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AbbVie(ABBV) - 2023 Q4 - Annual Report
2024-02-20 00:00
产品 - Humira在2023年占据了AbbVie总净收入的约27%[8] - Skyrizi是一种IL-23抑制剂,用于治疗多种自身免疫疾病[8] - Rinvoq是一种口服、每日一次的选择性和可逆JAK抑制剂,用于治疗多种炎症性疾病[8] - Imbruvica是一种口服、每日一次的疗法,用于抑制一种叫做Bruton's tyrosine kinase的蛋白质[9] - Venclexta被FDA批准用于成人慢性淋巴细胞白血病或小淋巴细胞淋巴瘤[10] - Botox Cosmetic在美国和世界其他主要市场拥有领先地位[11] - Botox Therapeutic被批准用于治疗慢性偏头痛、成人神经源性膀胱过度活动和与神经系统疾病相关的膀胱过度活动的尿失禁[13] - Ubrelvy被批准用于成人急性偏头痛的治疗[15] - Ozurdex被批准用于治疗因糖尿病黄斑水肿、视网膜静脉阻塞或眼后节非感染性葡萄膜炎导致的视力受损的成人患者[16] - AbbVie的其他关键产品包括针对丙型肝炎病毒(HCV)患者的治疗产品,代谢和激素产品,用于治疗胰外分泌不足和甲状腺功能减退等多种疾病,以及内分泌产品,用于晚期前列腺癌的姑息治疗,子宫内膜异位症和中枢性性早熟的治疗,以及子宫肌瘤引起的贫血患者的术前治疗[17] - Mavyret/Maviret在美国和欧盟(Maviret)获得批准,用于治疗成人和小儿(12岁及以上或体重至少45公斤)的慢性HCV基因型1-6感染,无肝硬化并伴有代偿性肝硬化(Child-Pugh A)。它还适用于先前接受含HCV NS5A抑制剂或NS3/4A蛋白酶抑制剂的疗程但未同时使用两者的HCV基因型1感染的成人和小儿(12岁及以上或体重至少45公斤)的治疗[17] - Creon是一种用于胰外分泌不足的胰酶疗法,适用于囊性纤维化、慢性胰腺炎和其他几种疾病的患者[17] - Lupron是一种用于晚期前列腺癌的姑息治疗,子宫内膜异位症和中枢性性早熟的治疗,以及子宫肌瘤引起的贫血患者的术前治疗的产品[17] - Linzess/Constella是一种每日一次的鸟苷酸环化酶C激动剂,用于治疗成人的腹泻型肠易激综合征(IBS-C)和慢性特发性便秘[17] - Synthroid用于治疗甲状腺功能减退[17] - AbbVie在美国拥有Creon和Synthroid的销售权[17] 专利和法律 - 专利保护对AbbVie的业务至关重要[24] - 美国专利的有效期为20年,但药品的专利保护期通常少于20年[24] - 美国法律允许专利持有人寻求专利延期,但延期期限有限[24] - 制药产品可能享有其他形式的法律或监管专属权[24] - 生物类药品可能享有专属权[24] - AbbVie拥有或持有大量专利和专利申请[26] - AbbVie的专利组合被认为对公司的经营至关重要[26] - ibrutinib的美国组合物专利预计将于2027年到期[26] - risankizumab和upadacitinib的美国组合物专利预计将于2033年到期[27] - AbbVie可能依赖商业秘密来保护其技术[27] 市场和监管 - AbbVie利用专门的商业资源、区域商业资源和分销来全球营销、销售和分销其产品[19] - AbbVie的产品市场竞争激烈,包括与其他研究型制药和生物技术公司的竞争,以及来自仿制药和生物仿制药的竞争[21] - FDA定期检查制造设施以评估cGMP的合规性[36] - 在欧盟获得营销授权后,需要提交定期安全报告和可能需要其他药物监管措施[39] - AbbVie的产品的制造、营销、销售、推广和分销受到全面的政府监管[40] - 遵守这些法律法规成本高昂,对AbbVie的业务产生重大影响[40] - 美国联邦法律要求制药厂商向州医疗补助计划支付一定的折扣[42] - 美国政府通过《医疗保健和教育和协调法案》要求AbbVie向政府计划中的患者提供品牌处方药的70%折扣[42] - 《通货膨胀减少法案》要求政府为某些高支出的Medicare Part D药物设定价格,并要求制药厂商在药物价格增长超过通货膨胀时支付回扣[42] - 欧盟通过指令和其他法规对药品的标签、广告、分销、供应、药物监测和营销进行监管[44] - 日本的国家医疗保险系统维护着药品价格清单,规定哪些药品有资格获得报销,并由卫生、劳工和福利部门设定这些药品的价格[44] - 许多新兴市场通过直接价格控制或推广仿制药/生物仿制药来降低药品价格[44] - AbbVie在全球市场推广其产品,必须满足其他国家的本地监管要求[44] - 美国FDA对AbbVie的医
AbbVie Unveils New Data from Robust Gastroenterology Portfolio at the 19th Congress of European Crohn's and Colitis Organisation (ECCO)
Prnewswire· 2024-02-19 21:30
– A total of 17 accepted abstracts, including nine oral presentations and eight posters, reinforce AbbVie's commitment to produce a portfolio of products that aim to improve the lives of patients living with inflammatory bowel diseases (IBD)– Oral data presentations include a new post-hoc analysis of clinical and endoscopic outcomes from the SEQUENCE trial comparing risankizumab (SKYRIZI®) versus ustekinumab, results from the COMMAND Phase 3 study of risankizumab as a maintenance therapy in adult patients w ...
