Feds tell China: Let U.S. health workers enter to help respond to coronavirus

Federal officials on Tuesday called for a team of Americans to be allowed to enter China and assist with the local response to the novel coronavirus outbreak there, an offer that U.S. officials say the Chinese government has not yet authorized since it was first extended three weeks ago.
A group of U.S. public health workers and scientific researchers is standing by to travel to China, according to health secretary Alex Azar, who said he and other officials have reiterated the offer twice to the Chinese government: once to the country’s health minister and again at a World Health Organization meeting in Beijing.
“We’re urging China: More cooperation and transparency are the most important steps you can take for a more effective response,” Azar said at a press conference.

Earlier on Tuesday, however, Chinese President Xi Jinping did agree to allow a team of WHO experts to enter the country “to work with Chinese counterparts on increasing understanding of the outbreak to guide global response efforts.”
Azar said he was “delighted” by the news, though it was not immediately clear whether personnel from the U.S. Centers for Disease Control and Prevention would be included within the WHO group. The U.S. already has personnel embedded within China’s disease control office, Azar said, but he urged that more American personnel be allowed to take a more active role in addressing the outbreak.
At the briefing, Azar and other health officials stressed that the coronavirus outbreak did not present an imminent threat to Americans. Azar, smiling, dismissed the recent rash of Americans attempting to purchase face masks at pharmacies and convenience stores as “unnecessary.”
The disease outbreak, which is most severe in the Chinese city of Wuhan, has resulted in over 4,500 reported cases and at least 100 deaths in China. At least 14 territories and countries outside the Chinese mainland have reported cases as well, including five in the U.S.
CDC Director Robert Redfield was also careful to emphasize that the disease is not spreading within the U.S. And its transmission rate as measured in early research, he said, is substantially lower than for other infectious diseases, including measles.
American authorities announced Monday they would expand coronavirus screenings of passengers arriving from China at 20 airports, up from a list of five airports to which authorities had directed flights from Wuhan specifically.

“Americans should know that this is a potentially very serious public health threat,” Azar said. “But at this point, Americans should not worry for their own safety.”
Nonetheless, Azar said, the U.S. government stood ready to deploy all available tools for dealing with the outbreak, citing efforts to determine whether the disease could be transmitted even by individuals who have not displayed symptoms and tracking down contacts of individuals who have fallen ill.
“All options for dealing with infectious disease spread have to be on the table, including travel restrictions,” Azar said. “But diseases are not terribly good at respecting borders, so we would have to assess carefully whether the evidence recommends any steps beyond the thoroughly tested methods I just described.”

Federal officials tell China: Let U.S. health workers enter to help respond to coronavirus

New Insurance Scheme Hit by Coalition of State Rheumatology Organizations

Coalition of State Rheumatology Organizations (CSRO) physicians are voicing concern for patients who will fall victim of a dangerous new prescription policy. New requirements from BlueCross BlueShield (BCBS) of Tennessee, which may be a bellwether for other insurers, are reversing the trend providers have achieved in keeping prices down for physician administered medications.
Normally provider administered drugs are obtained via a “buy and bill” system where a provider purchases medication and bills the insurance company under a patient’s medical benefit. The new BCBS policy moves the acquisition of these administered medication away from the physician to the patient’s pharmacy benefit, handled by pharmacy benefit managers (PBMs.)
The Centers for Medicare and Medicaid Services (CMS) dashboard purports that prices of Part D medications, those managed by a PBM, rise at much faster rates than physician “buy and bill” Part B medications.
“Now PBMs and insurers are integrated, they finally have the chance to move payments away from the medical side and put it on the pharmacy side, where more money is made with rebates and hidden fees,” said Dr. Madelaine Feldman, president of the CSRO.
“This policy is about one thing, profits,” Dr. Feldman, continued. “PBMs construct formularies encouraging pharmaceutical manufacturers to raise prices of drugs. The higher the price, the more money PBMs make, resulting in PBMs choosing higher priced drugs for the preferred tier.”
Another consequence of this new policy will be that physicians will no longer be able to infuse patients in their office. Dr. Robert Levin of the Alliance for Transparent and Affordable Prescriptions (ATAP) added, “We make decisions based on the needs of our patients, including how and where care is given. Needlessly driving up prices and making treatments more complicated to obtain is moving health care in the wrong direction. Patients deserve better.”
“Patients will be increasingly forced into expensive sites for care such as hospitals or where there is no direct supervision by physicians, nurse practitioners, or physician assistants,” said Dr. Aaron Broadwell, rheumatologist from Shreveport, Louisiana.
The CSRO is comprised of 43 state and regional professional rheumatology societies formed to advocate for excellence in rheumatologic disease care and ensure access to the highest quality care for the management of rheumatologic and musculoskeletal diseases.
https://www.biospace.com/article/releases/drug-prices-to-skyrocket-with-new-health-insurance-company-policy-according-to-coalition-of-state-rheumatology-organizations/

