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FDA panel undermines Lilly and Incyte’s baricitinib hopes
Mixed review doesn’t bode well in competitive market
BMS claims rapid FDA nod for Opdivo plus Yervoy in kidney cancer
Data shows the combo can improve survival compared to Pfizer’s Sutent
Reviews start for Pfizer’s wildcard lung cancer drug dacomitinib
Both EU and US regulatory advisors are currently assessing the drug
NICE rejects Sanofi’s Dupixent for atopic dermatitis at first call
Dupixent is still too expensive despite discount, says the UK’s cost effectiveness body
Sanofi’s PD-1 inhibitor starts EU review for skin cancer
Cemiplimab could be the first PD-1-targeting drug approved for CSCC
Alkermes slumps as FDA turns down depression drug
The drug needs to be supported with additional trials and a bioavailability study, says US regulator
First blood to Roche in Hemlibra patent fight with Shire
The new haemophilia drug does not infringe Baxalta’s patent, rules Tokyo court
Takeda’s Alofisel becomes Europe’s first allogeneic stem cell therapy
Will treat perianal fistulas in adult patients with Crohn’s disease
AZ finally gets EU nod for Veltassa rival Lokelma
And expects a US FDA verdict for the hyperkalaemia treatment later this year
Moving times
Continuity and stability are vital when it comes to the EMA's relocation when it leaves London
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SMC gives green light for Amgen’s KyprolisThe committee also gives verdict on three other products
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Facing the new wave of biosimilarsDon’t drown out the patient voice, says advocacy group
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ViiV’s two-drug HIV combo backed by CHMPThe committee also backs two biosimilar medicines
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Six new national standards are launched across UKWill help to improve public involvement in research says ABPI’s Mike Thompson
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Sun Pharma passes milestone with novel psoriasis drug approvalIlumya will treat adults with a moderate-to-severe form of the skin condition
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Seattle Genetics claims key US approval for Adcetris Becomes the first new treatment for advanced Hl in more than 40 years
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EMA starts review of Xtandi in non-metastatic prostate cancerThe evaluation is based on positive results from the PROSPER trial
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NICE says OK to Keytruda for bladder cancer via the CDFBecomes the first immunotherapy recommended for UC after chemotherapy
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FDA approves another home genetic testing service23andMe’s kit will check for an increased risk of certain cancers developing
Latest regulatory appointments
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Professor Carole Longson moves from NICE to the ABPIShe joins the UK pharma body as its chief scientific officer
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MedTech Europe appoints new board of directors
Chair of the board Michelle Brennan is among those newly elected
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Greg Perry joins IFPMA as assistant director generalWill move to the global industry body from the Medicines Patent Pool
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AVEO appoints Nikhil Mehta as its senior VP, regulatory and quality assurance
He joins the biopharma from Tang Capital Management
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IFPMA names new communications director
Helen Gallagher joins the association from Ferring Pharmaceuticals
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