Ecolab has formed the Ecolab Food Safety Advisory Board to identify and help solve emerging trends that could impact food safety. The insights gained from leading industry experts will help Ecolab develop new solutions and protocols to advance food safety at food processing, food retail and foodservice facilities throughout the world. Ecolab Food Safety Advisory Board members include: Mary Wagner, Ph.D., president of MK Wagner and Associates and chair of the Ecolab Food Safety Advisory Board. Scott Brooks, DVM, president of River Run Consulting. Hal King, Ph.D., president of Public Health Innovations. Mick Miklos, CP-FS, program director for the National Restaurant Association. Elsa Murano, Ph.D., professor and president emerita at Texas A&M University. Payton Pruett, Ph.D., president of Practical Food Safety Solutions. The Ecolab Food Safety Advisory Board steering committee includes Ecolab food safety experts and leaders from the Ecolab divisions that provide food safety solutions and expertise.
Thursday, May 24, 2018
Idera in trial, supply pact with Bristol-Myers
In a regulatory filing earlier, Idera Pharmaceuticals (IDRA) reported that the company entered into a clinical trial collaboration and supply agreement on May 18 with Bristol-Myers Squibb (BMY) to clinically evaluate the combination of the company’s TLR-9 agonist IMO-2125 with BMS’s therapy Yervoy. Under the Collaboration and Supply Agreement, the Company will sponsor, fund and conduct the Company’s ongoing global, open-label, multi-center Phase 3 clinical trial of tilsotolimod in combination with Yervoy in accordance with an agreed-upon protocol. Under the collaboration and supply agreement, BMS has granted to the company a non-exclusive, non-transferrable, royalty-free license, with a right to sublicense, under its intellectual property to use Yervoy in the trial and has agreed to manufacture and supply Yervoy, at its cost and for no charge to the company, for use in the trial.
AbbVie Phase 3 leukemia study meets primary endpoint
AbbVie (ABBV) announced that the Phase 3 iLLUMINATE, or PCYC-1130, trial met its primary endpoint of improvement in progression-free survival. The study evaluated IMBRUVICA in combination with GAZYVA in previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma patients, the most common adult leukemia. Specifically, the study met its primary endpoint for a clinically and statistically significant difference in PFS for patients treated with IMBRUVICA plus obinutuzumab versus those who received chlorambucil plus obinutuzumab, as assessed by an Independent Review Committee. Pharmacyclics and Janssen (JNJ) are sharing the primary analysis data from the study with regulatory authorities and plan to present the data in a future publication or medical congress. Based on the data and if approved by the FDA, IMBRUVICA plus obinutuzumab could be the first chemotherapy-free CD20 combination in first-line CLL treatment. “We are optimistic about the topline results from the iLLUMINATE study and the fact that IMBRUVICA plus obinutuzumab demonstrated marked improvement in progression-free survival compared to obinutuzumab plus chlorambucil, a combination which is currently recommended by the National Comprehensive Cancer Network guidelines as a Category 1 treatment,”2 said Danelle James, M.D., M.A.S., Head of Clinical Science, Pharmacyclics LLC, an AbbVie company. “Since its introduction nearly five years ago, IMBRUVICA has been regarded as an important treatment option for patients with CLL/SLL. As well, we now have long-term, five-year data in CLL. We are committed to researching the full potential of IMBRUVICA alone and in combination therapy across a range of B-cell blood cancers.”
Prothena restructuring to focus on neuroscience pipeline
Prothena (PRTA) has initiated a reorganization to align its resources on advancing its broad neuroscience pipeline – including its ongoing clinical-stage programs for PRX002/RG7935, being developed in collaboration with Roche (RHHBY), and its proprietary program PRX004, as well as its discovery-stage pipeline which includes a proprietary program targeting Abeta, and three programs being advanced as part of a neuroscience R&D collaboration with Celgene (CELG), including tau, TDP-43 and an undisclosed target. As a result of the discontinuation of the NEOD001 development program, Prothena has implemented a reorganization designed to concentrate resources around its neuroscience research, discovery and early development expertise to advance its discovery and clinical-stage pipeline and will reduce its workforce by approximately 57%. Following the reorganization to close down the NEOD001 program, and based on filling several open positions, Prothena expects its workforce to be approximately 63 positions. The company expects its 2018 net cash burn from operating and investing activities to be $40M-$50M, which includes $110M of cash provided by operating activities associated with the Celgene collaboration, and to end the year with approximately $421M in cash. Estimated 2018 net cash burn from operating and investing activities is primarily driven by a net loss of $170M-$185M, including an estimated $25M of non-cash share-based compensation expense. The estimated 2018 net loss includes $80M-$85M of operating expenses associated with NEOD001 and the company’s reorganization and approximately $8M of non-cash share-based compensation expense.
Cerner target upped by RBC
Cerner price target raised to $71 from $67 at RBC Capital. RBC Capital analyst George Hill raised his price target on Cerner to $71 and kept his Outperform rating after the company finalized its Veterans Affairs contract last week. Hill says the margins around the VA deal could outperform expectations as the contract contributes over $1B in revenue run rate exiting 2021 and into 2022, while the share buyback that the company announced may lead to positive earnings revisions for FY19
Akorn takeover by Fresenius still can close: RBC
RBC still believes Akorn takeover by Fresenius can close. After speaking with a legal expert “well-versed in Delaware law,” RBC Capital analyst Randall Stanicky says he still has not heard anything that makes him believe Akorn’s (AKRX) takeover by Fresenius SE (FSNUY) cannot close. While the outcome remains high risk and debate will continue, Akorn shares have high potential reward relative to the closing deal price of $34 per share, Stanicky tells investors in a research note. The legal expert the analyst spoke to expects a reasonably quick trial from Chancery Judge Laster with the decision likely in July. An appeal would go to the Delaware Supreme Court and could last several months, but expectations are that the trial decision will be “tough” to reverse given this is an issue of fact, the analyst adds. Stanicky has a Sector Perform rating on Akorn shares with a $25 price target.
Recro Pharma’s non-opioid pain shot fails to get approval from FDA
Recro Pharma’s IV meloxicam, a non-opioid injection, did not get approval from the U.S. Food and Drug Administration because the agency said the drug’s pain-relieving effect did not meet its expectations.
The company said it plans to meet with the FDA to find solutions.
Unlike the drug’s oral version, which has been on the market for several years, Recro’s intravenous formulation is long-acting for treating acute pain, particularly in patients who have undergone surgery.
In a so-called complete response letter, the FDA noted that although late-stage trials of the drug showed statistically significant outcomes on their main goals, it was unable to approve the marketing application in its current form.
Data from ad hoc analyses and selective secondary goals in the trials suggest that the pain-relieving effect of the drug did not meet expectations, the letter added.
The letter also raised questions on certain other data provided in the company’s application, Recro said.
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