The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time.
The Hogan Lovells Government Relations and Public Affairs group is tracking all of the latest developments in the U.S. Congress and relevant news stories. According to the Wall Street Journal, an undisclosed U.S. intelligence report says three researchers at the Wuhan Institute of Virology became sick enough to require hospitalization a month before the coronavirus outbreak in China. The State Department on Monday issued an advisory warning for Americans not to travel to Japan, just two months before the Summer Olympics are scheduled to begin in Tokyo. Pfizer announced yesterday it's testing the safety of giving patients a combination of a pneumonia vaccine along with their COVID-19 booster shot in adults ages 65 and older. Georgia state schools that required teachers and staff to wear masks and improved ventilation reported fewer COVID-19 cases, according to a Centers for Disease Control and Prevention (CDC) study released on Friday. The Biden Administration is considering allowing more employees to work from home permanently after the pandemic. Read about these developments here: 20 May and 24 May. (Authored by Ivan Zapien)
In the latest episode of our "A Perspective" podcast, Andrew Skipper speaks to the Chief Executive Officer of the African Private Equity and Venture Capital Association (AVCA), Abi Mustapha-Maduakor. Abi has several years of strategic leadership, financial and investment management, and operational management experience. Join them as they discuss AVCA, their mandate to promote investment into Africa, how they’re adding value to the sector, and what their focus has been during the COVID-19 pandemic. The two also delve into the key themes that are most relevant to the continent. Abi also shares her view on what the unique selling points are for Africa as an investment destination, how she and AVCA members see the AfCFTA as being a relevant factor in investment now and in the future, as well as her outlook on SMEs and the potential capacity for investment by and in SMEs on the continent.
The Hogan Lovells Government Relations and Public Affairs group is tracking all of the latest developments in the U.S. Congress and relevant news stories. The House on Tuesday passed legislation aimed at combating the sharp rise in hate crimes against Asian-Americans that have occurred during the coronavirus pandemic. At least 600,000 kids in the U.S. ages 12 to 15 have already received their first dose of the vaccine almost a week after the Centers for Disease Control and Prevention (CDC) recommended the Pfizer-BioNTech shot for the age group. The House on Wednesday rejected Minority Leader Kevin McCarthy's (R-CA) attempt to force a vote on a resolution dropping requirements for mask-wearing on the House floor. Dr. Anthony Fauci and other virologists are pushing for a deeper investigation into China’s Wuhan Institute of Virology as they try to piece together the origins of the coronavirus. Read more about these developments online here. (Authored by Ivan Zapien)
The U.S. Food and Drug Administration’s (FDA) commitment to expand mutual reliance with trusted regulatory partners may be a silver lining for biomedical innovation during an unprecedented public health emergency. Indeed, FDA was forced to accelerate its work to advance regulatory convergence with trusted foreign regulatory partners by sharing information to complete inspectional activities, to advance certain medical product applications through the review process, and to help mitigate potential drug shortages. FDA’s “Resiliency Roadmap for FDA Inspectional Oversight” summarizes the agency’s use of alternative inspectional tools and priorities going forward, calling the work to further leverage information shared through mutual recognition agreements (MRAs) “increasingly vital.” On 1 May, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) also made effective its Guide to Good Manufacturing Practice for Medicinal Products Part I PE 009-15 (Part I) describing the elements that manufacturers of medicinal products must meet to ensure that they are fit for their intended use. Online here we analyze how FDA has expanded mutual reliance and harmonization with trusted foreign regulators for inspectional oversight. FDA’s continued evolution of its inspectional operations by building on lessons made necessary by the pandemic was also a priority of the FDA COVID-19 Pandemic Recovery and Preparedness Plan (PREPP) Initiative, issued in January 2021, which we previously summarized here. (Authored by Jim Johnson)
The Hogan Lovells Government Relations and Public Affairs group is tracking all of the latest developments in the U.S. Congress and relevant news stories. The Centers for Disease Control and Prevention (CDC) released new guidance on 13 May that fully vaccinated individuals no longer need to wear masks both outside or inside. CDC Director Rochelle Walensky says the CDC’s mask turnaround was based wholly on science rather than public pressure. The CDC updated its guidance for K-12 schools on 15 May, noting that reopened schools should "require universal and correct use of masks and physical distancing.” The National Nurses Union and the California Nurses Association (CNA) condemned the CDC’s mask guidance, saying the protective measures helped keep health care workers safer. President Biden announced Monday that the U.S. will share an additional 20 million doses of domestically-authorized coronavirus vaccines with foreign countries by the end of June. The Department of Health and Human Services (HHS) has diverted more than $2 billion meant for other health initiatives to cover the cost of caring for unaccompanied immigrant children. Read about these developments online here. (Authored by Ivan Zapien)
