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Oct. 24, 2015, 7:50 AM
- “We’re trying to figure out where we are and what we do going forward," a Walgreens Boots Alliance (NASDAQ:WBA) source tells the WSJ. "We need to understand the truth."
- The drugstore chain has "no concrete plans at this stage" to expand its partnership with Theranos beyond the 41 stores in Arizona and California which already include Theranos "wellness centers," reports the Journal. That partnership also includes an equity stake in the startup.
- Walgreens made the move after meeting late this week with top brass at Theranos, including CEO Elizabeth Holmes. Said meeting came about after stories questioning the viability of the startup's technology. Walgreens was also unaware of the FDA's surprise inspection of Theranos facilities in August and September, according to sources.
- Previously: Theranos chief Holmes says technology sound (Oct. 21)
- Related tickers: Abbot Labs (NYSE:ABT), Quest Diagnostics (NYSE:DGX), Lab Corp. (NYSE:LH), Roche Holding (OTCQX:RHHBY)
Oct. 22, 2015, 4:30 PM
- Patient dosing is underway in a Phase 3 clinical trial, called SURPASS, evaluating Chimerix's (NASDAQ:CMRX) lead product candidate brincidofovir in kidney transplant recipients who are seropositive for cytomegalovirus (CMV). The primary endpoint of the 520-subject non-inferiority study is the incidence of CMV disease compared to valganciclovir [Roche's (OTCQX:RHHBY) Valcyte] over 100 days. According to clinicaltrials.gov, the estimated study completion date is February 2017.
- The company is also conducting a Phase 3 study for the prevention of clinically significant CMV infection in patients undergoing hematopoietic cell transplant (HCT). Enrollment was completed in June. Top-line data from this trial, called SUPPRESS, are expected in early 2016.
- Brincidofovir is a broad spectrum antiviral under development for the prevention and treatment of clinically significant infections caused by DNA viruses. It is an oral nucleotide that has shown antiviral activity in vitro against all five families of DNA viruses that affect humans including CMV, adenovirus, BK virus and herpes simplex viruses.
Oct. 22, 2015, 8:20 AM
- Roche (OTCQX:RHHBY) discloses that its breast cancer med, Kadcyla (ado-trastuzumab emtansine) failed to achieve its primary efficacy endpoint in a clinical trail, GATSBY, assessing it for the treatment of HER2-positive advanced gastric cancer. The company intends to present the data at a future medical conference.
- The company is developing Kadcyla with Immunogen (NASDAQ:IMGN), who entered into a royalty purchase agreement with TPG Special Situations Partners to monetize its Kadcyla-related royalties earlier this year.
- Previously: ImmunoGen raises $194M via royalty transaction (March 30)
Oct. 21, 2015, 12:44 PM
- During a technology conference in California hosted by the Wall Street Journal, Theranos CEO Elizabeth Holmes defended her company and its technology against critics who claim things are not what they seem at the high-flying early-stage firm.
- She said the company has moved away from one of its devices only briefly as it proceeds to getting FDA clearance for all of its tests. She also cites her personal involvement in enacting a law in Arizona that allows patients to get blood tests without a doctor's order, saying, "I personally in Arizona worked very hard to change the law. I can't do that without knowing that the tests that are offered are of the highest quality."
- Related tickers: (ABT +1.2%)(OTCQX:RHHBY -1%)(LH -1.2%)(DGX -0.7%)
- Previously: Upstart Theranos has arrived, the ax grinding has begun (Oct. 16)
- Previously: FDA clears upstart Theranos' test system (July 2)
Oct. 19, 2015, 9:32 AM
- Seattle Genetics (NASDAQ:SGEN) initiates a 110-subject, randomized, open-label, multi-center Phase 2 clinical trial assessing ADCETRIS (brentuximab vedotin), in combination with Roche's (OTCQX:RHHBY) Rituxan (rituximab) and bendamustine, in relapsed/refractory patients with CD30-expressing diffuse large B-cell lymphoma (DLBCL). Participants will receive Rituxan and bendamustine, agents commonly used to treat DLBCL, with or without ADCETRIS every three weeks for six cycles. The primary endpoint is the comparison of objective response rates between the treatment arms. Secondary endpoints include progression-free survival, complete remission rate, duration of response and overall survival. The trial is being conducted in ~50 sites across North America and Europe.
- Previously presented data from a Phase 2 study assessing ADCETRIS alone or with Rituxan every three weeks in relapsed/refractory CD30-positive non-Hodgkin lymphoma patients showed an objective response rate of 44% (19% complete remissions) in the ADCETRIS arm and an objective response rate of 46% (15% complete remissions) in the combination arm. The most common treatment-emergent adverse event at least Grade 3 was neutropenia (abnormally low neutrophil [type of white blood cell] count).
- ADCETRIS, an antibody-drug conjugate, is being evaluated in more than 30 ongoing clinical trials.
