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Shire claims FDA approval for slow-cooked ADHD drug
Mydayis will reach the US market in the third quarter of the year
GSK makes case for revaccination with Shingrix
The pharma giant seeks regulatory approval to treat people aged 50 plus
FDA panel backs CV claims for Novo Nordisk's Victoza
LEADER trial shows the diabetes treatment reduces risk of cardiovascular death by 13%
Sandoz joins Europe's MabThera biosimilar push
Novartis’ unit is second company to claim approval in Europe for biosimilar version
Bayer wins FDA approval for MS electronic autoinjector and app
US regulator gives green light to Betaconnect and myBETA app
NICE relents on Kadcyla after Roche pricing negotiations
HER2-positive breast cancer therapy to be made available on the NHS in England
NICE rejects Pfizer's antibody drug for leukaemia
Trial shows no survival benefit from Besponsa compared to current treatment
FDA fast-tracks Pfizer and Lilly's tanezumab
The novel pain drug treats osteoarthritis and chronic low back pain
GSK cues up regulatory filings for relapsing malaria drug
60% of patients on tafenoquine combination remained relapse-free for six months
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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Endo faces industry-first FDA call to pull its opioid painkillerMisuse of Opana ER has been associated with a ‘serious’ HIV and hep C outbreaks
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Novo Nordisk wins European approval for RefixiaPlans to launch the haemophilia B treatment in the fourth quarter
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Biogen wins European spinal muscular atrophy firstSpinraza wins accelerated approval to treat patients with the most common form of SMA
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ViiV files two-drug HIV maintenance regimenSWORD studies show treatment could maintain viral suppression
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Novo Nordisk's long-acting haemophilia B drug cleared by FDA
US approval sets up marketing battle with Bioverativ and CSL Behring
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Pfizer wins EU approval for MenB vaccine TrumenbaUS pharma firm’s injection can now be given to patients aged 10 and above
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Novartis' Zykadia claims US approval for first-line lung cancerThe Swiss pharma giant’s drug also receives CHMP positive opinion
Latest regulatory appointments
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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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Former Astellas regulatory lead joins Oxular
Robert Waters becomes regulatory affairs VP
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- Sanofi continues pharma's trend of ditching the corporate blog
- Bayer wins FDA approval for MS electronic autoinjector and app
- Warning sounded on pharma's long-term sales prospects
- Facing the new wave of biosimilars
- Sandoz joins Europe's MabThera biosimilar push
- FDA panel backs CV claims for Novo Nordisk's Victoza
- The new pharma marketing playbook
- PEGASUS SHOWREEL 2017
- Alzheon says data backs potential of Alzheimer's candidate
- Shift to value-based medicine will boost mHealth uptake
- Ashfield to host global webinar on Patient Service Team on 10 July
- Pharma needs to evolve from customer-centricity to stakeholder-centricity
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