Weekly Highlight
FDA and J&J are near a deal to resume Covid-19 vaccine production at Baltimore plant[0] (5/27)
The FDA and Johnson & Johnson expect to announce that contamination problems at a Covid-19 vaccine plant in Baltimore are resolved, clearing the way for millions more doses to become available.
Vaccine production at the plant run by contract manufacturer Emergent BioSolutions was halted after unsanitary conditions led to contamination of J&J vaccines. The Emergent has been taking corrective measures and been in talks with FDA and J&J over the steps needed to reopen the facility.
The facility made vaccine substance and finished vaccine doses for J&J and AstraZeneca.
<COVID-19 News>
Samsung becomes latest CDMO to produce major amounts of Moderna vaccine [1] (5/24)
Moderna has selected Samsung Biologics for large-scale, commercial fill-finish duties on its mRNA-based vaccine.
Once the deal closes, tech transfer will kick off immediately at Samsung's facilities in Incheon, South Korea, where the CDMO plans to leverage a finishing, labeling and packaging line to create out hundreds of millions of vaccine doses for countries other than the United States.
More specifically, the companies are angling to start deliveries from Incheon in the third quarter of 2021. Moderna didn't specify which other countries would receive the Samsung-made shots.
South Korea granted Moderna's shot with a conditional marketing authorization on Friday; the country has purchased 40 million Moderna doses.
Alongside news of the approval, Moderna said it was looking to set up a commercial subsidiary in Korea later in 2021.
Coronavirus variants threaten to undermine another Lilly COVID-19 drug [2] (5/24)
The US government has paused distribution of Eli Lilly's combination COVID-19 antibody drug in Massachusetts due to the growing prevalence of a coronavirus variant that is less susceptible to treatment.
The variant, first identified in Brazil, is circulating with more than 10% frequency in the state.
As a result, the government advised the area's healthcare providers to prescribe an antibody cocktail from Regeneron instead. Lilly's double antibody regimen was shown to be weaker against the variant in lab tests.
Covid-19 vaccine makers press countries to oppose patent waiver[3] (5/24)
Covid-19 vaccine makers have dialed up lobbying and public-relations efforts to rally opposition to a proposal to temporarily waive their patents.
Since the Biden administration announced its support behind the waiver proposal in early May, pharmaceutical industry trade groups have been moving to support Germany, Japan and other countries that expressed opposition.
The industry lobbyists have told the governments that a waiver wouldn’t address shortages any time soon, while straining raw material supplies.
Vaccine makers have also rolled out pledges to deliver more doses to developing countries, which have pressed for the waiver.
Half of US adults are fully vaccinated against Covid-19[4] (5/25)
Half of US adults are fully vaccinated against Covid-19, a sign of the nation’s progress in fighting the pandemic. More than 129 million people in the US 18 years and older have been vaccinated.
Moderna, with new results, set to seek vaccine clearance for young teens[5] (5/25)
Moderna announced that its coronavirus vaccine was strongly protective against COVID-19 in a late-stage study of adolescents between 12 and 17 years old, positioning the biotech to seek clearance for expanded use of the shot beyond its current authorization in adults.
The vaccine met the main goal of a placebo-controlled trial of 3,732 participants, spurring immune responses in adolescents comparable to what was observed in vaccinated adults. Vaccine efficacy was between 93% and 100% against symptomatic COVID-19, depending on how cases were defined, and no new safety concerns were reported.
Moderna will submit the data to regulators in the US and abroad in early June. Tests in younger children, meanwhile, are ongoing.
Covid-19 treatment from Vir Biotechnolgy and GlaxoSmithKline is authorized[6] (5/26)
Vir Biotechnology and GlaxoSmithKline (GSK) announced that a monoclonal antibody drug to treat early Covid-19 infections has been authorized by the FDA.
The drug, called sotrovimab, is the third antibody medicine authorized to treat patients early in the course of disease who are at high risk of developing severe cases.
Vir and GSK are betting that the globe will be fighting Covid-19 for years to come, even if at a much-reduced scale, because of new virus variants and uneven vaccination rates.
