TEMODAR® (temozolomide) Capsules and Injection
Therapeutic Areas
Oncology
37 Results Found
Merck (NYSE: MRK), known as MSD outside the United States and Canada, in conjunction with the U.S. Consumer Product Safety Commission (CPSC) today asked that all customers, including patients, inspect all bottles of TEMODAR® (temozolomide) capsules and all bottles of Temozolomide capsules (generic) for potential cracks in the child-resistant bottle caps. The medicine is manufactured by Merck and distributed in the United States by Merck as TEMODAR. The Temozolomide capsules (generic) are manufactured and packaged by Merck but sold and distributed by Sandoz, the authorized generic partner, under the Sandoz label. In addition to these supplies, Merck also provides TEMODAR in the United States in sachets (or pouches); TEMODAR in sachets are not affected. Merck believes that approximately 1,100 bottles out of an estimated 276,000 distributed bottles of TEMODAR and Temozolomide capsules (generic) could potentially have cracked caps. Those bottles could be at wholesalers,
Merck Wins TEMODAR® Patent Infringement Lawsuit on Appeal
Merck & Co., Inc. said today that a federal appellate court ruled in its favor in a TEMODAR patent infringement suit against Barr Laboratories, an affiliate of Teva Pharmaceuticals. By a 2-1 vote, the appellate court rejected Barr's arguments and reversed a lower court ruling that the U.S. patent was unenforceable. "The court appropriately ruled that the patent for TEMODAR in the U.S. is enforceable," said Bruce N. Kuhlik, executive vice president and general counsel of Merck. "We invest heavily in R&D to discover innovative medicines like TEMODAR, and we will vigorously defend our intellectual property rights." Teva had been seeking FDA approval to sell a generic version of the 5, 20, 100, 140, 180 and 250 mg capsules of TEMODAR. In connection with Teva's prior agreement not to launch during the appeal, Merck agreed that it will not object to Teva's launch of a generic version of TEMODAR in August 2013. The U.S. patent and exclusivity periods otherwise will expire on February 2014.
https://www.merck.com/news/merck-wins-temodar-patent-infringement-lawsuit-on-appeal/
Merck Announces Fourth-Quarter and Full-Year 2018 Financial Results
Fourth-Quarter 2018 Worldwide Sales Were $11.0 Billion, an Increase of 5 Percent, Including a 3 Percent Negative Impact from Foreign Exchange; Full-Year 2018 Worldwide Sales Were $42.3 Billion, an Increase of 5 Percent, Including a Minimal Impact from Foreign Exchange Fourth-Quarter 2018 GAAP EPS Was $0.69; Fourth-Quarter Non-GAAP EPS Was $1.04; Full-Year 2018 GAAP EPS Was $2.32; Full-Year Non-GAAP EPS Was $4.34 Returned $14 Billion to Shareholders Through Share Repurchases and Dividends in 2018 2019 Financial Outlook Anticipates Full-Year 2019 Worldwide Sales to Be Between $43.2 Billion and $44.7 Billion, Including an Approximately 1 Percent Negative Impact from Foreign Exchange Expects Full-Year 2019 GAAP EPS to Be Between $3.97 and $4.12; Expects Non-GAAP EPS to Be Between $4.57 and $4.72, Including an Approximately 1 Percent Positive Impact from Foreign Exchange Merck to Hold an Investor Event on June 20, 2019 Merck (NYSE:MRK), known as MSD outside the United States and Canada,
https://www.merck.com/news/merck-announces-fourth-quarter-and-full-year-2018-financial-results/
Merck Announces Third-Quarter 2018 Financial Results
Third-Quarter 2018 Worldwide Sales Were $10.8 Billion Third-Quarter 2018 GAAP EPS was $0.73, Third-Quarter Non-GAAP EPS was $1.19 Company Narrows 2018 Full-Year Revenue Range to be Between $42.1 Billion and $42.7 Billion, Including a Minimal Impact from Foreign Exchange Company Narrows and Lowers 2018 Full-Year GAAP EPS Range to be Between $2.41 and $2.47; Narrows and Raises 2018 Full-Year Non-GAAP EPS Range to be Between $4.30 and $4.36, Including an Approximately 1 Percent Negative Impact from Foreign Exchange Results from KEYNOTE-426 Studying KEYTRUDA in Combination with Axitinib as First-line Treatment for Advanced or Metastatic Renal Cell Carcinoma Met Primary Endpoints of Overall Survival and Progression-Free Survival Company Announces 15 Percent Increase to Quarterly Dividend to 55 Cents Per Outstanding Share and Authorizes an Additional $10 Billion Share Repurchase, Including a $5 Billion Accelerated Share Repurchase Program Merck (NYSE: MRK), known as MSD outside the United
https://www.merck.com/news/merck-announces-third-quarter-2018-financial-results/
Merck Announces Second-Quarter 2018 Financial Results
