California won't ease its mask rules until June 15

 Fully vaccinated Californians will need to wear face coverings in most indoor settings for another month, as the state announced Monday it will wait until June 15 to adopt the latest guidance by the Centers for Disease Control and Prevention. 

Many other states lifted their mask requirements last week after theCDC said fully vaccinated individuals do not need to wear masks outdoors in crowds and in most indoor settings. Its new guidance still calls for wearing masks in crowded indoor settings like buses, airplanes, hospitals, prisons and homeless shelters.

Dr. Mark Ghaly, secretary of California Health and Human Services, said the state reviewed the CDC's guidelines and decided it was important to wait to implement them.

"As the CDC even said, implementation of this is important," Ghaly said. "There’s different ways to implement, and giving California ... some time to do it in a way that allows it to be done well without a level of confusion is where we are."

"It’s in no way saying the science or the direction by the CDC is wrong or is a challenge to it," Ghaly added. 

Both vaccinated and unvaccinated Californians are currently required to wear face coverings in most indoor settings. 

Face coverings are not required outdoors for fully vaccinated Californians except during crowded events. Unvaccinated people are required to wear face coverings outdoors "any time physical distancing cannot be maintained, including when attending crowded outdoor events, such as live performances, parades, fairs, festivals, sports events, or other similar settings."

Ghaly said businesses and local governments can impose stricter face covering guidelines than the state. 

A county, for example, may choose to "further delay" the June 15 date or require masks "in certain other vendors and sectors," Ghaly said. Private businesses "can drive how they implement this as well," he added.

More than a dozen states quickly said they would follow the new federal guidelines, but others were like California in weighing their response. Some retailers were also split,with Walmart, Costco and Trader Joe’s saying Friday that they won’t require vaccinated shoppers to wear a mask unless state or local laws say otherwise.

Ghaly said he expects those businesses to adhere to "where the state is" and prepare to implement those standards "on June 15 as opposed to now."

Gov. Gavin Newsom has said the state is on track to fully reopen its economy on that date next month, signaling an end to most pandemic restrictions as infection rates stay at record lows and more people get vaccinated. The state began allowing children 12 to 15 to receive the vaccine last week. 

About 49% of Californians are fully vaccinated, according to state data.

Not everyone agreed with the state's decision to keep its mask mandates in place.

"This is like saying, 'we are going to follow the science, but we are going to wait until June 15 to do so,'" Assemblymember Chad Mayes, I-Rancho Mirage, wrote on Twitter.

California reported far fewer coronavirus cases in the week ending Sunday, adding 10,600 new cases. That's down nearly 20% from the previous week's tally of 13,200 new cases of the virus that causes COVID-19.

With about 12% of the country's population, California had roughly 5% of the country's cases in the last week. California ranked 50th among the states where coronavirus was spreading the fastest on a per-person basis, a USA TODAY Network analysis of Johns Hopkins University data shows. 

More than 3.7 million people in California have tested positive for the coronavirus since the pandemic began, and 62,690 people have died from the disease, Johns Hopkins University data shows. 

https://www.desertsun.com/story/news/health/2021/05/17/fully-vaccinated-californians-no-longer-have-to-wear-face-coverings-in-most-settings/5132042001/

Dr. Sanjay Gupta says CDC mishandled announcement of new mask guidelines

 Last week, the US Centers for Disease Control and Prevention advised that fully vaccinated people can be indoors and outdoors without wearing masks except when in health care settings, on public transportation, or in specified areas where masks are required.

When CNN's chief media correspondent Brian Stelter asked about the press' role in covering the return to normal, CNN's chief medical correspondent, Dr. Sanjay Gupta, said, "We can report what the news is, but then we have to explain the relevance of it."

Gupta said the CDC "made a critical error here in surprising basically everyone with a very significant change." He added that just days before the announcement was made, he spoke to senior leaders at the CDC who told him indoor masking would probably be the last thing to be lifted because "it is so effective and it's not that hard to do in most situations — just to put a mask on."

Another point of concern is the lack of guidance on how best to implement these new guidelines, and if the loosened restrictions could potentially increase the risk of infection for those who cannot yet get vaccinated and the immuno-compromised.

The announcement created a domino effect in the business world, prompting companies to announce that they would lift mask mandates for vaccinated customers in most cases. Walmart, Trader Joe's and Costco, for instance, are no longer requiring vaccinated customers to wear masks in stores. But Walmart did send out a letter Friday noting, "masks will also continue to be required by some city and state ordinances, and we will follow those requirements."

