France

A total of 748 key medicines are now affected by the four-month stock requirement, compared with 422 in 2021.

Casgevy, the world’s first CRISPR gene editing therapy, is the second drug to be accepted onto a managed access scheme via England’s Innovative Medicines Fund, offering a new treatment for patients with transfusion-dependent beta thalassemia.

England’s NICE has “misclassified” HER2-low metastatic breast cancer as a medium severity disease, say AstraZeneca and Daiichi Sankyo, the co-developers of Enhertu. NICE said it would consider a rapid re-appraisal if the companies offered a “fair price” for the drug.

UK regulator the Food Standards Agency intends to assess the risks associated with consuming supplements containing ashwagandha and to determine whether a safe level of the herb can be established. The launch of the consultation follows warnings from regulators across Europe about the safety of ashwagandha, with its consumption linked to a number of adverse health effects.

Quantum Surgical is on a mission to democratize minimally invasive cancer treatment. Its surgical robot Epione can treat inoperable abdominal and lung tumors using ablation. The company has treated over 500 patients across Europe and the US and secured €30m in funding to fuel expansion into Asia and into new cancer indications.

The antihistamine cyproheptadine is no longer available as a non-prescription allergy treatment in France after regulator ANSM said it had been misused for years to induce weight gain for “aesthetic purposes.”

Scotland’s health technology assessment body has agreed to reimburse Chiesi’s Elfabrio for Fabry disease, mirroring the decision from several other European countries – however, France turned down the rare disease drug, while Germany questioned its benefit.

Cooper Consumer Health has closed its acquisition of Viatris' OTC business as it commits to divesting the rights to infant laxative medicine Bebegel and earwax removal product Otowaxol in certain markets.

A round-up of the latest health and wellness industry moves: Reckitt hires chief supply officer from Beiersdorf; Weleda pharma management changes hands; Boiron names new CEO.

The Haute Autorité de Santé says that the risk of granting early access may only be justifiable if uncertainties over the clinical benefit of a drug can be addressed within a “reasonable” timeframe.

It has been a busy few weeks for Celltrion – a Korean approval for omalizumab biosimilar Omlyclo, three biosimilar supply contracts with France’s largest pharmaceutical procurement group, and new long-term data for subcutaneous infliximab.

Consumer health manufacturer Uriach has agreed to acquire Germany's Pascoe Naturmedizin and through a separate transaction France's Laboratoires Ineldéa, following investment by private-equity firm ICG.

Proposals for substantial changes to oversight of medtech notified bodies are likely to be part of the European Commission’s targeted evaluation of the MDR and IVDR, EU medtech lawyer, Erik Vollebregt, tells Medtech Insight.

J&J says it has “exhausted all current viable avenues” to get its antidepressant nasal spray Spravato reimbursed on England’s National Health Service, after NICE decided against re-appraising the drug following numerous funding rejections.

Shifting priorities sees Nestlé Health Science drop a long-term collaboration with Valbiotis for the development and commercialization of a plant-based dietary supplement targeted at sufferers of prediabetes and type-2 diabetes.

“We have been very clear with Servier that we do not want it to sell Biogaran,” France’s prime minister has indicated, suggesting that a foreign purchaser would face “drastic conditions” attached to any deal.

The CNIL plans to update its data protection methodologies based mostly on the results of a new consultation and the outcome of a pilot in which companies are asked to identify the challenges they have faced when designing trials with decentralized elements.

The CNIL plans to update its data protection methodologies based mostly on the results of a new consultation and the outcome of a pilot in which companies are asked to identify the challenges they have faced when designing trials with decentralized elements.

A study from the health technology assessment department of France’s national health agency, HAS, has identified which pharmaceutical products are most likely to receive a request for post-market studies. The agency hopes this information will aid in companies’ forward planning.

Adult immunization programs can save “billions” for society, but their value is underestimated because of challenges around measuring broader value evidence and a lack of incentives for companies to collect this data, says the Office of Health Economics.