<Weekly Highlight>
Novavax Covid-19 vaccine is 90% effective, including against variants, new study shows[1] (6/14)
An experimental Covid-19 vaccine from Novavax was 90.4% effective at preventing symptomatic disease in adults in a large clinical trial, results that move the shot a step closer to global use.
The 29,960-person study conducted in the U.S. and Mexico also found that the vaccine was similarly effective against newer coronavirus strains, especially the Alpha variant now dominant in the U.S.
Altogether, the results suggest Novavax’s vaccine is on track to become the fourth authorized for use in the U.S. Yet Novavax executives said the regulatory clearances are months away because the company still needs to finish preparing manufacturing.
If permitted by regulators, the shot could add a much-needed boost to global efforts to vaccinate people against the coronavirus, which has revealed growing disparities between developed and developing countries.
<COVID-19 News>
Positive Covid-19 tests fall to lowest recorded rate[2] (6/13)
The proportion of Covid-19 laboratory tests that are coming back positive is at the lowest recorded point since the pandemic took hold in the U.S., a sign of progress as the country moves ahead with reopening.
Laboratories processed more than 677,000 laboratory-based Covid-19 tests a day on average during the week ended June 3, down from the peak of more than two million during the fall and winter, according to the U.S. Centers for Disease Control and Prevention.
Some 2% of Covid-19 tests are coming back positive, compared with more than 13% during the height of the winter surge.
Regeneron antibody cuts risk of COVID-19 death in UK study[3] (6/16)
A major study found that Regeneron's antibody treatment can reduce the risk of death for certain people hospitalized with COVID-19, the first definitive evidence a drug aimed at the coronavirus can lower mortality among the sickest patients.
Regeneron's combination antibody regimen cut the risk of death by 20% in patients who had not mounted their own immune response to the virus, according to researchers from the U.K. RECOVERY trial.
Regeneron said it will immediately share the data with regulators and seek expanded use of its treatment for hospitalized patients in the U.S. who haven't produced their own antibodies against the disease.
Using a proprietary COVID-19 test first developed to screen its own workers during the pandemic, Amazon has now made its at-home sample collection kit available to the public online. Amid the launch of its own wellness-tracking smartwatch and the expansion of the Amazon Care telehealth service, Amazon has now reached into the diagnostics market.
The kit can be purchased without a prescription by anyone 18 years and older, retails for $39.99 and can be delivered in one day in some areas.
Each comes with a nose swab and collection tube, as well as a specimen bag and a prepaid shipping label to ship the sample back to one of Amazon’s labs around the country.
To use the kit, each test-taker must register on Amazon’s diagnostics portal, AmazonDx.com, using an Amazon account. Once registered, users can purchase a COVID test, watch a video demonstrating how to use the kit and, once they’ve sent their sample to the lab, access their test results.
CureVac’s Covid-19 vaccine disappoints in clinical trial[5] (6/16)
CureVac, a German company, delivered disappointing preliminary results from a clinical trial of its Covid-19 vaccine, dimming hopes that it could help fill the world’s great need.
The trial, which included 40,000 volunteers in Latin America and Europe, estimated that CureVac’s mRNA vaccine had an efficacy of just 47 percent, among the lowest reported so far from any Covid-19 vaccine maker.
The company plans to apply for authorization initially to the European Medicines Agency. The European Union reached an agreement last year to purchase 405 million doses of the vaccine if the agency authorizes it.
Some experts see that it would be difficult for CureVac to recover because it is unlikely the vaccine will turn out to be highly protective since most of the data is already in.
AstraZeneca wins in Europe's COVID-19 vaccine lawsuit, not being required to accelerate vaccine deliveries nor pay fines to EU[6] (6/18)
Early this year, AstraZeneca disclosed significant manufacturing shortfalls of the vaccine and warned the EU that it wouldn’t be able to meet delivery commitments. The European Commission, the EU’s executive arm, took the company to court, asking a judge to force the company to deliver 120 million doses by the end of June, or pay 10 euros, or about $12 a day, for each dose it failed to deliver—representing potential fines in the hundreds of millions of euros.
