Food and Drug Administration coronavirus update: May 29, 2020

May 29, 2020

The following is a press release from the U.S. Food and Drug Administration:

The U.S. Food and Drug Administration today continued to take action in the ongoing response to the COVID-19 pandemic:

  • FDA is making its previously developed FDA MyStudies app available to investigators as a free platform to securely obtain patients’ informed consent for eligible clinical trials when face-to-face contact is not possible or practical due to COVID-19 control measures. FDA MyStudies is now referred to as COVID MyStudies in the Apple App store and in the Google Play store.
  • As part of the FDA’s efforts to protect consumers, the agency issued warning letters to two companies for selling fraudulent COVID-19 products. There are currently no FDA-approved products to prevent or treat COVID-19. Consumers concerned about COVID-19 should consult with their health care provider.
    • The first seller to whom FDA sent a warning letter was Quadrant Sales & Marketing, Inc., which offers non-alcohol-based hand sanitizer products for sale in the United States with false or misleading claims including that the products maintain their effectiveness for up to 24 hours. Time-specific extended efficacy claims may give users the false impression that they need not rigorously adhere to interventions such as social distancing and engaging in good hygienic practices that have been demonstrated to curb the spread of COVID-19.
    • The second seller to whom FDA sent a warning letter was StayWell Copper Products, which offers copper “Germ Stopper” products for sale in the United States with misleading claims that the products are safe and/or effective for the prevention  of COVID-19.
  • Today, the FDA took steps to further support the development of COVID-19 tests for at-home self-collection by providing on its website a template that may be used to facilitate submission of requests for emergency use authorizations (EUA) for at-home sample collection kits. As explained in FDA’s guidance, Policy for COVID-19 Tests During the Public Health Emergency (Revised), this template reflects FDA’s current thinking on the data and information that developers should submit to facilitate the EUA process. In particular, this template includes recommendations for use by laboratories and commercial manufacturers who may choose to use it to facilitate the preparation and submission of an EUA request. Currently, developers can offer a COVID-19 test for at-home self-collection where specifically authorized under an EUA or as part of an Institutional Review Board (IRB)-approved study.
  • Testing updates:
    • During the COVID-19 pandemic, the FDA has worked with more than 400 test developers who have already submitted, or said they will be submitting, EUA requests to the FDA for tests that detect the virus or antibodies to the virus.
    • To date, the FDA has authorized 114 tests under EUAs, which include 101 molecular tests, 12 antibody tests, and 1 antigen test.

Additional Resources:

Food and Drug Administration coronavirus update: May 18, 2020

May 18, 2020

The following is a press release from the U.S. Food and Drug Administration:

The U.S. Food and Drug Administration today continued to take action in the ongoing response effort to the COVID-19 pandemic:

  • The FDA issued warning letters to two companies for selling fraudulent COVID-19 products, as part of the agency’s effort to protect consumers. There are currently no FDA-approved products to prevent or treat COVID-19. Consumers concerned about COVID-19 should consult with their health care provider.
    • The first seller warned, Noetic Nutraceuticals, offers CBD products for sale in the U.S. with misleading claims that the products are safe and/or effective for the prevention and treatment of COVID-19.
    • The second seller warned, The Golden Road Kratom, offers kratom products for sale in the U.S. with misleading claims that the products are safe and/or effective for the prevention and treatment of COVID-19.
  • The Agency issued a new FDA Voices titled, COVID-19 Supply Chain Update: Importation of Vital Food and Medical Products. It provides details on the FDA’s work to ensure the safety and security of the U.S. supply of food and medical products. Many of the medical products our health care workers and hospitals need to battle COVID-19 come from overseas, which makes the FDA’s Office of Regulatory Affairs (ORA) work imperative to ensure legitimate products are moving as quickly as possible through the ports of entry. At the same time, ORA imports staff also screens for, and blocks the entry of, unproven products that falsely claim to prevent, diagnose, treat or cure COVID-19.
  • Over the weekend, FDA issued an emergency use authorization (EUA) to Everlywell, Inc. for the Everlywell COVID-19 Test Home Collection Kit, the first standalone at-home sample collection kit that can be used with certain authorized tests. Everlywell’s kit is authorized to be used by individuals at home who have been screened using an online questionnaire that is reviewed by a health care provider. This allows an individual to self-collect a nasal sample at home using Everlywell’s authorized kit. The FDA has also authorized two COVID-19 diagnostic tests, performed at specific laboratories, for use with samples collected using the Everlywell COVID-19 Test Home Collection Kit.
  • Last week, the FDA approved another Abbreviated New Drug Application for Hydroxychloroquine Sulfate Tablets USP, 200 mg for the treatment of: (1) Uncomplicated malaria due to P. falciparum, P. malariae, P. ovale, and P. vivax. (2) Chronic discoid lupus erythematosus and systemic lupus erythematosus in adults and (3) Treatment of acute and chronic rheumatoid arthritis in adults. Side effects of hydroxychloroquine include irreversible retinal damage, cardiac effects (including cardiomyopathy and QT prolongation), worsening of psoriasis and porphyria, proximal myopathy and neuropathy, neuropsychiatric events, and hypoglycemia. The FDA recently posted information regarding shortages of hydroxychloroquine and chloroquine to its drug shortages webpage due to a significant surge in demand. The agency is working with manufacturers to assess their supplies and is actively evaluating market demand for patients dependent on hydroxychloroquine and chloroquine for treatment of malaria, lupus and rheumatoid arthritis.
  • Testing updates:
    • During the COVID-19 pandemic, the FDA has worked with more than 400 test developers who have already submitted or said they will be submitting EUA requests to the FDA for tests that detect the virus or antibodies to the virus.
    • To date, the FDA has authorized 103 tests under EUAs, which include 90 molecular tests, 12 antibody tests, and 1 antigen test.

