Bio Pharma Dive

SEPTEMBER 14, 2023

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

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Antibody Drugs 313

Pharmaceutical Technology

SEPTEMBER 14, 2023

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

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Drugs Production 173

Bio Pharma Dive

SEPTEMBER 14, 2023

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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Gene Therapy Gene 293

Pharmaceutical Technology

SEPTEMBER 14, 2023

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

Medicine 130

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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.

Clinical Trials

Bio Pharma Dive

SEPTEMBER 14, 2023

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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Pharmaceutical Technology

SEPTEMBER 14, 2023

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

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Drugs 147

Pharmaceutical Technology

SEPTEMBER 14, 2023

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

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Antibody Development 147

BioSpace

SEPTEMBER 14, 2023

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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Pharmaceutical Technology

SEPTEMBER 14, 2023

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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Clinical Trials Clinical Trials Vaccination Vaccine 130

Antidote

SEPTEMBER 14, 2023

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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There’s been a rapid shift towards decentralization in clinical trials & it’s clear why. The potential for reaching a larger pool of recruits is possible when sponsors can bring more trial activities to the patient. Tele visits, digital consent, new monitoring sensors, & direct-to-patient supply are virtual tools that existed before the pandemic, but now there’s swift adoption of these methods because they’ve been proven to help launch & complete trials more effectively.

Trials

Pharmaceutical Technology

SEPTEMBER 14, 2023

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

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Marketing 130

BioSpace

SEPTEMBER 14, 2023

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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Life Science Trials 111

Pharmaceutical Technology

SEPTEMBER 14, 2023

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

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Clinical Development Development 130

Drug Discovery World

SEPTEMBER 14, 2023

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.

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Reagent Life Science Scientist Drugs 111

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Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.

Clinical Trials

Pharmaceutical Technology

SEPTEMBER 14, 2023

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

Clinical Development 100

Clinical Development Development 100

BioSpace

SEPTEMBER 14, 2023

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.

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Sales 109

Pharmaceutical Technology

SEPTEMBER 14, 2023

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

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Clinical Development Development 130

Fierce Pharma

SEPTEMBER 14, 2023

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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Manufacturing Drugs Regulation 107

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

Clinical Research

Pharmaceutical Technology

SEPTEMBER 14, 2023

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

Clinical Development 100

Clinical Development Development 100

BioSpace

SEPTEMBER 14, 2023

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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Drugs Development 120

Pharmaceutical Technology

SEPTEMBER 14, 2023

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

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Gene Clinical Development Development 100

Outsourcing Pharma

SEPTEMBER 14, 2023

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.

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Genome Genomics Regulation Marketing 103

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Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic

Clinical Trials

Pharmaceutical Technology

SEPTEMBER 14, 2023

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

Clinical Development 100

Clinical Development Development 100

Intouch Solutions

SEPTEMBER 14, 2023

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.

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Medicine Marketing Branding Production 100

Pharmaceutical Technology

SEPTEMBER 14, 2023

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

Gene Clinical Development Development 100

BioSpace

SEPTEMBER 14, 2023

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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Drugs Production 104

Advertiser: FourKites

A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.

Research

Pharmaceutical Technology

SEPTEMBER 14, 2023

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

Clinical Development 100

Clinical Development Development 100

Pharma Times

SEPTEMBER 14, 2023

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

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Research 122

Fierce Pharma

SEPTEMBER 14, 2023

Otsuka teamed up with Shape Therapeutics in an eye disease gene therapy deal potentially worth $1.5 billion. Astellas will build its third Irish manufacturing facility. | Otsuka teamed up with Shape Therapeutics in an eye disease gene therapy deal potentially worth $1.5 billion. Astellas will build its third Irish manufacturing facility for $354 million.

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Gene Therapy Gene Drugs Medicine 96

Outsourcing Pharma

SEPTEMBER 14, 2023

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.

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Medicine Licensing Licensing Drugs 93

Speaker: Steve Goldstein, Sales Leader

Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g

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