US regulators have issued a complete response letter regarding Pfizer’s filing for a biosimilar version of Roche’s blockbuster cancer drug Herceptin.
News
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.
A great mix of companies represented at International Clinical Researcher of the Year
Having seen some outstanding performances from individuals and teams at the PharmaTimes International Clinical Researcher of the Year finals days, the 2018 PharmaTimes International Clinical Researcher of the Year Awards Ceremony looks set to be one of the best yet.
FDA clears first therapy for inherited rickets
US regulators have approved the first drug to treat adults and children with x-linked hypophosphatemia (XLH), a rare, inherited form of rickets.
Final NHS nod for Roche’s RoActemra
Roche/Chugai’s RoActemra should be routinely offered throughout the NHS to adults with giant cell arteritis (GCA) within the next three months, following a final green light from cost regulators.
