<Weekly Highlight>
CDC announces that fully vaccinated people can stop wearing face masks and end physical distancing in most settings[1] (5/13)
CDC announced that Fully vaccinated people don’t need to wear a mask or physically distance during outdoor or indoor activities, large or small.
The fully vaccinated should continue to wear a mask while traveling by plane, bus or train, and the guidance doesn’t apply to certain places such as hospitals, nursing homes and prisons.
This is the broadest easing of pandemic recommendations so far.
CDC’s new guideline was driven by scientific evidence that the vaccines play a major role in reducing infections and transmissions of the virus. In particular, three recent studies that demonstrated the impact of the vaccines on symptomatic and asymptomatic infections and one study published just last week on the effectiveness of Covid-19 vaccines against two variants that are known to be circulating in the United States.[2]
Not all states immediately accepted the guidance. States and businesses can still maintain their mask rules if they want.[3]
13 states accepted the guideline: Minnesota, Kentucky, Nevada, Oregon, Pennsylvania, Washington, Illinois, Connecticut, North Carolina, Michigan, Maryland, Maine, and Virginia.
Other states are keeping their mask requirements while they review the evidence: New York, Massachusetts, New Jersey, California
This new guideline creates ambiguity for the following reasons.
Creates ambiguity for retailers because it does not fully align with state and local orders.
It’s nearly impossible to police the use of face masks because there is no way of knowing who is or isn’t vaccinated.
This guideline may encourage more people to get vaccinated by enticing them with tangible benefits.
<COVID-19 News>
BioNTech, Fosun Pharma plan to plan 1B doses of COVID-19 vaccine capacity with new China JV[4] (5/10)
BioNTech and Fosun announced an an agreement to supply Mainland China with an initial 100 million doses of their BNT162 mRNA-based vaccine candidate against COVID-19 in 2021, subject to regulatory approval. Initial supply will be delivered from BioNTech’s production facilities in Germany.
BioNTech and Fosun Pharma are setting up a 50-50 joint venture with manufacturing capacity to produce up to 1 billion doses a year.
For the new company, Fosun will contribute up to $100 million of assets in cash and a manufacturing facility, while BioNTech will pour in another $100 million but in the form of proprietary manufacturing technology and know-how.
Eli Lilly out-licenses to 3 Indian drugmakers to bolster supply of COVID-19 drug baricitinib[5] (5/10)
Eli Lilly signed royalty-free, non-exclusive voluntary licensing agreements with three Indian generic drugmakers—Cipla, Lupin, and Sun Pharma—to expand baricitinib, an arthritis drug used to treat COVID-19, available in India.
Barcitinib has been given emergency use approval by India’s drug regulator for use with Gilead’s antiviral remdesivir. The combo therapy is used for the treatment of hospitalized COVID-19 adult patients requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
Covid-19 vaccine data on children under 12 expected by late fall[6] (5/11)
There will likely be enough evidence by late fall this year to potentially extend the use of Covid-19 vaccines to many children under age 12, according to Biden Administration’s health officials.
CDC panel endorses Pfizer vaccine for 12- to 15-year-olds[7] (5/12)
CDC panel of advisers endorsed the use of Pfizer-BioNTech’s Covid-19 vaccine in young teenagers of age 12-15.
The voting committee, made up of infectious disease doctors and pediatricians, voted 14-0 to recommend the shot for adolescents.
United Airlines and Abbott team up to provide at-home COVID testing kits to international travelers[8] (5/12)
United Airlines has partnered with Abbott to offer passengers traveling abroad access to at-home COVID testing kits, which will allow travelers to take the tests prior to their return to the United States.
Passengers can travel with the at-home COVID test in their carry-on bag and can register to administer the test via the eMed digital health platform while overseas.
CDC recently updated its guidelines to allow travelers to self-administer rapid antigen tests under the supervision of a telehealth service. Upon receipt of a negative COVID test result, the traveler can then board an international flight back to the U.S., according to the press release.
Merck, GSK and Pfizer vaccines get a boost as CDC lifts two-week restriction on pandemic shots[9] (5/13)
CDC had previously recommended people don’t get another shot within two weeks of their COVID-19 vaccine, but it took away the suggestion in an effort to boost routine immunization among teens.
With CDC’s previous recommendation, several big pharmaceutical companies faced a lowered vaccine revenue due to accelerated roll-out of COVID-19 vaccines.
CDC’s new recommendation states that COVID-19 vaccines may be administered with other shots during the same visit to the doctor.
This could bring benefits for leading vaccine companies such as Merck, GlaxoSmithKline and Pfizer.
Feds stop sending Eli Lilly’s COVID-19 cocktail to Illinois on concerns of P.1 variant[10] (5/13)
Federal officials are pausing shipments of the bamlanivimab-etesevimab COVID-19 cocktail to Illinois because of worries about one specific variant called P.1. In vitro studies have indicated that Lilly's combo medicine is not active against the P.1 variant.
