Thursday, January 24, 2019
NewYork-Presbyterian Hospital to expand telehealth capability with Philips
Royal Philips announced that NewYork-Presbyterian Hospital will expand its telehealth capabilities with Philips remote patient monitoring. The Hospital’s affiliated physicians at Weill Cornell Medicine will use Philips eCareCoordinator and eCareCompanion remote patient monitoring software solutions for patients who are under their care. The program will help clinicians monitor patients’ health from a distance, and enable timelier consultations with physicians when needed. The program is aimed to help reduce length of stay in the hospital, reduce preventable hospital readmissions, and reduce frequent costly visits to the emergency department. The Hospital’s affiliated physicians at Columbia University Irving Medical Center expect to participate as well.
https://thefly.com/landingPageNews.php?id=2853349
Finding Psychological Techniques for Traders That Actually Work
It is common that I hear traders describe techniques they are using to make changes that sound good on the surface but that, in fact, are not effective. A great example of this would be the use of trading journals to review the day. Such review might be helpful for learning and, if focused, could help with goal-setting. But the process of making personal changes is not going to be fulfilled by doing some writing. Change requires a different focus and a very different mindset and emotional state. Writing down an intention to be more disciplined in trading is worlds apart from using psychological methods to rehearse that discipline and create a sense of emotional urgency around the rules and practices.
In the most recent Forbes post, I lay out an important principle: the challenges that impact our trading are closely related to the personal challenges that bring people to counseling and psychotherapy. We first encountered this notion in the Psychology of Trading book, but the idea of a continuum linking all of our challenges is broader. As the Forbes post lays out, an important implication is that the techniques that help people with anxiety, depression, anger, and the like are effective for parallel problems in the performance domain: stress, negative thinking, frustration, etc.
This is huge.
There are evidence-based psychological methods known to help people with diagnosable emotional disorders. Every one of them can be adapted to help us with normal, developmental challenges and with the unique problems associated with the quest for peak performance. Moreover, all those techniques accomplish their goals relatively quickly, as the most recent research review of brief therapies lays out.
We would never consider turning to unproven home remedies when research-backed medical help was available. Similarly, it makes no sense to turn to pop-psych, feel-good solutions when there are reliable methods for lasting change readily at hand. In upcoming posts, I will review some of these methods and their application.
Advaxis suffers another blow as FDA puts phase 3 on partial hold
The FDA has put Advaxis’ phase 3 cancer vaccine clinical trial under a partial clinical hold, prohibiting it from enrolling patients. Advaxis suffered the latest in a string of setbacks after the FDA requested chemistry, manufacturing and controls (CMC) information.
In its release to disclose the partial clinical hold, Advaxis framed the FDA action as the result of a review that took place following a request to modify the analysis plan for the phase 3 cervical cancer trial. As Advaxis tells it, the review led the agency to request additional CMC information on the axalimogene filolisbac (AXAL) cancer vaccine being tested in the pivotal study.
“The primary focus of the items raised by the agency relates to providing additional clarifying details for CMC information previously provided in support of phase 3 development and which will help support a future biologics license application,” Advaxis CEO Kenneth Berlin said in a statement.
Advaxis can continue treating patients who are already in the trial but cannot recruit new subjects. The impact of that restriction on Advaxis’ prospects is tied to the duration of the partial hold. Advaxis said it is working to address the FDA’s requests for information and will respond as promptly as it can. The primary completion date for the 450-patient study is currently set for June 2020.
Prior setbacks mean Advaxis can ill afford delays. In recent years, two earlier, now-resolved clinical holds have slowed Advaxis’ progress and dragged down its stock. The company slipped deeper into penny stock territory in the back half of last year as a result of a share offering and loss of an Amgen pact.
The events have left Advaxis with a market cap of $22 million. As of the end of October, Advaxis had $45 million in cash. With its annual burn rate standing at $50 million following a cost-cutting drive, a cash crunch is looming on the horizon.
Advaxis’ ability to raise cash is hindered by its depressed stock price, making it vital that the biotech avoids setbacks and delivers impressive data in upcoming readouts. Data from an interim analysis of the AXAL phase 3 are due sometime in the future, and readouts from other studies are also on the roster for the first quarter and beyond.
