featuring modified amniotic fluid free of salts and cells. Treat various conditions with this innovative solution.

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Encouraging early engagement to revitalise Europe’s pharmaceutical landscape

pharmaphorum

In an on-site interview at Reuters Pharma Europe in Barcelona, this week’s podcast saw Tommy Bramley, SVP of market access and healthcare consulting at Cencora, discuss revitalising Europe’s pharmaceutical landscape and leveraging legislation for health and competitiveness.

Marketing 114
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Takara gets grant for selective separation of target nucleic acids from a composition

Pharmaceutical Technology

Unlock the potential of nucleic acid research with Takara Holdings Inc's patented method for depleting target nucleic acids. Discover how nucleic acid guided nucleases revolutionize diagnostics and research.

Research 130
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Novartis names ex-BMS CEO Caforio as chair amid strong Q1

pharmaphorum

Novartis has proposed ex-BMS CEO Caforio as the successor to chair Joerg Reinhardt when he steps down next year, as it posts a strong set of Q1 results

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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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Omeros gets grant for treating diffuse alveolar hemorrhage with MASP-2 inhibitory antibody

Pharmaceutical Technology

Discover Omeros Corp's groundbreaking patent for treating graft-versus-host disease post stem cell transplant with a MASP-2 inhibitory agent. Learn more about this innovative method now!

Antibody 130
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Innovative Strategies in Drug Repurposing

Drug Patent Watch

Drug repurposing, or identifying new therapeutic uses for existing drugs, is gaining significant momentum as a promising approach to accelerate drug development and reduce costs.

Drugs 111
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Insmed gets grant for treatment of gram-positive pulmonary bacterial infections

Pharmaceutical Technology

Discover Insmed Inc's groundbreaking patent for lipo-glycopeptide derivatives to combat bacterial infections in the lungs, including cystic fibrosis patients. Learn about the innovative method using nebulizers, DPIs, and MDIs.

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Another delay for Abeona's topical gene therapy pz-cel as FDA sends out a rejection

Fierce Pharma

Dating to a 2019 clinical hold of a phase 3 trial, getting its gene therapy ra | Dating to a 2019 clinical hold, getting its gene therapy pz-cel across the FDA finish line has been a challenge for troubled Abeona Therapeutics. Now the wait continues as the FDA has rejected the treatment due to CMC issues.

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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.