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Global Pharma Guidance Tracker – July 2024

 
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Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Hyloris Replaces Leadership After Continued Transaction Woes

 
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Marking a further development in the story of Hyloris’ in-licensing deal with QliniQ, the company’s board has announced significant leadership and organizational changes to address potential concerns.

Another Funding Win For Chiesi In Europe As Scotland OKs Elfabrio

 

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.

Netherlands Follows Belgium & Luxembourg In Piloting Electronic Medicine Pack Leaflets

 

The aim of the pilot project is to demonstrate that an electronic package leaflet has no negative effects on the proper use of medicinal products in a hospital setting, says the industry body VIG. 

EU Joint Clinical Assessments: ATMPs Need ‘More Ambitious' Approach

 

While the introduction of joint clinical assessments under the new EU HTA Regulation could be “fruitful,” the bloc should take a more “integrated approach” to enabling access to ATMPs, according to a Belgian HTA expert.

Richter Swallows Up Estetrol Franchise And More From Stricken Mithra

 
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Gedeon Richter is looking to chart its own path in women’s healthcare and expand its global footprint, after buying up a bundle of businesses and key products and pipeline assets from Belgium’s Mithra.

Final Funding Blow For J&J’s Spravato In England, Despite Reimbursement In 26 Other Countries

 

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.

Drug Shortages: Pharma Decries 'Yet Another Tax' For Companies In Belgium

 

“Incomprehensible” is how the industry group Medaxes describes a new annual tax that Belgium plans to impose on companies to address the costs arising from shortages of medicines.

Global Pharma Guidance Tracker – March 2024

 
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Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

England’s NICE Says No To Santhera’s DMD Drug Agamree Due To ‘Unreliable Modeling’

 

Santhera Pharmaceuticals did not provide enough evidence to demonstrate that its Duchenne muscular dystrophy drug Agamree was a cost-effective use of resources, according to draft guidance from England’s health technology assessment body, NICE.

Hyloris Reports 44% Revenue Growth Driven By Royalties In 2023

 
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Belgian company Hyloris Pharmaceuticals has reported a 44% revenue increase in its 2023 results while doubling down on its long-standing ambition to have 30 portfolio assets in the near future.

Global Pharma Guidance Tracker – January 2024

 
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Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

New Data Means Successful Joint Pricing Talks For Orchard’s Libmeldy in Europe

 

Orchard Therapeutics has secured reimbursement in Ireland, the Netherlands and Belgium nearly a year after the collapse of joint pricing talks between the company and the three countries.

Belgium Introduces Mandatory Reporting For Dietary Supplement Adverse Events

 
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Adverse reactions related to consumption of dietary supplements and novel foods in Belgium must be reported by companies within 10 days following the introduction of the new Nutrivigilance system.

Biocodex Broadens Probiotics Play With Investment in Belgium's My Health

 
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France's Biocodex will introduce to European markets a probiotic supplement targeted as sufferers of functional dyspepsia after taking in a stake the product's manufacturer, My Health.

Hemgenix: European Countries Start Joint HTA Of Another Costly Gene Therapy

 

CSL’s Hemgenix is the latest expensive gene therapy to come under scrutiny from the BeNeLuxA cross-country coalition.

Ceres Pharma Snaps Up Hungary's VitaPlus

 
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Ceres Pharma will grow its presence in Hungary, adding consumer health brands including 1x1 Vitamin and Innopharm supplements and Medistus medical devices, through its acquisition of Budapest's VitaPlus.

Belgium Aims To Drive Biologic Competition Through Tendering

 

New tendering rules in Belgium aim to improve competition between biosimilars and originators, for example by setting contract durations for tendering contracts and limiting the criteria for such contracts.

Belgium Aims To Drive Biologic Competition Through Tendering

 

New tendering rules in Belgium aim to improve competition between biosimilars and originators, for example by setting contract durations for tendering contracts and limiting the criteria for such contracts.

EU Country Coalition Wants New Unmet Needs System To Incentivize The Right Innovation

 

The European Commission’s proposals for legislative reform in the pharmaceutical sector are welcome but must go further to address patient and societal needs, says a coalition of five EU countries dedicated to improving access to medicines.

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