XTalks

DECEMBER 12, 2023

In an exclusive interview with Xtalks , Jörg Schüttrumpf, Chief Scientific Innovation Officer (CSIO) at Grifols , sheds light on the company’s commitment to innovation in the global healthcare industry, particularly both in the plasma and non-plasma medicines sector. Innovation — pardon the obvious metaphor — is our lifeblood.

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XTalks

JUNE 30, 2023

But to meet aggressive milestones and stringent performance standards, there’s a need for continuous innovation and streamlined development and quality control workflows. She has been involved in various medical and IVD product developments, certifications and registrations, both internally and externally.

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Cloudbyz

APRIL 8, 2024

Clinical trials are the cornerstone of drug development and medical research. One of the most significant challenges in conducting clinical trials is ensuring data quality and patient safety while managing costs effectively. Cost Efficiency: Traditional monitoring methods can be resource-intensive and costly.

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Clinical Trials Clinical Trials Trials Development 76

Advarra

JULY 27, 2022

As a pharmaceutical product makes its way through the lifecycle, there are often Food and Drug Administration (FDA) guidelines organizations should pay particular attention to. Managing regulatory submissions through increased product and process knowledge. Products affecting regulatory pathways are typically already approved.

Production 52

Production FDA Approval Compliance Marketing 52

pharmaphorum

MAY 11, 2022

However, the difficulty in developing a method to adequately produce sufficient levels of the product meant that the age of the antibiotic did not truly begin until the 1940s. The spread of drug-resistant pathogens poses a serious problem to treat common infections. Bacterial resistance proceeds inexorably.”.

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Bacteria Development Production Vaccination 144

Drug Discovery World

AUGUST 22, 2023

Claire D’Abreau-Hayling, Chief Scientific Officer at Sandoz, examines how generic products can relieve industry pressure and improve access to essential medicines. Off-patent medicines today account for about 80% of global prescriptions at an estimated 20% of the total cost. What are complex generics?

Production 52

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Advarra

JULY 19, 2022

If the sponsor wants their drug approved, they need to complete all clinical studies and submit an application. Q: Please discuss the transfer of investigational new drug (IND) sponsorship from one sponsor to another and that process. Q: What are the minimum requirements necessary to build a robust quality management system (QMS)?

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The Pharma Data

APRIL 19, 2022

Food and Drug Administration (FDA) has approved commercial production at the company’s new CAR T-cell therapy manufacturing facility in Frederick, Maryland. It must be fast and extremely high quality to give patients the best outcome.”. Kite, a Gilead Company (Nasdaq: GILD), today announced the U.S.

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Cloudbyz

JUNE 10, 2023

Food and Drug Administration (FDA). How to Ensure Compliance Here are some steps to ensure your clinical trial complies with 21 CFR Part 11: 1. 21 CFR Part 11 is a crucial component of regulatory compliance in clinical trials and, more broadly, any industry subject to the regulations of the U.S.

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XTalks

JUNE 8, 2022

A cure for RA has not been discovered, but there are several treatment options available such as medications with prescribed non-steroidal anti-inflammatory agents (NSAIDs), disease modifying anti-rheumatic drugs (DMARDs), corticosteroids and surgical approaches. million Americans. People with RA are usually diagnosed after 60 years of age.

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Drug Discovery World

DECEMBER 14, 2023

With leading academic institutions and significant recent investment, Glasgow is shaping up to be an important centre for drug discovery and development in the UK. DDW’s Diana Spencer explores the city’s unique ecosystem. In addition, Glasgow is an attractive location to the brightest and best scientists from all over the world.

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pharmaphorum

AUGUST 3, 2021

We have gone from making drugs for breast cancer to making drugs that are targeted to just specific types of breast cancer that express certain genetic markers. NICE needs to be able to say a product represents good clinical gain and good value for money, especially in a context where healthcare resources are constrained,” he said.

Medicine 57

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Drug Discovery World

NOVEMBER 24, 2023

 Traditional approaches to research won’t cut it The pursuit of scientific knowledge is not merely an academic endeavour, but a necessary pathway to improving the longevity and quality of human lives.

