Regulatory Alert

In a recently issued draft questions and answers guidance the US FDA offers insights into how it will handle certain aspects of submissions and labeling for interchangeable biosimilars. When finalized, the FDA will move the questions and answers from the draft guidance to its companion final questions and answers guidance on biosimilar development. In the first of four questions and answers in the draft guidance, the FDA explains how it anticipates handling applications for interchangeable biosimilars that include data to support licensure as a biosimilar but not as an interchangeable product.
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Washington, D.C., USA- January13, 2020: FDA Sign at its headquarters in Washington. The Food and Drug Administration (FDA or USFDA) is a federal agency of the USA.

At the kickoff meeting for the reauthorization process for the Biosimilar User Fee Act (BsUFA III) program, the US FDA and industry shared their wish lists for the third iteration of the agency’s biosimilars review program. While the FDA laid out four broad goals for the FY2023-2027 program, industry presented more specific proposals, including the creation of a new pre-development meeting and issuance of further guidance on interchangeable biosimilars. The meeting, which sets the stage for the months long negotiations between the FDA and regulated industry, began with an overview of the BsUFA program by Patrizia Cavazzoni, acting director of CDER and Andy Kish, director of the Office of Program and Strategic Analysis at CDER.
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The EMA has refreshed its points to consider document on remote pharmacovigilance inspections during a crisis, such as the current COVID-19 pandemic. The revisions to the document are minor and mostly relate to the preparation phase ahead of a pharmacovigilance inspection when an on-site inspection would not be feasible due to a crisis. In the revised document, EMA has replaced the term “distant/virtual” with “remote” and has expanded its explanation of a crisis situation that would prevent an on-site inspection from being conducted. One of the biggest changes to the document is the emphasis on the need to determine whether a marketing authorization holder has the technical capabilities to facilitate remote access to their electronic systems and maintain communication with inspectors.
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As the time draws near for the leaders in the global race for a vaccine against COVID-19 to submit emergency use authorization (EUA) authorizations to the US FDA, the agency has proclaimed a new commitment to transparency. With a stated goal of disclosing information from COVID-19-related EUA review documents “as appropriate and consistent with our longstanding practice of posting scientific reviews after new drug and biological product approvals,” the FDA also reserved to itself the ability to redact trade secrets or other information that would be exempt from disclosure under the Freedom of Information Act (FOIA) or protected from disclosure by other legislation.
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The U.S. FDA stunned Sanofi with a Complete Response Letter (CRL) for its blood cancer treatment sutimlimab. The medication was expected to be the first treatment approved for the treatment of cold agglutinin disease (CAD). The regulatory agency is understood to have rejected the medication due to deficiencies from a pre-license inspection of a third-party manufacturing facility. In its CRL, the FDA said there were no clinical or safety deficiencies with respect to the application. Sanofi said the BLA cannot be approved until there are “satisfactory resolutions of the observations by the third-party manufacturer.”
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In its November meeting, a committee of the European Medicines Agency gave its second thumbs down to the monoclonal antibody Gamifant (emapalumab), confirming a July 2020 negative opinion on the Novimmune SA drug. The US FDA approved Gamifant for pediatric use in primary hemophagocytic lymphohistiocytosis in November 2018; this was the same indication for which EMA has twice declined authorization. The EMA’s human medicines committee (CHMP) had positive recommendations on the first go for four new medicines: Roclanda (latanoprost/netarsudil), Xofluza (baloxavir marboxil), Phesgo (pertuzumab/ trastuzumab), and Onbevzi (bevacizumab).
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The Senate Committee on Appropriations this week released draft legislation proposing $3.21 billion in discretionary funding for the US FDA for FY2021, closely matching the amount the agency would receive under the minibus passed in the U.S. House of Representatives in July. In total, the draft bill would set FDA’s total FY2021 funding, including user fees, at $5.88 billion. As with the House bill, the draft Senate legislation would provide the FDA with $40 million in additional funding over the FY2020 enacted level and would release an additional $70 million in 21st Century Cures Act funds. Learn More

U.S. Senators Elizabeth Warren and Tina Smith are concerned about the safety of pharmaceuticals and drug components coming into the United States, as the coronavirus pandemic has put a halt to many inspections of overseas drug manufacturing facilities. In a letter to FDA Commissioner Stephen Hahn released this week, the senators wrote: “We are concerned that, absent proper oversight of our drug supply chain and the overseas facilities manufacturing products millions of Americans rely on, patients will face an increased risk of drug contamination or other problems with quality, purity, or potency.” Right now, inspections are only happening on a case-by-case basis and are limited to those described as mission-critical, pre-approved, or for cause. Learn More

The US FDA has granted an emergency use authorization for an outpatient therapy to treat mild to moderate COVID-19. The monoclonal antibody, bamlanivimab, is authorized for outpatient use in adults and pediatric patients. The treatment is reserved for patients who have positive direct SARS-CoV-2 viral tests, not antigen tests, and who are “at high risk for progressing to severe COVID-19 and/or hospitalization,” according to the FDA’s November 9th letter of authorization issued to bamlanivimab’s sponsor, Eli Lilly and Company. The conditions of the EUA granted to Lilly include a specific directive to retain an independent third party to review batch records and “any underlying data and associated discrepancies” of the drug substance. Learn More

Novavax has announced that the U.S. FDA has granted Fast Track Designation for NVX-CoV2373, the Company’s COVID-19 vaccine candidate. Currently in late-phase clinical development, NVXCoV2373 is a stable, prefusion protein made using Novavax’ nanoparticle technology and includes its proprietary MatrixM™ adjuvant. Novavax expects to begin its pivotal Phase 3 clinical trial in the United States and Mexico by the end of November. Data from the event-driven trial could support global authorization and approval, including in the U.S. The Company’s ongoing Phase 3 clinical trial in the UK to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373 is expected to be fully enrolled by the end of November. Learn More

An advisory committee to the US FDA handed the agency a resounding thumbs down not only on the Alzheimer’s disease candidate therapy aducanumab, but on the agency’s framing of the questions put before the committee and the contents of its briefing documents. The advisory committee heard from the FDA and from the sponsor, Biogen, in separate presentations, but an integrated briefing document was presented that, in the minds of some committee members, made it difficult to parse out the FDA’s perspective and that of the sponsor. The FDA is not obligated to follow the recommendations of its advisory committees, though it usually does. Learn More