Developing Nanoparticles to Eat Plaques that Cause Heart Attacks and Strokes

Bryan Smith, an associate professor of biomedical engineering at Michigan State University and associates at Stanford University, developed a type of nanoparticle that can “eat debris” related to the plaques that cause heart attacks. They dub it a type of Trojan Horse and believe it has the potential to treat atherosclerosis, a top cause of death in the U.S. The research was published in the journal Nature Nanotechnology.
Atherosclerosis is hardening and narrowing of the arteries, which can lead to heart attack or stroke. The plaques are made up of fat, cholesterol, calcium and other substances in the blood.
Smith’s nanoparticles are based on single-walled carbon nanotubes that are loaded with a chemical inhibitor of the antiphagocytic CD47-SIRPα signaling axis. In other words, the nanoparticle targets atherosclerotic plaques because it has a high affinity to a particular type of immune cell, monocytes and macrophages. Once the nanoparticle is inside the plaque’s macrophages, it delivers the drug that causes the cell to engulf and eat cellular debris.
“We found we could stimulate the macrophages to selectively eat dead and dying cells—these inflammatory cells are precursor cells to atherosclerosis—that are part of the cause of heart attacks,” Smith said. “We could deliver a small molecule inside the macrophages to tell them to begin eating again.”
The research team believes that future clinical trials with the nanoparticles will decrease the risk of most forms of heart attacks with minimal side effects. The minimal side effects are because of the nanoparticle’s unusual degree of selectivity.
This is because Smith’s research is built on identifying and intercepting the macrophage receptor signals and using a small molecule from its nano-immunotherapeutic platforms to send messages. Other research interacted with molecules on the cell surface, but this approach works intracellularly.
The investigators believe the technology has applications beyond atherosclerosis.
“We were able to marry a groundbreaking finding in atherosclerosis by our collaborators with the state-of-the-art selectivity and delivery capabilities of our advanced nanomaterial platform,” Smith said.
He went on to add, “We demonstrated the nanomaterials were able to selectively seek out and deliver a message to the very cells needed. It gives a particular energy to our future work, which will include clinical translation of these nanomaterials using large animal models and human tissue tests. We believe it is better than previous methods.”
Current treatments for atherosclerosis include lifestyle changes such as heart-healthy diets, losing weight, managing stress, exercise and quitting smoking. Decreasing blood cholesterol levels using drugs, such as statins, are often used, or in extreme cases, PCSK9 inhibitors. If it becomes severe enough, there are several medical procedures such as coronary angioplasty, which opens blocked or narrowed cardiac arteries, or surgery such as coronary artery bypass grafting (CABG) or carotid endarterectomy, which is surgery to remove the plaque buildup in the carotid arteries in the neck.
Smith has filed a provisional patent for the nanoparticle device and expects to begin marketing it later this year.
https://www.biospace.com/article/nanoparticles-that-eat-away-the-plaques-that-cause-heart-attacks/

