Forxiga approved in EU for chronic heart failure
European Pharmaceutical Review Magazine
by Catherine Eckford
12h ago
Forxiga (dapagliflozin) has been approved in the European Union for heart failure (HF) with reduced ejection fraction (HFrEF) across the full spectrum of left ventricular ejection fraction (LVEF). AstraZeneca’s Forxiga is the first and only heart failure therapy with proven mortality benefit across the full ejection fraction range. The first-in-class, oral, once-daily SGLT2 inhibitor has shown efficacy in preventing and delaying cardiorenal disease, while also protecting the organs, research has shown. The approval by the European Commission follows the positive opinion of the Committee for M ..read more
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MSD and Nectin to collaborate on clinical trial for KEYTRUDA® combination
European Pharmaceutical Review Magazine
by Catherine Eckford
19h ago
MSD (Merck & Co) and Nectin Therapeutics have agreed to enter into a clinical trial collaboration, to investigate anti-PVR monoclonal antibody NTX1088 in combination with KEYTRUDA® (pembrolizumab). PVR blockade by NTX1088 is the first and only therapeutic approach aiming at restoring the antitumor immune activity of DNAM1 (CD226). KEYTRUDA is MSD’s anti-PD1 therapy, in patients with locally advanced and metastatic solid tumours. The Phase I, open label clinical trial was initiated in November 2022. It aims to assess the safety and tolerability of the KEYTRUDA®/NTX1088 combination therapy ..read more
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Five potential EU regulatory changes impacting the life sciences industry in 2023
European Pharmaceutical Review Magazine
by Mandy Parrett
19h ago
A wave of important legislative changes is anticipated in the EU in 2023 making this year one of the biggest for the EU regulatory landscape governing the life sciences industry in recent times. Changes have been spurred by the COVID-19 pandemic, which emphasised the need to urgently modernise outdated EU pharmaceutical law and revise regulatory ambitions in the MedTech sector. In addition, the life sciences industry may be impacted by the introduction of class action mechanisms in the EU and initiatives to regulate the use of artificial intelligence (AI). Some of the current and anticipated ..read more
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First-in-class therapy shows potential for chronic fibrosis
European Pharmaceutical Review Magazine
by Catherine Eckford
2d ago
In a recent Phase II study, FT011, a novel, first-in-class oral therapy for chronic fibrosis in multiple organs showed meaningful improvements in over 60 percent of scleroderma patients after 12 weeks. FT011 is a novel biologic target in the fibrosis mechanism as a defined G protein-coupled receptor (GPCR). This GPCR is silent in healthy tissue but activated following injury or disease. Evidence demonstrates the role this GPCR has on multiple downstream pathways causing inflammation and fibrosis. FT011 inhibits this GPCR, offering potential to treat chronic fibrosis in multiple organs. Sclero ..read more
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Pembrolizumab plus chemo improves endometrial cancer survival
European Pharmaceutical Review Magazine
by Catherine Eckford
4d ago
A Phase III clinical trial evaluating pembrolizumab with chemotherapy (carboplatin and paclitaxel), improved progression free survival (PFS) for stage III-IV or recurrent endometrial carcinoma. An interim analysis of the results demonstrated that the treatment showed a statistically significant and clinically meaningful improvement in PFS, regardless of mismatch repair status. Status was defined by mismatch repair deficient (dMMR) and mismatch repair proficient (pMMR). The Phase III trial for pembrolizumab plus chemotherapy NRG-GY018, the randomised, blinded, placebo-controlled study evaluate ..read more
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ABPI warns against revenue clawback rate rises
European Pharmaceutical Review Magazine
by Catherine Eckford
4d ago
A key consultation by the Department of Health and Social Care (DHSC) is underway on plans to raise the statutory revenue clawback rate paid by companies subject to the Statutory Scheme for branded medicines from 24.4 percent to 27.5 percent. This is nearly three times what firms may have anticipated just a few years ago. The Association of the British Pharmaceutical Industry (ABPI) warned the planned rate rise sent the worst possible signal to global investors and boardrooms at a time UK life sciences are already facing significant challenges. The statutory revenue clawback rate rise The pha ..read more
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MHRA approves first oral advanced therapy for Crohn’s disease
European Pharmaceutical Review Magazine
by Catherine Eckford
6d ago
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved RINVOQ®▼ (upadacitinib), the first oral advanced therapy for adults with moderately to severely active Crohn’s disease (CD). This approval for Great Britain marks the first marketing authorisation globally for the use of upadacitinib in CD. Treating Crohn’s disease “There have been limited new treatment options approved for Crohn’s disease in recent years and many people struggle to stay in remission, demonstrating a clear unmet need,” shared Professor James Lindsay, Consultant Gastroenterologist at the Royal London H ..read more
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Halting Europe’s essential medicines manufacturing exodus
European Pharmaceutical Review Magazine
by Caroline Peachey
6d ago
While maintaining a healthy manufacturing industry for production of ‘high tech’ pharmaceuticals, Europe has stepped away from manufacturing essential medicines and active pharmaceutical ingredients (APIs) due to unrelenting price pressures and is now heavily reliant on the import of these critical ingredients. There is now a large regional concentration in the production of generic APIs in Asia with 66 percent  of the world’s API production by volume manufactured in India and China.1 Europe is one of the key customers for Asia’s massive API production, and our dependency is now so great ..read more
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Pharmapack Europe Awards 2023 winners announced
European Pharmaceutical Review Magazine
by Catherine Eckford
6d ago
The winners of Pharmapack Europe’s 2023 awards have been announced, presented across a range of innovative recyclable packaging, drug delivery solutions, and reusable connected devices. Three categories were available for entry in the Exhibitor Innovations section. The winning products were: Drug delivery innovation: UniSafe® reusable connected auto-injector by Owen Mumford Pharmaceutical Services Packaging innovation: PACKSYS GmbH for ampoule dispenser Sustainability initiative: Körber Pharma Packaging Materials AG for Sustainable Covid Rapid Tester In the Health Product category, the winner ..read more
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Clinical Trials Information System mandatory in EU
European Pharmaceutical Review Magazine
by Catherine Eckford
6d ago
From 31 January 2023, all initial clinical trial applications in the European Union (EU) must be submitted via the Clinical Trials Information System (CTIS). According to the European Medicines Agency (EMA), CTIS is now the single-entry point for sponsors and regulators of clinical trials for the submission and assessment of clinical trial data. This follows a one-year transition, during which sponsors could choose whether to apply for a new clinical trial in the EU/EEA in line with the Clinical Trials Directive or under the new Clinical Trials Regulation (CTR), which entered into application ..read more
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