Last week, U.S. Trade Representative Katherine Tai announced that the Biden Administration would support India and South Africa’s request for a World Trade Organization (WTO) waiver of intellectual property (IP) rights under the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The proposed waiver would remove WTO TRIPS protections for a broad range of technologies related to research, development, manufacturing, and supply of medical products for combating COVID-19, including vaccines, therapeutics, personal protective equipment (PPE), tests, and medical devices. The announcement kicks off what it is likely to be a lengthy multilateral negotiation regarding the draft waiver’s scope, product coverage, duration, and impact. We have analyzed the proposed WTO waiver of IP rights and the corresponding implications for innovators of COVID-19-related technologies, and for access to vaccines online here. (Authored by Warren H. Maruyama and Alice Valder Curran)
The Hogan Lovells Government Relations and Public Affairs group is tracking all of the latest developments in the U.S. Congress and relevant news stories. The Centers for Disease Control and Prevention (CDC) recommended the use of Pfizer's COVID-19 vaccine for youth who are ages 12-15 years old. The recommendation came hours after the Advisory Committee on Immunization Practices voted to adopt the recommendation 14-0 with one abstention. U.S. Trade Representative Katherine Tai faced contentious questioning by Republican members of the Senate Finance Committee over President Biden’s decision to support IP waivers for COVID-19 vaccines. Nearly every Republican on the panel opposed the move during a hearing on the Administration’s trade agenda. The White House warned state governors on Tuesday that no states would receive any Johnson & Johnson vaccine doses over the next week as the company continues to grapple with production problems. The Centers for Medicare & Medicaid Services (CMS) published a draft interim rule that will require long-term care facilities to offer COVID-19 vaccines to residents and staff, aiming to further fortify facilities hit especially hard by the coronavirus. Read more about these developments online here. (Authored by Ivan Zapien)
The U.S. Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) has confirmed that the grace period intended to provide developers of regenerative medicines with time to assess whether they needed to file an investigational new drug application (IND) or marketing application with FDA, will conclude at the end of the month. FDA had provided for a three-year period of risk-based enforcement discretion for certain human cell, tissue, or cellular- or tissue-based products (HCT/Ps) ending in November 2020, which FDA extended in July 2020, citing challenges presented by the COVID-19 pandemic. Now, however, FDA has established a bright-line for the agency to begin on 1 June a new enforcement era for regenerative medicines, and clinical trials or regulatory approvals will be needed for these products going forward. Online here, we discuss the significance this carries for companies in the regenerative medicine space, and outline the potential risks of noncompliance. These risks go well beyond FDA enforcement, and include the possibility of FTC action, False Claims Act liability, product liability claims, and susceptibility to private lawsuits under the Lanham Act and similar state laws. (Authored by Michael Druckman and Robert Church)
The Hogan Lovells Government Relations and Public Affairs group is tracking all of the latest developments in the U.S. Congress and relevant news stories. On Monday, FDA authorized use of the Pfizer vaccine for children ages 12-15. The Biden Administration is working with state health officials to get more COVID-19 vaccines administered through doctors’ offices. Also on 10 May, the Treasury Department announced it will begin distributing the $350 billion in funding that Congress allocated to aid states and cities. White House chief medical advisor Dr. Anthony Fauci says federal guidance on wearing face coverings indoors may change soon. Vaccine-maker Novavax said Monday that its combined COVID-19 and flu vaccine produced a positive immune response in animal tests. The Centers for Disease Control and Prevention (CDC) warned on 7 May of "repeatedly documented" instances of coronavirus spreading through the air to people more than six feet away under certain conditions. Read more about these developments here: 7 May and 10 May. (Authored by Ivan Zapien)
In the latest episode of our "Talking the Cure" podcast, we speak with Michael Druckman, Jane Kalinina and Bert Lao about the the impact of COVID-19 on cell, tissue, and gene therapy (CTGT) products. We discuss the end of the enforcement discretion period for tissue products, and focus on orphan drug sameness and individualized therapies issues.