Expect new guidance from the US FDA on the manufacture of CAR-T cells, said Peter Marks, director of the agency’s Center for Biologics Evaluation and Research (CBER). Marks answered questions on a range of issues related to cell and gene therapy development during a webinar hosted by Genetic Engineering & Biotechnology News. Saying that CBER is working on new guidelines for CAR T-cell therapy manufacturing, Marks said, “The agency is trying to put out some more clear information on what we’re expecting for CAR T-cells. I’m not sure exactly when it’s going to appear, but stay tuned,” Marks said. Learn More

While the world has largely been focused on the development of vaccines and therapeutics for COVID-19, the U.S. FDA has remained busy lining up potential approvals of medications for other diseases and illnesses. Many of these drugs have been granted Fast Track designation over the past several weeks, which is intended to expedite the review of these treatments. BioSpace takes a look at some of the most recent medications to receive this designation. Learn More

As the buzz builds around messenger RNA (mRNA) technology’s use for two leading COVID-19 candidates, manufacturers and regulatory professionals are facing facts: This is not simple technology. Complex manufacturing processes, delivery vehicles that must be treated more as drug substances than excipients, and potential immunogenicity headaches are among the challenges industry faces as this promising technology is harnessed to address an increasing number of health conditions. Messenger RNA is considered by both the US FDA and the EMA to be gene therapy even though RNA does not interact with the genome. However, mRNA, which is regulated by the FDA’s CBER is not yet classified as a regenerative medicine advanced therapy (RMAT). EMA considers mRNA to be an advanced therapy medicinal product (ATMP). Learn More

To comply with a recent executive order, the US FDA has released a list of more than 300 essential drugs and medical devices that will serve as a basis for prioritized federal procurement of those products from domestic sources. The list was developed in response to President Donald Trump’s “Buy American” executive order, issued in August, aimed at boosting domestic production of drugs and medical devices. In total, the list includes 223 drugs and biological products and 96 medical devices and in vitro diagnostics deemed “medically necessary to have available at all times,” in adequate supply and in appropriate dosage forms. The list also specifies the critical inputs, such as API’s or sensor components, necessary to produce each product. Learn More

Reflecting the extraordinary circumstances of the pandemic, the EMA has announced that the agency is speeding announcements regarding the progress of clinical trials of vaccines and therapeutics for COVID-19. The agency is also making public certain information about the progress of clinical trials that would not ordinarily be published. Perhaps the most notable departure from business as usual is publication of full deidentified clinical trial data for COVID therapeutics and vaccines after they receive marketing authorization, a move EMA had announced in September. Learn More

Researchers at the US FDA found that, for drugs that are new chemical entities, generic submissions were more likely when the reference brand-name drug generated more revenue. Looking into other factors that predict that an abbreviated new drug application (ANDA) will be filed for a reference drug, the investigators also found that sponsors were less likely to file ANDAs for complex drugs. In a retrospective study examining 400 brand-name drugs eligible for ANDA filing between 2011 and 2017, investigators at FDA's CDER identified 140 that had originally been approved as new chemical entities (NCEs). Learn More

Trust means everything. Trust in vaccines facilitated the incredible positive impact that vaccination had on public health in reducing illness and death over the past century. In the middle of a global pandemic, it is precisely a safe and effective COVID-19 vaccine that will help bring life back to normal if people are willing to receive the vaccine because they have confidence in it. Therefore, it is critical to be open and transparent about the process that the U.S. Food and Drug Administration will follow to help make safe and effective COVID-19 vaccines available. Learn More

Generic drugmakers have received finalized guidance from the US FDA. In finalizing a 2017 draft, the agency gives sponsors of abbreviated new drug applications (ANDAs) information about how to identify reference listed drugs (RLDs), further details on reference standards, and what forms the basis for an ANDA submission. In clarifying how to identify the basis of submission and reference standard, as well as how to identify RLDs, the FDA acknowledged in the Federal Register announcement of the guidance's availability that "A variety of factors has led to confusion among stakeholders on what these terms mean and how an ANDA applicant should use them." Learn More

The US FDA has deferred a decision on Spectrum Pharmaceuticals' SPPI.O drug candidate to treat chemotherapy induced loss of white blood cells in cancer patients due to COVID-19 related travel curbs. This comes after the regulatory agency was unable to inspect the company's South Korea-based manufacturing plant, a step required before the approval of the drug, the company said. The regulator had warned in April it may not be able to sustain its current level of timely reviews and approvals of marketing applications as many of its staff were allocated to the coronavirus crisis. Learn More

Clinical trials for the AstraZeneca Oxford coronavirus vaccine, AZD1222, have resumed across the world with regulators in the US, UK, Brazil, South Africa and Japan confirming that it was safe to do so. The FDA authorized the restart in the US, following the resumption of trials in other countries in recent weeks. The FDA reviewed all safety data from trials globally and concluded it was safe to resume the trial. As part of the standard review process for trial safety events, a voluntary pause to vaccination across all global trials was triggered on September 6th to allow the examination of safety data by independent monitoring committees. Learn More

After a vaccine against COVID-19 is authorized or approved, how will its safety and efficacy be assessed? In addition to ongoing postmarket surveillance requirements, the US FDA and the CDC will strive for near real-time safety and efficacy surveillance of COVID-19 vaccines. The FDA is currently developing master protocols to guide its safety and effectiveness oversight, said an FDA official during the FDA's first COVID-19 vaccine-focused advisory committee hearing. "We'll be posting the protocols for public comment," said Stephen Anderson, PhD, director at the FDA's Center for Biologics Evaluation and Research (CBER). Learn More

After four straight years of posting record numbers of abbreviated new drug application (ANDA) approvals, the US FDA has broken its streak, approving 22% fewer generic drugs in FY2020 than it did in FY2019. In FY2020, the FDA approved a total of 909 ANDAs, 737 full approvals and 172 tentative approvals, compared to a record 1,171 ANDAs in FY2019. Complete responses also declined to 2,010 compared to 2,310 in FY2019. The dip in approvals comes after the FDA increased its focus on generic drug approvals as part of the drug competition action plan championed by former FDA Commissioner Scott Gottlieb and three years into the second Generic Drug User Fee Amendments (GDUFA II) program. Learn More

