Novartis' Beovu meets primary endpoint in late-stage diabetic macular edema study

 

• Novartis (NYSE:NVS) announces positive findings from the Phase III KESTREL study, assessing the safety and efficacy of Beovu (brolucizumab) 3 mg and 6 mg in diabetic macular edema (DME).
• The trial met its primary endpoint of non-inferiority in change in best corrected visual acuity (BCVA) from baseline of Beovu 6 mg to aflibercept 2 mg at year one.
• Key secondary endpoint of non-inferiority in average change in BCVA of Beovu 6 mg to aflibercept 2 mg over week 40 through week 521 was also achieved.
• Significant improvement with Beovu 6 mg in change of central subfield thickness (CST) from baseline over the period of week 40 through week 52 was observed.
• As non-inferiority in change in BCVA of brolucizumab 3 mg was not demonstrated, no confirmatory testing of superiority on anatomical outcomes was performed.
• Beovu demonstrated an overall well-tolerated safety profile.
• In September 2020, Novartis announced positive topline results from Phase III KITE study.
• The company intends to submit the data from KESTREL, together with KITE study in DME, to health authorities in H1 2021.
• https://seekingalpha.com/news/3644287-novartis-beovu-meets-primary-endpoint-in-late-stage-study-in-diabetic-macular-edema

COVID-19 vaccines expected by spring 2021 at drugstore/grocery store

 

• Health care heroes across the U.S. received the first doses of Pfizer's vaccine on Monday.
• However, it will be months before the average person can access these shots at their local drugstore or grocery store.
• Walgreens Boots (NASDAQ:WBA) and CVS Health (NYSE:CVS) expect to give vaccines to the general public starting in the early spring, said officials to CNBC.
• “Over the next couple of months we anticipate that we’ll be able to have [it in] our stores similar to the flu season,” Rina Shah, group vice president of pharmacy operations at Walgreens, said Monday on CNBC’s “The Exchange.” She said that would be “hopefully in the spring timeframe.”
• Chris Cox, a senior vice president of CVS, said he hopes the company can give the vaccine at its drugstores “somewhere in the April/May timeframe.”
• Nearly 20 drugstores and grocers partnered with the U.S. Department of Health and Human Services in mid-November to help administer COVID-19 vaccines.
• Walgreens and CVS will also play a central role in an early phase of the vaccine rollout.
• Costco (NASDAQ:COST) is also assuming to begin offering COVID-19 vaccinations to the general public at its in-store pharmacies around early spring, CEO Craig Jelinek said to CNBC.
• Rite Aid (NYSE:RAD), Kroger (NYSE:KR), Publix and H-E-B are still waiting to hear when they will receive vaccine doses and can begin offering the shots to Americans.
• The vaccine from Pfizer (NYSE:PFE) and BioNTech (NASDAQ:BNTX), which requires two doses, is the first to receive emergency approval from the FDA.
• By the spring, however, public health officials anticipate vaccines from multiple manufacturers to be available.
• https://seekingalpha.com/news/3644281-covidminus-19-vaccines-expected-spring-2021-drugstore-grocery-store

Moderna vaccine rollout far-reaching and double that of Pfizer

 

• A coronavirus vaccine from Moderna (NASDAQ:MRNA) may shortly join a jab from Pfizer in being distributed across the country, with the FDA to decide on emergency use as early as Friday.
• As soon as it gets the green light, the federal government plans to ship just under 6M initial doses, which is more than double the 2.9M shipped by Pfizer this week.
• Distribution will also be more widespread. Medical supply company McKesson (NYSE:MCK) will obtain the doses from Moderna for packaging and distribution to 3,285 sites nationwide, five times more than those receiving the Pfizer vaccine, while FedEx (NYSE:FDX) and UPS (NYSE:UPS) will still be responsible for sending the doses to their final locations.
• Many states are also working with CVS Health, Walgreens and other local pharmacies to expand the availability of vaccines to rural areas and other places by the spring.
• https://seekingalpha.com/news/3644297-moderna-vaccine-rollout-far-reaching-and-double-of-pfizer