Second-Quarter 2018 Worldwide Sales Were $10.5 Billion, an Increase of 5 Percent, Including a 1 Percent Positive Impact from Foreign Exchange Second-Quarter 2018 GAAP EPS was $0.63, Second-Quarter Non-GAAP EPS was $1.06 Company Narrows 2018 Full-Year Revenue Range to be Between $42.0 Billion and $42.8 Billion, Including a Slightly Positive Impact from Foreign Exchange Company Narrows and Raises 2018 Full-Year GAAP EPS Range to be Between $2.51 and $2.59; Narrows and Raises 2018 Full-Year Non-GAAP EPS Range to be Between $4.22 and $4.30; Both Include an Approximately 1 Percent Negative Impact from Foreign Exchange Continued Leadership in NSCLC with Positive Results from Phase 3 KEYNOTE-407 and KEYNOTE-042 Studies Presented at ASCO 2018 Evaluating KEYTRUDA as a First-Line Treatment for NSCLC; sBLA for KEYNOTE-407 Under Priority Review in the United States with an Oct. 30, 2018 PDUFA Date KEYTRUDA Approved in China for the Treatment of Adult Patients with Unresectable or Metastatic
https://www.merck.com/news/merck-announces-second-quarter-2018-financial-results/
Merck Announces First-Quarter 2018 Financial Results
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced financial results for the first quarter of 2018. First-Quarter 2018 Worldwide Sales Were $10.0 Billion, an Increase of 6 Percent, Including a 3 Percent Positive Impact from Foreign Exchange First-Quarter 2018 GAAP EPS was $0.27, Reflecting a $1.4 Billion Aggregate Charge Related to the Formation of a Collaboration with Eisai; First-Quarter Non-GAAP EPS was $1.05 Company Narrows and Raises 2018 Full-Year Revenue Range to be Between $41.8 Billion and $43.0 Billion, Including an Approximately 2 Percent Positive Impact from Foreign Exchange Company Lowers 2018 GAAP EPS Range to be Between $2.45 and $2.57; Narrows and Raises 2018 Full-Year Non-GAAP EPS Range to be Between $4.16 and $4.28, Including an Approximately 1 Percent Positive Impact from Foreign Exchange Results from Phase 3 KEYNOTE-189 Study Presented at AACR 2018 and Published in The New England Journal of Medicine Showed KEYTRUDA in Combination
https://www.merck.com/news/merck-announces-first-quarter-2018-financial-results/
Merck Announces Fourth-Quarter and Full-Year 2017 Financial Results
Fourth-Quarter 2017 Worldwide Sales Were $10.4 Billion, an Increase of 3 Percent, Including a 1 Percent Positive Impact from Foreign Exchange; Full-Year 2017 Worldwide Sales Were $40.1 Billion, an Increase of 1 Percent Fourth-Quarter 2017 GAAP EPS Was $(0.32), Reflecting a $2.6 Billion Provisional Charge Related to U.S. Tax Legislation; Fourth-Quarter Non-GAAP EPS Was $0.98 Full-Year 2017 GAAP EPS Was $0.93, Reflecting a $2.6 Billion Provisional Charge Related to U.S. Tax Legislation and a $2.35 Billion Charge Related to the Formation of a Strategic Oncology Collaboration With AstraZeneca; Full-Year Non-GAAP EPS Was $3.98 2018 Financial Outlook Anticipates Full-Year 2018 Worldwide Sales to Be Between $41.2 Billion and $42.7 Billion, Including an Approximately 1 Percent Positive Impact from Foreign Exchange Expects Full-Year 2018 GAAP EPS to Be Between $2.97 and $3.12; Expects Non-GAAP EPS to Be Between $4.08 and $4.23, Including an Approximately 1 Percent Negative Impact from Foreign
https://www.merck.com/news/merck-announces-fourth-quarter-and-full-year-2017-financial-results/
Merck Announces Third-Quarter 2017 Financial Results
Third-Quarter 2017 Worldwide Sales Were $10.3 Billion, a Decrease of 2 Percent, Including a 1 Percent Positive Impact from Foreign Exchange KEYTRUDA as well as Animal Health Business Achieved Quarterly Sales of $1.0 Billion Third-Quarter 2017 GAAP EPS was $(0.02), Reflecting a $2.35 Billion Charge Related to the Formation of a Strategic Oncology Collaboration with AstraZeneca; Third-Quarter Non-GAAP EPS was $1.11 Company Narrows and Raises 2017 Full-Year Revenue Range to be Between $40.0 Billion and $40.5 Billion, Including a Less Than 1 Percent Negative Impact from Foreign Exchange Company Narrows and Raises 2017 Full-Year GAAP EPS Range to be Between $1.78 and $1.84; Narrows and Raises 2017 Full-Year Non-GAAP EPS Range to be Between $3.91 and $3.97, Including a Less Than 1 Percent Negative Impact from Foreign Exchange KEYTRUDA Development Program Advances with Key Regulatory Approvals Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced financial
https://www.merck.com/news/merck-announces-third-quarter-2017-financial-results/
Merck Announces Second-Quarter 2017 Financial Results
Second-Quarter 2017 Worldwide Sales Were $9.9 Billion, an Increase of 1 Percent, Including a 1 Percent Negative Impact from Foreign Exchange Second-Quarter 2017 GAAP EPS Was $0.71; Second-Quarter Non-GAAP EPS Was $1.01 Company Narrows and Raises 2017 Full-Year Revenue Range to be Between $39.4 Billion and $40.4 Billion, Including an Approximately 1 Percent Negative Impact from Foreign Exchange Company Reduces 2017 Full-Year GAAP EPS Range to be Between $1.60 and $1.72; Continues to Expect 2017 Full-Year Non-GAAP EPS Range to be Between $3.76 and $3.88, Including an Approximately 1 Percent Negative Impact from Foreign Exchange KEYTRUDA Development Program Significantly Advances with Several Key Regulatory Approvals Merck Enters Global Strategic Oncology Collaboration with AstraZeneca Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced financial results for the second quarter of 2017. “We continued to deliver strong results in the second quarter, driven
https://www.merck.com/news/merck-announces-second-quarter-2017-financial-results/