Additional Resources:

Food and Drug Administration coronavirus update: May 9, 2020

May 9, 2020

The following is a press release from the U.S. Food and Drug Administration:

The U.S. Food and Drug Administration has issued the first emergency use authorization (EUA) for a COVID-19 antigen test, a new category of tests for use in the ongoing pandemic. These diagnostic tests quickly detect fragments of proteins found on or within the virus by testing samples collected from the nasal cavity using swabs. The EUA was issued late Friday to Quidel Corporation for the Sofia 2 SARS Antigen FIA. This test is authorized for use in high and moderate complexity laboratories certified by Clinical Laboratory Improvement Amendments (CLIA), as well as for point-of-care testing by facilities operating under a CLIA Certificate of Waiver.

Diagnostic testing is one of the pillars of our nation’s response to COVID-19 and the FDA continues to take actions to help make these critical products available, including by issuing EUAs. During this pandemic, there have been two types of tests for which the FDA has issued EUAs. One type are polymerase chain reaction (PCR) tests, a molecular diagnostic testing technique that detects the genetic material from the virus and can help diagnose an active COVID-19 infection. The other type are serological tests that look for antibodies to the virus, which can help identify individuals who have developed an adaptive immune response to the virus, as part of either an active infection or a prior infection (serological, or antibody, tests should not be used to diagnose active infection).

This latest FDA authorization is for an antigen test, which is a new type of diagnostic test designed for rapid detection of the virus that causes COVID-19. Each category of diagnostic test has its own unique role in the fight against this virus. PCR tests can be incredibly accurate, but running the tests and analyzing the results can take time. One of the main advantages of an antigen test is the speed of the test, which can provide results in minutes. However, antigen tests may not detect all active infections, as they do not work the same way as a PCR test. Antigen tests are very specific for the virus, but are not as sensitive as molecular PCR tests. This means that positive results from antigen tests are highly accurate, but there is a higher chance of false negatives, so negative results do not rule out infection. With this in mind, negative results from an antigen test may need to be confirmed with a PCR test prior to making treatment decisions or to prevent the possible spread of the virus due to a false negative.

Antigen tests are also important in the overall response against COVID-19 as they can generally be produced at a lower cost than PCR tests and once multiple manufacturers enter the market, can potentially scale to test millions of Americans per day due to their simpler design, helping our country better identify infection rates closer to real time.

This is just the first antigen test to be authorized and we expect more to follow. We also anticipate providing an EUA template for antigen tests, similar to ones we’ve released for other test types, to help manufacturers streamline submissions and help expedite our review and issuance of additional EUAs.

Antigen tests will play a critical role in the fight against COVID-19 and we will continue to offer support and expertise to help with the development of accurate tests, and to review and monitor marketed tests to ensure accuracy, while balancing the urgent need for these critical diagnostics.

For More Information:
FDA: FAQs on Diagnostic Testing for SARS-CoV-2 | FDA
CMS: Clinical Laboratory Improvement Amendments (CLIA)
CDC: Testing for COVID-19

OpenTable waives fees and updates features to help restaurants prepare for re-openings after COVID-19

May 1, 2020

The following is a press release from OpenTable:

As restaurants look to reopen, the needs of each will change as government restrictions and safety recommendations evolve. Restaurants that have never taken reservations may find themselves looking for ways to adjust floor plans to allow more space between tables and manage capacity. To help restaurants reopen and adhere to these new norms, OpenTable is rolling out two new initiatives: an enhanced restaurant management platform and price cuts for 2020.

OpenTable’s technology has always enabled restaurants to connect with diners to manage reservations, prepare for shifts, and maximize table availability, but enhancements to the platform will provide added support for restaurants so they can adhere to social distancing guidelines while providing updated health and safety information to diners for when it is safe to eat out again.

