<Weekly Highlight>
Getting more people vaccinated against Covid-19 means wasting doses[1] (5/21)
Now that Covid-19 vaccine supplies are ample, CDC has issued a new guidance that sites should not miss an opportunity to vaccinate an individual, even if it means remaining doses in a vial will go to waste. Many health workers and state officials had already been saying that vaccinating people should be the priority over ensuring every dose in an open vial is used.
When Covid-19 vaccines first arrived, the demand was so high and the scarcity seemed so real that the focus was: not a wasted dose. Now the mentality has shifted to: not a missed opportunity.
The CDC has said it hopes to maintain wastage below 2% of total doses delivered. Most states are reporting wasted doses far below that number, with a national wastage rate of 0.4%, as of May 20. That is concerning some health officials who think that at this stage of the rollout, some waste should be acceptable. The CDC said that as vaccination supply expands and opportunities to receive the vaccine increase nationwide, it anticipates wastage may increase.
As part of the effort to reach the unvaccinated, authorities are aiming to send vaccines to smaller settings, such as doctor’s offices and pop-up clinics. However, bulk packaging, ideal for mass-vaccination sites, might lead to more wasted doses at smaller clinics. Generally, the more doses in the vials, the more potential for waste.
The full CDC guidance can be found here.
<COVID-19 News>
FDA authorizes longer time for refrigerator storage of thawed Pfizer-BioNTech COVID-19 vaccine prior to dilution, making vaccine more widely available[2] (5/19)
Based on a review of recent data submitted by Pfizer Inc. today, the U.S. Food and Drug Administration is authorizing undiluted, thawed Pfizer-BioNTech COVID-19 Vaccine vials to be stored in the refrigerator at 2°C to 8°C (35°F to 46°F) for up to 1 month.
Previously, thawed, undiluted vaccine vials could be stored in the refrigerator for up to 5 days.
The next Covid-19 test could be a dog’s sniff[3] (5/19)
Research by scientists and dog trainers from the U.S. to the United Arab Emirates suggests that dogs can use their powerful sense of smell to sniff out Covid-19 infections, including in people without symptoms.
With more than 300 million scent receptors (compared with roughly five million in humans), dogs can do this with a high degree of accuracy by detecting compounds the human body releases in secretions like sweat and saliva as it reacts to the coronavirus, according to scientists.
The World Health Organization is coordinating an international task force of researchers to investigate the use of sniffer dogs. It said in a March report that Covid-19-sniffing dogs could complement conventional diagnostic tools because—unlike nasal swab tests, which require contact between people and waiting at least 15 minutes for a result—dogs can screen large numbers of people noninvasively in real time and at low cost. If made possible, one dog can screen 250 to 300 people a day, according to the WHO.
Researchers say more research is needed to answer some unresolved questions, such as whether Covid-19-sniffing dogs can be confused by other viruses or by vaccinations.
Pfizer, BioNTech to send EU up to 1.8B coronavirus vaccine doses[4] (5/20)
Pfizer and BioNTech have agreed to sell up to 1.8 billion more doses of their coronavirus vaccine to the European Commission, which has struggled with obtaining enough supply of authorized shots.
Under the terms of the deal, the European Union will begin receiving 900 million new doses in December on a monthly schedule that lasts through 2023 and retain an option to buy another 900 million. All of the doses will be manufactured in the EU, the companies said Thursday.
The companies have already committed to delivering 600 million doses to the European bloc this year, bringing the potential total allotment to 2.4 billion.
Emergent has made over 100 million doses of J&J Covid-19 vaccine[5] (5/20)
Emergent BioSolutions has made enough of a key ingredient to yield more than 100 million doses of J&J’s Covid-19 vaccine, and federal health regulators are evaluating weather to release the shots.
The plant was also making AstraZeneca’s Covid-19 vaccines. Emergent said the problem was caused by having to produce both AstraZeneca and J&J vaccines at large scale, and the company strained the capacity of its equipment.
On May 19, Emergent CEO apologized at a congressional hearing for the problems at the company’s Baltimore plant that resulted in the contamination of a batch of the vaccine. Some Democrats criticized Emergent for failing to properly maintain its facilities, and some Republicans defended the company.