Government shutdown doesn’t stop Gossamer floating
Gossamer Bio isn’t letting the government shutdown put a brake on its financing plans as it files for a $230 million IPO to help fund its clinical programs.
The biotech—one of our Fierce 15 winners in 2018—is making use of a process that allows it to push the button on its flotation without needing a green light from the Securities and Exchange Commission (SEC), which is pretty much closed down as the partial shutdown heads toward its fifth week.
Gossamer is making use of Section 8(a) of the Securities Act, which means it can file its registration unilaterally providing it agrees to fix its IPO price for 20 days—in this case until Feb. 12. The company is offering 14,375,000 shares of its common stock at an IPO price of $16.00 per share, and if the listing goes through on that basis the company would be worth about $1 billion.
“In the event that the federal government and the SEC resume normal operations prior to February 12 … Gossamer Bio will re-evaluate the use of Section 8(a) in connection with the offering,” said the biotech in a statement.
Citing Renaissance Capital data, Reuters suggests about 80 companies across multiple business sectors have filed with the SEC for IPOs, but none have completed a listing on the U.S. stock exchange since the shutdown started on Dec. 22.
If it goes through as planned, San Diego-based Gossamer will get the cash injection it needs to push ahead with an ambitious development portfolio that includes three drugs in clinical trials across multiple immunology indications, including asthma, nasal polyposis, severe urticaria (hives), pulmonary arterial hypertension (PAH) and inflammatory bowel disease (IBD), and another three in preclinical development
The company already pretty flush with cash, having raised $100 million on its debut and followed that with a $230 million series B that made it one of the most well-funded Fierce 15 winners of all time.
Heading Gossamer’s pipeline is GB001, an oral antagonist of prostaglandin D2 receptor 2 already in a phase 2b trial in moderate-to-severe eosinophilic asthma and with midstage studies also planned in chronic rhinosinusitis caused by nasal polyps and chronic spontaneous urticaria for later this year, according to the firm’s SEC prospectus.
Following GB001 are GB002, an orally inhaled platelet-derived growth factor receptor kinase inhibitor for PAH, and hypoxia inducible factor-1a stabilizer GB004 for IBD, both of which are in phase 1 testing.
Gossamer is planning to push GB002 into a phase 2/3 trial in PAH before the end of the year and to start phase a 1b trials of GB004 in ulcerative colitis in the first half of 2019, with a phase 2 trial in Crohn’s disease following in 2020.
Roche dispatches strategy executive Alexander Hardy to take Genentech helm
After Roche lost its top pharma executive Dan O’Day to Gilead Sciences, the cancer giant tapped Genentech head Bill Anderson for the post, leaving a gap at the top of its crucial unit. Now, Genentech has named Roche executive Alexander Hardy to be its next CEO.
Hardy, who joined Genentech in 2005, now serves as head of global product Strategy for Roche Pharmaceuticals. Previously, he headed up Asia Pacific for Roche’s pharma outfit. He’ll start as Genentech CEO on March 1.
And he’ll bring broad experience to the role: During his previous stint at Genentech, he racked up experience leading patient access and commercial operations for therapeutic areas including HER2-positive cancer, flu and neuroscience, the company said.
The exec shuffling follows the surprise departure of O’Day, who’d headed up Roche Pharmaceuticals as CEO and left to become Gilead Sciences CEO in December. On the same day, Roche said Anderson would take O’Day’s former position.
Hardy “brings significant global expertise in the delivery of breakthrough medicines and a deep connection to the company culture,” Anderson said Thursday in a release.
“I look forward to seeing Genentech’s scientific excellence, employee experience and dedication to patients thrive under his leadership,” he added.
Hardy and Anderson have tough jobs ahead. The Roche and Genentech management teams will have to deal with a costly patent cliff expected this year, as a trio of blockbuster cancer meds lose patent protections or face new biosimilar entrants.
On a conference call last year, Roche CEO Severin Schwan said the company expects to compete with Rituxan biosimilars in the U.S. in the first half of 2019, and with Herceptin and Avastin biosimilars in the second half of the year.