Veru Reports Positive Phase 2 Clinical Trial Results for Breast Cancer Med

 -- Phase 2 Multicenter, International Clinical Study Selected as Spotlight Presentation at 2020 San Antonio Breast Cancer Symposium –

--Enobosarm Demonstrated Clinically Meaningful Clinical Benefit Rates, Overall Response Rates, Median Radiographic Progression-Free Survival and Well Tolerated Safety Profile in Heavily Pretreated Endocrine and Chemotherapy Resistant Metastatic Breast Cancer Cohorts--

--FDA Agrees to Phase 3 Clinical ARTEST Study for the Treatment of Endocrine Resistant ER+/HER2- Advanced Breast Cancer; Study to Commence in 2Q 2021 --

https://finance.yahoo.com/news/veru-reports-positive-phase-2-123000954.html

Arvinas Nearly Doubles

 Arvinas (ARVN) reported promising test results for breast and prostate cancer treatments on Monday — sending ARVN stock soaring to a record high.

On today's stock market, ARVN stock skyrocketed 95.1% to 58.38. That put ARVN stock among the best-performing biotechs on Monday.

The biotech company is working on protein degradation. Arvinas' drugs send bad actor proteins to the cellular garbage disposal. In a Phase 1 test, one patient partially responded to Arvinas' experimental breast cancer treatment.

Meanwhile, a study in prostate cancer patients continues to show promise with prostate-specific antigen reductions of greater than 50%. High levels of prostate-specific antigen, or PSA, can be a sign of prostate cancer.

"Though these programs are at relatively early stages of clinical development (albeit with line of sight to potential approval paths), it's important that we point out that Arvinas is now two for two for clinical programs with promising (effectiveness) and safety data," Wedbush analyst Robert Driscoll said in a report to clients.

Raising The Price Target On ARVN Stock

Driscoll raised his price target on ARVN stock to 93 from 62. He also has an outperform rating on shares.

Arvinas tested its cancer treatments in patients who previously worsened on other drugs.

The tumor in one breast cancer patient shrank by 51% after treatment. Two other patients partially responded, but Arvinas says it still needs to confirm those results.

The cancer treatment was well tolerated. The most common side effects were nausea, joint pain, fatigue and decreased appetite. But none of the side effects were serious and none of the patients dropped out of the study.

In prostate cancer, two of five men with a specific genetic mutation had PSA reductions of more than 50%. That included one patient whose tumor shrank by 80%. Further, two out of 15 patients with another genetic mutation had greater than 50% PSA reductions.

https://www.investors.com/news/technology/arvn-stock-rockets-promising-breast-prostate-cancer-treatments/

Multisystem inflammatory syndrome in children: A systematic review

 Mubbasheer Ahmed,a Shailesh Advani,b,c,1 Axel Moreira,a Sarah Zoretic,d John Martinez,d Kevin Chorath,e Sebastian Acosta,a Rija Naqvi,a,b,c,d,e Finn Burmeister-Morton,d Fiona Burmeister,d Aina Tarriela,d Matthew Petershack,d Mary Evans,d Ansel Hoang,d Karthik Rajasekaran,e Sunil Ahuja,d and Alvaro Moreirad,⁎

doi: 10.1016/j.eclinm.2020.100527

PDF: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7473262/pdf/main.pdf

Abstract

Background

Multisystem inflammatory syndrome in children (MIS-C), also known as pediatric inflammatory multisystem syndrome, is a new dangerous childhood disease that is temporally associated with coronavirus disease 2019 (COVID-19). We aimed to describe the typical presentation and outcomes of children diagnosed with this hyperinflammatory condition.

Methods

We conducted a systematic review to communicate the clinical signs and symptoms, laboratory findings, imaging results, and outcomes of individuals with MIS-C. We searched four medical databases to encompass studies characterizing MIS-C from January 1st, 2020 to July 25th, 2020. Two independent authors screened articles, extracted data, and assessed risk of bias. This review was registered with PROSPERO CRD42020191515.

