Tue.Oct 03, 2023

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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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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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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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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.

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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.

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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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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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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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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.

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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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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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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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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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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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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

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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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Automata raises $40 million to commercialize robotic lab bench

Outsourcing Pharma

The U.K. startup Automata Technologies has bagged $40 million in a funding round to expand its workforce and the geographic reach of its life sciences lab automation technology.

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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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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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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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CD123-targeted CAR-NK by Chongqing Precision Biotech for Natural Killer Cell Lymphomas: Likelihood of Approval

Pharmaceutical Technology

CD123-targeted CAR-NK is under clinical development by Chongqing Precision Biotech and currently in Phase II for Natural Killer Cell Lymphomas.

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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.

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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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CD123-targeted CAR-NK by Chongqing Precision Biotech for Natural Killer Cell Lymphomas: Likelihood of Approval

Pharmaceutical Technology

CD123-targeted CAR-NK is under clinical development by Chongqing Precision Biotech and currently in Phase II for Natural Killer Cell Lymphomas.

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Sanofi, Teva Ink Potential $1.5B Deal Aimed at Blockbuster IBD Drug

BioSpace

The French pharma paid $500 million upfront, with up to $1 billion in future milestone payments, to co-develop and co-commercialize Teva’s Phase II anti-TL1A antibody for inflammatory bowel disease.

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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.

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Investors Fuel Fountain of Youth Research with Longevity Company Funding

BioSpace

The call to develop therapeutics that interfere with aging, helping people live longer, healthier lives, is increasing—and experts say the market opportunity is high.

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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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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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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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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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Pharma Companies Form Coalition to Fight FTC Antitrust Overhaul

BioSpace

AbbVie, Amgen, Gilead, Merck and Novartis are among the 31 members that have formed the Partnership for the U.S. Life Science Ecosystem to push back against federal antitrust reforms.

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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.