Oct. 22, 2014, 5:30 PM
- AAL, AB, ACAT, AEP, ALK, ALV, ALXN, ARG, ASPS, AVT, BBW, BC, BCC, BHE, BKU, BMS, CAB, CAM, CAT, CCE, CELG, CFX, CHKP, CLI, CMCSA, CMS, CRI, CRS, CS, CSH, CVE, CWEI, DAN, DGX, DLX, DNKN, DO, DPS, EQM, EQT, FAF, GM, GMT, GPI, GRUB, HERO, HUB.B, IMAX, IVC, JAH, JAKK, JBLU, JNS, KKR, LAZ, LLY, LO, LSTR, LTM, LUV, MDP, MHO, MINI, MJN, MMM, MTRN, NLSN, NOK, NUE, NWE, ORI, OSIS, OSTK, OXY, PCP, PENN, PHM, PLD, POT, PRLB, PTEN, QSII, RCI, RCL, RS, RTN, RYL, SIAL, SILC, SJR, SLAB, SONS, SQNS, STC, TDY, TROW, UA, UAL, UFS, UNP, USG, UTEK, WCC, WSO, YNDX, ZMH
Oct. 21, 2014, 9:08 AM
- Privately-held Boehringer Ingelheim commences patient enrollment in a Phase 3 clinical trial evaluating the safety and efficacy of nintedanib in patients with colorectal cancer refractory to standard treatments. The double-blind randomized, placebo-controlled study will enroll more that 750 patients at 150 sites worldwide.
- Nintedanib (trade name Ofev) is a small molecule tyrosine kinase inhibitor that was recently approved by the FDA for idiopathic pulmonary fibrosis.
- CRC-related tickers: (NASDAQ:GILD) (NYSE:LLY) (NASDAQ:MGNX) (OTCPK:BAYRY) (OTCPK:BAYZF) (NASDAQ:AMGN) (OTC:MKGAF) (NYSE:BMY) (NASDAQ:ONXX) (NASDAQ:IMMU) (NASDAQ:ONCY) (NASDAQ:ARQL) (NYSE:SNY) (OTCQB:SNYNF) (NASDAQ:REGN)
Oct. 20, 2014, 4:22 PM
Oct. 13, 2014, 8:03 AM
- Lipocine's (NASDAQ:LPCN) oral testosterone replacement therapy candidate, LPCN1111, demonstrates positive top-line results in a 12-patient Phase 2a feasibility study in hypogonadal males.
- Study participants with serum total testosterone <300 ng/dL received a single dose of LPCN1111 (330 mg, 550 mg, 770 mg) followed by once-daily administration of 550 mg for 28 days (10 subjects) or once-daily administration of 770 mg for 28 days (eight subjects).
- The proportion of the 550 mg and 770 mg cohorts with 24-hour serum testosterone concentration within the normal range was 67% and 88%, respectively. The typical target for regulatory approval is 75%.
- A Phase 2b is expected to begin in Q1 2015.
- TRT-related tickers: (NASDAQ:RPRX) (NYSE:LLY) (NYSE:ABBV) (NASDAQ:AUXL) (NYSE:TEVA)
Oct. 8, 2014, 4:05 AM
- Three members of Novartis' executive committee will leave the company after the completion of transactions with GlaxoSmithKline (NYSE:GSK) and Eli Lilly (NYSE:LLY) expected in the first half of 2015.
- Division head of Novartis Animal Health, George Gunn, and division head of Novartis Vaccines, Andrin Oswald, will leave the company once the deals are concluded. Division head of Novartis OTC, Brian McNamara, will move over to Glaxo.
- Eli Lilly's acquisition of Novartis' Animal Health business was approved by the European Commission this past Friday.
Oct. 7, 2014, 9:54 AM
- Menlo Park, CA-based Virobay (VBAY) is set for its IPO of 3.8M shares at $12 - 14.
- The clinical stage biopharmaceutical firm develops drugs based on its cysteine cathepsin platform. Cysteine cathepsins are important enzymes in the biology of many diseases. The company believes that inhibiting these enzymes produces safer, more effective therapies. It currently focuses its efforts on inhibitors of cathepsins S and B.
- Its lead product candidates are cathepsin S inhibitors: VBY-036 for neuropathic pain and Crohn's disease and VBY-891 for psoriasis. Phase 2 development for all three indications should commence in 1H 2015 which means that meaningful product revenues are far in the distance.
- In 2013, the company generated $9.9M in collaboration revenue. Its operating loss was ($2.3M). In 1H 2015, collaboration revenue dropped to $1.1M and the loss from operations increased to ($3.6M).
