Oct. 21, 2014, 7:32 AM
- The Dermatologic and Ophthalmic Drugs Advisory Committee votes unanimously in favor of approving Novartis' (NYSE:NVS) interleukin-17A inhibitor secukinumab for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy. A final decision by the FDA is expected in early 2015.
- Novartis has also submitted its regulatory application with the European Medicines Agency. A decision is expected in late 2014 to early 2015.
- Psoriasis-related tickers: (NYSE:JNJ) (NASDAQ:DERM) (NYSE:MRK) (NASDAQ:CELG) (NASDAQ:IDRA) (NYSE:HSP) (NYSEMKT:CANF) (NASDAQ:AMGN) (NYSE:AZN) (NYSE:PFE)
Oct. 20, 2014, 5:35 PM
Oct. 20, 2014, 11:55 AM
Oct. 20, 2014, 11:44 AM
- The FDA accepts Merck (MRK) and Sanofi's (SNY -0.7%) (OTCQB:SNYNF) BLA for the firms' investigational hexavalent vaccine, DTaP5-IPV-Hib-HepB, for review. If approved, it will be the first pediatric combination vaccine in the U.S. designed to protect children from six diseases: diptheria, tetanus, pertussis, polio, H. influenza type B and hepatitis B.
- The antigens for H. influenza and hep B are from Merck. Sanofi supplied the remaining antigens.
Oct. 20, 2014, 10:40 AM
- Laboratory Corporation of America (LH -0.2%) launches its HIV GenoSure Archive, the first laboratory test that helps clinicians optimize antiretroviral (ARV) drug regimens for virally suppressed HIV patients. The test was developed using the Next Generation Sequencing Platform (NGS).
- Previous lab testing to guide ARV drug selection required higher viral loads than many HIV patients have. GenoSure Archive is performed by amplifying cell-associated HIV-1 DNA from infected cells in whole blood samples and then analyzing the polymerase region using NGS methods. The assay is analytically validated to identify mutations associated with resistance to all members of the most widely used ARV drug classes.
- HIV-related tickers: (ABBV +1.2%)(GILD +1.6%)(BMY +0.1%)(PFE -0.2%)(GSK -0.3%)(ABT +0.2%)(JNJ +0.1%)(PGNX +3%)(MRK +0.1%)(OTCQX:RHHBY +0.6%)
Oct. 20, 2014, 8:27 AM
- In two Phase 2a clinical trials, privately-held Genervon Biopharmaceuticals' drug candidate for Amyotrophic Lateral Sclerosis (ALS), GM6 (known as GM604 in the ALS trial and GM608 in a Parkinson's disease study), showed encouraging disease-modifying results albeit in a small number of patients.
- In the ALS study, GM604 significantly reduced the decline in ALSFRS-R versus the historical control (p=0.0047). Seven of eight patients has their ALS disease progression slowed or stopped at week 12 after six doses of GM604. Five of seven treated patients had their forced air capacity (FVC) disease progression slowed or reversed at week 12 compared to historical placebo (-11.5% compared to -4.7% after treatment).
- In the Parkinson's study, the difference in the treated patients' UPDRS scores versus historical placebo at week 12 were statistically significant (p=0.0085). Changes in secondary clinical outcomes measures at week 2 were statistically significant at the one-tailed 10% level for four of eight patients.
- Genervon has submitted these results to the FDA for guidance on how to make GM6 available for ALS and PD patients. GM604 for ALS has been designated Fast Track and an Orphan Drug by the FDA.
- ALS-related tickers:(NYSEMKT:CUR) (NASDAQ:BCLI) (NASDAQ:MNOV) (NASDAQ:BIIB) (NASDAQ:CYTK)
- PD-related tickers: (NASDAQ:ACOR) (Pending:CVTS) (NASDAQ:ACAD) (OTCQX:CYNAF) (NASDAQ:IPXL) (OTCQB:TTNP) (OTCQB:SGTH) (NYSE:TEVA) (NASDAQ:ADMS) (NASDAQ:PRAN) (NASDAQ:CHTP) (NASDAQ:PRTA) (NASDAQ:FOLD) (NASDAQ:AVNR) (NYSE:BSX) (NYSE:MRK)
Oct. 19, 2014, 9:49 AM| 2 Comments
Oct. 17, 2014, 8:12 AM
- Roche (OTCQX:RHHBY) and Merck (NYSE:MRK) are set to present data from their respective immunotherapy drugs for the treatment of triple negative breast cancer (TNBC) at December's San Antonio Breast Cancer Symposium. TNBC does not respond to either of two types of hormonal therapy or drugs that target HER2 receptors, such as Roche's Herceptin.
- Both companies' products are PD-1 inhibitors. Roche is also testing its candidate, called MPDL3280A, for the treatment of melanoma and lung, bladder, kidney, bowel and blood cancers. Merck's product, Keytruda (pembrolizumab) injection, is currently cleared for the treatment of melanoma.
- Bristol-Myers Squibb (NYSE:BMY) and AstraZeneca (NYSE:AZN) are also players in the space.
Oct. 16, 2014, 12:50 PM
- Without admitting to any wrongdoing, Merck's (MRK -2%) Organon unit agrees to pay $31M to settle allegations that it overcharged several states' Medicaid programs. Organon also allegedly offered kickbacks to nursing home pharmacies to support the use of its Remeron antidepressant and promoted it for non-approved indications.
- Merck acquired Organon as part of its takeover of Schering-Plough in 2009.
