Food distributor Sysco Corp said on Friday that a record U.S. outbreak of avian flu would limit its chicken and egg supply for nine to 18 months, based on information provided to the company by its suppliers.
Sysco is the biggest U.S. food distributor, whose clients include restaurants, hotels and hospitals. The company is discussing options with its customers, including creating alternative menu items during the period, a Sysco spokesman said in an email.
It is too soon to tell whether the supply squeeze will have a material impact on financial results, spokesman Charley Wilson said. Poultry accounted for 10 percent of Sysco's revenue in 2014, according to filings.
Read MoreNebraska declares state of emergency over bird flu
The U.S. poultry and egg industry is grappling with the country's biggest outbreak on record of avian influenza, which has proven highly infectious and deadly for poultry. Governors in Nebraska, Wisconsin, Minnesota and Iowa have declared a state of emergency, and the outbreak has shown few signs of waning.
Earlier this week, Cargill Inc said it has implemented increased biosecurity measures at its facilities receiving liquid egg tankers and shell eggs from impacted states and that it is working with egg suppliers to ensure they are employing measures to prevent spread of the flu.
Meanwhile, on Thursday, Post Holdings Inc, calling the flu a "force majeure event," said it now estimates that 25 percent of its egg supply has been affected. Sysco is a major customer for Post's Michael Foods business, which sells egg products, according to filings.
Stifel Nicolaus analyst Christopher Growe expects Post's previous estimate of a $20 million financial impact in 2015 to at least double, according to a research note.
Growe said that Post's contracts require the company to go to the open market and to third parties to replace the lost supply at high prices. "We believe that by declaring force majeure, the company will be able to either pass higher
Yes, I think there is an excellent chance that the FDA will approve for elderly AML. In fact, I am optimistic that the filing will get fast track status. There is a compelling need for new Rx.
I think that the pipeline of early stage drugs is under appreciated.
This stock is a strong recommendation of the medical G news letter. They point out that the current price of the stock has already discounted the walls of Angiomax, and they emphasize the powerful pipeline. There are three other drugs likely to get FDA approval this year.
VRTX down 6% today since apparently data did not live up to expectations
I suspect it had to do with either low $ offered by Takeda, or conflict with one of the many other collaborators already under SGEN's umbrella
MEIP dropped 66% this morning after disclosing the failure of its drug, pracinostat in ph2, to help patients with myelodysplastic syndrome in conjunction with azacytidene(Vidaza). CELG is a big player in the MDS area with both Reviled and Vidaza(the latter still has patent exclusivity in EU through 2018, although now generic in US). In addition, CELG also has under development CC-486, an oral version of vidaza, which is felt to be more effective. Pracinostat was felt to be very promising and likely the lead candidate for MDS, and having it knocked out of the box, shifts leadership back to CELG. I would also note that CELG is attacking the most prominent symtom of MDS, anemia, by exercising its collaboration option with XLRN to develop luspaterecpt and sotatercept, the data for which looked most exciting based on data presented at ASH 2014. MDS could easily be 1Bil market for CELG
just completed Palestine, Tx plant and starting new plant, all WITHOUT debt. Patience will win out here. Also a good chance that they will be bought out as the smallest co. in the field.
You are wrong! SNSS hopes to get FDA approval based on approval of a pre-defined sub-group of 60 years old, which was highly statistically significant. The head of FDA Heme/Onc Division, Richard Pazdur, seems much more amenable to approving a sub-group that demonstrates OS, which is the toughest parameter to obtain in a study.
Stock seems way undervalued by every metric. Unfortunately, my sense is that management is very conservative and unlikely to make a significant special dividend or borrow$$ to initiate a share buy back
In regards to the second question, the authors acknowledge that only 1 of 6 responses in patients with PMBCL is unexpectedly low, but owing to the limited numbers of these patients, they are unable to address this question further. Although accrual of PMBCL patients to a phase 2 trial with brentuximab vedotin may be challenging because of the rarity of this disease and the relatively high response rates with standard front-line regimens, such a study is needed. Patients with PMBCL who relapse are often particularly challenging to salvage because the disease tends to be quite aggressive and chemo-refractory, providing a clinical rationale for novel therapies in this patient population.