Following sweeping changes to mask and social distancing guidance for fully vaccinated people, CDC director Dr. Rochelle Walensky said on CNN's State of the Union Sunday that the agency is asking businesses to help workers get vaccinated.

"What we're saying to those essential workers is that if those workers are vaccinated, they are safe," she said. "We are really asking the businesses to work with their workers to make sure that they have the paid time off to get themselves vaccinated so they can be safe."

https://www.cnn.com/2021/05/16/media/sanjay-gupta-cdc-mask-messaging/index.html

Novo Nordisk Phase 2 med cut inflammatory biomarkers tied to atherosclerosis in chronic kidney disease

 Novo Nordisk today presented results from RESCUE, a  phase 2 randomised, double-blind, placebo controlled clinical trial assessing the effect of once-monthly, investigational ziltivekimab, an interleukin-6 (IL-6) inhibitor, on biomarkers of inflammation. The trial showed a significant reduction of multiple inflammatory biomarkers associated with atherosclerosis in people with advanced chronic kidney disease (CKD) and elevated high-sensitivity C-reactive protein (hsCRP), representing high cardiovascular risk. The data were announced today at the virtual American College of Cardiology's (ACC) 70th Annual Scientific Session1 and simultaneously published in The Lancet2.

Atherosclerosis is the major cause of cardiovascular disease (CVD), including heart attack and stroke3. Atherosclerosis is characterised by the build-up of fats, cholesterol and other substances in the artery walls that results in vessel narrowing and reduced blood flow3. Chronic inflammation contributes to the development and progression of atherosclerosis4, and biomarkers for inflammation, such as hsCRP, can be used to predict cardiovascular risk5.

The RESCUE trial met its primary endpoint, showing that after 12 weeks, median levels of hsCRP were significantly reduced with ziltivekimab compared with placebo (77%, 88% and 92% reduction in those receiving 7.5 mg, 15 mg and 30 mg of ziltivekimab, respectively, compared to 4% for placebo). The proportion of people achieving both a greater than 50% reduction in hsCRP and hsCRP levels of less than 2 mg/L, a secondary endpoint, was also significantly higher with ziltivekimab than placebo (66%, 80% and 93% in those receiving 7.5 mg, 15 mg and 30 mg of ziltivekimab, respectively, compared to 4% for placebo). Dose-dependent reductions were also observed for four additional inflammatory biomarkers (fibrinogen, serum amyloid A, haptoglobin and secretory phospholipase A2). Treatment emergent adverse events were considered to be mild, moderate, or severe and were similar between the placebo and ziltivekimab groups. Ziltivekimab was generally well tolerated, with no unexpected side effects2.

https://www.prnewswire.com/news-releases/ziltivekimab-reduced-inflammatory-biomarkers-associated-with-atherosclerosis-in-people-with-chronic-kidney-disease-in-phase-2-trial-301292574.html

Seelos cut to Neutral by Roth

 From Buy

https://finviz.com/quote.ashx?t=SEEL

ACC 2021: Amgen out of picture, Cytokinetics eyes supporting role for omecamtiv in heart failure

 A 14-year-long partnership with Amgen is coming to an end this week, but Cytokinetics is pressing on to file the heart drug the two companies collaborated on to the FDA—in more of a supporting role than originally planned.

Omecamtiv mecarbil is a selective cardiac myosin activator designed to target the contractile mechanisms of the heart and boost contraction. In a phase 3 clinical trial called GALACTIC-HF, the therapy was found to reduce heart failure events in patients with reduced ejection fraction and keep them out of the hospital. The condition is a type of heart failure where the heart muscle does not contract effectively, so less oxygen-rich blood gets pumped out to the body.

While this measure was a success, Amgen was clearly banking on the secondary goal of extending patients' lives, which was not observed. The Big Biotech walked, passing the rights to the program back to Cytokinetics in November along with a second program and ending a nearly 15-year collaboration.

The remaining red tape of that deal will finish up this week, CEO Robert Blum said in an interview, just as Cytokinetics displays data from the GALACTIC-HF trial that was sponsored by Amgen at the American College of Cardiology’s (ACC's) annual meeting. The data are also being published in the Journal of the American College of Cardiology.

“We are in a position now to take this forward by ourselves on a global basis, and we're pretty excited about that,” Blum said.

