Sanofi secures EC approval for two enzyme replacement treatments for rare diseases

By NS Healthcare Staff Writer

29 Jun 22

The European regulator approved Nexviadyme to treat the full spectrum of Pompe disease and Xenpozyme to treat non-Central…

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EMA begins review of Bavarian Nordic’s smallpox vaccine for monkeypox

By NS Healthcare Staff Writer

29 Jun 22

Imvanex is a non-replicating smallpox vaccine that contains a live modified form of the vaccinia virus, dubbed vaccinia…

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Novartis gets expanded EC approval for Cosentyx to include paediatric arthritic conditions

By NS Healthcare Staff Writer

28 Jun 22

The expanded approval is based on data from the JUNIPERA trial, which showed that Cosentyx reduced the risk…

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BMS gets US FDA approval for Breyanzi to treat large B-cell lymphoma

By NS Healthcare Staff Writer

27 Jun 22

The FDA approval was based on data from the Phase 3 TRANSFORM trial and Phase 2 PILOT study,…

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Novavax’ Covid-19 vaccine Nuvaxovid authorised for adults in Taiwan

By NS Healthcare Staff Writer

24 Jun 22

The vaccine has also been recommended by the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human…

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Novartis gets FDA nod for Tafinlar plus Mekinist to treat BRAF mutation-positive solid tumours

By NS Healthcare Staff Writer

23 Jun 22

The drug combination was indicated for metastatic solid tumours with BRAF V600E mutations in adults and children aged…

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Novartis loses patent litigation related to multiple sclerosis drug Gilenya

By NS Healthcare Staff Writer

22 Jun 22

A modified panel of CAFC reversed the decision upholding the validity of the Gilenya dosing regimen patent granted…

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China’s NMPA approves Tyvyt plus chemotherapy to treat oesophageal cancer

By NS Healthcare Staff Writer

21 Jun 22

The NMPA approval is based on the interim analysis of the Phase 3 ORIENT-15 clinical trial, in which…

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EMA initiates rolling review of Pfizer and BioNTech’s potential variant-adapted Covid-19 vaccine

By NS Healthcare Staff Writer

16 Jun 22

The rolling review is initially based on chemistry, manufacturing, and controls (CMC) data, which the vaccine manufacturers shared…

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FTC starts investigation into mental-health start-up Cerebral

By NS Healthcare Staff Writer

15 Jun 22

The US antitrust watchdog has issued a letter to the company that said the FTC was investigating whether…

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