<Weekly Highlight>
Pfizer to ask regulators to authorize Covid-19 vaccine booster, but CDC recommends to wait[1] (7/8)
Pfizer will seek clearance from US regulators in coming weeks to distribute a booster shot of its Covid-19 vaccine to heighten protection against infections, as new virus strains rise.
The company also plans to start clinical trials in August of an updated version of its vaccine that would better protect against the Delta variant.
Within hours of that news, though, the Centers for Disease Control and Prevention (CDC) and the FDA told Americans that they don't need to worry about boosters right now.
The CDC and FDA urged a wait-and-see approach. In a joint statement, the agencies made their position clear: "Americans who have been fully vaccinated do not need a booster shot at this time."
Joint CDC and FDA statement on vaccine boosters[2]
“Americans who have been fully vaccinated do not need a booster shot at this time. FDA, CDC, and NIH are engaged in a science-based, rigorous process to consider whether or when a booster might be necessary. This process takes into account laboratory data, clinical trial data, and cohort data – which can include data from specific pharmaceutical companies but does not rely on those data exclusively. We continue to review any new data as it becomes available and will keep the public informed. We are prepared for booster doses if and when the science demonstrates that they are needed.”
<COVID-19 News>
WHO backs Roche, Sanofi drugs for COVID-19 after research ups and downs[3] (7/7)
The World Health Organization has recommended the use of two arthritis drugs — Roche's Actemra as well as Sanofi and Regeneron's Kevzara — for patients with severe or critical COVID-19.
The decision was announced alongside a meta-analysis of 27 clinical trials that tested the two drugs in nearly 11,000 patients. According to that analysis, treatment with either Actemra or Kevzara on top of standard drugs lowered rates of death from any cause after 28 days or progression to mechanical ventilation.
The WHO's decision is only the second positive recommendation the organization has issued for a COVID-19 drug, following one in September 2020 for corticosteroids.
Delta Covid-19 variant is dominant US strain, CDC data show[4] (7/7)
The highly transmissible Delta variant has become the dominant strain of the Covid-19 virus circulating in the US, according to federal data.
The Delta variant, also known as B.1.617.2, made up 51.7% of Covid-19 infections in the two weeks ended July 3, according to genetic sequences from positive Covid-19 tests submitted to the U.S. Centers for Disease Control and Prevention.
Covid-19 vaccines available in the U.S. protect against the Delta variant, but the virus is of great risk to people who aren’t vaccinated, according to public-health and infectious-disease experts. It is estimated to be at least 50% more transmissible than the Alpha variant.
<Industry News>
Sanofi teams with Eureka Therapeutics and MSK on GPR5CD non-CAR myeloma treatment[5] (7/6)
Sanofi Genzyme has signed a license agreement with Eureka Therapeutics and Memorial Sloan Kettering Cancer Center for the non-CAR use of a new treatment targeting GPRC5D.
This new agreement allows the development of non-CAR myeloma treatments targeting GPRC5D in the joint venture.
Under the terms of the agreement, Sanofi has exclusive rights to the GPRC5D binder for non-CAR use. Eureka and MSK are eligible to receive an upfront payment and potential regulatory and sales milestone payments. Eureka and MSK are also eligible to receive tiered royalties on net sales.
AstraZeneca's $39B Alexion buyout scores EU blessing but still awaits key nod from the UK[6] (7/6)
AstraZeneca’s $39 billion takeover of rare disease specialist Alexion has another regulatory blessing, but the pair are still holding out for a key nod from the UK to settle the deal.
European Union has approved AZ’s acquisition of Boston-based Alexion, inching closer toward its goal of closing the deal by the end of September 2021. The company’s Alexion buyout also has the backing from the U.S., Japan, Canada and others. But it can’t go through without the UK’s approval, where it’s still pending.
The acquisition, the biopharma world’s largest in 2020, is set to boost AstraZeneca’s footprint in immunology, as well as bolster the drugmakers’ top line.
Moderna puts seasonal flu vaccine ambitions to the test[7] (7/7)
Moderna's plans to reinvent the seasonal flu shot began in earnest this week, as the first participants in a small clinical trial received an experimental influenza vaccine the biotech company is developing.
The experimental candidate uses the same messenger RNA technology that powered Moderna's vaccine for COVID-19 and is designed to target four influenza strains that widely circulate each year.
