Tue, Jan. 13, 8:44 AM
- Eli Lilly (NYSE:LLY) and Merck (NYSE:MRK) establish a clinical trial collaboration through a subsidiary to evaluate the safety, tolerability and efficacy of Merck's PD-1 inhibitor Keytruda (pembrolizumab) in combination with Lilly's compounds in multiple studies.
- Merck will conduct a Phase 2 trial assessing the combination of pembrolizumab and pemetrexed as a first-line treatment of non-small cell lung cancer (NSCLC).
- Lilly will conduct a multiple-arm Phase 1/2 trial assessing the combination of pembrolizumab and ramucirumab in multiple tumors and another Phase 1/2 assessing pembrolizumab and necitumumab in NSCLC.
- Additional details about the partnership are undisclosed.
Mon, Jan. 12, 7:13 AM
- Acknowledging that it needs to speed up its development efforts, Merck (NYSE:MRK) plans to file for another indication for Keytruda (pembrolizumab) by midyear, for the treatment of non-small cell lung cancer, the most common form of the disease.
- It also plans to submit its NDA for grazoprevir/elbasvir for the treatment of HCV infection in H1.
- Merck Research Laboratories President Roger Perlmutter says, "The tempo has changed. What we are doing is focusing our efforts more profoundly, increasing the speed at which we complete things."
Sun, Jan. 11, 10:29 PM
- Based on an assessment by the independent Data Monitoring Committee, Bristol-Myers Squibb (NYSE:BMY) stops its Phase 3 trial, CheckMate-017, evaluating Opdivo (nivolumab) versus docetaxel in previously treated patients with advanced squamous cell non-small cell lung cancer (NSCLC). The committee concluded that the study met its primary endpoint of demonstrating superior overall survival (OS) compared to docetaxel. This is the first time a PD-1 inhibitor has shown a survival advantage in lung cancer.
- Eligible patients will be informed of the opportunity to continue or start treatment with Opdivo in an open-label extension.
- The company will complete a full analysis of the data and work with investigators on the future presentation and publication of the results.
- PD-1-related tickers: (NASDAQ:MDVN) (NYSE:MRK) (NASDAQ:FPRX) (NASDAQ:CELG) (OTCQX:RHHBY) (NYSE:AZN)
Thu, Jan. 8, 7:55 PM
- The FDA approves Daiichi-Sankyo's (OTCPK:DSKYF) (OTCPK:DSNKY) Savaysa (edoxaban tablets) to reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation that is not caused by a heart valve problem.
- Edoxaban is an anticoagulant that inhibits factor Xa. It was approved in Japan in 2011 for the prevention of venous thromboembolism in patients undergoing total knee replacement surgery, total hip replacement surgery and hip fracture surgery.
- Anticoagulant-related tickers: (NASDAQ:ISIS) (NYSE:BAX) (NASDAQ:PTLA) (NASDAQ:MSLI) (NYSE:MRK) (NYSE:JNJ) (NASDAQ:MDCO) (NASDAQ:SCLN) (NYSE:PFE) (NYSE:BMY) (NYSE:AZN) (OTCPK:BAYRY)
Mon, Jan. 5, 9:24 AM
Fri, Jan. 2, 8:12 AM
- Under the terms of the Contingent Value Rights (CVR) Agreement, Cubist Pharmaceuticals (NASDAQ:CBST) purchases all of the 50,785,558 issued and outstanding CVRs related to its acquisition of Optimer Pharmaceuticals in July 2013 under the Failure Purchase clause. The company will pay $0.059225 per CVR which is 115% of the volume-weighted average price as calculated under the agreement.
- The CVRs had a maximum potential payout of $5 if certain sales of Dificid (fidaxomicin) were achieved. Optimer shareholders received $10.75 per share in cash plus one CVR in the transaction.
Dec. 22, 2014, 8:44 AM
- The U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) awards a $30M contract to NewLink Genetics (NASDAQ:NLNK) subsidiary BioProtection Systems as the prime contractor to support the development and manufacturing of its rVSV-EBOV (Ebola) vaccine candidate, including a new 330-subject Phase 1b study.
- The investigational vaccine was initially developed by the Public Health Agency of Canada. It is now being advanced by NewLink and Merck (NYSE:MRK).
Dec. 19, 2014, 6:35 PM
- The FDA has approved the use of Cubist's (NASDAQ:CBST) Zerbaxa (ceftolozane/tazobactam) for "the treatment of adults with complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI) caused by designated susceptible Gram-negative bacteria."
- Cubist adds the FDA's decision was "supported by positive data from two pivotal Phase 3 clinical trials - one in patients with cUTI and the other in patients with cIAI."
- Cubist, still set to be acquired by Merck (NYSE:MRK) for $9.5B, is up 2% AH.
