Thu.Sep 14, 2023

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Flagship-backed Generate raises $273M as its first drugs move to the clinic

Bio Pharma Dive

Since 2019, Generate has raised nearly $700 million in private financing and has now brought a monoclonal antibody into Phase 1 testing.

Antibody 306
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Astellas to build drug production facility in Ireland

Pharmaceutical Technology

Astellas Pharma is submitting a planning application for the construction of a new drug production facility in Ireland.

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UK biotech AlveoGene launches with plans for inhaled gene therapy

Bio Pharma Dive

The company is working on a treatment of alpha-1 antitrypsin deficiency, which it claims it can deliver direct to lung cells via a nebulizer.

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Improving health equity in Europe’s small countries: How can we remove the barriers to access?

Pharmaceutical Technology

Ensuring equitable access to medicines is a key challenge for many governments, particularly those of smaller nations. Pharmaceutical Technology reviews the data and explores European initiatives to improve the situation.

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

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RayzeBio, Neumora price some of biotech’s largest IPOs this year

Bio Pharma Dive

Pricing of the companies’ IPOs comes after a big day for Wall Street, which saw the SoftBank-owned chip maker Arm pull off the year’s largest new stock offering.

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FDA accepts Madrigal’s liver disease therapy NDA for review

Pharmaceutical Technology

The US FDA has accepted Madrigal Pharmaceuticals’ new drug application (NDA) for liver disease therapy resmetirom for review.

Drugs 147

More Trending

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AbCellera and Incyte partner for development of cancer antibodies

Pharmaceutical Technology

AbCellera and Incyte have entered a partnership for the discovery and development of therapeutic antibodies in oncology.

Antibody 147
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RayzeBio’s $311M, Neumora’s $250M IPOs Among Biotech’s Largest This Year

BioSpace

The two biotech companies announced initial public offering pricing Thursday, respectively, with shares beginning trading Friday and valued at more than $560 million cumulatively.

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ICON partners with US Government for clinical trials of Covid-19 vaccines

Pharmaceutical Technology

ICON will conduct Phase IIb clinical trials for the US BARDA-selected Covid-19 vaccine candidates as part of ‘Project NextGen’.

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A World Alzheimer's Month resource roundup

Antidote

Alzheimer’s disease, the most prevalent type of dementia , is diagnosed in more than 6 million Americans. Estimates project that by 2050, 13 million individuals will be diagnosed with Alzheimer’s disease. This condition ranks among the top 10 causes of death in the United States, profoundly impacting those diagnosed, their loved ones, and their caregivers.

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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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Pharmazz and Sun Pharma sign licence deal for Tyvalzi launch in India

Pharmaceutical Technology

Pharmazz and Sun Pharma have signed a licence agreement for the marketing of Tyvalzi (Sovateltide) in India.

Marketing 130
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Anavex’s Blarcamesine Slows Cognitive Decline in Alzheimer’s Patients

BioSpace

Following a controversial Rett Syndrome trial last year, Anavex Life Sciences’ blarcamesine has claimed another clinical victory—this time in an Alzheimer’s disease Phase IIb/III study.

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NME 2 by Bristol-Myers Squibb for Solid Tumor: Likelihood of Approval

Pharmaceutical Technology

NME 2 is under clinical development by Bristol-Myers Squibb and currently in Phase I for Solid Tumor.

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AstraZeneca’s Alexion Reaches $125M Settlement in Soliris Sales Lawsuit

BioSpace

After nearly seven years, the company’s rare diseases arm Alexion has reached a settlement in an investors’ lawsuit over alleged unethical sales practices for its hemoglobinuria therapy Soliris.

Sales 113
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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ZE-460134 by Eilean Therapeutics for Acute Myelocytic Leukemia (AML, Acute Myeloblastic Leukemia): Likelihood of Approval

Pharmaceutical Technology

ZE-460134 is under clinical development by Eilean Therapeutics and currently in Phase I for Acute Myelocytic Leukemia (AML, Acute Myeloblastic Leukemia).

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Busting common myths about lab automation 

Drug Discovery World

Ernesto Staroswiecki, Senior Manager, R&D, at Beckman Coulter Life Sciences takes readers through common lab automation myths. Many clinical and research laboratories today are having to do more with less: faced with ongoing staffing shortages, increased workloads, and budgetary constraints, many laboratory managers are feeling the stress, which is where the benefits of automation can be truly realised for labs in both academia and industry.