Moderna said it plans to enroll 180 adults in the Phase 1/2 trial, which will test a range of vaccine doses. While the drugmaker has previously tested mRNA vaccines against influenza in early studies, this newly launched trial is the first to evaluate one for protection against seasonal flu strains.
Alpha Tau hops aboard the SPAC train with $367M deal to take its tumor-blasting tech public[8] (7/8)
Armed with a recent breakthrough designation from the FDA for its tumor-destroying radiation technology, Alpha Tau Medical is plowing ahead with plans to go public before the end of 2021.
To do so, it’ll join the growing list of medtech and biotech startups taking the SPAC route to the public market: Alpha Tau plans to combine with the special purpose acquisition company Healthcare Capital Corp., after which it will be listed on the Nasdaq under a still-unannounced ticker symbol.
The deal will bring Alpha Tau up to $367 million in gross proceeds. Up to $275 million of that will come directly from HCC’s trust account.
The other $92 million will come from an already fully committed private investment round.
Eli Lilly taps Verge Genomics in ALS deal worth $25M upfront[9] (7/8)
As Verge Genomics, a neuroscience-focused drug discovery company, it is teaming up with Eli Lilly to pursue even more targets for new treatments against amyotrophic lateral sclerosis (ALS).
Verge Genomics will pick up $25 million in an upfront fee, equity and near-term payments but stands to collect up to $694 million down the line. Under the three-year deal, Verge will use its artificial-intelligence-powered drug discovery platform to identify new targets of which Lilly may select up to four to push into clinical development and commercialization.
The targets under the deal will not overlap with Verge’s in-house pipeline of treatments for ALS and other neurodegenerative ailments.
FDA narrows suggested uses for new Alzheimer’s drug[10] (7/8)
US health regulators narrowed the prescribing instructions for Biogen’s first new Alzheimer’s drug in nearly two decades, recommending the therapy be given to people with early-stage symptoms of the disease. The change recommends use of the drug, Aduhelm from Biogen be brought in line with the patients it was studied in.
It could also make it easier for Medicare, the federal insurance program that is expected to pay for most prescriptions, to limit the bill it faces from Aduhelm in coming years by restricting the number of patients who take it.
The FDA, which made the change, initially approved Aduhelm in June for all Alzheimer’s patients, rather than the specific group of patients with relatively mild symptoms for whom the drug was designed.
In rare double-SPAC deal, Hyperfine picks up brain-sensing tech company as it goes public[11] (7/9)
Hyperfine, with its portable brain scanner and direct sales model, has already worked to disrupt the $23 billion MRI market. Now, Hyperfine and special purpose acquisition companies, HealthCor Management and Catalio Capital Management, are using the opportunity to pick up new brain-sensing technology through the purchase of Liminal Sciences.
The total value of the three-way deal is set at about $580 million, including a $126 million private investment round supported by HealthCor and Catalio.
This deal will get Hyperfine $375 million in cash to continue the national rollout of its Swoop MRI scanner-on-wheels, designed to be small enough to move around a hospital, fit in an elevator and run off a standard power outlet and tablet.
Biden competition order targets hospital mergers, surprise medical bills[12] (7/12)
The White House call for revised enforcement guidelines to promote hospital competition will likely amplify federal scrutiny of hospital mergers, which have raised prices.
The Biden administration order encouraged the Justice Department and Federal Trade Commission to review and possibly revise their merger guidelines. It highlighted hospital consolidation, which the order said has harmed consumers.
The order also called for the Health and Human Services Department to support rules limiting surprise medical bills and requiring that hospitals disclose their prices. The Trump administration ordered hospitals to make their prices public starting on January 2021, but many hospitals have failed to comply.
Novo Nordisk, in rare deal, buys rights to Prothena amyloidosis treatment[13] (7/12)
Danish drugmaker Novo Nordisk is expanding further in researching drugs for the heart, announcing a deal to buy an experimental rare disease treatment from Dublin-based biotech company Prothena.
Novo will pay Prothena $100 million in the near term for rights to a drug called PRX004, which Prothena has been developing for the progressive protein disorder ATTR amyloidosis. All told, the deal could be worth as much as $1.2 billion for Prothena, should clinical development progress and the drug win approval.
