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FDA knocks-back second Vernalis cough and cold treatment
US regulator delivers another complete response letter to the UK firm
Shire files dry eye drug lifitegrast in Europe
Analysts predict Xiidra could become a $1bn product
NICE expands Merck KGaA’s Erbitux reach
Backs the medicines use for patients with SCCHN
Bayer's Nexavar backed by NICE for liver cancer
The drug is the only approved first-line treatment for advanced HCC
SMC gives green light for Amgen’s Kyprolis
The committee also gives verdict on three other products
European Commission approves Dompé’s orphan drug
Oxervate will treat patients with neurotrophic keratitis
EMA clears Bayer's Stivarga for liver cancer
The multikinase inhibitor will treat patients with HCC
European Commission backs LEO Pharma’s Kyntheum
Drug has been approved to treat moderate-to-severe plaque psoriasis
Celgene, Agios get FDA OK for leukaemia drug Idhifa
Duo’s drug becomes first new AML therapy since Novartis' Rydapt
Facing the new wave of biosimilars
Don’t drown out the patient voice, says advocacy group
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Promoting off-label use: where to draw the line?Looking at the trend among EU member states to actively promote the off-label use of medicines
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Ready for takeoff?A new pathway promises expedited approvals for innovative medicines
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Setback for J&J as FDA panel turns down arthritis drug sirukumabUS regulator concerned with the drug’s safety
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Chiesi Group's Trimbow wins European licence European Commission approves the COPD treatment
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Most of the EU would like to host the EMANineteen member states will compete to host the agency when it leaves the UK
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Clock starts ticking on FDA review of AZ's acalabrutinibIf approved, the BTK inhibitor could achieve annual peak sales of $5bn
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Kite files first CAR-T candidate in EuropeBut will need to play catch up in the US, where Novartis has a slight lead
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After MYSTIC setback, FDA gives some comfort to AZ
Awards its PD-L1 inhibitor Imfinzi breakthrough status in locally-advanced NSCLC
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Vifor wins European approval for VeltassaEuropean Commission approves the drug to treat hyperkalaemia
Latest regulatory appointments
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Dr Desiree Luthman joins Verona PharmaShe takes up its vice president position
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IFPMA appoints Fumie Griego as assistant director generalShe joins the global pharma association from Merck KGaA
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Ergomed appoints CEO of PrimeVigilanceDr Jan Petracek to drive pharmacoviglance business
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Greenleaf Health appoints drug and biological products principalDr John Jenkins joins the FDA regulatory consulting firm
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Bayer appoints head of EU liaison officeVolker Koch-Achelpöhler succeeds Bernd Halling
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