The U.S. health regulator's criteria for allowing emergency use of a COVID-19 vaccine and plans to monitor its safety after a regulatory go-ahead, are among the topics to be discussed at a closely watched meeting scheduled for Thursday. Details posted on the FDA website showed the U.S. Centers of Disease Control and Prevention has formulated plans to monitor safety and effectiveness of a vaccine even after the FDA allows for its emergency use. The FDA panel would make recommendations at the end of the meeting, according to the agenda, but did not specify details. Learn More

Two new pilot programs related to manufacturing quality management have been launched by the US FDA. The agency's Center for Drug Evaluation and Research (CDER) is hoping to "gain insight from third-party assessments of a manufacturer's quality management system to inform future development of an FDA rating system," according to CDER's announcement to industry of the new pilot programs. The rating system that FDA hopes to develop from the pilot programs would better allow an apples-to-apples comparison of facilities, which could be of benefit to a variety of stakeholders including healthcare facilities and consumers. The initiative is part of the broader FDA effort to shift to risk-based pharmaceutical quality assessment systems. Learn More

With negotiations underway for the next iterations of the US FDAs new and generic drug user fee programs, top officials from the Center for Drug Evaluation and Research (CDER) discussed budget and staffing priorities in a call with the Alliance for a Stronger FDA. "We have really made major strides thanks to Congress' support in the appropriations that we received in 2019, in investing in modernizing the platforms that support the review of applications and the data analytics platforms that we intend to build and refine to allow us to communicate with the external world, including sponsors and researchers, using cloud-based technologies," said CDER Acting Director Patrizia Cavazzoni. Learn More

While the US FDA is still receiving investigational new drug applications (INDs) for cell and gene therapies, officials are concerned about the impact of the COVID-19 pandemic on clinical trials. "It's clear that COVID-19 has adversely affected all aspects of development of cell and gene therapies," said Peter Marks, director of FDA's Center for Biologics Evaluation and Research (CBER), while speaking at the Alliance for Regenerative Medicine's Meeting on the Mesa. "For some of the studies that are ongoing there are some real challenges to overcome in terms of endpoints that may have been missed." The pandemic also has disrupted global harmonization efforts around gene therapies, Marks said. Learn More

Biosimilars have been slow to enter the US market for complex reasons ranging from the manipulation of patent protections to brand-name drug rebates. Now a new analysis, published in the Mayo Clinic Proceedings, suggests that a "high testing bar" for biosimilars to gain regulatory approval is another contributing factor. The analysis found that the median time from the start of a Phase I study to approval by the US FDA was more than 5 years. As of May 1st, 2020, the FDA has approved just 26 biosimilars, of which 17 products have been marketed. In contrast, the EMA has approved 64 biosimilars. Learn More

U.S. drug inspectors uncovered serious quality control problems at an Eli Lilly and Co pharmaceutical plant that is ramping up to manufacture one of two promising COVID-19 drugs according to government documents and three sources familiar with the matter. The three sources who spoke to Reuters requested that their names be withheld so they could speak freely without fear of retaliation. Inspectors who visited the Lilly plant in Branchburg, New Jersey, last November found that data on the plant's various manufacturing processes had been deleted and not appropriately audited, government inspection documents show. Following its November inspection, the FDA issued an "Official Action Indicated" (OAI) notice. Learn More

Avenue Therapeutics has announced that it has received a Complete Response Letter ("CRL") from the U.S. FDA regarding the Company's New Drug Application ("NDA") for IV tramadol. The CRL stated that although the pivotal Phase 3 clinical trials demonstrated statistically significant outcomes for all of the primary and many secondary endpoints, the FDA has determined that it cannot approve the application in its present form. The CRL stated that IV tramadol, intended to treat patients in acute pain who require an opioid, is not safe for the intended patient population. The FDA noted specific concerns of potential for opioid "stacking" and associated increased likelihood of adverse effects. Learn More

The US Government Accounting Office (GAO) found that many elements of an effort to improve laboratory safety at the U.S. FDA have not been met, over three years after establishing an Office of Laboratory Safety. For example, the safety oversight office still cannot perform unannounced laboratory inspections, according to the report. Prompted by the 2014 discovery of boxes of smallpox virus that were improperly stored in a laboratory cold room maintained by FDA on the campus of the National Institutes of Health, GAO began an investigation that led to a series of five recommendations made in 2016 aimed at improving the agency's laboratory safety. Learn More

Two days after the US FDA's surprise publication of guidance setting criteria for emergency use authorization (EUA) for COVID-19 vaccines, Peter Marks, director of the Center for Biologics Evaluation and Research shared some of the thought process that went in to its recommendations. One of the most significant recommendations in the guidance is FDA's insistence on a median of two months of follow-up of Phase 3 trial participants following their last dose. Speaking at the Food and Drug Law Institute's annual conference, Marks explained that FDA settled on a median of two months because that would provide data on enough patients for enough time to be able to observe most of the events that concern the agency. Learn More

The European Medicines Agency (EMA) is transitioning to an online platform for drug developers to use when requesting scientific advice. The change will become effective on October 19th for developers of both human and veterinary medicinal products. The regulatory and scientific information management platform, known as IRIS, "aims to make the handling of product-related regulatory procedures more efficient and user-friendly and to ensure better data quality through integration with other EMA systems," including EMA's substance, product, organization and referential (SPOR) portal, said EMA. Learn More

Amid reports that the White House had blocked stricter guidance from the US FDA on emergency use authorizations (EUAs) for COVID-19 vaccines, the agency has issued guidance hours after disclosing some of its advice to vaccine makers in briefing documents for an upcoming advisory committee meeting. The FDA appears to have sidestepped the White House by releasing five pages of advice given to vaccine makers on COVID-19 vaccine EUAs in briefing documents for its upcoming Vaccines and Related Biologics Advisory Committee meeting. Hours later, in a surprise move, the FDA released its COVID-19 vaccine EUA guidance in full. Learn More

The US FDA has announced historic low rates for the fiscal year 2021 fees to use its three priority review voucher programs. For the upcoming fiscal year, the rate to use a material threat medical countermeasure (MCM) priority review voucher (PRV) is an all-time low $1,360,879. The PRV rate is the same for the rare pediatric disease and rare tropical disease voucher programs, according to Federal Register announcements. This figure is in addition to the required prescription drug user fee amendments fees for FY 2021, and it represents the agency's estimate of the additional cost for the compressed 6-month review timeline earned by presentation of the PRV. Learn More