Oct. 19, 2015, 7:59 AM
- The FDA approves Roche's (OTCQX:RHHBY) cobas HBV and cobas HCV viral load tests, both of which will be performed on its automated cobas 6800 and cobas 8800 laboratory systems. The tests can be run simultaneously on the analyzers, which can generate up to 96 results in less than 3.5 hours.
- Its tests for HIV-1 viral load and cytomegalovirus (CMV) viral load are still under agency review.
Oct. 16, 2015, 2:00 PM
- Start-ups, especially biotechs, typically enjoy an "image honeymoon" period with stakeholders, constituency groups and the press as they try to pull themselves up from a "little company that could" to establishing themselves as sustainable enterprises and legitimate players in their respective markets. Anyone remotely familiar to the biotech arena knows how extraordinarily difficult it is to pull this off so it is rare to see anything but encouraging references to the upstarts as they pursue their visions of successful disruptions and the monetary rewards that follow. Once the company gets momentum and grows in size and valuation, the situation evolves as insiders position themselves for the big payday and competitors wake up to the potential threat. Those who feel threatened or disadvantaged typically use the press to drum up negative news either as "payback" for being excluded from the money train or to dim the aura of the upstart's halo.
- Palo Alto, CA-base Theranos is a case in point. The medical diagnostics firm, started by a teen-aged Stanford University drop-out in 2003, now sports a $9B market cap based on the disruptive potential of its automated microfluidics-based system to the $50B global diagnostics industry. Founder Elizabeth Holmes is a billionaire at age 31. The enormous amount of money at stake inevitably leads to "haves" and "have-nots."
- An article published in the Wall Street Journal yesterday is a superb example of this dynamic. The reporter based his article on information provided by four former (disgruntled) employees who allege that Theranos' dream is quite a distance from reality, saying, among other things, that most of the tests currently being offered are performed by traditional instruments rather than its proprietary Edison system. Other missteps cited in the article, such as providing an incorrect result, occur every day in the diagnostics industry. The selective use of individual examples paints a very biased view of reality. Some of the information may be true, but it is impossible to determine fact from fiction. No one said being a billionaire was easy.
- Previously: FDA clears upstart Theranos' test system (July 2)
- Previously: Upstart Theranos receives CLIA waiver for test system clearing the way for rapid diagnostics in Wellness Center setting (July 16)
- Related tickers: (LH +0.7%)(DGX +1.5%)(ABT -0.4%)(OTCQX:RHHBY +1.6%)
Oct. 15, 2015, 11:42 AM
- Cerulean Pharma (CERU +2.9%) completes enrollment of 110 subjects in a randomized Phase 2 clinical trial evaluating lead product candidate CRLX101, in combination with Roche's (OTCQX:RHHBY +1%) Avastin (bevacizumab), in third- and fourth-line relapsed renal cell carcinoma (RCC). The primary endpoint is progression-free survival per RECIST 1.1 criteria. Top-line data are expected in H1 2016.
- CRLX101 is a nanoparticle-drug conjugate which is designed to concentrate in tumors and slowly release the cytotoxin camptothecin.
Oct. 12, 2015, 10:44 AM
- Thinly traded nano cap Celsion (CLSN +9.2%) moves up on a healthy 10x surge in volume in response to its announcement of positive preclinical results for its GEN-1 IL-12 immunotherapy. Specifically, the combination of GEN-1 IL-12 with Roche's (OTCQX:RHHBY +0.7%) Avastin (bevacizumab) and J&J's (JNJ +0.9%) Doxil (doxorubicin HCl liposome injection) showed a greater than 98% reduction in tumor burden compared to the combination of Avastin and Doxil alone in an ovarian cancer cell line called SKOV3 implanted into immunocompromised mice.
- GEN-1 is an immunotherapy consisting of an interleukin-12 (IL-12) DNA plasmid vector encased in a nanoparticle delivery system. It is administered via an intraperitoneal (body cavity) injection.
- The company is currently enrolling patients in a Phase 1b trial called OVATION. A Phase 1/2 combination study should commence in mid-2016.
Oct. 12, 2015, 7:17 AM
- The Netherlands' National Institute for Public Health and the Environment (RIVM) awards a five-year contract to Roche (OTCQX:RHHBY) to implement its cobas HPV test as the first-line primary screening test in its national cervical cancer screening program, expected to start in H2 2016. It will be the first country in the world with an organized cervical screening program to fully transition from the Pap test to primary HPV screening with the aim of improving the detection rate of pre-cancerous disease.
- The cobas HPV test is the only FDA-cleared HPV assay that identifies HPV 16 and 18, the highest risk types, in addition to the other 12 HPV types. All are identified simultaneously as a pooled result from one cervical swab sample. The test will be performed on the automated cobas 4800 System.
- The Dutch program includes a longer time interval between routine screening visits as well as an option for women to self-collect their cervical samples.
- Financial terms are not disclosed.
Oct. 9, 2015, 7:46 AM
- Roche (OTCQX:RHHBY) acquires Berkeley, CA-based privately held Adheron Therapeutics. Under the terms of the deal, Adheron shareholders will receive $105M upfront plus potential milestones of up to $475M.