The Belgian court ruled that AstraZeneca isn’t required to accelerate deliveries of its Covid-19 vaccine to the European Union and isn’t on the hook for big fines.
Both sides claimed victory. AstraZeneca said the court’s decision supported its claim that production problems outside its control hampered deliveries. The EU said the decision—while not forcing the company to expedite doses or face fines—showed AstraZeneca was in breach of its contract. Lawyers for the European Commission also said AstraZeneca would have fallen further behind in deliveries if it hadn’t taken legal action.
Moderna plans to expand production to make Covid-19 vaccine boosters, supply more countries[7] (6/21)
Moderna is adding two new production lines at the rebuilt former Polaroid plant where it manufactures its Covid-19 vaccine, part of a push to prepare for making booster shots and the future of the pandemic.
The additions will help Moderna increase overall production capacity by 50% at its plant in the Boston suburb of Norwood.
Moderna and its manufacturing partners also are expanding production capacity outside the U.S., with a goal to roughly triple the annual global output of Covid-19 vaccine doses to about 3 billion in 2022 from as many as 1 billion this year.
<Industry News>
FDA approves StrataGraft for the treatment of adults with thermal burns[8] (6/15)
The FDA approved StrataGraft for the treatment of adult patients with thermal burns containing intact dermal elements (remaining deep skin layers) for which surgical intervention is clinically indicated (also referred to as deep partial thickness burns). StrataGraft is made by Stratatech, a subsidiary of Mallinckrodt.
StrataGraft is for topical application, placed onto the burn by a healthcare provider. Over time, the patient’s skin cells should grow to replace the skin cells lost as a result of the burn. Treatment with StrataGraft can help avoid or decrease the amount of healthy skin that is needed for grafting.
Medidata goes all in on decentralized, virtual capabilities for clinical trials with end-to-end platform[9] (6/16)
Dassault Systemes’ Medidata is betting big on the virtualization of clinical trials as it rolled out a decentralized technology platform. Medidata, whose cloud platform was used to support the clinical trial life cycle of Moderna’s COVID-19 vaccine, is billing its platform as the most comprehensive suite of unified tools for full decentralization throughout the clinical trial process.
The platform is meant to be used across the spectrum of clinical trials, whether traditional on-site, fully decentralized or a combination hybrid model. As a single platform, Medidata says the product reduces the chances for data discrepancies and transfer lags, which sometimes raise security concerns and increase the possibilities of trial disruption.
Gene editing biotech Verve to raise $267M in large IPO[10] (6/17)
Verve Therapeutics, a high-profile startup developing a more precise form of gene editing, announced it raised nearly $270 million in an initial public offering that will rank as one of the largest in biotech this year.
The company sold just over 14 million shares at $19 apiece through the IPO. Shares will begin trading on the Nasdaq stock exchange on June 17 under the ticker "VERV."
A wave of more than three dozen emerging biotech companies have cashed in via IPOs this year, collectively raising more than $7 billion.
Costly Brain-Cancer Drug No Longer Covered by Medicare[11] (6/17)
NextSource Biotechnology, the seller of the brain-cancer drug Gleostine has pulled out of a federal discount program for Medicare patients, leaving some struggling to pay for a therapy that can cost as much as $1,000 per capsule.
NextSource Biotechnology’s decision to leave the program comes after the company raised the drug’s price exponentially since acquiring rights in 2013. Gleostine, which treats a tumor known as glioblastoma and other brain cancers, is off-patent but has no generic alternative.
The company’s move highlights the limits of federal actions to reduce drug prices as well as programs meant to help people pay for their medications.
Danaher makes $9.6B buyout for next-gen contract manufacturing player Aldevron[12] (6/17)
Danaher Corporation, a global science and technology conglomerate, has signed a definitive agreement to acquire privately-held Aldevron for $9.6B.
