European Pharmaceutical Review

OCTOBER 25, 2022

The US Food and Drug Administration’s (FDA) approval took data from the HIMALAYA Phase III trial into consideration. The safety profiles for both Imjudo added to Imfinzi and for Imfinzi on its own were consistent with previous data for the medications. No new safety precautions were identified.

Food and Drug Administration 98

Food and Drug Administration Patients Safety Physicians 98

Clarivate

OCTOBER 10, 2022

Clarivate oncology experts share key takeaways from the 2022 ESMO Congress and their expected impact on the drug treatment landscape and patients. Read on to for insights from our analysts on: Global highlights from ESMO 2022. Key ESMO 2022 highlights from Mainland China. Seven global highlights from ESMO 2022.

Marketing 52

Marketing Safety Patients Competition 52

European Pharmaceutical Review

APRIL 10, 2024

Over the past decade, there has been an increase in discussions involving industry stakeholders, regulatory agencies, and physicians about developments in the emerging microbiome therapeutics industry. During the development of clinical trials that use faecal-derived material, the necessity of safety is paramount.

Safety 85

Safety Patients Medical FDA 85

European Pharmaceutical Review

DECEMBER 6, 2023

The US Food and Drug Administration (FDA) has approved the first oral monotherapy treatment for adults with paroxysmal nocturnal haemoglobinuria (PNH). Over one-third of those patients require blood transfusions at least once per year, according to research published in a 2017 paper in Blood and a 2022 paper in Annals of Hematology.

Food and Drug Administration 85

Food and Drug Administration Patients Physicians Food 85

Pharmaceutical Technology

DECEMBER 5, 2022

Notably, Lupkynis is the first oral therapy approved by the US Food and Drug Administration (FDA) and EC for the treatment of active LN. However, the lack of in-person administration by physicians will likely also impact patient compliance. Additionally, Benlysta recently showed that efficacy in LN was maintained beyond two years.

Food and Drug Administration 59

Food and Drug Administration Physicians Competition FDA 59

PM360

APRIL 7, 2023

Med Device Department: Medicare Sets Precedent for Virtual Reality Therapeutic Payments In November 2021, the FDA approved a virtual reality (VR) therapy that provides an immersive experience for relieving chronic lower back pain. CMS factored in the efficacy of the device as well as its safety beyond the use of opioids. In the U.S.,

Healthcare 52

Healthcare Healthcare Insurance Physicians 52

PM360

OCTOBER 13, 2023

Of the eight FDA-approved weight loss drugs on the market, these two are making waves for doctors who believe they represent “a new era for weight loss medications,” and “changing options and giving hope.” “They are effective but too expensive for the majority of patients, even with insurance coverage,” said one primary care physician (PCP).

Healthcare 59

Healthcare Healthcare Doctors Pharma 59

Nixon Gwilt Law

NOVEMBER 5, 2021

Overview The Centers for Medicare and Medicaid Services (CMS) issued its Omnibus COVID-19 Health Care Staff Vaccination Interim Final Rule (IFR) on November 4, 2021, the same day the Department of Labor’s Occupational Safety and Health Administration (OSHA) issued its COVID-19 Vaccination and Testing Emergency Temporary Standard (ETS).

Healthcare 52

Healthcare Healthcare Training Safety 52

pharmaphorum

DECEMBER 14, 2022

Sodium oxybate — which in the late 1980s was marketed to bodybuilders and then became known as GHB and criminally used as a date rape drug — has been sold under the brand name Xyrem after gaining FDA approval in 2002. In 2020, the FDA-approved indication was expanded to include those patients who suffer from cataplexy.

Competition 103

Competition FDA Pharmaceutical Marketing 103

Pharma Marketing Network

MARCH 25, 2022

Members of a multidisciplinary care team may include physicians, nurses, pharmacists, radiologists, dieticians…the list goes on. The FDA has studied the importance of caregivers to drug development and regulatory decision-making. Accessed March 21, 2022. Accessed March 12, 2022. Accessed March 15, 2022.

