Tue.Oct 03, 2023

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Regeneron, Intellia target neurological diseases in expanded gene editing deal

Bio Pharma Dive

The longtime partners believe that, by combining their technologies, they can create “in vivo” genetic medicines for nervous system and muscular disorders.

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Viatris announces plan to divest some businesses for $3.37bn

Pharmaceutical Technology

Drug manufacturer Viatris has announced the divestment of a number of businesses owned by the company in a $.37bn deal.

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Lilly to enter radiopharmaceutical drug field with $1.4B Point buyout

Bio Pharma Dive

The deal will hand Lilly a pipeline of experimental radioligand therapies, including a potential rival to Novartis’ Pluvicto, as well as a valuable manufacturing plant.

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Australian Seaweed Boosts Collagen Levels in Human-Like Skin Cells in The Lab

AuroBlog - Aurous Healthcare Clinical Trials blog

If you believe the headlines, seaweeds can do almost anything from storing tons of carbon and stopping cows from belching methane, to making biofuels and renewable plastics – all while sustaining vibrant coastal ecosystems and feeding communities.

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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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How biotech IPOs performed in the third quarter

Bio Pharma Dive

Only two of the eight biotech companies that priced offerings since July 1 trade at or above their debut share price, according to data from BioPharma Dive.

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Indian medical devices cos to invest in innovation for products minimizing environmental footprint

AuroBlog - Aurous Healthcare Clinical Trials blog

Indian medical devices companies are increasingly looking to invest in innovation for developing products that help to minimize environmental footprint. Also companies like the healthtech startup HaystackAnalytics are engaged in developing India’s first Universal Infectious Disease (UID) genomic test, which highlights the need to put in place preventive health strategies.

More Trending

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NIHR awards £97.5m to fund its new Research Support Service

Pharma Times

NIHR awards £97.

Research 147
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BW-20507 by Argo Biopharma Australia for Hepatitis B: Likelihood of Approval

Pharmaceutical Technology

BW-20507 is under clinical development by Argo Biopharma Australia and currently in Phase II for Hepatitis B.

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Vortex expands research at London Cancer Hub’s Innovation Gateway

Pharma Times

The Cancer Hub aims to create a world-leading ecosystem for cancer research - News - PharmaTimes

Research 136
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Super DC Vaccine by Shanghai Cell Therapy Group for Solid Tumor: Likelihood of Approval

Pharmaceutical Technology

Super DC Vaccine is under clinical development by Shanghai Cell Therapy Group and currently in Phase I for Solid Tumor.

Vaccine 130
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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FDA spots manufacturing wrinkles in Galderma's filing for liquid botulinum toxin

Fierce Pharma

As Galderma attempts to round out its injectable aesthetics portfolio with approvals to resolve crow’s feet and frown lines, the FDA spotted a few manufacturing wrinkles in its RelabotulinumtoxinA | The agency spotted issues relating to chemistry, manufacturing and controls (CMC) processes in the company's application for its liquid botulinum toxin type A.

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Nitric oxide by NOxy Health Products for Diabetic Foot Ulcers: Likelihood of Approval

Pharmaceutical Technology

Nitric oxide is under clinical development by NOxy Health Products and currently in Phase I for Diabetic Foot Ulcers.

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Digital therapeutics at a turning point: What we heard at DTx East

pharmaphorum

Digital therapeutics at a turning point: What we heard at DTx East Mike.

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Nitric oxide by NOxy Health Products for Diabetic Foot Ulcers: Likelihood of Approval

Pharmaceutical Technology

Nitric oxide is under clinical development by NOxy Health Products and currently in Phase I for Diabetic Foot Ulcers.

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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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How the rise of medical device use in pharma R&D is driving wearable technology in healthcare and revolutionising the medical industry

pharmaphorum

How the rise of medical device use in pharma R&D is driving wearable technology in healthcare and revolutionising the medical industry Mike.

