European Pharmaceutical Review

OCTOBER 25, 2023

The document by the Medicines and Healthcare products Regulatory Agency (MHRA), US Food and Drug Administration (FDA) and Health Canada, contains key guidance on predetermined change control plans (PCCPs) for MLMDs. The device may be reassessed to ensure the performance and safety of the device is negatively impacted.

Medical 88

Medical Food and Drug Administration Manufacturing Safety 88

World of DTC Marketing

APRIL 12, 2021

QUICK READ: Pharma supply chain issues are a concern for us all but especially patients. Patients should be scared. We need a 21st-century approach that puts patient safety first. The adulterated product was found to have caused nine patient deaths and 574 serious adverse events (SAEs).

Food and Drug Administration 187

Food and Drug Administration Prescription Pharma Manufacturing 187

Clarivate

NOVEMBER 10, 2022

Clinical outcome assessments can take years to generate but may pay big dividends in patient-focused drug development, centering the patient experience and potentially bolstering a product’s case with regulators and payers. Patient focused drug development in alopecia areata clinical trials.

Patients 52

Patients Food and Drug Administration FDA Safety 52

European Pharmaceutical Review

DECEMBER 8, 2023

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has authorised diabetes medicine, Mounjaro (tirzepatide), for weight loss and weight management in adults aged 18 and over. Tirzepatide works by regulating a patient’s appetite, making them feel less hungry and experience fewer food cravings. “We

Management 82

Management Medicine Food Healthcare 82

Legacy MEDSearch

SEPTEMBER 18, 2023

Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) supplement to permit the expansion of the study of the eShunt System in patients with Normal Pressure Hydrocephalus (NPH) to additional study participants and clinical sites. Located in Massachusetts’ healthcare hub, CereVasc, Inc.,

Food and Drug Administration 52

Food and Drug Administration FDA Patients Recruitment 52

LEVO Health

OCTOBER 26, 2022

With seemingly countless treatment options on the table, how can your device cut through the clutter and get in front of the right patients at just the right time? You need to be a trusted partner for both patients and their providers alike. . Food & Drug Administration (FDA) classifies medical devices.

Medical 52

Medical Marketing Patients Food and Drug Administration 52

European Pharmaceutical Review

AUGUST 11, 2023

Crizanlizumab is a once-a-month, humanised monoclonal antibody infusion, indicated for the prevention of recurrent vaso‑occlusive crises (pain crises) in sickle cell disease patients aged 16 years and above. However, the STAND results did not suggest new safety concerns with crizanlizumab.

Marketing 81

Marketing Food and Drug Administration Medicine FDA 81

pharmaphorum

DECEMBER 19, 2022

The US Food and Drug Administration (FDA) has approved Swiss drugmaker Ferring Pharmaceuticals’ Adstiladrin (nadofaragene firedenovec-vncg) for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumours.

FDA 111

FDA Food and Drug Administration Patients Food 111

Pharmaceutical Technology

AUGUST 19, 2022

The European Commission (EC) has granted approval for Celltrion Healthcare ’s Vegzelma (CT-P16) to treat metastatic breast cancer, advanced and/or metastatic renal cell cancer, non-small cell lung cancer, ovarian cancer, metastatic carcinoma of the colon or rectum and cervical cancer.

Food and Drug Administration 52

Food and Drug Administration Safety Medicine Food 52

Pharma Marketing Network

JULY 26, 2023

The Food and Drug Administration (FDA) plays a critical role in regulating the pharmaceutical industry and ensuring that medications and medical devices marketed to the public are safe, effective, and appropriately labeled. The post Why Is FDA Issuing Fewer Marketing Violation Letters? appeared first on Pharma Marketing Network.

Marketing 97

Marketing FDA Food and Drug Administration Pharmaceutical 97

European Pharmaceutical Review

JULY 25, 2022

The European Commission (EC) has issued a draft proposal for a new EU Regulation on blood, tissues and cells (BTC) to help increase the safety and quality of substances of human origin (SoHO). The EC noted that the EDQM’s standards “will now become the primary means to meet the EU standards of quality and safety for BTC.”.

Safety 102

Safety Consulting Healthcare Healthcare 102

Pharmaceutical Technology

APRIL 20, 2023

The US Food and Drug Administration (FDA) has approved Roche ’s Polivy (polatuzumab vedotin-piiq), along with Rituxan (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP), to treat certain types of previously untreated diffuse large B-cell lymphoma (DLBCL) in adult patients.