Mesoblast has made public a decision by the U.S. to issue a Complete Response Letter to its Biologics License Application (BLA) for remestemcel-L for the treatment of pediatric steroid-refractory acute graft versus host disease (SR-aGVHD). While the Oncologic Drugs Advisory Committee (ODAC)1 of the FDA voted 9:1 that the available data support the efficacy of remestemcel-L in pediatric patients with SR-aGVHD, the FDA recommended that Mesoblast conduct at least one additional randomized, controlled study in adults and/or children to provide further evidence of the effectiveness of remestemcel-L for SR-aGVHD. Learn More

Solid Biosciences has announced that the U.S. FDA has lifted the clinical hold placed on the Company's IGNITE DMD Phase I/II clinical trial. The news helped drive the company's share price up roughly 70% in trading. As announced in July 2020, the FDA had requested further manufacturing information, updated safety and efficacy data for all patients dosed, and provided direction on total viral load to be administered per patient. Based on the Company's response to these requests, the FDA acknowledged that the Company satisfactorily addressed all clinical hold questions. Learn More

The U.S. FDA has broadened its investigation of a serious illness in AstraZeneca's COVID-19 vaccine study and will look at data from earlier trials of similar vaccines developed by the same scientists, three sources familiar with the details told Reuters. AstraZeneca's large, late-stage U.S. trial has remained on hold since Sept. 6, after a study participant in Britain fell ill with what was believed to be a rare spinal inflammatory disorder called transverse myelitis. The widened scope of the FDA probe raises the likelihood of additional delays for what has been one of the most advanced COVID-19 vaccine candidates in development. The requested data was expected to arrive this week. Learn More

Speaking at the Financial Times' US Pharma and Biotech Summit this week, US FDA Commissioner Stephen Hahn said the agency will stick to the standards and criteria it has laid out to approve or authorize applications for vaccines to prevent coronavirus disease (COVID-19). In recent weeks, Hahn has made numerous statements asserting that the agency will not approve or authorize a vaccine that does not meet the agency's "rigorous expectations," despite repeated claims by President Donald Trump that a vaccine could be greenlighted before the November election. Learn More

The U.S. FDA has put a hold on Inovio Pharmaceuticals plans to start final trials of its coronavirus vaccine as the agency seeks more information, including details on a delivery device used to inject genetic material into cells. The mid-to-late trials, which were awaiting approval from the U.S. FDA, were scheduled to start this month after they were postponed from this summer. The drug developer said this week that the latest delay due to the FDA's "partial clinical hold" was not due to any side effects in the early-stage study of the vaccine, which was continuing. Learn More

The US Department of Health and Human Services (HHS) has issued a final rule that clears a path for importation of some Canadian drugs into the US. The measure follows a July 24th, 2020 executive order issued by President Donald Trump that directed the HHS secretary to take action to expand access to lower cost imported drugs. In a September 24th press release, the US FDA said that the final rule would help affordability of drugs for US patients. The final rule allows states, Indian tribes and potentially pharmacies and wholesalers to seek FDA authorization of importation programs. Learn More

President Donald Trump claimed this week that the White House could override the US FDA if the agency released tougher standards for the authorization of a Covid-19 vaccine, casting such a move as "political." His comments come as the FDA considers new Covid-19 vaccine guidelines that would likely push an authorization beyond Election Day, according to three sources familiar with the situation. That timeline would dash Trump's hopes of a pre-election authorization, having repeatedly said the vaccine could be ready by November 3. "We're looking at that and that has to be approved by the White House. We may or may not approve it," the President said of the new FDA guidelines. Learn More

Testifying before the Senate Health, Education, Labor and Pensions Committee this week, US FDA Commissioner Stephen Hahn said that politics will not play a part in the decision to approve or authorize a vaccine for coronavirus disease (COVID-19). Hahn's reassurances come amid reports from the Washington Post, Financial Times and New York Times that the agency is preparing to issue guidance on its expectations for a COVID-19 vaccine EUA that will ask for a median two months of monitoring after Phase 3 trial participants receive their last dose, making an EUA for a vaccine before the election unlikely. Hahn and CBER Director Peter Marks have both previously said that such guidance is coming. Learn More

Investigators of new drugs must continue to send safety reports of serious and unexpected adverse events to their institutional review boards during the public health emergency of the novel coronavirus pandemic, according to an updated guidance from the US FDA. The updated information came on September 21st, 2020 in the form of a new addition to the questions and answers in the FDA's guidance on conduct of clinical trials of medical products during the COVID-19 public health emergency. The guidance, originally issued in March 2020, has been expanded and updated throughout the pandemic. Learn More

As trust in federal health agencies has withered over the last few months, a group of Black physicians has been working on an antidote: creating their own expert task force to independently vet regulators' decisions about Covid-19 drugs and vaccines as well as government recommendations for curbing the pandemic. Organized by the National Medical Association - founded in 1895 as an answer to racist professional societies excluding Black doctors - the committee is meant to safeguard against any unscientific guidance from the Centers for Disease Control and Prevention and the Food and Drug Administration. Learn More

In a stunning declaration of authority, Alex M. Azar II, the secretary of health and human services, this week barred the nation's health agencies, including the Food and Drug Administration, from signing any new rules regarding the nation's foods, medicines, medical devices and other products, including vaccines. Going forward, Mr. Azar wrote in a Sept. 15 memorandum obtained by The New York Times, such power "is reserved to the Secretary." The bulletin was sent to heads of operating and staff divisions within H.H.S. It's unclear if or how the memo would change the vetting and approval process for coronavirus vaccines, three of which are in advanced clinical trials in the United States. Learn More

The European Medicines Agency is on the verge of releasing revised guidance for advanced therapy medicinal products containing genetically modified cells, which includes chimeric antigen receptor (CAR)-T cell therapies. The "Guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells" was originally issued in 2012 but underwent revision and consultation from July 2018-July 2019. The revised version is expected to be adopted in October and published in November, according to Ana Hidalgo-Simon, MD, PhD, head of advanced therapies at EMA. Learn More

Investigators should use a patient-reported outcomes approach, with an emphasis on electronic data collection, in their research on therapies to treat or prevent COVID-19, according to a new guidance from the US FDA. The guidance, which is effective immediately during the public health emergency of the coronavirus pandemic, outlines how to capture disease-related symptoms in clinical trials focusing on COVID-19 prevention or treatment for outpatient adults and adolescents. Learn More