- Indian generic firm Ranbaxy Laboratories (OTC:RBXLY) agrees to pay almost $40M to Texas to resolve allegations that it violated the Medicaid Fraud Prevention Act there by charging inflated prices.
Oct. 16, 2014, 11:46 AM
- The Dermatologic and Ophthalmic Drugs Advisory Committee meets on Monday, October 20 to review Novartis' (NVS -1.7%) BLA for secukinumab, a human mAb, for the treatment of adults with moderate-to-sever plaque psoriasis who are candidates for systemic therapy or phototherapy.
- Briefing docs
- Psoriasis-related tickers: (JNJ -1%)(DERM -5%)(MRK -2.2%)(CELG -0.9%)(IDRA +6.8%)(HSP +1.1%)(CANF)(AMGN -1.5%)(AZN -1.1%)(PFE -1.3%)
Oct. 16, 2014, 9:52 AM
- In conjunction with development partner Actavis (ACT -0.5%), Ironwood Pharmaceuticals (IRWD -0.7%) initiates a Phase 2 clinical trial (~240 patients) to assess the safety and efficacy of linaclotide for the treatment of adults with opioid-induced constipation (OIC). Data is expected in 2H 2015.
- Linaclotide is currently FDA-approved for the treatment of adults with irritable bowel syndrome with constipation or chronic idiopathic constipation.
- OIC-related tickers: (SLXP -0.6%)(PGNX +1.9%)(NKTR -0.5%)(AZN -2%)(CBST +0.1%)(SGYP +0.7%)(SCMP -0.3%)
Oct. 14, 2014, 9:24 AM
Oct. 7, 2014, 11:57 AM
- BC, Canada-based Xenon Pharmaceuticals (XENE) is set for its IPO of 4M shares at $10 -12.
- The clinical-stage biopharmaceutical firm discovers and develops differentiated therapeutics for orphan indications based on its Extreme Genetics platform. It focuses its discovery efforts on rare human diseases with extreme traits, including diseases caused by mutations in ion channels.
- The Extreme Genetics platform yielded the first gene therapy product approved in the EU, uniQure's (QURE +1.5%) Glybera (alipogene tiparvovec) for the treatment of adult patients with familial lipoprotein lipase deficiency.
- Its pharma partners include (TEVA -0.3%), Genentech (OTCQX:RHHBY -2.5%) and Merck (MRK -1.2%). Collaborations have generated over $140M in revenue to Xenon so far. Future milestone payments could potentially surpass $1B.
- The company's lead product is TV-45070 for the treatment of osteoarthritis of the knee. A 300-patient Phase 2b clinical trail run by Teva subsidiary Ivax International GmbH is underway.
- A second product candidate, GDC-0276, for the treatment of pain is being developed in collaboration with Genentech. A Phase 1 study commenced in September 2014.
- Osteoarthritis of the knee-related tickers: (AMPE +0.3%)(FLXN -4.6%)(ANIK -1.2%)(ZMH -0.7%)
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. 6, 2014, 1:55 PM
- Privately-held Danbury, CT-based Perosphere enters into a third collaboration agreement with Daiichi Sankyo to study PER977, Perosphere's investigational anticoagulant reversal agent, in Phase 3 trials with edoxaban, Daiichi's investigational oral, once-daily factor Xa-inhibitor.
- In Phase 1 and 2 studies, PER977 showed that it directly binds to heparin as well as circulating direct factor Xa- and IIa-inhibitors reversing their anticoagulant effect. PER977 does not bind to blood coagulation factors or other blood proteins. In healthy volunteers, it reverses anticoagulant activity after a single IV dose of 100 mg - 300 mg and does not require an extended infusion in order to maintain the reversal.
- Under the terms of the agreement, Perosphere will seek FDA and EMA approval of PER977 to reverse anticoagulant activity of edoxaban and commercialize PER977 in the U.S. and EU. It retains full worldwide commercial rights to PER977. Perosphere will receive an upfront payment from Daiichi Sankyo as well as clinical development-related milestones. It plans to submit an NDA to the FDA by June 2015.
- Related tickers: (JNJ -0.4%)(OTCPK:BAYRY -0.4%)(OTCPK:BAYZF +0.1%)(PFE -0.3%)(BAX)(BMY -0.3%)(ISIS -1.9%)(PTLA)(AZN -0.1%)(MRK -0.6%)
Oct. 3, 2014, 1:53 PM
- The Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee voted against recommending regulatory approval of SonaCare Medical's Sonablate 450 for the treatment of recurrent prostate cancer in patients previously treated with external beam radiation therapy. The device utilizes high intensity focused ultrasound (HIFU) to ablate tissue.
- The panel's rejection was due to the fact that Sonacare's clinical trial data were based on an interim analysis of the first 100 patients in a planned 200-patient study. The company obviously believed the data were compelling enough to proceed with its submission prior to the conclusion of the study but the reviewers felt otherwise.
- The panel voted 7-3 against (1 abstention) recommending that the treatment was safe if used as intended; 9-2 against recommending that the treatment was effective if used as intended and 10-0 against recommending that the benefits outweigh the risks.
- Briefing docs
- Prostate cancer therapy-related tickers:(TKAI -2.1%)(MDVN +1.2%)(NYMX +4.8%)(EXEL -0.3%)(PGNX +2.8%)(MRK +1.8%)(ADXS +2.7%)(EBS +1.8%)(EDAP +3%)(ISIS +2.1%)(NVGN)(DNDN +0.7%)(ISR +1.4%)(OGXI +0.4%)
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