European regulators are still probing the safety of Novartis AG's multiple sclerosis pill Gilenya, one of the Swiss firm's top new drug hopes, delaying an expected update on the medicine until April.
The European Medicines Agency (EMA) initially aimed to give an update on the medicine by March 16 but a spokeswoman said on Friday that the review had not yet been finalised. As a result, an announcement is now due on April 19 or 20.
The delay leaves a question mark over the product, which has seen its prospects clouded by concern about serious heart problems.
But there was also good news for Gilenya as Britain's healthcare cost-effectiveness watchdog NICE, in an about-turn, decided it was ready to recommend its use on the state health service.
Gilenya, the first multiple sclerosis (MS) pill of its kind, is seen by analysts as a potential blockbuster with annual sales of $2 billion by 2015, according to consensus forecasts collected by Thomson Reuters Pharma.
However, that is down on the $2.2 billion seen at the end of 2011 as doctors have grown more cautious about the drug following reports of heart problems in some patients and the death of one person in the United States within 24 hours of starting treatment.
Those cases prompted the EMA to start its review in January, when it also advised doctors to continuously monitor patients for six hours after giving them a first dose. The U.S. Food and Drug Administration (FDA) is also looking into the drug.
Novartis said in a statement it was working with the EU regulator to finalise the label for Gilenya and was also liaising with the FDA on its review.
Gilenya represents a significant change in MS treatment, since existing medicines like beta interferons and Elan and Biogen Idec's Tysabri must be injected.
Rival oral MS treatments in development include BG-12 from Biogen, teriflunomide from Sanofi and laquinimod from Teva.
Britain's National Institute for Health and Clinical Excellence (NICE), whose opinions are also watched closely in other countries, initially said it was unclear if Gilenya was any better than existing treatments.
It changed its mind after Novartis presented data showing benefit in a subgroup of adults with highly active disease, whose relapses had increased or stayed the same compared with the previous year despite them taking beta interferons.
Carole Longson, director of NICE's health technology evaluation centre, said it was now clear Gilenya was a cost-effective option for these patients, provided Novartis supplied the drug at the discounted price it previously suggested.
A NICE spokeswoman said the size of the discount remained confidential. The list price for 28 capsules is 1,470 pounds ($2,300) or just over 19,000 pounds per person for a year.
Novartis and Britain's MS Society welcomed the final NICE decision, which is expected to be officially published next month. ($1 = 0.6376 British pounds)
Greece has already received two bailouts totalling 240 billion euros but fellow euro zone member Ireland said last week that it would have to negotiate a third programme.
The Ukraine crisis has tested the loyalties of Bulgaria, a Balkan country with historical ties to Moscow and heavily dependent on Russian energy supplies.
Syria expels three United Nations aid workers hindering aid development in the country
Russia has overcome a "psychological barrier" and is ready to deepen its economic ties with China, Deputy Prime MinisterArkady Dvorkovich said
With Chancellor Angela Merkel's right-left coalition plus the opposition Greens, it was the biggest majority for any euro zone rescue package so far in the 631-seat chamber.
The agreement commits Tanzania, Kenya, Uganda, Rwanda and Burundi to cooperate with the United States in customs issues, ease red tape at borders, reduce customs wait times and harmonize trade standards.
Sri Lankan President Maithripala Sirisena has unnerved China with his re-examination of certain projects that Chinahas invested in, including a $1.5 billion "port city" project in Colombo.
EU energy chief Maros Sefcovic invited Russian Energy Minister Alexander Novak and his Ukrainian counterpart Volodymyr Demchyshyn for talks
Gazprom and Ukrainian state energy firm Naftogaz have accused each other of not sticking to agreements on gas supplies.
The new canal, that will allow two-way traffic of larger ships, is supposed to increase revenues by 2023 to $13 billion.
A day after euro zone finance ministers agreed to a four-month extension of a financial rescue, Finance Minister Yanis Varoufakis gave a frank assessment of Greece's financial position.
The agreement is the culmination of talks that began in September after the government decided its own solutions to its fiscal crisis were failing to convince investors.
Energy union highlights bloc's attempt to seek independency from its main gas supplier - Russia.
Merkel's right-left coalition is set to prevail, despite vocal pockets of resistance on the right and left.
Republicans passed the bill to increase pressure on Obama to approve the pipeline, a move the president said would bypass a State Department process that will determine whether the project is in the U.S. national interest.
Turkish PM Davutoglu expresses Turkey's readiness to help in supplying energy to Central Europe.