Eli Lilly gets Department of Justice subpoena related to its NJ plant[7] (5/27)
Eli Lilly received a subpoena from the Justice Department seeking documents related to the drugmaker’s manufacturing plant in Branchburg, N.J.
In November 2019, the FDA notified Eli Lilly that during an inspection of the plant, where the company makes the blockbuster diabetes drug Trulicity and its Covid-19 antibody drug bamlanivimab, it had found that appropriate controls weren’t exercised over computers or related production and laboratory systems.
Earlier this month, a group of employees had filed an internal complaint that accused a top quality official at the plant of altering documents required by government regulators in an effort to play down quality-control problems.
Eli Lilly said an investigation was under way, and that the company would take appropriate action based on its outcome.
Sanofi, GSK kick-start phase 3 COVID-19 vax test as the pair targets variants, Q4 approval[8] (5/27)
Sanofi and GlaxoSmithKline got the approval for a much bigger phase 3, which could lead to a full approval by the fourth quarter. The companies had passed the phase 2 test in mid-May.
Novartis and Molecular Partners launch a global study of novel COVID-19 drug[9] (5/27)
Novartis and Molecular Partners are beginning phase 2/3 study of its prospect in adults with early-stage COVID-19 to see whether it can prevent severe disease and hospitalization.
The study will test the drug, ensovibep in adults with COVID-19 infection confirmed by an antigen test and who experience at least two predetermined mild to moderate symptoms within a week of their diagnosis.
The companies initially signed a $69 million collaboration agreement on ensovibep in October 2020.
The antivirals are protein drugs based on Molecular Partners’ DARPin technology, which could result in treatments that have a long half-life, may not need to be refrigerated and can be injected just under the skin. These features would be particularly important in the fight against COVID-19 in low- and middle-income countries.
<Industry News>
CVS Health launching new business arm to drive greater clinical trial participation[10] (5/25)
CVS Health has launched a new business arm that aims to drive greater, and more diverse, participation in clinical trials. Called “Clinical Trials Services”, the business focuses on three core areas: patient recruitment, delivering clinical trials in multiple ways and generating real-world evidence on therapies and devices.
These will be done by targeting its local position, especially in recruitment and delivery, where it can use local resources to help boost awareness of clinical trials while also opening up its stores for studies to help facilitate decentralized options for the delivery of phase 3 and 4 clinical trials.
During Covid-19 pandemic, CVS Health saw that the pandemic decreased visits to pharmacies but boosted demand for diagnostics, and it helped pharma companies and CROs find trial subjects for COVID-19 tests.
Google strikes deal with hospital chain to develop healthcare algorithms[11] (5/26)
Google and national hospital chain HCA Healthcare have struck a deal to develop healthcare algorithms using patient records, the latest foray by a tech giant into the $3 trillion healthcare sector.
HCA, which operates across about 2,000 locations in 21 states, would consolidate and store with Google data from digital health records and internet-connected medical devices under the multiyear agreement. Google and HCA engineers will work to develop algorithms to help improve operating efficiency, monitor patients and guide doctors’ decisions, according to the companies.
FDA approves Myovant's Pfizer-partnered uterine fibroids med[12] (5/26)
The US FDA approved Myovant’s relugolix in combination with two hormone drugs as the first once-daily treatment for heavy menstrual bleeding linked to uterine fibroids in premenopausal women, with a treatment duration for up to two years. The drug will be marketed as Myfembree.
Pfizer will help Myovant sell Myfembree for uterine fibroid patients in the US as early as June, 2021. Pfizer paid $650 million upfront and made payments last year for the drug, which launched in prostate cancer patients in early 2021.
Myovant predicts roughly 19 million women in the US have uterine fibroids, although only a quarter of those women, or about 5 million, will experience symptoms and seek care from a physician, Marek said. About 3 million will fail on first-line treatments, he added. The company's immediate goal will be to target those patients.
FDA Authorizes additional monoclonal antibody for treatment of Covid-19[13] (5/26)
The FDA issued an emergency use authorization (EUA) for GlaxoSmithKline’s (GSK) investigational monoclonal antibody therapy sotrovimab for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients with Covid-19 and who are at high risk for progression to severe COVID-19, including hospitalization or death.
