The duo some time back attended Isha Ambani and Anand Piramal's engagement bash at Lake Como, Italy.
Reported by Zee News 2 hours ago.
Sonam Kapoor piggybacks on hubby Anand Ahuja and the pic spills love!
↧
↧
Italy's new budget sees debt/GDP falling in 2019: League lawmaker
Italy's new budget expects debt to fall in terms of gross domestic output in 2019, a prominent lawmaker of the League ruling party said on Friday.
Reported by Reuters 1 hour ago.
↧
Italian Lawmaker Bagnai: Would be a risk for Europe to open a new front with Italy while dealing with Brexit
Following the comments from the Italian Finance Minister Tria, an Italian lawmaker Bagnai was on the wires last minutes, via Reuters, noting that there would be a risk for Europe to open a new front with Italy while dealing with Brexit.
Meanwhile, Italy’s Lega Party said that the budget deficit numbers in Italy’s budget document are not written in stone. Reported by FXstreet.com 2 hours ago.
Meanwhile, Italy’s Lega Party said that the budget deficit numbers in Italy’s budget document are not written in stone. Reported by FXstreet.com 2 hours ago.
↧
EUR/USD drops to fresh lows near 1.1630 ahead of EMU CPI
· *The pair sinks further and tests fresh daily lows near 1.1630.*
· *The greenback manages to retake the 95.00 handle.*
· *Italian budget headlines keep weighing on spot.*
The selling bias around the European currency is now picking up pace and is dragging *EUR/USD* to fresh lows in the 1.1630 region.
*EUR/USD looks to EMU data, Italy*
The pair remains vigilant on the developments in the Italian political arena and the bonds market, where the announcement of the 2.4% budget deficit seems to have disappointed expectations among traders. This figure represents the upper end of the 2.0%-2.4% initial target.
In addition, the greenback continues its march north as investors continue to price in a fourth rate hike by the Federal Reserve (likely in December), particularly after Wednesday’s FOMC meeting and auspicious results in the US docket.
Later in the day, advanced CPIs in France, Spain and Italy are due seconded by German labour market figures and the more relevant flash inflation figures in the euro area.
Across the pond, inflation tracked by the Core PCE will be the salient event seconded by Personal Income/Spending and the final print of the U-Mich index.
*EUR/USD levels to watch*
At the moment, the pair is losing 0.13% at 1.1626 and a breakdown of 1.1618 (55-day SMA) would target 1.1526 (low Sep. 10) en route to 1.1508 (low May 29). On the flip side, the next up barrier aligns at 1.1815 (high Sep.24) seconded by 1.1853 (monthly high Jun.14) and finally 1.1944 (200-day SMA). Reported by FXstreet.com 1 hour ago.
· *The greenback manages to retake the 95.00 handle.*
· *Italian budget headlines keep weighing on spot.*
The selling bias around the European currency is now picking up pace and is dragging *EUR/USD* to fresh lows in the 1.1630 region.
*EUR/USD looks to EMU data, Italy*
The pair remains vigilant on the developments in the Italian political arena and the bonds market, where the announcement of the 2.4% budget deficit seems to have disappointed expectations among traders. This figure represents the upper end of the 2.0%-2.4% initial target.
In addition, the greenback continues its march north as investors continue to price in a fourth rate hike by the Federal Reserve (likely in December), particularly after Wednesday’s FOMC meeting and auspicious results in the US docket.
Later in the day, advanced CPIs in France, Spain and Italy are due seconded by German labour market figures and the more relevant flash inflation figures in the euro area.
Across the pond, inflation tracked by the Core PCE will be the salient event seconded by Personal Income/Spending and the final print of the U-Mich index.
*EUR/USD levels to watch*
At the moment, the pair is losing 0.13% at 1.1626 and a breakdown of 1.1618 (55-day SMA) would target 1.1526 (low Sep. 10) en route to 1.1508 (low May 29). On the flip side, the next up barrier aligns at 1.1815 (high Sep.24) seconded by 1.1853 (monthly high Jun.14) and finally 1.1944 (200-day SMA). Reported by FXstreet.com 1 hour ago.
↧
Italy's President Mattarella asked Tria not to resign - Reuters
Several Italian newspapers carried a story on Friday, citing that the Italian President Sergio Mattarella had asked Finance Minister Giovanni Tria not to resign in order to avoid market uncertainty, Reuters reports.
On Wednesday, the government announced a budget deficit target of 2.4% for the next three years. In contrast, Tria wanted a deficit set as low as 1.6% next year. Reported by FXstreet.com 1 hour ago.
On Wednesday, the government announced a budget deficit target of 2.4% for the next three years. In contrast, Tria wanted a deficit set as low as 1.6% next year. Reported by FXstreet.com 1 hour ago.
↧
↧
EU's Moscovici: Italy must cut ‘explosive debt’
‘Not in our interests’ that Italy doesn’t respect EU budget rules, commented the EU Economics Commissioner Pierre Moscovici.
*Additional quotes:*
• Will be able to respond to Italy's budget proposals after 15th October.
• No interest in triggering Italian crisis.