Even before COVID-19 further tightened the screws, many Chinese companies were in desperate need of debt financing, something which has led foreign funds to seek out opportunities to invest in China’s burgeoning private debt market. Greater China presents attractive opportunities for foreign investors as the world gradually comes out of the pandemic particularly in terms of China’s non-performing loan (NPL) market. The rapid growth of credit in China over the years has been tempered more recently as the Peoples' Bank of China focuses on reining in financial risks given the uncertainties currently surrounding the regional and global economy. With banks being forced to cleanse their balance sheets to make way for fresh lending, businesses are having to turn to alternative sources of finance. This combination of factors has created a "perfect storm" of opportunities for investors who feel confident in navigating the complexities of China’s investment regime. We analyze these opportunities online here. (Authored by Jonathan Leitch)
On Friday, the U.S. Food and Drug Administration (FDA) revoked the emergency use authorization (EUA) of the Battelle CCDS Critical Care Decontamination System, which was authorized for use in decontaminating compatible N95 respirators for multiple-user reuse by health care personnel. FDA revoked the EUA in response to Battelle's request for voluntary withdrawal of the authorization. In response to changing customer needs, as of 31 March, Battelle has ceased all Battelle CCDS decontamination site operations and marketing activities. Decontaminated respirators and respirators that have undergone bioburden reduction should be used only when there are insufficient supplies of new filtering facepiece respirators (FFRs) or any new respirators. Earlier in April, FDA had issued a letter to health care providers recommending transitioning from use of decontaminated disposable respirators. (Authored by Randy Prebula)
The Hogan Lovells Government Relations and Public Affairs group is tracking all of the latest developments in the U.S. Congress and relevant news stories. FDA is reportedly preparing to authorize the Pfizer vaccine to children 12 to 15 years-old. The U.S. Department of Health and Human Services (HHS) announced Monday a new reimbursement program for providers that vaccinate patients enrolled in health plans that either do not cover vaccination fees or cover them with patient cost-sharing. New York, New Jersey, and Connecticut are lifting most COVID-19-related restrictions on 19 May, allowing many businesses to re-open fully. NY Gov. Andrew Cuomo announced the easing of pandemic restrictions on Monday, including lifting curfews for food and beverage service. The Biden Administration will ban most travel from India starting Tuesday amid a surge in coronavirus cases in the country. Read more about these developments online here: 3 May and 30 April. (Authored by Ivan Zapien)
On 21 April, both houses of the New York state legislature announced passage of the NY Hero Act, which will require NY employers to implement extensive new workplace health and safety protections in response to the COVID-19 pandemic. Governor Cuomo is expected to sign the Act into law in the coming weeks. When it takes effect, all New York employers, regardless of size, will need to take action to comply with the new obligations that this law will impose. Read more online here. (Authored by Michael E. DeLarco)
Regulators are becoming increasingly active in imposing measures on deals or prohibiting them altogether under foreign direct investment (FDI) rules – with prohibitions happening in the EU’s largest economies Germany, France, and Italy in the past months. Against this backdrop, Germany is moving forward on its plans for stricter foreign investment control laws. On 27 April, the German government voted on a revised regulation, following a draft that was presented in January for public consultation. Among the key results of this consultation are a couple of changes to the draft that should be welcomed. First, the revised regulation makes it clear that intra-group restructurings do not fall into the scope of the German FDI rules anymore. Moreover, concerning the additional areas of target activities which require a mandatory filing, the voting share threshold has been increased from the initially suggested 10 to 20 percent. Read more online here. (Authored by Falk Schoening)
In the latest episode of the A Perspective Podcast, Andrew Skipper talks with Jacko Maree, non-executive the Deputy Chairman at Standard Bank Group and Chairman of the Liberty Group. Having been CEO of Africa’s largest bank, Standard Bank, for 13 years, including building their pan African business across 20 countries and securing a 20% investment in the bank by Chinese investors; he is a renowned and experienced leader in South Africa. Listen as they discuss a wide range of topics at the center of South African economic trajectory including the challenging targets set for delivering investment into the country, the roadblocks to delivering these targets and how COVID-19 has impacted the market. Jacko also shares his thoughts about the development of South Africa’s trade relationships, how well the nation is working together to deliver success, and his six reasons to be cheerful about the country’s future.
Compiled by Aaron Armstrong
FDA offers guidance on clinical trial waivers for investigators at non-U.S. sites
Expedited breakthrough device coverage, “reasonable and necessary” definition delayed until Dec. 15
Time’s up: New enforcement era for regenerative medicines begins June 1
First company receives FDA violation notice for ClinicalTrials.gov submission omission
Biden signs bill limiting new drug exclusivity awards to innovations in active moiety
Ramping up the drug pricing debate: Dueling bills and paying for health care infrastructure
FDA issues guidance on conducting remote interactive evaluations during the COVID-19 pandemic
Court puts health care providers on notice that illegal kickbacks can trigger significant damages
Safeguarding drug development at academic institutions
COVID-19 Report for Life Sciences and Health Care Companies (April 2021)
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