Sotrovimab is not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19.
Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful antigens such as viruses. Sotrovimab is a monoclonal antibody that is specifically directed against the spike protein of SARS-CoV-2 and is designed to block the virus’ attachment and entry into human cells.
FDA clears radar-powered, contactless patient monitor from Xandar Kardian[14] (5/27)
Xandar Kardian, a hardware developer, received FDA approval for its XK300 non-contact patient monitoring system which automatically alerts clinicians when a person’s vital signs drop below normal levels.
The FDA approval allows it to be used in general hospital wards, as well as all categories of nursing homes, including specialized facilities. It is also cleared for at-home health monitoring.
Olympus acquires Israeli medical device company Medi-Tate to drive global urology business growth[15] (5/27)
Olympus Corporation, a Japanese medical device company, acquired Medi-Tate, an Israeli medical device company.
Through this acquisition, Olympus expands its business line in offering in-office treatment for benign prostatic hyperplasia (BPH) treatment and solidifies its position as a leader in the field of urological devices.
Medi-Tate is a medical device manufacturer engaged in the research and development, production, and sale of devices for the minimally invasive treatment of BPH. The company’s flagship product “iTind” has received US FDA de Novo authorization and a European CE mark.
Olympus had invested in Medi-Tate previously, and has had the right of distribution since November 2018.
Amgen wins FDA approval for pathbreaking lung cancer drug[16] (5/28)
A Pathbreaking pill for lung cancer from Amgen, a US biopharmaceutical company, was approved by the FDA, adding a new potential blockbuster to the biotech.
The drug, called Lumakras, was approved treat a portion of lung cancer patients with a particular genetic mutation who have already tried other therapies.
The FDA’s approval is a validation for Amgen’s drug-discovery capabilities and a landmark in harnessing genetic discoveries to find new drugs for hard-to-treat cancers and other diseases.
Amgen reunites with longtime partner Kyowa Kirin in $400M dermatitis deal[17] (6/1)
Amgen and Kyowa Kirin announced an agreement to jointly develop and commercialize KHK4083 an anti-OX40 fully human monoclonal antibody currently set for Phase 3 studies in atopic dermatitis with potential application in other autoimmune diseases.
Per the terms, Amgen will make a $400M up-front payment to Kyowa Kirin in addition to future contingent milestone payments potentially worth up to an additional $850M as well as royalty payments on future global sales.
Amgen will lead the development, manufacturing, and commercialization of KHK4083 for all global markets, except Japan, where Kyowa Kirin will retain all rights
<Policies & Announcements>
HHS to dedicate $4.8 billion from American Rescue Plan to Covid-19 testing for the uninsured[18] (5/25)
The US Department of Health and Human Services (HHS) is announcing that it is dedicating $4.8 billion from the American Rescue Plan (ARP) to support the HRSA COVID-19 Uninsured Program.
This funding will allow the program to continue reimbursing health care providers for testing uninsured individuals for COVID-19.
FDA announces draft guidances to help increase transparency, assist reporting and timely completion for certain medical device studies after FDA approval or clearance[19] (5/26)
The FDA issued two guidances regarding the surveillance of certain medical devices.
The first guidance on postmarket surveillance guidance will assist manufacturers of devices, on an order which authorizes the FDA to require postmarket surveillance at any time in the lifecycle of certain Class II (moderate risk) and III (high risk) devices that meet any of the following criteria:
A failure with the device would be reasonably likely to have a serious adverse health consequence.
The device is expected to be used significantly in pediatric populations.
The device is intended to be implanted in the human body for more than one year or a device that is intended to be life-sustaining or life-supporting and used outside of a device user facility.
The second guidance is an updated post-approval study guidance that will assist stakeholders with understanding post-approval study requirements imposed as a condition of Premarket approval (PMA) by providing procedural information, recommendations concerning post-approval related submissions and other.
Statement on the swearing-in of Chiquita Brooks-LaSure as Administrator of the Centers for Medicare and Medicaid Services[20] (5/27)
Chiquita Brooks-LaSure was formally sworn in as the Administrator of the Centers for Medicare and Medicaid Services (CMS). She is the first black woman to lead the CMS.
