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Genmab
Genmab A/S is a Danish biotechnology company, founded in February 1999 by Florian Schönharting, at the time managing director of BankInvest Biomedical venture fund. The company is based in Copenhagen, Denmark - internationally, it operates through the subsidiaries Genmab B.V. in Utrecht, The Netherlands, Genmab U.S., Inc. in Princeton, USA, and Genmab K.K. in Tokyo, Japan. It's a dual listed company with shares traded on the Copenhagen Stock Exchange in Denmark, and on NASDAQ Global Select Market in the US. The company has 6 approved antibodies used in 6 marketed products, covering cancer indications and autoimmune diseases: Proprietary, marketed with Seagen: * Tivdak (tisotumab vedotin-tftv) for the treatment of previously treated recurrent or metastatic cervical cancer Marketed by partners: * Darzalex ( IV) (daratumumab) / Darzalex Faspro ( SC) ( daratumumab and hyaluronidase-fihj) for the treatment of all stages of multiple myeloma as combination therapy or monotherapy, ...
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Ofatumumab
Ofatumumab is a fully human monoclonal antibody to CD20, which appears to provide rapid B-cell depletion. Under the brand name Kesimpta, it is approved for the treatment of multiple sclerosis in the United States as well as in the European Union and other regions. Under the brand name Arzerra, it is approved for the treatment of certain types of chronic lymphocytic leukemia (CLL) in the United States. It is sold by Novartis under license from Genmab. The most common side effects for ofatumumab (Kesimpta) include upper respiratory tract infection, headache, injection-related reactions, and local injection site reactions. The most common side effects for ofatumumab (Arzerra) include infusion reactions and neutropenia. Medical uses Ofatumumab (Kesimpta 20 mg solution for injection in pre-filled syringe/pen) is indicated for the treatment of relapsing forms of multiple sclerosis in adults. The recommended dose is 20 mg of ofatumumab administered by subcutaneous injection with m ...
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Amivantamab
Amivantamab, sold under the brand name Rybrevant, is a bispecific monoclonal antibody used to treat non-small cell lung cancer. Amivantamab is a bispecific epidermal growth factor (EGF) receptor-directed and mesenchymal–epithelial transition (MET) receptor-directed antibody. It is the first treatment for adults with non-small cell lung cancer whose tumors have specific types of genetic mutations: epidermal growth factor receptor (EGFR) exon 20 insertion mutations. The most common side effects include rash, infusion-related reactions, skin infections around the fingernails or toenails, muscle and joint pain, shortness of breath, nausea, fatigue, swelling in the lower legs or hands or face, sores in the mouth, cough, constipation, vomiting and changes in certain blood tests. Amivantamab was approved for medical use in the United States in May 2021, and in the European Union in December 2021. The U.S. Food and Drug Administration considers it to be a first-in-class medication. ...
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Teprotumumab
Teprotumumab, sold under the brand name Tepezza, is a medication used to treat adults with thyroid eye disease, a rare condition where the muscles and fatty tissues behind the eye become inflamed, causing the eyes to bulge outwards. The most common side effects are muscle spasm, nausea, hair loss, diarrhea, fatigue, high blood sugar, hearing loss, dry skin, altered sense of taste and headache. Teprotumumab should not be used if pregnant, and women of child-bearing potential should have their pregnancy status verified prior to beginning treatment and should be counseled on pregnancy prevention during treatment and for six months following the last dose. It is a human monoclonal antibody developed by Genmab and Roche for tumour treatment but was later researched by River Vision Development Corporation and Horizon Therapeutics to be used for ophthalmic uses. It binds to IGF-1R. Teprotumumab was approved for use in the United States in January 2020. The U.S. Food and Drug Admi ...
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Daratumumab
Daratumumab, sold under the brand name Darzalex, is an anti-cancer monoclonal antibody medication. It binds to CD38, which is overexpressed in multiple myeloma cells. Daratumumab was originally developed by Genmab, but it is now being jointly developed by Genmab along with the Johnson & Johnson subsidiary Janssen Biotech, which acquired worldwide commercialization rights to the drug from Genmab. Daratumumab was granted breakthrough therapy drug status in 2013, for multiple myeloma. It was granted orphan drug status for multiple myeloma, diffuse large B cell lymphoma, follicular lymphoma, and mantle cell lymphoma. Medical uses In May 2018, the U.S. Food and Drug Administration (FDA) approved daratumumab for use in combination with bortezomib, melphalan and prednisone to include the treatment of people with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. In the European Union it is indicated as monotherapy for the treatment of adults with ...
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Daratumumab/hyaluronidase
Daratumumab/hyaluronidase, sold under the brand name Darzalex Faspro, is a fixed-dose combination medication for the treatment of adults with newly diagnosed or relapsed/refractory multiple myeloma. It is a combination of daratumumab and hyaluronidase. It is administered via subcutaneous injection. The most common adverse reaction using daratumumab/hyaluronidase as monotherapy is upper respiratory tracts infection. The most common adverse reactions (≥20%) in people with amyloid light-chain amyloidosis who received daratumumab/hyaluronidase in combination with bortezomib, cyclophosphamide, and dexamethasone are upper respiratory tract infection, diarrhea, peripheral edema, constipation peripheral sensory neuropathy, fatigue, nausea, insomnia, dyspnea and cough. The most common adverse reactions (≥20%) occurring in people treated with daratumumab/hyaluronidase, carfilzomib, and dexamethasone were upper respiratory tract infections, fatigue, insomnia, hypertension, diarrhea, c ...
