U.S. allotting 85% less J&J vaccines to states next week

 The U.S. government will allot nearly 85% less Johnson & Johnson COVID-19 vaccines to states next week, data from Centers for Disease Control and Prevention (CDC) showed.

Only 785,500 J&J doses will be allocated, compared to 4.95 million doses this week. The U.S. Department of Health and Human Services (HHS) and J&J did not immediately respond to requests, made outside regular hours, for comment on the drop in numbers.

A New York Times report last week said that workers at an Emergent BioSolutions facility in Baltimore, which produced both AstraZeneca Plc and J&J doses, mixed up ingredients of the two vaccines, ruining 15 million J&J doses.

However, the Baltimore facility has not yet been authorized by the U.S. Food and Drug Administration, and a federal health official told Reuters last week that none of the vaccine doses from the plant have been used in vaccination efforts so far.

J&J has reiterated that it expected to deliver 100 million doses to the government by the end of May.

According to the CDC data, California is the main recipient of the J&J vaccine, followed by Texas and Florida. The vaccine allocation for California is down by about 88%, with the state set to receive only a maximum of 67,600 doses next week.

A California health official told Reuters that the number will be down further in the week starting April 18, with only 22,400 doses of the J&J vaccine allocated to the state.

U.S. President Joe Biden on Tuesday moved up the COVID-19 vaccine eligibility target for all American adults to April 19.

https://www.reuters.com/article/us-health-coronavirus-usa-johnson-johnso/u-s-allotting-85-less-jj-vaccines-to-states-next-week-data-shows-idUSKBN2BV0QO

BeiGene Covid-19 Treatment Trial Misses Efficacy Endpoints

 BeiGene Ltd.'s trial of a potential treatment for patients in hospital with respiratory symptoms of Covid-19 failed to meet the two primary efficacy endpoints of the study.

The biotechnology company said its Phase 2 trial evaluating zanubrutinib in patients hospitalized with respiratory symptoms of Covid-19 and requiring supplemental oxygen without mechanical ventilation, didn't meet the co-primary efficacy endpoints of respiratory failure-free survival or reduction in days on oxygen as compared with a placebo.

There were no new or additional safety signals for zanubrutinib identified in the trial, it added.

The U.S. trial enrolled 67 patients with Covid-19 disease who either required supplemental oxygen or mechanical ventilation. It was designed to assess quickly whether treatment with zanubrutinib could help hospitalized patients with Covid-19-related pulmonary distress. Zanubrutinib is a small molecule inhibitor of Bruton's tyrosine kinase discovered by BeiGene scientists.

Following the update on the trial, BeiGene's American depositary receipts were down 0.9% in premarket trading after ending Wednesday at $321.60, a gain of almost 25% so far in 2021.

https://www.marketscreener.com/quote/stock/BEIGENE-LTD-26123632/news/BeiGene-Clinical-Trial-of-Covid-19-Treatment-Misses-Co-Primary-Efficacy-Endpoints-32914044/

Lilly- Incyte Phase 3 baricitinib in hospitalized COVID-19 patients misses endpoint

 - Randomized, double-blind, placebo-controlled study of 1,525 patients did not meet statistical significance on primary endpoint (progression to non-invasive ventilation or invasive mechanical ventilation or death)

- Data showed 38% reduction in mortality by Day 28 (nominal p-value=0.0018) in patients treated with baricitinib in addition to standard of care, including corticosteroids and remdesivir

https://www.prnewswire.com/news-releases/lilly-and-incyte-announce-results-from-the-phase-3-cov-barrier-study-of-baricitinib-in-hospitalized-covid-19-patients-301264421.html

FDA OKs Gilead Trodelvy for Metastatic Triple-Negative Breast Cancer

 Gilead Sciences Inc. (GILD) said that the U.S. Food and Drug Administration has granted full approval to Trodelvy or sacituzumab govitecan-hziy for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer or TNBC who have received two or more prior systemic therapies, at least one of them for metastatic disease.

Trodelvy significantly reduced the risk of death by 49% compared with single-Agent Chemotherapy in the phase 3 ASCENT study.

Trodelvy demonstrated a statistically significant and clinically meaningful 57% reduction in the risk of disease worsening or death (progression-free survival or PFS), extending median PFS to 4.8 months from 1.7 months with chemotherapy.

The FDA granted accelerated approval to Trodelvy in April 2020 based on objective response rate and duration of response results in a phase 1/2 study.

https://www.nasdaq.com/articles/fda-approves-gileads-trodelvy-to-treat-metastatic-triple-negative-breast-cancer-2021-04-07

Production of the Pfizer vaccine in France begun

 France now produces vaccines on its soil . The first anti-Covid-19 serums were bottled on Wednesday, even if the doses will not be intended only for the French, confirmed the subcontractor Delpharm in charge of the operation. "It started this morning," said the group that bottles Pfizer / BioNTech vaccines in Eure-et-Loir . An event hailed by President Emmanuel Macron.

"250 million doses of Covid-19 vaccines produced in France in 2021: this is our goal", welcomed the President of the Republic. “It begins in concrete terms today with the first BioNTech-Pfizer vaccines produced at the Delpharm site in Saint-Rémy-sur-Avre: congratulations to all the teams! “, He greeted again.

