Grupo Guayacán, Popular provide $90,000 in Covid-19 relief grants

To aid winners of EnterPRize small business competition

SAN JUAN – Grupo Guayacán, a Puerto Rico-based non-profit that provides business training and development programs, and Popular, the largest financial institution on the island, have again partnered to provide economic relief to small businesses that are struggling to maintain operations amid the COVID-19 pandemic.

The financial aid is for companies that are” working hard and reinventing themselves in order to survive the challenges of this difficult time,” a joint news release reads.

Guayacán said the initiative is part of its “efforts to help the business community continue operating in the midst of the public health measures taken to control the pandemic.”

The economic incentive will be benefit 17 small businesses that employ about 100 people and were winners of Guayacán’s 2019 EnterPRize business competition. Grants totaling $90,000 will be awarded, with individual contributions ranging from $2,000 to $10,000.

The organization explained that the grant amounts were determined “according to each company’s financial needs and the impact that the COVID-19 crisis has had on its operations. The funds will help protect 104 jobs from the benefited companies, which reported $2 million in combined sales” in 2019.

“We are convinced that, once again, small businesses will be at the forefront of Puerto Rico’s recovery. These funds will help them navigate the great difficulties they are currently facing, emerging stronger and more resilient. Today we are dealing with an unimaginable and unprecedented crisis, but our business community has risen to the occasion and we are proud to partner with Popular once again to support them,” said Laura Cantero, executive director of Grupo Guayacán.

Companies will use the funds to cover payroll, rent and other operational costs, “as well as to develop new and innovative ways to keep their businesses operating,” the release reads. “Prior to disbursement, each company was required to present a milestone plan, and a detail of the proposed use of funds. In addition to the cash funds, participants will get mentoring on finance, accounting, and access to other incentives and emergency aid from Lianabel Oliver, founder of OBALearn.”

The release highlights TAIS, one of the small businesses that benefited from the initiative.

“Due to the lockdown, TAIS lost the opportunity to service new clients, as well as existing contracts with restaurants that were forced to close their operations. With these funds, we will be able to retain our talented team, allowing us to continue developing our new strategy to service residential customers. This way, even if people stay at home, they can use our services to reduce the waste that reaches our landfills and contribute to improving our environment. Furthermore, they can directly support local agriculture by composting,” TAIS spokesman Oscar Meléndez said about the company’s recycling service.

“This investment reaffirms our commitment to Puerto Rico’s business community. It is a priority for Popular to collaborate with organizations like Grupo Guayacán, which we know work nonstop to foster the growth and development of local companies,” said Beatriz Polhamus, first vice president of the Social Commitment Division of Popular.

The following EnterPRize 2019 winners are benefiting from the announced aid, as listed by Grupo Guayacán:

1. A Medias makes high quality socks with creative designs and contributes to local non-profit organizations. 

2. El Mundo de los Muñecos facilitates fun and educational memories through the art of puppetry. 

3. Entre Panas is an agribusiness focused on gluten free breadfruit products. 

4. Fishi is a local to global, character-based, brand that evokes the tropical life. 

5. Fitverz is a smart wellness platform that allows people to access a universe of fitness centers. 

6. Grown Ups specializes in recreation and wellness programs for independent seniors and those living in nursing homes. 

7. Grupo Encuentra Estudios is a mobile occupational counselling tool for students. 

8. Guilty is a subscription for women’s clothing rentals. 

9. Huerto Rico is an up and coming unique gourmet mushroom farm. 

10. Moralito manufactures natural sofrito and other products with fresh and locally sourced ingredients. 

11. OGMA Language Studio offers linguistic expertise to provide more options for your language needs. 

12. Pública is an arts incubator, that focuses on creative entrepreneurs. 

13. Raincoat creates insurance policies that pay instantly after natural disasters. 

14. Remora is a machine that filters and improves water quality for communities in need of clean water sources. 

15. TAIS offers businesses and households clean and simple food scrap recycling services to create a circular food system. 

16. TeeChealo is a full-service garment decorator that specializes in high quality products. 

17. Y No Había Luz is a local theater company focused on changing the way arts impact the children of Puerto Rico. 

During the lockdown period, Guayacán has offer free online lectures covering aspects of a business operation facing the COVID-19 crisis. Topics include available financial aid, remote-working strategies and business transactions. To learn more about Grupo Guayacán, visit www.guayacan.org.