• Italy must cut ‘explosive debt’.
Meanwhile, Italian bond yields surged in early trades as investors digested the news of a 2.4% budget deficit target, with the spread between German-Italy 10-year bond yields rising to a three-week high and eventually weighing on the shared currency.
Reported by FXstreet.com 1 hour ago.
*Additional quotes:*
• Will be able to respond to Italy's budget proposals after 15th October.
• No interest in triggering Italian crisis.
• Italy must cut ‘explosive debt’.
Meanwhile, Italian bond yields surged in early trades as investors digested the news of a 2.4% budget deficit target, with the spread between German-Italy 10-year bond yields rising to a three-week high and eventually weighing on the shared currency.
Reported by FXstreet.com 1 hour ago.
↧
Journalist Who Spread Conspiracy Theories Will Oversee Italy’s State TV
The appointment of Marcello Foa has raised alarms and marks a victory of the populist parties over the establishment media that once discounted them.
Reported by NYTimes.com 58 minutes ago.
↧
Arsenal balls: Aaron Ramsey takes his one goal a season and heads to Italy
Yesterday Arsenal fans learned something that had escaped them. The Mirror’s John Cross told them and readers of his Daily Mirror “exclusive” that Aaron Ramsey is “one of Europe’s top goal-scoring midfielders”. Last season, Ramsey scored one goal in the Premier League. Are goals from midfield so hard to come by that one represents the apogee? That question to David Silva, Mo Salah, Deli Alli, Kevin de Bruyne, James Maddison, Bernardo Silva, Abdoulaye Doucoure and Pascal Groß. We could go round Europe looking at goalscoring midfielders, but the point is made: Ramsey is not as effective as his PR says he is.
But the impression that he hits the net pervades. Last night, former Arsenal star Ian Wright told Sky Sports: “…Aaron Ramsey is captain material… It should have been done ages ago. Ivan Gazidis [the Arsenal chief executive who left for AC Milan] has got a lot to answer for for this to happen because Ramsey should be a focal point in the team… He’s somebody that I’d like to see stay because I think he is that player who is never afraid. *He scores goals*.”
He scores very few goals. And another player on the big money Ramsey’s after might score more goals than him. Arsenal’s habit in recent years of sticking with players on the drift has seen them not challenge for the title and slip out of the Champions League slots. Unai Emery is building his own team. Why does he need Wenger’s journeymen?
So Ramsey’s off in search of vast riches and loyalty payments elsewhere. As soon as Arsenal agreed to pay £350,000 a week to Mesut Ozil, every other player; on Arsenal’s books thought themselves worth more. But they’re not. So Arsenal withdrew their contract offer to Ramsey – the one he hadn’t agreed to sign.
The Standard says he’s booking a one-way flight this January to Juventus or AC Milan. Or maybe it’ll be Chelsea or Manchester United? Anyone in the market for a skilful but slowing midfielder who scores one goal a season knows his agent’s number. Reported by Anorak 40 minutes ago.
But the impression that he hits the net pervades. Last night, former Arsenal star Ian Wright told Sky Sports: “…Aaron Ramsey is captain material… It should have been done ages ago. Ivan Gazidis [the Arsenal chief executive who left for AC Milan] has got a lot to answer for for this to happen because Ramsey should be a focal point in the team… He’s somebody that I’d like to see stay because I think he is that player who is never afraid. *He scores goals*.”
He scores very few goals. And another player on the big money Ramsey’s after might score more goals than him. Arsenal’s habit in recent years of sticking with players on the drift has seen them not challenge for the title and slip out of the Champions League slots. Unai Emery is building his own team. Why does he need Wenger’s journeymen?
So Ramsey’s off in search of vast riches and loyalty payments elsewhere. As soon as Arsenal agreed to pay £350,000 a week to Mesut Ozil, every other player; on Arsenal’s books thought themselves worth more. But they’re not. So Arsenal withdrew their contract offer to Ramsey – the one he hadn’t agreed to sign.
The Standard says he’s booking a one-way flight this January to Juventus or AC Milan. Or maybe it’ll be Chelsea or Manchester United? Anyone in the market for a skilful but slowing midfielder who scores one goal a season knows his agent’s number. Reported by Anorak 40 minutes ago.
↧
10 things you need to know in markets today
Good morning! Here is what you need to know on Friday.1. The Securities and Exchange Commission is suing Tesla CEO Elon Musk on charges that he made "false and misleading statements" and wants to bar him from helming a public company. The SEC says the charges stem from Musk's tweets about taking his electric-car company private at $420 a share, a claim he tweeted to his 22 million followers on August 7. Tesla shares fell as much as 11% in after-hours trading on the news.
2. The US Senate Judiciary Committee will vote on Brett Kavanaugh's confirmation to the Supreme Court on Friday morning, after a day of contentious hearings during which Christine Blasey Ford testified about her claim that Kavanaugh sexually assaulted her, and Kavanaugh testified in his own defense. If the committee's confirmation vote on Friday lands in Kavanaugh's favor, then senators would move forward with a procedural vote on the Senate floor Saturday. That could potentially set up a final confirmation vote next week.