Health and Human Services Secretary Alex Azar led an escalating pressure campaign against his own Food and Drug Administration this spring and summer, urging the agency to abandon its responsibility for ensuring the safety and accuracy of a range of coronavirus tests as the pandemic raged. Then in late August, Azar took matters into his own hands. Overriding objections from FDA chief Stephen Hahn, Azar revoked the agency's ability to check the quality of tests developed by individual labs for their own use, according to seven current and former administration officials with knowledge of the decision. Learn More

A Phase 1 trial assessing Cellectis' investigational CAR T-cell therapy, UCARTCS1A, has been placed on hold by the U.S. FDA. The MELANI-01 study (NCT04142619) was assessing the safety and clinical activity of different doses of UCARTCS1A, administered in a single infusion, with the aim of determining the optimal dose for further testing. The clinical hold came after one patient, who received the second dose level of the therapy, died from cardiac arrest during the study. Cellectis is working closely with the FDA to lift this clinical hold, which will require the company to make changes to the study's protocol to enhance participants' safety. Learn More

A new temporary guidance for drug and biologics manufacturers from the US FDA details recommendations for returning to normal production operations during the public health emergency of the COVID-19 pandemic. "This guidance provides recommendations to help manufacturers prioritize products as they resume normal operations and as they remediate current good manufacturing practice (CGMP) activities that were necessarily delayed, reduced, or otherwise modified during the public health emergency in order to maintain production and the drug supply," said FDA in announcing the availability of the temporary guidance. Learn More

The head of the US FDA, Commissioner Stephen Hahn, said he has "no intention" of overruling career scientists at the agency on an approval of a coronavirus vaccine even though he has the authority. He went on to add that any vaccine data released will be discussed publicly by an advisory committee of outside experts and that Peter Marks, who runs the FDA division that oversees vaccine approvals, will ultimately make a recommendation. "I have complete and absolute confidence in the scientists at the FDA and the decision-making that they have here," he added. Learn More

Manufacturers can request emergency use authorizations under the public health emergency of the coronavirus pandemic for multi-analyte respiratory panels, the US FDA clarified this week. The agency added a new item to its questions and answers (Q&As) for laboratories and manufacturers of tests for SARS-CoV-2, the virus that causes COVID-19. The new Q&A cites "the overlap in signs and symptoms between SARS-CoV-2 and other respiratory viral infections, including influenza." Multi-analyte panels for respiratory infections, noted the agency, "are useful when multiple respiratory pathogens are circulating at the same time, as is expected with the upcoming flu season." Learn More

An Indonesian firm was warned by the US FDA for failures in product testing and method validation, among other breaches of current good manufacturing practice (CGMP). In a November 2019 inspection of PT. MegaSura Mas, FDA inspectors found that some assays conducted for batch releases of an over-the-counter product were performed after the batches were released. According to the warning letter, the firm also used an assay testing method for the active ingredient in the finished product that was not a US Pharmacopeia (USP) method, nor was it validated by high-performance liquid chromatography. Learn More

Since the outset of our discovery of impurities called nitrosamines in some types of drugs more than two years ago, the U.S. FDA has undertaken a thorough investigation in an effort to protect patients. While nitrosamines are common in water and foods, nitrosamine impurities may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time. For this reason, the discovery of unexpected nitrosamine impurities in some drug products is a serious concern, and the FDA has been working, in collaboration with regulatory counterparts around the world, to find and remove drugs with unacceptable nitrosamine impurities from the U.S. drug supply. Learn More

In its suite of post-transition guidance's released this week, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) issued a dozen documents explaining how medicines licensure will work after the Brexit transition period expires on January 1st, 2021. The guidance, which largely mirrors the "no deal" scenario laid out in now-withdrawn guidance issued last year, explains a range of issues from converting centrally authorized products (CAPs) to UK marketing authorizations to how to register new packaging information for medicines after the transition date. Learn More

A second Trump administration appointee has been ousted at the FDA in the wake of the agency's botched announcement about an experimental therapy for COVID-19, which medical experts said damaged the health regulator's credibility with the public. An FDA spokesperson confirmed this week that John "Wolf" Wagner, a political appointee installed by the White House earlier this summer, is no longer heading the agency's office of external affairs. Instead, Heidi Rebello, a longtime FDA career official, has stepped into the position on an acting basis, overseeing all FDA public communications. Politico first reported the news. Learn More

The US FDA last month warned Mylan Laboratories and Acella Pharmaceuticals over good manufacturing practice (GMP) violations. The FDA's warning letter to Mylan cites the company for issues related to its cleaning procedures and handling of recovered solvents. While the warning letter to Acella Pharmaceuticals follows a three-week inspection that ran from December 2019 into January 2020 and uncovered issues with the company's NP Thyroid products that led to the company recalling 13 lots of the tablets due to super potency in May. The warning letter also cites Acella for its quality unit's failure to adequately oversee its CMO. Learn More

FDA Commissioner Stephen Hahn said in a new interview that he is willing to fast-track a coronavirus vaccine before clinical trials are complete if it is determined to be "appropriate." Hahn stressed politics would play no part in such a move, telling the Financial Times that "this is going to be a science, medicine, data decision." "It is up to the sponsor to apply for authorization or approval, and we make an adjudication of their application," Hahn told the newspaper while discussing scenarios in which the FDA grants vaccine approval. "If they do that before the end of Phase Three, we may find that appropriate. We may find that inappropriate, we will make a determination." Learn More

The US FDA has released its latest batch of product-specific guidance's, posting 19 new and 17 revised draft guidance's, bringing the total number of product-specific guidance's issued by the agency to 1,938. The guidance's, which FDA posts quarterly, are intended to promote generic competition by clarifying the agency's expectations for the studies required to demonstrate that a generic drug is equivalent to a reference listed drug. So far this year FDA issued nearly 150 product-specific guidance's. Learn More

Cassiopea has won approval for its first medicine, an acne treatment, from the U.S. FDA, setting the stage for a likely capital increase to support its launch. Winlevi, a twice-daily topical prescription medicine that targets hormones called androgens, won approval for males and females 12 years and older, Cassiopea said. Winlevi reduced acne in trials. The most frequent local reaction was skin redness, or erythema. The drug is expected to be available in the United States in early 2021 and Cassiopea plans to announce the price in the fourth quarter. It did not give sales expectations. Learn More

