Thu, Feb. 5, 3:23 PM
- The resignation of prominent healthcare investor/entrepreneur Dr. Phillip Frost, M.D., from Teva Pharmaceutical Industries' (TEVA +1.8%) Board of Directors prompts aggressive buying from speculators who think a potential deal is afoot with Opko Health (OPK +4.6%). Teva is up on 50% higher volume while Opko's turnover is 3x average.
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%)
Jul. 8, 2014, 3:59 PM
- Shares of Zogenix (ZGNX -12.9%) tumble today on more than a 2x surge in volume in response to the competitive threat from Purdue. The FDA granted its tamper-resistant hydrocodone product Priority Review which means that it could debut in the U.S. by the end of 2014.
- Zogenix is working on its own abuse deterrent version of Zohydro. It plans to submit an sNDA in October. The time frame for regulatory review may delay its U.S. launch until the mid-2015, however.
- Related tickers: (ABBV -3%) (TEVA -1.7%) (ALKS -2.4%) (MNK -2.2%) (PFE -1.1%)
May. 15, 2014, 3:51 PM
- Shares of Momenta Pharmaceuticals (MNTA +11.3%) are up on slightly higher volume in response to a federal judge's tossing of Teva's (TEVA -0.9%) lawsuit accusing the FDA of acting improperly by not demanding additional testing of generic forms of Copaxone before clearing them for marketing.
- Teva gets a "A" for effort in trying to stop competitors from selling their generic offerings especially since it is usually on the other side of the aisle. The U.S. Supreme Court has yet to rule on its patent infringement case vs Mylan and Sandoz.
Apr. 28, 2014, 9:11 AM
- Teva's (TEVA) and OncoGenex Pharmaceuticals's (OGXI) Custirsen treatment for prostate cancer has failed in a Phase III trial.
- When given with standard chemotherapy, the drug didn't improve the overall survival of patients with advanced castrate-resistant prostate cancer vs those who received just chemotherapy.
- OncoGenex's shares are -52%, while those of Teva are +0.25%. (PR)
Apr. 28, 2014, 7:55 AM
- Shares of OncoGenex (OGXI) are off 53% premarket on modest volume in response to its announcement that its Phase 3 clinical trial for custirsen failed to meet its primary endpoint of a statistically significant improvement in overall survival in men with metastatic castrate-resistant prostate cancer.
- The SYNERGY trial compared the addition of custirsen to the standard first-line therapy of docetaxel/prednisone to docetaxel/prednisone alone.
- The company will hold an investors conference call this morning to discuss the matter.
- (TEVA +1.6%)
Mar. 31, 2014, 11:05 AM
- Shares of generic drug maker Momenta Pharmaceuticals (MNTA -11.4%) are down in early trading after the Supreme Court agrees to hear Teva's (TEVA +4.7%) appeal of a lower court's ruling invalidating its Copaxone patents.
- Without a reversal the product's exclusivity expires May 24.
Jan. 29, 2014, 4:57 AM
- Teva's (TEVA) shares are +2.7% in Tel Aviv after the FDA approved a 40 mg dose of the company's multiple sclerosis drug Copaxone that would be administered three times a week.
- Teva now plans to convert 57% of patients to the new regimen by the year-end from the daily dose of 20 mg.
- The longer-lasting regimen should help Teva cope with generic competition when Copaxone's patent protection expires in May. The higher-dosage version is protected until 2030. (PR)
Jan. 14, 2014, 3:37 PM
- Shares of Teva Pharmaceutical (TEVA +8.4%) are on their way to a solid session.
- The move higher is likely attributable to the reportedly upbeat tone struck at the JPMorgan Healthcare Conference, where the company presented today at 1:30 ET.
- According to chatter, the company says it is moving quickly with its new CEO.
- Also overheard during the presentation: The company is keeping the biosimilars business and remains interested in acquisitions.
- In other company news, TEVA says data published in the online scientific journal PLOS ONE suggests there are significant differences in biological and immunological effects between Copaxone and a purported generic." (PR)
Jan. 8, 2014, 12:46 PM
Jan. 8, 2014, 9:11 AM
Jan. 7, 2014, 9:58 AM
- BofA upgrades Perrigo (PRGO +1.2%) to Buy from Neutral. RBC starts the shares as a Top Pick, with a $187 price target.
- BofA upgrades Becton Dickinson (BDX +0.8%) to Neutral from Underperform.
- RBC upgrades Johnson & Johnson (JNJ +1.6%) to Outperform from Sector Perform. Price target is $104.
- Citi upgrades Varian Medical (VAR +1.6%) to Neutral from Sell.
- Roth starts ANI Pharma (ANIP +9.5%) at Buy. Price target is $27.
- RBC starts Teva (TEVA +0.1%) at Sector Perform. Price target is $39.
- RBC starts AcelRx (ACRX +2.5%) at Outperform. Price target is $15.
- RBC starts Mylan (MYL +2.3%) at Outperform. Price target is $50.
- RBC starts Allergan (AGN +1.3%) at Outperform. Price target is $131.
- RBC starts Impax Labs (IPXL +0.2%) at Sector Perform. Price target is $25.
Dec. 17, 2013, 12:17 PM
- Teva Pharmaceuticals (TEVA -0.1%) will be allowed to launch a generic version of Viagra on Dec. 11, 2017 (or earlier under certain circumstances) following a settlement of Pfizer's (PFE -0.1%) patent litigation case against the company. Teva will pay Pfizer a royalty for a license to produce the generic version. Other terms of the settlement are confidential.
- Press release
Dec. 16, 2013, 5:42 PM
Dec. 16, 2013, 12:46 PM
Dec. 16, 2013, 9:11 AM
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