Coronavirus TV Episode 29: Therapeutic antibody updateRegeneron is beginning its Phase 3 program for its antibody cocktail against COVID-19, just one month after first entering human clinical trials. In accepting funding from the US government and Operation Warp Speed, the company is mitigating some of the clinical risk, although this will certainly come at the cost of strategic freedom in pricing and wider global supply. Eli Lilly is not far behind in development with its two antibody programs, while a host of other companies will be seeking to initiate their own Phase I clinical trials shortly.
Coronavirus TV Episode 28: Pfizer and BioNTech’s early successThe BioNTech/Pfizer vaccine has yielded encouraging early-stage results, showing strong and predictable immunogenicity data, allowing it to progress to late-stage trials. The incidence of side effects may complicate blinding in these larger trials, but it is another positive step towards the wider goal of developing and manufacturing effective vaccines that will bring the pandemic to a close.
Coronavirus TV Episode 27: Deciphering the dexamethasone resultThe UK’s RECOVERY trial is the first to show a conclusive mortality benefit for a COVID-19 treatment, revealing the low-cost steroid dexamethasone to be a life-saving treatment for patients requiring ventilation and/or oxygen support. This result will change treatment practices and clinical trial design globally, and with the widespread availability of the steroid for other indications then this shift can happen overnight. It is also another example of the huge importance of central oversight into clinical trial design – one of the UK’s unique strengths – rather than rushing out small-scale academic research.
Coronavirus TV Episode 26: Forecasting remdesivirThe well-known Wall Street analyst Geoffrey Porges has released his remdesivir forecast, predicting stable sales of $6bn annually from 2021. The projection is supported by some optimistic assumptions surrounding drug pricing, number of infections and government demand, painting a best-case picture for Gilead. Such impressive pandemic sales might prove problematic for Gilead’s reputation, although a likelier scenario is a more modest commercial outlook.
Coronavirus TV Episode 25: Clinical trial recoveryThe first signs are emerging that clinical trial activity is picking up again after a 2–3 month drop caused by COVID-19 disruption. The number of temporarily closed studies has dropped, with trials beginning to open their doors again to new patients. The industry must capitalize on the relaxation of lockdowns in order to maintain momentum in bringing new drugs to the market, although a potential second wave and fear of healthcare institutions remain longer term threats.
Coronavirus TV Episode 24: Moderna and vaccine milestonesCongratulations are in order for Moderna, after announcing highly encouraging Phase I data for its COVID-19 vaccine mRNA-1273. The vaccine appears to consistently yield an immune response, with neutralizing antibodies at levels that are suggestive of immunity. Future challenges will be to reproduce this in a larger, placebo-controlled population in Phase II, while Phase III will be the critical hurdle to address whether these antibodies prevent infection in the real-world, rather than a petri dish or within mice. In the meantime, considerable scale-up will allow for hundreds of millions of doses to be ready by the end of the year.
Pink Sheet Podcast: Coronavirus Oversight, Rick Bright On Capitol Hill, BIO’s New CEOPink Sheet reporter and editor discuss the virtual appearances by US FDA Commissioner Stephen Hahn and others on Capitol Hill, GOP right-to-try questions for former BARDA Director Rick Bright, and new BIO CEO Michelle McMurry-Heath.
Coronavirus TV Episode 23: COVID-19 cocktailsThe NIAID is sponsoring a new clinical trial, this time adding baricitinib to a remdesivir backbone. This is one of the first drug cocktails for COVID-19, and expect such combination designs to feature heavily as the field moves forward and conducts research ethically. One complication is discerning the absolute effects of the constituent drugs, which may leave us with superior drugs to remdesivir, but unable to quantify quite how much better they are, without a direct head-to-head study.
Coronavirus TV Episode 22: Calculating a fair price for remdesivirWith 1.5 million donated doses, Gilead has invested considerably to provide remdesivir as widely as possible. As the drug transitions into commercial availability, Gilead will now carefully recoup some of its $1bn+ investment. ICER calculates remdesivir to be cost effective at a price of $4.5k, depending on mortality reduction, although reducing time spent in hospital also produces cost savings. Whatever price Gilead chooses, it will set an important precedent that must balance public perception with an entry point that incentivizes additional innovation.
