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Europe

Set Alert for Europe

PTC’s ‘Life-Changing’ Gene Therapy Among Nine Drugs To Win EU Thumbs Up

The European Medicines Agency has delivered its verdict on the latest medicines it believes should be approved for marketing in the EU. By contrast, it has given the thumbs down to one biosimilar anticancer drug and its duplicate.

Europe Approvals

England’s Innovative Medicines Fund To Put Spotlight On Rare Disease Treatments

While the much-anticipated Innovative Medicines Fund is likely to benefit rare diseases in particular, other products must gain too.

Cost Effectiveness United Kingdom

ATMP Withdrawals Are Keeping EU Regulators Awake At Night

Europe is becoming less competitive in the advanced therapy space, something that is reflected in the number of EU ATMP marketing authorization withdrawals, speakers said at an event organized by the Alliance for Regenerative Medicine.

Europe Gene Therapy

Bavarian Nordic To Supply Vaccine As Monkeypox Appears In UK & Portugal

The monkeypox cases reported this month are evidence of chains of transmission of the virus, according to the European Centre for Disease Prevention and Control, which says that vaccination of high-risk close contacts should be considered after a benefit-risk assessment.

United Kingdom Portugal

UK Lucentis Biosimilar Nod Offers Teva Potential First-Mover Advantage

Teva is gearing up to introduce the Ongavia ranibizumab biosimilar in the UK, following an approval by the local regulator ahead of its European counterpart. The development means the Israeli firm and partners Bioeq and Formycon could secure a global first launch of a rival to Lucentis, ahead of expected imminent launches by Samsung Bioepis of its Byooviz version in the US and Europe.

Biosimilars Approvals

Roche’s Eye Drug Scores First UK Approval Under Access Consortium

The UK MHRA has approved its first drug under an international work-sharing initiative that also includes regulators from Australia, Canada, Singapore and Switzerland.

Approvals Review Pathway

EFPIA On How To Prepare EU For Future Health Crises

A report from industry federation EFPIA and its Vaccines Europe arm says that R&D has produced safe and effective tools for tackling COVID-19 but that the EU needs to address a set of short- to medium-term priorities if it is to be in a position to tackle future health emergencies.

Europe Coronavirus COVID-19

UK MHRA Specifies Eligibility For Consultancy Firms To Monitor GMP, GDP Compliance

Consultancy firms must have at least five years of experience in carrying out independent GMP or GDP audits if they want to apply to become a “compliance monitor” under a new MHRA scheme to keep track of drug companies that fail to comply with GMP/GDP requirements. 

Compliance Manufacturing

High-Stakes Meeting With EMA On The Cards For Oncopeptides’ Pepaxto

Oncopeptides is nearing the end of the regulatory review cycle in the EU for its multiple myeloma drug, melphalan flufenamide. The product has had an erratic journey in the US, where it was approved but then withdrawn, and the withdrawal was subsequently rescinded.

Drug Review Regulation

EU Marketing Decisions For New Drugs Imminent For Sanofi, PTC, Calliditas & Others

The European Medicines Agency’s human medicines committee, the CHMP, is expected to decide whether 11 drugs should be recommended for marketing approval during its latest monthly meeting, which started today.

Drug Review Europe

Digital Data Deluge Can Affect Oversight Of Patient Safety In Trials

The digitalization of clinical trials is generating more patient safety data than companies can process. A senior EMA official says sponsors should carefully select what is needed to maintain appropriate subject oversight by “getting the science right.”

Clinical Trials Digital Health

EMA Proposes Extending Remote QP Batch Certification Post-Pandemic

Stakeholders given one month to weigh in on proposal to allow relaxations introduced in response to COVID-19-related travel restrictions to continue on a routine basis.

Distribution Manufacturing
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