On April 30, Emergent submitted a remediation plan to the FDA, which includes improvements to housekeeping, sanitation, material storage, and more. The Baltimore plant is now solely devoted to J&J vaccines.
Novavax seeks for another Australian manufacturer as its intended partner focuses on AstraZeneca vaccine production[6] (5/21)
CSL, an Australian biotech that was a likely contender to produce Novavax’s late-stage COVID-19 vaccine in Australia, now says it’ll be too busy manufacturing AstraZeneca’s vaccine because CSL lacks the capacity to make both AstraZeneca and Novavax’s vaccines at the same time.
CSL is now producing more than a million doses of AZ's shot a week. The company is open to additional talks with the Australian government to figure out how it can support Australia’s ongoing vaccination needs.
Novavax has agreed to sell 51 million doses to Australia. The company is now in the hunt for long-term manufacturing in Australia.
<Industry News>
AbbVie routinely raised Humira and Imbruvica prices to maintain monopoly [7] (5/18)
AbbVie owns two of the best-selling drugs in the world in Humira and Imbruvica. However, the company is investigated for its actions to build and defend its market monopoly, and the company has repeatedly raised prices and exploited the U.S. patent system.
According to a report from the congressional investigation on AbbVie, Humira is the nation’s top selling drug in large part due to AbbVie’s price increases and left financial strains on patients. Humira’s cost increased from $522 per syringe in 2003 to $2,984 today which is a 470% increase.
As a result of the investigation, three high-ranking Democrats requested the FTC launch a formal inquiry into AbbVie’s actions to delay US biosimilar entry for its blockbuster drug Humira.
The US government is the biggest customers due to Medicare, and the US is unable to negotiate directly with companies for lower prices for Medicare beneficiaries, which adds burden to American taxpayers.
Bristol Myers pays Agenus $200M for drug aimed at top immunotherapy target[8] (5/18)
Bristol Myers Squibb (BMS) will pay $200 million to acquire rights to an experimental cancer immunotherapy developed by Agnes, a US biotech.
Per deal terms, Bristol Myers could pay Agenus up to $1.36 billion more in conditional payments if certain development, regulatory and marketing milestones are hit. Agenus also retains options to participate in testing the drug or co-promote it in the US if it's ever approved by the FDA.
The drug, which could enter clinical testing later this year, is aimed at a protein target called TIGIT that's lately become of interest to several top cancer drug makers, including Merck, Roche, and Gilead.
HHS orders pharmaceutical companies to repay hospitals for 340B violations[9] (5/18)
The US Department of Health and Human Services (HHS) has called out six pharmaceutical companies for violating rules under the 340B drug discount program, ordering them to repay affected healthcare providers for previous overcharges and warning of more penalties if they don't comply.
In July 2020, some pharma companies stopped giving the 340B ceiling price (the maximum price they can charge) on medicines sold to covered entities and dispensed through contract pharmacies. Others limited sales by requiring specific data or selling products only after a covered provider demonstrated 340B compliance.
HHS asked AstraZeneca, Eli Lilly, United Therapeutics, Sanofi, Novo Nordisk, and Novartis give an update by June 1, 2021 to restart selling outpatient drugs covered at the 340B price to entities that dispense medications through contract pharmacies.
Roivant is expecting a SPAC IPO and aims to reacquire its subsidiary, Immunovant[10] (5/20)
Roivant is expected to be listed on NASDAQ in the third quarter of 2021 through a SPAC deal with Montes Archimedes Acquisition Corp. This will yield $411 million and another $200 million through a private round.
When the deal is settled, Roivant aims to reacquire Immunovant, one of its subsidiaries that went public in December 2019 through a different SPAC. Roivant owns 57.5% of Immunovant and is trying to acquire it.
It is not clear why Roivant wants to reacquire Immunovant. As Immunovant’s majority shareholder, the company said in the filing that it has received nonpublic information about Immunovant and its lead candidate.
GlaxoSmithKline (GSK) sells Innoviva shares back to the respiratory partner for $392M[11] (5/20)
GSK announced that it will sell all its 32 million common stocks of Innoviva back to the company at a total of $392 million. GSK would no longer hold any quantity of Innoviva stock following the transaction.
