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EMA committee recommends 13 medicines for approval in January meeting
The committee for human medicinal products recommended AstraZeneca’s COVID-19 vaccine be granted conditional marketing authorisation alongside 12 other approvals.
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Multiple Sclerosis (MS)
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FDA approves Kesimpta® (ofatumumab) for patients with relapsing multiple sclerosis
Kesimpta was approved based on trial results showing the monthly injection significantly reduced the relapse rate and disability progression of MS patients compared to a currently approved treatment.
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Sanofi to acquire Principa Biopharma for $3.68 billion
Sanofi is set to acquire Principia Biopharma Inc. for a total aggregate equity value of $3.68 billion, at $100 per share.
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Top 10 biopharma workplaces in the US
A Fortune report reveals the best 10 places to work in the US biopharmaceutical industry.
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EMA recommends 11 new medicines for approval following July meeting
Dapivirine Vaginal Ring (dapivirine) and Blenrep (belantamab mafodotin) have been recommended for approval by the EMA's CHMP, along with nine other medicines.
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NICE does not recommend Novartis’ siponimod for secondary progressive MS
NICE has decided to not recommend Mayzent (siponimod) for use on the NHS as a secondary progressive multiple sclerosis treatment because its clinical trial did not directly compare it to interferon beta-1b.
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Triple antiviral drug combination shows early promise for treating COVID-19 in Phase II trial
A Phase II clinical trial has shown that a two-week course of interferon beta-1b plus lopinavir-ritonavir and ribavirin, started within seven days of showing COVID-19 symptoms, is safe and effective.
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FDA approves Zeposia® (ozanimod) to treat relapsing forms of multiple sclerosis
The US FDA has granted approval to BMS for Zeposia, a once daily oral medication for the treatment of relapsing forms of multiple sclerosis.
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Committee for Medicinal Products for Human Use (CHMP) meeting highlights
A summary of the CHMP meeting conclusions, including medicines recommended for approval and indication extension and several safety review findings.
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US drug prices rose three times faster than inflation since 2007
A study of over 602 brand-name prescription drugs shows that list prices increased over 1.5 times and net prices rose over 3.5 times inflation in the past decade.
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FDA and EMA accept licence applications for multiple sclerosis treatment
The FDA and EMA have accepted licence applications for ofatumumab, a novel B-cell therapy for patients with relapsing forms of multiple sclerosis (RMS).
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BTK inhibitor meets primary endpoint in Phase IIb trial treating MS
According to its developers, SAR442168 significantly reduced the appearance of new gadolinium (Gd)-enhancing T1-hyperintense brain lesions in the 120 trial patients.
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EC approves Mayzent® for secondary progressive multiple sclerosis
Mayzent (siponimod) has been approved by the European Commission (EC) for adults with secondary progressive multiple sclerosis (SPMS) based on the results of the EXPAND trial.
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MS treatment trial to compare stem cell transplantation to biologic drugs
The BEAT-MS trial aims to compare the experimental autologous hematopoietic stem cell transplantation (AHSCT) therapy to the best available biologic therapies for multiple sclerosis (MS).
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Multiple sclerosis drug market predicted to reach $32.9bn by 2028
Driven by the launch of various pipeline agents, a new report has projected that the multiple sclerosis therapeutics market will reach $32.9 billion in 2028.
