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Elevar Therapeutics Announces Orphan Drug Designation for Rivoceranib (Apatinib) for the Treatment of Adenoid…

first_img Facebook WhatsApp Previous articleSchneider Electric Calls for Stronger Collaboration in Industries of the FutureNext articleElematec Corporation To Distribute NevadaNanotech Inc.’s Innovative Molecular Property Spectrometer™ Flammable Gas Sensors In Japan Digital AIM Web Support Twitter Twitter Elevar Therapeutics Announces Orphan Drug Designation for Rivoceranib (Apatinib) for the Treatment of Adenoid Cystic Carcinoma (ACC) Facebook SALT LAKE CITY, Feb. 8, 2021 /PRNewswire/ — Elevar Therapeutics, Inc. (“Elevar”), a fully integrated biopharmaceutical company built on the promise of elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, today announced that the U.S. Food and Drug Administration (FDA) has granted rivoceranib (apatinib) with orphan drug designation for the treatment of adenoid cystic carcinoma (ACC), a rare form of cancer that most commonly develops in the salivary glands or other regions of the head and neck. Approximately 1,200 new cases of ACC are diagnosed each year in the United States. The FDA’s Office of Orphan Drug Products grants orphan status to medicines for underserved patient populations, or rare disorders, that affect fewer than 200,000 people in the U.S. “We are pleased by the FDA’s recognition of the critical need to develop treatments for adenoid cystic carcinoma (ACC) given the progressive nature of the disease,” said Alex Kim, chief executive officer of Elevar. “The orphan drug designation provides further momentum for the rivoceranib development program, which we are committed to advancing as quickly as possible for patients in need.” ACC is considered a slow growing but relentless cancer that is characterized by nerve invasion and metastases. Although good local control is usually achieved by resection of the primary tumor and adjuvant radiation therapy, more than half of patients eventually have recurrent and/or metastatic disease. Currently, no curative treatments are available for these patients which underscores the need for effective new therapies. “With no approved treatments for adenoid cystic carcinoma (ACC), a significant unmet need remains for therapies that slow or stop this relentless disease,” said Mark Gelder, M.D., chief medical officer of Elevar. “The orphan drug designation from the FDA reinforces the urgency of Elevar’s work with rivoceranib in ACC and our commitment to improving treatment experiences and outcomes for patients who have limited or inadequate therapeutic options.” In November 2020, Elevar announced that the Company met its initial 55 patient enrollment target for its Phase 2, open-label, multicenter, clinical trial of rivoceranib in patients with recurrent or metastatic ACC one year ahead of schedule. The Company also announced increasing the target size of the trial to approximately 72 patients to further explore the potential clinical benefit of rivoceranib in this patient population. About Rivoceranib (apatinib) Rivoceranib is the first small-molecule tyrosine kinase inhibitor (TKI) to be approved in gastric cancer (China, Dec 2014). It has been granted Orphan Drug designation in the U.S., Europe and South Korea and has been clinically tested in over 1,000 patients worldwide. Rivoceranib acts by inhibiting angiogenesis, a critical process in cancer growth and proliferation. Specifically, rivoceranib potently and selectively inhibits VEGFR-2 which mediates the primary pathway for tumor-mediated angiogenesis. As a best-in-class therapeutic known for its safety and tolerability, Elevar believes rivoceranib has the potential to significantly improve clinical outcomes in combination with chemotherapeutics and immunotherapy, as well as for maintenance therapy. Elevar Therapeutics is developing rivoceranib for the treatment of patients with gastric cancer, colorectal cancer, hepatocellular carcinoma, and adenoid cystic carcinoma. About Elevar Therapeutics Elevar Therapeutics (formerly LSK BioPharma) is a rapidly growing, fully integrated biopharmaceutical company built on the promise of elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options. Elevar’s lead proprietary drug candidates include rivoceranib (apatinib) and Apealea® (paclitaxel micellar). Rivoceranib is the first small-molecule tyrosine kinase inhibitor (TKI) to be approved in gastric cancer (China, Dec 2014). It has been granted Orphan Drug designation in the U.S., Europe and South Korea and has been clinically tested in over 1,000 patients worldwide in numerous cancer indications. Apealea is a non-Cremophor EL based formulation of paclitaxel that received marketing authorization by the European Commission in November 2018, making it Europe’s first non-Cremophor EL formulation of paclitaxel approved for use in ovarian cancer. Elevar Therapeutics has offices in Utah, California and South Korea, and additional information is available at www.elevartherapeutics.com. Elevar Media Contact: Elixir Health Public Relations Lindsay Rocco (862) 596-1304 [email protected] View original content to download multimedia: http://www.prnewswire.com/news-releases/elevar-therapeutics-announces-orphan-drug-designation-for-rivoceranib-apatinib-for-the-treatment-of-adenoid-cystic-carcinoma-acc-301223366.html SOURCE Elevar Therapeuticscenter_img TAGS  By Digital AIM Web Support – February 8, 2021 WhatsApp Local NewsBusiness Pinterest Pinterestlast_img read more

