Sep. 29, 2014, 6:07 PM
- Following a successful Phase 3 trial, the FDA has approved Relistor for "the treatment of opioid-induced constipation in patients taking opioids for chronic non-cancer pain."
- Salix (NASDAQ:SLXP) will sell Relistor under a license from developer Progenics (NASDAQ:PGNX). Many expected FDA approval to arrive following a favorable July ruling.
- PGNX +3.4% AH.
- Related tickers: (AZN)(CBST +0.9%)(SGYP -3.4%)(NKTR -0.9%)
Sep. 29, 2014, 11:52 AM
Sep. 29, 2014, 11:19 AM
Sep. 29, 2014, 8:25 AM
- In a 29-patient Phase 1b clinical study of Keytruda (pembrolizumab) evaluating the anti-PD-1 therapeutic for the treatment of advanced urothelial cancer (bladder cancer), early results show an overall response rate of 24% and complete response rate of 10%.
- Merck (NYSE:MRK) presented the data today at the European Society for Medical Oncology Congress in Madrid, Spain.
- Keytruda is currently approved for the treatment of unresectable or metastatic melanoma.
Sep. 26, 2014, 8:35 AM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval of Nektar Therapeutics' (NASDAQ:NKTR) Moventig (naloxegol) for the treatment of opioid-induced constipation (OIC) in adult patients who have had an inadequate response to laxatives.
- Moventig is a peripherally-acting mu-opioid receptor antagonist (PAMORA). The once-daily tablet blocks the binding of opioids to opioid receptors in tissues such as the gastrointestinal tract.
- The drug candidate is based on Nektar Therapeutics' (NKTR) oral small molecule polymer conjugate technology which AstraZeneca (NYSE:AZN) licensed in 2009. It was cleared for sale in the U.S. on September 16 under the name Movantik. AstraZeneca is responsible for commercialization worldwide.
- Under the terms of the license agreement, Nektar is eligible to receive up to $235M in aggregate regulatory and launch milestones, tiered sales-related milestones up to $375M and double-digit royalties on net global sales.
- Related tickers: (NASDAQ:PGNX) (NASDAQ:CBST) (NASDAQ:SLXP) (NASDAQ:SGYP)
Sep. 23, 2014, 4:09 PM
- Merck (MRK -0.4%) sells an exclusive worldwide license to Mumbai-based Sun Pharmaceutical Industries for tildrakizumab, a humanized mAb for the treatment of chronic plaque psoriasis.
- Under the terms of the agreement, Merck will receive an upfront payment of $80M, undisclosed regulatory- and sales-based milestone payments and mid-single-digit through teen royalties on commercial sales. It will continue all clinical development and regulatory activities which will be funded by Sun. Once approved, Sun will assume regulatory responsibilities as well as manufacturing and commercialization.
- Tildrakizumab is an investigational humanized anti-IL-23p19 monoclonal antibody that binds to IL-23p19 to block the cytokine IL-23 which has a role in inflammation.
Sep. 23, 2014, 12:31 PM| Comment!
Sep. 19, 2014, 7:18 AM
- The European Commission approves Novo Nordisk's (NYSE:NVO) Xultophy for the treatment of adult patients with type 2 diabetes to improve glycemic control in combination with oral glucose-lowering medicines when these alone or combined with basal insulin do not provide adequate glycemic control.
- Xultophy (IDegLira) is a once-daily injection combination of insulin degludec (Tresiba) and liraglutide (Victoza).
- Novo plans to launch the product in Europe in 1H 2015.
- Related tickers: (NYSE:NVS) (NYSE:LLY) (NYSE:MRK) (NYSE:SNY) (NYSE:AZN) (NYSE:GSK)
Sep. 18, 2014, 4:03 PM
- The FDA approves Eli Lilly's (LLY +1.1%) Trulicity (dulaglutide), a once-weekly subcutaneous injection to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes.
- Trulicity is a glucagon-like peptide-1 (GLP-1) receptor agonist, a hormone that helps normalize blood sugar levels.
- Related tickers: (NVS +0.1%) (MRK +0.7%) (SNY +0.7%)(AZN +1.3%)(GSK +0.4%)
Sep. 17, 2014, 10:00 AM
- Merck's (MRK -1%) once-weekly DPP-4 inhibitor, omarigliptin, achieves its primary objectives in a Phase 3 clinical trial on Japanese patients with type 2 diabetes. Its efficacy and tolerability were comparable to Merck's once-daily DPP-4 inhibitor Januvia (sitagliptin). The company plans to file its marketing application with Japanese regulators by the end of 2014.