Aldevron, founded in 1998, is a global player in production of plasmid DNA, mRNA and recombinant proteins used in vaccines, gene and cell therapies, and more. The products have become increasingly popular in recent years, straining many segments of the global supply chain.
When the buyout closes pending regulatory approvals, Aldevron will operate as an independent company inside of Danaher.
FDA approves a nasal antihistamine for nonprescription use[13] (6/17)
The FDA approved Bayer’s nasal antihistamine for nonprescription use through a process called a partial prescription to nonprescription switch.
The drug, called Astepro, is for seasonal and perennial allergic rhinitis—commonly known as allergies—for adults and children six years of age and older.
For a drug to switch from prescription to nonprescription status, the data provided must demonstrate that the drug is safe and effective for use in self-medication as directed in proposed labeling. The manufacturer must show that consumers can understand how to use the drug safely and effectively without the supervision of a healthcare professional.
Bristol Myers pays $650M for rights to Eisai's phase 1 ADC[14] (6/18)
Bristol Myers Squibb is paying $650 million to secure rights to Eisai’s folate receptor alpha-targeted antibody-drug conjugate (ADC) MORAb-202.
The deal, which is worth up to $2.5 billion in milestones, sets Bristol Myers up to work with Eisai to get the drug into a registrational study next year.
Eisai is receiving $200 million to cover its R&D expenses and a further $450 million upfront payment, plus the promise of major milestones and royalties. In return, Bristol Myers has secured the right to jointly develop and commercialize the ADC with Eisai in North America, Europe, Russia, Japan, China and a clutch of other countries in the Asia Pacific region. Bristol Myers is solely responsible for MORAb-202 in the rest of the world.
Google reorganizes health division, shedding 130 employees and dropping consumer health focus[15] (6/18)
Google’s health division has undergone a significant reorganization, resulting in a downsized team and a streamlined focus on clinical and regulatory work rather than consumer-facing offerings.
The reorg includes a transfer of nearly 20% of Google Health’s staff to other teams throughout the company, including its search division and newly acquired Fitbit, a wearable device maker. Google closed its $2.1 billion deal for Fitbit in January with a promise to spark more competition in wearable devices, including with the Apple Watch and its health-focused features.
<Policies & Announcements>
HHS releases Project US@ draft technical specification version 1.0 for public comments[16] (6/16)
HHS Office of the National Coordinator for Health Information Technology (ONC) in collaboration with standards development organizations and a broad community of experts released the Project US@ (‘USA’) Draft Technical Specification Version 1.0 for public comment.
Project US@ was created to develop a unified, cross-standards, healthcare industry-wide specification for representing patient addresses to improve patient matching.
The comment period for the draft specification will be open from July 1 through July 31, 2021. The final version 1.0 of the Project US@ Technical Specification is expected to be released later in 2021.
More information and the draft can be found here.
FDA issues draft guidance on remanufacturing and discussion paper seeking feedback on cybersecurity servicing of medical devices[17] (6/17)
The FDA published a draft guidance entitled Remanufacturing of Medical Devices to help clarify whether activities performed on devices are likely remanufacturing. This draft guidance also includes recommendations for information that should be included in labeling to help assure the continued quality, safety and effectiveness of devices that are intended to be serviced over their useful life.
The FDA will begin accepting comments from the public on the draft guidance on June 18, 2021, and will be holding a webinar in the weeks following issuance of the draft guidance to allow industry to learn more about the draft guidance and ask questions of FDA subject matter experts on this topic.
The FDA is also issuing a discussion paper outlining cybersecurity challenges and opportunities associated with the servicing of medical devices. Stakeholders are invited to submit comments on the issues raised in the document to help address the challenges related to medical device servicing in order to maximize the benefits and minimize the risks for patients.
The draft guidance “Remanufacturing of Medical Devices” can be found here.
The discussion paper can be found here.