a month ago​Rodgers: Maddison still an injury doubt for Leicester recall

first_imgTagsPremiership NewsAbout the authorIan FerrisShare the loveHave your say ​Rodgers: Maddison still an injury doubt for Leicester recallby Ian Ferrisa month agoSend to a friendShare the loveLeicester boss Brendan Rodgers has been giving the latest update on the injured James Maddison.”We’ll see over the next couple of days. He’s obviously going to be a doubt. He’s put some weight on his ankle so we’ll see over the coming days.”He’s a big talent and he’s been playing great. We’ve got a really strong squad. We made some changes in the week, and the rhythm, speed and intensity in the team was the same.”It’s just the risk of whether he’s going to last the game or not. It’s questionable whether he’ll play or not. He’s such a talented player, we’ll give him every chance.” last_img read more

Here’s Video Of Jim Harbaugh Wearing Michigan State Gear In 1999

first_imgHead coach Jim Harbaugh of the Michigan Wolverines (L) jogs off the fiedl with his brother Baltimore Ravens head coach John Harbaugh (R) following halftime of the Michigan and Maryland Terrapins.COLLEGE PARK, MD – OCTOBER 03: Head coach Jim Harbaugh of the Michigan Wolverines (L) jogs off the fiedl with his brother Baltimore Ravens head coach John Harbaugh (R) following halftime of the Michigan and Maryland Terrapins game at Byrd Stadium on October 3, 2015 in College Park, Maryland. (Photo by Rob Carr/Getty Images)It’s a safe bet that Michigan head coach Jim Harbaugh, who also played for the Wolverines, isn’t a fan of Michigan State. But for at least one day in 1999, he intentionally wore Spartan green. This week, WXTZ-TV in Detroit unearthed footage of Harbaugh celebrating with the 1999 Michigan State basketball team during their national title run.Why does this exist? Harbaugh’s sister, Joani, is married to Tom Crean, who was then MSU’s assistant coach. Crean is now the head coach at Indiana.Harbaugh probably isn’t thrilled that this footage exists. But if his team beats MSU tomorrow, he probably won’t care.last_img read more

Flex LNG to Buy Two LNG Carrier Newbuildings

first_imgzoomIllustration; Image Courtesy: Flex LNG Oslo-listed ship owner and operator Flex LNG has reached an agreement to purchase two 174,000 cbm LNG carrier newbuildings under construction at South Korea’s Hyundai Heavy Industries.Under the deal, agreed on May 28, Flex LNG said it would pay “an attractive price” of USD 184 million per vessel.The company added that payment terms “are favorable” with 20 per cent of amount due following signing of such agreement while remaining 80 per cent is due at delivery.The newbuildings, to be named Flex Aurora and Flex America, are scheduled for delivery in June and August 2020, respectively.Both newbuildings are fitted with Selective Catalytic Reduction (SCR) to comply with IMO Tier III regulation both in gas and liquid mode giving them high trading flexibility.Furthermore, on May 28, Flex LNG received credit approval for a sale leaseback of the LNG carrier newbuilding Flex Rainbow with an undisclosed Asian lessor based on term sheet signed by the parties in March 2018.The sale price under the lease is 75% of the relevant ship building price for Flex Rainbow and where the remaining 25% represent the advance hire for the ten-year lease period.The developments were unveiled as part of the company’s financial report for the period ended March 31, 2018, in which Flex LNG said it was “disappointed by the financial performance in first quarter”.The company’s revenues for the quarter were at USD 15.1 million, compared to USD 1.3 million reported in the first quarter of 2017. Net loss stood at USD 1.8 million, widening from a net loss of USD 1 million seen a year earlier, mainly due to weak utilization of the Flex Enterprise during the quarter as well as increased financing costs related to its USD 315 million term loan facility.“Although we are disappointed by the financial performance in first quarter, we are pleased to be able to announce an attractive sale-leaseback of Flex Rainbow. This lease enables the Company to grow organically based on its existing paid-in equity by the acquisition of two additional high specification LNGC newbuildings at very attractive terms and conditions,” Øystein M Kalleklev, CFO at Flex LNG, said.“The market for LNG transportation is cyclically recovering from lows experienced beginning of first quarter and we remain very confident about the long-term structural prospects for this market and are thus positioning for this up-turn with this accretive fleet expansion,” Kalleklev added.last_img read more

