‘New Era’ To Begin For UK’s ILAP In 2025, With Focus On ‘Transformative’ Drugs

‘New Era’ To Begin For UK’s ILAP In 2025, With Focus On ‘Transformative’ Drugs

 
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Some stakeholders say that the entry criteria for the licensing and access pathway have been too broad, leading to an overburdening of the scheme.

New Swiss Clinical Trial Framework Takes Effect With Updated Reporting Rules

New Swiss Clinical Trial Framework Takes Effect With Updated Reporting Rules

 
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Transitional provisions have been put in place to ensure the smooth implementation of new trial rules and requirements in Switzerland.

‘Unforeseen’ Variations & ‘Super-Grouping’ Addressed In New EU Guidance

‘Unforeseen’ Variations & ‘Super-Grouping’ Addressed In New EU Guidance

 
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Updated guidance issued by the EU regulator explains how to comply with the provisions of the amended Variations Regulation, which will apply to new submissions from January 2025 and is intended to make lifecycle management “more efficient and future-proof.”

Lytenava: England Becomes First to Fund Ophthalmic Bevacizumab For Wet AMD

Lytenava: England Becomes First to Fund Ophthalmic Bevacizumab For Wet AMD

 

Up to 40,000 people could be set to access Outlook Therapeutics’ Lytenava in England, according to health technology assessment institute NICE, which found the drug for wet age-related macular degeneration had similar health benefits to aflibercept and ranibizumab, and similar costs to aflibercept.


Teva Fined Half A Billion Dollars Over European Copaxone Antitrust Breach

Teva Fined Half A Billion Dollars Over European Copaxone Antitrust Breach

 
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Teva has been fined €463m – just over half a billion US dollars – over a breach of EU antitrust rules, after the European Commission found that it abused its dominant position to delay competition to Copaxone, including by misusing the patent system and disparaging rivals. The firm has strongly disagreed with the decision – which is claims is “legally untested” and “not supported by the facts” – and says it will appeal.

New EMA Fees Could Shake Up Pharma Submission Strategies

New EMA Fees Could Shake Up Pharma Submission Strategies

 
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Companies that delay their drug application submissions to the European Medicines Agency by more than 60 days will face an additional fees of €4,200 per delay under a new regulation effective from 2025.

EMA Seeks Feedback On COI Policy Changes Following Legal Rulings

EMA Seeks Feedback On COI Policy Changes Following Legal Rulings

 

The European Medicines Agency is conducting a public consultation on proposed revisions to its policy on how it handles any conflicts of interest of its scientific committee members and experts.

Astellas Praises EU & US Regulators For Collaboration In Gene Therapy Space

Astellas Praises EU & US Regulators For Collaboration In Gene Therapy Space

 

The move towards greater regulatory collaboration is a positive step for gene therapy developers, Astellas’ gene therapy strategy lead Richard Wilson says – adding, however, that pharma still needed to understand the Asian markets better.


EMA Considers Cracking Down On Late Filings From Companies By Auto-Releasing Rapporteurs

EMA Considers Cracking Down On Late Filings From Companies By Auto-Releasing Rapporteurs

 
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The European Medicines Agency is monitoring the frequency with which it must re-appoint experts to assess EU drug filings due to companies' failure to submit their applications as scheduled, thereby disrupting the evaluation process. It warns action may be needed if the “situation worsens.”

‘Ambitious Platform’ Among EU Proposals For Increasing mHealth Data Use In Regulatory  Decision-Making

‘Ambitious Platform’ Among EU Proposals For Increasing mHealth Data Use In Regulatory Decision-Making

 

mHealth data generated by smartphones and wearables show potential for enhancing the clinical evidence used in regulatory decision-making, but there are “notable challenges” that may hinder the use of such data, EU regulators say.

Astellas Withdraws Izervay’s European Approval Filing

Astellas Withdraws Izervay’s European Approval Filing

 
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Decision contrasts with successful journey in the US, where it was approved with Fast Track designation in 2023. Astellas says its considering “every potential action” to bring GA drug to patients in Europe.

Regulatory Reviewers In Europe Face Overtime And Cancelled Vacations Due To Submission Delays

Regulatory Reviewers In Europe Face Overtime And Cancelled Vacations Due To Submission Delays

 
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EU national competent authorities are stressed about having to put up with an “unacceptably high workload” due to poor submission planning by drug companies when it comes to their EU filings. Poor predictability relating to submissions could also impact industry.


EMA Should Lead AI Oversight In Pharma & Align With Global Regulators, Says EFPIA

EMA Should Lead AI Oversight In Pharma & Align With Global Regulators, Says EFPIA

 

The European Medicines Agency should be responsible for the regulatory oversight of AI in the drug development process in the EU and provide clarity on its “risk-based” approach to governance, pharma industry federation EFPIA says.

EU HTA Reg: CoI Rules Limit Participation Of Experts In Joint Clinical Assessments

EU HTA Reg: CoI Rules Limit Participation Of Experts In Joint Clinical Assessments

 

The European Commission has now adopted the third implementing act for the Health Technology Assessment Regulation. This sets out rules for managing conflicts of interest of anyone involved in joint clinical assessments or joint scientific consultations under the regulation.

Italy Sets Up Project To ‘Break Industry Monopoly’ On Drug Information

Italy Sets Up Project To ‘Break Industry Monopoly’ On Drug Information

 
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The COSIsiFA initiative includes a new independent website, regular newsletters, a six-monthly bulletin, and training courses to help promote the appropriate use of medicines.

ATMP Makers Encouraged To Consult Local Regulators On Compliance with EU GMP Guidelines

ATMP Makers Encouraged To Consult Local Regulators On Compliance with EU GMP Guidelines

 

Cell and gene therapy manufacturers based in Europe should speak to local regulators to understand how to demonstrate compliance with EU-level good manufacturing practice guidelines, as each country will apply the rules differently, an expert explains.


Industry Wants UK Clinical Trial Diversity Plans To ‘Work Alongside’ Global Regulations

Industry Wants UK Clinical Trial Diversity Plans To ‘Work Alongside’ Global Regulations

 

The deadline for comments is nearing for a draft UK guidance that seeks to increase inclusivity and diversity across clinical trials and investigations.

Future EU Health Commissioner Pledges Action On Pharma Reform, Shortages & Biotech

Future EU Health Commissioner Pledges Action On Pharma Reform, Shortages & Biotech

 
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Olivér Várhelyi’s plans for his new role boil down to continuing legislative projects and other initiatives that have already been set in motion.

EU HTA Regulation: Assessors Risk Exclusion for Secrecy Breaches

EU HTA Regulation: Assessors Risk Exclusion for Secrecy Breaches

 

The second of six implementing acts for the Health Technology Assessment Regulation has now been adopted. It deals with how the European Medicines Agency is to cooperate with the European Commission and HTA experts in Europe.

UK’s ‘World First’ Point Of Care Manufacturing Rules Enter Parliament

UK’s ‘World First’ Point Of Care Manufacturing Rules Enter Parliament

 

The UK government has introduced draft legislation that will regulate the manufacturing of innovative medicines such as cell and gene therapies at the point of care. The country’s medicines regulator, the MHRA, says the framework is the “first of its kind in the world.”