Kura Gets FDA Breakthrough Status for Head and Neck Squamous Cell Carcinoma

 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today announced that its investigational drug, tipifarnib, has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with recurrent or metastatic HRAS mutant head and neck squamous cell carcinoma (HNSCC) with variant allele frequency ≥ 20% after disease progression on platinum-based chemotherapy. Tipifarnib is currently being evaluated in an ongoing registration-directed clinical trial (AIM-HN) in this indication of high unmet need.

HNSCC is the seventh most common cancer worldwide, accounting for more than 885,000 new cases each year. Despite recent treatment advances, prognosis remains poor, with a 5-year survival rate of less than 40%. Second-line treatments provide limited clinical benefit for many patients, with objective response rates (ORR) of 6-16%, median progression-free survival (PFS) of 2-3 months and median overall survival (OS) of 5-8 months.

https://finance.yahoo.com/news/kura-oncology-receives-fda-breakthrough-120000100.html

CVS to Administer COVID-19 Vaccines in 6 Additional States

 CVS Health (NYSE: CVS) has added Alabama, Arizona, Florida, Louisiana, Ohio, and Pennsylvania to the list of states where select CVS Pharmacy locations will offer COVID-19 vaccinations to eligible populations through the Federal Retail Pharmacy Program. This follows the successful February 12 rollout in 11 states: California, Connecticut, Hawaii, Maryland, Massachusetts, New Jersey, New York, Rhode Island, South Carolina, Texas, and Virginia. Appointments for the latest allocation of approximately 570,000 doses will start to become available for booking today, with shots beginning February 25.

https://www.prnewswire.com/news-releases/cvs-health-will-administer-covid-19-vaccines-in-six-additional-states-301234055.html

Takeda Updates on Phase 1/2 Trials of Novavax, Moderna COVID-19 Vaccine Candidates in Japan

 

• Takeda is making two COVID-19 vaccines available in Japan, by manufacturing Novavax’ recombinant vaccine candidate and by distributing Moderna’s mRNA vaccine candidate, with the support of the Japanese Government
• Phase 1/2 immunogenicity and safety trials designed to include 200 healthy Japanese adults followed for 12 months after second vaccination
• Primary analysis results from both studies expected in CY2021 and will support New Drug Applications (NDA) in Japan

Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) announced today that the first subject was dosed in its Phase 1/2 immunogenicity and safety study of Novavax’ COVID-19 vaccine candidate (TAK-019) in Japan. Earlier this month, Takeda completed enrollment in the company’s Phase 1/2 immunogenicity and safety study of Moderna’s COVID-19 vaccine candidate (TAK-919) in Japan.

“Early in the pandemic, we made the decision to partner with other companies and leverage our substantial vaccine experience and capabilities to make COVID-19 vaccines available in Japan,” said Rajeev Venkayya, M.D., President of the Global Vaccine Business Unit, Takeda. “We have been pleased to see the outstanding Phase 3 efficacy data from the Moderna and Novavax programs and are excited to work with each company and the Government of Japan to help bring the pandemic to an end.”

Takeda previously announced its commitment to providing rapid and sustained access to COVID-19 vaccines in Japan through partnerships with Novavax and Moderna. Takeda will receive a manufacturing technology transfer from Novavax and will be responsible for the development and commercialization based on manufacturing capacity of over 250 million doses of TAK-019. The company will also import and distribute 50 million doses of TAK-919 as part of a joint partnership with Moderna and the Government of Japan’s Ministry of Health Labour and Welfare (MHLW).

Results from the TAK-919 study are expected in the first half of 2021 and results from the TAK-019 study in the second half of 2021. Once available, the study results will be submitted to the Japan Pharmaceuticals and Medical Devices Agency (PMDA) as part of the NDA filing process. Pending regulatory approval, Takeda intends to start distributing TAK-919 in the first half of 2021 and aims to start distributing TAK-019 in late 2021.

https://www.biospace.com/article/releases/takeda-provides-updates-on-phase-1-2-clinical-trials-of-novavax-and-moderna-s-covid-19-vaccine-candidates-in-japan/

Combined Metabolic Activators accelerate recovery in mild-to-moderate COVID-19

 Ozlem Altay, Muhammad Arif, Xiangyu Li, Hong Yang, Mehtap Aydın, Gizem Alkurt, Woonghee Kim, Dogukan Akyol, Cheng Zhang, Gizem Dinler-Doganay, Hasan Turkez, Saeed Shoaie, Jens Nielsen, Jan Borén, Oktay Olmuscelik, Levent Doganay, Mathias Uhlén, Adil Mardinoglu

doi: https://doi.org/10.1101/2020.10.02.20202614

This article is a preprint and has not been certified by peer review [what does this mean?]. It reports new medical research that has yet to be evaluated and so should not be used to guide clinical practice.

PDF: https://www.medrxiv.org/content/10.1101/2020.10.02.20202614v2.full.pdf

ABSTRACT

There is a need to treat COVID-19 patients suffering from respiratory problems, resulting in decreased oxygen levels and thus leading to mitochondrial dysfunction and metabolic abnormalities. Here, we investigated if a high oral dose of a mixture of Combined Metabolic Activators (CMA) can restore metabolic function and thus aid the recovery of COVID-19 patients. We conducted a placebo-controlled, open-label phase 2 study and a double-blinded phase 3 clinical trials to investigate the time of symptom-free recovery on ambulatory patients using a mixture of CMA consisting of NAD+ and glutathione precursors. The results of both studies showed that the time to complete recovery was significantly shorter in the CMA group (6.6 vs 9.3 days) in phase 2 and (5.7 vs 9.2 days) in phase 3 trials. A comprehensive analysis of the blood metabolome and proteome showed that the plasma levels of proteins and metabolites associated with inflammation and antioxidant metabolism are significantly improved in patients treated with the metabolic activators as compared to placebo. The results show that treating patients infected with COVID-19 with a high dose of CMAs leads to a more rapid symptom-free recovery, suggesting a role for such a therapeutic regime in the treatment of infections leading to respiratory problems.