Research 59

Research Life Science Gene Editing Vaccination 59

XTalks

DECEMBER 20, 2023

These advancements and trends addressed important industry challenges and offered opportunities to foster innovations and solutions in areas including drug development, healthcare and medical devices. The shortages have been partly blamed on the off-label prescribing of the drugs for weight loss.

Life Science 59

Life Science Clinical Trials Clinical Trials FDA Approval 59

pharmaphorum

MAY 26, 2022

Before the full-scale war, pharmacovigilance – detection, assessment, understanding, and prevention of drug-related adverse events – was going well in Ukraine. Every company hired employees or outsourcers whose job was to manually monitor medical literature, searching for any adverse effects of medicinal products. .

Drugs 52

Drugs Production Marketing Medicine 52

pharmaphorum

OCTOBER 12, 2022

Having spent 10 years working in the genomics field, Del Bourgo noticed manufacturers spending extensive resources on drug development without harnessing the transformative power of data. David Del Bourgo (CEO and co-founder, Whitelab Genomics) has always been passionate about introducing disruptive, innovative technologies to markets.

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The Pharma Data

DECEMBER 18, 2020

Action Follows Thorough Evaluation of Available Safety, Effectiveness, and Manufacturing Quality Information by FDA Career Scientists, Input from Independent Experts. SILVER SPRING, Md. , 18, 2020 /PRNewswire/ — Today, the U.S. The emergency use authorization allows the Moderna COVID-19 Vaccine to be distributed in the U.S.

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The Pharma Data

MARCH 16, 2022

using SNAP-tag) involves labeling cell proteins with a fluorescent dye, thereby enabling researchers to observe how proteins interact in the living cell and where in the cell they are located. The Bayer Foundation has presented the Hansen Family Award, complete with its prize money of EUR 75,000, to Professor Kai Johnsson.

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Protein Scientist Gene Development 52

The Pharma Data

NOVEMBER 12, 2021

In addition to fiscal support for the airman program, Pfizer and BioNTech handed specialized backing and know-how specific to the operation and storehouse of the Pfizer-BioNTech COVID-19 Vaccine at-90 °C to-60 °C. This cooperation has paved the way for drone deliveries of all mRNA vaccines.

Vaccination 40

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Pharmaceutical Technology

SEPTEMBER 23, 2022

These companies often have limited in-house resources for product development or scale-up, and so depend on CDMO partnerships to achieve development milestones. Narrower Product Focus Emphasis on Development End-to-End Support and Manufacturing Flexibility Manufactured in the USA Continuous Reinvestment. Narrower product focus.

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FDA Law Blog

AUGUST 17, 2022

While the Proposed Rule was a year and a half overdue, FDA impressively turned out the Final Rule about 7 months after the close of comments on the Proposed Rule, which is only one month after it was due and before Congress could pass a bill chastising FDA for the anticipated delay.

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Licensing Licensing Regulation Marketing 40

The Pharma Data

SEPTEMBER 1, 2020

Point of care testing increases access to high quality diagnostics solutions for the detection of a current SARS-CoV-2 infection, regardless of laboratory testing infrastructure or patient mobility. Food and Drug Administration (FDA). Roche also intends to file for Emergency Use Authorisation (EUA) to the U.S.

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The Pharma Data

MAY 6, 2021

During a conversation between Albert Bourla, Chairman and Chief Executive Officer, Pfizer, and Suga Yoshihide, Prime Minister of Japan, which is the host country of Tokyo 2020, Mr. Bourla made an offer to donate the Pfizer-BioNTech COVID-19 Vaccine for athletes and their delegations participating in Tokyo 2020.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

JUNE 26, 2021

Roche’s Chief Medical Officer and Head of Global Product Development. For more information on how Roche is responding to the global COVID-19 pandemic, please visit our COVID-19 response page. Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. The most common adverse reactions seen (incidence ?

Clinical Trials 40

Clinical Trials Clinical Trials In-Vitro Antibody 40

The Pharma Data

SEPTEMBER 18, 2020

Chief Medical Officer and Head of Global Product Development. This represents an important milestone in a deadly malignancy and is part of our long-term commitment to improve the lives of people with various types and stages of liver disease.”. 0.76; p<0.0001), compared with sorafenib. 0.76; p<0.0001), compared with sorafenib.