3. The dollar rose against peers, advancing to a nine-month high versus the yen, after data reinforced upbeat views about the US economy and backed the Federal Reserve's signal for a steady course of rate increases over the next year. US gross domestic product grew at a 4.2% clip in the second quarter, the fastest in nearly four years, according to government data on Thursday.
4. Ryanair is bracing on Friday for another strike by staff as walkouts in six European countries, mainly cabin crew, force flight cancellations that will disrupt the plans of more than 40,000 travellers. Europe's largest low-cost carrier has faced a string of strikes since it recognized trade unions for the first time in December, damaging bookings and forcing it to consider cutting short-term growth plans if labor unrest continues.
5. Streaming service Netflix plans to double its investments in France and produce 14 local shows, twice as many as previously planned, chief executive Reed Hastings said Friday. Hastings did not disclose how much Netflix would invest in France, though it would be "many millions of euros", he told French radio station BFM Business.
6. Italy’s government on Thursday targeted the budget deficit at 2.4% of gross domestic product for the next three years, defying Brussels and marking a victory for party chiefs over economy minister Giovanni Tria, an unaffiliated technocrat. Tria had initially wanted a deficit set as low as 1.6% next year, hoping to respect European Union demands that Italy progressively cut the fiscal gap to rein in its high debt.
7. Global mergers and acquisitions dropped to $783 billion in the third quarter, down 35% from the prior quarter, as the escalating trade dispute between the United States and China cast a shadow on the financial and regulatory prospects of some deals.
8. Britain's biotechnology industry has raised a bumper £1.56 billion ($2.05 billion) in the first eight months of this year, surpassing the £1.2 billion reached in the whole of 2017, despite anxiety in the sector about the fallout from Brexit. The increase has been fueled by recent changes to venture capital tax incentives, according to UK BioIndustry Association (BIA) CEO Steve Bates, as well as global investor enthusiasm for drug discoveries emanating from biotech labs.
9. Macquarie Bank CEO Nicholas Moore has been implicated in a financial investigation by German authorities. The inquiry concerns a complex dividend trading scheme that is currently the subject of civil litigation. In a statement to the ASX this morning, Macquarie said the Cologne Prosecutor’s Office is expected to speak with at least 30 senior staff members involved in the deal.
10. Sword-wielding headhunter: A senior executive at one of Wall Street’s top recruiting firms was arrested for allegedly slashing a bride with a sword after a dispute broke out. Luckily, the bride suffered non-life threatening injuries to her arm. The man, however, now faces multiple charges and has been suspended without pay, pending the result of the investigation.
Join the conversation about this story »
NOW WATCH: Ray Dalio says the economy looks like 1937 and a downturn is coming in about two years Reported by Business Insider 43 minutes ago.
↧
↧
EUR/GBP Technical Analysis: Set-up points to an extension of the declining trend
* • The cross has been trending lower alongside a downward sloping channel and remained under some selling pressure for the fifth consecutive session on Friday.*
* • The fact that it remains well below important intraday moving averages - 50, 100 & 200-hour SMAs support prospects an extension of the ongoing downward trajectory. *
* • Technical indicators on the 1-hourly chart have been gradually gaining negative momentum and add credence to the near-term negative outlook amid concerns over Italy’s budget proposal.*
* • Today's macroeconomic releases - the flash EZ CPI, the final GDP growth figures and current account deficit figures from the UK, will now be looked upon for some fresh impetus.*
*EUR/GBP 1-hourly chart*
Spot Rate: 0.8895
Daily High: 0.8907
Trend: Bearish
*Resistance*
R1: 0.8915 (horizontal zone)
R2: 0.8933 (R1 daily pivot-point)
R3: 0.8944 (50-day SMA)
*Support*
S1: 0.8873 (recent daily closing low)
S2: 0.8855 (S2 daily pivot-point)
S3: 0.8841 (200-day SMA)
Reported by FXstreet.com 51 minutes ago.
* • The fact that it remains well below important intraday moving averages - 50, 100 & 200-hour SMAs support prospects an extension of the ongoing downward trajectory. *
* • Technical indicators on the 1-hourly chart have been gradually gaining negative momentum and add credence to the near-term negative outlook amid concerns over Italy’s budget proposal.*
* • Today's macroeconomic releases - the flash EZ CPI, the final GDP growth figures and current account deficit figures from the UK, will now be looked upon for some fresh impetus.*
*EUR/GBP 1-hourly chart*
Spot Rate: 0.8895
Daily High: 0.8907
Trend: Bearish
*Resistance*
R1: 0.8915 (horizontal zone)
R2: 0.8933 (R1 daily pivot-point)
R3: 0.8944 (50-day SMA)
*Support*
S1: 0.8873 (recent daily closing low)
S2: 0.8855 (S2 daily pivot-point)
S3: 0.8841 (200-day SMA)
Reported by FXstreet.com 51 minutes ago.
↧
EUR/USD seen consolidative in the next months – Danske Bank
Chief Analyst at Danske Bank Arne Rasmussen expects the pair to move within a consolidation theme in the next months.
