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Tuesday, December 31, 2019

BioXcel Therapeutics Starts Pivotal Phase 3 Studies

BioXcel Therapeutics (“BTI” or “Company”) (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to identify and advance the next wave of medicines in neuroscience and immuno-oncology, today announced the initiation of its SERENITY (Sub-Lingual DExmedetomidine in Agitation Associated With SchizophRENIa and Bipolar Disorder STudY) program, two Phase 3 studies of BXCL501 for the acute treatment of agitation in patients with schizophrenia and bipolar disorder. Topline data from both Phase 3 trials are expected in mid-2020.
“The initiation of the SERENITY trials represents a critical next step in our aim to provide a safe and effective therapy to millions of individuals who suffer from agitation associated with schizophrenia and bipolar disorder,” commented Vimal Mehta, Chief Executive Officer of BTI. “Managing agitation in patients with neuropsychiatric disorders is a major challenge for both physicians and caregivers. BXCL501, designed as a non-invasive, fast acting therapy, may be able to overcome the limitations associated with current standards of care, as we believe it provides calming without excessive sedation while protecting the caregiver patient relationship.”

Drugmakers to hike U.S. prices of over 200 meds

Reuters reports that pharmaceutical companies, including Pfizer (NYSE:PFE), GlaxoSmithKline (NYSE:GSK) and Sanofi (NASDAQ:SNY), are planning to raise prices on more than 200 medicines in the U.S. tomorrow.
The price hikes are expected to be relatively modest, almost all below 10% and half between 4 – 6%.
Pfizer intends to boost prices on more than 50 drugs, including breast cancer med Ibrance (palbociclib) and arthritis/UC med Xeljanz (tofacitinib). A spokesperson stated that the average increase will be 5.6%.
GSK plans to raise prices on more than 30 medicines by 1 – 5%.
Sanofi will follow suit on ~10 drugs by 1 – 5%.
According to healthcare research shop 3 Axis Advisors, Teva Pharmaceutical Industries (NYSE:TEVA) raised prices on more than 15 drugs by more than 6%.
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Research Continues Into Shingles Vax for Certain Cancer Patients

In December 2018, we reported on a study that found higher risk of herpes zoster, or shingles, in certain cancer patients, and discussed the roles that vaccine development could potentially play in preventing these painful episodes. Here, we examine research on zoster vaccines in immunocompromised patient populations appearing after that initial study was published.
In November, Clinical Infectious Diseases published a systematic review of 34 studies that examined risk of herpes zoster among patients with hematopoietic cell transplants, hematologic and solid tumors, as well as solid tumor malignancies, and other immunocompromised populations, such as HIV. The authors found estimates of herpes zoster incidence ranging from 9 to 92 cases/1,000 patient-years. Similar to the December 2018 study, the CID authors found incidence was higher in patients with hematopoietic cell transplants, followed by solid organ transplant and solid tumor malignancies.
In February, The Lancet Infectious Diseases published a summary of guidelines from the most recent European Conference on Infections in Leukaemia about vaccination in patients with hematologic malignancies who did not have transplantations.
Examining patients with multiple myeloma, the authors recommended valacyclovir prophylaxis, an antiviral used to treat active infections including shingles. Zoster live attenuated vaccine is contraindicated in such patients, the authors noted, and there are no data in this population yet about an approved inactivated subunit vaccine, though it is “much awaited” for these patients.
The guidelines also observed that there are no data on either the live attenuated or the inactivated vaccine among patients with chronic lymphocytic leukemia, despite their elevated risk for zoster attacks.
“The inactivated zoster vaccines should be assessed in adult and child patients with [hematological] disorders,” the authors said.
Researchers continued to examine the role of inactivated vaccines against herpes zoster in patients with solid tumor malignancies. A study published in August found that an inactivated varicella zoster virus vaccine was effective, meeting pre-specified criteria for preventing confirmed herpes zoster infection in patients with solid tumor malignancies who were receiving chemotherapy. However, the vaccine was not effective in patients with hematologic malignancies.
But a second study found that the adjuvanted recombinant zoster vaccine, Shingrix, produced an immunologic response in a cohort of adult patients with hematological malignancies during or soon after they underwent cancer treatment compared to placebo.
Adding to the evidence for the effectiveness of Shingrix, a July study also found that patients undergoing autologous hematopoietic stem cell transplantation who received the vaccine had lower incidence of shingles versus patients who received placebo.
Alison Freifeld, MD, of the University of Nebraska Medical Center in Omaha, who was not involved in the research, told MedPage Today in July that transplant patients couldn’t receive the zoster vaccine until at least 2 years after transplantation, due to the potential risk of a patient developing disseminated vaccine strain live virus.
“[Shingrix] is a great advantage for autologous transplant patients because it permits the vaccine to be given much earlier than the previous live virus vaccine,” she said.
Jeanne Marrazzo, MD, of the University of Alabama at Birmingham, told MedPage Today at that time that “protection was less than that observed in immune-competent people, which the investigators attribute to a generally weaker immune system in the HSCT recipients.”
“Regardless, this outcome is considerably better than no vaccine, which was the earlier alternative,” Marrazzo added.
In addition to cancer patients, researchers continued to discuss the use of both live-attenuated vaccines and inactivated vaccines among immunocompromised populations, such as patients with autoimmune conditions.
And research presented at the American College of Rheumatology annual meeting in November provided reassuring evidence about the safety of live attenuated herpes zoster vaccine, Zostavax, among patients treated with tumor necrosis factor inhibitors. A randomized trial found that no patients developed varicella (chicken pox, the predecessor to shingles) infections or shingles attacks, and there was no difference in rates of rheumatologic disease flare between groups receiving vaccine or placebo.