South San Francisco, California-based Cytokinetics has a goal of filing for FDA approval by the end of the year. The filing will mark the culmination of 20 years of development for Cytokinetics and Executive Vice President for R&D Fady Malik, M.D., Ph.D., including 30 trials over 15 years of clinical research.

That research program tried to establish omecamtiv as what Malik calls a “foundational” medicine, but the results fell short of the lofty goal. Instead, Cytokinetics is turning its focus to patients who are at the highest risk of experiencing events that land them in the hospital or cause death due to heart failure. They’ll show the ACC’s virtual audience an analysis of which patients might benefit the most from the therapy.

“It's concentrated really in the more severe heart failure patients which is very gratifying because ultimately they're the ones that don't have treatment options,” Malik said. He added that many heart drugs on the market took decades to sort out which patients might benefit the most from treatment.

Omecamtiv was well tolerated and did not adversely affect heart rate, blood pressure, kidney function or blood potassium levels, which can occur with other types of heart drugs, Malik said. He's optimistic the therapy could provide a strong option for doctors trying to give their patients more quality time outside of the hospital.

Blum said the potential market opportunity in heart failure is huge, with about 6.2 million Americans affected in the U.S., according to the Centers for Disease Control and Prevention.

“These data underscore this drug, added on top of best medical therapy, is contributing to a meaningfully large reduction in hospitalizations and rehospitalizations,” Blum said. “So this is something that should be a welcome add, both from a clinical, but also an economic standpoint.”

He told investors during a first-quarter earnings call in early May that the FDA had signaled the GALACTIC-HF data could stand by themselves in a filing, spurring analysts to dig deeper for details on whether the agency has hinted on which way it will land.

“I don't think the FDA is newly realizing the unmet need in heart failure,” Blum said during the call. “And you've seen how they've been leaning forward in connection with approvals in that space.”

Cytokinetics is also trialing omecamtiv in a phase 3 study called METEORIC to show whether the drug can have an impact on exercise capacity, which in turn could improve cardiac functioning. The study has completed enrollment and is expected to read out sometime at the beginning of 2022.

The company remains laser-focused on getting the filing into the FDA for the U.S. market. Blum said they are also having conversations on potential partners to bring omecamtiv to geographies where another company might be better placed to lead the rollout.

Blum hinted that a deal could be imminent this year tying up several other Cytokinetics pipeline assets to bring them to Japan. He said the company aims to have two to three medicines on the market by 2025.

As for the next generation of drugs that could enter the Cytokinetics pipeline, Blum said Cytokinetics will look first to its in-house scientists. But the company is now sliding into position as a potential deal-maker.

“We're both looking at potential in-licensing and buy-side activities, which we could not have done a few years ago,” Blum said. “We're in a better position to be scouting for those opportunities and integrating them into the work we do organically.”

https://www.fiercebiotech.com/biotech/acc-2021-as-amgen-partnership-ends-cytokinetics-preps-heart-drug-for-narrower-fda-filing

Seagen eyes major growth, but bladder cancer med sales estimates are 'tall order'

  Seagen is one of the industry’s antibody-drug conjugate powerhouses. Its growth hinges on bladder cancer drug Padcev and small-molecule breast cancer med Tukysa, which carry blockbuster sales estimates. But one analyst suggests Wall Street might have gotten a little too excited about those programs.

While Seagen has made great strides in recent years, current expectations of $8.6 billion in 2030 sales are “a tall order,” Evercore ISI analyst Maneka Mirchandaney wrote in an investor note Monday. The estimates assume success in several studies and indications, but clinical and commercial questions remain, she said. She thinks Seagen will come up about $900 million short of that estimate.

In Wall Street’s consensus estimates, analysts are counting on Padcev’s ability to move up the treatment line into newly diagnosed bladder cancer patients as a key factor in the drug’s 2030 sales projection of $2.8 billion. Mirchandaney argues the number is too optimistic. She estimates the med will generate $2.3 billion that year, up from $222 million last year.

Seagen and partner Astellas are expecting an FDA decision for Padcev in second-line bladder cancer later this year. The pair’s plan to move the drug into the front line is two-pronged.

First, the two are eyeing a quick approval for a combination of Padcev and Merck & Co.’s Keytruda in cisplatin-ineligible patients that’ll be based on tumor response data from the cohort K of the phase 2 EV-103 trial.

