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Merck & Co Inc (MRK.N)

MRK.N on New York Stock Exchange

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25 Sep 2017
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Latest Key Developments (Source: Significant Developments)

Merck says Isentress HD now available in Canada
Tuesday, 12 Sep 2017 02:20pm EDT 

Sept 12 (Reuters) - Merck & Co Inc ::Now available in Canada: Isentress HD (raltegravir), a new once-daily option, in combination with other antiretroviral agents, for the treatment of HIV-1 infection in appropriate patients.‍Availability of Isentress HD, a new 1200 mg once-daily dose of company's integrase strand transfer inhibitor, Isentress​.  Full Article

European Commission approves Merck’S KEYTRUDA (pembrolizumab)
Tuesday, 5 Sep 2017 06:30am EDT 

Sept 5 (Reuters) - Merck & Co Inc :European Commission approves Merck’s KEYTRUDA (pembrolizumab) for the treatment of certain patients with locally advanced or metastatic urothelial carcinoma, a type of bladder cancer.Merck & Co Inc - ‍there was no statistically significant difference between KEYTRUDA and chemotherapy with respect to PFS​.Merck - ‍KEYTRUDA now approved for adults previously treated with platinum-containing chemotherapy, for adults ineligible for cisplatin-containing chemotherapy ​.Merck- ‍KEYTRUDA approved for use as monotherapy for treatment of locally advanced/metastatic urothelial carcinoma in adults who received prior platinum-containing chemotherapy​.  Full Article

CDER's Director Woodcock issues statement on investigational use of Keytruda
Thursday, 31 Aug 2017 11:50am EDT 

Aug 31 (Reuters) - Center for Drug Evaluation and Research: :Center for Drug Evaluation and Research director Janet Woodcock issues statement regarding safety concerns related to investigational use of Keytruda in multiple myeloma.  Full Article

U.S. FDA alerts about 2 clinical trials on hold evaluating Keytruda with multiple myeloma
Thursday, 31 Aug 2017 11:16am EDT 

Aug 31 (Reuters) - U.S. FDA :U.S. FDA alerts healthcare professionals and oncology clinical investigators about two clinical trials on hold evaluating Keytruda in patients with multiple myeloma.Says Merck was made aware of issue through external data monitoring committee recommendation and suspended the trials to enrollment on June 12, 2017‍​.Says statement does not apply to patients taking Keytruda (pembrolizumab) for an approved indication​.Says on July 3, 2017, the FDA required that all patients in these trials be discontinued from further investigation with the drug​.Says will be working with sponsors of Keytruda, PD-1/PD-l1 cancer drugs, clinical investigators to determine extent of safety issue.  Full Article

Merck announces results of REVEAL outcomes study of Anacetrapib
Tuesday, 29 Aug 2017 02:31am EDT 

Aug 29 (Reuters) - Merck & Co Inc :Merck announces results of REVEAL outcomes study of Anacetrapib, investigational medicine for cardiovascular disease.Merck- reviewing results of trial with external experts,will consider whether to file new drug applications with U.S. FDA and other regulatory agencies.The safety of Anacetrapib was generally consistent with data from earlier trials of the drug.However, a sub-study also showed that Anacetrapib accumulates in adipose tissue with prolonged dosing.  Full Article

Merck & Co says received investigative subpoena from california insurance commissioner’s fraud liaison bureau - sec filing
Tuesday, 8 Aug 2017 05:28pm EDT 

Aug 8 (Reuters) - Merck & Co Inc :Merck & co says recently received investigative subpoena from california insurance commissioner’s fraud liaison bureau - sec filing.Merck - the fraud liaison bureau investigating if cubist pharmaceuticals unlawfully induced presentation of false claims for cubicin to private insurers.Merck & co - investigative subpoena from fraud liaison bureau seeks information from jan 1, 2007 to present related to pricing and promotion of cubicin‍​.  Full Article

Sanofi files suit in U.S. to defend patent rights on Lantus
Tuesday, 8 Aug 2017 03:32pm EDT 

Aug 8 (Reuters) - Sanofi SA ::Sanofi files suit in the U.S. to defend its patent rights on Lantus.Says ‍filed a patent infringement suit against Merck Sharp & Dohme Corp​.Says ‍in its suit co alleges infringement of two patents​.  Full Article

MSD Animal Health to purchase manufacturing facility in Krems, Austria
Monday, 7 Aug 2017 07:00am EDT 

Aug 7 (Reuters) - Merck & Co Inc :MSD Animal Health to purchase manufacturing facility in Krems, Austria.Merck & Co Inc - ‍additional terms of deal will not be disclosed.​.Merck & Co Inc - ‍MSD Animal Health intends to immediately begin renovating facility and expects to be ready for production in coming years​.Merck & Co Inc - facility, currently owned by Shire PLC., was built in 2002 and will add to company's global manufacturing capabilities.  Full Article

Generex announces collaboration with Merck to evaluate Keytruda in combination with ae37 in patients with triple-negative breast cancer
Monday, 31 Jul 2017 09:30am EDT 

July 31 (Reuters) - Generex Biotechnology Corp :Generex announces collaboration with Merck to evaluate keytruda (pembrolizumab) in combination with ae37 in patients with triple-negative breast cancer.Generex Biotechnology Corp - ‍antigen express has entered into a clinical trial collaboration agreement with merck​.Generex Biotechnology Corp - ‍additional details were not disclosed​.Generex Biotechnology Corp - under terms of agreement, trial will be sponsored by antigen express.  Full Article

Merck reports Q2 non-GAAP earnings of $1.01/shr
Friday, 28 Jul 2017 06:45am EDT 

July 28 (Reuters) - Merck & Co Inc :Merck announces second-quarter 2017 financial results.Q2 non-GAAP earnings per share $1.01.Q2 GAAP earnings per share $0.71.Q2 sales $9.9 billion versus I/B/E/S view $9.75 billion.Q2 earnings per share view $0.87 -- Thomson Reuters I/B/E/S.Merck & Co Inc qtrly Keytruda sales $‍881​ million versus $314 million.Merck & Co Inc - Q2 Januvia/Janumet sales $‍1,511​ million versus $1,634 million.Merck & Co Inc- Q2 Remicade sales $ 208 million versus $339 million.Merck & Co Inc - ‍company reduces 2017 full-year GAAP EPS range to be between $1.60 and $1.72.Merck & Co Inc - ‍second-quarter pharmaceutical sales increased 1 percent to $8.8 billion, including a 1 percent negative impact from foreign exchange​​.Sees FY 2017 non-GAAP earnings per share $3.76 to $3.88 including items.Merck & Co Inc - ‍continues to expect 2017 full-year non-GAAP EPS range to be between $3.76 and $3.88​.FY 2017 earnings per share view $3.85 -- Thomson Reuters I/B/E/S.Merck & Co - Narrows and raises 2017 FY revenue range to be $39.4 billion - $40.4 billion, including approximately 1 percent negative impact from foreign exchange​.FY 2017 revenue view $40.07 billion -- Thomson Reuters I/B/E/S.Merck & Co Inc - sees FY restructuring costs of $600 million.Merck & Co Inc - sees FY acquisition- and divestiture-related costs of $3,600 million.Merck & Co Inc - ‍anticipates that it will have temporary delays in fulfilling orders for certain products in certain markets​.  Full Article

BRIEF-Merck says FDA approves Keytruda(pembrolizumab) for previously treated patients

* Fda approves Merck’s keytruda® (pembrolizumab) for previously treated patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction cancer whose tumors express pd-l1 (cps greater than or equal to 1)