In hiring O’Day as its next CEO, analysts saw Gilead’s move as a boon to its oncology business at a time when its hep C meds are sputtering. Jefferies analyst Michael Yee wrote that oncology “historically has not been [Gilead’s] strong suit, so the hiring of an executive from a major oncology company reflects in part [Gilead’s] future direction.”
After Gilead purchased Kite Pharma for nearly $12 billion back in 2017, CAR-T launch Yescarta has struggled commercially out of the gate. But it’s early days, and Gilead has big hopes for the technology.
Bio Techne Launches Cell and Gene Therapy Portfolio
Bio-Techne announces the launch of their cell and gene therapy portfolio. As a leading manufacturer of GMP-grade ancillary materials and automated instrumentation, Bio-Techne is uniquely able to offer solutions that advance the translation of cell and gene therapies, from discovery-level research to the optimization of cell therapy manufacturing unit operations. Bio-Techne’s multi-brand portfolio of cell and gene therapy tools can now be viewed at www.bio-techne.com.
Bio-Techne’s cell and gene therapy portfolio includes GMP cytokines and growth factors, GMP small molecules, GMP media, and high-quality antibodies for flow cytometry and immunocytochemical characterization. In addition, Bio-Techne has focused on developing innovative solutions that optimize and simplify cell therapy manufacturing, including their pioneering technologies, Cloudz™ Cell Activation Kits and the Simple Plex immunoassays. These technologies are designed to expedite cell expansion and improve product quality control, respectively.
“We are thrilled to now have our tools for cell and gene therapy organized on the Bio-Techne website under a unifying workflow,” commented Dave Eansor, President of Bio-Techne’s Protein Sciences Segment. “The website provides a vision of how our company can uniquely move this field forward, at both the therapeutic and research level. That vision is to provide simple and flexible solutions that streamline the delivery of effective therapies to patients. The portfolio displayed on the website is also an excellent showcase of Bio-Techne’s current pioneering cell therapy manufacturing solutions.”
The Bio-Techne cell and gene therapy portfolio is currently on display at Phacilitate – Cell and Gene Therapy World from January 22 – 25th, 2019 in Miami, Florida. On Wednesday, January 25th, Dr. Joy Aho, Senior Product Manager for Cell and Gene Therapy, will present on “Optimizing Workflows for Ex Vivo Cell Therapy Manufacturing” (Wednesday, January 25th, 2:20-2:35 pm) and Nithya Jesuraj, R&D Manager for Cell and Gene Therapy, will present a poster on “Optimizing Cell Activation, Cytokine Stimulation, and Bioreactor Systems for Efficient Ex Vivo Expansion of Human T Cells” (Wednesday January 25th, 6-7:30 pm).
Bristol Myers Squibb Strong Q4
Bristol-Myers Squibb Company (NYSE:BMY) reported results for the fourth quarter of 2018 which were highlighted by strong demand for Opdivo (nivolumab) and Eliquis (apixaban) and a robust operating performance across the portfolio.
The company increased fourth-quarter revenues 10% to $6.0 Billion, 9% for a full-year to $22.6 Billion. It also posted fourth-quarter GAAP EPS of $0.73 and Non-GAAP EPS of $0.94. The company also announced Strategic Acquisition of Celgene Corporation
The company reported net earnings attributable to Bristol-Myers Squibb of $1.2 billion, or $0.73 per share, in the fourth quarter, compared to a net loss of $2.3 billion, or $1.42per share, for the same period in 2017.
The results in the fourth quarter last year included the transitional impact of U.S. tax reform.
Research and development expenses decreased 29% to $1.4 billion in the quarter primarily due to license and asset acquisition charges of $377 million in the fourth quarter last year.
CEO Giovanni Caforio said “I am proud of our results in 2018, which were based on superior commercial performance for our prioritized brands and important scientific advances that continue to diversify our R&D pipeline. We are beginning 2019 with good momentum in our current business, with Opdivo and Eliquis continuing as strong and growing franchises.
“Our planned acquisition of Celgene will position us to create a leading biopharma company, with best-in-class franchises, significant near-term launch opportunities and a deep and broad pipeline, creating an even stronger foundation for long-term sustainable growth.”
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