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Friday, June 26, 2020

All regular ICU beds in Texas Med Center occupied, but hospitals have surge space

All regular ICU beds in the Texas Medical Center are now being used, according to numbers just released on the TMC website, but officials say they can add more.
Hospitals in Houston’s Medical Center will now move some ICU patients to beds not normally used for critical care.
Twenty-eight percent of the ICU patients are being treated for COVID-19.
Despite reaching surge capacity, four hospital CEOs said Thursday there’s no cause for “unwarranted alarm.”
Those same CEOs signed a letter to Houstonians Wednesday warning, “If this trend continues, our hospital system capacity will become overwhelmed.”
Dr. Marc Boom explained in a virtual news conference Thursday that the purpose of the letter was to “urge people to do the right things in the community and do so by talking about capacity, but really ended up unintentionally sounding an alarm bell too loudly about capacity.”

The average ICU occupancy rate at the world’s largest medical center is 70 to 80 percent, but higher rates aren’t unheard of.
“It is completely normal for us to have ICU capacities that run in the 80s and 90s,” Methodist Hospital CEO Dr. Marc Boom said. “That’s how all hospitals operate.”
Boom said what is different now is that more than one in four ICU patients have COVID-19, forcing hospitals to shift the balance of care.
“We are watching numbers increase. We are seeing more people in the community with the disease. So we know we will need to take care of more individuals. That obviously cannot go on forever, so we need the community to do the right things to bend this curve right now,” said Dr. Boom.
They said the majority of hospitalizations they are now seeing are coming from younger people, but most patients don’t stay at the hospitals long and are less likely to die from COVID.
All of the CEOs said Thursday their hospitals are equipped with plenty of PPE and ventilators to treat COVID-19 patients.
“The spread is increasing and it’s very concerning. However, our hospitals are okay and ready to manage this surge effectively and appropriately,” said Dr. Doug Lawson, CEO of CHI St. Luke’s Health, CHI. “The reality is our capacity to care for those patients significantly exceeds what we’re staffing on any given day.”
Lawson said that while the hospitals have enough beds, equipment, and staff to handle this first level of “sustainable surge capacity,” they would need to contract out more health care workers from out-of-state if the need becomes greater.
The concern from Texas Medical Center leaders is that the current rate of people getting sick with COVID-19 and going to the hospital would become unsustainable if it persists.

Thursday morning, Gov. Greg Abbott issued an Executive Order to ensure hospital bed availability for COVID-19 patients as the number of cases increase at an alarming rate.
The governor’s order suspends elective surgeries at hospitals in Harris, Bexar, Dallas and Travis counties.

Vertex Gets Positive CHMP Opinion for Kaftrio/Kalydeco Combo

Vertex Pharmaceuticals Inc. on Friday said the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended approval of Kaftrio in combination with Kalydeco in people ages 12 and older with cystic fibrosis with the most common genotypes.
The Boston drug maker said the combination, if approved by the European Commission, would be the first cystic fibrosis transmembrane conductance regulator modulator for people with one F508del mutation and one minimal function mutation and would bring additional benefit to people with two F508del mutations.
The European Commission generally follows the CHMP’s recommendations.

FDA OKs Zogenix drug for rare childhood epilepsy

Zogenix (NASDAQ:ZGNX) says the Food and Drug Administration approved its Fintepla drug to treat seizures associated with Dravet syndrome, a rare form of childhood epilepsy.
Fintepla uses a low-dose liquid solution of fenfluramine, which was used in an obesity drug combination that was later withdrawn from the market due to evidence of heart valve damage.
The drug’s main competition will come from GW Pharmaceuticals’ (NASDAQ:GWPH) cannabis-based Epidiolex, which also is approved to treat seizures related to Dravet Syndrome and Lennox-Gastaut syndrome.
Fintepla is expected to bring in peak sales of ~$450M in 5-7 years for its use against Dravet syndrome, Guggenheim analyst Yatin Suneja says.


Roche launches automated pathology algo for lung cancer

Roche (OTCQX:RHHBY) announces the commercial launch of uPath-L1, an automated digital pathology algorithm for non-small cell lung cancer. The company says the algorithm provides pathologists with automated assessments of scanned slide images that are objective and reproducible, and have the potential to aid diagnosis and, ultimately, targeted treatment options for patients.

MediciNova +14% on encouraging ibudilast data in glioblastoma

MediciNova (NASDAQ:MNOV) is up 14% premarket on positive preclinical findings published in Frontiers in Immunology regarding the prospect of MN-166 (ibudilast) as an adjunct treatment for glioblastoma.
In this research publication, in collaboration with Dr. Richard Bucala (Yale University), they report the monocytic subset of myeloid-derived suppressor cells (M-MDSCs) expressed high levels of the macrophage migration inhibitory factor (MIF) cognate receptor CD74 in the tumor microenvironment.
Targeting M-MDSCs with ibudilast resulted in decreased MDSC function and enhanced CD8 T cell activity in the tumor microenvironment as compared to treatment with an immune stimulatory therapy alone, which is not effective in treating GBM, and the company hypothesized that better clinical outcomes can be achieved when combined with ibudilast.
Ibudilast readily crosses the blood-brain barrier, an advantage over other agents, and has a strong safety profile.

Novartis strikes out with dry eye med Xiidra in Europe

Novartis (NYSE:NVS) has withdrawn its marketing application in Europe seeking approval of Xiidra (lifitegrast) for the treatment of dry eye disease.
The advisory group CHMP was not on board citing a lack of data proving efficacy. In studies, “some effect” was observed in reducing eye dryness, but the improvement was not considered clinically significant. Since lifitegrast was targeted for patients with more severe disease for whom artificial tears were not sufficient to improve the condition, the agency had “concerns” about how these patients were to be selected, noting that studies compared Xiidra with vehicle (placebo) and had not used artificial tears in an optimal way. Also, there were no data on the effects of long-term treatment despite eye dryness being a chronic disease.
The setback has to be painful for the company since it paid $3.4B in upfront cash to Takeda a year ago for the product (the deal also included up to $1.9B in potential milestones).
The FDA approved Xiidra for the indication in July 2016.

J&J bails on Stelara for lupus

Johnson & Johnson (NYSE:JNJ) unit Janssen Pharmaceutical Companies will terminate its Phase 3 LOTUS study evaluating Stelara (ustekinumab) in patients with an autoimmune disorder called systemic lupus erythematosus.
The company decided to pull the plug after a pre-planned analysis of preliminary data failed to show enough of a treatment effect.
It says its decision will not affect any other ongoing studies or current indications.