This would help GSK invest in other priorities, which is likely its plans to separate the company in to two main offerings. GSK plans to separate into 1) business focused on prescription drugs and vaccines 2) over-the-counter products. More plans are to be announced in June.
The split has initially jeopardized the company’s earnings, the new business model may provide long-term pay offs.
Merck-partnered Janux seeks $100M IPO on preclinical promise of bispecific pipeline[12] (5/21)
Janux Therapeutics, a biotech partner of Merck, has filed to raise up to $100 million in an IPO.
The company plans to use the fund to take a clutch of T-cell engager drug candidates into phase 1 clinical trials. It plans to submit four INDs in the first half of 2022.
The company has raised $201 million since its 2017 establishment. With the fund, Janux has established a preclinical pipeline based on its TRACTr platform, which is designed to overcome the limitations of existing T-cell engagers and to realize the potential of the modality in solid tumors.
Overjet gains FDA clearance for gum-disease-spotting deep learning software[13] (5/21)
The FDA has authorized a software platform from dental developer Overjet, which one of the first AI-based technologies for use in dentistry.
Overjet received 510(k) clearance and it will be able to market its “Dental Assist” software for clinical us, selling it directly to dental practices. The software is already employed by insurance companies to make claims processing more accurate and efficient.
Dental Assist uses deep-learning algorithms to measure bone loss in dental X-rays. Those measurements are then used to diagnose periodontal disease, which is estimated to affect nearly half of all U.S. adults.
Because Dental Assist’s analyses are performed in real time, dentists are able to begin treating gum disease much more quickly than with traditional methods, which require them to manually study X-rays to estimate bone levels.
Janssen of Johnson & Johnson receives FDA approval for first exon-20 targeted drug in EGFR lung cancer[14] (5/21)
J&J’s Janssen received FDA’s accelerated approval of its drug Rybrevant for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations.
Rybrevant is the first treatment for NSCLC with a group of EGFR mutations found in 2-3% of patients. It is cleared for patients whose disease has progressed on or after platinum-based chemotherapy.
The FDA approved Rybrevant alongside Guardant Health’s cancer test Guardant360CDx as a companion diagnostic to find the exon 20 insertion mutations.
<Policies & Announcements>
The 2021 FDA Science Forum highlights regulatory science advancements in protecting and promoting public health[15] (5/18)
The 2021 FDA Science Forum, Science as the Foundation for Protecting and Promoting Public Health, is a unique opportunity for stakeholders to engage with and learn directly from FDA experts about a variety of cutting-edge research topics that are at the forefront of public health. The event will take place virtually on May 26 from 9 a.m. – 3:30 p.m. and May 27 from 9 a.m. – 2 p.m.
The event is hosted biannually by the FDA’s Office of the Chief Scientist, which provides strategic leadership and support for the FDA’s regulatory science and innovation initiatives through cross-agency coordination and collaboration.
Key topic areas include:
Improving Clinical and Postmarket Evaluation
Tools to Effectively Use Big Data
Empowering Patients and Consumers
Product Development and Manufacturing
Advancing Products Based on Novel Technologies
Medical Countermeasures, Infectious Disease, and Pathogen Reduction Technologies
Food and Cosmetic Safety
Substance Use, Misuse, and Addiction
View more information about the event here
FDA issues draft guidance on early clinical studies for certain medical devices to improve glycemic control for type 2 diabetes[16] (5/19)
The FDA issued a draft guidance providing recommendations for feasibility and early feasibility clinical studies for certain medical devices intended to therapeutically improve glycemic control in patients with Type 2 Diabetes Mellitus, independent of medication delivery.
Such medical devices include, but are not limited to, neurostimulators and those that mimic or result in anatomical changes similar to those made by bariatric surgical procedures, alter the anatomy and/or physiology of the small intestines or manipulate the sympathetic nervous system.
Comments may be submitted to the public docket here. Comments can be submitted for consideration in the development of the report by July 20, 2021.
FDA advises against use of SARS-CoV-2 antibody test results to evaluate immunity or protection from COVID-19, including after vaccination[17] (5/19)
The FDA issued a safety communication informing the public that results from SARS-CoV-2 antibody tests should not be used to evaluate immunity or protection from COVID-19 at any time, and especially after the person received a COVID-19 vaccination.