- Crohn's disease-related tickers: (ABBV -1.6%)(MRK -1.2%)(RDHL +0.4%)(VBLX)(OTCPK:TKPHF)(OTCPK:TKPYY)(CNDO +1.1%)(OTCQB:SNGX)(PSTI +2.3%)
- Neuropathic pain-related tickers: (DARA -4.4%)(AVNR -3.4%)(ZLCS +0.9%)(IPCI -2%)(BLRX -1.9%)(MNOV +0.6%)(PFE -0.3%)(OTCPK:NGSX)
- Psoriasis-related tickers: (DERM -0.5%)(NVS -2.5%)(CELG -1.4%)(LLY -1.3%)(CANF -2.3%)(IDRA -1.4%)(JNJ -0.8%)(XNPT +0.5%)(HSP -0.2%)
Oct. 3, 2014, 4:00 PM
Oct. 3, 2014, 7:45 AM| Comment!
Oct. 2, 2014, 10:18 AM| Comment!
Sep. 24, 2014, 10:52 AM
- Lipocine's (LPCN +40.8%) oral testosterone replacement therapy candidate, LPCN 1021, achieves its primary efficacy endpoint in a Phase 3 clinical trial.
- The FDA guidelines for primary efficacy success stipulate a minimum of 75% of trial subjects on active treatment achieve a serum testosterone concentration within the normal range of 300-1140 ng/dL and the lower bound of the 95% CI (confidence interval) must be greater than 65%.
- In the Phase 3 study, 88% of LPCN 1021-treated patients achieved testosterone levels in the normal range with a lower bound CI of 82%.
- LPCN 1021's safety profile was acceptable as well. Three percent of the subjects reported a serious adverse event, though none were drug-related. All drug-related adverse events were mild or moderate. The safety extension phase of the trial is ongoing.
- One aspect of the value proposition of oral TRT therapy is the elimination of the risk of inadvertent testosterone transfer associated with transdermal gels (before the gel dries).
- Related tickers: (LLY +0.6%)(ABBV +1.1%)(RPRX +8.1%)(AUXL -0.2%)(TEVA +0.4%)
Sep. 22, 2014, 10:47 AM
- Plandai Biotechnology (OTCQB:PLPL -3%) plans to develop and test an all-natural product for erectile dysfunction (ED). The compound, called icariin, is an extract from the plant Epimedium, also called the horny goat weed. Icariin is a phosphodiesterase type 5 (PDE5) inhibitor similar to sildenafil, the active ingredient in Viagra.
- The company has begun cultivating and cloning epimedium and expects to begin testing on a potential ED product in mid-2015. Icariin is less potent than sildenafil, but Plandai believes its extraction process will enhance epimedium's absorption and retention in the bloodstream to a sufficient degree that it will be a viable all-natural ED treatment alternative.
- Related tickers: (PFE -0.7%) (LLY -0.5%) (GSK +0.4%) (OTCPK:BAYRY +0.9%)(AUXL -0.7%)
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. 18, 2014, 1:31 PM
- In a joint meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee today, members vote 18-3 against approval for privately-held Clarus Therapeutics' oral testosterone Rextoro.
- The committees voted yesterday 20-1 in favor of revising who should be prescribe testosterone replacement therapies (TRT) and the need to conduct further studies to assess the cardiovascular risks. The revised population of patients appropriate for TRT will be much smaller as a result.
- Related tickers: (LLY +0.9%) (ABBV -0.5%) (RPRX -25.4%) (LPCN -25.3%) (AUXL -0.5%) (TEVA +0.3%)
Sep. 18, 2014, 7:40 AM
- In a joint meeting between the Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, panel members vote 20-1 in favor of drug developers' need to further assess the cardiovascular risks of testosterone products. Sixteen voted that it should be studied only in certain situations.
- Members also voted 20-1 in favor of a revision of who should be prescribed the drugs. The panel says there is little evidence that testosterone replacement therapies (TRT) are effective for treating low levels of hormone caused by aging.
- Prescriptions for TRT products almost doubled from 2010 to 2013. About 20% of TRT patients do not have laboratory evidence that they need the therapy.
- Eli Lilly (NYSE:LLY) says that current evidence does not support a causal link between TRT and cardiovascular events. Based on the committee's statements, though, it will work with the FDA on how to communicate the cardiovascular risk to patients.
- The committees meet today to discuss Clarus Therapeutics' NDA for an oral testosterone.
- Related tickers: (NYSE:ABBV) (NASDAQ:AUXL) (NYSE:TEVA)
Sep. 16, 2014, 12:33 PM
- On Thursday, September 18, the Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will jointly meet to discuss privately-held Clarus Therapeutics' New Drug Application for Rextoro, an orally-available testosterone for patients with hypogonadism.
- Briefing docs
- Tomorrow, the two committees will jointly meet to discuss the appropriate population for testosterone therapy and the potential for adverse cardiovascular outcomes associated with testosterone replacement therapy.
- Related tickers: (ABBV +0.7%) (LLY +0.9%) (AUXL -1.6%) (TEVA +1.8%)
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