US regulators have approved Biocodex’ Diacomit for the treatment of seizures associated with Dravet syndrome (DS), a rare and difficult to treat form of epilepsy.
News
Gov’t asks drugmakers to stockpile meds for Brexit
The government has asked drug manufacturers to increase stockpiles of medicines to ensure continued supply in the event that the UK leaves the EU in a ‘no-deal’ scenario.
Shire’s HAE drug Takhzyro gets green light in the US
Shire’s Takhzyro has been approved in the US for the prevention of attacks of hereditary angioedema (HAE) in patients 12 years of age and older.
Mallinckrodt’s stannsoporfin turned away by FDA
US regulators have rejected an application by Mallinckrodt to market stannsoporfin for newborns at risk of jaundice.
US approves first drug for neurotrophic keratitis
US regulators have approved the first drug to treat neurotrophic keratitis, a rare degenerative disease affecting the cornea.
Sobi secures NHS reimbursement for Ravicti
Rare disease group Swedish Orphan Biovitrum (Sobi) says it has gained NHS England reimbursement for Ravicti for long-term management of urea-cycle disorders (UCDs) in adults and children.
Novimmune submits lead drug emapalumab in Europe
Swiss biotech Novimmune has submitted a marketing application in Europe seeking permission to market its lead compound emapalumab for the treatment of patients with primary Hemophagocytic Lymphohistiocytosis (HLH).
AZ mulling over mixed data for Bevespi Aerosphere
AstraZeneca has announced mixed top-line results from the AERISTO Phase IIIb trial for Bevespi Aerosphere in patients with moderate to very severe chronic obstructive pulmonary disease (COPD).
Vectura concludes paediatric asthma studies
Chippenham, UK-based Vectura says it has now successfully concluded two paediatric studies to support the potential use of asthma drug/device combo VR647.
NICE clears use of steam therapy for benign enlarged prostate
A NICE green light is allowing men with benign prostatic hyperplasia to receive a procedure called transurethral water vapour ablation on the NHS.
MSD bags full US nod for Keytruda/Alimta combo in NSCLC
MSD’s Keytruda has been awarded full approval in the US in combination with Lilly’s Alimta and platinum chemotherapy as first-line treatment for metastatic non-squamous non-small cell lung cancer.
Researchers hail “exciting results” in ovarian, lung cancer trial
A chemo/targeted drug combination being trialed by UK researchers has shown promise in patients with advanced ovarian or lung cancer in whom all other treatments have failed.
Scientists uncover potential new target for lung cancer therapy
Cancer Research UK-funded scientists based at the University of Cambridge have identified a new target for the treatment of lung squamous cell carcinoma.
Measles cases in Europe hit record high
The World Health Organisation is calling on countries to implement broad measures to stop the spread of measles after the number of cases reached a record high in the region.
Pfizer’s lorlatinib clears first hurdle to UK early access scheme
Pfizer’s lorlatinib has been designated a Promising Innovative Medicine for the treatment of some patients with ALK-positive advanced non-small cell lung cancer.