- Adheron has developed a technology that disrupts immune cell adhesion through a cell surface protein called Cadherin-11, which has the potential for treatments for a range of inflammatory and autoimmune diseases. Its lead product candidate is SDP051, a humanized monoclonal antibody targeting Cadherin-11 that just completed Phase 1 development.
- Cadherin-11, a protein that acts as an "adhesive" between cells, is a key mediator of joint destruction in rheumatoid arthritis and plays a key role in fibrotic pathology.
Oct. 6, 2015, 9:01 AM
- Final results from Roche's (OTCQX:RHHBY) Phase 3 coBRIM clinical trial showed a significant improvement in overall survival (OS) in treatment-naive BRAF V600 mutation-positive advanced melanoma patients treated with the combination of Cotellic (cobimetinib) and Zelboraf (vemurafenib) compared to Zelboraf alone. The specific data will be presented at an upcoming medical conference.
- Last month, the European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion recommending approval of Cotellic + Zelboraf for the treatment of advanced melanoma. A final decision by the European Commission is expected by the end of the year. The FDA's action date for the combo is November 11.
Oct. 5, 2015, 8:55 AM
- Roche (OTCQX:RHHBY) launches its new CE-Mark'd high throughput analyzer for HbA1c testing for diabetics, the cobas c 513, which replaces its existing analyzer, the COBAS INTEGRA 800 CTS. The c 513 can process up to 400 patient results per hour, twice the throughput of INTEGRA.
- The c 513 also features direct results reporting and higher on-board test capacity (the lab can load more tests at a time).
Sep. 30, 2015, 10:02 AM
- Cerulean Pharma (CERU +4%) announces that its lead product candidate, CRLX101, achieved its pre-defined gating criteria for advancement into the second stage of an open-label Phase 2 clinical trial in patients with recurrent cisplatin-resistant ovarian, tubal and peritoneal cancer. In the study's first stage, 8 of 15 (53%) of patients treated with CRLX101, in combination with Roche's (OTCQX:RHHBY +1.3%) Avastin (bevacizumab), achieved at least six months of progression-free survival (PFS). This compared favorably to the historical expectation of ~20%.
- CRLX101 is a nanoparticle-drug conjugate (NDC) that delivers its anti-cancer payload, camptothecin, inside tumor cells. It inhibits topoisomerase 1 (topo 1), an enzyme involved in cellular replication and hypoxia-inducible factor-1, which is a master regulator of cancer cell survival mechanisms.
- The FDA has designated CRLX101 an Orphan Drug for the treatment of ovarian cancer and for Fast Track review, in combination with Avastin, for the treatment of metastatic renal cell carcinoma.
Sep. 28, 2015, 7:44 AM
- A Phase 3 clinical trial, called ORATORIO, evaluating Roche's (OTCQX:RHHBY) investigational ocrelizumab in patients with primary progressive multiple sclerosis (PPMS) met its primary endpoint of demonstrating reduced progression of clinical disability compared to placebo. The endpoint was defined as an increase in Expanded Disability Status Score (EDSS) that was sustained for at least 12 weeks. The incidence of serious adverse events was similar to placebo, most were infusion-related reactions. The results will be presented at the 31st congress of the European Committee for Treatment and Research in Multiple Sclerosis in Barcelona, Spain on October 10 (Abstract #228).
- Head of Global Product Development Sandra Horning, M.D., says, "People with the primary progressive form of MS typically experience symptoms that continuously worsen after the onset of their disease and there are no approved treatments for this debilitating condition. Ocrelizumab is the first investigational medicine to show a clinically meaningful and statistically significant effect on the progression of disease in [PPMS]."
- Roche intends to pursue marketing authorization for ocrelizumab in both relapsing MS and PPMS. Late-stage study data will be submitted to the FDA in early 2016. About 10% of MS patients have PPMS.
Sep. 27, 2015, 7:00 PM
- Two Phase 2 clinical trials assessing Roche's (OTCQX:RHHBY) atezolizumab in patients with advanced non-small cell lung cancer (NSCLC) met their primary endpoints.
- The first, POPLAR, showed that patients with recurrent NSCLC whose tumors expressed medium/high levels of PD-L1 who received atezolizumab experienced a statistically significant survival benefit compared to chemotherapy (p=0.014). Median survival had not yet been reached.
- The second, single-arm BIRCH, showed a 27% objective response rate in patients treated with atezolizumab whose cancer had progressed on prior therapies and also expressed the highest level of PD-L1.
- The data were presented at the European Cancer Congress in Vienna, Austria.
- In February 2015, the FDA designated atezolizumab a Breakthrough Therapy for the treatment of PD-L1-positive NSCLC patients whose disease worsened during or after standard treatments. The company has seven ongoing Phase 3 studies of the PD-L1 antagonist, alone or in combination with other medicines, for the treatment of various types of lung cancer.
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and... More
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