These advanced features are now paired with discounted pricing to reduce the reopening costs of our customers and to encourage new restaurants to join OpenTable. Beginning in May, restaurants that sign up for our “Open Door” pricing program will enjoy: no OpenTable subscription fees through the end of 2020, no cover fees through September 30, 2020 and a 50% discount on cover fees through 2020. OpenTable’s standard subscription and cover pricing will resume only in January 2021.

“Restaurants need help to reopen quickly, safely, and successfully as local restrictions lift.  We’re doing our part to help them by waiving fees and updating features with the post-COVID-19 dining experience in mind,” said Andrea Johnston, COO, OpenTable.

Restaurants interested in the Open Door Program can receive follow-up information and first-access to participate here. Over the past few weeks, OpenTable has rolled out a number of efforts to support the restaurant industry from releasing data on the staggering decline in seated diners, to launching OpenTable for groceries to help manage overcrowding and long lines, to hosting weekly webinar series providing expert support for restaurants during this time. For a summary of all the efforts that OpenTable has done to support restaurants during this time, please visit https://restaurant.opentable.com/news/.

About OpenTable
OpenTable, part of Booking Holdings Inc. (NASDAQ: BKNG), is the world’s leading provider of online restaurant reservations, with nearly 60,000 restaurants globally using its software to seat over 134 million diners monthly. OpenTable helps diners discover and book the perfect table and helps restaurants deliver personalized hospitality to keep guests coming back.

Food and Drug Administration coronavirus update: May 1, 2020

May 1, 2020

The following is a press release from the U.S. Food and Drug Administration:

The U.S. Food and Drug Administration today continued to take action in the ongoing response effort to the COVID-19 pandemic:

  • Today, the FDA issued an Emergency Use Authorization (EUA) for the investigational antiviral drug remdesivir. The EUA allows for remdesivir to be distributed in the U.S. and administered by health care providers, as appropriate, to treat suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease. Severe disease is defined as patients with low blood oxygen levels or needing oxygen therapy or more intensive breathing support such as a mechanical ventilator. Based on evaluation of the emergency use authorization criteria and the scientific evidence available, it was determined that it is reasonable to believe that remdesivir may be effective in treating COVID-19, and that, given there are no adequate, approved, or available alternative treatments, the known and potential benefits to treat this serious or life-threatening virus currently outweigh the known and potential risks of the drug’s use. For more information see: news releaseHealth Care Provider Fact Sheet and Patient Fact Sheet.
  • Today, the FDA updated its guidance on convalescent plasma and associated web page. The updated guidance provides clarification for investigators on how to submit investigational applications for COVID-19 convalescent plasma. In addition, the guidance includes updated information regarding potential donors. Previously, the FDA’s guidance noted that to qualify, individuals should have complete resolution of symptoms for 28 days or resolution for 14 and a negative diagnostic test. The revised guidance recommends that individuals  have complete resolution of symptoms for at least 14 days prior to donation A negative lab test for COVID-19 disease is not necessary to qualify for donation. The revised guidance also clarifies that FDA does not recommend storing a retention sample from the convalescent plasma donation for single patient emergency INDs.
  • To help address shortages of continuous renal replacement therapy (CRRT) products during the COVID-19 public health emergency, today the FDA issued an EUA to Fresenius Medical Care for emergency use of the multiFiltrate PRO System and multiBic/multiPlus Solutions. CRRT is a type of dialysis therapy used to filter and clean the blood when the kidneys are damaged or are not functioning normally. The Fresenius multiFiltrate PRO System and multiBic/multiPlus Solutions have been authorized to provide CRRT to treat patients in an acute care environment during the COVID-19 public health emergency.
  • Diagnostics update to date:
    • During the COVID-19 pandemic, the FDA has worked with more than 380 test developers who have said they will be submitting EUA requests to the FDA for tests that detect the virus.
    • To date, the FDA has issued 54 individual EUAs for test kit manufacturers and laboratories. In addition, 23 authorized tests have been added to the EUA letter of authorization for high complexity molecular-based laboratory developed tests (LDTs).
    • The FDA has been notified that more than 235 laboratories have begun testing under the policies set forth in our COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance.
    • The FDA also continues to keep its COVID-19 Diagnostics FAQ up to date.
  • The FDA included, under the ventilator emergency use authorization (EUA), a ventilator developed by the National Aeronautics and Space Administration (NASA), which is tailored to treat patients with COVID-19. The ventilator was added to the list of authorized ventilators, ventilator tubing connectors and ventilator accessories under the ventilator EUA that was issued in response to concerns relating to insufficient supply and availability of FDA-cleared ventilators for use in health care settings to treat patients during the COVID-19 pandemic. The NASA VITAL (Ventilator Intervention Technology Accessible Locally) is intended to last three to four months and is specifically tailored for patients with COVID-19, by providing respiratory support for patients that are experiencing respiratory failure or insufficiency. The device is designed to be built with components outside the current medical device supply chain and therefore does not impact the existing supply chain of currently made ventilators.
  • The FDA issued a Consumer Update, Helpful Questions and Answers about Coronavirus (COVID-19) and Your Pets, that provides answers to frequently asked questions. Based on the limited information available to date, the risk of pets spreading the virus that causes COVID-19 in people is considered to be low. At this time, there is no evidence that animals play a significant role in spreading the virus that causes COVID-19. There is a small number of animals around the world reported to be infected with the virus that causes COVID-19, mostly after having close contact with a person with COVID-19.
  • Today, the FDA issued a guidance highlighting flexibility under the Drug Supply Chain Security Act (DSCSA). This guidance is intended to facilitate the distribution of prescription drug products needed to respond to COVID-19, including drugs to treat symptoms of COVID-19. During the COVID-19 emergency, the DSCSA requirements related to certain product tracing and product identification activities, and wholesale distribution, do not apply to qualifying distribution activities. This flexibility balances the need for effective distribution of products under emergency conditions with protecting consumers from exposure to products that may be counterfeit, stolen or otherwise harmful.