Food and Drug Administration 52

Food and Drug Administration FDA Food Safety 52

Pharmaceutical Technology

JULY 28, 2022

Cobitolimod, an agent being developed for patients with moderate to severely active UC, has both a novel MOA and a route of administration that is unique among marketed agents. Obefazimod also demonstrated efficacy in patients who had previously been exposed to biologics or JAK inhibitors.

Food and Drug Administration 98

Food and Drug Administration Safety Side effects Marketing 98

European Pharmaceutical Review

DECEMBER 21, 2022

Despite the tidal wave of renewed interest in psychedelic therapies, there is still much to be learned about them, including their precise mechanisms of action, their long- and short-term safety profiles, the durability of their effect, and their adverse effects—which can be severe. Authorisation under exceptional circumstances.

Food and Drug Administration 105

Food and Drug Administration Medicine Food Government 105

Pharmaceutical Technology

DECEMBER 7, 2022

On 29 November, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) warned of some new and potentially serious eye-related side effects associated with Dupixent, an interleukin (IL)-4/13 inhibitor drug used in the treatment of numerous allergic indications such as atopic dermatitis, asthma and nasal polyps.

Side effects 64

Side effects Food and Drug Administration Safety Physicians 64

Clarivate

MAY 24, 2022

Recent policy and regulatory moves have begun to sketch out a framework for rare disease drug approvals in the country, but obstacles to approvals and patient access remain. Mainland China has taken significant steps toward improving access to treatment for its estimated 20 million rare disease patients in recent years. [1]

Patients 52

Patients Food and Drug Administration Marketing Pharma 52

European Pharmaceutical Review

SEPTEMBER 2, 2022

To ensure the safety of medicines post-regulatory approval, a risk management plan (RMP) is established. As does the US Food and Drug Administration (FDA): REMS Assessment: Planning and Reporting Guidance for Industry Draft Guidance. What are risk minimisation methods?

Food and Drug Administration 72

Food and Drug Administration Medicine Safety Food 72

European Pharmaceutical Review

MARCH 4, 2024

Indeed, in 2022, biologics constituted 40 percent of all US Food and Drug Administration (FDA) approved drugs, projecting a compound annual growth rate (CAGR) of 9.5 Advancement of these oral medical devices is still in its infancy and further investigation is needed to ensure their effectiveness and safety in use for humans.

Food and Drug Administration 86

Food and Drug Administration Transportation FDA Medical 86

Clarivate

MARCH 14, 2024

Over the past few years nitrosamines and nitrosamine impurities have been increasingly gaining the reputation of being high-risk containments in the food industry. The food sector has already initiated the publication of preliminary regulations aimed at restricting PFAS in packaging. [3].

Pharmaceutical 52

Pharmaceutical Manufacturing Food Healthcare Provider 52

Pharmaceutical Technology

SEPTEMBER 15, 2022

It is being evaluated for treating hospitalised adult Covid-19 patients with moderate to severe disease who are at increased risk of acute respiratory distress syndrome (ARDS) and mortality. . Due to clear clinical efficacy without any safety concerns, the Independent Data Monitoring Committee stopped the trial.

Food and Drug Administration 52

Food and Drug Administration Food Pharma Safety 52

Pharmaceutical Technology

DECEMBER 5, 2022

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has also since granted the Great Britain marketing authorisation of Lupkynis to treat adults with active LN. Notably, Lupkynis is the first oral therapy approved by the US Food and Drug Administration (FDA) and EC for the treatment of active LN.

Food and Drug Administration 59

Food and Drug Administration Physicians Competition FDA 59

Pharmaceutical Technology

FEBRUARY 7, 2023

The US Food and Drug Administration (FDA) has accepted Sandoz’s biologics license application (BLA) for its proposed biosimilar denosumab. Denosumab will be used to treat several conditions, including osteoporosis in postmenopausal women and in men with high fractures risk, treatment-induced bone loss.

Food and Drug Administration 52

Food and Drug Administration FDA Medicine Food 52

Pharma Marketing Network

AUGUST 9, 2023

It’s crucial for marketing teams to stay informed about the latest guidelines, policies, and updates from regulatory bodies such as the Food and Drug Administration (FDA) in the United States or the European Medicines Agency (EMA) in the European Union.

Marketing 52

Marketing Pharma Food and Drug Administration Media 52

PM360

AUGUST 9, 2022

The industry has been limited in its ability to implement creative solutions to engage and motivate patients because the FDA has strict guidelines for what pharma companies can communicate with patients. Today, we still can’t easily discern whether a patient took their pill or not and the reason why. Michael Oleksiw.