Grupo Guayacán Announces Grant To Support EnterPRize Participants Affected By COVID-19 Crisis

Call for EnterPRize 2020 Remains Open Until April 30

  • Posted April 14, 2020

Guayacán Kicks Off 15th EnterPRize Competition—Online

Seeks to Help Start Up Businesses Despite Government’s Outbreak Measures

  • Posted March 17, 2020

Nonprofit Grupo Guayacán Looks Back At Work Done After Hurricane Maria

Has helped 175 businesses in past 2 years of recovery

  • Posted September 18, 2019




AbbVie Completes Acquisition of Allergan

(Screen grab of https://www.abbvie.pr/)

Receives approval for $63 billion closing

SAN JUAN – Giant pharma company AbbVie has completed its acquisition of Allergan plc, the Dublin-based pharmaceutical that makes Botox, after receiving approval from the U.S. government and the Irish High Court.

In its news release, AbbVie says the transaction “significantly expands and diversifies” its revenue base and “complements existing leadership positions in Immunology, with Humira®, and recently launched Skyrizi TM and RinvoqTM, and Hematologic Oncology, with Imbruvica® and Venclexta®. Allergan provides new growth opportunities in Neuroscience, with Botox® Therapeutics, Vraylar® and UbrelvyTM and a global aesthetics business, with leading brands including Botox® and Juvederm®.”

Under the terms of the transaction agreement, Allergan shareholders will receive 0.8660 AbbVie shares and $120.30 in cash for each Allergan share, for a total consideration of $193.23 per Allergan share (based on the closing price of AbbVie’s common stock of $84.22 on May 7). Allergan common stock ceased trading on the New York Stock Exchange as of the close of trading Friday.

“We are pleased to reach this important milestone for the Company, its employees, shareholders and the patients we serve” said Richard A. González, chairman and chief executive officer of AbbVie. “Our new Allergan colleagues should be commended for all their efforts, along with those of our own employees, to achieve this turning point for our Company. The new AbbVie will be a well-diversified leader in many important therapeutic categories, with both on-market and pipeline assets, and our financial strength will allow us to continue to invest in innovative science and continue to serve unmet medical needs of patients that rely upon us. I am proud of both organizations and look forward to the opportunities ahead.”

AbbVie has manufacturing sites in Barceloneta and Jayuya, and a Commercial Affiliate Office in San Juan. The company employs hundreds of people among its joint manufacturing and commercial operations in Puerto Rico.

Alejandro Drevon, Puerto Rico Commercial Affiliate’s general manager, said that “we are enthusiastic by this acquisition, which strengthens our commitment to making a remarkable impact in people’s lives. We provide broader support to our patients and help address the health needs of underserved communities. We strive to protect our environment and to make a positive impact in the areas where we live and work.”

The portfolio is expected to drive AbbVie’s “growth platform (ex-Humira) to approximately $30 billion in revenues in full year 2020, with combined revenues of approximately $50 billion,” the company says, adding that it also positionsit for “enhanced long-term growth potential, a growing dividend and investment in innovation in each of its therapeutic categories.”

AbbVie anticipates rapidly paying down the incremental debt with its increased operating cash flows and said it expects to provide updated financial guidance for the combined company on its second-quarter earnings call.

Additionally, in connection with the closing of the transaction, the AbbVie board has elected Thomas C. Freyman, retired executive vice president and chief financial officer of pharmaceutical company Abbott, from which Abbvie was spinned off in 2011, to join the AbbVie board. Freyman recently served on Allergan’s board.




Puerto Rico CPA Society will hold a series of virtual forums

Including annual industry meetings; Covid-19 taking center stage

SAN JUAN – The Puerto Rico Society of Certified Public Accountants (CCPA by its Spanish initials) will hold a series of virtual forums and seminars this month that will count as continuing education for its members. Some deal with issues related to the ongoing Covid-19 crisis

“At CCPA we continue to be an institution that is committed to offering our members the tools for their professional success,” CCPA President David E. González said in a press release. “One of our strengths is the continuing education that our members receive. As a result of the emergency we are going through, the forums and seminars will be offered in a virtual manner.”