Pharma 98

Pharma Education Transportation Training 98

pharmaphorum

DECEMBER 22, 2022

Prediction 1: the FDA will become more directive and collaborative on guidelines for DCTs. The risk of not having these discussions is to conduct expensive trials only to discover too late that they were measuring the wrong endpoint, in the wrong way, or with a tool or technology the FDA does not accept.

FDA 92

FDA Patients Electronics Medical 92

Pharmaceutical Technology

JANUARY 23, 2023

In recent years, with the advent of biologics and novel therapeutic targets such as anti-TNF, anti-interleukin, and anti-integrin, there has been a steady increase in the number of agents approved to treat inflammatory bowel diseases (IBD), which has provided physicians with an increasing number of options to treat Crohn’s disease (CD).

Medical 59

Medical Ethics Specialization Physicians 59

Legacy MEDSearch

JULY 21, 2023

“We are addressing the observations by so many physicians that there is a vast unmet need for a better way to definitively treat this female population.” This first-in-female procedure was approved by the National Agency for the Safety of Medicines and Health Products (or ANSM, the French equivalent to the U.S.

Food and Drug Administration 52

Food and Drug Administration Patients Safety Recruitment 52

European Pharmaceutical Review

JULY 13, 2023

In many European countries physicians can now prescribe medical cannabis for an array of chronic health conditions, including chronic pain, mental health disorders and neurological conditions. 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 86

Medical Food and Drug Administration Pharmacology Medicine 86

Pharmaceutical Technology

AUGUST 8, 2022

In 2017, the US Food and Drug Administration (FDA) broke ground by approving the first drug with an embedded biosensor to track its use. Yet, despite the landmark FDA approval, digital pills have not exploded in pharma. Proteus Health’s Abilify MyCite had an ingestible sensor that could track if a patient consumed the drug.

Food and Drug Administration 122

Food and Drug Administration FDA Medicine Patients 122

Pharmaceutical Technology

JANUARY 10, 2023

The erosion of Januvia is due to patent expiry in that had been expected in 2022 and physicians’ preference for sodium-glucose linked transporter-2 inhibitor (SGLT-2I) therapies such as Farxiga (dapagliflozin) and Jardiance (empagliflozin) due to their ability to improve glycemic control and address cardiorenal comorbidities.

Marketing 52

Marketing Physicians Leads Sales 52

pharmaphorum

SEPTEMBER 16, 2022

Findings presented at EADVC 2022. The week 16 data of lebrikizumab […] points towards a drug with robust efficacy with hardly any safety trade-offs. The FDA granted lebrikizumab Fast Track designation in December 2019. He explained just how promising the recent trial’s maintenance data compared to short-term data results are.

Management 85

Management Side effects Patients Safety 85

Medgadget

MARCH 2, 2023

In 2022 the company went public on the NASDAQ and raised about $100 million more. To make implantation of the Alpha DaRT sources easy and precise, the company developed dedicated applicators andadapted existing biopsy devices, that physicians are already acquainted with, to deliver the radioactive sources.

Manufacturing 83

Manufacturing Leads Patients Medicine 83

European Pharmaceutical Review

DECEMBER 27, 2023

4 Manufacturing of CAR T-cell therapies: an overview In addition, multi-disciplinary teams must be established for in-house CAR T-cell therapy programmes to ensure maximum success and safety. FDA; 2022 [cited 2023 Mar]. Overview of approved car‐t therapies, ongoing clinical trials, and its impact on clinical practice.

Manufacturing 85

Manufacturing Food and Drug Administration Patients Pharma 85

Legacy MEDSearch

AUGUST 11, 2022

OSSIOfiber Suture Anchors were FDA cleared in March 2022 for use in “fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow” in a variety of specific orthopedic procedures. This is another big step for OSSIOfiber in becoming a new material standard in orthopedic fixation.”. About OSSIO.

Recruitment 52

Recruitment Marketing Safety Medicine 52

PM360

AUGUST 9, 2022

Levrx also engages physician groups and members directly, giving healthcare consumers the information needed at the point of care to keep costs low, avoid prescription rewrites, and prevent cost-related non-adherence. andrew.mills@caretrack.com CareTrack Health is a fully integrated physician practice extension. CareTrack Health.

Prescription 105

Prescription Medical Side effects Patients 105