Pink Sheet Podcast: Coronavirus Vaccine Trials, Approval Trends With Telework, Donut Hole Fix IssuesPink Sheet reporters and editor discuss the potential trade-offs associated with speedy coronavirus vaccine development, changes in FDA approval volume since mass-teleworking began, and a study showing the Part D donut hole fix is not keeping up with price increases.
Coronavirus TV episode 21: Deciphering remdesivir’s clinical trial dataData from three trials paint a complex picture for remdesivir, although crucially the NIAID’s study provides placebo-controlled evidence and positions it as a standard of care for hospitalized patients. The most relevant readout from Gilead’s own SIMPLE trial is that a shorter dosing period can be used, although potential liver toxicity is a concern. FDA has moved quickly to assign an emergency use authorization and a full approval is still likely, despite questions remaining as to how best use the drug.
Coronavirus TV Episode 20: Drug profiles in the telemedicine eraWith telemedicine becoming part of the new normal, the properties that make a drug attractive to physicians are going to change. Sanofi is experiencing continued support from pulmonologists for Dupixent, but the balance of power across the entire pharmaceutical market is likely to shift. Investment decisions will also need to adjust to take into account the increasingly digital nature of the physician-patient interaction..
Pink Sheet Podcast: Rick Bright leaves BARDA, COVID-19 drug shortage efforts, New Part D Preferred Specialty TierPink Sheet reporters and editors discuss the ramifications of Rick Bright’s removal as head of BARDA, government efforts to help prevent coronavirus-related drug shortages, and a proposed preferred specialty tier for Medicare Part D.
Coronavirus TV Episode 19: How useful are antibodies as COVID-19 drugs?Antibody specialists such as Regeneron and Amgen are developing COVID-19 treatments that work on the same premise as convalescent plasma. Proven platforms will likely result in effective drugs, although timelines mean that they won’t be ready in time for the current pandemic wave. They may also act as a bridge to vaccines as preventative drugs, which will be essential if vaccine development does not achieve the promised timelines.
Coronavirus TV Episode 18: Does COVID-19 buck the trend?Our knowledge of other viruses, especially coronaviruses, helps to provide crucial insights into COVID-19. In this episode we tackle three key questions: can you get re-infected with COVID-19 straightaway? What happens if COVID-19 mutates? And finally, how long will immunity last after initial infection or vaccination?
Pink Sheet Podcast: US FDA’s Coronavirus-mandated Virtual Advisory Committees, Proventil HFA First Generic, Zofran Liability SuitPink Sheet reporters and editor discuss how the US FDA was pulled into a product liability suit for GSK’s Zofran and the approval of Cipla’s first generic of an albuterol sulfate metered dose inhaler, as well as the agency’s plans for virtual advisory committee meetings.
Coronavirus TV Episode 17: Vaccine expertise and R&D in IndiaWhile the leading vaccine manufacturers – by value at least – are Western Big Pharma companies, Indian manufacturers produce around 60% of the global total, and so will also play an essential role to meet global demand for a potential coronavirus vaccine. This episode discusses the domestic R&D efforts underway, including programs by Serum Institute of India, Indian Immunologicals, Bharat Biotech and Cadila Healthcare.
Coronavirus TV Episode 16: Remdesivir anecdotesClinical data from the remdesivir trials are being drip-fed into the media, creating a lot of reporting and hype around the drug, before its trials have formally completed. All of the information so far, while encouraging at face value, must also be seen in the context that most COVID-19 patients get better over time, so the exact treatment effect is difficult to tease out. Look to the full trial result from Gilead in severe patients later in April, and placebo-controlled data from moderate patients in May, for a more conclusive picture as to the drug’s clinical effect.
