TRACON Pharmaceuticals announced positive top-line clinical results from a Phase 1 study of TRC105 and Opdivo for the treatment of non-small cell lung cancer. The combination of TRC105 and Opdivo was well-tolerated without the development of dose limiting toxicity in six patients who were treated as part of dose escalation. One of these six patients, whose archival tumor did not express PD-L1 and who had not received prior PD-1/PD-L1 checkpoint inhibition treatment, developed a partial response and remains on study after 10 months. Two of the other five patients, one of whom who progressed following prior Opdivo treatment, remain on trial with stable disease. Patients are currently enrolling into two parallel 12 patient expansion cohorts. TRC105 is currently being studied in a pivotal Phase 3 trial in angiosarcoma and multiple Phase 2 clinical trials, in combination with VEGF inhibitors, as well as in a Phase 1 trial with Opdivo. TRC105 has received orphan designation for the treatment of soft tissue sarcoma in both the U.S. and EU.
Wednesday, December 26, 2018
Crispr gains on Vertex stake
Crispr Therapeutics AG (NASDAQ:CRSP) is trading up 9.9% at $24.98 today, after it was revealed Friday evening that cystic fibrosis specialist Vertex Pharmaceuticals (VRTX) took a 10.1% stake in the gene editing company. On Friday, CRSP stock touched a nearly 52-week low of $22.22, as it’s struggled mightily in the second half of the year.
To be more specific, the shares traded as high as $73.88 in late May, but since then have been stuck in a relentless downtrend. In just the past three months, Crispr Therapeutics has shed 45%, and not surprisingly ended up in oversold territory, like many stocks across the market, according to its 14-day Relative Strength Index (RSI) of 22.
Still, analysts have mostly remained bullish. Of the 11 brokerage firms in coverage, seven say to buy CRSP. Even more notable, the average 12-month price target from the brokerage bunch stands all the way up at $66.17.
Henry Schein files statement to spin off, merge animal health business
Henry Schein announced that HS Spinco has filed a registration statement on Form S-4/S-1 with the SEC relating to the planned spin off of the Henry Schein Animal Health business and the subsequent merger with Vets First Choice. Spinco intends to list its common stock on Nasdaq under the symbol (CVET) and the new standalone company will be named Covetrus.
https://thefly.com/landingPageNews.php?id=2841399
Stemline Gets First FDA Approval for Rare Blood Disease Therapy
Blastic plasmacytoid dendritic cell neoplasm (BPDCN) is a highly aggressive, rare form of blood cancer that is often improperly diagnosed or underdiagnosed because of similarities and overlap with other types of cancer. It is a disease of the bone marrow and blood that can affect multiple organs, including the lymph nodes and the skin, that often presents with features similar to acute myeloid leukemia, non-Hodgkins lymphoma, acute lymphocytic leukemia, myelodysplastic syndromes and chronic myelomonocytic leukemia, as well as other malignancies with skin manifestations. BPDCN constitutes less than 1% of all hematologic malignancies, according to the Leukemia and Lymphoma Society, with an estimated 1,000 to 1,400 cases in the US and Europe combined each year. Patients can develop BPDCN at any age, but the median age at diagnosis is in the mid-60s, with about 75% of cases affecting men. Prior to last Friday, there have been no approved therapies for BPDCN.
New York City based Stemline Therapeutics (STML) is developing treatments for difficult-to-treat cancers. The company announced last Friday just before the close that it received approval for Elzonris (tagraxofusp), its first approved drug and the first FDA-approved therapy for BPDCN. Elzonris is also the first FDA-approved therapy that targets CD123, an antigen that has been shown to be highly expressed in leukemic stem cells and that is an emerging target for many cancer researchers. The FDA granted approval of Elzonris for the treatment of BPDCN in adult and pediatric patients two years and older, in both treatment-naive and previously-treated populations.
Tuesday, December 25, 2018
VA Considers Swapping Epic Scheduling System With Cerner Software
VA is leaning toward scrapping its 2015 scheduling system contract with Epic in favor of Cerner’s scheduling software, according to Subcommittee on Technology Modernization chairman Jim Banks (R-IN.)
In a letter to VA Acting Deputy Secretary James Byrne, Banks urged the federal agency to make a decision about which appointment scheduling software it plans to implement as part of VA’s $10 billion EHR modernization project.
“In the coming days, my understanding is that VA will be complying with the requirement of H.Rpt. 115-929 and announcing a decision as to how the nationwide implementation of a modernized medical scheduling system will be accelerated,” wrote Banks.
“I share the Appropriations Committee’s interest that such a scheduling system, meaning one that is resource-based, permits comprehensive veteran self-scheduling, and is accessible on multiple platforms, reaches all Veterans Health Administration facilities as quickly as possible,” he added.
The scheduling module part of VA’s homegrown VistA system is riddled with inefficiencies and lacks internal controls, leading to long wait lists for veterans.
A pilot of Epic’s Cadence scheduling system at VA’s care sites in Columbus, Ohio was successful in improving appointment scheduling. The system launched on time and came under budget, according to reports.
“While all available information indicates VA’s pilot of the Epic Cadence scheduling system in Columbus, Ohio has been successful, my understanding based on testimony from and conversations with Department leaders is that VA’s preference is to implement the Cerner Millennium scheduling package, because it has either already been purchased or a commitment has been made to purchase it,” said Banks.