The vaccines in question were delivered in bulk to Delpharm on Tuesday from BioNTech's plant in Marburg, Germany, where they are manufactured. Delpharm is responsible for putting them in the vials which will ultimately be distributed to the vaccinators.

After Pfizer, Moderna

Even if they leave the French factory today, they will not be immediately injected, because it will take almost a month to approve them. Thereafter, they will not be specifically dedicated to the French. Delpharm specified that the proportion should correspond to the quota of anti-Covid vaccines planned by the European Union for France on all of its orders, or around 15%.

In a few days, a competitor of Delpharm will begin to bottle Moderna vaccines , in Indre-et-Loire. At the end of May, the Fareva company will take care of the CureVac vaccine - not yet approved in the EU - in the Eure and in the Pyrénées-Atlantiques. Finally, the giant Sanofi will lend a hand from this summer to its competitor Johnson & Johnson by bottling its vaccine, near Lyon.

Already approved in the EU but subject to restrictions for certain age groups, the AstraZeneca vaccine is not currently supposed to be bottled in France.

https://www.leparisien.fr/economie/covid-19-la-production-du-vaccin-pfizer-en-france-a-commence-ce-mercredi-07-04-2021-FPEIMKYAS5DP3CIPGWES3ENPUA.php

1/3 of remote workers say they’d rather quit than return to full-time office work

 A new survey of WFH (work-from-home) employees suggests that many are not yet ready to return to the office. In fact, they may never be ready.

The survey found that 34% of WFH respondents say they would rather quit than return to a full-time office job.

Will WFH jobs become the norm?

The survey was published by staffing firm Robert Half. It involved more than 1,000 adult employees of US companies, all of whom are currently working from home due to the pandemic.

As mentioned above, more than 1 in 3 said they would look for a new job if they had to again work in the office full time.

• Related news: A new study of 2,000 Americans who have been working from home during the pandemic has found that 76% say the shift to remote work has improved their relationships with their co-workers (i.e. the co-workers they never actually see anymore).

Just under half of all the surveyed WFH employees (49%) said they would prefer a hybrid work arrangement, dividing their time between the office and another location. Likewise, 26% said they want to remain fully remote, and 25% wanted to return to a full-time office situation.

Easing the transition: relax the hours and the dress code

The survey also reveals what employers can do to help “ease” the transition back to office life.

For example, the most important aspect that the surveyed employees mentioned is the freedom. Above all, that means freedom to set their own office hours.

They’ve also grown increasingly fond of the highly-personalized workspace that WFH jobs allow for. Along the same lines, they indicated that WFH provides a more distraction-free environment. That includes, for example, not needing to make chit-chat with co-workers.

The WFH survey respondents also said they prefer the “relaxed” dress code that they’ve grown used to at home.

And if they do need to come back to the office, even part-time, employees said they expect some changes. For example, they’d want their employer to cover their commuting costs, and also provide some form of childcare.

Benefits of working from home

Working from home (WFH) is a growing trend in the workplace, and a great way to make work more flexible. Below are some of the benefits.

• If your company allows it, it’s often a great idea to take advantage of the time you have to yourself, especially if you have children.
• Working at home gives you time to work uninterrupted, set your own schedule, and connect with your kids at home.
• It also enables you to work when and where you want to, without the obligations of an office.
• You can set up a schedule that enables regular work, but also work-life balance.
• The day-to-day responsibility of managing a business is often the cause of stress. But working from home is usually much more stress-free.

https://www.psychnewsdaily.com/a-third-of-wfh-employees-say-theyd-rather-quit-than-return-to-full-time-office-work/

FDA approves Bausch + Lomb dispersive ophthalmic viscosurgical device

 Bausch + Lomb announced today that it received FDA approval for its ClearVisc dispersive ophthalmic viscosurgical device (OVD).

Laval, Quebec–based Bausch + Lomb — the eye health business unit of Bausch Health — developed the ClearVisc OVD for use in ophthalmic surgery to aid in cataract extraction and intraocular lens (IOL) implantation through the creation and maintenance of space, tissue manipulation, visualization enhancement and corneal endothelium protection, according to a news release.

ClearVisc contains the chemical agent Sorbitol, which is designed to deliver superior free radical protection compared to other dispersive OVDs. The device helps to provide physical protection of the cornea from thermal and mechanical damage and chemical protection from damaging free radicals.

A multicenter, randomized clinical study of 372 subjects saw ClearVisc meet its primary safety and efficacy endpoints, while the device proved non-inferior to Viscoat. No serious adverse events were seen in ClearVisc eye surgeries, with clear corneas seen in 91% of eyes treated with ClearVisc, compared to 92% of those treated with Viscoat at one day post-operation.

However, 100% of those treated with ClearVisc has clear corneas at one-week post-operation, while 98% of eyes treated with Viscoat had the same result.

“The ClearVisc dispersive OVD is the latest advancement in Bausch + Lomb’s rich pipeline of ophthalmic surgical devices and is representative of our company’s ongoing commitment to delivering innovations that fulfill the unmet needs of our customers,” Bausch + Lomb U.S. president Joe Gordon said in the release. “OVDs play a critical role in cataract surgery as well as many other ophthalmic surgeries. ClearVisc™ offers significant advantages that can help surgeons deliver the best possible outcomes for their patients.”

https://www.massdevice.com/fda-approves-bausch-lomb-dispersive-ophthalmic-viscosurgical-device/