Additional Resources:

AMC Theatres announces worldwide boycott of Universal Pictures due to ‘Trolls World Tour’ home-video release

April 28, 2020

by Carla Hay

On April 28, 2020, AMC Theatres (the world’s largest cinema company) announced that it is implementing a worldwide boycott of Universal Pictures because the movie studio broke the 90-day embargo for when a movie can be released on home video after being in movie theaters. The boycott was announced after Universal Pictures released the DreamWorks Animation film sequel “Trolls World Tour” directly to home video on April 10, 2020, the day that the movie had been scheduled to be released in movie theaters.

Corporate-owned movie theaters have traditionally refused to carry movies that are released on home video or streaming services within a 90-day period of the movies being released in movie theaters. These movies typically play at independently owned movie theaters, which do not have this strict 90-day embargo policy. It’s why Netflix movies do not play in major theater chains such as AMC, Regal, Cinemark and Cineplex.

Due to the coronavirus pandemic, AMC shut down all of its cinema locations in the U.S. and Canada, as of March 18, 2020. Almost all other movie theaters (corporate and independent) in the U.S., Canada and several other countries also closed the same week. As of this writing, most of the movie theaters have remained closed with no specific re-opening dates announced yet. The majority of AMC theater locations are in the United States, which has about 660 AMC theaters, making AMC the largest movie-theater chain in the U.S.

AMC Entertainment president/CEO Adam Aron issued a statement about the Universal Pictures boycott that read, in part: “Going forward, AMC will not license any Universal movies in any of our 1,000 theatres globally on these terms. Accordingly, we want to be absolutely clear, so that there is no ambiguity of any kind. AMC believes that with this proposed action to go to the home and theatres simultaneously, Universal is breaking the business model and dealings between our two companies. It assumes that we will meekly accept a reshaped view of how studios and exhibitors should interact, with zero concern on Universal’s part as to how its actions affect us. It also presumes that Universal in fact can have its cake and eat it too, that Universal film product can be released to the home and theatres at the same time, without modification to the current economic arrangements between us.”

The statement continues: “Therefore, effectively immediately AMC will no longer play any Universal movies in any of our theatres in the United States, Europe or the Middle East. This policy affects any and all Universal movies per se, goes into effect today and as our theatres reopen, and is not some hollow or ill-considered threat. Incidentally, this policy is not aimed solely at Universal out of pique or to be punitive in any way, it also extends to any movie maker who unilaterally abandons current windowing practices absent good faith negotiations between us, so that they as distributor and we as exhibitor both benefit and neither are hurt from such changes. Currently, with the press comment today, Universal is the only studio contemplating a wholesale change to the status quo. Hence, this immediate communication in response.”

Universal Pictures released “Trolls World Tour” in North America at the premium video-on-demand (PVOD) rental price of $19.99, which allowed renters to watch the movie for up to 48 hours. Universal has not yet announced when “Trolls World Tour” will be available for purchase on digital, DVD or Blu-ray. On April 28, 2020, Universal Pictures announced that “Trolls World Tour” had revenue of $100 million in PVOD rentals in its first three weeks of availability in North America.