Findings

Our search yielded 39 observational studies (n = 662 patients). While 71·0% of children (n = 470) were admitted to the intensive care unit, only 11 deaths (1·7%) were reported. Average length of hospital stay was 7·9 ± 0·6 days. Fever (100%, n = 662), abdominal pain or diarrhea (73·7%, n = 488), and vomiting (68·3%, n = 452) were the most common clinical presentation. Serum inflammatory, coagulative, and cardiac markers were considerably abnormal. Mechanical ventilation and extracorporeal membrane oxygenation were necessary in 22·2% (n = 147) and 4·4% (n = 29) of patients, respectively. An abnormal echocardiograph was observed in 314 of 581 individuals (54·0%) with depressed ejection fraction (45·1%, n = 262 of 581) comprising the most common aberrancy.

Interpretation

Multisystem inflammatory syndrome is a new pediatric disease associated with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that is dangerous and potentially lethal. With prompt recognition and medical attention, most children will survive but the long-term outcomes from this condition are presently unknown.

Funding

Parker B. Francis and pilot grant from 2R25-HL126140. Funding agencies had no involvement in the study

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7473262/

'New variant' of coronavirus identified in UK

 A "new variant" of coronavirus has been identified in the UK, which is believed to be causing the faster spread in the South East, Health Secretary Matt Hancock has said.

More than 1,000 cases of the new variant have been found, "predominantly in the south of England", Mr Hancock told the House of Commons this afternoon.

It is spreading faster than the existing strain of coronavirus and is believed to be fuelling the "very sharp, exponential rises" in cases across the South East, he said.

So far it has been found in 60 local authority areas and is thought to be similar to the mutation discovered in other countries in recent months.

It was first identified in Kent last week during routine surveillance by Public Health England (PHE), with ministers told about it on Friday.

The health secretary said that there is currently no evidence that the new variant will not respond to the COVID-19 vaccines being rolled out across the country.

"I must stress at this point there is currently nothing to suggest that this variant is more likely to cause serious disease," he told MPs.

"And the latest clinical advice is that it's highly unlikely this mutation would fail to respond to a vaccine."

Speaking at a Downing Street news briefing later, chief medical officer Professor Chris Whitty said the new strain will still show up on tests and is not "more dangerous" than existing ones.

He said it is possible vaccine efficacy might be affected, but that would be "surprising".

Dr Bharat Pankhania, senior clinical lecturer at the University of Exeter, told Sky News he is "very confident that we won't have to refashion our vaccines" because of the new strain.

But he said the fast rate of the new spread could mean this variant becomes the most dominant nationwide.

"The best way to describe it is, imagine a giant oak tree, and then a little branch that breaks off from that tree. Then that branch becomes the main trunk and the main artery of that tree," he explained.

Mr Hancock said government scientists are studying the new variant at its Porton Down facility and the World Health Organisation (WHO) has been informed.

WHO's top emergency expert Mike Ryan told a news briefing in Geneva it was aware of the new strain and said: "Authorities are looking at its significance. We have seen many variants, this virus evolves and changes over time."

The surge in cases in parts of the south of England saw the health secretary also announce that London, some of Hertfordshire and Essex will go into the toughest Tier 3 restrictions at midnight on Wednesday.

A decision on whether the capital and parts of the South East should move up a tier was due on Wednesday, but Mr Hancock said the surge in cases made it necessary to bring the changes forward.

He told the Commons experts don't yet know how far the increases are down to the new variant, but added: "No matter its cause we have to take swift and decisive action which unfortunately is absolutely essential to control this deadly disease while the vaccine is rolled out.

"In some parts of these areas the doubling time is around every seven days."

https://news.sky.com/story/new-variant-of-coronavirus-identified-in-uk-health-secretary-says-12161416