AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 25, 2024

The Central government’s actions to mandate licensing of all medical devices is posing a challenge to the industry, especially the micro and small enterprises in the sector, says the Surgical Manufacturers and Traders Association (SMTA), the pan India organisation of manufacturers and traders of surgical equipment for healthcare services providers in the country.

Licensing 189

Licensing Licensing Manufacturing Clinical Trials 189

Bio Pharma Dive

JANUARY 25, 2024

The company is developing an oral alternative to J&J’s lung cancer medicine Rybrevant, and adds to a trend of late-stage drugmakers finding investor demand on Wall Street.

Medicine 189

Medicine Development 189

Pharmaceutical Technology

JANUARY 25, 2024

Evaxion Biotech has announced plans to develop customised cancer vaccines by targeting a category of AI-discovered tumour antigens.

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Vaccine Vaccination Development 173

Bio Pharma Dive

JANUARY 25, 2024

A two-day workshop highlighted the lack of investment and inadequate understanding of what causes early births, making development efforts more challenging.

Development 189

Development Drugs 189

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

Medicine

Pharma Times

JANUARY 25, 2024

Around 50% of babies born with the condition are affected by heart defects

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Gene Research 149

Bio Pharma Dive

JANUARY 25, 2024

Two “global biopharmaceutical companies” made bids to buy the radiopharma specialist, but lost out to Bristol Myers, which negotiated aggressively to secure a $4.1 billion buyout.

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Bio Pharma Dive

JANUARY 25, 2024

The pharma veteran will take over the AI-focused biotech after a year that included a restructuring, job cuts and the resignation of its CFO.

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Pharmaceutical Technology

JANUARY 25, 2024

MSD will supply Keytruda to be evaluated as a combination treatment with Lava’s LAVA-1207 in an ongoing Phase I/IIa study.

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Fierce Pharma

JANUARY 25, 2024

Three months after launching an investigation into the risk of patients developing secondary T-cell cancers after receiving a CAR-T drug, the FDA has shared more information on the cases it has see | Three months after launching an investigation into the risk of secondary T-cell cancers after treatment with a CAR-T medicine, the FDA has shared more information on the cases that it has seen.

Medicine 131

Medicine Development Drugs 131

Pharmaceutical Technology

JANUARY 25, 2024

Kyowa Kirin has acquired Orchard Therapeutics, a developer of hematopoietic stem cell gene therapies, for an equity value of $477.6m.

Gene Therapy 147

Gene Therapy Gene Development 147

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Clinical Supply

Rethinking Clinical Trials

JANUARY 25, 2024

The NIH Pragmatic Trials Collaboratory this week published a new chapter in its Living Textbook of Pragmatic Clinical Trials. Part of the Living Textbook’s new ethics and regulatory collection, the chapter discusses the logistics of using a single IRB (sIRB). In 2016, the NIH issued a policy establishing the expectation that a “single IRB of record” will be used for all NIH-funded, multisite, human subjects research.

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Clinical Trials Clinical Trials Trials Research 130

Pharmaceutical Technology

JANUARY 25, 2024

The US FDA has requested a different safety label for Gilead’s Tecartus compared to other approved CAR-T cell therapies.

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Antidote

JANUARY 25, 2024

Recruiting patients for clinical trials is a common challenge for study sponsors conducting research. For this reason, it is often a wise strategy to work with an agency that specializes in outreach. These agencies excel at helping sponsors achieve their research goals within defined timelines and budgets.

Clinical Trials 120

Clinical Trials Clinical Trials Trials Research 120

Pharmaceutical Technology

JANUARY 25, 2024

As a new variant spearheads a Covid-19 infection Winter spike, the range of vaccines and antivirals is very different today to 2020.

Vaccine 130

Vaccine Vaccination Drugs 130

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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

Clinical Trials

pharmaphorum

JANUARY 25, 2024

Discover the role of GenAI in life sciences in 2024. Explore how artificial intelligence and machine learning techniques like GenAI are revolutionising drug development, diagnostics, and research. Learn how industry leaders, including Google, are leveraging GenAI to advance healthcare and enhance patient outcomes.