Post-vaccination antibody test results will be negative in individuals without a history of previous natural infection if the test used does not detect the type of antibodies induced by the vaccine.
Currently authorized SARS-CoV-2 antibody tests are not validated to evaluate immunity or protection from COVID-19 infection. SARS-CoV-2 antibody tests should be ordered only by health care providers who are familiar with the use and limitations of the test.
FDA announces seizure of adulterated dietary supplements containing kratom[18] (5/21)
The FDA seized more than 207,000 units of dietary supplements and bulk dietary ingredients that are or contain kratom, manufactured by Atofil LLC. The seized products are worth approximately $1.3 million.
The dietary supplements are marketed under the brand names Boosted Kratom, The Devil’s Kratom, Terra Kratom, Sembuh, Bio Botanical, and El Diablo.
Kratom, also known as mitragyana speciosa, is a plant that has concerns around its toxicity in multiple organ systems.
The FDA continues to warn consumers not to use any products labeled as containing kratom. The FDA encourages health care professionals and consumers to report any adverse events related to products containing kratom.
FDA approves first targeted therapy for subset of non-small cell lung cancer by Janssen[19] (5/21)
The FDA granted approval of Rybrevant to Janssen Pharmaceutical Companies of Johnson & Johnson as the first treatment for adult patients with non-small cell lung cancer whose tumors have specific types of genetic mutations: epidermal growth factor receptor (EGFR) exon 20 insertion mutations. The FDA also approved the Guardant360 CDx (Guardant Health Inc.) as a companion diagnostic for Rybrevant.
[1]https://www.wsj.com/articles/getting-more-people-vaccinated-against-covid-19-means-wasting-doses-11621594802 [2]https://www.fda.gov/news-events/press-announcements/fda-brief-fda-authorizes-longer-time-refrigerator-storage-thawed-pfizer-biontech-covid-19-vaccine [3]https://www.wsj.com/articles/your-next-covid-19-test-could-be-a-dogs-sniff-11621425603 [4]https://www.biopharmadive.com/news/pfizer-biontech-eu-vaccine-supply-deal/600539/ [5]https://www.wsj.com/articles/covid-19-vaccine-maker-blames-problems-on-producing-two-different-shots-11621434060 [6]https://www.fiercepharma.com/manufacturing/novavax-hunts-for-australian-manufacturer-as-csl-homes-astrazeneca-vaccine-production [7]https://www.fiercepharma.com/pharma/abbvie-repeatedly-raised-prices-for-humira-imbruvica-and-abused-u-s-patent-system-to-extend [8]https://www.biopharmadive.com/news/bristol-myers-agenus-tigit-cancer-drug/600364/ [9]https://www.biopharmadive.com/news/eli-lilly-challenges-hhs-order-to-repay-hospitals-for-340b-violations/600369/ [10]https://www.fiercebiotech.com/biotech/roivant-unexspacted-twist-wants-to-bring-immunovant-back-into-fold [11]https://www.biospace.com/article/gsk-sells-entire-shares-in-respiratory-partner-innoviva-for-392-million/ [12]https://www.fiercebiotech.com/biotech/merck-partnered-janux-seeks-100m-ipo-preclinical-promise-bispecific-pipeline [13]https://www.fiercebiotech.com/medtech/overjet-nets-fda-clearance-f [14]https://www.fiercepharma.com/pharma/johnson-johnson-snares-fda-green-light-for-first-ever-treatment-group-mutation-specific-non [15]https://www.fda.gov/news-events/press-announcements/fda-brief-science-forum-highlights-regulatory-science-advancements-protecting-and-promoting-public [16]https://www.fda.gov/news-events/press-announcements/fda-brief-fda-issues-draft-guidance-early-clinical-studies-certain-medical-devices-improve-glycemic [17]https://www.fda.gov/news-events/press-announcements/fda-brief-fda-advises-against-use-sars-cov-2-antibody-test-results-evaluate-immunity-or-protection [18]https://www.fda.gov/news-events/press-announcements/fda-announces-seizure-adulterated-dietary-supplements-containing-kratom [19]https://www.fda.gov/news-events/press-announcements/fda-approves-first-targeted-therapy-subset-non-small-cell-lung-cancer