US biotech to submit new psoriasis treatment to the FDA in summer

Dermavant Sciences has presented an interim analysis of phase III results from trial involving new treatment for plaque psoriasis, which will form basis for FDA new drug application.

BY MIKKEL AABENHUS HEMMINGSEN, TRANSLATED BY NIELSINE NIELSEN

In 2022, US skin doctors may get their hands on a new tool for treating patients with plaque psoriasis.

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Almirall acquires rights to new psoriasis drug in Europe
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EU Health Commissioner Stella Kyriakides has received an open letter from trade association Medtech Europe and 34 national organizations. | Foto: Julien Warnand/AP/Ritzau Scanpix

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European trade association calls for comprehensive reform of MDR and IVDR

Medtech Europe considers EU regulations to be unpredictable, complex and slow.

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Pharma & biotech

Kåre Schultz: Former chairman of Novo Nordisk Foundation cost me the job as Novo Nordisk CEO

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Søren Nielsen, CEO of hearing aid company Demant. | Foto: Demant / Pr

Hearing health

Jyske Bank questions Demant's continued momentum

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Foto: Jim Vondruska/Reuters/Ritzau Scanpix

Pharma & biotech

Third time's the charm: Novo Nordisk makes new bid to get obesity drug reimbursed in Danish home market

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Novo Nordisk Foundation's investment company, Novo Holdings, together with Gurnet Point Capital, has completed the acquisition of the US biotech company Paratek for USD 462 million including debt corresponding to DKK 3.2 billion. | Foto: Novo Holdings / Pr

Pharma & biotech

Novo Holdings completes acquisition of US antibiotics company for DKK 3.2bn

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Pharma & biotech

Leo acquisition negotiated with four suitors while struggling to survive

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Jefferies on Novo Nordisk: Little risk of semaglutide patent dispute - but could raise concerns
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Media: Issues at Novo Nordisk factory have been known for more than a year
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Novo Nordisk and UNICEF extend joint initiative to combat childhood obesity
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Board member appointed as new CEO of Orphazyme
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Eli Lilly sues clinics for selling fake diabetes drug
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Media: This is why the FDA has reprimanded Novo Nordisk following US plant inspection
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Kåre Schultz: Former chairman of Novo Nordisk Foundation cost me the job as Novo Nordisk CEO

The former chairman of the Novo Nordisk Foundation, Sten Scheibye, however, says that he does not recognize this interpretation.

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Pharma & biotech

Media: Issues at Novo Nordisk factory have been known for more than a year

Already in May of last year, the FDA released a report documenting quality control failures at Novo Nordisk’s factory in Clayton, USA, Reuters reports. (Updated)

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Other

European trade association calls for comprehensive reform of MDR and IVDR

Medtech Europe considers EU regulations to be unpredictable, complex and slow.

For subscribers

Inadequate oversight of batch deviations and messy microbial controls are the cause of an FDA notice for a Novo Nordisk factory in the US, says media outlet Fiercepharma. | Photo: Novo Nordisk/pr

Pharma & biotech

Media: This is why the FDA has reprimanded Novo Nordisk following US plant inspection

Inadequate oversight of batch deviations and messy microbial controls are the cause of an FDA Form 483 for a Novo Nordisk plant in the US, reports media outlet Fierce Pharma.

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Novo Nordisk's manufacturing facility in Clayton, the US. | Foto: Novo Nordisk/pr

Pharma & biotech

Novo Nordisk facility in the US allegedly receives FDA notice

The FDA has reportedly notified the company’s management of problematic conditions.

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Hearing health

Jyske Bank questions Demant's continued momentum

With increasing competition in the hearing aid market, Jyske Bank analyst Janne Vincent Kjær does not expect Demant to continue its strong momentum into 2024.

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