Pharmaceutical Technology

MAY 16, 2023

UniQure is selling a part of its royalty rights to the haemophilia B gene therapy Hemgenix (etranacogene dezaparvovec) to HealthCare Royalty and Sagard Healthcare for a gross purchase price of up to $400 million dollars. HealthCare Royalty is a royalty acquisition company. HealthCare Royalty is a royalty acquisition company.

Food and Drug Administration 52

Food and Drug Administration Healthcare Healthcare Sales 52

Pharmaceutical Technology

APRIL 13, 2023

Following the increased use of telemedicine during the Covid-19 pandemic, the potential of digital technologies in communication, data collection, and analysis has become increasingly realised by patients, healthcare systems, and clinical trial sponsors.

Food and Drug Administration 52

Food and Drug Administration Electronics Healthcare Healthcare 52

Pharmaceutical Technology

JULY 14, 2022

This analysis covers late April to May and is based on a list of CMOs impacted by regulatory decisions by the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and reimbursement authorities like the UK’s National Institute of Health and Care Excellence (NICE). Consequential FDA and EMA decisions.

Manufacturing 52

Manufacturing Food and Drug Administration FDA Pharma 52

Pharmaceutical Technology

JULY 29, 2022

This data has been shared with regulators, including the US Food and Drug Administration (FDA), and a request for US Emergency Use Authorisation (EUA) is planned. Mikael Dolsten, Pfizer’s chief scientific officer, told Goldman Sachs’ 43rd Annual Global Healthcare Conference on 15 June: “The upgraded vaccine is about two weeks from now.

Manufacturing 52

Manufacturing Food and Drug Administration FDA Marketing 52

Pharmaceutical Technology

JUNE 21, 2023

In the past year, Hemgenix has been granted approval by the US Food and Drug Administration (FDA) and has received conditional marketing authorisation from the European Commission (EC) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). GlobalData is the parent company of Pharmaceutical Technology.

Patients 98

Patients Food and Drug Administration Engineering Sales 98

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. There’s no dearth of interest, however, in applying digital solutions to healthcare.

Food and Drug Administration 122

Food and Drug Administration FDA Medicine Patients 122

Pharmaceutical Technology

NOVEMBER 15, 2022

Paxlovid first hit the shelves in the US last December after the Food and Drug Administration (FDA) granted the treatment an emergency use authorisation (EUA). A relapse of symptoms following a period of improvement after treatment with Paxlovid has been described in several papers over the last few months.

Food and Drug Administration 64

Food and Drug Administration Government Distribution FDA 64

Pharmaceutical Technology

MAY 24, 2023

Innoviva has snagged a win for its bacterial pneumonia drug Xacduro (durlobactam sodium + sulbactam) with a US Food and Drug Administration FDA approval for use in patients of ages 18 or older. The FDA approval stemmed from results from Entasis’ Phase III Attack trial (NCT03894046).

FDA 52

FDA Food and Drug Administration Patients Prospecting 52

Pharmaceutical Technology

MAY 3, 2023

Since 2015, the US Food and Drug Administration (FDA) has approved more than 450 “first generics” or the first generic equivalent for a branded drug. In its 2022 annual report on generics, the US FDA stated it had approved 106 first generics, which it claimed would offer significant cost savings for patients.

Food and Drug Administration 98

Food and Drug Administration FDA Medicine Competition 98

Pharmaceutical Technology

MAY 26, 2023

The FDA has flagged this issue as pharmacies selling prescription drugs illegally have proliferated over the years. The US Food and Drug Administration (FDA commissioner Dr. Robert Califf says, “The illegal sale of prescription drug stimulants online puts Americans at risk and contributes to potential abuse, misuse, and overdose.”

Food and Drug Administration 52

Food and Drug Administration Prescription FDA Medical 52

Pharmaceutical Technology

APRIL 12, 2023

However, according to the US Food and Drug Administration (FDA), non-human primates are still the most scientifically relevant large model to test biologic drugs for safety. The ABPI points to the FDA in the US as an example. The FDA’s Modernization Act 2.0 In 2021, they accounted for 0.2%

Pharma 98

Pharma Food and Drug Administration Safety Medicine 98

Pharmaceutical Technology

APRIL 26, 2023

With constantly evolving primary packaging pharmaceutical products are being offered with improved safety, efficacy, and convenience to patients and healthcare professionals.

Manufacturing 52

Manufacturing Medical Food and Drug Administration Pharmaceutical 52