Thu.Feb 15, 2024

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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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Psychedelic treatments for mental health: Is there substance behind the hype?

Pharmaceutical Technology

The success of recent trials treating mental health problems with psychedelic therapies has driven a rapid rise in investment in the area.

Trials 290
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Obesity Disrupts Mitochondria, And We May Have Figured Out How

AuroBlog - Aurous Healthcare Clinical Trials blog

Scientists have revealed in unprecedented detail how obesity affects mitochondria in mice, causing the cellular powerhouses to fragment into smaller pieces. Mitochondria are famous as “powerhouses of the cell,” given their crucial role in generating energy. Yet the vital work of these organelles is often impaired in people with obesity, for reasons that remain unclear.

Scientist 211
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Biotechs ride obesity drug wave with novel approaches that go beyond GLP-1RAs

Pharmaceutical Technology

As the market is progressively becoming saturated by GLP-1 receptor agonists, companies are investigating alternative mechanisms of action.

Drugs 264
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Intellia, ReCode partner on genetic medicines for cystic fibrosis

Bio Pharma Dive

The partnership will use Intellia's "DNA writing” technology, and initially focus on people with the lung disease who have limited or no available treatment options.

Genetics 171
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FDA approves Eicos’s Aurlumyn for severe frostbite treatment

Pharmaceutical Technology

The US FDA has granted approval for Eicos Sciences' Aurlumyn for adults with severe frostbite to lower the risk of amputation.

More Trending

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GSK to license Elsie’s oligonucleotide discovery platform

Pharmaceutical Technology

GSK has exercised its option for a licence for Elsie Biotechnologies’ discovery platform to detect and develop new oligonucleotides.

Licensing 240
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Agilent Technologies wins two scientists’ choice awards for drug discovery and development products

AuroBlog - Aurous Healthcare Clinical Trials blog

Agilent Technologies Inc., a global leader in analytical and clinical laboratory technologies, announced that it has received two prestigious awards from SelectScience: Best New Drug Discovery & Development Product of 2023 and Drug Discovery & Development Webinar of the Year. These accolades highlight Agilent’s commitment to innovation and excellence in drug discovery and development.

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Japan’s FY 2024 pricing reform expected to favour new listed innovative drugs

Pharmaceutical Technology

In 2023, Japan approved the outlines of its drug pricing and repricing reform for NHI-listed drugs that will take effect in FY 2024 and FY 2025.

Drugs 130
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Aurinia to cut research after sale process fails to find a buyer

Bio Pharma Dive

The Canadian lupus drug developer said it engaged more than 60 parties during its eight-month business review, but only one expressed interest before walking away.

Sales 131
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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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Ono and Numab to develop antibody for cancer treatment

Pharmaceutical Technology

Ono Pharmaceutical has entered an agreement with Numab Therapeutics for developing and commercialising NM49 in the oncology field.

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PrecisionLife partners with Metrodora Institute to offer new hope for long COVID sufferers

BioPharma Reporter

PrecisionLife has partnered with healthcare center the Metrodora Institute to jumpstart the diagnosis and treatment options for a range of chronic diseases including long COVID, ME/CFS, ALS and SjÃgren's syndrome.

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Latigo secures $135m for non-opioid pain drug development

Pharmaceutical Technology

Latigo Biotherapeutics has secured $135m in a Series A funding round to advance the development of its non-opioid pain medicines.

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Celebrating Black History Month: Black Scientists that Have Revolutionized the Life Sciences

XTalks

February is Black History Month, a time dedicated to celebrating the achievements and contributions of African Americans throughout history. In the life sciences, countless Black scientists, researchers and medical professionals have made groundbreaking discoveries that have significantly advanced our understanding of biology and medicine. Their outstanding achievements are even more remarkable given that many worked during dark times of racial discrimination and segregation.

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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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HHS guidance on using online tracking technologies: How to make your analytics HIPAA-compliant

pharmaphorum

The HHS provides guidance on using online tracking technologies in a HIPAA-compliant manner. Learn how to ensure your analytics practices align with healthcare regulations and protect patient privacy.

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Good Measures’ Good Food Prescription Program + Misleading Food Ads That Led to Lawsuits – Xtalks Food Podcast Ep. 146

XTalks

The Good Food Prescription program, designed to combat diet-related conditions, combines expert clinical coaching, personalized meal planning and medically tailored grocery deliveries in partnership with Instacart. In this episode of the Xtalks Food Podcast, Sydney talks about this program from Good Measures, a company founded with a vision to revolutionize the intersection of nutrition and health management.

