<Weekly Highlight>
Biden Administration recommends policy changes to secure US pharmaceutical supply chain[1] (6/8)
After investigating America’s supply chains, including those for drugs and pharmaceutical ingredients, the Biden administration is proposing a strategy to boost domestic drug production.
Under the plan, the White House is establishing a public-private partnership to select 50 to 100 essential medicines to be the focus of an enhanced onshoring effort.
Further, the government is committing around $60 million to research new technologies to boost domestic API production.
While the US was up to speed in producing Covid-19 vaccines, the Biden administration conceded that the country is “critically dependent on imports for a range of key pharmaceutical products and APIs,” which make up 90% of all prescription medicines filled in the US.
Meanwhile, some 87% of generic active pharmaceutical ingredient facilities are located abroad, leaving US supplies of essential meds “vulnerable,” the administration said.
View the full White House report here.
<COVID-19 News>
Covid-19 Delta variant first found in India is quickly spreading across the globe[2] (6/9)
The highly transmissible Covid-19 variant that first emerged in India is rapidly spreading around the world, health authorities say, intensifying the race to increase global vaccinations.
The B.1.617.2 variant, now dubbed the Delta variant, is in at least 60 countries, including the U.S. and the U.K., and British scientists recently estimated that it might be 40% to 50% more transmissible than the B.1.1.7 variant, or Alpha, which in turn is more transmissible than the original virus and quickly spread across the globe.
In the U.K., the Delta variant is rapidly displacing the Alpha variant, and health officials believe that it is contributing to an uptick in Covid-19 cases and hospitalizations in the country, though it is starting from a low baseline.
US pays $1.2B on Merck's last hope for a COVID-19 drug[3] (6/9)
The U.S. government has agreed to pay Merck & Co. $1.2 billion for roughly 1.7 million courses of an experimental COVID-19 drug should the treatment, currently in late-stage testing, win emergency authorization.
The drug, known as molnupiravir, is an antiviral pill being tested in COVID-19 patients who haven't yet been hospitalized.
In addition to the U.S. deal, Merck, which is developing the treatment as part of a partnership with biotech Ridgeback Biotherapeutics, is also discussing advanced purchase agreements with other governments. The pharma has alliances with generic manufacturers to provide access to the drug in low- and middle-income countries.
If successful in clinical testing, molnupiravir has the chance to become the first oral COVID-19 treatment, an improvement over the injectable and infused medicines used now.
Amazon gets FDA approval to sell COVID-19 tests directly to consumers[4] (6/9)
Amazon has gotten the approval from the FDA to begin selling its own COVID-19 test directly to consumers.
The FDA’s emergency use authorization allows Amazon’s subsidiary STS Lab Holdco to sell its Amazon Real-Time RT-PCR test kits to anyone 18 years or older without requiring buyers to obtain a prescription or show proof of any COVID symptoms or recent contact with the virus.
The EUA also allows for pooled testing, in which up to five individual samples may be combined and tested at the same time, exponentially increasing the reach of Amazon’s lab resources.
After each nasal swab kit is sent to one of Amazon’s processing labs using the included prepaid shipping label, users will receive notifications via text message and email once their test results are ready. The results can then be accessed through an online portal located at AmazonDx.com.
US government buys 500 million Pfizer COVID-19 vaccine doses for global use[5] (6/10)
The Biden administration is purchasing 500 million doses of Pfizer's COVID-19 vaccine to donate to the global supply. That will provide enough shots to fully vaccinate 250 million people.
The U.S. is donating 200 million doses this year and 300 million doses in the first half of 2022. All of the doses will be distributed through COVAX — the global entity that is working to ensure equitable access to COVID testing and vaccines — and will be given to 92 low- and middle-income countries and the African Union.
Moderna’s Covid-19 Vaccine Seeks FDA Authorization for Use in Adolescents[6] (6/10)
Moderna has asked U.S. health regulators to authorize the use of its Covid-19 shot in adolescents ages 12 to 17, setting up the potential availability of a second vaccine option for adolescents.
Moderna is seeking authorization from the U.S. Food and Drug Administration after releasing results of a study in May showing that the vaccine safely induced immune response in adolescents and appeared to be protective against Covid-19 disease.
The FDA could make a decision on Moderna’s request by early July if it follows the same kind of timetable it took with the Covid-19 vaccine from Pfizer.
Johnson & Johnson told to throw out 60M COVID-19 shots made at troubled Emergent site[7] (6/11)
After spending weeks inspecting the site, the FDA has instructed COVID-19 vaccine maker Johnson & Johnson and its production partner Emergent BioSolutions to throw out 60 million vaccine doses.
Federal regulators have decided tens of millions of doses will have to be discarded because of possible contamination. The FDA will allow about 10 million doses to ship out to the U.S. and other countries, but those shots will come with a warning that regulators can’t guarantee Emergent followed good manufacturing practices.