*Key Quotes*
“For FX markets we have over the past months seen a significant repricing of the Italian political risk premium embedded into the EUR”.
“Indeed, diminished Italy worries and consensus over summer positioning for a budget deficit fairly close to the announced figure was an important reason for us to raise our near-term *EUR/USD* forecast profile this month”.
“As a result, the announced budget should have but a limited impact on the EUR and we still pencil in a range-trading EUR/USD over the coming months with risks skewed towards a slightly stronger USD”. Reported by FXstreet.com 51 minutes ago.
*Key Quotes*
“For FX markets we have over the past months seen a significant repricing of the Italian political risk premium embedded into the EUR”.
“Indeed, diminished Italy worries and consensus over summer positioning for a budget deficit fairly close to the announced figure was an important reason for us to raise our near-term *EUR/USD* forecast profile this month”.
“As a result, the announced budget should have but a limited impact on the EUR and we still pencil in a range-trading EUR/USD over the coming months with risks skewed towards a slightly stronger USD”. Reported by FXstreet.com 51 minutes ago.
↧
Italy: Finally agreement reached on budget deficit – Danske Bank
Analysts at Danske Bank note that the Italian government said last night that it has reached an agreement that the budget deficit will be 2.4% in 2019.
*Key Quotes*
“It is well above market consensus, which was probably around 2% or maybe even lower after the comments over the last week from FM Tria. It was also in the upper end of our own 2.0-2.4% range.”
“Importantly, it is also above the assumption used by Fitch when Italy was put on negative outlook. A one-notch downgrade by Fitch will now be difficult to avoid. Moody's also has a lower assumption and has Italy on 'negative watch', and could come out anytime (deadline end of October) with a potential downgrade.”
“2.4% is of course well below the important 3% EU limit. But few expected that Italy would dare to breach the 3% level. Hence, we should expect quite a negative opening for BTPs this morning.” Reported by FXstreet.com 37 minutes ago.
*Key Quotes*
“It is well above market consensus, which was probably around 2% or maybe even lower after the comments over the last week from FM Tria. It was also in the upper end of our own 2.0-2.4% range.”
“Importantly, it is also above the assumption used by Fitch when Italy was put on negative outlook. A one-notch downgrade by Fitch will now be difficult to avoid. Moody's also has a lower assumption and has Italy on 'negative watch', and could come out anytime (deadline end of October) with a potential downgrade.”
“2.4% is of course well below the important 3% EU limit. But few expected that Italy would dare to breach the 3% level. Hence, we should expect quite a negative opening for BTPs this morning.” Reported by FXstreet.com 37 minutes ago.
↧
Takeda and Lundbeck submit New Drug Application (NDA) for vortioxetine in Japan for the treatment of Major Depressive Disorder (MDD)
Copenhagen, Sept. 28, 2018 (GLOBE NEWSWIRE) --
· NDA submission highlights four key studies involving approximately 1,400 patients, including the pivotal phase III study conducted in Japan
· Pivotal phase III study demonstrated positive results of vortioxetine as compared to placebo for the treatment of MDD in Japanese adults
*Valby, Denmark and Osaka, Japan, 28 September 2018* - H. Lundbeck A/S (Lundbeck) and its partner Takeda Pharmaceutical Company Limited (Takeda) today announced the submission of a New Drug Application (“NDA”) to the Japanese Ministry of Health, Labour and Welfare for vortioxetine for the treatment of Major Depressive Disorder (MDD) in adults. MDD is a complex but common disorder with more than 3.5 million cases in Japan, affecting 3% of the population^i.
The NDA filing included data from the pivotal phase III randomized, placebo-controlled study (NCT02389816) in MDD. Approximately 490 Japanese adults with recurrent MDD were randomized to receive vortioxetine (10 and 20 mg), or placebo. The primary endpoint was the change from baseline (i.e. the start of double-blind treatment) in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score after 8 weeks of treatment. The study demonstrated positive results of vortioxetine as compared to placebo for the treatment of MDD in adults. Full results will be presented at a scientific meeting in the future. The regulatory submission also featured data from three other key studies conducted globally (NCT01255787) and in Japan (NCT01355081, NCT01395147).
“Today's filing for regulatory approval in Japan by our partner Takeda is an important step for Lundbeck and Takeda to bring vortioxetine to patients suffering from major depressive disorder in Japan”, said Jacob Tolstrup, Executive Vice President, Commercial Operations and continues “Japan is an important strategic market for Lundbeck and we look forward to collaborating with the Japanese Ministry of Health, Labour and Welfare as they review the package”.
“MDD is a multifaceted condition that has emotional and physical symptoms and can impair cognitive functions. As such, it represents a significant medical need,” says Naoyoshi Hirota, head of Takeda Development Center Japan. “We are pleased by today’s regulatory filing, as it demonstrates our joint commitment with Lundbeck, and the belief that vortioxetine has the potential to become a new treatment option for patients in Japan suffering from this serious and complex condition.”