The US FDA has authorized emergency use of a coronavirus test that costs $5 and can produce results in 15 minutes without the use of any lab equipment. Test-maker Abbott says it could soon manufacture 50 million of the rapid antigen tests per month, which could ease the country's testing bottleneck by greatly increasing overall capacity and the speed at which results arrive. Abbott's test is designed for use within seven days of the onset of symptoms. It gives results on a card reminiscent of the stick used in many over-the-counter pregnancy tests. If one line appears on the card, the patient is negative for the coronavirus; two lines indicates a positive result. Learn More

A quality improvement study led by the US FDA found that over 200 difficult-to-manufacture drug product samples met US standards for dosage unit uniformity and dissolution. The 252 products that were sampled in the largest such study to date included 35 innovator and 217 generic drug samples. In all, the products contained 17 different active pharmaceutical ingredients (APIs) and the samples originated from 46 firms. Adam Fisher, PhD, and his colleagues at the FDA's CDER examined drug products from the US, Canada, Europe, India and the rest of Asia. Learn More

The US this week announced it will not begin collecting drug manufacturing volume data next month as required by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). Section 3112 of the CARES Act establishes new reporting requirements for drug manufacturers intended to improve the response to drug shortages, including expanding shortage reporting requirements for life-saving drugs to include drugs that are "critical to the public health during a public health emergency," and the active pharmaceutical ingredients of those drugs. Drugmakers are also now required to report manufacturing volume data annually. Learn More

Novartis has announced that the US FDA has approved Kesimpta® as an injection for subcutaneous use for the treatment of relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Kesimpta is a targeted, precisely dosed and delivered B-cell therapy that has shown superior efficacy with a similar safety profile compared with teriflunomide and is a first-choice treatment option for RMS patients1. Kesimpta is the first B-cell therapy that can be self-administered once monthly at home via the Sensoready® autoinjector pen3. Learn More

A US FDA emergency use authorization for blood plasma to treat Covid-19 is on hold, but could still be issued in the near future, Dr. H. Clifford Lane, deputy director at the National Institute of Allergy and Infectious Diseases, told The New York Times. The hold came after a group of federal health officials -- including National Institutes of Health Director Dr. Francis Collins, NIAID Director Dr. Anthony Fauci and Lane -- stepped in to argue the emerging data on the treatment was too weak, the Times reported, citing two senior administration sources. News of the hold led President Trump to suggest that it might be of a political nature and not based on science. Learn More

The US FDA this week issued an immediately effective frequently asked questions guidance explaining its approach to inspections and manufacturing and supply chain changes during the coronavirus disease (COVID-19) pandemic. For the time being, the FDA says it is still following the approach to resuming domestic inspections it laid out last month and will continue to postpone non-mission-critical foreign pre-approval and for-cause inspections. For domestic inspections, this means conducting mission-critical inspections on a case-by-case basis or, when it can be done safely, resuming domestic inspections based on priority. Learn More

Poseida announced this week that the FDA paused enrollment in the Phase I clinical study of its prostate cancer treatment P-PSMA-101 following the death of a patient. In a filing with the U.S. Securities and Exchange Commission, Poseida said the patient in question was diagnosed with metastatic castrate-resistant prostate cancer and had failed previous treatment with multiple anti-cancer agents. The direct cause of the patient's death has not yet been determined, but Poseida said the patient developed symptoms consistent with macrophage activation syndrome (MAS), a serious and potentially fatal over-activation of the immune system that has been associated with CAR-T therapies. Learn More

In a new manual of policies and procedures (MAPP) released this week, the US FDA's Center for Drug Evaluation and Research (CDER) explains how and when it will notify applicants when the agency plans to study a product using its Sentinel active risk identification and analysis (ARIA) system. Before the FDA can require a post marketing study or clinical trial for a drug, it must determine whether its ARIA system or adverse event reporting systems would be sufficient to answer the question of interest. In the newly released MAPP, FDA lays out how it will notify applicants when it determines that a study using ARIA would be sufficient to assess a potential serious risk. Learn More

A saliva-based laboratory diagnostic test developed by researchers at the Yale School of Public Health to determine whether someone is infected with the novel coronavirus has been granted an emergency use authorization by the U.S. FDA. The method, called SalivaDirect, is being further validated as a test for asymptomatic individuals through a program that tests players and staff from the NBA. SalivaDirect is simpler, less expensive, and less invasive than the traditional method for such testing, known as nasopharyngeal (NP) swabbing. Results so far have found that SalivaDirect is highly sensitive and yields similar outcomes as NP swabbing. Learn More

Passage Bio's first attempt to develop a GM1 gangliosidosis gene therapy treatment has run into a roadblock in the form of a clinical hold. The company disclosed in its quarterly report this week that the FDA placed a clinical hold pending risk assessments for its experimental treatment PBGM01, which the company is developing in collaboration with the University of Pennsylvania's Gene Therapy Program. In its announcement, Passage Bio said it is evaluating options for conducting additional risk assessments while it awaits official written feedback from the FDA. Learn More

American Gene Technologies (AGT) has announced approval by the FDA to begin Phase 1, the first human clinical trial for AGT's HIV program. AGT will conduct its Phase 1 study at clinical sites in the Baltimore/D.C. area and has named Washington Health Institute, University of Maryland, Institute of Human Virology and Georgetown University as its initial trial sites. These sites are expected to begin enrollment in September 2020.  AGT hopes to report initial data before the end of the year. Learn More

Dr. Scott Gottlieb is wary of the safety and effectiveness of a new coronavirus vaccine touted by Russian President Vladimir Putin as the world's first drug approved to prevent Covid-19. "I wouldn't take it, certainly not outside a clinical trial right now" where patients are closely monitored, Gottlieb said this week. "They're claiming that it's fully approved, but it's not fully approved." Russia plans to begin its first large-scale, phase three trials of its vaccine today even though health officials have already cleared it for public distribution. Researchers have yet to publish any data on the vaccine trials thus far, including information on the safety, efficacy or possible long-term side effects. Learn More

A new draft guidance from the US FDA gives industry direction in how to assess drug-drug interactions for therapeutic proteins. The guidance, issued jointly by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) recommends that sponsors use a "systematic, risk-based" approach to determine whether their therapeutic protein candidates for investigational new drug applications (INDs) and biologic license applications (BLAs) require drug-drug- interaction studies. The draft document covers therapeutic proteins (TPs) licensed as therapeutic biological products, but the FDA notes that the general concepts could be applicable to other biological products. Learn More