A webinar titled “Coronavirus (COVID – 19) – Issues and Realities CPAs and Their Clients Should Be Aware Of” will be conducted Wednesday, May 13, from 9 a.m. to 11:45 a.m.

CCPA’s third “Export Services Forum – From Theory to Practice,” will be held via Zoom on Friday, May 15, from 9 a.m. to 2:30 p.m. It will include discussion of information and experiences on efforts to explore markets outside of Puerto Rico, González said, noting that it will feature a talk by the secretary if the Economic Development & Commerce Department, Manuel Laboy.

The 21st Puerto Rico Insurance Industry Annual Forum will be held via Zoom on Wednesday, May 20, from 8:45 a.m. to 1:15 p.m. The challenges facing the local insurance industry, from an economic perspective—including the effects of Hurricane Maria, the earthquakes and Covid-19— will be discussed, González said, adding that there will also be a talk on insurance fraud.

On Friday, May 22, the Community-Based Nonprofit Entities Forum will be held via Zoom from 9 a.m. to 1 p.m. Among the topics to be discussed in this event are how to apply for funding through proposals submitted to foundations and other entities, the purpose of financial statements and the meaning of their items, as well as the indicators that should be observed and what they tell us, the CCPA head said.

Moreover, the society will hold its 17th Financial Institutions Forum on Wednesday, May 27, as well as the 10th CPA-Attorneys Annual Conference Annual Forum on Tuesday, May 26; Thursday, May 28; and Friday, May 29.

“Without a doubt, this year has been filled with many challenges, but we remain firm in offering our professionals relevant information in tune with the economic and social realities we are living in,” González said, calling on those interested in CCPA events to follow the organization’s social media and visit its website, www.colegiocpa.com.

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Health Secretary says ‘Puerto Rico is illuminated’ and alleges COVID-19 peak has passed

Health Department Secretary Lorenzo González in interview with Centro de Periodismo Investigativo (CPI). Foto by Nahira Montcourt | Centro de Periodismo Investigativo (Via CyberNews)

To date, at least 107 people have died from the disease

SAN JUAN – The Secretary of the Department of Health, Lorenzo González Feliciano, said on Friday that the peak period of COVID-19 infections in Puerto Rico has passed, although it is still important to maintain individual preventive measures and those implemented by the government.

“Despite all the crises it has had, we are illuminated. Whoever believes that this is false does not live in Puerto Rico. Puerto Rico is illuminated. We have a lot of crises and we pulled ourselves out, and the blow is powerful but we got up,” González Feliciano said in a radio interview (WKAQ).

Upon assuming the leadership of the department in late March, the official had indicated that the peak period of infections on the island would be between May 4 and 8.

“Categorically, yes [the peak has passed]. We have to look prospectively at how we transform and modify the quarantine process. The governor will receive input from the Health Department, from the other secretaries, particularly the [Economic Development Department’s], to see how we continue our country’s normalization process. What we see today is something that should give us a certain sense of tranquility and a little bit of peace but not let our guard down,” he said.

He said that between Monday and Wednesday this week there were no deaths, while on Thursday three were reported and five on Friday.
“We have remained stable in terms of the infection process. We continue to monitor this,” he explained, indicating that the data indicate the transmission rate is currently between 4 and 5 percent.

However, the official said that does not mean that the social distancing measures implemented by the government will be lifted, precisely to contain the spread.

“People have to do the right thing. It is our country. We have to do the right thing to see if we…see a beautiful Christmas this year and we can celebrate,” the official added.

The figures released by the department on Friday showed 107 deaths from the disease and 2,156 cases on the island to date.

For more information, visit https://statuscovid19.pr.gov or the website of the Department of Health, www.salud.pr.gov/coronavirus.




HHS Awards Over Half Billion Dollars to Expand COVID-19 Testing

Puerto Rico health centers receive nearly $8.6 million

SAN JUAN — The U.S. Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), awarded nearly $583 million to 1,385 HRSA-funded health centers to expand COVID-19 testing.

