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FDA advisors back Lilly/Incyte’s rheumatoid arthritis drug
US regulatory advisors are backing approval of the lower dose form of Eli Lilly and Incyte’s once-daily JAK inhibitor baricitinib as treatment for rheumatoid arthritis (RA).
MHRA bans valproate without pregnancy prevention programme
The Medicines and Healthcare products Regulatory Agency (MHRA) has changed the licence for valproate medicines, so that they can no longer be prescribed to females of child-bearing age unless they are on the pregnancy prevention programme.
EU reviewing MSD’s Keytruda/chemo combo
European regulators have kicked off a review of MSD’s Keytruda/pemetrexed combination for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC).
FDA rejects Pfizer’s Herceptin biosimilar
US regulators have issued a complete response letter regarding Pfizer’s filing for a biosimilar version of Roche's blockbuster cancer drug Herceptin.
AZ lung cancer combo fails to hit targets
A combination of immunotherapy drugs being tested by AstraZeneca in the third-line setting in patients with lung cancer has failed to slow disease progression or extend survival.
Ministers write letter to Vertex over Orkambi debate
Ministers from the Department of Health have written a letter asking that Vertex bring negotiations with NHS England over access to cystic fibrosis drug Orkambi “to an urgent resolution”.
Fresenius pulls out of $4.3bn Akorn merger
German healthcare firm Fresenius Kabi is walking away from a $4.3-billion merger with US generics group Akorn, claiming that the latter has failed to fulfill several closing conditions.
Takeda ups its offer for Shire
Takeda has put forward a new proposed bid for Shire, increasing the cash portion of the deal.
CHMP rejects AB Science’s ALS drug
AB Science’s share price has taken a hit after European Medicine Agency's advisors rejected approval of masitinib for amyotrophic lateral sclerosis.
Communications Team of the Year: Join our exclusive alumni of fellow Pharma winners!
The PharmaTimes Communications Team of the Year competition is the only pharma industry award that tests the competencies and potential of communications agency teams, benchmarking talent agency side – and as such, entry is a must.
Clinical Researcher of the Year finalists to face toughest challenge yet
With just 9 days to go until the prestigious PharmaTimes Clinical Researcher of the Year Awards Ceremony, the 2018 finalists are gearing up for their biggest challenge yet.
Shire turns down Takeda’s advances
Shire has now confirmed that it has thus far rejected three merger proposals from Takeda, the last one being valued at around $44 billion.
FDA advisors back approval of GW’s Epidiolex
As expected, an FDA advisory panel has backed approval of GW Pharmaceuticals/Greenwich Bioscience’s Epidiolex for treating seizures associated with Lennox-Gastaut syndrome and Dravet syndrome.
US widens use of AZ’ Tagrisso in lung cancer
AstraZeneca’s Tagrisso has been approved in the US as a first-line treatment for patients with metastatic non-small-cell lung cancer whose tumours have epidermal growth factor receptor (EGFR) mutations.
Merck sells consumer healthcare unit to P&G
Germany’s Merck is selling its consumer health unit to Procter & Gamble for around for 3.4 billion Euros.
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