Bank of Canada holds rate suggests more hikes likely at more cautious

first_imgOTTAWA – The Bank of Canada left its benchmark interest rate unchanged Wednesday following two straight hikes but suggested future increases are still likely, albeit at a more gradual pace.In its scheduled announcement, the central bank said it held off this time in part because it expects the recent strength of the Canadian dollar to slow the rise in the pace of inflation.To make its case, the bank also pointed to the substantial, persistent unknowns around geopolitical developments as well as U.S.-related fiscal and trade policies, such as the renegotiation of the North American Free Trade Agreement.Governor Stephen Poloz has introduced two rate hikes since July — at consecutive policy meetings — in response to the economy’s impressive run over the last four quarters. The increases removed the two rate cuts introduced in 2015 as insurance following the collapse in oil prices.The bank suggested Wednesday that it will stick to its rate-hiking trajectory, although at perhaps a more-tentative pace.“While less monetary policy stimulus will likely be required over time, governing council will be cautious in making future adjustments to the policy rate,” the bank said in a statement.The bank stressed it will pay particular attention to incoming data to assess four areas: the unfolding impact of higher interest rates on indebted households, the evolution of the economy’s capacity, wage growth and inflation. Its next rate announcement is set for Dec. 6.Later Wednesday, Poloz told reporters that almost any departure from the bank’s projections on these four issues would be fodder for deeper discussion about the trend-setting rate.“We must be open. We can be surprised in either direction relative to our forecast,” Poloz said. “But we need to be extremely interpretive of those movements.”Poloz reiterated his recent comments that each policy meeting is “live.”The central bank also released updated projections Wednesday that forecast economic growth to moderate after Canada’s powerful performance, particularly since the start of the year.It now expects real gross domestic product to slow from its robust annual pace of 3.1 per cent this year to 2.1 per cent in 2018 and 1.5 per cent in 2019.The economy expanded at an annual rate of 3.7 per cent in the first three months of 2017 and 4.5 per cent in the second quarter. The bank’s latest outlook now predicts real GDP to grow at an annual rate of 1.8 per cent in the third quarter and 2.5 per cent in the final three months of 2017.“Real GDP growth is expected to moderate to a still-solid pace close to two per cent … over the second half of the year,” the bank said.The bank forecasts declining contributions from residential investment and consumption, which largely fuelled Canada’s recent growth spurt. These changes will largely be consequences of higher borrowing rates, higher household indebtedness and policy measures aimed at cooling hot real estate markets, the report said.The bank provided an estimate for the economic impact of incoming guidelines to reinforce mortgage underwriting practices, which were announced recently by the Office of the Superintendent of Financial Institutions. The changes, which will take effect next year, are expected to trim 0.2 per cent from GDP by the end of 2019, the bank said.Moving forward, the bank said economic activity will advance on a “more-sustainable” trajectory led by rising foreign demand, recent increases in commodity prices, still-low borrowing rates and government infrastructure spending. It also projects steady growth in business investment, which rebounded in early 2017.The weaker-than-expected rollout of federal infrastructure spending will provide a smaller boost for the economy in 2017 than the bank had anticipated. The commitments, however, are expected to lift growth over the coming quarters, the report said.Poloz was asked Wednesday about the potential economic impacts of the Trudeau government’s announcement this week that it would enhance its child-benefit program so payments to families with kids start rising with the cost of living next July, two years earlier than Ottawa had initially promised.The change will lower government revenues by $5.6 billion over five years, the government estimates.Poloz declined to comment on the specifics of the government’s announcement, but he did credit the introduction of the original program last year as a “significant contributor” to the economy. He said the child benefit lifted GDP growth for a year by 0.5 per cent.“As for the change, at the moment, it doesn’t sound anywhere near as large as what was done last year,” said Poloz, who added the bump in growth from the child benefit was likely only felt in the program’s first year.“In real terms, it’s maintaining it.”Follow @AndyBlatchford on Twitter.last_img read more