Reagent 111
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(Islatravir + ulonivirine) by Merck for Human Immunodeficiency Virus (HIV) Infections (AIDS): Likelihood of Approval

Pharmaceutical Technology

(Islatravir + ulonivirine) is under clinical development by Merck and currently in Phase II for Human Immunodeficiency Virus (HIV) Infections (AIDS).

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5 Key Regulatory Guidance Documents Issued in 2023

BioSpace

The FDA has issued more than 30 guidance documents related to drug development so far this year. BioSpace takes a closer look at five of them.

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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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CD123-targeted CAR-NK by Chongqing Precision Biotech for Refractory Acute Myeloid Leukemia: Likelihood of Approval

Pharmaceutical Technology

CD123-targeted CAR-NK is under clinical development by Chongqing Precision Biotech and currently in Phase II for Refractory Acute Myeloid Leukemia.

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UKRI report reveals impact of COVID-19 research and innovation funding

Pharma Times

The report highlights steps needed to ensure future pandemics are handled effectively - News - PharmaTimes

Research 135
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BCMA-GPRC5D CAR-T Cells by Guangzhou Bio-gene Technology for Refractory Multiple Myeloma: Likelihood of Approval

Pharmaceutical Technology

BCMA-GPRC5D CAR-T Cells is under clinical development by Guangzhou Bio-gene Technology and currently in Phase II for Refractory Multiple Myeloma.

Gene 100
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Novartis Shareholders Approve Sandoz Spin-Off as Company Bolsters Product Plans

BioSpace

The Swiss pharma’s shareholders on Friday approved spinning off the generics and biosimilars division, with plans to launch at least five additional biologic drugs.

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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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CD123-targeted CAR-NK by Chongqing Precision Biotech for Relapsed Acute Myeloid Leukemia: Likelihood of Approval

Pharmaceutical Technology

CD123-targeted CAR-NK is under clinical development by Chongqing Precision Biotech and currently in Phase II for Relapsed Acute Myeloid Leukemia.

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FDA, manufacturers make progress in resolving key cancer drug shortages: White House

Fierce Pharma

While there's certainly more work to do, the U.S. | Efforts from regulators and manufacturers have brought the U.S. supply of cisplatin back to nearly 100% of pre-shortage levels, according to the White House. The moves are “greatly alleviating the shortages of carboplatin,” too, the White House said.

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BCMA-GPRC5D CAR-T Cells by Guangzhou Bio-gene Technology for Relapsed Multiple Myeloma: Likelihood of Approval

Pharmaceutical Technology

BCMA-GPRC5D CAR-T Cells is under clinical development by Guangzhou Bio-gene Technology and currently in Phase II for Relapsed Multiple Myeloma.

Gene 100
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Rome Therapeutics adds $72 million to Series B round to harness “dark genome”

Outsourcing Pharma

The U.S. company Rome Therapeutics plans to use the proceeds of its $72 million Series B round to take an experimental autoimmune disease treatment through early clinical testing.

Genome 105
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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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Digital Medicine in Pharma: A Marketers’ Guide for Launch, Promotion and Life Cycle Management

Intouch Solutions

Digital medicine is emerging as a revolutionary field that can transform the entire spectrum of healthcare, from proactive prevention to effective treatment of diverse medical conditions. Unlike traditional pharmaceutical medications, digital medicine products need to speak to the clinical, economic and technological benefits to differentiate themselves from competitors.

Medicine 105
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LY-3885125 by Eli Lilly and Co for Non Alcoholic Fatty Liver Disease (NAFLD): Likelihood of Approval

Pharmaceutical Technology

LY-3885125 is under clinical development by Eli Lilly and Co and currently in Phase I for Non Alcoholic Fatty Liver Disease (NAFLD).

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Exelixis licenses AI-designed cancer drug from Insilico Medicine

Outsourcing Pharma

Insilico Medicine is due to receive $80 million upfront plus potential milestone payments as Exelixis gains global rights to develop and commercialize the Hong Kong firmâs small molecule cancer treatment.

Medicine 105
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UK government invests £200m to boost NHS resilience this winter

Pharma Times

The funding will reduce waiting lists and ease the demand on the NHS during Winter - News - PharmaTimes

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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.