CHMP recommends EU approval of Roche’s Kadcyla for the adjuvant treatment of people with HER2-positive early breast cancer with residual invasive disease after neo-adjuvant treatment

15 November 2019 - Kadcyla cut the risk of disease recurrence or death by half compared to Herceptin in the adjuvant ...

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CHMP recommends conditional EU approval of Roche’s Polivy for people with previously treated aggressive lymphoma

15 November 2019 - First-in-class antibody-drug conjugate that specifically targets CD79b, a protein expressed in the majority of B-cells. ...

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Novartis receives positive CHMP opinion for Mayzent (siponimod) for the treatment of adult patients with active secondary progressive multiple sclerosis

15 November 2019 - If approved, Mayzent (siponimod) will be the first and only oral treatment specifically indicated for patients ...

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Highlights from the CHMP 11-14 November 2019 meeting

15 November 2019 - Seven new medicines recommended for approval. ...

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FDA approves first targeted therapy to treat patients with painful complication of sickle cell disease

15 November 2019 - Today, the U.S. FDA approved Adakveo (crizanlizumab-tmca), a treatment to reduce the frequency of vaso-occlusive crisis – ...

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FDA approves new antibacterial drug to treat complicated urinary tract infections as part of ongoing efforts to address antimicrobial resistance

14 November 2019 - The U.S. FDA today approved Fetroja (cefiderocol), an antibacterial drug for treatment of patients 18 years of ...

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FDA approves therapy to treat patients with relapsed and refractory mantle cell lymphoma supported by clinical trial results showing high response rate of tumour shrinkage

14 November 2019 - Today, the U.S. FDA granted accelerated approval to Brukinsa (zanubrutinib) capsules for the treatment of adult patients ...

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NICE ‘OK’ for Sativex in MS

14 November 2019 - NICE has recommended Bayer’s Sativex (delta-9 tetrahydrocannabinol cannabidiol), for spasticity in people with multiple sclerosis. ...

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Regulators’ advice can make a difference for faster patient access to highly innovative therapies

12 November 2019 - Early dialogue and frequent interactions between medicine developers, regulators, health technology assessment bodies and patients can play ...

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NICE recommends Elmiron for bladder pain syndrome

13 November 2019 - NICE has recommended Consilient Health’s Elmiron (pentosan polysulfate sodium) for bladder pain syndrome. ...

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NICE during the pre-election period

12 November 2019 - As a public body, NICE is required to follow civil service principles on communicating during the lead ...

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Exelixis’ partner Ipsen announces Health Canada’s approval of Cabometyx (cabozantinib) tablets for the treatment of patients with previously treated advanced hepatocellular carcinoma

12 November 2019 - Approval based on statistically significant and clinically meaningful overall survival benefit demonstrated in the CELESTIAL phase 3 ...

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Drug Utilisation Sub-Committee outcome statement

13 November 2019 - The outcome statement from the October 2019 Drug Utilisation Sub-Committee meeting is now available. ...

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Health economic assessment of Tecentriq for triple negative breast cancer

8 November 2019 - TLV has produced a health economic knowledge base for the county council for the drug Tecentriq (atezolizumab).  ...

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Merck’s Ervebo [Ebola Zaire vaccine (rVSVΔG-ZEBOV-GP) live] granted conditional approval in the European Union

12 November 2019 - Authorisation represents significant advancement in the global response to Ebola. ...

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