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Neuraxpharm Expands Into The Nordics With New Leader From Viatris

 
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In line with its plan to expand into the Nordics, CNS specialist Neuraxpharm has established a new business unit in Stockholm and has recruited Viatris’ Magnus Wassén to lead it as general manager. The company is expecting Neuraxpharm Sweden to provide an immediate sales platform for Buccolam. 

Global Pharma Guidance Tracker – Test sabbah

 
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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.

Global Pharma Guidance Tracker – August 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.

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.

Global Medtech Guidance Tracker: July 2024

 
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Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Nearly 30 documents have been posted on the tracker since its last update.

UK Follows EU’s Lead In Scrutinizing Ashwagandha Safety In Supplements

 
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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.

Global Pharma Guidance Tracker – June 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.

Nordic HTA Initiative Offers ‘Practice Ground’ For Worrisome EU-Level Joint Clinical Assessment

 

Industry shoulders some blame for growing unease about joint clinical assessments after its failure to participate in pilots.

New Danish ‘Critical Medicine’ Stockpiling Rules Take Effect, With 6-Month Grace Period

 
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The Danish regulator says the new stockpiling and reporting requirements will give stakeholders time to take steps to mitigate the impact of long-term supply issues, but the pharma industry body, LIF, fears the move could create more problems than it will solve.

Hemophilia Gene Therapy Hemgenix Gets Funding In England, With More Talks Underway In Europe

 
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After an initial funding rejection last year, CSL Behring’s gene therapy for hemophilia B is to be made available to English patients under the Innovative Medicines Fund via a “first-of-its-kind” agreement. Hemgenix is also the subject of a funding deal in Denmark.

Newbury Secures Approval For Victoza Generic In Denmark

 
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Only days after the EU-wide decentralized approval of Adalvo’s Victoza generic, Newbury broke news with the greenlighting of its own Victoza rival in Denmark.

Global Pharma Guidance Tracker – May 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.

Global Medtech Guidance Tracker: May 2024

 
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Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Sixty-five documents have been posted on the tracker since its last update.

Global Pharma Guidance Tracker – April 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.

Global Medtech Guidance Tracker: April 2024

 
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Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-five documents have been posted on the tracker since its last update.

Industry Slates Decision To Exempt Parallel Importers From New Danish Stockpile Rules

 
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The bill on new rules on companies holding minimum stock levels for “critical medicines” has been amended but is still likely to take effect at the beginning of July.

Danes Advise Pharma Firms To Test Their Anti-Tamper Devices

 
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About 10% of marketed medicines chosen at random in Denmark had “non-functioning” anti-tamper devices, leaving them open to possible interference.

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.

Denmark Planning To Impose Drug Stockpiling Obligations From July

 
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A new bill is intended to address the increase in medicine supply problems in Denmark in recent years.

Global Medtech Guidance Tracker: February 2024

 
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Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-six documents have been posted on the tracker since its last update.

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