Following Patient Death, Spring Bank Abandons Hepatitis B Program

Spring Bank Pharmaceuticals, based in Hopkinton, Massachusetts, announced it was discontinuing development of inarigivir soproxil for chronic hepatitis B virus (HBV). The therapy was in Phase II development.
The company based the decision on safety information after unexpected serious adverse events, including one patient death in its Phase IIb CATALYST trial. Inarigivir is an orally available immunomodulator that binds the cellular proteins retinoic acid-inducible gene 1 (RIG-1) to inhibit viral replication and induce the intracellular interferon signaling pathways.
“We are deeply saddened by the death of a patient in our CATALYST 2 trial,” said Martin Driscoll, president and chief executive officer of Spring Bank. “Because we are guided by an overriding interest in protecting patients, we have made the difficult decision to discontinue the further development of inarigivir for the treatment of HBV at Spring Bank. We will continue to work in close collaboration with external experts and our clinical study investigators to provide the care necessary for all study patients and will continue to conduct a series of investigative actions to better understand the unexpected serious adverse events observed in our Phase IIb program.”
On December 26, 2019, the company indicated it had halted dosing and enrolling patients in the CATALYST trial as well as all other studies of inarigivir in chronic HBV. Lab tests from three patients showed hepatocellular dysfunction and an increased alanine transaminase (ALT) level consistent with liver injury.
It essentially plans to abandon R&D into HBV but will refocus on immuno-oncology and inflammation. This is primarily its lead product candidate from its STING agonist platform, SB 11285, which is in a Phase Ia/Ib trial.
On November 20, 2019, Spring Bank announced it had begun dosing patients in the Phase I trial of SB 11285 in patients with advanced solid tumors. Part 1 of the trial is a dose-escalation study with SB 11285 alone. It will be followed by a combination with a checkpoint inhibitor. Part 2 of the trial will evaluate intravenous SB 11285 antitumor activity in combination with a checkpoint inhibitor in various tumor types. The company hopes to report topline data in mid-2020.
“Working with our principal investigators in the United States, we are thrilled to announce that we have been able to deliver SB 11285 intravenously to the first patient in our Phase I trial of advanced solid tumors,” said Atif Abbas, vice president and head of Oncology/Immunology Development at Spring Bank, at the time.
He went on to say, “We believe the primary benefit of delivering SB 11285 by the intravenous route, as opposed to intratumorally like other STING agonist compounds currently in development, is the potential ability to treat a broader range of cancers and patients in the community oncology treatment setting.”
Now that Spring Bank is halting all HBV drug development, it is launching talks with external parties to license the program. And by eliminating the costs related to the HBV program, it believes it has funds to continue operations into late 2022. As of December 31, 2019, the company reported $54.5 million in cash.
https://www.biospace.com/article/spring-bank-pharma-discontinues-hepatitis-b-drug-development/

Illumina EPS beats by $0.12, beats on revenue

Illumina (NASDAQ:ILMN): Q4 Non-GAAP EPS of $1.70 beats by $0.12; GAAP EPS of $1.61 beats by $0.16.

Revenue of $953M (+9.9% Y/Y) beats by $2.84M.

Press Release

https://seekingalpha.com/news/3535973-illumina-eps-beats-0_12-beats-on-revenue

Align Tech down 9% despite Q4 beat as coronavirus creates headwinds in China

Align Technology (NASDAQ:ALGN) Q4 results:

Revenues: $649.8M (+21.7%); Clear Aligner sales: $543.6M (+22.0%); Scanner & Services: $106.2M (+20.1%).

Invisalign case shipments: 413.7K (+23.9%).

Net income: $121.3M (+24.5%); EPS: $1.53 (+27.5%).

Cash flow ops (full year): $747.3M (+34.7%).

Q1 guidance: Revenues: $615.0M – 630.0M (includes the impact in China cited below). Invisalign case shipments: 396K – 406K; EPS: $18.65 – 18.74; non-GAAP EPS: $1.19 – 1.28.

Reduction of 20K – 25K Invisalign case shipments and $30M – 35M less Invisalign and iTero revenue in China due to coronavirus outbreak. Gross margin will be negatively impacted by 0.5% due to the absorption of $3.0M – 4.0M in idle plant capacity costs in China.

Align Technology EPS beats by $0.13, beats on revenue 

https://seekingalpha.com/news/3536012-align-tech-down-9-despite-q4-beat-coronavirus-creates-headwinds-in-china

Varian Medical Systems EPS misses by $0.04, revenue in-line

Varian Medical Systems (NYSE:VAR): Q1 Non-GAAP EPS of $1.16 misses by $0.04; GAAP EPS of $0.96 misses by $0.09.

Revenue of $828.9M (+11.9% Y/Y) in-line.

Press Release

https://seekingalpha.com/news/3535985-varian-medical-systems-eps-misses-0_04-revenue-in-line