<Weekly Highlight>
US recommends pause in Johnson & Johnson vaccinations due to concerns over rare blood clots[1]
In a joint statement[2], CDC and FDA recommended pausing use of Johnson & Johnson's coronavirus vaccine while they investigate an apparent side effect to the shot.
As of April 12, more than 6.8 million doses have been administered, and there has been six reported cases of rare and severe types blood clot, all among women aged 18-48.
The cases look similar to AstraZeneca’s rare blood clotting cases in Europe.
This issue will raise vaccine doubts, deterring people who are already hesitant about COVID-19 vaccines. Hesitancy to get vaccinated has been one of the biggest challenges for vaccination efforts.[3]
J&J privately reached out to vaccine rials to ask them to join an effort to study the risks of blood clots, but Pfizer and Moderna declined.[4]
CDC will hold a virtual meeting to discuss J&J COVID-19 vaccine of the Advisory Committee on Immunization Practices (ACIP) on April 23, 11 am – 5 pm ET
(Webcast link https://www.ustream.tv/channel/VWBXKBR8af4)
<COVID-19 News>
New legal guidance and resources published by government agencies to ensure and expand access to COVID-19 vaccines for people with disabilities and older adults[5] (4/13)
Office for Civil Rights (OCR), Department of Health and Human Services (HHS) and other agencies have published several new resources to help states, vaccination providers, and other leading COVID-19 response activities improve access to vaccines for people with disabilities and older adults.
These resources clarify legal requirements and illustrates some of the barriers to vaccine access and provide strategies to ensure accessibility.
The resources highlight the following among others: civil rights laws prohibiting discrimination and providing concrete examples of the application of the legal standards in vaccine programs; steps that vaccine distribution personnel should follow.
Moderna discusses Covid-19 vaccine manufacturing with Nexus Pharmaceuticals[6] (4/14)
Moderna, looking to boost production of its Covid-19 vaccine, met with Nexus Pharmaceuticals to discuss manufacturing the shot at the company’s new plant in Wisconsin.
Although there is enough supply in the US, there could still be supply concerns later in the year, particularly if people require a booster shot at some point to protect against concerning virus variants that may be circulating.
Moderna’s chief executive said the company was unlikely to markedly speed up its vaccine production in the next few months, though it expects the output to have increased significantly by 2022.
NIH-funded COVID-19 testing initiative aims to safely return children to in-person school[7] (4/15)
NIH is awarding up to $33 million over two years to fund projects at 10 institutions across eight states to build evidence on safely returning students, teachers, and support staff to in-person school in areas with vulnerable and underserved populations.
It is known as the Safe Return to School Diagnostic Testing Initiative.
Lilly asks FDA to not allow lone use of COVID-19 antibody drug bamlanivimab[8] (4/16)
Eli Lilly and Co requested for cancellation of the US authorization granted to its COVID-19 antibody, bamlanivimab.
Instead, it will now be used in combination with another antibody, named etesevimab, to achieve greater efficacy against emerging variants.
The US government stopped the distribution of the therapy in March, and now hospitals with bamlanivimab supply should order etesevimab to pair with it.
The FDA officially revoked the EUA on 4/16. [9]
Moderna cuts COVID-19 vaccine deliveries to Canada, U.K. amid European supply struggles[10] (4/16)
Moderna warned that it will cut back deliveries of COVID-19 vaccines to “a number of countries” including UK and Canada due to supply problems.
The reduced estimates come as countries face supply shortage due to safety concerns of AstraZeneca and J&J vaccines, especially in Europe.
Moderna didn’t specify how many doses and where it would be cut, but warned up to 2 million of a planned 12.3 million shots in Q2 will be delayed until Q3.
Canada’s shipments this month was reduced to 650,000 doses instead of the expected 1.2 million.
Deliveries to EU and Switzerland remain on track.
Moderna doesn’t stockpile doses but ships doses to governments as released.
The company previously estimated it could provide 600 million to 1 billion doses globally by the end of 2021 thanks to its partnership with a Swiss CDMO. However, the Swiss CDMO warned in late January that it could take a couple of months to get the company’s three plants up to cruising speed.