- Previous: PDUFA date approaches for Zerbaxa
Dec. 18, 2014, 12:29 PM
- The FDA's PDUFA date for its Fast Track/Priority Review of Cubist Pharmaceuticals' (CBST) New Drug Application (NDA) for its combination drug, ceftolozane/tazobactam, for the treatment of complicated urinary tract infections is December 21. Since this is Sunday, the agency may issue its decision tomorrow.
- Ceftolozane/tazobactam is designated a Qualified Infectious Disease Product (QIDP). If approved, it will have a five-year period of market exclusivity.
- Previously: Cubist NDA gets Priority Review (June 20, 2014)
Dec. 18, 2014, 8:31 AM
- Chinese authorities approve the start of clinical trials for an experimental Ebola vaccine developed by the Academy of Military Medical Sciences and Chinese biotech outfit Tianjin CanSino Biotechnology. The trials are supposedly going to commence this month. No other details are available.
- Glaxo (NYSE:GSK) and Merck (NYSE:MRK) remain the front runners.
Dec. 18, 2014, 8:23 AM
- Merck (NYSE:MRK) acquires privately-held Lausanne, Switzerland-based Oncoethix for an upfront payment of $110M and up to an additional $265M in clinical and regulatory milestones.
- Oncoethix's lead product is OTX015, a BET bromodomain inhibitor (2,3,4) currently in Phase 1b development for the treatment of hematological malignancies and advanced solid tumors.
- Bromodomain proteins 2,3 and 4 are considered potential cancer targets because of their pivotal role in regulating the transcription of growth-promoting genes and cell cycle regulators. In experimental models, the inhibition of BRD2/3/4 produced a potent antiproliferative effect associated with cell cycle arrest and cellular senescence.
Dec. 17, 2014, 2:06 PM
- According to Bloomberg, Amgen (AMGN +1%) intends to charge $178,000 per standard course of treatment for its blood cancer therapy, Blincyto (blinatumomab). The price assumes two cycles of treatment at $89,000 per cycle, the median duration of treatment for patients who responded to therapy in clinical trials.
- For comparison purposes, Merck's (MRK +0.7%) Keytruda (pembrolizumab) costs $150,000 per year and Bristol-Myers Squibb's (BMY +2.2%) Yervoy (ipilimumab) costs $120,000 per course.
- Previously: FDA clears Amgen blood cancer immunotherapy (Dec. 3, 2014)
Dec. 16, 2014, 1:55 AM| 3 Comments
Dec. 11, 2014, 11:58 AM
- The Global Alliance for Vaccines and Immunisation, Gavi, plans to spend as much as $300M for up to 12 million doses of an Ebola vaccine as soon as the World Health Organization (WHO) recommends one for use. An additional $90M could be used to support countries that introduce the vaccine and to rebuild devastated health systems and restore immunisation services in Ebola-stricken countries.
- Gavi is funded by governments and the Bill & Melinda Gates Foundation.
- Two vaccine candidates are currently being tested in humans in Phase 1 trials. The first trial, assessing Merck (MRK +0.8%) and NewLink Genetics' (NLNK -0.8%) candidate, experienced a hiccup recently when four volunteers complained of joint pain in their hands and feet. The trial is on hold as a precaution, but will restart on January 15 contingent on no further adverse events. The second trial, assessing the combination of GlaxoSmithKline's (GSK +0.4%) monovalent cAd3-EBO Z Ebola vaccine candidate with Bavarian Nordic's MVA-BN Filo booster vaccine, has experienced no adverse events to date.
- Johnson & Johnson (JNJ +0.8%) will begin testing its Ebola vaccine candidate in January and says it will have 250K doses for clinical study by May.
- Previously: Merck-NewLink Ebola vaccine trial interrupted (Dec. 11, 2014)
- Previously: Phase 1 underway for Ebola booster vaccine regimen (Dec. 4, 2014)
- Previously: J&J to begin testing Ebola vaccine in January; expects 250K doses ready by May (Oct. 22, 2014)
Dec. 11, 2014, 8:08 AM
- The Phase 1 study assessing the safety of the Ebola vaccine candidate from Merck (NYSE:MRK) and NewLink Genetics (NASDAQ:NLNK) has been stopped a week early as a precaution after four volunteers (out of a total of 59) complained of joint pain in their hands and feet. All are being monitored by the medical team. The trial is due to resume on January 5 in as many as 15 volunteers after investigators confirm that the pain symptoms are benign and temporary.
Dec. 10, 2014, 2:15 PM
- The FDA approves Merck's (MRK +0.4%) Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) for the prevention of certain diseases caused by nine types of Human Papillomavirus (HPV), five more than previously-approved Gardasil.
- Gardasil 9 is a vaccine approved for use in females ages 9 through 26 and males ages 9 through 15. It is indicated for the prevention of cervical, vulvar, vaginal and anal cancers caused by seven types of HPV and for the prevention of genital warts caused by HPV types 6 or 11. The additional HPV types - 31, 33, 45, 52 and 58 - cause ~20% of cervical cancers and are not covered by previously FDA-approved HPV vaccines.
- Gardasil generated ~$1.8B in sales over the past four quarters.
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