Markets & Regulations

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Adcendo raises $34 million to fund ADC treatments for sarcoma

By Jonathan Smith

The Danish biotech Adcendo has bagged a Series A extension round of €31 million ($33.8 million), taking its Series A winnings so far to €82 million ($89.5 million). The round will bankroll the development of Adcendo’s pipeline of antibody-drug...

Exterior of new German logistics hub © UPS Healthcare

UPS Healthcare opens logistics facility in Germany

By Jane Byrne

UPS Healthcare says its first dedicated healthcare logistics facility in Giessen, Germany is now up and running. Up to 150 jobs have been created as a result of this operation, added the provider.

The extra MHRA funding will help accelerate patient access to new treatments, says the government. Pic: getty/221A

MHRA gets £10m boost from UK government

By Rachel Arthur

The UK Medicines and Healthcare products Regulatory Agency (MHRA) will receive £10m ($12m) in extra government funding over the next two years: targeted at helping the agency adapt post-Brexit and accelerating routes for bringing new medicines onto the...

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Urgent action needed to reduce high costs of gene therapies

By Jane Byrne

The extremely high costs of gene therapies are unsustainable, and a global commitment to affordable, equitable access to these treatments is urgently needed, concluded the organising committee of a conference on human genome editing.


Sanofi to acquire Provention Bio for $2.9bn

By Rachel Arthur

Sanofi will acquire US-based Provention Bio: gaining Tzield (teplizumab-mzwv), which was approved by the FDA last year as the first and only therapy to delay the onset of Stage 3 type 1 diabetes.

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Biosimilars organization hails US legislative effort

By Jane Byrne

The Biosimilars Forum has welcomed a move by US congressman, Richard Hudson, to introduce legislation that would establish a shared savings reimbursement model for biosimilars in Medicare Part B.


Moderna reports mixed earnings as costs jump 

By Jonathan Smith

The Boston-based messenger RNA (mRNA) specialist Moderna revealed $19.3bn in revenues last year, but rising costs and falling demand for its COVID-19 vaccine cut into its earnings in the fourth quarter of 2022.


FDA approves once-weekly hemophilia A therapy

By Rachel Arthur

The US Food and Drug Administration (FDA) has approved Sanofi and Sobi’s Altuviiio (efanesoctocog alfa): a first-in-class, high-sustained factor VIII replacement therapy.


FDA decision on Pfizer’s maternal RSV vaccine expected by August

By Rachel Arthur

The US Food and Drug Administration (FDA) has accepted Pfizer’s Biologics License Application (BLA) for its maternal RSV vaccine under priority review. If approved, the vaccine will become the first RSV vaccine for pregnant women to protect against RSV...


EU approves first gene therapy for hemophilia B

By Jonathan Smith

Three months after receiving the US green light, CSL’s candidate Hemgenix has become the first gene therapy to gain EU approval for the treatment of hemophilia B.