<Industry News>
FDA clears wireless patient monitoring devices from Masimo, MyHomeDoc[11] (4/13)
The FDA made two 510(k) clearances for a pair of portable devices for wireless patient monitoring by Masimo and MyHomeDoc.
Both devices connect to separate analytics platforms for untethered monitoring, but Masimo’s is meant to be used in clinical settings while MyHomeDoc’s device allows for at-home data gathering.
Masimo is a California-based maker of noninvasive monitoring device, sensors, and other technologies.
MyHomeDoc is Israel-based company. Its product combines another wireless device with a smartphone app and clinical software integration.
Cancer biotech Tango Therapeutics to go public via $353 million SPAC deal[12] (4/14)
A Massachusetts-based cancer biotech Tango Therapeutics has agreed to go public by combining with BCTG Acquisition, a special purpose acquisition company (SPAC), in the third quarter of 2021.
Through this all-stock deal, the company will receive $167 million from the SPAC and $186 million through a private round.
Tango’s pipeline is based on synthetic lethality to treat cancer.
Through this deal, Tango will carry three of its programs into the clinic by 20213 and set up multiple preclinical programs.
Thermo Fisher buys PPD for $17.4 billion[13] (4/15)
Thermo Fischer Scientific, one of the largest medical device makers in the world, is buying PPD, also one of the world’s largest CRO, to add to its pharmaceutical service business.
This deal adds a $13 billion market cap on top of Thermo Fisher’s $187 billion market cap.
CRO sector is rising in the M&A space once again.
FTC clears AstraZeneca’s acquisition of Alexion, the largest M&A deal announced in 2020[14] (4/16)
The Federal Trade Commission (FTC) authorized AstraZeneca’s $39 billion acquisition of rare disease drug developer Alexion. The deal is expected to be completed in the third quarter of 2021, pending approvals in some remaining jurisdictions.
This acquisition will add Alexion’s marketed drugs for orphan blood conditions and enzyme deficiencies to AstraZeneca’s portfolio.
The FTC’s clearance is good news for the biopharma dealmakers because it has been signaled that the FTC will be looking more closely at bio/pharma acquisitions out of concern they may be thwarting the research and development of new drugs.
Medical device manager Agiliti sets $500M IPO to pay down debt[15] (4/15)
Agiliti, one of the largest medical device management companies in the US, has set terms for a $500 million IPO on the NYSE in the following week. This IPO can potentially result in a $2.6 billion valuation.
The company plans to sell 26.3 million shares for $18-20 per share.
Majority of the proceeds is slated to pay the company’s debt, which is near $1 billion.
<Policies & Announcements>
HHS marks Black Maternal Health Week by announcing measures to improve maternal health outcomes[16] (4/12)
President Biden proclaimed April 11 – April 17, 2021 as Black Maternal Health Week to raise awareness of Black maternal health and racial discrimination.[17]
The US Department of Health and Human Services (HHS) marked Black Maternal Health Week by announcing actions to expand access to continuous health care coverage and access to preventive care in rural areas to improve maternal health outcomes.
Illinois is the first state to provide continuity of full Medicaid benefit coverage for mothers by offering extended eligibility for a woman during the entire first year after delivery.
HHS also announced a Notice of Funding Opportunity (NOFO) that will make $12 million available over four years for the Rural Maternity and Obstetrics Management Strategies (RMOMS) program that will allow awardees to test models to address unmet needs for their target population.
The Centers for Medicare & Medicaid (CMS) approved Illinois' request to test the effects of providing full Medicaid benefits to women for 12 months, significantly expanding coverage from the current 60-day postpartum period. This approval, effective April 12, 2021, and authorized through December 31, 2025, supports the Biden Administration’s commitment to increase and strengthen overall Medicaid coverage.
FDA provides guidance on remote interactive evaluations for oversight of drug facilities during COVID-19[18] (4/14)
The FDA announced a guidance document titled “Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency.”[19]
This guidance describes how remote interactive evaluations will be requested by the FDA and conducted for the duration of the COVID-19 public health emergency at any facility where pharmaceutical products, including biological products, are manufactured, processed, packed, or held.