In the wake of the coronavirus pandemic, major and independent studios have dramatically changed their theatrical release schedules for their films, with most the theatrical releases getting pushed back several months. Universal Pictures movies whose theatrical release dates have been postponed and rescheduled include  “Fast & Furious 9,” now due out on April 2, 2021; “Jurassic World: Dominion” (June 11, 2021); “Minions: The Rise of Gru” (July 2, 2021); and “Sing 2” (December 22, 2021). Universal Pictures’ next release after “Trolls World Tour” is the comedy “The King of Staten Island” (starring Pete Davidson and directed by Judd Apatow), which will be released directly to video on June 12, 2020, a week before the movie’s originally scheduled theatrical release date.

After the success of “Trolls World Tour” being released directly to video, Warner Bros. Pictures announced that it would follow a similar strategy for the animated Scooby Doo film “Scoob!,” which was originally scheduled to be released in theaters on May 15, 2020. The movie’s release date is still the same, but it will now be on digital and VOD. Unlike Universal’s rental-only strategy for “Trolls World Tour,” Warner Bros. is making “Scoob!” available for rent and purchase on the same day.

Meanwhile, AMC Theatres, like many other cinema companies, is reportedly running out of operational cash. The company is headquartered in Leawood, Kansas, but AMC is actually owned by the Chinese corporation Wanda Group. In October 2019, AMC began offering VOD rentals and purchases of digital film releases under the name AMC Theatres On Demand, but AMC’s studio boycott does not extend to that service. Universal Pictures titles (such as  “The Invisible Man” and “The Hunt”) are still available on AMC Theatres On Demand.

So far, AMC is the only corporate-owned movie theater to announce that it is boycotting any studios that break the 90-day embargo. Alamo Drafthouse and Landmark are two of the independent cinema companies with several U.S. locations that do not limit their selections to movies that have a 90-day home-video/streaming service embargo, so this boycott war does not apply to them.

However, as long as any movie theaters are closed for an undetermined period of time, their financial clout has significantly weakened. Boycotted studios will just take their movies to other theaters that are willing to carry their films. And even after theaters have re-opened, no one knows yet how long it will take for business at movie theaters to get back to “normal,” or if the peak of cinema attendance is now a thing of the past.

April 29, 2020 UPDATE: Cineworld/Regal Cinemas has now joined the boycott. Click here for more details.

July 28, 2020 UPDATE: AMC Theaters and Universal Pictures have reached a truce in their feud. According to Variety, AMC has agreed to carry Universal’s films in AMC Theatres, as long as AMC can have those movies in AMC’s U.S. theaters for a minimum of 17 days, including three weekends.

After the 17 days, Universal will likely make the movies available through premium video on demand (PVOD), which allows viewers to rent a movie on digital and TV platforms for up to 48 hours, for about twice the cost of a regular, non-3D movie theater ticket. The agreement also says that three months after a movie’s theatrical release, the movie’s rental price can then drop to a regular VOD rental price range, which is about half the cost of a regular non-3D movie theater ticket.

The financial terms of the deal were not disclosed but AMC CEO Aron said that AMC will “share in these new revenue streams” with Universal. It has also not been revealed yet if AMC Theatres will have this policy for its locations outside the United States.

Click here for an updated list of other corona virus-related cancellations and postponements in the entertainment industry.

Food and Drug Administration coronavirus update: April 20, 2020

April 20, 2020

The following is a press release from the U.S. Food and Drug Administration:

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

  • The FDA issued information on the use of serological (antibody) tests to help identify people who may have been exposed to the SARS-CoV-2 virus or have recovered from the COVID-19 infection. This information includes:
  • The FDA issued a face mask emergency use authorization (EUA) in response to concerns relating to insufficient supply and availability of face masks for use by members of the general public, including health care personnel in healthcare settings as personal protective equipment (PPE), to cover their noses and mouths, in accordance with Centers for Disease Control and Prevention (CDC) recommendations, to prevent the spread of the SARS-CoV-2 virus during the pandemic. Manufacturers of face masks that are used as described in the EUA and meet the requirements in the EUA, do not need to take any action, other than complying with the Conditions of Authorization in the EUA, to be authorized under this EUA.

  • Today, the FDA issued a guidance explaining a temporary policy regarding state-licensed pharmacies and federal facilities, that are not outsourcing facilities, compounding certain human drugs for hospitalized patients during the COVID-19 public health emergency. This guidance explains the agency’s policy to help address reported issues with accessing certain FDA-approved drugs used for hospitalized patients with COVID-19. As a temporary measure, with regard to certain drugs, under the circumstances outlined in the guidance, FDA does not intend to take action against state-licensed pharmacies and federal facilities for compounding a drug that is essentially a copy of a commercially available drug, or for providing a drug to a hospital without obtaining a patient-specific prescription. When a hospital is unable to access FDA-approved drug products and is considering the use of compounded drugs for hospitalized patients, outsourcing facilities may be able to offer a supply of compounded drugs that are subject to more robust quality standards than are drugs produced by State-licensed pharmacies or Federal facilities that are not required to comply with CGMP requirements.