- The primary criterion in the trial was non-inferiority (no worse than) compared to sitagliptin for the control of HbA1c levels.
- Merck has an ongoing global clinical development program for omarigliptin that includes 10 Phase 3 trials involving ~8,000 patients.
Sep. 17, 2014, 9:05 AM
- Mumbai-based Sun Pharma acquires worldwide rights to Merck's (NYSE:MRK) tildrakizumab for use in all human applications for an upfront fee of $80M. Merck will continue all clinical development and regulatory activities which will be funded by Sun. Once approved, Sun will be responsible for all regulatory, manufacturing and commercial activities. Merck is eligible to receive milestone payments and mid-single-digit to teen royalties on commercial sales.
- Tildrakizumab is an investgational humanized anti-IL-23p19 monoclonal antibody that selectively blocks the cytokine IL-23 which has a role in inflammation. Potential indications for tildrakizumab are plaque psoriasis, psoriatic arthritis and Crohn's disease.
Sep. 16, 2014, 10:51 AM
- The FDA approves Nektar Therapeutics' (NKTR -0.1%) Movantik (naloxegol) for the treatment of patients with opioid-induced constipation who take opioids for the management of chronic non-cancer pain.
- Movantik is distributed by AstraZeneca (AZN -0.9%).
- Related tickers: (PGNX -0.2%) (SLXP +3.7%) (CBST +0.1%)
Sep. 15, 2014, 2:07 PM
- Merck's (MRK +0.1%) odanacatib achieves its primary endpoints in a pivotal Phase 3 fracture outcomes study in post menopausal women with osteoporosis.
- Odanacatib reduced the relative risk of new and worsening morphometric vertebral fractures by 54%, clinical hip fractures by 47%, non-vertebral fractures by 23% and clinical vertebral fractures by 72%. All the results were statistically significant.
- The company plans to submit an NDA to the FDA in 2015 in addition to marketing applications in Europe and Japan.
Sep. 11, 2014, 7:08 PM
- After moving back above the $100/share level, Apple (NASDAQ:AAPL) is back over the $600B mark in market cap, pushing it nearly $200B above Exxon Mobil (NYSE:XOM), the next largest company in the U.S.
- XOM is still valued at more than $400B, but Google (NASDAQ:GOOG) at $397B and Microsoft (NASDAQ:MSFT) - which has surged in 2014, adding $74B in market cap to $386B - are closing the gap.
- Berkshire Hathaway (NYSE:BRK.B) completes the top five with a $339B market cap; no other companies are worth more than $300B.
- Rounding out the top 20 market caps: JNJ, WFC, GE, WMT, CVX, PG, JPM, FB, VZ, IBM, PFE, KO, ORCL, T, MRK.
Sep. 4, 2014, 3:19 PM
- The FDA approves Merck's (MRK -0.8%) Keytruda (pembrolizumab) for the treatment of patients with advanced or unresectable melanoma who are no longer responding to other drugs. Keytruda is intended for use following treatment with Yervoy (ipilimumab) (BMY -0.4%). For BRAF V600-mutated melanoma, Keytruda is intended for use after ipilimumab and a BRAF inhibitor.
- Pembrolizumab is the first PD-1 inhibitor approved in the U.S. It works by increasing the ability of the body's immune system to fight melanoma. Pembrolizumab blocks the interaction between programmed death receptor-1 (PD-1) and its ligands, PD-L1 and PD-L2.
Sep. 4, 2014, 10:11 AM
- The FDA designates Merck's (MRK +0.8%) investigational beta-lactamase inhibitor, relebactam, a Qualified Infectious Disease Product (QIDP) with Fast Track status. The designations apply to the IV use of relebactam for the treatment of complicated urinary tract infections, complicated intra-abdominal infections and hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia.
- QIDP qualification provides certain incentives for antibiotic developers including a five-year extension of the data exclusivity provisions under the Hatch-Waxman Act and priority review of NDAs. Fast Track provides enhanced communication with senior FDA officials during a drug's development as a means to expedite the process.
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