Mon.Mar 04, 2024

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Bayer pays $310M to buy into BridgeBio heart drug

Bio Pharma Dive

The deal gives the German pharma partial rights to a closely watched medicine for transthyretin amyloidosis cardiomyopathy that analysts expect to become a multibillion-dollar product.

Medicine 280
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Oncology emerges as dominant therapy area for CRISPR technology

Pharmaceutical Technology

In late 2023, the Medicines and Healthcare products Regulatory Agency approved Vertex’s Casgevy, which became the inaugural clustered regularly interspaced short palindromic repeats (CRISPR)-based drug for the haematological indications beta thalassemia and sickle cell disease (SCD).

Medicine 278
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CVS, Walgreens to start selling abortion pill in some states

Bio Pharma Dive

The two pharmacy retailers will begin dispensing mifepristone in some states weeks before the start of a Supreme Court case that will decide how widely the pill can be accessed.

Pharmacy 265
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EMA awards double validation for Daiichi Sankyo and AstraZeneca’s cancer ADC

Pharmaceutical Technology

The EMA has validated the jointly developed TROP2-directed therapy for patients with breast or lung cancer following positive Phase III data.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Akero strengthens MASH drug’s case with new study data

Bio Pharma Dive

The updated results show that responses to the drug, which is currently in late-stage testing, deepened with time, helping the company rebound from an earlier setback.

Drugs 164
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FDA doubles down on patient engagement to support rare disease research

Pharmaceutical Technology

For Rare Disease Day, several panels organised by the FDA discussed the importance overcoming accessibility barriers during drug development.

Research 195

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Sandoz strengthens US biosimilar market with CIMERLI acquisition

Pharmaceutical Technology

Sandoz has concluded the acquisition of the US biosimilar CIMERLI from Coherus BioSciences, bolstering ophthalmology and biosimilar expertise.

Marketing 147
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AstraZeneca’s drug pricing lawsuit dismissed by federal judge

Bio Pharma Dive

The rejection is the latest setback in the pharmaceutical industry’s efforts to use the courts to challenge Medicare’s new pricing powers.

Drugs 148
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F. Hoffmann-La Roche in advanced materials: theme innovation strategy

Pharmaceutical Technology

How many patents did F. Hoffmann-La Roche submit related to advanced materials last quarter, and how many were granted? Discover the latest information here.

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130
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Cannabinoids show promise in acute migraine clinical trial

pharmaphorum

Inhaled cannabinoids have been shown to perform better than placebo in providing pain relief for people suffering from acute migraine in a clinical trial

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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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CARsgen’s CAR-T therapy for multiple myeloma gains NMPA approval

Pharmaceutical Technology

The China's NMPA has granted approval for CARsgen Therapeutics' NDA for zevorcabtagene autoleucel to treat multiple myeloma.

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Pfizer stops buildout of $350M Seagen plant, leaving 120 workers' roles in question

Fierce Pharma

When Pfizer completed its $43 billion buyout of Seagen in December | Less than three months after completing its $43 billion acquisition of Seagen, Pfizer has confirmed a report that it is shutting down construction of a $350 million manufacturing facility in Everett, Washington. The decision will affect 120 employees working on the initial setup of the site, the company said.

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FogPharma secures $145m to develop cancer therapy

Pharmaceutical Technology

FogPharma has secured $145m in a Series E financing round to support the clinical development of its cancer therapy, FOG-001.

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Antibody therapy shows anti-tumour activity in advanced cancer

Drug Discovery World

In an early phase clinical trial, a combination of antibody-based medications targeting the immune system generated promising safety data and anti-tumour activity in individuals with advanced cancer. Both medications tested in the trial support immune responses against tumour cells. CS1002 increases the activation and proliferation of T immune cells by binding to a T cell receptor called CTLA-4.

Antibody 115
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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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GLP1ra’s linked with reduced risk of depression, study claims

Pharmaceutical Technology

The study looked at medical records of over three million diabetic patients and almost one million non-diabetic patients.