Finally, addressing the third question, the study by Jacobsen et al did not assess cell of origin, myc, or bcl-2 expression in the DLBCL patients. Therefore, it is unclear whether response is associated with a specific DLBCL subtype as is observed with lenalidomide and ibrutinib, where OR is higher in the activated B-cell subtype. However, in a recent study by Hu et al, 461 cases of de novo DLBCL (PMBCL was excluded) were assessed for CD30 expression, and 14% were found to have CD30 expression of at least 20%.9 Of these 65 cases, 38, 26, and 1 were germinal-center, activated B cell, or unclassifiable, respectively, by gene expression profiling. None of the CD30+ cases had a detectable myc translocation by fluorescence in situ hybridization, although 38, 26, and 15 patients were found to have myc, bcl-2, or both myc and bcl-2 overexpression by IHC analysis. Moreover, CD30+ patients had a superior overall survival and progression-free survival, with 5-year overall survival and progression-free survival of 79% and 73%, respectively, in the CD30+ group compared with 59% and 57% for the CD30– cases. The favorable outcome of the CD30+ patients was observed regardless of cell of origin. The studies by Hu et al and others demonstrate that we still have a lot to learn about how best to use the
With respect to question 1, patients who entered this study were required to have visible CD30 expression by immunohistochemistry (IHC) analysis in a relapse biopsy sample reviewed by a local pathologist. This tissue was also sent for central pathology review, where CD30 expression on the neoplastic cells was visually quantified, and for analysis using computer-assisted quantification of CD30 expression on all cells (malignant and nonmalignant) in a specimen. Surprisingly, no statistical correlation between response and CD30 expression by central visual IHC or by computer-assisted review was observed. Specifically, in 48 DLBCL patients, the median percent of CD30+ cells by visual central review was 25% (0, 90) in the responders vs 25% (0, 100) in the nonresponders. Twenty-one percent of the responders had
Sentiment: Strong Buy
An Editorial on the article by Jacobs in this month's issue of BLOOD- the Journal of the American Society of Hematology:
Although most investigators are well aware of the incredible success of brentuximab vedotin in the treatment of patients with Hodgkin lymphoma (HL)1 and anaplastic large-cell lymphoma (ALCL),2 the study by Jacobsen and colleagues in this issue of Blood demonstrates surprising activity of this agent in patients with B-cell non-Hodgkin lymphoma (NHL).3
In a planned subset analysis of a phase 2 multicenter trial of brentuximab vedotin in patients with relapsed/refractory CD30+ NHL, overall response (OR) and complete response (CR) rates of 44% and 17%, respectively, were observed in 49 patients with diffuse large B-cell lymphoma (DLBCL). Although only 20% of the enrolled DLBCL patients had a prior autologous transplant, 82% were refractory to prior therapy and 24% were transformed from low-grade NHL. OR was 44% and 50% in the patients with refractory and transformed DLBCL, respectively. This efficacy rivals that of other single agents in DLBCL, namely lenalidomide and ibrutinib, where ORs of 22% to 53% have been described.4⇓-6
Nineteen patients with B-cell NHL other than DLBCL were also enrolled. Seventy-four percent of these patients were refractory to their last therapy, and OR in this group was 26%, with responses observed in patients with gray-zone lymphoma (n = 3), primary mediastinal B-cell lymphoma (PMBCL, n = 1), and posttransplant lymphoproliferative disorder (n = 1).
Three questions arise in reviewing this study: (1) Can we predict response based on CD30 expression; (2) Why is the activity in PMBCL so low (overall response rate 17%), particularly w
Valor's data barely missed statistical significance for the entire study BUT were stunning in the pre-defined sub-set of patients 60 and in those with short remissions. The FDA appears to have set a precedent with the NVS drug just approved for multiple myeloma in approval based on a sub-set group. Hence, things look more favorable for FDA approval for vosaroxin based on its sub-set success.
The FDA just approved Novartis" new drug for multiple myeloma on basis of sub-groupp analysis:
The US Food and Drug Administration (FDA) today granted accelerated approval to panobinostat (Farydak, Novartis) for the treatment of patients with relapsed multiple myeloma.
Late last year, panobinostat was voted down at an FDA Oncologic Drugs Advisory Committee meeting that had considered its use in relapsed multiple myeloma. The agency said that after that meeting the company submitted additional information supporting the agent's use for a slightly different indication, and it was this that was approved.
The approval is for use of the panobinostat in patients with relapsed multiple myeloma who have received at least two prior standard therapies, including bortezomib (Velcade, Millennium) and an immunomodulatory agent. This is an area of unmet medical need, the company noted.
Panobinostat is approved for use in combination with bortezomib and dexamethasone.
The drug is a first in a new class of agents that act as inhibitors of histone deacetylases.
"Panobinostat has a new mechanism of action that distinguishes it from prior drugs approved to treat multiple myeloma, making it a potentially attractive candidate agent," said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, in a statement. This FDA approval is based on efficacy and safety data in a prespecified subgroup analysis of 193 patients who had received prior treatment with both bortezomib and an immunomodulatory agent. This subgroup of patients participated in the phase 3, randomized, double-blind, placebo-controlled, multicenter global registration trial, known as PANORAMA-1 (PANobinostat ORAl in Multiple MyelomA).
The findings showed that, in this subgroup, the median progression-free survival in patients treated with panobinostat was higher than that in the placebo arm (10.6 months, n = 94 vs 5.8 months, n = 99; hazard ra