Coronavirus TV Episode 15: How widespread will vaccines need to be?Viral reproduction number and herd immunity are both important concepts when it comes to the development and deployment of coronavirus vaccines. The higher the basic reproduction number, the more widespread immunity will need to be in order to disrupt transmission. The critical vaccination level is likely to be between 55–83%, although the number may rise further if vaccines are not fully effective or patients lose immunity over time.
Coronavirus TV Episode 14: Modelling the complexities of COVID-19Due to asymptomatic, undiagnosed cases, we are missing critical information of the spread of SARS-CoV-2, so current models will likely be inaccurate and tend to disagree with each other. The Diamond Princess cruise ship provides a better indication of the coronavirus’s true infectiousness as case testing was universal, although outcomes data should not be related to the general population owing to its unique demographics. Other important complexities include judging virus reproduction rate and the susceptible population, both of which are moving targets and require large assumptions. Nevertheless, models are still essential to predict healthcare resource use, and their accuracy will improve over time, especially once asymptomatic carriers are better characterized.
Coronavirus TV Episode 13: Test, test, testTesting is crucial to any pandemic response, and the coronavirus outbreak has seen multiple different types employed, including PCR-, antigen- and antibody-based diagnostics. This episode discusses the merits and limitations of each of these, while reviewing the scale of testing in COVID-19 patients across different countries.
Coronavirus TV Episode 12: Let’s talk vaccinesAlthough there are over 50 vaccines in development for SARS-CoV-2, the pace of R&D is much slower. This episode summarizes the latest vaccine approaches and sets their timelines against the overall trajectory of coronavirus, posing the question whether they will be ready in time to have a meaningful effect in the current outbreak.
Coronavirus TV Episode 11: Immunology drugs for pneumonia complicationsBesides antivirals and vaccines, an important third pillar of treatment includes anti-inflammatory drugs to manage severe immune responses. Industry is sponsoring trials of IL-6 blockers and JAK inhibitors, while a range of other targets are under investigation, in order to manage this dangerous complication of COVID-19.
Coronavirus TV Episode 10: Quantifying trial disruptionsMany of Eli Lilly’s peers have now issued similar statements detailing the disruption caused by COVID-19 to their clinical research operations. New indexing within Trialtrove allows this subset of COVID-19-affected trials to be identified, revealing the breadth and scale of disruption. Industry should feel a duty of care to their patients to maintain momentum and improve trial designs, providing long-term benefit.
Coronavirus TV Episode 9: (Hydroxy)chloroquine, againMuch of the drug development news surrounding COVID-19 continues to be dominated by the malaria drugs chloroquine and hydroxychloroquine, with the US FDA providing a controversial emergency use authorization. This episode explores the known evidence for the drug and some of the ongoing development work that may yield firm clinical data over the coming months.
Coronavirus TV Episode 8: Gilead’s expanded accessStruggling under the weight of individual compassionate use requests, Gilead is scaling up its expanded access scheme for remdesivir ahead of an all-important data readout in April. Physicians and hospitals will be able to apply for multiple patients at once, accelerating access and enabling open-label data collection, adding real-world data to the clinical evidence base.
Coronavirus TV Episode 7: Sobering predictionsOver the weekend, Dr Fauci shared the latest models that project total mortality due to COVID-19 in the US of 100–200k, while slowing growth of new cases in Europe has yet to translate into reduced numbers of deaths. Day-to-day fluctuations and lagging indicators make it difficult to quantify the effect of social measures and potential therapeutic interventions.
Coronavirus TV Episode 6: COVID-19 Therapeutics AcceleratorNovartis is the latest company to join the collaboration initiative, spearheaded by the Bill and Melinda Gates Foundation. The accelerator is designed to act with central oversight into the collective efforts of industry and other partners, to expedite the development and availability of medicines for treating the COVID-19 pandemic.
Coronavirus TV Episode 5: Transitioning from R&D ethically
As the forerunner in COVID-19 R&D, all eyes are on Gilead as it navigates through R&D but also acts as a commercial entity. So far, it is making all the right moves such as giving up Orphan Drug status, building goodwill for the industry, although pharma’s detractors are never far away.