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Novo Nordisk gains FDA approval for primary hyperoxaluria therapy

Pharmaceutical Technology

Novo Nordisk has received approval from the US Food and Drug Administration (FDA) for Rivfloza (nedosiran) injection

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AstraZeneca ponies up $425M to settle US lawsuits over Nexium, Prilosec

Fierce Pharma

Four months after GSK settled a key case in California over its heartburn medication Zantac, AstraZeneca is following suit, agreeing to resolve personal injury claims over its heartburn drugs Nexiu | Four months after GSK settled a key case in California over its heartburn medication Zantac, AstraZeneca is following suit, agreeing to resolve personal injury claims over its heartburn drugs Nexium and Prilosec.

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Sanofi and Janssen to develop vaccine candidate for E coli

Pharmaceutical Technology

Sanofi has signed an agreement with Janssen Pharmaceuticals for potential first-in-class vaccine against extraintestinal pathogenic E coli.

Vaccine 130
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Empowering patients: How to match to clinical trials

Antidote

Clinical trials are an integral part of the medical industry, as they are required for any new treatment to be approved. Every medicine used today, whether prescription or over the counter, is a result of the rigorous research process that is a clinical trial — and for these trials to take place, volunteers are vital.

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MHRA grants authorisation for GSK’s endometrial cancer treatment

Pharmaceutical Technology

The UK MHRA has granted authorisation for GSK's Jemperli (dostarlimab) to treat adult patients with certain endometrial cancer types.

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Finding a long-term fix to UK’s growing patient waiting list

pharmaphorum

Finding a long-term fix to UK’s growing patient waiting list Mike.

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Takeda to pull lung cancer med Exkivity around the world after confirmatory trial flop

Fierce Pharma

After a confirmatory trial flop this past summer, Takeda is calling it quits on its targeted non-small cell lung cancer (NSCLC) drug Exkivity. | Takeda will work with the FDA to chart a voluntary withdrawal of Exkivity in the U.S., where the drug is approved for certain adult lung cancer patients whose disease has progressed on or after platinum-based chemotherapy.

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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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AZ pays $425m to settle claims heartburn drugs caused harm

pharmaphorum

AZ pays $425m to settle claims heartburn drugs caused harm Phil.

Drugs 115
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Ahead of adcomm, FDA flags 'systemic bias' in Amgen's late-stage Lumakras trial

Fierce Pharma

As an FDA advisory committee gears up to discuss the data supporting Amgen’s Lumakras, a pre-meeting briefing document from the agency suggests the KRAS inhibitor might have a tough road ahead. | An FDA advisory committee is set to determine if the trial was adequate and well-controlled as the agency weighs a potential full approval for Amgen's KRAS inhibitor.

Trials 110
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Takeda pulls Exkivity in US after failed confirmatory trial

pharmaphorum

Takeda pulls Exkivity in US after failed confirmatory trial Phil.

Trials 111
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Vertex Touts Promising Data for Stem Cell-Based Type 1 Diabetes Treatment

BioSpace

New Phase I/II trial results show that one more type 1 diabetes patient achieved insulin independence after treatment with Vertex Pharmaceuticals’ investigational stem cell therapy VX-880.

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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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Exscientia trims pipeline to focus on top cancer prospects

pharmaphorum

Exscientia trims pipeline to focus on top cancer prospects Phil.

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BGBA-3055 by BeiGene for Solid Tumor: Likelihood of Approval

Pharmaceutical Technology

BGBA-3055 is under clinical development by BeiGene and currently in Phase I for Solid Tumor.

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FDA Says ‘Systemic Bias’ in Amgen’s Lumakras Trial Ahead of Adcomm Meeting

BioSpace

In its briefing document for Thursday’s FDA advisory committee meeting, the regulator contends that the company’s confirmatory CodeBreaK 200 trial for Lumakras is not an “adequate and well-controlled” study.

Trials 94
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MC-232 by MC2 Therapeutics for Hidradenitis Suppurativa: Likelihood of Approval

Pharmaceutical Technology

MC-232 is under clinical development by MC2 Therapeutics and currently in Phase II for Hidradenitis Suppurativa.

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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.