Puerto Rico received nearly $8.6 million to support the following 22 health centers:

“Nearly 88 percent of HRSA-funded health centers report testing patients, with more than 65 percent offering walk-up or drive-up testing. Health centers are currently providing more than 100,000 weekly COVID-19 tests in their local communities,” HHS said in its news release.

The funding is part of the Paycheck Protection Program and Health Care Enhancement Act, signed April 24. The legislation provides funding for small businesses and individuals financially affected by COVID-19, additional funding for hospitals and healthcare providers, and increased testing capabilities to help track the spread and impact of the coronavirus.

“This new funding secured by President Trump will expand the work health centers are doing to test Americans for COVID-19,” said HHS Secretary Alex Azar. “Widespread testing is a critical step in reopening America, and health centers are vital to making testing easily accessible, especially for underserved and minority populations. Further, because health centers can help notify contacts of patients who test positive, they will continue playing an important role in cooperating with state and local public health departments.”

The health centers are expected to use this funding to “expand the range of testing and testing-related activities to best address the needs of their local communities, including the purchase of personal protective equipment; training for staff, outreach, procurement and administration of tests; laboratory services; notifying identified contacts of infected health center patients of their exposure to COVID-19; and the expansion of walk-up or drive-up testing capabilities,” the release reads.

“Health centers are a first line of defense, as they are testing for coronavirus and delivering high-quality primary care to our nation’s most vulnerable populations.” said HRSA Administrator Tom Engels. “In the fight against COVID-19, we must marshal all of our resources to keep Americans healthy and care for those who become ill.”

To date the HRSA had awarded $1.42 billion to health centers to address COVID-19, with the new allotment bringing the total COVID-19 investment in health centers to nearly $2 billion.

For a list of award recipients, visit https://bphc.hrsa.gov/emergency-response/expanding-capacity-coronavirus-testing-FY2020-awards

For more information about health center capacity and the impact of COVID-19 on health center operations, patients and staff, visit https://bphc.hrsa.gov/emergency-response/coronavirus-health-center-data.

For more information about COVID-19, visit http://coronavirus.gov/.




San Juan-based Nonprofit chosen to manage UPR scholarship money

Fiscal Agency: Fundación Comunitaria to manage $213 million fund

SAN JUAN – The Puerto Rico Fiscal Agency and Financial Advisory Authority (Aafaf by its Spanish acronym) chose Santurce-based nonprofit Fundación Comunitaria de Puerto Rico (FCPR) to manage and provide investment services for a new scholarship fund for University of Puerto Rico (UPR) students, established in accordance with the UPR Fiscal Plan, Aafaf Executive Director Omar J. Marrero said Thursday.

“After careful analysis of the independent firms that were interested in the project, we have chosen the organization that has the most comprehensive capacity to manage the new scholarship fund for our university,” Marrero said in a press release. “We are very pleased with the selection of Fundación Comunitaria de Puerto Rico given its reputation and proven level of experience that will translate into efficiency and expediency in the management and distribution of these scholarships for our students.”

The scholarship fund will consist of approximately $213 million to be awarded to students during a five-year period ending in 2023, in accordance with the UPR Fiscal Plan and the Certified Fiscal Plan for the Central Government, Marrero said, noting that “this initiative is the product of long negotiations between AAFAF and the Fiscal Oversight Board to provide scholarships for university students in the main public university of the of the Island.”

FCPR, which is an independent tax-exempt entity, has provided consulting in Puerto Rico and overseas for 35 years. The foundation provides services involving establishing, safekeeping and managing scholarship funds or donations.

FCPR has designed programs related to grants, technical assistance and capacity building. After the devastation wrought by Hurricane María in 2017, FCPR’s strategic plan has prioritized equitable access to potable water, renewable energy, public housing, community economic development and education, among other key areas for society’s well-being.

(Screen capture of https://www.facebook.com/FundacionComunitaria)




Small Businesses Concerned About Complex Guides To Restart Operations

United Retailers Center (CUD by its Spanish initials), Jorge Argüelles (Screen capture of www.centrounido.com)

SAN JUAN – The president of the United Retailers Center (CUD by its Spanish initials), Jorge Argüelles, said Monday that there is much concern among business owners about the guidelines established to resume their operations in accordance with the new executive order, which he stressed does not allow many businesses to run yet.