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Tisotumab Vedotin
Tisotumab vedotin, sold under the brand name Tivdak, is an antibody-drug conjugate used to treat cervical cancer. It is a combination of tisotumab, a monoclonal antibody against tissue factor, and monomethyl auristatin E (MMAE), a potent inhibitor of cell division. It is administered by infusion into a vein. Tisotumab vedotin was approved for medical use in the United States in September 2021. The U.S. Food and Drug Administration considers it to be a first-in-class medication. Adverse effects In the United States, Tivdak carries a black box warning for ocular toxicity, which occurs in up to 60% of treated patients. In clinical trials, the most common forms of ocular toxicity were dry eye, conjunctivitis, corneal damage, and blepharitis. Other common adverse effects include bleeding (occurring in approximately 60% of patients, most often nosebleed) and peripheral neuropathy (42% of patients). Like all drugs containing MMAE, tisotumab vedotin can cause inflamm ...
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Cervical Cancer
Cervical cancer is a cancer arising from the cervix. It is due to the abnormal growth of cells that have the ability to invade or spread to other parts of the body. Early on, typically no symptoms are seen. Later symptoms may include abnormal vaginal bleeding, pelvic pain or pain during sexual intercourse. While bleeding after sex may not be serious, it may also indicate the presence of cervical cancer. Human papillomavirus infection (HPV) causes more than 90% of cases; most women who have had HPV infections, however, do not develop cervical cancer. HPV 16 and 18 strains are responsible for nearly 50% of high grade cervical pre-cancers. Other risk factors include smoking, a weak immune system, birth control pills, starting sex at a young age, and having many sexual partners, but these are less important. Genetic factors also contribute to cervical cancer risk. Cervical cancer typically develops from precancerous changes over 10 to 20 years. About 90% of cervical cancer ...
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Japan
Japan ( ja, 日本, or , and formally , ''Nihonkoku'') is an island country in East Asia. It is situated in the northwest Pacific Ocean, and is bordered on the west by the Sea of Japan, while extending from the Sea of Okhotsk in the north toward the East China Sea, Philippine Sea, and Taiwan in the south. Japan is a part of the Ring of Fire, and spans an archipelago of 6852 islands covering ; the five main islands are Hokkaido, Honshu (the "mainland"), Shikoku, Kyushu, and Okinawa. Tokyo is the nation's capital and largest city, followed by Yokohama, Osaka, Nagoya, Sapporo, Fukuoka, Kobe, and Kyoto. Japan is the eleventh most populous country in the world, as well as one of the most densely populated and urbanized. About three-fourths of the country's terrain is mountainous, concentrating its population of 123.2 million on narrow coastal plains. Japan is divided into 47 administrative prefectures and eight traditional regions. The Greater Tokyo Ar ...
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Copenhagen Stock Exchange
The Nasdaq Copenhagen, formerly known as the Copenhagen Stock Exchange ( da, Københavns Fondsbørs), is an international marketplace for Danish securities, including shares, bonds, treasury bills and notes, and financial futures and options. Nasdaq Copenhagen is one of the Nasdaq Nordic Exchanges. Nasdaq Nordic goes back to the 2003 merger of ''OM AB'' and ''HEX plc'' to form ''OMX'' and is, since February 2008, part of Nasdaq, Inc. (formerly known as ''NASDAQ OMX Group''). Background and structure The exchange was converted to a limited company in 1996 with share capital issued in a ratio of 60-20-20 to members, issuers of shares, and issuers of bonds. In 1997 the FUTOP Clearing Center A/S, the Danish derivatives market, became a wholly owned subsidiary. FUTOP issues, clears, and guarantees futures and options on shares, indices, and interest rate products. FUTOP products can be traded electronically. In 1998, the CSE and the Stockholmsbörsen formed the NOREX Allianc ...
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NASDAQ
The Nasdaq Stock Market () (National Association of Securities Dealers Automated Quotations Stock Market) is an American stock exchange based in New York City. It is the most active stock trading venue in the US by volume, and ranked second on the list of stock exchanges by market capitalization of shares traded, behind the New York Stock Exchange. The exchange platform is owned by Nasdaq, Inc., which also owns the Nasdaq Nordic stock market network and several U.S.-based stock and options exchanges. History 1971–2000 "Nasdaq" was initially an acronym for the National Association of Securities Dealers Automated Quotations. It was founded in 1971 by the National Association of Securities Dealers (NASD), now known as the Financial Industry Regulatory Authority (FINRA). On February 8, 1971, the Nasdaq stock market began operations as the world's first electronic stock market. At first, it was merely a "quotation system" and did not provide a way to perform electronic tra ...
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Public Company
A public company is a company whose ownership is organized via shares of stock which are intended to be freely traded on a stock exchange or in over-the-counter markets. A public (publicly traded) company can be listed on a stock exchange ( listed company), which facilitates the trade of shares, or not ( unlisted public company). In some jurisdictions, public companies over a certain size must be listed on an exchange. In most cases, public companies are ''private'' enterprises in the ''private'' sector, and "public" emphasizes their reporting and trading on the public markets. Public companies are formed within the legal systems of particular states, and therefore have associations and formal designations which are distinct and separate in the polity in which they reside. In the United States, for example, a public company is usually a type of corporation (though a corporation need not be a public company), in the United Kingdom it is usually a public limited company (plc), ...
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