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Using knowledge graphs to drive drug discovery

Bio Pharma Dive

How are knowledge graphs changing the path of drug discovery?

Drugs 139
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FDA approves J&J’s RYBREVANT for NSCLC treatment

Pharmaceutical Technology

The US FDA has granted full approval for Johnson & Johnson's (J&J) RYBREVANT for types of NSCLC.

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Q&A: How AI and ML are reshaping the research landscape

Bio Pharma Dive

Panalgo’s Meg Richards and Mike Munsell discuss how AI and ML are transforming the healthcare research landscape.

Research 114
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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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F. Hoffmann-La Roche in internet of things: theme innovation strategy

Pharmaceutical Technology

How many patents did F. Hoffmann-La Roche submit related to internet of things last quarter, and how many were granted? Discover the latest information here.

113
113
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Perrigo's over-the-counter birth control launch takes flight in the US

Fierce Pharma

A little more than half a year after winning a historic over-the-counter nod, Perrigo’s nonprescription birth control pill Opill is set to hit store shelves in the “coming weeks.” | A little more than half a year after winning a historic over-the-counter nod, Perrigo’s nonprescription birth control pill Opill is set to hit store shelves in the “coming weeks.

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102
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F. Hoffmann-La Roche in cybersecurity: theme innovation strategy

Pharmaceutical Technology

How many patents did F. Hoffmann-La Roche submit related to cybersecurity last quarter, and how many were granted? Discover the latest information here.

147
147
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Dark factories for a bright future

pharmaphorum

Explore the future of drug manufacturing with dark factories, robotic and automated facilities that promise efficiency and innovation. Learn how these advancements are shaping a bright future for the pharmaceutical industry.

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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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F. Hoffmann-La Roche in robotics: theme innovation strategy

Pharmaceutical Technology

How many patents did F. Hoffmann-La Roche submit related to robotics last quarter, and how many were granted? Discover the latest information here.

113
113
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RSV vaccines may raise risk of Guillain-Barré syndrome, FDA preliminary analysis finds

Fierce Pharma

After decades of research into respiratory syncytial virus (RSV), Pfizer and GSK’s groundbreaking vaccines made waves as the first immunizations against the common respiratory illness. | After a preliminary analysis found a potentially higher risk of Guillain-Barré syndrome following RSV vaccination in older adults, GSK and Pfizer said they will conduct further safety studies.

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F. Hoffmann-La Roche in digitalization: theme innovation strategy

Pharmaceutical Technology

How many patents did F. Hoffmann-La Roche submit related to digitalization last quarter, and how many were granted? Discover the latest information here.

100
100
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Architect of Indian Pharmacy Education : Prof. Mahadev Lal Schroff

Pharma Tutor

Architect of Indian Pharmacy Education : Prof. Mahadev Lal Schroff admin Mon, 03/04/2024 - 16:44 ABOUT AUTHOR Dr. R. S. Thakur Former Secretary, Pharmacy Council of India. Email : drramsthakur@gmail.

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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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F. Hoffmann-La Roche in big data: theme innovation strategy

Pharmaceutical Technology

How many patents did F. Hoffmann-La Roche submit related to big data last quarter, and how many were granted? Discover the latest information here.

Big Data 100
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EMA starts twin reviews of AZ, Daiichi’s Dato-DXd

pharmaphorum

The clock has started ticking in the EU on two marketing applications for AstraZeneca and Daiichi Sankyo’s TROP2-targeting antibody-drug conjugate datopotamab deruxtecan in breast and lung cancer. The EMA has validated the two parallel applications for the drug, also known as Dato-DXd, in adults with previously treated non-small cell lung cancer (NSCLC) and hormone receptor-positive, HER2-negative breast cancer.

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F. Hoffmann-La Roche in mobile: theme innovation strategy

Pharmaceutical Technology

How many patents did F. Hoffmann-La Roche submit related to mobile last quarter, and how many were granted? Discover the latest information here.

100
100
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Poor spatial navigation could predict Alzheimer’s before symptom onset

Pharma Times

Around 900,000 people in the UK are affected by the progressive neurodegenerative disease

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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.