Thu.Jan 04, 2024

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A new startup from Feng Zhang and an ex-Illumina executive zeroes in on the epigenome

Bio Pharma Dive

Moonwalk Biosciences, the latest biotech cofounded by the gene editing scientist, joins other startups aiming to alter gene expression without changing DNA.

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Shock Result Reveals The Fruit You May Want to Leave Out of Smoothies

AuroBlog - Aurous Healthcare Clinical Trials blog

The next time you make yourself a berry smoothie, you might want to hold off on the banana. Sure, this fruit is full of potassium and makes a drink deliciously thick and creamy, but according to researchers from the University of California Davis (UCD), there’s something in bananas that might overpower the antioxidants in berries.

Research 211
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Allogene to shift strategy in bid to reposition CAR-T

Bio Pharma Dive

The company plans to restructure and will start a new late-stage study testing whether its “off-the-shelf” therapy can boost cure rates when used early on.

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Pfizer receives Health Canada approval for haemophilia B therapy

Pharmaceutical Technology

Pfizer Canada has received Health Canada approval for gene therapy Beqvez (fidanacogene elaparvovec) for the treatment of haemophilia B.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Lilly launches online service for home delivery of weight loss drug

Bio Pharma Dive

The new program, dubbed LillyDirect, will help patients connect with telehealth providers and deliver medicines like the company’s obesity treatment Zepbound.

Medicine 273
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Gene Therapy to Target CD19 and CD22 for Refractory and Relapsed B-cell Acute Lymphoblastic Leukemia by China Immunotech (Beijing) Biotechnology for B-Cell Acute Lymphocytic Leukemia (B-Cell Acute Lymphoblastic Leukaemia): Likelihood of Approval

Pharmaceutical Technology

Gene Therapy to Target CD19 and CD22 for Refractory and Relapsed B-cell Acute Lymphoblastic Leukemia is under clinical development by China Immunotech (Beijing) Biotechnology and currently in Phase I for B-Cell Acute Lymphocytic Leukemia (B-Cell Acute Lymphoblastic Leukaemia).

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Tonabersat by Inflammx Therapeutics for Wet (Neovascular / Exudative) Macular Degeneration: Likelihood of Approval

Pharmaceutical Technology

Tonabersat is under clinical development by Inflammx Therapeutics and currently in Phase II for Wet (Neovascular / Exudative) Macular Degeneration.

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Intellia to lay off staff, cut some early research

Bio Pharma Dive

The CRISPR specialist joins some of its genetic medicine peers in trimming staff, announcing an “organizational streamlining” to focus resources on prioritiy drug programs.

Genetics 177
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Tonabersat by Inflammx Therapeutics for Diabetic Macular Edema: Likelihood of Approval

Pharmaceutical Technology

Tonabersat is under clinical development by Inflammx Therapeutics and currently in Phase II for Diabetic Macular Edema.

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Novo taps Flagship startups to develop drugs for obesity, MASH

Bio Pharma Dive

The research deals with Omega Therapeutics and Cellarity are the first under a broad alliance Novo struck with Flagship last spring.

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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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SP-624 by Sirtsei Pharmaceuticals for Major Depressive Disorder: Likelihood of Approval

Pharmaceutical Technology

SP-624 is under clinical development by Sirtsei Pharmaceuticals and currently in Phase II for Major Depressive Disorder.

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DDCDA devises strategies to differentiate their service with improved customer experience

AuroBlog - Aurous Healthcare Clinical Trials blog

Dharwad District Chemists & Druggists Association (DDCDA) is devising strategies to differentiate their service with improved customer experience. These span attention to details like patient education to manage their medication, ensure fair business practices in pricing and dispensing medicines efficiently among others.

Medicine 146
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BridGene and Galapagos partner for oncology drugs discovery

Pharmaceutical Technology

BridGene has entered into a strategic partnership and licensing deal with Galapagos for the discovery of drug candidates for oncology targets.

Drugs 147
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Novo Nordisk, Eli Lilly's weight-loss drugs under FDA scrutiny for suicidal thoughts, hair loss

Fierce Pharma

Use of Novo Nordisk and Eli Lilly’s popular diabetes and weight loss drugs come with warnings about a rare intestinal blockage condition called ileus, which can be life threatening. | Use of Novo Nordisk and Eli Lilly’s popular diabetes and weight loss drugs come with warnings about a rare intestinal blockage condition called ileus. Could cautions about more common side effects soon be added to the labels of popular treatments such as Novo’s Ozempic and Lilly’s Mounjaro?