Coronavirus TV Episode 4: Digital ASCO
The 40k+ ASCO annual meeting, like many other industry conferences, is going online only. Some aspects of the digital experience may prove popular, although doctors and the influence of sponsors will likely bring a return to normality once the coronavirus outbreak is brought under control.
Coronavirus TV Episode 3: Eli Lilly and trial postponements
Eli Lilly has announced that most of its 300 ongoing or planned trials will be postponed to new patients, citing the pressure of COVID-19 on healthcare systems. A sensible step that many peers will follow, although the industry needs to evolve and incorporate decentralized trials to protect R&D momentum in the future.
Coronavirus TV Episode 2: Anti-malarials and Presidential endorsements
A small clinical trial in France suggests that hydroxychloroquine is an effective treatment for COVID-19. This episode dissects the hype surrounding the use of anti-malarials, and why rushing to adopt these drugs in hospitals globally may do more harm than good
Coronavirus TV Episode 1: Anti-viral developments
As the COVID-19 pandemic threatens to overwhelm hospitals, there is an immediate need for anti-virals to manage the growing numbers of patients. Using pharmaceutical industry pipeline data, this blog discusses where the most likely effective treatment will come from.
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US position remains that boosters are not needed yet, but CBER Director Peter Marks says regulators are discussing how to harmonize applications for booster shots.
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Based on the results of a study with 234 smokers, the FDA cleared an updated indication for Carrot’s Pivot breath sensor, an over-the-counter carbon monoxide sensor that helps motivate people to stop smoking.
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EU rapidly revises new guidance document on registration requirements under the new MDR and IVDR to address question of when importers need to register in Eudamed medical device database.
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Supplement OWL advisory board members Guru Ramanathan and Russ Michelson answer HBW Insight questions about the site’s progress and the potential for mandatory registration for dietary supplements sold in the US.
The WHO indicates that several claim applications have been made under the COVAX no-fault lump-sum compensation program for COVID-19 vaccines. It remains to be seen how the scheme may apply to countries like India, which is also expected to take a call on indemnity to vaccine makers.
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Industry experts will share their analysis of the current industry landscape and present their views on the future of biopharma following the impact of COVID-19 on new business opportunities and challenges. Supported by insights and expert opinions into what lies in store for biopharma in the 2020s, and now covering the uncertainty within the Pharma Industry from the impact of COVID-19.
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CPhI North America goes Digital
This May, CPhI is launching 5 days of content-rich webinars to provide the pharmaceutical industry with the essential information needed for a fast-changing world. Designed for the needs of remote workers, this will be a week of important content from industry experts.
Join Informa Pharma Intelligence as we kick off the week on May 4th at 11AM EDT with the webinar The response of Pharma and Biopharma to the Covid-19 Pandemic.
Watch the recorded panel discussions address the Covid-19 pandemic from BIO-Europe Spring, delivered digitally from March 23-27, 2020
The Covid-19 pandemic is creating unprecedented Healthcare challenges with far reaching effects yet to be measured. There is a need for greater collaboration and communication among researchers, healthcare systems, government agencies, NGOs, and the public at large. Behind the scenes, the biopharma industry is rallying to innovate and collaborate to develop diagnostics, vaccines and treatments as quickly as possible.
Coronavirus disease 2019 (COVID-19) is a highly infectious disease caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The first cases of COVID-19 were documented in China at the end of 2019 and now in 2020 this disease has spread to become a global pandemic.
As COVID-19 is a new disease, investigations are still ongoing to fully understand it and develop a vaccine. Spread of the disease is thought to be transmitted via respiratory droplets through coughing or sneezing, and can result in a variety of symptoms. It primarily targets the respiratory system with mild symptoms ranging from fever and cough to more severe cases where dyspnea and pneumonia can develop resulting in the need for respiratory assistance.
This disease is affecting us all globally but there are measures we can all take as individuals to fight COVID-19 so it is critical to follow government guidelines to stay safe and prevent COVID-19 from spreading.
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