<Industry News>
FDA approval of new Alzheimer’s drug may boost prospects of other treatments[8](6/8)
The Food and Drug Administration’s approval of Biogen’s Aduhelm on June 7th may have boosted the prospects of other experimental Alzheimer’s disease drugs that target the disease in a similar way.
In approving Aduhelm, the FDA endorsed a hypothesis about Alzheimer’s that not long ago was thought dead: The disease can be treated by clearing the buildup of a sticky substance in the brain known as amyloid.
The decision was cheered by many Alzheimer’s patient groups and doctors, who have lacked good options for treatment. The move was criticized, however, by many researchers who said there wasn’t enough evidence to show the drug worked and at a $56,000 yearly list price, it will be costly.
Datavant and Ciox Health announce $7B merger [9] (6/9)
Datavant, a real-world health data company, and Ciox Health, a health record IT firm, announced a merger in a transaction valued at $7 billion.
Under the deal, Datavant will expand its reach to thousands of U.S. clinics. The resulting company plans to offer a joint technology ecosystem that brings disparate health records together and allow for secure, anonymous exchanges among patients, providers, and biopharma companies alike.
It's the largest transaction by far among recent deals in the space, which focuses in part on de-identifying patient data so researchers can easily—and legally—use it.
Valo Health to go public through a SPAC deal[10] (6/9)
Valo Health LLC, an early-stage company focused on drug discovery and development, is going public through a combination with a special-purpose acquisition company, a deal that values the combined entity at about $2.8 billion.
Boston-based Valo and the SPAC, Khosla Ventures Acquisition Co. expect to use proceeds from the transaction to help Valo develop its software platform and advance its preclinical and clinical drug pipeline.
Valo, which isn’t currently generating revenue, operates a platform called Opal, which it said would be able to speed up drug discovery and development using data analysis and artificial intelligence.
US FDA approves CyMedica’s Intellihab system to treat knee osteoarthritis[11] (6/9)
CyMedica Orthopedics has secured approval from the US Food and Drug Administration (FDA) for its Intellihab system, a non-invasive modality to treat knee osteoarthritis pain.
The home-based therapeutic and digital health ecosystem has been designed to treat pain that is associated with the debilitating osteoarthritis disease.
With this regulatory clearance, CyMedica will be able to further focus on evidence-based medicine and its dedication to helping patients manage symptoms related to osteoarthritis.
Pfizer’s pneumococcal vaccine Prevnar 30 wins FDA approval[12] (6/9)
A Pfizer vaccine that addresses 20 types of pneumococcal bacteria has won FDA approval, giving the company a successor to a blockbuster product and the edge in a race to protect against more of these strains that can lead to serious infections, such as pneumonia and meningitis.
Prevnar 20 vaccine protects against 20 of these strains, improving on Prevnar 13, a Pfizer product that accounted for more than $5.8 billion in global sales last year. Approval of Prevnar 20 covers adults 18 and older.
Prevnar 20 is what’s called a conjugate vaccine. The antigens for the vaccine are polysaccharides, chains of sugar molecules from the bacteria’s outer coat. The polysaccharides are conjugated, or bonded, to a carrier protein. By carrying more of these polysaccharides, a vaccine can protect against more strains.
FDA approves Medtronic's long-lasting Vanta spinal cord stimulator[13] (6/10)
Medtronic received FDA approval for its latest spinal cord stimulation implant for chronic pain, with a non-rechargeable device promising nearly double the battery life of previous hardware.
With properly optimized power delivery settings, the Vanta system can last up to 11 years—or 10% longer than the company’s last-generation neurostimulator, the PrimeAdvanced device, while also being 20% smaller.
The Vanta device also includes Medtronic’s AdaptiveStim technology that tracks the patient's movement and body position with an internal accelerometer. This can adjust the intensity of stimulation based on whether they are lying down, sitting or standing up
GSK pays iTeos $625M upfront, joining the TIGIT immuno-oncology race[14] (6/14)
GlaxoSmithKline is paying iTeos Therapeutics $625 million upfront for rights to phase 1 anti-TIGIT monoclonal antibody EOS-448. The deal sets GSK up to challenge in the immuno-oncology market.
Other major pharmaceutical companies including Merck, Roche, Bristol Myers, and Gilead were interested in TIGIT. GSK has put together a biggest upfront to land EOS-448, paying more initially than Bristol Myers and Gilead combined.
The $625 million upfront secures GSK the right to co-commercialize and evenly split the profits from EOS-448 in the US. In other countries, GSK has an exclusive license and will pay iTeos tiered royalties. It can go up to $1.45 billion in milestones.