Medical 105

Medical Electronics Patients Healthcare 105

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. For this reason, a unique ‘abridged’ procedure was introduced to provide a specific regulatory pathway for biosimilars in the EU.

Medicine 52

Medicine Biopharma Safety Food 52

Legacy MEDSearch

AUGUST 23, 2023

Food and Drug Administration (FDA) Circulatory Systems Devices Panel of the Medical Devices Advisory Committee met to discuss the pre-market approval application (PMA) for the Paradise Ultrasound Renal Denervation (RDN) system, indicated to reduce blood pressure in patients with hypertension. Otsuka Medical Devices Co.,

Medical 52

Medical Food and Drug Administration FDA Recruitment 52

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. The US Food and Drug Administration (FDA) further estimates that 97 percent of online pharmacies are operating illegally. About the author.

Medicine 88

Medicine Food and Drug Administration Pharmaceutical products Pharmaceutical 88

pharmaphorum

AUGUST 11, 2022

The system did not only spend money and resources trying to address issues caused by those treatments, but patients also wasted time looking for answers; precious time that could have been spent receiving proper and effective treatment. billion in the United States alone.

Side effects 88

Side effects Medical Prescription Patients 88

Pharmaceutical Technology

FEBRUARY 24, 2023

The overhaul will address drug marketing exclusivity length, pricing, patient access, innovation incentives, antimicrobial resistance, clinical trials, supply chain security and shortages, and environmental impact. The EU is planning a sweeping revision of its pharma legislation in March, the largest change in 20 years.

Pharma 64

Pharma Medicine Competition Food 64

Pharma Marketing Network

AUGUST 9, 2023

It’s crucial for marketing teams to stay informed about the latest guidelines, policies, and updates from regulatory bodies such as the Food and Drug Administration (FDA) in the United States or the European Medicines Agency (EMA) in the European Union.

Marketing 40

Marketing Pharma Food and Drug Administration Media 40

Legacy MEDSearch

JUNE 19, 2023

The US Food and Drug Administration has approved the use of iTFlow® in blood flow analysis. The FDA approval is significant as it recognizes the safety and effectiveness of iTFlow® in analyzing blood flow through 4D Flow MRI data, with the potential to enhance diagnostic accuracy for patients with cardiovascular diseases and heart conditions.

FDA 52

FDA Food and Drug Administration Recruitment Physicians 52

Legacy MEDSearch

AUGUST 29, 2022

Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) application to initiate a pilot trial of the eShunt ® System in patients who develop communicating hydrocephalus post aneurysmal subarachnoid hemorrhage (paSAH). . Located in Massachusetts’ healthcare hub, CereVasc, Inc.,

FDA 52

FDA Food and Drug Administration Recruitment Physicians 52

Pharmaceutical Technology

JUNE 15, 2023

But before pharmaceutical companies can go to market with a breakthrough drug, they need to ensure safety and efficacy through clinical trials. Food and Drug Administration approval. Pharma companies need tools like AI that can reliably improve this percentage without jeopardizing safety.

Food and Drug Administration 52

Food and Drug Administration Side effects Recruitment Safety 52

European Pharmaceutical Review

JULY 13, 2023

1,2 Moreover, except for countries such as Czechia, Denmark and Germany, the cost of these medications is borne by the patient, rather than national insurance or healthcare systems. It is estimated that only one in 10 drugs that enter Phase I trials are subsequently licensed by the US Food and Drug Administration (FDA).

Medical 82

Medical Food and Drug Administration Pharmacology Medicine 82

Nixon Gwilt Law

SEPTEMBER 7, 2023

However, as with any emerging area of healthcare innovation, new legal and regulatory considerations arise that must be thoughtfully addressed. Beyond approval, be prepared for a higher bar in terms of safety data, clinical endpoints accepted, trial size and duration, and supplemental post-market surveillance requirements.

Food and Drug Administration 52

Food and Drug Administration Education Insurance Healthcare 52

Evolve Your Success

MAY 17, 2022

Antra and Karen started a company and have a podcast where they speak about patient advocacy, impacting how nurses receive an education. Private Patient Advocacy: The Medical Sales Rep’s Role In The Nursing World With Antra Boyd And Karen DiMarco, Part 2. The influence we have is better patient outcomes.

Medical sales 52

Medical sales Medical Sales Patients 52

pharmaphorum

NOVEMBER 9, 2022

The present moment within and without healthcare, biotech, and pharma is a difficult and pivotal time in history, a time in which such issues need must be addressed. The keynote address of the event entire came from Stella Kyriakides, commissioner for health and food safety at the European Commission. Her opener?

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Insurance Patients Healthcare Healthcare 90