2006, Healthcare and Safety - Pharma Rep Focus

Drug pricing increases are disgraceful

World of DTC Marketing

DECEMBER 10, 2020

In November 2017, a study published in JAMA Internal Medicine examined the costs of developing 10 cancer drugs approved by the FDA from 2006 to 2015 and provided a strong contrast to the Tufts study from a year before. After all, 90 percent of all drugs that enter human testing fail.

Insurance

Insurance Pharma Manufacturing Retail

RFID: The future of smart labelling?

Pharmaceutical Technology

MARCH 22, 2023

Pfizer was the first to use the tech, adding RFID tags to track a Viagra (sildenafil) shipment circa 2006. Various uses soon became apparent including those for supply chain management, anti-counterfeiting, and to improve patient safety. In 2020, Fresenius Kabi introduced their first RFID-enabled medication, Diprivan +RFID.

Food and Drug Administration

Food and Drug Administration Electronics Pharma Pharmaceutical products

Gene therapy: a radical pharmaceutical revolution

European Pharmaceutical Review

SEPTEMBER 21, 2023

Considerable progress has been made in other areas including enhancing safety, improving treatment administration and patient monitoring systems and implementing innovative pricing strategies – all with the goal of providing timely access to eligible patients who can benefit from these treatments. 1995; 270(5235): 475-480. cited 2023August].

Pharmaceutical

Pharmaceutical Food and Drug Administration Medicine Patients

The Evolution of Biosimilars from Their Beginning Until Now—And What’s Next

PM360

SEPTEMBER 28, 2022

Chrys Kokino has been involved in the biosimilars market prior to the first biosimilar being approved in Europe in 2006. The entire premise was that because biosimilars were so new, and there was not a lot of information on the safety and efficacy of those products, customers should be a bit leery prior to jumping on the biosimilar bandwagon.

Competition

Competition Marketing Manufacturing Biopharma

Interchangeability of biosimilars in the EU – the industry impact

European Pharmaceutical Review

DECEMBER 19, 2022

3 Under this pathway, comparability studies are required to substantiate the similar nature, in terms of safety and efficacy, of the biosimilar and the reference product. Chris was named a ‘Rising Star’ in the 2022 Legal 500 Rankings for Life Sciences and Healthcare. References/Endnotes. Biosimilars in the EU.

Medicine

Medicine Biopharma Safety Food

Sweeping changes in leaked EU pharma law draft reignite profit vs access conflict

Pharmaceutical Technology

FEBRUARY 24, 2023

The products that are authorised in EU are largely the same as other regions,” argued European Commission Directorate-General for Health and Food Safety Florian Schmidt, during the same online event. But others do not accept that the EU is less competitive for the pharma industry than North America and Asia. You can compare timelines.

Pharma

Pharma Medicine Competition Marketing

Bringing the patient voice into clinical trials with clinical outcome assessments

Clarivate

NOVEMBER 10, 2022

The purpose of clinical trials is to understand the efficacy and safety of treatments for the patients who need them. In this article, we share how a sponsor partnered with Clarivate to incorporate COAs into clinical trials for alopecia areata. The regulatory landscape around COAs is fast evolving.

Patients

Patients Food and Drug Administration FDA Safety

How clinical outcome assessments can help us understand the patient experience

Clarivate

NOVEMBER 13, 2023

The purpose of clinical trials is to understand the efficacy and safety of treatments for the patients who need them. Last year alone the Clarivate COA team conducted over 300 interviews with patients, caregivers or healthcare professionals. The PFDD series will eventually take the place of the PRO Guidance for Industry.

Patients

Patients Food and Drug Administration FDA Safety

Five potential EU regulatory changes impacting the life sciences industry in 2023

European Pharmaceutical Review

FEBRUARY 7, 2023

In addition, the devices must not present an unacceptable risk to patient and user health and safety as established in Articles 94 and 95 of the MDR. Edward Turtle is a products lawyer, regulatory advisor and litigator with particular experience in the healthcare, technology and consumer product sectors.

Medical

Medical Government Marketing Medicine

Comparison of Humira biosimilars in the US and Europe

Pharmaceutical Technology

MARCH 24, 2023

Currently, 40 biosimilars are FDA-approved and 25 have launched, whereas the EMA has approved 86 biosimilars since 2006. Further, there remains scepticism on the efficacy and safety of biosimilars. The US biosimilars market is notably underdeveloped and biosimilar entry in the US has been difficult, consistently lagging behind Europe.

Competition

Competition Marketing FDA Physicians

Japan’s M&A Boom

Pharmaceutical Technology

OCTOBER 5, 2008

According to market intelligence provider Pharmaceutical Insights, Japan’s $6m generic drug sector is currently experiencing a renaissance, primarily because the government wants to control healthcare costs. Like in many other sectors, China and India are the ones labelled as those which will lead the expansion.

Government

Government Marketing Pharmaceutical Physicians

Synthesis-to-Clinic®: integrating isotopic labeling and human ADME to reduce time to clinic

Pharmaceutical Technology

NOVEMBER 24, 2022

At Quotient Sciences, our state-of-the-art facilities follow cGMP guidelines for the production of 14 C-labeled pharmaceuticals for human investigations and are accredited by the UK Medicines and Healthcare products Regulatory Agency (MHRA). How does your unique Synthesis-to-Clinic® offering streamline the drug development process?

Manufacturing

Manufacturing Pharmaceutical Specialization Medicine

Securing every dose with an edible security technology for safe medicines

European Pharmaceutical Review

AUGUST 23, 2022

FAKE MEDICINES are not a new problem, and pose a tremendous threat to patient safety and public health in society regardless of a country’s economic status. We hope that this article serves draws attention from the community and makes funding agencies aware of this imperative healthcare sustainability problem. About the author.

Medicine

Medicine Food and Drug Administration Pharmaceutical products Pharmaceutical

How can the pharma industry address the gap in talent recruitment and development?

pharmaphorum

AUGUST 4, 2022

AR has developed enormously over the last few years, meaning that highly visual step-by-step guidance and training procedures can be delivered to employees to ensure they follow safety protocols without being exposed to actual real-life risks in the manufacturing facility. Raising the profile. She joined NSF in 2017. appeared first on.

Recruitment

Recruitment Training Pharma Pharmaceutical manufacturing

Pharma Rep Focus

Drug pricing increases are disgraceful

RFID: The future of smart labelling?

Trending Sources

Gene therapy: a radical pharmaceutical revolution

The Evolution of Biosimilars from Their Beginning Until Now—And What’s Next

Interchangeability of biosimilars in the EU – the industry impact

Sweeping changes in leaked EU pharma law draft reignite profit vs access conflict

Bringing the patient voice into clinical trials with clinical outcome assessments

How clinical outcome assessments can help us understand the patient experience

Five potential EU regulatory changes impacting the life sciences industry in 2023

Comparison of Humira biosimilars in the US and Europe

Japan’s M&A Boom

Synthesis-to-Clinic®: integrating isotopic labeling and human ADME to reduce time to clinic

Securing every dose with an edible security technology for safe medicines

How can the pharma industry address the gap in talent recruitment and development?

Stay Connected