AHA largely silent on suing patients for unpaid bills, as chair’s hospital partakes

The American Hospital Association has stayed relatively quiet on suing patients for overdue bills despite growing scrutiny around the controversial tactic, according to Kaiser Health News.
AHA, which represents about 5,000 hospitals, has published few guidelines on aggressive collection practices like suing, seizing homes or wages and pushing families into bankruptcy over unpaid medical bills. Morris Plains, N.J.-based Atlantic Health System, the hospital that the association’s board chair leads, has sued patients more than 8,000 times in 2019 for unpaid bills, according to KHN‘s review of court records.
In a statement to KHN, an Atlantic Health System spokesperson said its “billing policy complies with all state and federal guidelines. While we are willing to assist patients no matter their financial situation, those who can pay should do so.”
At the same time, Yale New Haven (Conn.) Health, whose CEO also sits on AHA’s board, rarely sues patients for bills, with one leader telling KHN they haven’t signed off on a legal action against patients since 2015.
Still, several health systems, like UVA Health System in Charlottesville and Richmond-based Virginia Commonwealth University Health System have faced criticism for suing patients. The AHA still has not issued an industry-wide standard on the practice.
When asked this month about the practice, AHA CEO Rick Pollack told KHN: “We are reevaluating the guidelines [for collections and financial assistance] to ensure they best serve the needs of patients.” AHA has previously said billing offices should “assist patients who cannot pay” and treat them with “dignity and respect.”
For the full article, click here.

Cancer misinformation leads popular fake health news on social media: NBC

In 2019, the most popular articles sharing unproven cures and other health misinformation collectively received more than 12 million shares, comments and reactions on social media, according to an NBC News analysis.
Researchers compiled a list of articles touting false information that received more than 25,000 engagements on social media by searching for keywords related to the most common diseases and causes of death, as well as oft-targeted health topics such as vaccines, fluoride and natural cures. Many on the resulting list of 80 viral news items claimed that governments and medical communities were conspiring to withhold healthcare information and presented “cures” not backed by scientific proof as an alternative to common medical treatment of life-threatening diseases.
According to the analysis, the most viral health misinformation of 2019 pertained to cancer, followed by unproven cures and vaccines. In some cases, these illegitimate stories completely overshadowed real news on their respective topics. For example, the cancer-related article that received the most social media engagement this year comprised several conspiracies, including one claiming physicians and federal health organizations are hiding a cure for cancer.
The majority of the articles’ online engagement came via Facebook. In a statement to NBC News, a company spokesperson said, “While we have made progress this year, we know there is more work to do. We hope to continue our partnership with health organizations to expand our work in this space.”
Read the full report here.

Med Student Accused of Attempt to Smuggle Cancer Research to China

A Harvard University medical student and cancer researcher who allegedly tried to smuggle stolen scientific material into China has been charged and will be held without bail, a federal judge in Boston ruled Tuesday.
The 29-year-old Chinese student, Zaosong Zheng, was found with 21 vials in his luggage as he prepared to board a flight at Logan International Airport bound for Beijing on Dec. 9, court documents stated. The vials were wrapped in a plastic bag and hidden inside a sock.
Zheng was a cancer researcher who earned an educational visa with Beth Israel Deaconess Medical Center last year, according to The Boston Globe. Beth Israel fired Zheng after he was arrested for allegedly making false statements about the items in his bags. His visa was also revoked.

The vials appeared to contain a brown liquid and were being tested to confirm whether they were stolen from the lab. If so, Zheng could face more charges.
“Zheng’s appointment to [Beth Israel] was not an accident; he was knowingly gathering and collecting intellectual property from [Beth Israel] possibly on behalf of the Chinese government,” FBI agent Kara Spice said in a court affidavit.
Some of the vials included a colleague’s work Zheng said he had replicated without the lab’s knowledge, according to court documents.
Zheng said he had intended to “immediately” head to his lab in China to work with the vials and publish a paper taking credit for the findings, according to the documents.
U.S. District Court Magistrate Judge David H. Hennessy granted a request from federal prosecutors to detain Zheng until he can be tried, acknowledging his connections to the Chinese government made him a flight risk, the Globe reported.

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