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European Commission approves long-acting HIV drug option
The first long-acting injectable PrEP option proven superior to daily oral FTC/TDF in reducing HIV acquisition, has been approved in the European Union (EU).
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Regs & Legs
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First treatment for myelofibrosis with anaemia approved
The US Food and Drug Administration (FDA) has granted approval of a treatment for anaemic patients with a rare blood cancer.
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CHMP’s September 2023 meeting highlights
In its September 2023 meeting, the EMA’s human medicines committee (CHMP) recommended nine medicines for approval and the extension of therapeutic indications for 11 medicines.
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CPHI Pharma Awards 2023 finalists announced
The finalists for CPHI’s Pharma Awards 2023 across twelve categories for innovation, manufacturing, sustainability, best start-up initiative and breakthrough digital technologies have been announced.
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Pfizer’s migraine medicine recommended by NICE
The National Institute for Health and Care Excellence (NICE) has published final draft guidance on Pfizer’s Rimegepant, recommending it for the first time as a treatment for acute migraines.
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EU tax compliance proposals to streamline business investment
New tax compliance cost and transfer pricing proposals from the European Commission (EC) aim to support simpler, clearer and more cost-effective tax systems in the EU.
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New regulatory relief to benefit Europe’s pharma SMEs
To support small and medium-sized enterprises (SMEs) in the current economic climate, newly proposed measures aim to provide short-term relief, increase long-term competitiveness, and improve equality in the business environment across the Single Market.
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UK ATMP facility granted cGMP approval
A UK CDMO is now permitted through MHRA certification to produce clinical supply of gene therapy AAV, including bioprocess through to cGMP manufacturing.
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Uncovering new frontiers in microbiology and EM
In this Q&A, Laure Pomares Voisin, Quality Director, Catalent Biologics and Tony Cundell Principal Consultant, Microbiological Consulting, LLC discuss some of the key microbiology and environmental monitoring challenges and trends in pharmaceutical manufacturing today.
whitepaper
Technical document: Introducing: Ami Polymer’s Sterile Sampling Systems
Next-Gen Sterile Sampling System: Pinnacle Compliance - USP Standards 87, 88, 85, 661.1, 788, 71, and ISO 11737-1 for Unparalleled Pharma & Biopharma
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MHRA releases its CTA application performance metrics
Recent data reveals how many clinical trial authorisation (CTA) applications and substantial amendments the Medicines and Healthcare products Regulatory Agency (MHRA) received and assessed in the past year, including statistics for novel trial designs.
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NICE recommends new type 2 diabetes treatment
A safer alternative to current first line therapies has been recommended by the National Institute for Health and Care Excellence (NICE) as a new treatment option for type 2 diabetes.
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Leveraging PAT for environmental monitoring in light of Annex 1
The pharma industry’s adaptation to Industry 4.0 has been slow, due to the extensive regulatory requirements imposed on manufacturers. However, regulatory agencies are starting to embrace movement towards more rapid/automated systems, as illustrated in the revised EU GMP Annex 1, which entered into force in August. Here, Isabella Jul-Jørgensen from the Technical…
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QA/QC & Environmental Monitoring In-Depth Focus 2023
In this in-depth focus, explore how automation is transforming environmental monitoring in line with Annex 1, implementation of contamination control strategies and discover the emerging trends and challenges in pharmaceutical microbiology.
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Guidance recommending BMS cardiac myosin inhibitor published
NICE’s final guidance recommending Bristol Myers Squibb’s first-in-class obstructive hypertrophic cardiomyopathy (oHCM) drug on the NHS, is now published.