Authorities raised concerns about the combo's effectiveness against that variant, first identified in Brazil. The Office of the Assistant Secretary for Preparedness and Response said it is pausing distribution of the antibody cocktail, plus etesevimab alone, in the state.
CDC saw that the P.1 variant is circulating with increasing frequency in Illinois.
Zero Johnson & Johnson COVID-19 vaccine doses set to ship next week as production holdup lingers[11] (5/14)
The federal government doesn’t plan to ship any J&J COVID-19 vaccine doses to states next week as production holdups linger at J&J’s manufacturing partner Emergent BioSciences.
Previously, Emergent’s plant in Baltimore ruined up to 15 million doses of the J&J shot. Also, the feds and Emergent have halted production at the plant because a list of issues were highlighted by the FDA during a recent site visit.
Lawmakers are now investigating Emergent's production contracts and errors. The company's top members are set to testify in front of Congress next week.
Sanofi-GSK Covid-19 Vaccine Set for Large-Scale Trials After Positive Results[12] (5/17)
Sanofi, based in France, and GaxoSmithKline (GSK), based in UK, said their Covid-19 vaccine candidate showed positive interim trial results and is expected to move into large-scale human trials soon, putting the long-delayed shot on track for potential regulatory approval later this year.
The companies’ two-dose shot produced strong antibody responses in phase-two trials with 722 volunteers. A single dose generated high levels of antibodies in volunteers with evidence of prior Covid-19 infection. They suggest the vaccine could be useful as a booster for people already vaccinated with other shots.
Now the companies plan to begin pivotal phase-three trials, which will involve more than 35,000 people, and use two formulations: one targeting the original Covid-19 strain, and the variant that was originally detected in South Africa.
Covid-19 drugmakers take on TV shows and other media channels to tackle vaccine hesitancy[13] (5/16)
Pfizer, Moderna, Regeneron and other Covid-19 vaccine makers are sponsoring advertisements on TV, radio, and social media to raise awareness of the vaccine.
The direct-to-consumer ads paid for by pharmaceutical companies aimed at hesitancy and lack of awareness toward vaccines and drugs for Covid-19. The different types of ads include skits on TV shows like Jimmy Kimmel, sponsorship of online video discussions, and social media ads.
The advertising isn’t typical for pharmaceutical companies. Unlike most drug promotions, the ads aren’t aimed at gaining a leg up on competitors or boosting sales. The goal is to persuade Americans to use potentially lifesaving products that are already bought and paid for by the U.S. government and provided free to consumers.
<Industry News>
BioNTech’s Covid-19 Vaccine Success Sparks Investments in German Biotech[14] (5/10)
The German company’s success in coming up with the West’s first Covid-19 vaccine is drawing attention from investors in a country where biotech has struggled to raise funding in recent years.
Now more German and international investors are looking to invest in the search for the next hidden gem in German biotech, according to venture capitalists, executives and analysts.
In 2020, German biotech companies raised a record of $3.7 billion, through venture capital, share offerings and convertible bonds, which is triple the amount for 2019. While half of that went into BioNTech and CureVac, another German biotech that’s currently developing a new COVID-19 vaccine, companies working on non-Covid-19 related treatments also got important financing rounds.
Ginkgo Bioworks to go public through $2.5B SPAC deal[15] (5/11)
Ginkgo Bioworks, a specialist in engineering cells for biotechnology, industrial and agricultural uses, will go public by merging with a special purpose acquisition company, or SPAC, in a deal that values the company at a lofty $15 billion.
The merger with Soaring Eagle Acquisition Corp. will give Gingko Bioworks a place on the Nasdaq stock exchange as well as approximately $2.5 billion in proceeds, $775 million of which will come through private investments in public equity by an array of high-profile backers.
Sanofi accused of destroying emails tied to Zantac recall[16] (5/11)
Sanofi, a French pharmaceutical company, is accused of destroying internal emails tied to a 2019 recall of the heartburn medication Zantac. More than 70,000 former patients sued the company in the US.
The deleted emails, including those of Michael Bailey, the head of regulatory affairs for the company’s U.S. Consumer Healthcare division, will make it more difficult for consumers to show Sanofi and other drug makers allowed a suspected carcinogen, a substance capable of causing cancer, to taint Zantac, an over-the-counter medication.
In 2018, the FDA found the drug contained dangerous levels of nitrosodimethylamine, or NDMA. It was pulled from shelves in the U.S. and Canada at the request of regulators. Sanofi, GlaxoSmithKline, and Boehringer Ingelheim—along with 33 generic drug makers, 25 retailers and four distributors—are accused in the lawsuits of failing to properly warn users about Zantac’s health risks.