A technical specifications document regarding bioresearch monitoring technical conformance has been updated by the US FDA. The guide provides detailed information for electronic submission of clinical trial data (e-CTD) by sponsors in advance of submissions for new drug applications, biologics license applications, and supplemental submissions. The technical specifications document delineates details of the electronic submissions framework laid out in a related draft guidance, Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions. Learn More

Since the outbreak of the covid-19 pandemic, developing a safe and effective vaccine has been an urgent worldwide priority: to save lives, and to bolster the public's confidence in returning to a semblance of normal life. That being said, I have been asked repeatedly whether there has been any inappropriate pressure on the FDA to make decisions that are not based on good data and good science. I have repeatedly said that all FDA decisions have been, and will continue to be, based solely on good science and data. The public can count on that commitment. Learn More

The US FDA this week finalized the guidance explaining its recently created program intended to spur the development of new antibiotic and antifungal drugs intended for limited patient populations. The final guidance comes more than two years after the FDA issued the draft guidance for comment and a year after the agency held a public meeting to receive input on the guidance from the scientific community. In the final guidance, FDA further clarifies how it interprets "limited population" by contrasting two examples of drugs, one that would be fit for the LPAD pathway and one that would not. Learn More

Advanced manufacturing techniques can be employed to help address some of the manufacturing and supply chain problems the US has seen during the COVID-19 pandemic, Stephan Hahn, FDA commissioner, and Anand Shah, FDA deputy commissioner, wrote in a blog post on the FDA website. They highlighted key regulations the agency has promulgated in recent years to support advanced manufacturing, specifically, supporting companies in developing process control measures for continuous manufacturing, supporting developers by addressing technical considerations needed to create gene therapies and the development of "leapfrog" guidance's sharing the agency's thinking on emerging technologies. Learn More

The US FDA, in updating the Purple Book, its database of FDA-licensed biologic products, will also include exclusivity information for biological products as well as a glossary. Biosimilar and interchangeable biological products are included in the searchable online database. The current list of products maintained by CBER will not be further updated by the FDA. The Purple Book Database now contains biosimilar and interchangeable biological products and allergenic, cell and gene therapy, hematologic, and vaccine products. Transition biologic products that were originally approved via New Drug Applications (NDAs) but transitioned to Biologic License Applications (BLAs) also appear in the database. Learn More

Regulators participating in the International Coalition of Medicines Regulatory Authorities (ICMRA) have reached a consensus on endpoints that would be acceptable as primary endpoints in randomized controlled trials for therapeutics to treat coronavirus disease (COVID-19). In a teleconference co-chaired by the European Medicines Agency (EMA) and Japan's Pharmaceuticals and Medical Devices Agency (PMDA), ICMRA members reviewed potential endpoints with the goal of agreeing on acceptable endpoints that could "facilitate rapid and consistent implementation of future clinical trials for COVID-19 medicines across the world." Learn More

The head of the U.S FDA this week said the agency would consider an "emergency use authorization" to expedite getting a vaccine against the Coronavirus strain Covid-19 to millions of Americans. FDA Commissioner Dr. Stephen Hahn said the agency would "consider an emergency use authorization if we felt that the risks associated with the vaccine were much lower than the risks of not having a vaccine and the potential benefit of having a vaccine." The FDA has used several emergency use authorizations in the pandemic as a way to get many diagnostic tests for Covid-19 more quickly to the market than the agency's typical approval process. Learn More

Oncology drug and biologics developers received new guidance on setting limits for endotoxins during the clinical trial process, in the form of a draft document from the US FDA. The draft guidance addresses the reality of oncologic drug development, where investigational therapies are frequently used in combination with other approved treatments, or in conjunction with another investigational drug. Specifically addressed are parenterally administered anticancer drugs under investigation to treat serious and life-threatening cancers. Learn More

At an event marking the launch of Moderna's Phase 3 clinical trial for its mRNA coronavirus vaccine in Miami this week, US FDA Commissioner Stephen Hahn repeated assurances that his agency would not cut corners in approving a COVID-19 vaccine. Hahn's remarks come as some observers have raised concerns that the FDA might be pressured to approve a vaccine before the November election without adequate evidence of safety and efficacy. Officials have also sought to reassure the public that an eventual vaccine will be held to rigorous standards as recent polls have found a significant number of Americans are hesitant about getting a coronavirus vaccine. Learn More

Biotech companies and industry groups are raising questions about the US FDA's recent draft guidance on interpreting sameness of gene therapy products under its orphan drug regulations. The draft guidance, issued for comment in January, explains how the FDA intends to determine the sameness of two gene therapies intended for the same use or indication for the purposes of awarding orphan drug designation and exclusivity. While current regulations "do not elaborate on how the 'same drug' definition applies specifically to gene therapy products," the FDA explains that it will consider the principal molecular structural features of the gene therapies to make its determination. Learn More

Increasing the timely, safe, and cost-effective availability of generic drugs requires that excipient issues be addressed as an integral part of the process, said Priscilla Zawislak, Immediate Past-Chair of International Pharmaceutical Excipients Council (IPEC)-Americas. Zawislak, speaking at the June 21st, 2020 public hearing kicking off the reauthorization process for the third Generic Drug Fees User Amendments (GDUFA III), said that excipient manufacturers are also asking for improvements in communication with FDA on excipient issues, and for formal inclusion of IPEC-Americas in the ongoing GDUFA discussions. Learn More

At its first public meeting in the runup to the reauthorization of the Prescription Drug User Fee Act, the US FDA, industry and other stakeholders this week shed light on their goals for what will be the agency's seventh PDUFA program. The meeting, held fully virtually for the first time due to the COVID-19 pandemic, is the starting point for the negotiations with industry and discussions with stakeholders that will shape FDA's new drug review program from FY2023-FY2027. Learn More

In its warning letter to Irvine, CA-based CDMO Stason Pharmaceuticals, the U.S. FDA cites the company for product testing and data integrity issues uncovered during a three-week inspection last October. According to THE FDA, the company was not able to assure that temozolomide capsules it produced met dissolution attributes throughout their shelf life. After obtaining out-of-specification (OOS) results for multiple lots of the drug, the company investigated some of the OOS results and had a relaxed dissolution specification for the drug approved by the FDA. However, FDA says Stason's "response was inadequate because did not determine a clear root cause"... Learn More

