European Pharmaceutical Review

NOVEMBER 15, 2022

As ISPE GAMP 5 Second Edition notes in the preface “Operating in a highly regulated industry may lead practitioners to apply prescriptive and rigid compliance-based approaches that are not commensurate with and not effective in managing any actual risk to the product and the patient.” Takeaways from ISPE’s GAMP 5 Second Edition update.

Manufacturing 98

Manufacturing Pharma Food and Drug Administration Safety 98

Clarivate

MARCH 17, 2022

How feasible is it to establish a drug’s safety for use in a population that may be unwilling or unable to participate in clinical trials? The health of pregnant people and their fetuses can be compromised if the dose/dosing regimen, safety, and efficacy of treatments used during pregnancy are not established.

Food and Drug Administration 10

Food and Drug Administration Safety FDA Ethics 10

pharmaphorum

AUGUST 17, 2022

GSK – which originally developed the drug in the early 1980s and sold it as a prescription and over-the-counter (OTC) product for indications like heartburn and acid indigestion – has been named as a defendant in approximately 3,000 filed personal injury cases in federal and state court. .”

Sales 52

Sales Prescription Manufacturing FDA 52

Clarivate

OCTOBER 25, 2023

of fee-for-service beneficiaries having a type 2 diabetes diagnosis in 2019 , it is among the most widespread chronic conditions in the over-65 population. While more expensive than type 2 diabetes drugs, blood thinners follow a similar pattern of high prescription volumes. With 27.5%

Prescription 52

Prescription Physicians Manufacturing Healthcare 52

Pharmaceutical Representative Training

JANUARY 29, 2025

These high prices are the result of multiple factors: theyre derived from living organisms making them sensitive and complex for both manufacturers and patients, research requires advanced technology to test for safety and effectiveness, and theyre in high demand without much competition. Starting in 2019, the US market was valued at $4.5

Marketing 52

Marketing Healthcare Healthcare Physicians 52

Clarivate

MAY 11, 2023

Mainland China has streamlined regulatory protocols for testing and approving prescription drugs in recent years, making dozens of urgently needed treatments, from domestic and international manufacturers alike, available to patients in the process. 4] Second list of overseas new drugs urgently needed in clinical practice , May 2019. [5]

Marketing 52

Marketing Patients Management Prescription 52

Medico Reach

JUNE 20, 2024

Cutera has evolved into a global leader in dermatology and aesthetics devices that fascinate forward-thinkers pursuing the next generation of performance, safety and effectiveness. Peachy Peachy runs Botox studios that deliver sunscreen products, prescription retinoids and wrinkle treatments.

Medical 52

Medical Physicians Engineering Marketing 52

European Pharmaceutical Review

JANUARY 13, 2025

At Chiesi, we are conducting the same rigour in terms of safety and bioavailability studies as we would for a new molecule, navigating regulatory and reimbursement discussions, and having to build entirely new manufacturing sites and capabilities. He has previously held positions at GSK and Sanofi. Pulmonary Pharmacology & Therapeutics.

Medicine 52

Medicine Pharmaceutical Manufacturing Government 52

Pharmaceutical Technology

APRIL 21, 2023

The US Food and Drug Administration (FDA) has pushed quizartinib’s Prescription Drug User Fee Act (PDUFA) date in newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML) for the review of updates of Risk Evaluation and Mitigation Strategies (REMS) included in the application. Quizartinib had a 11.3%

Food and Drug Administration 98

Food and Drug Administration FDA Safety Prescription 98

PM360

DECEMBER 14, 2022

From hair loss to allergies and acne, Amazon Clinic allows patients to message clinicians for a diagnosis, treatment, and medication prescription. billion in 2019. Offering a so-called “healthcare store” experience, Amazon Clinic will be accessible by customers in 32 states, 24/7, via Amazon.com or the mobile app.

Medical 52

Medical Manufacturing Healthcare Healthcare 52

Pharmaceutical Technology

OCTOBER 10, 2022

In 2019, the agency authorized the use of Vyleesi, an injectable form of bremelanotide, for the same condition. Despite the recognized need and demand for options to treat female sexual dysfunction, several safety and access issues associated with the use of available options. There are no approved treatments in the EU.

Pharmacology 59

Pharmacology Side effects FDA Safety 59

Pharmaceutical Technology

NOVEMBER 4, 2022

According to GlobalData’s Social Media Analytics, supply chains were mentioned on Reddit and Twitter 1,908 times in 2019. For example, digital twins of pharmaceutical supply chains can predict bottlenecks and give suggestions for how to respond using prescriptive AI. As such, few people were focused on them. The tech solution.

Biopharma 52

Biopharma Manufacturing Media Pharmaceutical 52

World of DTC Marketing

SEPTEMBER 28, 2021

According to STAT News, “groups representing the largest businesses in the country, including Walmart, Tesla, Apple, Microsoft, IBM, Boeing, and The Walt Disney Company, have demanded wide-reaching reforms to help lower the cost of prescription drugs” Costs on just about all products are rising, and consumers are taking notice.

Pharma 37

Pharma Prescription Healthcare Healthcare 37

PM360

DECEMBER 20, 2023

Medicines that are not listed in either Category 1 or 2, such as over the counter (OTC) and other prescription therapies (pembrolizumab, CAR-T therapy, etc.), All provinces must follow the NRDL for drug reimbursement since 2019 without the opportunity of adding extra drugs to the reimbursement list.

Marketing 105

Marketing Insurance Medical Manufacturing 105