Only Sanofi has been accused in the filings of mishandling emails.
Biogen licenses a stroke drug from Japanese drugmaker TMS[17] (5/12)
Biogen exercised an option to buy an experimental drug from Japan’s TMS Co. used for the treatment of stroke.
A mid-stage study showed the drug, called TMS-007, could help patients within 12 hours of an acute ischemic stroke, which is caused by a blocked blood vessel.
The deal has Biogen paying $18 million to TMS. TMS, a privately held company, will also receive royalties if the drug reaches the market and as much as $335 million in payouts if TMS-007 reaches certain developmental and commercial milestones.
Heron, on third attempt, secures FDA approval for non-opioid painkiller[18] (5/13)
Heron Therapeutics secured FDA approval for a post-operative painkiller that the San Diego-based company claims can help keep patients off opioids.
The FDA cleared Zynrelef to treat pain in patients for as long as 72 hours after a bunionectomy, hernia repair or knee replacement surgery.
The FDA previously withheld approval twice in 2019 and asked Heron for more information on manufacturing and other non-clinical issues.
MSD Partners, Panacea's biotech SPAC raises $200M IPO[19] (5/13)
Orion Biotech Opportunities Corp., a special purpose acquisition company (SPAC) formed by MSD Partners and Panacea Venture, completed a $200 million IPO. Now, it is searching for biotech or life sciences companies to acquire in North America, Europe or Asia.
Like other SPACs, Orion is keeping options open, saying only that it will focus on healthcare companies with the potential to drive transformational change through novel therapies or technologies.
Ginkgo Bioworks plans next acquisition just days after inking $2.5B SPAC deal[20] (5/17)
Ginkgo Bioworks is showing moves to go international through acquisition of Utrecht, a Netherlands-based contract manufacturing organization that makes enzymes, proteins, and organic acids using its fungus-based technology.
This announcement is only a week after Ginkgo announces a $2.5 billion SPAC deal to go public.
Under the deal, Ginkgo will acquire 100% of the Utrecht, Netherlands-based company through a combination of cash and equity. The deal is expected to close in July.
Landos Biopharma teams up with LianBio for $218M-plus collab and sales deal for 2 immunology assets in Asia[21] (5/17)
Landos Biopharma, an American autoimmune biotech that recently went through an IPO, and LianBio, a Chinese drug licenser, announced an exclusive collaboration and license agreement to the development of omilancor and NX-13, two ulcerative colitis (UC) and Crohn’s disease (CD) assets, in China and parts of Asia.
Under the terms of the deal, LianBio will receive exclusive rights to develop and sell omilancor and NX-13 in greater China, South Korea, Singapore, Thailand, Vietnam, Myanmar, Cambodia, Indonesia and the Philippines. Landos will receive an upfront cash payment of $18 million and is eligible to receive development and commercial milestone payments of up to $200 million.
<Policies & Announcements>
FDA finalizes guidance with internationally harmonized recommendations to further support safe, high-quality human drug products[22] (5/11)
The FDA announced the availability of a final guidance for the industry, titled “Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management,” which provides a framework to facilitate the management of post-approval chemistry, manufacturing, and controls changes in a more predictable and efficient manner.
The guidance discusses how to identify the elements in an application that are considered necessary to assure product quality and therefore would require a regulatory submission if changed post-approval.
In addition to post-approval changes, the guidance has the potential to help facilitate innovations in manufacturing through a flexible, risk-based approach to regulatory oversight. Encouraging continual product improvement can help reduce product variability and prevent and mitigate shortages related to manufacturing and quality issues.
Read the full guideline here.
CMS expanding efforts to grow COVID-19 vaccine confidence and uptake amongst nation’s most vulnerable[23] (5/11)
As part of the ongoing response to address the COVID-19 pandemic and to improve healthcare access, Centers for Medicare & Medicaid Services (CMS) issued a rule that will ensure long-term care facilities, and residential facilities serving clients with intellectual disabilities, educate and offer the COVID-19 vaccine to residents, clients, and staff.
The rule also requires long-term care facilities to report weekly COVID-19 vaccination status data for both residents and staff. The new vaccination reporting requirement will not only assist in monitoring uptake amongst residents and staff, but will also aid in identifying facilities that may be in need of additional resources and/or assistance to respond to the COVID-19 pandemic.
Medicaid & CHIP and the COVID-19 public health emergency[24] (5/14)
To monitor the impact of the COVID-19 public health emergency (PHE), CMS conducted extensive data analysis using the Transformed Medicaid Statistical Information System and is releasing a comprehensive overview of the PHE’s impact on Medicaid and Children’s Health Insurance Program (CHIP) beneficiaries and service utilization through October 2020. Specifically, CMS is releasing updated data that examines:
COVID-19 treatment, acute care use, and testing,
Service use among Medicaid & CHIP beneficiaries age 18 and under
Services delivered via telehealth to Medicaid and CHIP beneficiaries
Services for mental health and substance use disorders (SUDs) among Medicaid and CHIP beneficiaries.