Lundbeck and Takeda will co-commercialize vortioxetine in Japan once approved and both companies are currently in the process of evaluating and planning the commercialization strategy.
About Major Depressive Disorder (MDD)
MDD is a complex mental health illness that affects approximately 300 million people globally^ii. Also known as clinical depression, MDD is the leading cause of disability worldwide and a major contributor to the overall global burden of disease. MDD may trigger emotional, cognitive and physical symptoms, which includes depressed mood, loss of interest or pleasure, significant weight loss or gain or change in appetite, insomnia or hypersomnia, psychomotor agitation or retardation, fatigue or loss of energy, feelings of worthlessness or excessive guilt, diminished ability to think or concentrate, or indecisiveness, and recurrent suicidal ideation.
About vortioxetine
The mechanism of the antidepressant effect of vortioxetine is not fully understood. It is an inhibitor of serotonin (5-HT) reuptake and that is thought to be a mechanism of its action. It is also an agonist at 5-HT[1A] receptors, a partial agonist at 5-HT[1B] receptors and an antagonist at 5-HT[3], 5-HT[1D] and 5-HT[7] receptors. The contribution of each of these activities to vortioxetine’s antidepressant effect has not been established. It is considered to be the first and only compound with this combination of pharmacodynamic activity. The clinical relevance of this is unknown.
Vortioxetine was discovered by Lundbeck researchers in Copenhagen, Denmark. The clinical trial program in Japan was conducted by Takeda.
The World Health Organization has issued an Anatomical Therapeutic Chemical (ATC) code for vortioxetine that places it in the category of "Other" antidepressants.
The U.S Food and Drug Administration (FDA) approved vortioxetine (Trintellix®) on 30 September 2013 for the treatment of MDD in adults. Vortioxetine is furthermore approved in 77 countries (including Europe, Australia, Brazil, Canada, Chile, China, Hong Kong, Mexico, Saudi Arabia, Singapore, South Africa, South Korea and Turkey). It is available in more than 60 countries to date. Depending on market vortioxetine is recognized as Trintellix^® or Brintellix^®.
Lundbeck contacts
Investors: Media:
Palle Holm Olesen Mads Kronborg
Vice President, Investor Relations Senior Director, Corp. Communication
PALO@lundbeck.com MAVK@lundbeck.com
+45 30 83 24 26 +45 36 43 40 00
Takeda Pharmaceutical Company Limited Contacts
Japanese media: Media outside Japan
Taeko Katuono Rachel Wiese
taeko.katuono@takeda.com rachel.wiese@takeda.com
+81 3 3278 2095 +1 917 796 8703
About H. Lundbeck A/S
H. Lundbeck A/S (LUN.CO, LUN DC, HLUYY) is a global pharmaceutical company specialized in psychiatric and neurological disorders. For more than 70 years, we have been at the forefront of research within neuroscience. Our key areas of focus are Alzheimer's disease, depression, Parkinson's disease and schizophrenia.
Our approximately 5,000 employees in 55 countries are engaged in the entire value chain throughout research, development, manufacturing, marketing and sales. Our pipeline consists of several late-stage development programmes and our products are available in more than 100 countries. We have production facilities in Denmark, France and Italy. Lundbeck generated revenue of DKK 17.2 billion in 2017 (EUR 2.3 billion; USD 2.6 billion).
For additional information, we encourage you to visit our corporate site www.lundbeck.com and connect with us on Twitter at @Lundbeck.
About Takeda Pharmaceutical Company Limited
Takeda Pharmaceutical Company Limited (TSE: 4502) is a global, research and development-driven pharmaceutical company committed to bringing better health and a brighter future to patients by translating science into life-changing medicines. Takeda focuses its R&D efforts on oncology, gastroenterology and neuroscience therapeutic areas plus vaccines. Takeda conducts R&D both internally and with partners to stay at the leading edge of innovation. Innovative products, especially in oncology and gastroenterology, as well as Takeda’s presence in emerging markets, are currently fueling the growth of Takeda. Approximately 30,000 Takeda employees are committed to improving quality of life for patients, working with Takeda’s partners in health care in more than 70 countries. For more information, visit https://www.takeda.com/newsroom/.
*Safe Harbor/Forward-Looking Statements*
*The above information contains forward-looking statements that provide our expectations or forecasts of future events such as new product introductions, product approvals and financial performance. *
*Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions. This may cause actual results to differ materially from expectations and it may cause any or all of our forward-looking statements here or in other publications to be wrong. Factors that may affect future results include interest rate and currency exchange rate fluctuations, delay or failure of development projects, production problems, unexpected contract breaches or terminations, government-mandated or market-driven price decreases for Lundbeck's products, introduction of competing products, Lundbeck's ability to successfully market both new and existing products, exposure to product liability and other lawsuits, changes in reimbursement rules and governmental laws and related interpretation thereof, and unexpected growth in costs and expenses.*
*Certain assumptions made by Lundbeck are required by Danish Securities Law for full disclosure of material corporate information. Some assumptions, including assumptions relating to sales associated with product that is prescribed for unapproved uses, are made taking into account past performances of other similar drugs for similar disease states or past performance of the same drug in other regions where the product is currently marketed. It is important to note that although physicians may, as part of their freedom to practice medicine in the US, prescribe approved drugs for any use they deem appropriate, including unapproved uses, at Lundbeck, promotion of unapproved uses is strictly prohibited.*
--------------------^i Global Burden of Disease. GHDx. Available at http://ghdx.healthdata.org/gbd-results-tool. Accessed August 29, 2018.