3 Cash Cows to Boost Your Confidence During the February Chill
InvestorPlace· 2024-02-19 04:20
What are cash cow stocks? If “Jeopardy!” ever broadcasted a category called “Market Downturn,” this may be your answer (in the form of question).By definition, cash cows are ventures or operations that provide steady, reliable income or other benefits with minimal maintenance or oversight, according to U.S. News & World Report. Naturally, they’re best deployed during periods of market uncertainty. That said, the advantage is that cash cows are essentially permanently relevant.No, they probably won’t get you ...
AbbVie Declares Quarterly Dividend
Prnewswire· 2024-02-16 01:03
AbbVie公司股息政策 - AbbVie公司董事会宣布每股现金股息为1.55美元[1] - 自2013年成立以来,AbbVie已将股息增加了超过285%[2] AbbVie公司使命与愿景 - AbbVie的使命是发现和提供创新药物和解决当今严重健康问题的解决方案[3]
Global Fibromyalgia Treatment Market Expected to Reach $4.6 billion by 2032
Newsfilter· 2024-02-15 21:45
纤维肌痛治疗市场 - 全球纤维肌痛治疗市场预计将在未来十年继续增长[1] - 目前市场上的治疗方法并不完全有效,导致对更多有效治疗选择的需求增加[1] - Tonix Pharmaceuticals Holding Corp.宣布与Rho, Inc.合作准备并计划提交其新药申请(NDA)给美国食品和药物管理局(FDA)以获得Tonmya™的批准[3] - Tonix的第二个积极的第三阶段研究,RESILIENT,达到了预先指定的主要终点,显著降低了与纤维肌痛患者相比的每日疼痛[4] - Tonix Pharmaceuticals Holding Corp.举办了关键意见领袖(KOL)网络研讨会,讨论了Tonmya™的积极第三阶段数据以及在2024年下半年提交FDA批准的路径[5] 乳腺癌治疗 - Pfizer和Arvinas最近宣布,他们正在与Carrick Therapeutics共同开发samuraciclib和vepdegestrant的组合治疗,用于治疗先前接受CDK4/6抑制剂的ER+、HER2-转移性乳腺癌患者的第1b/2期临床试验[9] 药物研究和批准 - Eli Lilly and Company最近宣布,AK-OTOF-101研究的初步临床结果显示,在首位接受AK-OTOF的参与者中,AK-OTOF治疗后30天内实现了药物性听力恢复[11] - AbbVie最近宣布完成对ImmunoGen的收购,ImmunoGen现已成为AbbVie的一部分,ELAHERE®是美国食品和药物管理局(FDA)批准的第一款抗体药物结合物(ADC),用于卵巢癌患者[13] - Merck最近宣布,加拿大卫生部已批准KEYTRUDA®与三叠体抗体、含氟嘧啶和铂类化疗药物联合用于成人局部晚期不可切除或转移性HER2阳性胃癌或胃食管结合部(GEJ)腺癌的一线治疗[15]
AbbVie Cuts Its Guidance on ImmunoGen Deal
Investopedia· 2024-02-13 01:20
Key TakeawaysAbbVie reduced its current quarter outlook related to costs from its acquisition of ImmunoGen.The drug maker announced the $10.1 billion purchase in November, giving it access to ImmunoGen's key ovarian cancer treatment.AbbVie reiterated its full-year outlook, taking into account effects of its purchase of Immunogen and pending acquisition of Cerevel Therapeutics.Drug maker AbbVie (ABBV) is lowering its current quarter guidance because of costs related to its acquisition of ImmunoGen.AbbVie red ...
AbbVie's stock dips premarket after it lowers Q1 guidance to reflect dilutive impact of ImmunoGen deal close
Market Watch· 2024-02-12 20:51
AbbVie Inc.’s stock ABBV, -0.41% fell 0.5% early Monday, after the drug company lowered its first-quarter guidance to reflect the dilutive impact of its closure of the acquisition of ImmunoGen. The company said it now expects first-quarter per-share earnings to range from $2.26 to $2.30, down from prior guidance of $2.30 to $2.34, including a 4 cent per share dilutive impact from the Immunogen deal. AbbVie announced the $10.1 billion all-cash deal for Immunogen in November, that includes ImmunoGen’s antibo ...
AbbVie Completes Acquisition of ImmunoGen
Prnewswire· 2024-02-12 20:37
Adds flagship antibody-drug conjugate (ADC) ELAHERE® (mirvetuximab soravtansine-gynx) for folate receptor-alpha (FRα) positive platinum-resistant ovarian cancer (PROC) to AbbVie's portfolio ImmunoGen's pipeline complements AbbVie's existing oncology pipeline with potential to be transformative across multiple solid tumors and hematologic malignancies ImmunoGen's late-stage development programs for ELAHERE provide opportunity to expand into earlier lines of therapy and additional patient populations AbbVie ...
Is It Too Late to Buy These 2 Brilliant Passive Income Stocks?
The Motley Fool· 2024-02-12 20:30
If you're looking to generate passive income in the new year, there are plenty of ways to do so that don't involve starting a second job or freelance gig. As you work toward your short-term and long-term financial goals, investing is one of many ways you can grow wealth with time.Dividend stocks can help you build your passive income streams, because you can benefit not just from the share price performance of the business, but from regular (usually quarterly) dividend distributions. There are dividend stoc ...
These 17 Words From AbbVie's CEO Explain Why the Stock Is Still a Buy
The Motley Fool· 2024-02-11 21:25
There are thousands of drugs on the market, and there are thousands more that are no longer in use. However, none has been more successful in terms of sales than AbbVie's (ABBV -0.41%) Humira. That's why investors were rightly concerned when the immunology medicine ran out of patent exclusivity in the U.S. last year. AbbVie's CEO, Rick Gonzalez, called it the "largest loss of exclusivity event" in the history of the industry.However, AbbVie saw this headwind coming from a mile away. Though its sales are dec ...