“If that is the case, accelerating the nationwide implementation would entail decoupling scheduling from the rest of the Electronic Health Record Modernization (EHRM) program’s timetable,” he added.
Banks expressed frustration with the stunted implementation of VA’s Medical Appointment Scheduling System (MASS), which has “stopped and started repeatedly,” he wrote.
“It seems if Epic Cadence’s implementation had been unimpeded it could have been nearly complete by now,” stated Banks.
Given VA is now considering terminating its contract with Epic and instead implementing a Cerner scheduling system, Banks requested answers to six questions pertaining to the scheduling system installation process within the next 90 or 150 days.
First, Banks requested information about how the scheduling system’s resource-based capabilities will be used to increase efficiency, reduce wait times, and make better use of healthcare resources.
“What metrics will be put in place, and how will results be measured?” asked Banks.
The Congressman also asked about how much the Cerner Millenium scheduling package will cost.
“If it is not severable from a larger software package, how was that determined, and how much does that software package cost?” inquired Banks.
Banks also seeks information about how the EHR modernization implementation cost will be affected by the decision to separate the cost of the scheduling software from the rest of the project.
Additionally, the Congressman asked about the cost of deploying Epic Cadence according to the accelerated timeline being considered for the Cerner Millenium scheduling package as opposed to the original timeline established for the MASS contract.
“Would there be meaningful schedule differences in an accelerated Cerner scheduling implementation compared to an accelerated Epic scheduling implementation?” he wrote.
Finally, Banks asked whether VA has considered publishing scheduling resources along with its recently-launched Fast Healthcare Interoperability Resources (FHIR) server.
Overall, Banks urged VA to continue operating its Epic scheduling system at care sites in Columbus, Ohio regardless of the scheduling system it ultimately chooses to implement.
“Time and money have already been invested to implement it, and by all accounts it is functioning well,” wrote Banks. “Perhaps more significantly, the MyChart patient portal which was implemented along with Cadence could serve as a valuable interoperability test bed at little or no additional cost.”
Daiichi Sankyo: Date for Dissolution of Japan Vaccine; Handling Its Products
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that it has reached an agreement with GlaxoSmithKline K.K. (hereafter, GSK) regarding the dissolution date for Japan Vaccine Co., Ltd. (hereafter, Japan Vaccine), a joint venture between Daiichi Sankyo and GSK whose dissolution was announced on November 14, 2018, and also regarding other matters, such as how to handle Japan Vaccine’s products following the dissolution.
1. Dissolution date
On April 1, 2019, Japan Vaccine’s commercial activities, except for certain functions, will be transferred to Daiichi Sankyo or GSK. From April 1, 2019, Japan Vaccine will continue to operate until all legally required procedures have been completed, at which point it will be dissolved.
2. Measures to be taken with products
Among Japan Vaccine’s products, marketing promotion activities and sales for those products shown below will be handled by Daiichi Sankyo from April 1, 2019.
List of products
| Product Name |
| Freeze-dried Live Attenuated Mumps Virus Vaccine ‘Kitasatodaiichisankyo’ |
| Freeze-dried Live Attenuated Rubella Virus Vaccine ‘Kitasatodaiichisankyo’ |
| Freeze-dried Live Attenuated Measles, Rubella Combined Vaccine ‘Kitasatodaiichisankyo’ |
| INFLUENZA HA VACCINE ‘KITASATO DAIICHI SANKYO’ SYRINGE 0.25mL・0.5mL |
| INFLUENZA HA VACCINE ‘KITASATO DAIICHI SANKYO’ 1mL |
| SQUAREKIDS® SUBCUTANEOUS INJECTION SYRINGE* |
| Adsorbed Diphtheria-Tetanus Combined Toxoid ‘Kitasatodaiichisankyo’ |
| Adsorbed Tetanus Toxoid ‘Kitasatodaiichisankyo’ Syringe |
* Adsorbed Diphtheria-Purified Pertussis-Tetanus-Inactivated Polio (Salk Vaccine) Combined Vaccine.
Rotarix®, a rotavirus vaccine, is to be transferred to GSK but distribution to wholesalers will be continued by Daiichi Sankyo for a certain period of time.
3. Measures to be taken with products that are currently being developed
VN-0102, which is a measles-mumps-rubella combined vaccine currently being developed by Japan Vaccine, is to be developed independently by Daiichi Sankyo, with support by GSK, from April 1, 2019, with the aim of achieving regulatory approval as soon as possible.
Daiichi Sankyo and GSK intend to continue their collaborative relationship with the aim of improving public health by manufacturing and providing vaccines and other medicines so as to contribute to prevention and treatment of disease, and to the health of the Japanese population.
California PUC Evaluates Possible Breakup of Pacific Gas and Electric
–The California Public Utilities Commission has started a process to evaluate whether PG&E Corp.’s (PCG) Pacific Gas and Electric utility should be split up, Bloomberg News reported.
–PG&E’s stock price has been hurt amid concerns about potential liabilities from this year’s Camp Fire in Northern California. PG&E said in a statement that it acknowledged regulators’ concerns and that it needs to “re-earn” the trust of customers, Bloomberg reported.
–Citigroup analyst Praful Mehta said in a research note that the changes being considered by regulators will “only help reduce ongoing risk without destroying shareholder value,” Bloomberg reported.
Subscribe to:
Posts (Atom)