^ii World Health Organization (WHO). Depression. http://www.who.int/news-room/fact-sheets/detail/depression. Accessed on June 4, 2018.
*Attachment*
· Vortioxetine-JPfiling UK Reported by GlobeNewswire 28 minutes ago.
· NDA submission highlights four key studies involving approximately 1,400 patients, including the pivotal phase III study conducted in Japan
· Pivotal phase III study demonstrated positive results of vortioxetine as compared to placebo for the treatment of MDD in Japanese adults
*Valby, Denmark and Osaka, Japan, 28 September 2018* - H. Lundbeck A/S (Lundbeck) and its partner Takeda Pharmaceutical Company Limited (Takeda) today announced the submission of a New Drug Application (“NDA”) to the Japanese Ministry of Health, Labour and Welfare for vortioxetine for the treatment of Major Depressive Disorder (MDD) in adults. MDD is a complex but common disorder with more than 3.5 million cases in Japan, affecting 3% of the population^i.
The NDA filing included data from the pivotal phase III randomized, placebo-controlled study (NCT02389816) in MDD. Approximately 490 Japanese adults with recurrent MDD were randomized to receive vortioxetine (10 and 20 mg), or placebo. The primary endpoint was the change from baseline (i.e. the start of double-blind treatment) in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score after 8 weeks of treatment. The study demonstrated positive results of vortioxetine as compared to placebo for the treatment of MDD in adults. Full results will be presented at a scientific meeting in the future. The regulatory submission also featured data from three other key studies conducted globally (NCT01255787) and in Japan (NCT01355081, NCT01395147).
“Today's filing for regulatory approval in Japan by our partner Takeda is an important step for Lundbeck and Takeda to bring vortioxetine to patients suffering from major depressive disorder in Japan”, said Jacob Tolstrup, Executive Vice President, Commercial Operations and continues “Japan is an important strategic market for Lundbeck and we look forward to collaborating with the Japanese Ministry of Health, Labour and Welfare as they review the package”.
“MDD is a multifaceted condition that has emotional and physical symptoms and can impair cognitive functions. As such, it represents a significant medical need,” says Naoyoshi Hirota, head of Takeda Development Center Japan. “We are pleased by today’s regulatory filing, as it demonstrates our joint commitment with Lundbeck, and the belief that vortioxetine has the potential to become a new treatment option for patients in Japan suffering from this serious and complex condition.”
Lundbeck and Takeda will co-commercialize vortioxetine in Japan once approved and both companies are currently in the process of evaluating and planning the commercialization strategy.
About Major Depressive Disorder (MDD)
MDD is a complex mental health illness that affects approximately 300 million people globally^ii. Also known as clinical depression, MDD is the leading cause of disability worldwide and a major contributor to the overall global burden of disease. MDD may trigger emotional, cognitive and physical symptoms, which includes depressed mood, loss of interest or pleasure, significant weight loss or gain or change in appetite, insomnia or hypersomnia, psychomotor agitation or retardation, fatigue or loss of energy, feelings of worthlessness or excessive guilt, diminished ability to think or concentrate, or indecisiveness, and recurrent suicidal ideation.
About vortioxetine
The mechanism of the antidepressant effect of vortioxetine is not fully understood. It is an inhibitor of serotonin (5-HT) reuptake and that is thought to be a mechanism of its action. It is also an agonist at 5-HT[1A] receptors, a partial agonist at 5-HT[1B] receptors and an antagonist at 5-HT[3], 5-HT[1D] and 5-HT[7] receptors. The contribution of each of these activities to vortioxetine’s antidepressant effect has not been established. It is considered to be the first and only compound with this combination of pharmacodynamic activity. The clinical relevance of this is unknown.
Vortioxetine was discovered by Lundbeck researchers in Copenhagen, Denmark. The clinical trial program in Japan was conducted by Takeda.
The World Health Organization has issued an Anatomical Therapeutic Chemical (ATC) code for vortioxetine that places it in the category of "Other" antidepressants.
The U.S Food and Drug Administration (FDA) approved vortioxetine (Trintellix®) on 30 September 2013 for the treatment of MDD in adults. Vortioxetine is furthermore approved in 77 countries (including Europe, Australia, Brazil, Canada, Chile, China, Hong Kong, Mexico, Saudi Arabia, Singapore, South Africa, South Korea and Turkey). It is available in more than 60 countries to date. Depending on market vortioxetine is recognized as Trintellix^® or Brintellix^®.