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Life Science Development Drugs Research 115

Pharmaceutical Technology

JANUARY 25, 2024

We speak with BAP Pharma to learn more about the challenges and possible benefits of medicines access solutions.

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Medicine 130

Fierce Pharma

JANUARY 25, 2024

A decade after Translarna's initial marketing authorization in Europe, it looks like the drug's run in the region is coming to an end. | A decade after Translarna's initial marketing authorization in Europe, it looks like the drug's run in the region is coming to an end.

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Drugs Marketing 115

Pharmaceutical Technology

JANUARY 25, 2024

Theratechnologies has received a CRL from the US Food and Drug Administration (FDA), denying approval for its F8 formulation of tesamorelin.

Drugs 130

Drugs 130

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Clinical Supply

pharmaphorum

JANUARY 25, 2024

On today’s podcast, host Jonah Comstock is joined by Arturo Araya, EVP of commercialisation at Cellares, a company that is attempting to create a new kind of contract manufacturing organisation for the rapidly crystalizing world of cell and gene therapy.

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Gene Therapy Manufacturing Gene Contract Manufacturing 111

Pharmaceutical Technology

JANUARY 25, 2024

Synnovation Therapeutics has launched with a $102m Series A financing to progress the development its pipeline of targeted therapies.

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Development 130

pharmaphorum

JANUARY 25, 2024

NICE firms up guidance backing NHS use of five digital health wearables for remote monitoring of Parkinson's disease patients

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Pharma Times

JANUARY 25, 2024

CAD is responsible for around 68,000 deaths per year in the UK

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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.

Clinical Trials

pharmaphorum

JANUARY 25, 2024

Indian pharma Glenmark has licensed rights to subcutaneous PD-L1 inhibitor envafolimab from China’s Alphamab and 3D Medicines

Licensing 110

Licensing Licensing Medicine Drugs 110

Fierce Pharma

JANUARY 25, 2024

Two months ago, in presenting quarterly earnings, CEO Barry Greene said Sage Ther | Two months ago, in presenting quarterly earnings, CEO Barry Greene said Sage Therapeutics was on its way to becoming a “leaner and stronger company.” Part of that mission will come to fruition later this year with a move of its headquarters in Cambridge, Massachusetts.

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pharmaphorum

JANUARY 25, 2024

Our latest crop of biotech financings features rounds for Synnovation Therapeutics and Adicet Bio, Calluna Pharma, Accent Therapeutics, GenEdit and IMU Bio

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Fierce Pharma

JANUARY 25, 2024

Last year proved a challenging year for contract manufacturers across the board, but Korea’s Samsung Biologics appears to have bucked the losing trend by charting what it called an “exceptional" pe | Last year proved a challenging year for contract manufacturers across the board, but Korea’s Samsung Biologics appears to have bucked the losing trend by charting what it called an “exceptional" performance.

Contract Manufacturing 105

Contract Manufacturing Manufacturing 105

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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

Clinical Research

pharmaphorum

JANUARY 25, 2024

UK government is reported to be considering financial aid for AstraZeneca to seal a deal to expand a vaccines manufacturing facility in Speke

Vaccine 105

Vaccine Vaccination Manufacturing 105

Fierce Pharma

JANUARY 25, 2024

The FDA will convene an advisory committee to discuss Johnson & Johnson and Legend's Carvykti filing in earlier multiple myeloma. | The FDA will convene an advisory committee to discuss Johnson & Johnson and Legend's Carvykti filing in earlier multiple myeloma. AstraZeneca has won a world-first approval for its rare blood disorder add-on therapy in Japan.

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Drugs 97

pharmaphorum

JANUARY 25, 2024

UK biotech shows "resilience" in 2023, raising £1.

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Marketing 105

Outsourcing Pharma

JANUARY 25, 2024

Meghan Harrington recently joined Medidata as vice president of product, clinical trial financial management and is responsible for driving the strategic direction of the grants manager and payments products.

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Trials Clinical Trials Clinical Trials Production 91

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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