Grande Prairie RCMP currently on scene at unfolding event in the Countryside

first_imgThe RCMP can confirm that there is a lone male possibly armed and barricaded in a residence in the Countryside South neighbourhood.Traffic is currently being re-routed in the area.RCMP will issue an update when more information is available, and thank the public for their cooperation. UPDATE – The RCMP attended with Police Dog Services and the RCMP Emergency Response Team. One male was arrested without further incident. To read more CLICK HEREGRANDE PRAIRIE, AB –  RCMP are currently on scene at an unfolding event on 65 Avenue in the Countryside South neighbourhood and are advising the public to avoid the area until further notice.While the public is not believed to be in danger, RCMP are currently asking residents in the area to stay in their homes or stay away from the area.last_img read more

Local Youth Liason Officer Goes Back to School

first_imgFORT ST. JOHN, B.C. – In September of 2018 the Fort St. John RCMP initiated a pilot project for a Youth Liaison Officer for the Detachment.Constable Chad Neustaeter had been selected for this position for his extensive history in working with youth.Staff Sergeant Steve Perret chose to implement this proactive position as it is part of the RCMP’s strategic priorities. Officer Chad looks for any opportunity to connect with students while visiting various schools. His interactions vary from schools visits, participating in recess activities with the youth, to presenting classes with proactive information on topics that are relevant to their safety.Officer Chad says the interactions with the youth in elementary schools is about Who are the police and what do they do. While Sexting and managing your online presence, are key topics for middle school students, the Party (Preventing Alcohol-Related Trauma in Youth) Program allows him to connect with students in the Senior Secondary Schools.“Although the program is still in its early stages, I am starting to see the benefits already. In the fall, I received feedback from a parent who let me know their children couldn’t stop talking about how I had participated in a game of Tag with them. I am extremely flattered that the youth in our community recognize me and feel comfortable just stopping to say hi.”If anyone has any questions or concerns about this project, please feel free to contact S/Sgt. Steve Perret of the Fort St John RCMP at 250-787-8100. “Youth Involvement is of the RCMP’s national strategic priorities that impact RCMP planning and operations within our community. Our goal is to reduce youth involved in crime, both as victims and/or offenders.”The RCMP say this position will run until June 2019 where it will be re-evaluated at that time to determine its effectiveness and if any modifications will be required.Constable Neustaeter introduces himself to students as Officer Chad.Even though he has almost three years’ experience as a police officer, he comes to the position with 16 years of experience in working with youth.Officer Chad is one of two DARE (Drug Awareness Resistance Education) trained officers at the detachment that is instructing the DARE Program to grade five students.The goal of the program is to provide students with the knowledge to make safe and responsible choices with the hope of protecting themselves now and in the future.last_img read more

Hardik Patel moves SC challenging Guj HC order rejecting to stay his

first_imgNew Delhi: Congress leader Hardik Patel Monday moved the Supreme Court challenging the Gujarat High Court order rejecting his plea to stay his conviction in the 2015 Vispur rioting case. His petition is likely to be mentioned Tuesday for urgent hearing and his lawyers would seek stay of the March 29 order of the High Court which is coming in the way of his contesting the Lok Sabha election. Patel, 25, had started preparations to contest from Jamnagar on a Congress ticket after joining the party on March 12 and the last date for filing of nominations is April 4. Polling for 26 Lok Sabha seats in Gujarat will be held on April 23. The Sessions Court at Visnagar in Mehsana district sentenced Patel to two years’ imprisonment last July for rioting and arson in Visnagar town in 2015 during the Patidar quota stir which he led. The high court in August 2018 suspended the sentence but not the conviction. Under the Election Law — Representation of the People Act and a related Supreme Court ruling — a convict facing a jail term of two years or more cannot stand for election unless the conviction is stayed. In the high court, the state government had submitted that there were 17 FIRs including two sedition complaints against Patel who is known for making inflammatory speeches. The high court had declined the contention of Patel’s lawyers that if the conviction was not stayed, it will cause “irreparable damage” as he intended to contest the Lok Sabha election. In the order, the high court noted that a conviction can be stayed only in rare and exceptional cases, and the case did not fall into that category.last_img read more