EU Health Commissioner Stella Kyriakides has received an open letter from trade association Medtech Europe and 34 national organizations. | Photo: Julien Warnand/AP/Ritzau Scanpix

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

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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Photo: 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

In a new and narrowed application for public reimbursement for the obesity drug Wegovy, Novo Nordisk aims to cover only ”a limited group.” However, the company will not disclose who this includes.

For subscribers

Did you read?

President of North American operations to lead GN Hearing from October

The future head of GN Hearing will report to Peter Karlströmer, who will become Group CEO in October.

For subscribers

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. | Photo: Novo Holdings / Pr

Pharma & biotech

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

The acquisition of Paratek Pharmaceuticals is Novo Holdings’ largest single investment in antimicrobial resistance treatments to date.

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Pharma & biotech

Leo acquisition negotiated with four suitors while struggling to survive

Leo Pharma had to quintuple the initial purchase offer.

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Pharma & biotech

Jefferies on Novo Nordisk: Little risk of semaglutide patent dispute - but could raise concerns

The actual risk of competition from generic drugs is limited, according to Jefferies analyst, although pharmaceutical company Viatris is challenging patents related to Novo Nordisk’s semaglutide.

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Did you read?

After two years of losses Leo Pharma is on track to profitability

The pharmaceutical company is on track to deliver on the big goal: to become profitable by 2023.

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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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Photo: Jacob Gronholt-Pedersen/Reuters/Ritzau Scanpix

Pharma & biotech

Novo Nordisk and UNICEF extend joint initiative to combat childhood obesity

As part of the extended agreement, Novo Nordisk will invest USD 8m over the next three years.

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Other

Board member appointed as new CEO of Orphazyme

The biotech company prepares new activities.

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Pharma & biotech

Eli Lilly sues clinics for selling fake diabetes drug

Novo Nordisk was also out in force in June.

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Did you read?

Novo Nordisk performs stock split

On Wednesday, shareholders woke up to a halved Novo Nordisk share price.

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Feature article: Hearing health

Chairman praised successful turnaround in GN Hearing despite financial decline

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Read the article here

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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Medtech

Ambu receives clearance from US authorities for colonoscope

On Wednesday, the US Food and Drug Administration (FDA) approved Ambu’s disposable colonoscope, Ascope Colon, and the endoscopy system, Ambu Abox 2.

For subscribers

A 0.25 mg injection pen of Novo Nordisks weight-loss drug Wegovy is shown in this photo illustration in Oslo, Norway, September 1, 2023. | Photo: Staff/Reuters/Ritzau Scanpix

Pharma & biotech

Obesity-drug mania propels top stock fund to beat 94% of peers

A top-performing equity fund with years-long investments in the insulin makers behind the recent weight-loss stock frenzy is betting the rally has further to run.

For subscribers

Novo in supply deal with Ypsomed for auto-injector pens

With increased production capacity, Ypsomed signs a long-term deal with Novo Nordisk on supply of auto-injectors.

For subscribers

Scott Thomas Smith, CFO of Ascendis Pharma. | Photo: Ascendis Pharma / Pr

Pharma & biotech

Sale of royalties marks new approach to funding for Ascendis

Ascendis has historically raised capital through share issues, but that way of business is coming to an end.

For subscribers

Pharma & biotech

Novo Nordisk is rumored to have hired another US contract manufacturer

The Danish pharmaceutical company is struggling to increase production of weight loss drug Wegovy.

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Robert Langer has received several honorary awards in his career. Here, he is pictured in 2013, when then US President Barack Obama presented him with the National Medal of Technology and Innovation. | Photo: Charles Dharapak/AP/Ritzau Scanpix

Pharma & biotech

Robert Langer to open doors for young biotech company: "But ultimately people need to be convinced by the idea and the data"

With Robert Langer on board, Hervolution will have a huge network of professionals to benefit from, and the renowned scientist’s reputation will increase investor interest, according to the analysis.

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Other

New study: Older people with migraines are harder to treat

The elderly typically experience more frequent bouts and more often have chronic migraines than younger people. This is evident in a new Danish study.

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Medtech

Ambu expands in Malaysia with new innovation center

The medico company has been present in the country for more than two decades.

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Pharma & biotech

Novo Nordisk enters new partnership for the production of insulin in South Africa

In collaboration with South African Aspen Pharmacare, Novo Nordisk will increase the production of insulin on the African continent in the coming years.

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Medtech

Danske Bank: Acquisition of Icelandic wound care company will boost sales at Coloplast

However, the Danish bank sees less share price potential in the Coloplast stock than before.

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Novo Nordisk's manufacturing facility in Clayton, the US. | Photo: 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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Pharma & biotech

CHMP recommends nine drugs in September

11 drugs are recommended for extended usage.

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Ascendis' headquarters in Hellerup. | Photo: Ascendis Pharma / Pr

Pharma & biotech

Ascendis has launched weekly growth hormone in first European market

The biotech company is also looking for country managers for a number of European locations.

For subscribers

Helge Lund is currently chairman of both BP and Novo Nordisk.

Other

Novo Nordisk chairman highlighted as candidate for CEO position at BP

British energy company BP is seeking a replacement for outgoing chief executive officer Bernard Looney. The company’s chairman, former Statoil boss Helge Lund, is named as a candidate.

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