Drugs 133
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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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Tonabersat by Inflammx Therapeutics for Dry (Atrophic) Macular Degeneration: Likelihood of Approval

Pharmaceutical Technology

Tonabersat is under clinical development by Inflammx Therapeutics and currently in Phase II for Dry (Atrophic) Macular Degeneration.

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Why amplifying the patient voice is crucial to clinical trial success

pharmaphorum

Amplifying the patient voice is essential for the success of clinical trials. Learn why it is crucial for patient engagement, recruitment, and overall trial success, and how it can address challenges such as transportation and financial barriers.

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CB-010 by Caribou Biosciences for Follicular Lymphoma: Likelihood of Approval

Pharmaceutical Technology

CB-010 is under clinical development by Caribou Biosciences and currently in Phase I for Follicular Lymphoma.

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Newron's antipsychotic add-on drug produces 'never reported before' positive results

Outsourcing Pharma

Positive results of a study into the effects of an add-on to antipsychotics for the management of treatment-resistant schizophrenia (TRS) have been announced by Newron Pharmaceuticals.

Drugs 105
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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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(Amlodipine + indapamide + telmisartan) by George Medicines for Hypertension: Likelihood of Approval

Pharmaceutical Technology

(Amlodipine + indapamide + telmisartan) is under clinical development by George Medicines and currently in Phase III for Hypertension.

Medicine 130
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2024 forecast: As CDMOs come off pandemic's highs and lows, employment and funding hitches persist

Fierce Pharma

Even after the heady highs of the COVID-19 era, the contract development and manufacturing organization (CDMO) realm remains one of biopharma's buzziest fields. | Even after the heady highs of the COVID era, the CDMO realm remains one of biopharma's buzziest fields. In 2024, CDMOs can advance their priorities on three fronts, a group of experts said during a recent Evaluate webinar on the state of the industry.

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Agios’s mitapivat meets endpoints in Phase III thalassemia trial

Pharmaceutical Technology

Agios plans to file regulatory approval for mitapivat by the end of the year after it met primary endpoint in the Phase III trial.

Trials 130
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Risk model predicts response and survival of cancer patients treated with ICIs

Pharma Times

Metastatic cancer is estimated to be responsible for 90% of cancer deaths

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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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ENYO Pharma raises €39m Series C funding to advance Vonafexor

Pharmaceutical Technology

ENYO Pharma has secured €39m Series C funding to advance Vonafexor for the treatment of the kidney disease Alport syndrome.

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Roche antibiotic tackles serious drug-resistant pathogen

pharmaphorum

Scientists at Roche and Harvard University have discovered a new class of antibiotic that can kill carbapenem-resistant Acinetobacter baumannii (CRAB), a major public health threat

Scientist 101
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CVS to remove Humira from reimbursement lists in biosimilar push

Pharmaceutical Technology

In a move to drive down customer costs, CVS will replace AbbVie’s blockbuster with more affordable biosimilars.

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ACG's capsule manufacturing facility secures place in WEF's Global Lighthouse community

Outsourcing Pharma

Integrated supplier and service provider to the pharma industry, ACG, has secured a position in the World Economic Forum's prestigious community of Global Lighthouses.

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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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Esperion and Daiichi Sankyo Europe amend partnership

Pharmaceutical Technology

Daiichi Sankyo Europe (DSE) has amended its existing collaboration with Esperion Therapeutics valued at $125m.

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Click bags FDA breakthrough tag for schizophrenia DTx

pharmaphorum

Digital health company Click Therapeutics has won an FDA breakthrough device designation for CT-155, a digital therapeutic (DTx) for the negative symptoms of schizophrenia, like social withdrawal and apathy, that tend not to respond well to antipsychotic drugs.

Drugs 98
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IMA-203 by Immatics for Rhabdomyosarcoma: Likelihood of Approval

Pharmaceutical Technology

IMA-203 is under clinical development by Immatics and currently in Phase II for Rhabdomyosarcoma.

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Bluebird bio's Lyfgenia launch progresses with 2nd major outcomes-based coverage deal

Fierce Pharma

Despite competitive pressure from a buzzy CRISPR therapy, bluebird bio keeps striding forward with its sickle cell disease gene therapy Lyfgenia. | Despite competitive pressure from a buzzy CRISPR therapy, bluebird bio has signed a second outcomes-based reimbursement agreement for its sickle cell gene therapy Lyfgenia.

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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.