“Many business people have contacted us with concern about the requirements of this new self-certification that the Department of Labor is demanding and for which we have not received any guidance. From what I have heard it is quite a long document. Many have had to turn to labor lawyers and others for help. This is a document that was normally filled out alongside OSHA [Occupational Safety and Health Administration] officials and this time they are leaving that responsibility to the business owner,” Argüelles said in a radio interview (NotiUno).

“Many have even expressed to me that they preferred not to open. I am not opening the United Center because I am really afraid that now a battalion of various agencies is being formed to make sure that the business people comply with something that was hastily presented over the weekend and one doesn’t know if you are doing it correctly or not,” he added.

The secretary of the Department of Economic Development and Commerce (DDEC), Manuel Laboy Rivera, announced Monday the publication of the Business Reactivation Plan for the reopening of certain economic activities, after the closure decreed as a precautionary measure to prevent the spread of COVID-19. In addition to the plan, a risk assessment template was published containing mitigation measures and the Employer Self-certification. It must be sent by employers to autocertificacionprosha@trabajo.pr.gov.

The protocols and documents can be found at https://refuerzoeconomico.com/reactivacion-de-negocios. If you have questions, e-mail emergencia@ddec.pr.gov.

Argüelles recommended that the document be reconsidered to make it easier.

“We have been closed for 50 days, to now have to open up scared, hoping they will not come and catch me for something I innocently could not comply with due to being unaware and they fine me $5,000 or God knows what,” he said.

He added that business people are desperate to open but still want to be able to comply with specifications. He pointed out that the government administration’s chief of staff, Antonio Pabón, contacted him Sunday and that he expects a response Monday.

“I predict that many will not open Monday because they will not have the document ready and for fear that they will be fined. Some have told me that they are not going to dare to do it,” he stressed.

In addition, the trade group spokesperson alleged unfair competition that is taking place because while small businesses have been closed, large chains have continued to operate and sell all kinds of items and that there have even been specials for Mother’s Day.

Argüelles said that although he has not communicated with business people from the south, the earthquake Saturday further complicates the picture, despite the fact that many of them are closed by COVID-19.




Guidelines published for first phase of economic reopening

SAN JUAN – The secretary of the Department of Economic Development and Commerce (DDEC by its Spanish initials), Manuel Laboy Rivera, announced on Monday the publication of the Business Reactivation Plan that includes a series of tools, developed by the Economic Task Force, for the reopening of certain economic activities, after the closure decreed as a precautionary measure to prevent the spread of COVID-19.

In addition to the plan, a risk assessment template was published containing mitigation measures and the Employer Self-certification.

“These documents will be the initial tools that employers will use to determine the actions to be followed in the preparation process to protect the health of their employees and customers ahead of the start of operations. It is important that the best health conditions are guaranteed to avoid a significant increase in COVID-19 infections,” Laboy Rivera said in a statement.

He noted that as part of the process, a survey prepared by the Business Emergency Operations Center, an organization that is part of the Economic Task Force, in conjunction with the Puerto Rico Institute of Statistics, was included, which will be used to collect frequent and updated data on aspects related to COVID-19 in businesses in Puerto Rico.

This data in turn will allow businesses to take all necessary measures to provide services safely, effectively and efficiently. This survey will serve as a baseline for the recommendations of the sector revival plan. The information provided by employers is considered confidential and the results will only be used to offer suggestions to the various economic sectors.

On the other hand, the secretary of the DDEC, said the Institute of Statistics of Puerto Rico (PRSI) will help in data management to guarantee the publication of accurate data that is necessary to make decisions about the reopening of other sectors or the adjustments needed in the event of an increase in coronavirus cases. The determination to resume the operation of new economic activities must be based on data that is as accurate as possible, always safeguarding everyone’s health.

PRSI Executive Director Orville Disdier said they developed a Unique ID Generator, which will collect basic and initial business information and assign each one a unique identification number, which will be used to protect company confidentiality. They also created the COVID-19 Business Survey, which will collect weekly information on the characteristics of active employees, the impact of COVID-19 on employees, the level of risk to employees and customers, and the capacity of the business to mitigate the impact of COVID-19.

