FDA OKs Jazz Pharma’s lurbinectedin for lung cancer

Under accelerated review status, the FDA approves Jazz Pharmaceuticals’ (JAZZ +4.6%) Zepzelca (lurbinectedin) for adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemo.

The company in-licensed U.S. rights from Spanish drugmaker PharmaMar (OTCPK:PHMMF +2.8%) in December 2019.

Lurbinectedin is an alkylating agent that kills cancer cells by interrupting the DNA replication process.

https://seekingalpha.com/news/3583139-fda-oks-jazz-pharmas-lurbinectedin-for-lung-cancer

Aetna nabs Medicaid contract in West Virginia

CVS (CVS -1.3%) unit Aetna Better Health of West Virginia has been awarded a Medicaid contract in the state through the Mountain Health Trust managed care program.

It begins on July 1, 2020 and runs through June 30, 2021.

The contract value is not disclosed.

https://seekingalpha.com/news/3583170-aetna-nabs-medicaid-contract-in-west-virginia

FDA warns on use of malaria drugs with remdesivir

The FDA has issued a warning to healthcare providers that it does not recommend co-administering malaria meds chloroquine or hydroxychloroquine with Gilead Sciences’ (NASDAQ:GILD) remdesivir for COVID-19 patients since they may compromise the antiviral effect of the latter.

The agency says it is not aware of any instances in the field of this reduced activity but is continuing to “evaluate all data” related to remdesivir.

Earlier today, the FDA rescinded emergency use authorization of the malaria drugs for COVID-19.

https://seekingalpha.com/news/3583169-fda-warns-on-use-of-malaria-drugs-remdesivir

Vir Biotech inks broad coronavirus partnership with Glaxo

Vir Biotechnology (NASDAQ:VIR) discloses that, on June 9, it inked a collaboration agreement with GlaxoSmithKline (NYSE:GSK) aimed at developing and commercializing products for the prevention, treatment and prophylaxis of SARS-CoV-2-related diseases.

The partnership will focus on three principal programs: antibodies targeting the virus, vaccines and products based on CRISPR screening of host targets expressed in connection to exposure to SARS-CoV-2. All three include the possibility of including other coronaviruses.

For the next four years, the companies will conduct R&D activities under mutually agreed plans and budgets for each of the three programs. Subject to an opt-out mechanism, the parties will share development, manufacturing and commercialization costs. Specifically, VIR will be responsible for 72.5% of the costs of the antibody program, 27.5% of the costs of the vaccine program and 50% of the costs of the functional genomics program.

GSK will lead commercialization globally. VIR has the right to co-promote antibody products in the U.S. on a case-by-case basis.

The agreement will remain in place as long as a collaboration product is being developed or commercialized by the lead party.

https://seekingalpha.com/news/3583210-vir-biotech-inks-broad-coronavirus-partnership-glaxo

New kid on the block in race for NASH drug

French biopharma Inventiva (OTCPK:IVEVF) has emerged as a new player in the pursuit of a treatment for nonalcoholic steatohepatitis (NASH).

Today, it announced positive results from a Phase 2 clinical trial, NATIVE, evaluating lanifibranor in adult NASH patients with liver steatosis and moderate-to-severe necroinflammation without cirrhosis.

The trial met the primary endpoint in the intent-to-treat population (1200 mg/day) demonstrating a statistically significant proportion of patients experiencing a decrease of at least two points in SAF (combines hepatocellular inflammation and ballooning) activity score at week 24 with no worsening of fibrosis. Specifically, 49% of treated participants achieved the endpoint compared to 27% in the placebo arm.

Key secondary endpoints were also met.

The company says lanifibranor, a pan-PPAR (peroxisome proliferator-activated receptors) agonist, is the first drug candidate to show statistically significant results on the two FDA and EMA primary efficacy endpoints relevant to potential accelerated approval during Phase 3 development.

The company’s current cash runway extends into Q3 2021 but the company is “open to all options” related to raising additional capital.

Next up are meetings with regulators before advancing into late-stage studies.

PPARs have stuck out so far in treating NASH. Genfit’s (NASDAQ:GNFT) elafibranor flopped in a Phase 3 study while CymaBay Therapeutics (NASDAQ:CBAY) terminated a Phase 2b trial of seladelpar on a potential safety signal, although shares rallied a month ago after the company announced that further analyses support a restart.

Inventiva says lanifibranor is different since it targets all three types of PPAR instead of just one.

NASH-related tickers: MDGL, VKTX, ICPT, ABBV

https://seekingalpha.com/news/3583247-new-kid-on-block-in-race-for-nash-drug

24% of workers at high risk of severe Illness from COVID-19

Nearly a quarter of U.S. workers are considered at high risk of severe illness from COVID-19 due to underlying health conditions or age, a consideration for employers as they reopen and try to protect these workers, according to a new Kaiser Family Foundation study.
The analysis estimates 37.7 million workers (based on their work status in 2018), including 10 million people age 65 and older and27.7 million who have preexisting medical conditions, are at greater risk for severe illness from COVID-19. They make up 24 percent of all adult workers, according to the study.
For the analysis, KFF examined data from the CDC’s 2018 National Health Interview Survey. Analysts looked at the number of workers at high risk of serious illness based on the CDC’s risk factors. People 65 and older are considered higher-risk, as are those who have diabetes, chronic obstructive pulmonary disease, heart disease, a body mass index above 40, moderate to severe asthma or a functional limitation because of cancer.
The analysis also estimates there are 12 million at-risk adults who do not work, including 6.5 million people age 65 and older who live with at least one full-time worker.
“This is a conservative estimate because additional nonworking at-risk adults live with people who work part time or who are in and out of the workforce,” researchers wrote. “The safety of these family members will need to be part of the considerations for employees and employers as businesses continue to refine safety protocols and others reopen their workplaces.”
Read more about the study here.
https://www.beckershospitalreview.com/workforce/24-of-workers-at-high-risk-of-severe-illness-from-covid-19-study-finds.html

Only 26% of parents believe flu vaccine is effective

Only 1 in 4 parents believe the flu shot is effective, and 1 in 8 parents worry about vaccine safety for both flu shots and routine childhood vaccines, according to a new article published in the journal Pediatrics.
U.S. families with children were surveyed online in February 2019, with a total of 2,176 parents responding.
Five key takeaways:
1. Of all respondents, 6.1 percent were hesitant about routine childhood vaccines, with 25.8 percent of parents hesitant about flu shots.
2. Seventy percent of respondents strongly agreed that routine childhood vaccines are effective, compared to 26 percent for flu shots.
3. Almost 1 in 15 parents are hesitant about routine childhood vaccines, and more than 1 in 4 are hesitant about the flu vaccine.
4. For both routine childhood and flu shots, 1 in 8 parents are concerned about vaccine safety.
5. Parents with less than a bachelor’s degree and a household income 400 percent greater than the federal poverty level were more hesitant about both routine childhood vaccines and flu shots.
https://www.beckershospitalreview.com/public-health/only-26-of-parents-believe-flu-vaccine-is-effective.html