HHS announces Notice of proposed rulemaking ensuring access to equitable, affordable, client-centered, quality family planning services[20] (4/14)
HHS is proposing a new rule to revise the Title X family planning program regulations. This proposal is open for public comment for 30 days starting April 15, 2021.
The Title X Family Planning Program is the only federal grant program dedicated to providing individuals with comprehensive family planning and related preventive health services.
HHS proposes to revise the rules issued on March 4, 2019, which establishes standards for compliance by family planning services projects authorized by Title X. HHS claims that those rules have undermined the public health of the population the program is meant to serve, and proposed modifications to ensure access to equitable, affordable, client-centered, quality family planning services for all clients, especially for low-income clients.
HHS Announces Nearly $150 Million from American Rescue Plan to Support Community-Based Health Care Providers with COVID-19 Response[21] (4/19)
HHS is announced the availability of $150 million to community-based healthcare providers to aid their response to COVID-19.
These funds will support approximately 100 Health Center Programs.
[1]https://www.biopharmadive.com/news/johnson-johnson-fda-cdc-pause-vaccine-blood-clots/598265/ [2] https://www.cdc.gov/media/releases/2021/s0413-JJ-vaccine.html [3]https://www.wsj.com/articles/j-j-covid-19-vaccine-blood-clot-cases-could-stir-vaccine-hesitancy-11618425733 [4]https://www.wsj.com/articles/j-j-privately-asked-rival-covid-19-vaccine-makers-to-probe-clotting-risks-11618570802?mod=hp_lead_pos1 [5]https://www.hhs.gov/about/news/2021/04/13/new-legal-guidance-and-resources-to-ensure-and-expand-access-to-covid-19-vaccines-for-people-with-disabilities-and-older-adults.html [6]https://www.cnbc.com/2021/04/14/moderna-discusses-covid-19-vaccine-manufacturing-with-nexus-pharmaceuticals-sources-say.html [7]https://www.nih.gov/news-events/news-releases/nih-funded-covid-19-testing-initiative-aims-safely-return-children-person-school [8]https://www.wsj.com/articles/new-covid-19-strains-prompt-lilly-to-seek-to-end-u-s-use-of-single-antibody-drug-alone-11618569000 [9]https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-revokes-emergency-use-authorization-monoclonal-antibody-bamlanivimab [10]https://www.fiercepharma.com/pharma/moderna-cuts-covid-19-vaccine-deliveries-to-canada-u-k-amid-european-supply-struggles [11]https://www.fiercebiotech.com/medtech/fda-clears-wireless-patient-monitoring-devices-from-masimo-myhomedoc [12]https://medcitynews.com/2021/04/cancer-biotech-tango-therapeutics-picks-a-spac-as-its-ipo-dance-partner/ [13]https://www.fiercebiotech.com/cro/thermofisher-to-buy-ppd-for-15b-wsj-report [14]https://www.biopharmadive.com/news/astrazeneca-alexion-ftc-clear-acquisition/598571/ [15]https://www.fiercebiotech.com/medtech/medical-device-management-provider-agiliti-sets-up-500m-ipo [16]https://www.hhs.gov/about/news/2021/04/12/hhs-marks-black-maternal-health-week-announcing-measures-improve-maternal.html [17]https://www.whitehouse.gov/briefing-room/presidential-actions/2021/04/13/a-proclamation-on-black-maternal-health-week-2021/ [18]https://www.fda.gov/news-events/press-announcements/fda-provides-guidance-remote-interactive-evaluations-oversight-drug-facilities-during-covid-19 [19]https://www.fda.gov/regulatory-information/search-fda-guidance-documents/remote-interactive-evaluations-drug-manufacturing-and-bioresearch-monitoring-facilities-during-covid [20]https://www.hhs.gov/about/news/2021/04/14/fact-sheet-notice-of-proposed-rulemaking-ensuring-access-to-equitable-affordable-client-centered.html [21]https://www.hhs.gov/about/news/2021/04/19/hhs-announces-nearly-150-million-dollars-from-american-rescue-plan.html