  • A new FDA Voices was issued, The Path Forward: Coronavirus Treatment Acceleration Programdescribing a new program that aims to move new treatments to patients as soon as possible, while at the same time finding out whether they are helpful or harmful. So far, 72 clinical trials of potential therapies for COVID-19 are underway with FDA oversight. Both the pharmaceutical industry and academic researchers have submitted many innovative and well-designed studies for prevention and treatment of COVID-19. The FDA has streamlined its review and advice process to get studies started as quickly as possible.

  • Diagnostics update to date:
    • During the COVID-19 pandemic, the FDA has worked with more than 340 test developers who have said they will be submitting emergency use authorization (EUA) requests to FDA for tests that detect the virus.
    • To date, the FDA has issued 41 individual emergency use authorizations for test kit manufacturers and laboratories. In addition, 16 authorized tests have been added to the EUA letter of authorization for high complexity molecular-based laboratory developed tests (LDTs).
    • The FDA has been notified that more than 210 laboratories have begun testing under the policies set forth in our COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance.
    • The FDA also continues to keep its COVID-19 Diagnostics FAQ up to date.

Additional Resources:

Regal Cinemas joins AMC Theatres in boycott of Universal Pictures and any movie studio that breaks home-video embargo

April 29, 2020

by Carla Hay

Regal Cinemas (which is owned by Cineworld) has joined AMC Theatres in its boycott of Universal Pictures and any major film studio that releases any movie directly to home video instead of the original plan to release the movie first in cinemas. Regal’s announcement comes one day after its competitor AMC Theatres announced it was implementing this boycott immediately, for an undetermined period of time.

Regal issued this statement on April 29, 2020, that read in part: “Cineworld’s roots go back 90 years in the industry and it was always open to showing any movie as long as the rules were kept and not changed by one-sided moves. Today we make it clear again that we will not be showing movies that fail to respect the windows as it does not make any economic sense for us.”

The boycott was prompted by Universal Pictures releasing DreamWorks Animation sequel “Trolls World Tour” directly to video on April 20, 2020. “Trolls World Tour” had originally been scheduled to be released in movie theaters on that date. But due to the coronavirus pandemic shutting down almost all movie theaters worldwide, as of mid-March 2020, Universal opted to not postpone the “Trolls World Tour” release date and released the movie directly to digital/video-on-demand as a premium-priced rental.

Cineworld (based in Brentford, England) is the second-largest cinema company in world and in the U.S.,  with approximately 790 locations worldwide, of which more than 570 locations are in the United States. Regal Cinemas, a Cineworld subsidiary, is based in Knoxville, Tennessee. AMC Theaters (based in Leawood, Kansas) is the largest cinema company in the world, with more than 1,000 locations worldwide, of which more than 660 locations are in the United States.

Just like AMC Theatres, Regal has a subscription service that is suspended while its theater locations remain closed. The theater re-opening dates for Cineworld/Regal, AMC and other major cinema companies have not yet been announced, as of this writing.

The following is the full press release/statement from Cineworld/Regal:

Cineworld and Regal’s policy with respect to the window is clear, well known in the industry and is part of our commercial deal with our movie suppliers. We invest heavily in our cinemas across the globe and this allows the movie studios to provide customers all around the world the opportunity to watch movies in the best experience. There is no argument that the big screen is the best way to watch a movie.

Universal unilaterally chose to break our understanding and did so at the height of the Covid-19 crisis when our business is closed, more than 35,000 employees are at home and when we do not yet have a clear date for the reopening of our cinemas.

Universal’s move is completely inappropriate and certainly has nothing to do with good faith business practice, partnership and transparency.

Mooky Greidinger, Cineworld’s CEO approached Brian Roberts, the Chairman of Comcast, back on the 19th of March (after Universal announced that Trolls 2 would be released in breach of the window) and told him among other things that:

“Nice words from your team are worthless if we cannot trust you as a partner. The message that the media has portrayed is: “Hollywood breaks the window” – well, this is not true! All our partners called us in a timely manner and told us that in the current situation they want to shorten the window for movies that were already released as cinemas are closing, most importantly, they all reassured us that there will be no change to their window policy once the cinema business returned. Unfortunately I missed a similar message in Universal’s announcement… not only did Universal provide no commitment for the future window – but Universal was the ONLY studio that tried to take advantage of the current crisis and provide a ‘day-and-date’ release of a movie that was not yet released.”

Cineworld’s roots go back 90 years in the industry and it was always open to showing any movie as long as the rules were kept and not changed by one-sided moves. Today we make it clear again that we will not be showing movies that fail to respect the windows as it does not make any economic sense for us.

