Iceland

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. 

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.

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

Alvotech stepped into its 2023 annual financing results call bursting with positive news and momentum, on the back of obtaining USFDA approval for its biosimilar Humira product and a bullish outlook for its strong pipeline of biosimilar candidates.

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.

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.  

Since Dropi launch in 2015, “the founders’ original idea has been refined, improved and made available for thousands of customers, in and outside of Iceland,” marketing chief Lára Margrét Möller tells HBW Insight.

Alvotech has its eyes on raising more cash to fund operations and ease the pain of missing out on an FDA approval for its Teva-partnered Humira (adalimumab) biosimilar.

For all its good intentions and lauded action toward gender equality, the biotech industry in Scandinavia and the Nordics has a female CEO rate hovering around 23%. While the number of women entering academia, innovative companies and laboratories is healthy, gender equality in the C-suite leaves a lot to be desired. 

For all its good intentions and lauded action toward gender equality, the biotech industry in Scandinavia and the Nordics has a female CEO rate hovering around 23%. While the number of women entering academia, innovative companies and laboratories is healthy, gender equality in the C-suite leaves a lot to be desired. 

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.

As Alvotech reported its first annual financial results, the company spoke of the imminent FDA inspection at its Icelandic manufacturing facility. An earlier inspection has so far put the kibosh on US approval for Alvotech’s proposed Humira (adalimumab) biosimilar.

Alvotech has once again raised more than $100m in financing, the second time in a matter of months, via a private placement involving what it expects to be previously issued treasury shares held by one of its subsidiaries.

Recently public Alvotech had much to share as part of its nine-month financial report, including updates on adalimumab in the US and the process to begin biosimilar golimumab trials.

Months after it become a public company, Alvotech has once again turned to the debt/equity markets to provide financial firepower for its pipeline of biosimilar candidates.

Tipped to bring in revenues from its proposed Stelara biosimilar of $600m in 2027, Alvotech has confirmed plans for a potentially landmark filing with major regulators by the end of the year.

Alvotech is furthering efforts to have a debt facility in place worth up to $125m as it kicks off life as a public company, amid challenging global market conditions.

Five Nordic countries are agreeing a common strategy for closer collaboration on access to hospital drugs.

Alvotech is celebrating an “historic milestone” as it became a publicly listed company in New York, with its shares set to also trade in its domestic Iceland next week.

Alvotech will cease to be a privately listed company next week, with its merger with special purpose acquisition company Oaktree Acquisition Corp. II set to close “on or about 15 June.”