Novo plans to focus on developing PRX004 for a type of ATTR amyloidosis that affects the heart. Prothena has completed a Phase 1 safety test of the drug in hereditary ATTR amyloidosis but designed the drug to work for what's known as the "wild-type," or non-hereditary, form of the disease, too.
<Policies & Announcements>
FDA issues systems recognition draft guidance[14] (7/9)
The FDA issued the draft guidance, FDA Oversight of Food Products Covered by Systems Recognition Arrangements, that explains how the agency plans to adjust its regulatory oversight activities for foods subject to FDA regulatory requirements, when the foods are produced in or imported from countries covered by a Systems Recognition Arrangement, such as those that the FDA currently has with Australia, Canada and New Zealand.
The New Era of Smarter Food Safety Blueprint outlines the approach the FDA will take over the next decade to bend the curve of foodborne illness through the use of new technologies and modernized approaches for risk-based allocation of oversight resources.
The FDA Food Safety Modernization Act (FSMA) provides the FDA with a variety of new authorities to help ensure the safety of imported foods and recognizes the role of the food safety regulatory system in exporting countries to assure compliance with FDA food safety standards for a given food.
The FDA’s Strategy for the Safety of Imported Food describes how the agency may leverage the oversight efforts of regulatory counterparts with strong food safety systems to help ensure the safety of food offered for import.
The full draft guidance can be found here.
HHS updates interoperability standards to support the electronic exchange of sexual orientation, gender identity and social determinants of health[15] (7/9)
The US Department of Health and Human Services’ Office of the National Coordinator for Health Information Technology (ONC) today released the United States Core Data for Interoperability version 2, a standardized set of health data classes and constituent data elements for nationwide, interoperable health information exchange.
With this new update, health IT stakeholders nationwide will have clearer direction toward the standardized, electronic exchange of social determinants of health (SDOH), sexual orientation, and gender identity (SO/GI) among several other updated data elements.
While encouraged, this update does not require health professionals, such as doctors and nurses, to record this data or individuals to share such data. It does however set a path forward for health IT to build in support for exchanging these data as they become applicable to an individual's care.
[1] https://www.wsj.com/articles/pfizer-to-ask-regulators-to-authorize-covid-19-vaccine-booster-11625784072 https://www.fiercepharma.com/pharma/staying-vigilant-pfizer-and-biontech-plot-delta-busting-covid-19-booster-shot [2] https://www.hhs.gov/about/news/2021/07/08/joint-cdc-and-fda-statement-vaccine-boosters.html [3] https://www.biopharmadive.com/news/who-actemra-kevzara-covid-sanofi-roche/602950/ [4] https://www.wsj.com/articles/delta-covid-19-variant-is-dominant-u-s-strain-cdc-data-show-11625695319 [5] https://www.myelomacrowd.org/sanofi-teams-with-eureka-therapeutics-and-msk-on-gpr5cd-non-car-myeloma-treatment/ [6] https://www.fiercepharma.com/pharma/astrazeneca-s-39b-alexion-buyout-scores-eu-s-blessing-but-awaits-key-nod-from-uk [7] https://www.biopharmadive.com/news/moderna-mrna-vaccine-seasonal-flu-trial/602934/ [8] https://www.fiercebiotech.com/medtech/alpha-tau-hops-aboard-spac-train-367m-deal-to-take-its-tumor-blasting-tech-public [9] https://www.fiercebiotech.com/biotech/eli-lilly-taps-verge-genomics-als-deal-worth-25m-upfront [10] https://www.wsj.com/articles/fda-narrows-suggested-uses-for-new-alzheimers-drug-11625759738 [11] https://www.fiercebiotech.com/medtech/portable-mri-maker-hyperfine-to-go-public-add-brain-sensing-tech-rare-double-spac-deal [12] https://www.wsj.com/articles/biden-competition-order-targets-hospital-mergers-surprise-medical-bills-11625932801 [13] https://www.biopharmadive.com/news/novo-prothena-amyloidosis-drug-heart/603156/ [14] https://www.fda.gov/news-events/press-announcements/fda-brief-fda-issues-systems-recognition-draft-guidance [15] https://www.hhs.gov/about/news/2021/07/09/hhs-updates-interoperability-standards-to-support-electronic-exchange-of-sogi-sdoh.html
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