These analyses are essential to increasing our understanding of COVID-19’s impacts, as Medicaid and CHIP covered over 100 million Americans for at least one day between January and October 2020.
Read the full fact sheet here.
FDA provides guidance on master protocols for evaluating prevention, treatment options for COVID-19[25] (5/17)
The FDA issued a final guidance entitled, “COVID-19: Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention Guidance for Industry.”
This guidance describes FDA’s current recommendations to sponsors of master protocols (a protocol designed with multiple substudies) evaluating drugs for the treatment or prevention of COVID-19.
This guidance focuses on the design, conduct, and statistical considerations of master protocols intended to generate or contribute to substantial evidence of effectiveness and adequate characterization of safety of drugs for the treatment or prevention of COVID-19. Additionally, this guidance provides administrative and procedural recommendations to sponsors of master protocols for COVID-19 drugs.
Read the full guideline here.
[1]https://www.wsj.com/articles/fully-vaccinated-people-can-stop-wearing-face-masks-physical-distancing-in-most-settings-cdc-says-11620928800 [2]https://www.nbcnews.com/science/science-news/s-science-convinced-cdc-lift-mask-mandates-rcna932 [3]https://www.businessinsider.com/cdc-guidelines-mask-guidance-list-of-states-relaxing-keeping-mandates-2021-5 [4]https://www.fiercepharma.com/manufacturing/biontech-fosun-pharma-eye-1b-doses-covid-19-vaccine-capacity-new-china-jv [5]https://www.fiercepharma.com/pharma/eli-lilly-taps-three-indian-drugmakers-to-bolster-supply-covid-19-drug-baricitinib [6]https://www.wsj.com/articles/data-on-covid-19-vaccines-for-children-under-12-expected-by-late-fall-health-officials-say-11620757066 [7]https://www.biopharmadive.com/news/cdc-acip-pfizer-coronavirus-vaccine-adolescents/600049/ [8]https://www.nbcchicago.com/news/coronavirus/united-airlines-abbott-team-up-to-provide-at-home-covid-testing-kits-to-intl-travelers/2508963/ [9]https://www.fiercepharma.com/pharma/cdc-throws-out-covid-19-vaccine-coadministation-rule-to-boost-routine-immunizations-but [10]https://www.fiercepharma.com/pharma/feds-stop-sending-lilly-s-covid-19-cocktail-to-illinois-concerns-p-1-variant [11]https://www.fiercepharma.com/pharma/zero-johnson-johnson-covid-19-vaccine-doses-set-to-ship-next-week-as-production-holdup [12]https://www.wsj.com/articles/sanofi-gsk-covid-19-vaccine-set-for-large-scale-trials-after-positive-results-11621252866 [13]https://www.wsj.com/articles/covid-19-drugmakers-take-on-your-favorite-tv-shows-to-tackle-vaccine-hesitancy-11621166403 [14]https://www.wsj.com/articles/how-a-promising-covid-19-vaccine-lost-its-wayand-found-it-again-11616583600?mod=article_inline [15]https://www.fiercebiotech.com/biotech/ginkgo-lands-nyse-via-spac-merger-gaining-2-5b-to-fuel-growth [16]https://www.bloomberg.com/news/articles/2021-05-11/sanofi-accused-of-destroying-internal-emails-about-zantac-recall [17]https://www.biopharmadive.com/news/biogen-stroke-drug-tms/600060/ [18]https://www.biopharmadive.com/news/heron-fda-approval-zynrelef-surgery-pain/600132/ [19]https://www.fiercebiotech.com/biotech/msd-partners-panacea-s-biotech-spac-hits-street-200m-ipo [20]https://www.fiercebiotech.com/biotech/ginkgo-tees-up-its-next-acquisition-just-days-after-inking-2-5b-spac-deal [21]https://finance.yahoo.com/news/landos-biopharma-lianbio-announce-exclusive-110000499.html [22]https://www.fda.gov/news-events/press-announcements/fda-brief-fda-finalizes-guidance-internationally-harmonized-recommendations-further-support-safe [23]https://www.cms.gov/newsroom/press-releases/cms-expanding-efforts-grow-covid-19-vaccine-confidence-and-uptake-amongst-nations-most-vulnerable [24]https://www.cms.gov/newsroom/fact-sheets/fact-sheet-medicaid-chip-and-covid-19-public-health-emergency [25]https://www.fda.gov/news-events/press-announcements/fda-brief-fda-provides-guidance-master-protocols-evaluating-prevention-treatment-options-covid-19