But as Mirchandaney pointed out, Pfizer and Merck KGaA’s PD-L1 inhibitor Bavencio is already allowed as a maintenance therapy for patients who respond to one round of front-line platinum-containing chemotherapy after it posted a death risk reduction of 31% over best supportive care. This means Bavencio has become the standard of care for a “reasonable portion” of patients, including those who aren’t eligible for cisplatin but can take another platinum chemo, carboplatin.

Meanwhile, previous accelerated nods granted to Keytruda and Roche’s Tecentriq in front-line bladder cancer were later restricted and are now being challenged because those meds have failed confirmatory trials.

Given the troublesome experience with the two PD-1/L1 inhibitors as well as gold-standard patient survival data from Bavencio, “the ‘bar’ may have changed” for Padcev to seek an accelerated approval in the front-line use, Mirchandaney said. Still, the Padcev-Keytruda combo’s early tumor response rate of 73% was impressive, she acknowledged.

As the second part of Astellas and Seagen’s front-line plan for Padcev, the companies last year launched the phase 3 EV-302 trial. That trial is studying the Padcev-Keytruda pairing against chemotherapy in patients regardless of cisplatin eligibility.

Based on Padcev's existing data, Mirchandaney figured this trial will likely be successful. But again, the treatment paradigm has shifted toward Bavencio, the analyst wrote, so it’ll be important to eventually compare Padcev's data with those for Bavencio.

Overall, Mirchandaney expects Padcev to play an important role in front-line bladder cancer, but the trials have uncertainties. She projects the drug could get $1.6 billion U.S. sales from previously untreated patients in 2030.

Besides Padcev, Mirchandaney also questioned Tukysa’s opportunity in breast cancer. Consensus estimates currently project the HER2 drug will reach $2.3 billion in 2030 as Seagen’s second-largest program. For her part, Mirchandaney has put the number at $1.8 billion thanks to potential competition from AstraZeneca and Daiichi Sankyo’s closely watched ADC Enhertu.

All told, Mirchandaney projected Seagen 2030 sales will reach $7.7 billion. The numbers may change if Seagen is picked up by a larger firm, she wrote, noting that the company is an attractive M&A target as it is “one of a small group of $20-30bn [market cap] growth stories in biotech.”

https://www.fiercepharma.com/pharma/seagen-s-a-foundational-leader-adc-but-padcev-sales-estimates-are-a-tall-order-analyst

No masks in most indoor places starting Wednesday: Cuomo

 New York will finally adopt new federal indoor mask guidelines that say those vaccinated against COVID-19 can ditch face coverings, Gov. Andrew Cuomo said Monday — after refusing to green-light them last week.

Vaccinated New Yorkers will be clear to go mask-free in most indoor settings beginning Wednesday, Cuomo announced at a press conference.

“We have to reopen smart. We have to reopen with a cautious eye, but we have to get back to life,” he said. “Effective this Wednesday, we’re going to adopt the CDC’s new guidance and regulations on masks and social distancing for vaccinated people.”

The new rule won’t apply on public transportation or at schools or nursing homes, where people will still be required to mask up, he said.

Face covers will also be required at homeless shelters and jails. And private businesses can still set their own restrictions, he said.

The Centers for Disease Control and Prevention gave the go-ahead Thursday for fully vaccinated Americans to go mask-free inside under most circumstances

But Cuomo and New York Mayor Bill de Blasio initially balked at approving the guidelines, saying they would “review” them.

Gov. Andrew Cuomo’s announcement about masks comes as New York is set to list nearly all capacity restrictions.

AP

The delay sparked confusion among New Yorkers, who weren’t clear on what advice to follow inside businesses, including gyms and restaurants. 

Over the weekend, six county executives from around the state demanded Cuomo adopt the guidance. 

By Monday, he was singing a very different tune.  

“The whole point of the CDC’s change, the whole point of our change is to say to people: There are benefits to being vaccinated,” he said.

Masks will still be required in settings such as nursing homes and subways.

AP

“For our part, we’re adopting the CDC and we’re saying, let’s open. This comes at a good time for New York, because we had already said we were going to do our major reopening this Wednesday.”

Earlier in the day, de Blasio also changed his stance, calling the new rules “balanced.”

“I like the guidance. I think it makes sense. It focuses on folks who are vaccinated and are going to have more freedom. That’s a tremendously positive helpful message,” he said at his own press briefing. “I think it’s balanced.”

He added, “Now we’re going to watch carefully … We’re going to watch the data. If we think something needs to be adjusted, we’ll say it.”

https://nypost.com/2021/05/17/cuomo-adopts-cdcs-new-covid-mask-guidelines-for-new-york/