Competing Interest Statement

AM, JB and MU filed a patent application on the use of CMA on COVID-19 patients. The other authors declare no competing interests.

Clinical Trial

ClinicalTrials.gov NCT04573153

Funding Statement

This work was supported by Knut and Alice Wallenberg Foundation. The authors would like to thank ChromaDex (Irvine, CA, USA) for providing NR for this study.

https://www.medrxiv.org/content/10.1101/2020.10.02.20202614v2

Fresenius Confirms 2021, Medium-Term Guidance Despite Covid-19 Headwinds

 Fresenius SE & Co. on Tuesday confirmed its 2021 guidance as reported in preliminary statements and backed its medium-term goals until 2023 despite the projected impact of the coronavirus pandemic on business.

Net profit at the German healthcare company declined slightly in the fourth quarter of 2020 on mostly flat sales. It posted a profit of 494 million euros ($600.6 million) for the quarter before special items, down from EUR506 million in the previous year, the company said.

Sales came in flat at EUR9.3 billion, Fresenius said.

The figures are within company guidance, Fresenius said, as it had previously reported in a preliminary statement.

For 2021, the company expects a hit from the coronavirus pandemic as previously reported in preliminary statements. It sees sales growth in the low to mid-single digit percentage range and broadly stable net income year-over-year, it said.

For the period from 2020 until 2023, the company said it continues to expect group sales to grow organically with a compounded annual growth rate of 4% to 7%. It expects group net income before special items to increase organically with a compounded annual growth rate of 5% to 9% in the period, Fresenius said.

Fresenius declared a dividend of EUR0.88 a share for 2020, up from EUR0.84 in 2019.

As a result of uncertainty prompted by the coronavirus pandemic, Fresenius is planning to launch cost-saving measures in order to safeguard the confirmed medium-term targets, it said. The company targets yearly cost savings of at least EUR100 million by 2023, after tax and minority interest, it said.

Fresenius Medical Care, the company's dialysis division, reported net income of EUR372 million excluding special items in the fourth quarter, slightly up from EUR368 million the previous year, the company said. This helped Fresenius Medical Care achieve its 2020 targets as previously announced in preliminary results. A dividend proposal for EUR1.34 a share for Fresenius Medical Care is planned for the annual general meeting in May, the company said.

Fourth-quarter earnings were hurt by impairments in the Latin America region, as the company previously reported in preliminary results.

https://www.marketscreener.com/quote/stock/FRESENIUS-SE-CO-KGAA-436083/news/Fresenius-Confirms-2021-Medium-Term-Guidance-Despite-Covid-19-Headwinds-Update-32511920/

Medtronic Posts 3Q Profit as Pandemic Shapes Sales Mix

 Medtronic PLC Tuesday logged a profit and higher revenue in the latest earnings period but said that the Covid-19 pandemic was detracting from sales for some of its divisions as people delayed medical procedures during the crisis.

The Ireland-based medical-technology company logged earnings of 94 cents a share, down from $1.42 a share in the same three months a year earlier. Net income attributable to the company was $1.27 billion, a decline from $1.92 billion in the year-ago period.

On an adjusted basis, Medtronic's profit was $1.29 a share. Analysts surveyed by FactSet had forecast an adjusted profit of $1.15 a share.

Sales were $7.78 billion, in line with the FactSet analysts consensus. Sales in the prior year's third quarter were $7.72 billion.

Revenue from the company's largest segment, its cardiac and vascular group, declined 4% year over year to $2.71 billion. Minimally invasive therapies revenue rose 6.3% to $2.31 billion, while revenue from the restorative-therapies segment rose 0.7% to $2.13 billion.

The resurgence of Covid-19 cases in December and January weighed on procedure volumes for the cardiac, vascular and restorative-therapies divisions, Medtronic said. On the other hand, sales of diagnostics and therapies related to the pandemic boosted results for the company's minimally invasive therapies segment.

Medtronic declined to provide earnings guidance for the upcoming year or quarters, citing continuing uncertainty caused by the pandemic.

https://www.marketscreener.com/quote/stock/MEDTRONIC-PLC-20661655/news/Medtronic-Posts-3Q-Profit-as-Pandemic-Shapes-Sales-Mix-32514692/

HHS will stop distributing COVID-19 antibody drugs, says no longer in short supply

 HHS said it will no longer allocate doses of COVID-19 antibody drugs from Eli Lilly and Regeneron because they are no longer in short supply, according to the American Hospital Association. 

Healthcare providers should now order the drugs directly from AmerisourceBergen, the sole distributor of the antibody drugs. 

The drugs will still be free, HHS said, according to a Feb. 19 news release from the hospital association. 

"HHS will continue to monitor all direct orders, and we retain the capacity to resume allocation of these and future therapies if needed," HHS said. 

HHS last month launched an online treatment locator that tracks facilities that have received shipments of Eli Lilly and Regeneron's COVID-19 antibody drugs.

https://www.beckershospitalreview.com/pharmacy/hhs-will-stop-distributing-covid-19-antibody-drugs-says-they-re-no-longer-in-short-supply.html