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Merck & Co Inc (MRK.N)

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Latest Key Developments (Source: Significant Developments)

Merck announces U.S. FDA grants tentative approval for Lusduna™ Nexvue™
7:30am EDT 

July 20 (Reuters) - Merck & Co Inc :Merck announces U.S. FDA grants tentative approval for Lusduna™ Nexvue™ (insulin glargine injection), a follow-on biologic basal insulin.Says trade name "lusduna nexvue" was granted provisional approval by FDA.  Full Article

Lannett receives approval for Cyproheptadine Hydrochloride Syrup, 2 mg/5 mL
Friday, 14 Jul 2017 06:53am EDT 

July 14 (Reuters) - Lannett Company Inc :Lannett receives approval for cyproheptadine hydrochloride syrup, 2 mg/5 ml.Lannett company inc - ‍product was previously marketed under brand name periactin syrup, 2 mg/5 ml of merck and co., inc.​.  Full Article

Aduro Biotech reports $2 mln milestone payment under licensing deal with Merck
Thursday, 13 Jul 2017 08:00am EDT 

July 13 (Reuters) - Aduro Biotech Inc :‍​:Aduro Biotech- $2.0 million milestone payment under worldwide licensing deal with merck for work supporting preparation of ind for anti-cd27 antibody​.‍Aduro announces milestone achieved relating to collaboration with merck for development of anti-cd27 antibody for treatment of cancer​.  Full Article

PDS Biotechnology enters a clinical trial collaboration agreement with a subsidiary of Merck
Monday, 10 Jul 2017 07:00am EDT 

July 10 (Reuters) - Merck & Co Inc :PDS Biotechnology says has entered a clinical trial collaboration agreement with a subsidiary of Merck.Agreement to evaluate combination of PDS's lead PDS0101, with Merck's anti-PD-1 therapy, Keytruda in a phase II clinical trial.Says details of collaboration were not disclosed.  Full Article

Merck to present new data from clinical trials at IAS 2017
Thursday, 6 Jul 2017 07:00am EDT 

July 6 (Reuters) - Merck & Co Inc :Merck to present new data from clinical trials evaluating Isentress HD (raltegravir) and investigational HIV therapies Doravirine and MK-8591 at IAS 2017.Merck says late-breaker abstract will be presented of a phase 1 study of MK-8591, Merck's investigational NRTTI in adult patients with HIV-1 infection​.Merck - ‍recommendation is under review by European commission for marketing authorization in EU with decision on approval expected in H2 of 2017​.  Full Article

Merck provides further update on 3 multiple myeloma studies evaluating Keytruda in combination with Pomalidomide, Lenalidomide
Wednesday, 5 Jul 2017 04:30pm EDT 

July 5 (Reuters) - Merck & Co Inc ::Merck provides further update on three multiple myeloma studies evaluating Keytruda® (pembrolizumab) in combination with pomalidomide or lenalidomide.Merck provides further update on three multiple myeloma studies evaluating Keytruda® (pembrolizumab) in combination with pomalidomide or lenalidomide.Merck & Co Inc - U.S. Food and drug administration (FDA) has placed a clinical hold on keynote-183, keynote-185 and keynote-023.Merck & co inc - ‍decision follows a review of data by dmc in which more deaths were observed in Keytruda arms of keynote-183 and keynote-185​.Merck - FDA determined data available indicates risks of Keytruda + pomalidomide or lenalidomide outweigh potential benefit for patients with multiple myeloma.Merck & co inc - clinical hold does not apply to other studies with Keytruda.Merck & co - ‍all patients enrolled in keynote-183,keynote-185 will discontinue investigational treatment with Keytruda​.Merck & co - patients enrolled in Keytruda/lenalidomide/dexamethasone cohort in keynote-023 will also discontinue investigational treatment with Keytruda​.  Full Article

Leap Therapeutics says Merck will sponsor and fund initial trials of their combo drug study
Wednesday, 21 Jun 2017 05:41pm EDT 

June 21 (Reuters) - Leap Therapeutics Inc -:Leap Therapeutics - under agreement with unit of Merck, Co to sponsor and fund phase i/ii clinical trials of combination of dkn-01 and keytruda(reg).Leap Therapeutics Inc says under agreement, merck will be responsible for manufacturing and supplying Keytruda(reg) for clinical trials - sec filing.Leap Therapeutics Inc - agreement provides that both Leap and Merck will jointly own clinical data generated from this clinical trial.  Full Article

Leap Therapeutics announces collaboration with Merck
Wednesday, 21 Jun 2017 09:07am EDT 

June 21 (Reuters) - Leap Therapeutics Inc :Leap therapeutics announces collaboration with merck to evaluate keytruda® (pembrolizumab) in combination with dkn-01 in esophagogastric cancer.Leap therapeutics inc - additional details of collaboration were not disclosed..Leap therapeutics inc - collaboration agreement is between leap and merck, through a subsidiary.Leap therapeutics inc - study is expected to begin enrolling patients in second-half of 2017.  Full Article

PV Nano Cell says cooperating with Merck for single-crystalline metal particles technology applications
Tuesday, 20 Jun 2017 03:37pm EDT 

June 20 (Reuters) - PV Nano Cell Ltd::Is entering a cooperation with Merck to develop technology applications for single-crystalline metal particles.  Full Article

Serimmune announces research, development collaboration agreement with subsidiary of Merck
Tuesday, 20 Jun 2017 01:00pm EDT 

June 20 (Reuters) - Serimmune Inc::Announced a research and development collaboration agreement with a subsidiary of Merck.Under agreement terms Co will apply immune repertoire characterization platform to clinical and preclinical specimens provided by Merck.Merck will lead preclinical and clinical development and commercialization of candidates identified from collaboration.Serimmune will be eligible to receive development, regulatory milestone payments, tiered royalties on sales of any products resulting from collaboration.  Full Article

BRIEF-Merck announces U.S. FDA grants tentative approval for Lusduna™ Nexvue™

* Merck announces U.S. FDA grants tentative approval for Lusduna™ Nexvue™ (insulin glargine injection), a follow-on biologic basal insulin