We have full confidence in the industry’s current business model. No one should forget that the theatrical side of this industry generated an all-time record income of $42 billion last year and the movie distributors’ share of this was about $20 billion.

About Cineworld:
Cineworld aims to be the best place to watch a movie, offering an unparalleled cinema experience in the UK & Ireland, with 102 cinemas and over 1,030 screens. Cineworld Group was founded in 1995 and is currently the second largest cinema chain in the world following the acquisition of US cinema group Regal Entertainment Group in February 2018. In 2014, the Cineworld Group combined with Cinema City International (CCI) and appointed CCI Founder and CEO Mooky Greidinger, as CEO of the Cineworld Group. In August 2016 Cineworld acquired 5 Empire Cinemas, including the iconic Empire Theatre in Leicester Square. This was followed by the acquisition of Empire Newcastle in 2017. Cineworld currently has 24 IMAX® auditoriums, and 15 Superscreens nationwide, as well as a special VIP experience currently available at 5 of their cinemas. Cineworld are the only operators in the UK to offer ScreenX – a 270-degree format that projects onto the front and side walls of the theatre across 16 auditoriums and 4DX – the immersive multi-sensory cinema experience, with 30 auditoriums across the UK and Ireland, including Cineworld Leicester Square.

About Regal:
Regal, a subsidiary of the Cineworld Group, operates one of the largest and most geographically diverse theatre circuits in the United States, consisting of 7,155 screens in 542 theatres in 42 states along with the District of Columbia and Guam as of March 31, 2020. We believe that the size, reach and quality of the company’s theatre circuit provides its patrons with a convenient and enjoyable moviegoing experience. We are committed to being “The Best Place to Watch a Movie!” Additional information is available on Regal’s website: www.REGmovies.com

2020 Comic-Con International in San Diego cancelled due to coronavirus pandemic; San Diego Comic-Con and WonderCon 2021 dates announced

April 17, 2020

by Carla Hay

After weeks of speculation about the fate of the 2020 edition of Comic-Con International (also known as San Diego Comic-Con) during the coronavirus pandemic, the event’s producers have finally announced what was widely expected: For the first time in San Diego Comic-Con’s 50-year history, the event has been cancelled. The event had been set for July 23 to July 26, 2020, with preview night taking place on July 22. Comic-Con International will return to San Diego from July 22 to July 25, 2021, with preview night taking place on July 21.

Comic-Con International, which has been a sold-out event every year for past several years, is one of the world’s largest fan conventions for sci-fi, fantasy, horror and action entertainment. An estimated 130,000 people attend each year.

In addition, Comic-Con International’s sister convention WonderCon (which takes place in Anaheim, California) has also been cancelled for 2020, with plans to return in 2021. WonderCon was originally set for April 10 to April 12, 2020 and was originally planned to be rescheduled in the summer of 2020.  The next WonderCon will now take place from March 26 to March 28, 2021.

Comic-Con International’s full programming lineup had not been announced at the time of the cancellation. However, many companies that make movies, TV shows, comic books and video games (which all provide the majority of the event’s biggest programming and much of its sponsorship) were not going to participate this year, due to many releases being postponed and productions being halted because of the coronavirus pandemic.

Furthermore, it is still uncertain when large gatherings will be approved in California. All indications are that ever since widespread U.S. shutdowns began taking place in March 2020, it might take months for things to go back to “normal,” depending on when there will be widespread testing and a vaccine for the coronavirus pandemic.

Here’s the full statement from Comic-Con International:

Comic-Con Announces Plans in Light of the Covid-19 Pandemic

The Current Situation Requires Exceptional Measures

For the first time in its 50-year history San Diego Comic Convention (SDCC), the organizers behind the annual pop culture celebration, announced today with deep regret that there will be no Comic-Con in 2020. The event will instead return to the San Diego Convention Center from July 22-25, 2021.

Recognizing that countless attendees save and plan for its conventions each year, and how many exhibitors and stakeholders rely upon its events for a major portion of their livelihood, they had hoped to delay this decision in anticipation that COVID-19 concerns might lessen by summer. Continuous monitoring of health advisories and recent statements by the Governor of California have made it clear that it would not be safe to move forward with plans for this year.

Similarly, WonderCon Anaheim, which was to have been held April 10-12, 2020 will return to the Anaheim Convention Center from March 26-28, 2021.

In addition to their conventions, Comic-Con has been planning a major renovation of Balboa Park’s Federal Building to be completed for the grand opening of the Comic-Con Museum in the summer of 2021. However, the COVID-19 situation has had an effect on those efforts as well. As such, they will be rephasing the Museum’s initially planned major renovations, but will not scale back the experience to be offered to visitors upon the Museum’s grand opening. They anticipate releasing building plans illustrating the Museum’s transformation and sharing more information about those efforts in the coming months.