<Policies & Announcements>
FDA Provides Guidance on Measuring Patient-Reported Outcomes in Cancer Clinical Trials[15] (6/9)
Today, the U.S. Food and Drug Administration issued a draft guidance document, “Core Patient-Reported Outcomes in Cancer Clinical Trials,” which will provide recommendations to sponsors on which patient-reported outcomes (PRO) concepts to measure in cancer clinical trials.
The draft guidance addresses how to incorporate assessment of PRO in clinical trials of drugs and biological products that are intended to support product labeling describing anti-tumor activity in patients with cancer.
The draft guidance also addresses the frequency of these PRO assessments within cancer trials, highlighting that PRO assessments should be of sufficient frequency to take into account the administration schedule of the products being studied. It also discusses labeling considerations for PROs submitted with oncology product applications.
View the full draft guidance here.
FDA extends J&J vaccine shelf life just as millions of doses were set to expire[16] (6/10)
The U.S. FDA has extended the shelf life for J&J’s single-shot vaccine from three months to four and a half, the drugmaker said Thursday. The agency based its decision on ongoing stability studies that found the vaccine could last longer when kept at refrigerated temperatures.
Dwindling demand for COVID-19 vaccines, coupled with safety concerns clouding J&J’s shot, have led to a larger-than-expected stockpile of doses. In order to work through the backlog, the federal government has suspended shipments of the vaccine so states can catch up.
In addition to FDA’s announcement to extend the shelf-life, the FDA approved an EUA for two batches of J&J’s Covid-19 vaccines manufactured at the Emergent BioSolutions facility in Baltimore.
HHS issues revised notice of reporting requirements and reporting timeline for recipients of Provider Relief Fund Payments [17] (6/11)
The US Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA) is releasing revised reporting requirements for recipients of Provider Relief Fund (PRF) payments.
This announcement includes expanding the amount of time providers will have to report information, aims to reduce burdens on smaller providers, and extends key deadlines for expending PRF payments for recipients who received payments after June 30, 2020.
The revised reporting requirements will be applicable to providers who received one or more payments exceeding, in the aggregate, $10,000 during a single Payment Received Period from the PRF General Distributions, Targeted Distributions, and/or Skilled Nursing Facility and Nursing Home Infection Control Distributions.
[1] https://www.fiercepharma.com/manufacturing/biden-administration-unveils-plan-to-resurrect-drug-manufacturing-stateside https://www.hhs.gov/about/news/2021/06/08/biden-administration-recommends-policy-changes-secure-us-pharmaceutical-supply-chain.html [2] https://www.wsj.com/articles/covid-19-variant-first-found-in-india-is-quickly-spreading-across-globe-11623257849 [3] https://www.biopharmadive.com/news/merck-ridgeback-molnupiravir-us-supply-deal/601528/ [4] https://www.fiercebiotech.com/medtech/prime-day-deal-amazon-lands-fda-go-ahead-to-sell-covid-19-tests-directly-to-consumers [5] https://www.cbsnews.com/news/covid-vaccine-pfizer-global-distribution-biden-administration/ [6] https://www.wsj.com/articles/modernas-covid-19-vaccine-seeks-fda-authorization-for-use-in-adolescents-11623338454 [7] https://www.fiercepharma.com/pharma/johnson-johnson-told-to-throw-out-60m-covid-19-shots-made-at-troubled-emergent-site-report [8] https://www.wsj.com/articles/fda-approval-of-new-alzheimers-drug-may-boost-prospects-of-other-treatments-11623179622 [9] https://www.fiercebiotech.com/medtech/datavant-to-absorb-ciox-health-7b-medical-data-deal [10] https://www.wsj.com/articles/valo-health-to-go-public-through-spac-deal-11623232801 [11] https://www.medicaldevice-network.com/news/us-fda-cymedicas-intellihab-knee-osteoarthritis/ [12] https://medcitynews.com/2021/06/pfizers-prevnar-20-wins-fda-nod-getting-edge-in-pneumococcus-vax-race-for-now/ [13] https://www.fiercebiotech.com/medtech/fda-approves-medtronic-s-long-lasting-vanta-spinal-cord-stimulator [14] https://www.fiercebiotech.com/biotech/gsk-pays-iteos-625m-upfront-to-join-merck-roche-and-rest-tigit-immuno-oncology-race [15] https://www.fda.gov/news-events/press-announcements/fda-brief-fda-provides-guidance-measuring-patient-reported-outcomes-cancer-clinical-trials [16] https://www.fiercepharma.com/pharma/j-j-s-covid-19-vaccine-cleared-by-fda-for-more-time-shelf-just-as-millions-doses-were-set-to https://www.fda.gov/news-events/press-announcements/fda-takes-steps-increase-availability-covid-19-vaccine [17] https://www.hhs.gov/about/news/2021/06/11/hhs-issues-revised-reporting-requirements-timeline-for-provider-relief-fund-recipients.html