Tue.Oct 24, 2023

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Pear Therapeutics: a lesson for future DTx developers

Pharmaceutical Technology

Pear Therapeutics was a pioneer in developing DTx for neurological conditions traditionally treated by evidence-based behavioural or psychological management strategies.

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OrbiMed raises $4.3B in new funds for startup investing

Bio Pharma Dive

The money will be spread across three investment funds and comes at a time when investment into biotech remains shakier than in years past.

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ADDF announces speech database to identify biomarkers for Alzheimer’s

Pharmaceutical Technology

SpeechDx will contain recorded voice samples and other data, which will be used to develop algorithms for creating new speech biomarkers.

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Aiolos Bio raises $245M on prospect of better asthma drug

Bio Pharma Dive

The startup is taking aim at an inflammation-linked protein known as TSLP, which is the target of an approved asthma medicine.

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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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Certa wins FDA orphan drug designation for scleroderma therapy

Pharmaceutical Technology

The candidate recently went through a Phase II trial, with results to be presented in mid-November.

Drugs 246
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An Orbimed-backed biotech launches with $85M and plans for a new kind of DNA medicine

Bio Pharma Dive

Rampart Biosciences closed a Series A round that will fund its goal to develop more potent DNA-based medicines that avoid immune responses.

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More Trending

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The Brain Cells That Give You Motion Sickness May Have Been Identified

AuroBlog - Aurous Healthcare Clinical Trials blog

If the idea of driving down a winding road makes you feel queasy, spare a thought for the mice employed in a new study, which sought to pinpoint the brain cells responsible for motion sickness.

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Novartis delays FDA filing for in-demand radiopharma drug

Bio Pharma Dive

Mixed survival data from a study of Pluvicto in earlier prostate cancer sparked the slower regulatory timeline.

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NABH releases first edition of NABH Certification standards for stroke care centres

AuroBlog - Aurous Healthcare Clinical Trials blog

The National Accreditation Board for Hospitals and Healthcare Providers (NABH) has released the first edition of NABH Certification standards for stroke care centres. It has urged all the centres across the country to apply for accreditation depending on the self-assessment of the standards.

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CpHI Europe: CDMOs prioritise innovation and flexibility in an evolving landscape

Pharmaceutical Technology

At the ongoing CpHI Europe meeting, experts outline the key elements that will be expected in future pharma partnerships.

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

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Johns Hopkins study shows potential for chemical vaccine against malaria

Pharma Times

Malaria was responsible for over 600,000 worldwide deaths in 2021 - News - PharmaTimes

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Astraveus wins €10.4m French grant to advance CGT manufacturing

Pharmaceutical Technology

The award will fund the development of the company’s automated, microfluidic cell and gene therapy manufacturing platform.

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NIHR awards £1.5m to fund 13 work and health research projects

Pharma Times

The funding will allow several projects to support the health of working people - News - PharmaTimes

Research 140
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Amgen plans to lay off 350 former Horizon employees after $28B buyout

Fierce Pharma

In the biopharma industry, post-merger layoffs are often a question of when and how many. | In the biopharma industry, post-merger layoffs are often a question of when and how many. In the case of Amgen’s $27.8 billion buyout of Horizon, they came quickly. Around 350 former Horizon employees are being told this week that their positions will be eliminated.

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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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HDT Bio navigates vaccine strategy in a changing Covid-19 landscape

Pharmaceutical Technology

Amidst a changing, complex Covid-19 marketplace, HDT-Bio looks towards harnessing multivalence for its Covid-19 candidate, HDT-301.

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3 Key Takeaways from Global Genes Summit 2023

Worldwide Clinical Trials

In the US, a rare disease is one with 200,000 or fewer patients. Rare diseases exist in every therapeutic area and are often the more complex indications of each therapeutic area. While this is a small number of people in each rare disease patient community, the significant and continued growth of rare disease drug development is unsurprising given that there are over 10,000 rare diseases , with more being discovered every year.

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Sponsors urged to compensate oncology patients and meet trial staff face-to-face

Pharmaceutical Technology

Sponsors are being urged to compensate participants in oncological clinical trials, as well as make in-person visits to contract research organisations to keep exploratory studies from slowing down.

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Amgen Lays Off 350 Employees Following $27.8B Horizon Acquisition

BioSpace

In its most recent round of layoffs this year, the California-based biopharma company is letting go of 350 former Horizon Therapeutics staff whose roles overlap with existing positions at Amgen.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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AstraZeneca and Daiichi score another win with Enhertu’s EU approval in lung cancer

Pharmaceutical Technology

AstraZeneca will pay $75m to Daiichi Sankyo as a milestone payment following the latest EU approval to treat NSCLC patients with a HER2 mutation.

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ESMO: Merck, in flurry of studies, shows Keytruda's power and limitations

Fierce Pharma

At this year’s congress of the European Society for Medical Oncology (ESMO), Merck & Co. unleashed a flurry of studies showing Keytruda’s power across multiple tumor types. | Across four separate studies, Merck’s PD-1 juggernaut Keytruda—in combination with other cancer meds—charted complete and partial wins in cervical cancer, early breast cancer and stomach cancer.

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Trial sponsors say CROs need to own their mistakes and take responsibility

Pharmaceutical Technology

A panel discussion at a Copenhagen conference saw representatives from sponsor organisations sharing their hopes for CROs to take ownership when trials go wrong.

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Creating behavioural change through incremental, small steps

pharmaphorum

Creating behavioural change through incremental, small steps Mike.

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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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Health Canada approves Sumitomo’s prostate cancer treatment

Pharmaceutical Technology

Health Canada has granted approval for Sumitomo Pharma Canada’s Orgovyx (relugolix) to treat advanced prostate cancer in men.

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AstraZeneca's self-administered nasal flu vaccine gets one step closer to FDA approval

Fierce Pharma

On the market for two decades, AstraZeneca’s nasal spray flu vaccine, FluMist, may become available for self-administration as soon as next year. | On the market for two decades, AstraZeneca’s nasal spray flu vaccine, FluMist, may become available for self-administration as soon as next year. The FDA has accepted AZ’s supplemental biologics license application (sBLA) for self-administered FluMist Qudrivalent.

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Samsung Biologics and Kurma collaborate for biologics development

Pharmaceutical Technology

Samsung Biologics has entered into a collaboration with Kurma Partners to develop biologics for Kurma's portfolio companies.

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ESMO: Survival data mars Pluvicto prostate cancer trial

pharmaphorum

ESMO: Survival data mars Pluvicto prostate cancer trial Phil.

Trials 111
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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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Genexine-KGbio’s CKD-linked anaemia drug gains approval in Indonesia

Pharmaceutical Technology

The Indonesian Ministry of Food and Drug Safety approved Genexine and KGbio's Efepoetin alfa for chronic kidney disease-induced anaemia.

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ESMO: Can BioNTech’s revved-up CAR-T hit solid tumours?

pharmaphorum

ESMO: Can BioNTech’s revved-up CAR-T hit solid tumours? Phil.

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INVO to acquire NAYA to establish life science company

Pharmaceutical Technology

INVO Bioscience has signed an agreement to acquire NAYA Biosciences to establish a publicly traded life science company.

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Novartis delays Pluvicto filing as CEO spots industry 'conundrum' with FDA

Fierce Pharma

Novartis entered a new era after spinning off Sandoz earlier in October. | Novartis entered a new era after spinning off Sandoz earlier in October. As the pure-play innovative medicines company reports strong growth from the business it’s now built on, one product faces a delay.

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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.