Both tools can be accessed at: https://estadisticas.pr/en/encuesta-covid19-negocios. The information obtained through these tools will also complement the information that the Institute already receives from the Department of Health, which is analyzed and published in the COVID-19 Indicators Platform, available at: https: //statistics.pr/en/covid-19.

For the economist Roberto Toledo, who is a member of the Economic Task Force and worked on the recommended model of the first gradual reopening, it is a fundamental effort that is the basis and guide for a successful reopening.

“The initial results in a scenario without standardized mitigation protocols, with high-risk businesses operating such as supermarkets and after three incubation windows, were encouraging. Of the 63,000 employees reported in the survey as active, we have reported 25 positive cases with COVID-19, this figure is proportional to the data provided by the Department of Health. This does not mean that we let our guard down, the key continues to be a gradual reopening tied to the integration of monitoring, tracking and mitigation tools,” he said.

The DDEC secretary said the Department of Labor and Human Resources was key in these efforts because, through the guides published by the Puerto Rico Occupational Safety and Health Administration (OSHA), the tools needed to support employers to resume operations safely were established.

“In the past few months, we have guided and assisted the private sector in creating their exposure control plans for COVID-19. The new Self Certification, which employers must send by email to autocertificacionprosha@trabajo.pr.gov, contains the essential elements that an adequate plan must include, to guarantee the safety of employees in their workplaces, according to the PR OSHA guidelines,” said Labor Secretary Briseida Torres Reyes.

Those interested in obtaining these protocols and documents can access refuerzoeconomico.com. If you have questions, e-mail them to emergencia@ddec.pr.gov.




CPI Sues Demographic Registry for Third Time for Failing to Deliver Full Information on Deaths

Photo by Dennis M. Rivera Pichardo | Center for Investigative Journalism

The Center for Investigative Journalism (CPI) today turned to the court with a writ for mandamus for access to information claiming the Demographic Registry has not fully delivered the database on the causes of death in Puerto Rico, as requested five weeks ago.

The lawsuit filed at the San Juan Superior Court names as defendant Wanda Llovet Díaz, director of the Puerto Rico Demographic Registry, and the Commonwealth. It responds to investigations done by the CPI into deaths on the island.

“It’s unbelievable that at a time like this, and with the urgency that people have to feel some degree of trust and certainty about how the issue of deaths from COVID-19 is being handled, the island is being failed again. The request for the complete database and death certificates is identical to the one that the CPI submitted after Hurricane María and for which, as we know, the Superior Court ordered its full disclosure in 2018,” said Carla Minet, executive director of the CPI.

“In 2009, the CPI had also filed a suit against the same official seeking the same document, and gained access to it. We urge the director of the Demographic Registry to deliver this information without omitting any fields, as soon as possible,” said Minet.

On March 23, journalist Laura Moscoso, on behalf of the CPI, began the process of requesting the data on the deceased in a letter addressed to Llovet Díaz, former Acting Health Secretary Concepción Quiñones De Longo, and press officers for the Health Department and La Fortaleza. She requested Puerto Rico’s mortality database from 2007 to 2020.

After examining a digital disc that the Health Department delivered, Moscoso contacted government officials again on April 6 to inform them that the database they provided was incomplete, “since some fields, such as the name of the deceased, were removed.”

Given the incomplete information, the CPI insisted on obtaining the full document and also requested a digital copy of the death certificates issued from Jan. 1, 2020 to the present. Despite the request to the public officials involved, including Llovet Díaz and the new Health Secretary, Lorenzo González Feliciano, “no representative of the parties that were contacted responded to the follow-up messages,” the legal remedy states.

Attorneys Luis José Torres Asencio, Annette Martínez Orabona and Steven Lausell Recurt, of the InterAmerican University Law School’s Legal Clinic are representing the CPI in this lawsuit.

“The information the CPI requested is not protected in any way by any confidentiality or privilege, nor is it protected under any of the exceptions to the right of access to information,” the lawsuit states.

And even if the government invokes some confidentiality or privilege over the information requested, “the public interest to access the information exceeds any claim that seeks to limit citizen access to information on this issue,” the lawsuit adds.

