FINWIRES · TerminalLIVE
FINWIRES

最新消息:FDA 擬將替澤帕肽、索馬魯肽和利拉魯肽從 503B 大宗藥品清單中排除

By

-- (第三段更新了禮來公司的評論。) 美國食品藥物管理局(FDA)週四表示,擬將替拉肽、索瑪魯肽和利拉魯肽從503B原料藥清單中移除,理由是臨床上沒有必要將原料藥外包給其他機構進行配製。 禮來公司(LLY)生產替拉肽,其商品名為Mounjaro,用於治療第2型糖尿病;以及Zepbound,用於慢性體重管理。諾和諾德公司(NVO)生產索瑪魯肽,其商品名為Ozempic,用於治療第2型糖尿病;以及利拉魯肽,其商品名為Victoza,用於治療第2型糖尿病;以及Saxenda,用於治療慢性體重管理。 禮來公司在發給的電子郵件聲明中表示:“很高興FDA確認目前沒有臨床需要使用複方替唑帕肽。這意味著配藥機構沒有理由製造替唑帕肽仿製藥。禮來將繼續努力保護患者免受未經批准且無醫療需求的藥物所帶來的風險。” FDA表示,根據聯邦法律,外包機構通常不得使用原料藥配製藥物,除非該原料藥出現在503B原料藥清單上,或者配製後的藥物在配製、分銷和配藥時已列入FDA的藥品短缺清單。 FDA正在就此提案徵求公眾意見,截止日期為6月29日。向諾和諾德公司發出置評請求,但該公司尚未立即回應。 週四,禮來公司股價上漲9.8%,諾和諾德股價上漲5.7%。

Price: $934.57, Change: $+83.36, Percent Change: +9.79%

Related Articles

International

TSX Closer: Index Up For the First Day In Six On Bargain Hunting, Economic Rebound In Q1

The Toronto Stock Exchange on Thursday posted its first wining session in six, recovered all the 630 points and more lost over the prior five sessions, on some bargain hunting and a first-quarter rebound for the Canadian economy.The S&P/TSX Composite Index rose 645.94 points, or 1.9% to close at 33,964.33, with most sectors higher, led by Base Metals, up near 3%, even with gold prices deflated. Even Energy was up 0.8%, despite lower oil prices.The Battery Metals Index lost 2.7%.On the economy, Derek Holt, Head of Capital Markets Economics at Scotiabank noted Canada's economy rebounded in Q1 and "might be performing a smidge better" than the Bank of Canada's published forecast yesterday. "Still," Holt said, "it's backward data that settles nothing much other than to reject gloomier consensus views on the underlying performance of the economy coming into the start of the year."Holt noted the economy grew by 0.17% month over month seasonally-adjusted, rounded up to 0.2% on screens. Statcan's preliminary guidance for March was that GDP was unchanged, absent any details. What this translates into is Q1 GDP tracking growth of 1.7% on a quarter over quarter SAAR (Seasonally Adjusted Annual Rate), a rebound from the 0.3% q/q SAAR contraction in Q4, "with an asterisk beside both readings", Holt added.That asterisk speaks to the fact that we're using monthly, production-side GDP accounts, Holt said. The BoC and the street focuses upon more complete quarterly GDP accounts that also consider how activity was generated, such as by considering swings in inventory investment, he added.Holt said the difference may be material. Q4 GDP in expenditure-based terms shrank by -0.6% q/q SAAR because inventory depletion drove a 4.2 percentage point weighted drag against GDP economy. Final domestic demand excludes inventory effects and it grew by 2.3% q/q SAAR in Q4. "We don't have the complete inventory and trade picture for Q1 yet and so there continues to be some tracking risk," Holt added.Holt cited a chart that shows what drove February GDP. Manufacturing punched above its weight while the rest was an evenly distributed mixture of small growth additions and drags, he said. Some of the drags were weather oriented in his view, like construction, and maybe some of the leisure categories, he added.So, while GDP rebounded, it likely outpaced the supply side of the economy which will probably translate into a narrower output gap when we get the full set of Q1 GDP accounts, according to Holt.Of commodities, gold traded higher by midafternoon Thursday as the dollar dropped after a report showed a key U.S. inflation measure rose last month, while first-quarter gross domestic product rose less than expected. Gold for June delivery was up US$71.30 to US$4,632.80 per ounce, remaining within the US$200 range it has traded within for the past month.But West Texas Intermediate crude oil closed lower, falling off four-year highs touched overnight during Asian trade on a report the U.S. may end the ceasefire with Iran as the largest-ever supply shock hits hardest for the continent that relies on Persian Gulf supplies now trapped behind the closed Strait of Hormuz. WTI crude oil for June delivery closed down US$1.81 to settle at US$105.07 per barrel after touching US$110.93 overnight, while June Brent oil was last seen down US$4.12 to US$113.91, after it reached US$126.34 overnight, the highest since 2022.

$^GSPTSE$.GSPTSE
Mining & Metals

Earnings Flash (CYBT.CN) Cybeats Technologies Reports Q4 Revenue $0.72M Vs $0.511M Year Ago; Net Loss in Q4 $299,318 Vs Loss of $3.226M

$CYBT.CN
Commodities

EU Clears Itochu, Peninsula Petroleum Ammonia Marine Fuel Joint Venture

The European Commission on Thursday cleared an Itochu-Peninsula joint venture for ammonia fuel trading, citing limited market share and negligible activity in the European Economic Area.The Commission approved the joint venture between Japan-based Itochu and Peninsula Petroleum, based in Ireland, under the EU Merger Regulation.The companies will focus on marketing services for ammonia bunkering and trading ammonia as a marine fuel, according to the Commission.The Commission found no competition concerns due to the venture's minimal presence in the European Economic Area and the companies' limited combined market positions, following a simplified review process.