In a public meeting held via webcast, officials of the US FDA kicked off the process for reauthorizing the Generic Drug User Fee Amendments (GDUFA). The meeting, which included presentations by members of industry and the public, is the first of many that will shape the agency's third GDUFA program. GDUFA II, authorized in 2017, expires at the end of September 2022. Learn More

The EMA this week issued a new guideline on the quality of water for pharmaceutical use that will replace its nearly two-decades-old guidance and position statement on water quality when it takes effect in February 2021. The adoption of the guideline follows a public consultation that kicked off in November 2018, with EMA making mostly minor changes to the guideline aside from revisions to the table listing minimum acceptable quality of water for manufacturing active substances. The EMA says the guideline applies to the manufacture of active substances for both human and veterinary, as well as to advanced therapy medicinal products (ATMPs), and should be consulted for new marketing authorization applications. Learn More

As the COVID-19 pandemic continues, researchers and manufacturers are moving potential therapeutics into clinical trials at a dizzying pace. The search is on to find treatment candidates that lower mortality rates and lessen the severity of COVID-19. To date, three therapeutics are approved to treat COVID-19: dexamethasone in the United Kingdom; Avigan (favilavir) in China, Italy and Russia; and Veklury (remdesivir) in Japan and Australia. This tracker, created and maintained by RAPS, was last updated on July 17th, 2020 to include new information on Veklury, dexamethasone, Avigan, RLF-100, INOpulse, JS016, and Actemra (tocilizumab). Learn More

The House Energy and Commerce Committee this week advanced 17 health-related bills for consideration by the House, several of which have implications for the US FDA. Among them is H.R. 4866, the National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2019. It would direct the U.S. FDA to designate national centers of excellence in continuous pharmaceutical manufacturing that would work with the agency and industry "to craft a national framework for continuous manufacturing implementation." The bill would provide $80 million in appropriations for designated centers of excellence each year from FY2021-2025. Learn More

The US FDA has added three more hand sanitizers to its rolling list of products recalled because of possible contamination with a toxic chemical. In total, over 65 of the cleansers have now tested positive for methanol, which can be poisonous if absorbed through the skin or ingested, according to the FDA's latest update. A majority of the products appear to have been manufactured in Mexico, with recalls issued by the manufacturer or distributor. The FDA's continuously updated list, which climbed to 59 products as of July 12, began in June when the regulator observed an increase in hand sanitizers that purportedly contained ethanol but tested positive for methanol contamination. Learn More

At a virtual briefing this week, several experts told members of the House Committee on Oversight and Reform Subcommittee on Economic and Consumer Policy that a transparent process and advisory committee review will be key to the effective rollout of a vaccine to prevent coronavirus disease (COVID-19). The briefing comes just two weeks after the US FDA issued guidance on the development and licensure of vaccines against SARS-CoV-2, the virus that causes COVID-19, and at a time when some of the most advanced vaccine candidates are moving into Phase 3 trials. Learn More

Last week, the US FDA's Center for Biologics Evaluation and Research (CBER) withdrew 20 draft and final guidances, more than half of which date back to the 1980s and 1990s. Many of the withdrawn guidance's relate to blood and blood products, donor screening and HIV. Among the guidances are a Y2K-era guidance on handling the year 2000 date change for computer systems and software applications used to manufacture blood products and a 2003 guidance on screening donors for severe acute respiratory syndrome (SARS). Learn More

Months after halting most inspections amid the coronavirus disease (COVID-19) pandemic, the US FDA has announced that it plans to resume on-site domestic inspections beginning the week of July 20th, 2020. As a safety measure, the FDA will pre-announce all inspections, save for retail tobacco inspections, for the foreseeable future. The announcement comes nearly two months after the agency said it will implement a phased approach to restarting surveillance inspections and four months after the agency halted its domestic inspection program. The FDA said it will prioritize which inspections it conducts in the coming months using a new risk assessment system. Learn More

A week after the US FDA issued guidance on vaccines to prevent coronavirus disease (COVID-19), Peter Marks, director of the Center for Biologics Evaluation and Research, shed light on the reasoning behind the agency's 50% efficacy threshold and where the agency stands on challenge trials and emergency use authorizations (EUAs). His comments came this week during a teleconference with the Alliance for a Stronger FDA. Learn More

The National Institutes of Health (NIH) has announced the kickoff of a national clinical trials network to test vaccines and other treatments that could prevent infection with SARS-CoV2, the virus that causes infection with the novel coronavirus COVID-19. The network has been established by the National Institute of Allergy and Infectious Diseases (NIAID) through the merger of four previously existing clinical trials networks that focused on HIV/AIDS. The network, dubbed the COVID-19 Prevention Trials Network (COVPN), is a functional unit of Operation Warp Speed, the federal partnership focused on speeding the development and delivery of COVID-19 diagnostics, therapeutics and vaccines. Learn More

This week, the US House Committee on Appropriations' Subcommittee which governs the FDA held a markup session for fiscal year 2021 appropriations. Of the total budget of $23.98 billion - a 2.3% increase from the prior fiscal year -- the bill allocates $3.212 billion for the FDA. This amount is an increase of $40.8 million over the prior fiscal year's approximate $3.2 billion budget. FDA funding will total $5.99 billion when user fee revenue is included. The FDA budget hike contained in the 2021 budget represents a smaller increase than the $91 million, or 3%, boost in appropriations the agency received in fiscal year 2020 compared with the prior fiscal year. Learn More

The European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) this week released their next five-year network strategy aimed at steering the regulators through a "time of rapid charge" for a two-month public consultation. The 46-page European medicines agencies network strategy to 2025 sets out six priorities for the regulatory network in the post-coronavirus era and follows the agencies' previous network strategy to 2020. Within the document, goals, challenges and interdependencies for each focus area are laid out. Once finalized, the goals and recommendations in the strategy will inform the work of EMA and the national competent authorities for the next five years. Learn More

A little-known but powerful law, 28 USC 1498, allows federal agencies to take control of industry owned patents using a tool known as government patent use. Essentially, government patent use would let HHS control both the manufacturing and distribution of remdesivir by simply paying compensation to Gilead for the use of its patents. HHS could license remdesivir manufacturing to multiple competing drug manufacturers, which would provide adequate supply while pushing prices down. Patients and payers would pay low prices for remdesivir, close to its manufacturing costs. Learn More