The Transparency and Expedited Procedure for Access to Public Information Act (Law 141-2019) creates a special mechanism for access to information, but its Article 12 recognizes that it will not be interpreted restrictively, “nor does it imply the exclusion of other rights and procedures pertaining to people requesting public information and not specifically mentioned, such as the traditional mandamus remedy.”

The Transparency Act says, among other things, that the information and documentation that the Government generates is presumed to be public and accessible to all people equally; that the information and documentation the Government produces in its analyses, transactions, and in the exercise of public authority are the legacy and memory of the people of Puerto Rico.

The CPI also asked that the Court order the parties to disclose the information when requested to do so in the future, under the same terms and in compliance with the same regulations on access to information.




Remdesivir Receives FDA Emergency Use Authorization for COVID-19 Treatment

This scanning electron microscope image shows SARS-CoV-2 (round gold objects) emerging from the surface of cells cultured in the lab. SARS-CoV-2, also known as 2019-nCoV, is the virus that causes COVID-19. The virus shown was isolated from a patient in the U.S. NIAID-RML

Under EUA, 10-day dosing suggested for patients requiring ventilators; 5-day dosing for others

SAN JUAN – California-based Gilead Sciences Inc. announced Friday that the U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for the investigational antiviral remdesivir to treat COVID-19.

The biopharmaceutical company said allocation of the limited available supply of remdesivir will be made “based on guiding principles that aim to maximize access for appropriate patients in urgent need of treatment, with direction from and in collaboration with the government.”

The optimal duration of treatment is still being studied in ongoing clinical trials. Under the EUA, both 5-day and 10-day treatment durations are suggested, based on the severity of disease. The authorization is temporary and still requires FDA approval.

“The U.S. government will coordinate the donation and distribution of remdesivir to hospitals in cities most heavily impacted by COVID-19. Given the severity of illness of patients appropriate for remdesivir treatment and the limited availability of drug supply, hospitals with intensive care units and other hospitals that the government deems most in need will receive priority in the distribution of remdesivir. Gilead is working with the U.S. government on the logistics of remdesivir distribution and will provide more information when the company begins shipping the drug under the EUA,” the company’s press release reads.

The EUA is based on available data from two global clinical trials – the National Institute for Allergy and Infectious Diseases’ placebo-controlled Phase 3 study in patients with moderate to severe symptoms of COVID-19, including those who were critically ill, and Gilead’s global Phase 3 study evaluating 5-day and 10-day dosing durations of remdesivir in patients with severe disease.

“Multiple additional clinical trials are ongoing to generate more data on the safety and efficacy of remdesivir as a treatment for COVID-19,” Gilead said,

Remdesivir must be administered intravenously. The optimal dosing and duration of remdesivir for the treatment of COVID-19 is still unknown. Under the EUA, the 10-day dosing duration is suggested for patients “requiring invasive mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO), and the 5-day dosing duration is suggested for patients not requiring invasive mechanical ventilation and/or ECMO. If a patient on the 5-day dosing duration does not demonstrate clinical improvement after five days, treatment may be extended for up to five additional days (10 days total),” the company explained.

Gilead has donated its supply “to help address the urgent medical needs posed by this pandemic around the world,” it said. “Assuming a 10-day treatment course, Gilead’s donation of 1.5 million individual doses of remdesivir equates to more than 140,000 treatment courses that will be provided at no cost to treat patients following potential emergency authorizations and regulatory approvals, including this EUA. “

Gilead said it has “aggressively implemented a multipronged approach to scale up production and rapidly build supply” of remdesivir.

“The company has invested significant capital, at risk, to meet the supply needs for clinical trials and emergency treatment programs, and to prepare for even greater demand following regulatory authorizations, should these occur,” it said.

“There are limited clinical data available for remdesivir. Serious and unexpected adverse events may occur that have not been previously reported with remdesivir use. Warnings: In clinical studies with remdesivir, infusion-related reactions and liver transaminase elevations have been observed,” the release reads.

The FDA has authorized distribution with accompanying Fact Sheets, which can be accessed at www.gilead.com/remdesivir.

Information from the FDA about the authorized emergency use of remdesivir is available at https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.