As CMS administrator, Brooks-LaSure will have extensive oversight over the massive Medicare and Medicaid insurance programs and the exchanges set up by the Affordable Care Act.
Industry groups including the Federation of American Hospitals and the Surgical Care Coalition say that Brooks-LaSure's policy know-how and experience managing insurance programs should help increase equitable access to affordable care in the US.
FDA Seeks $6.5 billion to further investments in critical public health infrastructure, core food safety and medical product safety programs[21] (5/28)
The US Food and Drug Administration is requesting a total budget of $6.5 billion as part of the President’s fiscal year (FY) 2022 budget – a nearly 8% ($477 million) increase over the agency’s FY 2021 funding level for investments in critical public health infrastructure, core food safety and medical product safety programs and other vital public health programs.
The FY 2022 request, which covers the period from Oct 1 - Sep 30, 2022, includes the following budget authority increases:
$185 million in additional investments in FDA’s Critical Public Health Infrastructure.
$97 million in additional investments in Core FDA Safety Programs.
$61 million in additional investments in Public Health Issues Confronting the US.
[0] https://www.wsj.com/articles/fda-j-j-near-deal-for-covid-19-vaccine-production-at-baltimore-plant-11622154824 [1]https://www.fiercepharma.com/manufacturing/moderna-taps-samsung-for-fill-finish-duties-hundreds-million-covid-19-vaccine-doses [2]https://www.biopharmadive.com/news/lilly-covid-antibody-variant-massachusetts/600687/ [3]https://www.wsj.com/articles/covid-19-vaccine-makers-press-countries-to-oppose-patent-waiver-11622021402 [4]https://www.wsj.com/articles/half-of-u-s-adults-are-fully-vaccinated-11621974770 [5]https://www.biopharmadive.com/news/moderna-coronavirus-vaccine-results-adolescents/600735/ [6]https://www.wsj.com/articles/covid-19-treatment-from-vir-glaxosmithkline-is-approved-11622066958 [7]https://www.wsj.com/articles/eli-lilly-gets-doj-subpoena-related-to-n-j-plant-11622144731 [8]https://www.fiercebiotech.com/biotech/sanofi-gsk-kickstart-phase-3-covid-vax-test-as-pair-target-variants-and-a-q4-approval [9]https://www.pmlive.com/pharma_news/novartis,_molecular_partners_launch_global_study_of_novel_covid-19_drug_1370817 [10]https://www.fiercebiotech.com/cro/pharmacy-giant-cvs-health-launches-new-clinical-trial-services-biz-eyes-siteless-trials [11]https://www.wsj.com/articles/google-strikes-deal-with-hospital-chain-to-develop-healthcare-algorithms-11622030401 [12]https://www.fiercepharma.com/pharma/fda-approves-myovant-s-pfizer-partnered-uterine-fibroids-med-setting-up-showdown-abbvie [13]https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-additional-monoclonal-antibody-treatment-covid-19 [14]https://www.fiercebiotech.com/medtech/fda-clears-radar-powered-contactless-patient-monitor-from-xandar-kardian [15]https://www.fiercebiotech.com/medtech/olympus-acquires-minimally-invasive-bph-device-developer-medi-tate [16]https://www.wsj.com/articles/amgen-wins-approval-for-pathbreaking-lung-cancer-drug-11622220249 [17]https://seekingalpha.com/news/3701614-amgen-and-kyowa-kirin-in-pact-for-experimental-atopic-dermatitis-therapy [18]https://www.hhs.gov/about/news/2021/05/25/hhs-to-dedicate-billions-from-the-american-rescue-plan-for-the-uninsured.html [19]https://www.fda.gov/news-events/press-announcements/fda-brief-fda-announces-draft-guidances-help-increase-transparency-assist-reporting-and-timely [20]https://www.hhs.gov/about/news/2021/05/27/statement-on-the-swearing-in-of-chiquita-brooks-lasure-as-administrator-of-the-cms.html [21]https://www.fda.gov/news-events/press-announcements/fda-seeks-65-billion-further-investments-critical-public-health-infrastructure-core-food-safety-and