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Catalent restructuring leaves 300 without jobs as CDMO awaits $16.5B Novo buyout

Fierce Pharma

Even as Catalent moves toward a $16.5 billion sale to Novo Holdings, hundreds of the CDMO's former staffers won't be in the mix going forward. | A recent buyout announcement didn't spare Catalent staffers from layoffs after the company this week revealed it's trimmed hundreds of jobs over the last few months. The move forms part of an ongoing restructuring scheme at Catalent.

Sales 106
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Drug Excipient Business Development Reports now Available on Amazon

Drug Patent Watch

Elevate your excipient business strategies with the comprehensive Drug Excipient Business Development Reports from DrugPatentWatch. Designed for excipient manufacturers seeking lucrative opportunities in the pharmaceutical industry, these reports offer invaluable… The post Drug Excipient Business Development Reports now Available on Amazon appeared first on DrugPatentWatch - Make Better Decisions.

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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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Alnylam changes analysis plan for key Amvuttra heart trial, jolting investors

Fierce Pharma

Changing a clinical trial’s statistical analysis plan on the cusp of a readout? | Changing a clinical trial’s statistical analysis plan on the cusp of a readout? That’s exactly what Alnylam just did for a closely watched study of its next-generation RNA interference therapy Amvuttra in a rare heart disease.

RNA 103
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Artax announces first patient dosed in psoriasis treatment trial

Outsourcing Pharma

Artax Biopharma, a clinical-stage biotech company focused on transforming the treatment of autoimmune diseases, has dosed the first patient in its phase 2a trial evaluating oral, small molecule, AX-158 for the treatment of psoriasis.

Trials 104
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Innsena backs CancerX’s digital drive to improve access

pharmaphorum

Healthtech specialist Innsena has committed funding and expertise to CancerX, launched last year to encourage the use of digital health technologies to overcome challenges in cancer care.

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Aurlumyn Gets First FDA Approval for a Severe Frostbite Medication

Pharmaceutical Commerce

Patients with severe frostbite who were administered Aurlumyn monotherapy experienced a significantly reduced risk of the need for amputation.

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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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Exercise ‘may be better than drugs for depression’

pharmaphorum

Exercise matched psychotherapy and was more effective than medication as a treatment for #depression in a meta-analysis of randomised clinical trials

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Closed Loop Medicine shares results of proprietary technology for hypertension

Pharma Times

CLM-HT01 improved blood pressure and minimised adverse reactions in patients

Medicine 136
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Prime Medicine joins the biotech IPO queue, seeking $140m

pharmaphorum

Gene-editing biotech Prime Medicine has priced an initial public offering, hoping to raise $140 million to advance its pipeline of one-shot therapies for severe genetic disorders. The Cambridge, Massachusetts-based company is offering 19.2 million shares at $6.25 each and expects to start trading on the Nasdaq on 20th February under the PRME symbol.

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Stroke brain-bleed deaths predicted to increase by 40% in the UK

Pharma Times

In Europe, stroke-related brain-bleed deaths are expected to increase by 8.

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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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Pfizer quells 12 years of Lipitor antitrust litigation with $93M settlement

Fierce Pharma

With a $93 million settlement, Pfizer can wash its hands of more than a decade's worth of antitrust litigation over the once-lucrative cholesterol med Lipitor. | Purchasers have long accused Pfizer—and Sun Pharma's Ranbaxy—of conspiring to keep Lipitor generics off the market with a "reverse payment" agreement. After the Pfizer settlement, the class action lawsuit against Ranbaxy will continue.

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FTC targets middlemen in generic drug shortages probe

pharmaphorum

The FTC is investigating wholesalers and other middlemen in the pharma supply chain to assess their possible role in worsening shortages of generic medicines

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Anti-Stress Skin Care

Pharma Tutor

Anti-Stress Skin Care admin Thu, 02/15/2024 - 16:12 Vinay Kumar Singh. Head-Formulation Kumar Organic Products Research Centre Pvt. Ltd., Bengaluru Email : formulation_krc@kopresearchcentre.

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With good news on Lybalvi, Alkermes sees 10% share price increase

Fierce Pharma

As stripped down and divested Alkermes enters 2024 as a “pure-play neuroscience company”—as described by CEO Richard Pops on a conference call on Thursday—much will depend on the success of new sch | As Alkermes enters 2024 as a “pure-play neuroscience company”—as described by CEO Richard Pops on a conference call on Thursday—much will depend on the success of new schizophrenia and bipolar disorder drug Lybalvi.

Sales 79
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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.