Medicine 52

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The Pharma Data

SEPTEMBER 19, 2020

While we have made great progress in the treatment of many forms of breast cancer, TNBC remains an aggressive and difficult-to-treat disease,” said Levi Garraway, M.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We pCR was observed in 57.6% (95% CI: 49.7–65.2) from 41.1% (95% CI: 33.6–48.9)

HR 52

HR Medicine In-Vitro Development 52

The Pharma Data

SEPTEMBER 17, 2020

Food and Drug Administration (FDA). 3 Knowing a given population’s seroprevalence is important in understanding how to contain the spread of the virus, as well as how to safely ease lockdown restrictions. The test targets antibodies against the spike protein. Roche has filed for Emergency Use Authorisation (EUA) from the U.S.

Antibody 52

Antibody Vaccination Vaccine In-Vitro 52

pharmaphorum

JANUARY 6, 2023

From enabling patient choice during clinical trials to strengthening vital partnerships across the quality ecosystem, connected data will become the lifeblood that enables life sciences teams to collaborate efficiently and effectively in 2023. Launching a new drug has always been fraught with risks, and the pandemic raised the stakes.

Life Science 109

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pharmaphorum

FEBRUARY 4, 2021

The UK has a voluntary agreement that was struck by the government and NHS England (now referred to as NHSE&I) with the Association of the British Pharmaceutical Industry (ABPI) in 2018, which governs pricing for branded medicines and offers commitments on access. Enhanced horizon scanning. UK PharmaScan is the tool used.

Medicine 88

Medicine Branding Production Marketing 88

Cloudbyz

JUNE 13, 2023

Monitoring and Quality Assurance: Monitoring and quality assurance activities ensure the integrity and reliability of the trial. Budgets should include costs associated with on-site monitoring visits, data monitoring committees, independent audits, and quality assurance processes. Key Considerations 2.1 Best Practices 3.1

Clinical Trials 68

Clinical Trials Clinical Trials Trials Marketing 68

Pharmaceutical Technology

JUNE 26, 2022

Drug substance plays a key part in ensuring a drug program achieves its major milestones, keeps to budget and delivers on its corporate goals. To increase the likelihood of clinical success, drug developers must identify challenges and potential red flags early on in the candidate selection stage.

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pharmaphorum

JANUARY 12, 2021

Whilst regulatory approval is only a starting step on market access, the UK has made steps to put the UK on the priority list for companies seeking marketing authorisation. It’ll also reveal just what the Target Development Profile (TDP) living document will cover and how it can evolve over time. The promise of faster market access .

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Marketing Medicine Branding Production 67

Drug Discovery World

JUNE 14, 2023

In acknowledgement of Blood Donor Day 2023, DDW spoke with industry experts about the significance of blood donorship in drug discovery. Either way, the BCA Advanced Therapies Network is engaged with therapeutic developers, hospitals, patients and donors to ensure these life-saving products are available to patients in our communities.

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Manufacturing Production Gene Therapy Development 52

XTalks

AUGUST 2, 2023

Whether you’re an industry enthusiast or simply intrigued by the remarkable strides made in modern medicine, this article promises to be an insightful and inspiring guide to the leading pharma and biotech companies at the forefront of innovation and human welfare. 2022 Revenue: Pfizer reported an annual revenue of $100.33 billion, a 42.74

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FDA Law Blog

JUNE 14, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — “Total Product Life Cycle Advisory Program or TAP pilot — the most exciting thing in MDUFA V. Given Dr. Shuren’s propensity to use the phrase, we have yet to see it formally defined by CDRH.

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The Pharma Data

MARCH 15, 2021

A critical component of our medicinal product development is clinical research. This involves conducting clinical trials in humans to evaluate the safety and efficacy of new pharmaceutical products. We are committed to Good Clinical Practice. Within each of our therapeutic areas, we have various products in development.

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Clinical Trials Clinical Trials Trials Medicine 40

pharmaphorum

JULY 15, 2021

The topic rose to significance in the American Society of Clinical Oncology (ASCO) whereby they updated their mission statement in 2020 to “Conquering cancer through research, education, and promotion of the highest quality, equitable patient care.” CREATION.co’s Mary Kangley explores what HCPs think about health equity in cancer care.

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Clinical Trials Clinical Trials Trials Production 113