SDCC also announced that individuals who purchased badges for Comic-Con 2020 will have the option to request a refund or transfer their badges to Comic-Con 2021. All 2020 badge holders will receive an email within the next week with instructions on how to request a refund. Exhibitors for Comic-Con 2020 will also have the option to request a refund or transfer their payments to Comic-Con 2021 and will also receive an email within the next week with instructions on how to process their request.

In the next few days onPeak, Comic-Con’s official hotel affiliate, will be canceling all hotel reservations and refunding all deposits made through them. There is no need for anyone who booked through onPeak to take any action, including trying to cancel their reservations online or contacting the company via phone as the process will be handled automatically. Those who booked rooms through onPeak will be notified when refunds have been completed.

“Extraordinary times require extraordinary measures and while we are saddened to take this action, we know it is the right decision,” said David Glanzer, spokesperson for the organization. “We eagerly look forward to the time when we can all meet again and share in the community we all love and enjoy.”

July 7, 2020 UPDATE:  Instead of an in-person event for the 2020 edition of Comic-Con, there will be a virtual online event called Comic-Con@Home, which will take place from July 22 to July 26, 2020. The Comic-Con International official site has more details.

Food and Drug Administration coronavirus update: April 10, 2020

April 10, 2020

The following is a press release from the U.S. Food and Drug Administration:

 

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

  • The FDA recently issued an emergency use authorization (EUA) for a blood purification system to treat patients 18 years of age or older with confirmed COVID-19 admitted to the intensive care unit with confirmed or imminent respiratory failure. The FDA issued the EUA to Terumo BCT Inc. and Marker Therapeutics AG for their Spectra Optia Apheresis System and Depuro D2000 Adsorption Cartridge devices.
  • The FDA recently issued an EUA to decontaminate compatible N95 or N95-equivalent respirators for reuse by health care workers in hospital settings. The FDA issued the EUA to STERIS Corporation for the STERIS V-PRO 1 Plus, maX and maX2 Low Temperature Sterilization Systems using the STERIS N95 Decontamination Cycle (non-lumen cycle), which uses vaporized hydrogen peroxide. This EUA will support decontamination of approximately 750,000 N95 respirators per day in the U.S.
  • The FDA issued a guidance for immediate implementation for pharmacy compounders that experience shortages of the personal protective equipment (PPE) they typically use to compound human drugs that are intended or expected to be sterile. PPE shortages have the potential to significantly impact the quality, purity and availability of drugs that are compounded for patients, including those in critical need. The guidance discusses how pharmacies may be able to preserve PPE if supplies are limited. Further, as a temporary measure to address the public health emergency posed by COVID-19, the agency is providing limited regulatory flexibility for compounders that cannot obtain sufficient supplies of PPE for sterile compounding, provided they adopt risk mitigation strategies as described in the guidance. FDA adopted this policy to help assure patient access to needed medicines and to reduce the risks of compounding when standard PPE are not available.
  • Yesterday, the FDA and Federal Trade Commission issued a warning letter to one company for selling fraudulent COVID-19 products, as part of the agency’s effort to protect consumers. The seller warned, Earthley Wellness DBA Modern Alternative Mama LLC., offers unapproved and misbranded herbal tinctures and herbal remedy products for the prevention or treatment of COVID-19. There are currently no approved preventatives or treatments for COVID-19. Consumers should not purchase or take any product to prevent or treat COVID-19 unless it is prescribed by their health care provider and acquired from a legitimate source.
  • FDA Voices: A Perspective on the FDA’s COVID-19 Response by Mitch Zeller, director of the FDA’s Center for Tobacco Products, was issued. It provides a perspective of the FDA’s “all-hands-on-deck” approach to tackling this pandemic. The FDA is integral in the fight against the coronavirus, using science and innovative approaches to take a broad range of actions that advance our nation’s response.
  • The FDA issued a Letter to Stakeholders advising people not use ivermectin intended for animals as a treatment for COVID-19 in humans. People should never take animal drugs, as the FDA has only evaluated their safety and effectiveness in the particular animal species for which they are labeled. These animal drugs can cause serious harm in people. People should not take any form of ivermectin unless it has been prescribed to them by a licensed health care provider and is obtained through a legitimate source.
  • Diagnostics update to date:
    • During the COVID-19 pandemic, the FDA has worked with more than 300 test developers who have said they will be submitting emergency use authorizations (EUA) requests to FDA for tests that detect the virus.
    • To date, 33 emergency use authorizations have been issued for diagnostic tests.
    • The FDA has been notified that more than 170 laboratories have begun testing under the policies set forth in our COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance.
    • The FDA also continues to keep its COVID-19 Diagnostics FAQ up to date.

Additional Resources:

Consumer Inquiries: 888-INFO-FDA

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.