FDA announces qualification of a medical device development tool to help assess patient- reported outcomes with LASIK surgery[18] (6/17)
Patient-Reported Outcomes with LASIK Symptoms and Satisfaction—also known as PROWL-SS—has been qualified through the Medical Device Development Tools (MDDT) program as a scientifically validated tool to assess individuals’ symptoms and satisfaction with vision associated with LASIK surgery.
PROWL-SS is designed to assess the presence, bother and impact of four visual symptoms and satisfaction with vision in patients undergoing LASIK surgery in support of both premarket and post-market medical device regulatory reviews.
Qualification means that the FDA has evaluated the tool and concurs with available supporting evidence that the tool produces scientifically plausible measurements and works as intended within the specified context of use. The use of a qualified MDDT by a product sponsor is voluntary.
PROWL-SS can be found here.
Biden administration to invest $3 billion for COVID-19 antiviral development[19] (6/18)
Biden Administration is betting on development of a pill for COVID-19. It announced plans to invest more than $3 billion in the research, testing and manufacturing of antiviral treatments for the coronavirus and other viruses that may emerge in the future.
The funding draws from the American Rescue Plan that President Joe Biden signed into law in March and will involve the National Institutes of Health as well as the Biomedical Advanced Research and Development Authority, both of which played key roles in the U.S.'s coronavirus vaccine program.
In contrast to the remarkably rapid development of several safe and effective coronavirus vaccines, research into new antiviral drugs for COVID-19 has moved more slowly.
[1] https://www.wsj.com/articles/novavax-covid-19-vaccine-is-90-effective-in-key-study-11623664800 [2] https://www.wsj.com/articles/positive-covid-19-tests-fall-to-lowest-recorded-rate-11623585601 [3] https://www.biopharmadive.com/news/regeneron-antibody-covid-19-reduce-death-recovery/601909/ [4] https://www.fiercebiotech.com/?page=3 [5] https://www.nytimes.com/2021/06/16/health/covid-vaccine-curevac.html [6] https://www.wsj.com/articles/astrazeneca-not-required-to-accelerate-covid-19-vaccine-deliveries-pay-fines-to-eu-11624039560 [7] https://www.wsj.com/articles/moderna-plans-to-expand-production-to-make-covid-19-vaccine-boosters-supply-more-countries-11624273200 [8] https://www.fda.gov/news-events/press-announcements/fda-approves-stratagraft-treatment-adults-thermal-burns [9] https://www.fiercebiotech.com/cro/medidata-goes-all-decentralized-virtual-capabilities-for-clinical-trials-end-to-end-platform [10] https://www.biopharmadive.com/news/verve-ipo-gene-editing-lyell/601983/ [11] https://www.wsj.com/articles/costly-brain-cancer-drug-no-longer-covered-by-medicare-11623927600 [12] https://www.fiercepharma.com/manufacturing/danaher-strikes-9-6b-buyout-for-next-gen-contract-manufacturing-player-aldevron [13] https://www.fda.gov/news-events/press-announcements/fda-approves-nasal-antihistamine-nonprescription-use [14] https://www.fiercebiotech.com/biotech/bristol-myers-pays-650m-for-rights-to-eisai-s-phase-1-adc [15] https://www.fiercebiotech.com/medtech/google-reorganizes-health-division-shedding-130-employees-and-dropping-consumer-health [16] https://www.hhs.gov/about/news/2021/06/16/hhs-releases-project-us-draft-technical-specification-for-comment.html [17] https://www.fda.gov/news-events/press-announcements/fda-brief-fda-issues-draft-guidance-remanufacturing-and-discussion-paper-seeking-feedback [18] https://www.fda.gov/news-events/press-announcements/fda-brief-fda-announces-qualification-medical-device-development-tool-help-assess-patient-reported [19] https://www.biopharmadive.com/news/biden-coronavirus-antiviral-3-billion-funding/602063/ https://www.hhs.gov/about/news/2021/06/17/biden-administration-invest-3-billion-american-rescue-plan-as-part-covid-19-antiviral-development-strategy.html
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