Lundbeck contacts
Investors: Media:
Palle Holm Olesen Mads Kronborg
Vice President, Investor Relations Senior Director, Corp. Communication
PALO@lundbeck.com MAVK@lundbeck.com
+45 30 83 24 26 +45 36 43 40 00
Takeda Pharmaceutical Company Limited Contacts
Japanese media: Media outside Japan
Taeko Katuono Rachel Wiese
taeko.katuono@takeda.com rachel.wiese@takeda.com
+81 3 3278 2095 +1 917 796 8703
About H. Lundbeck A/S
H. Lundbeck A/S (LUN.CO, LUN DC, HLUYY) is a global pharmaceutical company specialized in psychiatric and neurological disorders. For more than 70 years, we have been at the forefront of research within neuroscience. Our key areas of focus are Alzheimer's disease, depression, Parkinson's disease and schizophrenia.
Our approximately 5,000 employees in 55 countries are engaged in the entire value chain throughout research, development, manufacturing, marketing and sales. Our pipeline consists of several late-stage development programmes and our products are available in more than 100 countries. We have production facilities in Denmark, France and Italy. Lundbeck generated revenue of DKK 17.2 billion in 2017 (EUR 2.3 billion; USD 2.6 billion).
For additional information, we encourage you to visit our corporate site www.lundbeck.com and connect with us on Twitter at @Lundbeck.
About Takeda Pharmaceutical Company Limited
Takeda Pharmaceutical Company Limited (TSE: 4502) is a global, research and development-driven pharmaceutical company committed to bringing better health and a brighter future to patients by translating science into life-changing medicines. Takeda focuses its R&D efforts on oncology, gastroenterology and neuroscience therapeutic areas plus vaccines. Takeda conducts R&D both internally and with partners to stay at the leading edge of innovation. Innovative products, especially in oncology and gastroenterology, as well as Takeda’s presence in emerging markets, are currently fueling the growth of Takeda. Approximately 30,000 Takeda employees are committed to improving quality of life for patients, working with Takeda’s partners in health care in more than 70 countries. For more information, visit https://www.takeda.com/newsroom/.
*Safe Harbor/Forward-Looking Statements*
*The above information contains forward-looking statements that provide our expectations or forecasts of future events such as new product introductions, product approvals and financial performance. *
*Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions. This may cause actual results to differ materially from expectations and it may cause any or all of our forward-looking statements here or in other publications to be wrong. Factors that may affect future results include interest rate and currency exchange rate fluctuations, delay or failure of development projects, production problems, unexpected contract breaches or terminations, government-mandated or market-driven price decreases for Lundbeck's products, introduction of competing products, Lundbeck's ability to successfully market both new and existing products, exposure to product liability and other lawsuits, changes in reimbursement rules and governmental laws and related interpretation thereof, and unexpected growth in costs and expenses.*
*Certain assumptions made by Lundbeck are required by Danish Securities Law for full disclosure of material corporate information. Some assumptions, including assumptions relating to sales associated with product that is prescribed for unapproved uses, are made taking into account past performances of other similar drugs for similar disease states or past performance of the same drug in other regions where the product is currently marketed. It is important to note that although physicians may, as part of their freedom to practice medicine in the US, prescribe approved drugs for any use they deem appropriate, including unapproved uses, at Lundbeck, promotion of unapproved uses is strictly prohibited.*
--------------------^i Global Burden of Disease. GHDx. Available at http://ghdx.healthdata.org/gbd-results-tool. Accessed August 29, 2018.
^ii World Health Organization (WHO). Depression. http://www.who.int/news-room/fact-sheets/detail/depression. Accessed on June 4, 2018.
*Attachment*
· Vortioxetine-JPfiling UK Reported by GlobeNewswire 28 minutes ago.
↧
↧
Reaction to Italian budget targets
Italy's government has targeted a budget deficit of 2.4 percent of gross domestic product for the next three years, defying Brussels and marking a victory for ruling-party chiefs over Economy Minister Giovanni Tria.
Reported by Reuters 26 minutes ago.
↧
Atletico Madrid mulling move for Nikola Milenkovic
La Liga hotshots Atletico Madrid are said to be keeping a close eye on the Fiorentina defender Nikola Milenkovic. The Serbian talent moved to Italy in 2017 from Partizan and wasted no time in announcing himself at the brightest stage. The towering centre-back made 23 Serie A appearances in his maiden season in Italy whereas […]
The post Atletico Madrid mulling move for Nikola Milenkovic appeared first on Soccer News. Reported by SoccerNews.com 16 minutes ago.
The post Atletico Madrid mulling move for Nikola Milenkovic appeared first on Soccer News. Reported by SoccerNews.com 16 minutes ago.
↧
Italian stocks plunge on higher deficit target
ROME (AP) — Italy's stock market has plunged after the new populist government announced a sharp public spending increase that will push the budget deficit to 2.4 percent of gross domestic product next year.The benchmark FTSE MIB...
Reported by New Zealand Herald 20 minutes ago.
↧
Bayern Munich monitoring Krzysztof Piatek
Bundesliga title holders Bayern Munich are keeping a close eye on Genoa forward Krzysztof Piatek who is enjoying a stellar spell in Italy. The Polish forward only joined Serie A outfit Genoa this summer in a €4.5 million deal from Cracovia but he has done more than enough to outshine some of the league’s most […]
The post Bayern Munich monitoring Krzysztof Piatek appeared first on Soccer News. Reported by SoccerNews.com 16 minutes ago.
The post Bayern Munich monitoring Krzysztof Piatek appeared first on Soccer News. Reported by SoccerNews.com 16 minutes ago.
↧
↧
Euro slips as Italy agrees 'people's budget'; dollar buoyant
The euro fell to an eleven-day low on Friday after Italy's government agreed a budget overnight seen by some investors as defying Brussels.
Reported by Reuters 8 minutes ago.
↧
ECB’s Lane: There will be more precise rate hike debate next summer
The ECB's Governing Council member Philip Lane was out on the wires in the last hour, saying that the ECB expects inflation pressure to pick up through 2020.
*Additional Quotes:*
• As of today, aggregate inflation pressure isn't that strong.
• ECB has a robust forecast, the strategy isn't fragile.
• There will be more precise rate hike debate next summer
• He stands ready to serve on the ECB board next year if needed.
• Italy's budget plans will be analyzed.
He also touched upon the recent hot topic of trade tariffs/emerging market crisis and said:
• A severe trade war would have a big negative impact.
• Watching emerging markets could cause stress. Reported by FXstreet.com 11 minutes ago.
*Additional Quotes:*
• As of today, aggregate inflation pressure isn't that strong.
• ECB has a robust forecast, the strategy isn't fragile.
• There will be more precise rate hike debate next summer
• He stands ready to serve on the ECB board next year if needed.
• Italy's budget plans will be analyzed.
He also touched upon the recent hot topic of trade tariffs/emerging market crisis and said:
• A severe trade war would have a big negative impact.
• Watching emerging markets could cause stress. Reported by FXstreet.com 11 minutes ago.
↧
USD/JPY eases from YTD tops, dips below mid-113.00s
* • A subdued USD price action fails to assist the pair to build on the positive momentum.
• Weaker European equities underpin JPY’s safe-haven status and exert some pressure.*
The USD/JPY pair retreated around 20-pips from YTD tops, set earlier, but has still managed to hold with modest daily gains, just below mid-113.00s.
The pair quickly reversed the post-FOMC dip and regained strong traction on Thursday. Resurgent US Dollar demand, which got an additional boost from upbeat final US GDP print and durable goods orders data, turned out to be one of the key factors behind the pair's overnight strong up-move.
The positive momentum extended through the Asian session on Friday and seemed rather unaffected by slightly better-than-expected Tokyo core CPI, coming in at 1.0% y/y for September as against 0.9% recorded in the previous month.
The pair touched an intraday high level of 113.64, the highest since December 12, albeit seemed losing momentum amid a subdued USD price action and a mildly softer tone around the US Treasury bond yields.
Adding to this, the prevalent cautious mood around European equity markets, led by concerns over Italy’s budget proposal, underpinned the Japanese Yen's safe-haven status and exerting some downward pressure.
Market participants now look forward to a slew of second-tier US economic data, due for release later during the North-American session, for some fresh impetus on the last trading day of the week.
*Technical outlook*
Omkar Godbole, Analyst and Editor at FXStreet writes, “the pair could rise toward the large inverse head-and-shoulders neckline resistance, currently located around 126.50, in the next 12 months.”
“The bullish outlook would be invalidated if the pair finds acceptance below the previous month's low of 109.76,” he adds further.
Reported by FXstreet.com 4 minutes ago.
• Weaker European equities underpin JPY’s safe-haven status and exert some pressure.*
The USD/JPY pair retreated around 20-pips from YTD tops, set earlier, but has still managed to hold with modest daily gains, just below mid-113.00s.
The pair quickly reversed the post-FOMC dip and regained strong traction on Thursday. Resurgent US Dollar demand, which got an additional boost from upbeat final US GDP print and durable goods orders data, turned out to be one of the key factors behind the pair's overnight strong up-move.
The positive momentum extended through the Asian session on Friday and seemed rather unaffected by slightly better-than-expected Tokyo core CPI, coming in at 1.0% y/y for September as against 0.9% recorded in the previous month.
The pair touched an intraday high level of 113.64, the highest since December 12, albeit seemed losing momentum amid a subdued USD price action and a mildly softer tone around the US Treasury bond yields.
Adding to this, the prevalent cautious mood around European equity markets, led by concerns over Italy’s budget proposal, underpinned the Japanese Yen's safe-haven status and exerting some downward pressure.
Market participants now look forward to a slew of second-tier US economic data, due for release later during the North-American session, for some fresh impetus on the last trading day of the week.
*Technical outlook*
Omkar Godbole, Analyst and Editor at FXStreet writes, “the pair could rise toward the large inverse head-and-shoulders neckline resistance, currently located around 126.50, in the next 12 months.”
“The bullish outlook would be invalidated if the pair finds acceptance below the previous month's low of 109.76,” he adds further.
Reported by FXstreet.com 4 minutes ago.
↧
More Pages to Explore .....
