J&J Covid-19 vaccine shows promising preliminary signs of protecting against Delta variant (7/1)
Johnson & Johnson’s Covid-19 vaccine showed promising signs in a small laboratory study of protecting against the Delta variant spreading across the US and other countries.
In laboratory testing, the vaccine triggered a strong immune response in blood samples taken from eight vaccinated people.
The positive performance adds to a growing set of evidence indicating currently authorized Covid-19 vaccines can safeguard against the Delta variant, which appears to be more contagious than earlier strains.
J&J also said its vaccine, in a separate study, generated immune responses against Covid-19 lasting for at least eight months, the most time that researchers were able to study the shot’s durability.
Covid-19 vaccine sites start to shut down (6/30)
America’s rapid mobilization to vaccinate the masses against Covid-19 is entering a new phase. Hundreds of Rite Aid stores will end extended Friday vaccine hours. Mass-inoculation sites set up to administer thousands of shots daily are shutting down across the country.
Covid-19 vaccines are no longer a scarce commodity in the US as supply now outstrips waning demand, and getting a shot is becoming akin to getting a flu shot, easy and generally uneventful.
The Biden administration has said it plans to export 80 million donated doses by the end of July to alleviate global shortages, both through Covax, the international vaccine effort, and directly with partners based on regional need.
For the US public, there will be fewer vaccine locations to choose from as government-run sites shut down.
CureVac vows to seek vaccine approval despite low efficacy in COVID-19 study (7/1)
German biotech CureVac plans to seek regulatory approval for its experimental coronavirus vaccine despite full results from a large international study confirming a disappointing overall efficacy against COVID-19 of just 48%.
The final estimate is little changed from the 47% interim figure previously disclosed by CureVac and is far lower than the high efficacy set by Pfizer, Moderna and, more recently, Novavax for their respective vaccines.
CureVac, however, has emphasized the wider prevalence of coronavirus variants that threaten vaccine potency during the period in which it ran the trial. About half of the COVID-19 cases sequenced and included in the efficacy analysis were due to infections with so-called variants of concern, although only about 1% were the Delta variant that's now triggering alarm among public health officials worldwide.
Pardes Biosciences, a biotech working on antiviral treatments for COVID-19, and a high-profile Big Pharma is going through an IPO through a SPAC deal with Foresite Capital. This is Foresite’s second SPAC.
Pardes will add about $276 million to the bank through the merger, which will help get its lead candidate into the clinic later this year. The deal is slated to close by October and the combined company will list on the Nasdaq under the ticker PRDS.
Sanofi dives deeper into mRNA in search for next-generation vaccines (6/29)
Sanofi plans to spend 400 million euros, or about $476 million, a year to speed the development of next-generation vaccines based on messenger RNA technology, announcing a center of excellence that will help advance shots developed through its partnership with biotech Translate Bio.
The new mRNA vaccines center will have 400 employees at two sites in Massachusetts and France and will be fully financed through resource reallocation. The center is expected to help the French pharmaceutical giant bring at least six experimental shots into human testing by 2025.
Though Sanofi is a global leader in vaccine development, the company has not played a big role combating the spread of COVID-19, as the two programs it's worked on with Translate and GlaxoSmithKline have yet to prove their worth. But Sanofi has identified mRNA technology as key to the future of its vaccine business and plans to use its new center to develop shots that prevent disease well after the pandemic ends.
The Institute for Clinical and Economic Review (ICER) said that Biogen’s new Alzherimer’s disease drug, Aduhelm’s controversial price tag is not in reasonable alignment with its clinical benefits. In ICER’s view, Aduhelm would need an 85% to 95% discount from its current list price to meet what the watchdog would consider fair.
That would be $3,000 per year on the low end and, potentially, as much as $8,400, ICER said, far below Biogen’s asking price, which was $56,000.
Aduhelm’s cost would be justified if the treatment halted the progression of dementia in Alzheimer’s patients, ICER said. If that were the case, its fair price could go up to $70,000. But the antibody therapy is not close to being this effective.
Nestlé joins Seres in deal to market microbiome drug (7/1)
Food and beverage company Nestlé is expanding its collaboration with Massachusetts-based Seres Therapeutics, placing a bigger bet on an experimental drug that regulates microbes in the body to treat a prominent kind of infection.
The health science unit at Nestlé may pay more than $500 million to secure commercialization rights in the US and Canada for SER-109, a spore-filled capsule that targets the microbiome. SER-109 is meant for patients who have recurrent infections from Clostridioides difficile, or C. diff, a leading cause of hospital-acquired infections in the US.
Nestlé Health Science already had rights outside of those markets because of a four-drug deal that was inked in 2016. Under the expanded agreement, Seres is responsible for development costs in the US prior to commercialization, while Nestlé would take the lead in marketing. Nestlé has agreed to pay Seres $175 million up front, another $125 million upon FDA approval, and as much as $225 million if certain sales goals are met. Additionally, Seres would get half of future profits.
Jazz receives FDA approval for Rylaze in 2 blood cancers, including the most common cancer among children (7/1)
Jazz Pharmaceuticals, a Dublin-based company well known for its narcolepsy blockbuster Xyrem, received FDA approval for a blood cancer therapy Rylaze as part of a chemotherapy regimen to treat acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL). The drug, formerly known as JZP-458, is an asparaginase—an enzyme that fights cancer cells by starving them of the nutrients they need to survive—derived from the bacteria erwinia.
The company expects to start selling the drug in mid-July.
Rylaze is specifically approved for adults and children one month and older who have developed hypersensitivity to E. coli-derived asparaginase. Up to 30% of ALL or LBL patients treated with the widely used E. coli-derived version suffer hypersensitivity reactions, and the diseases' many pediatric patients simply can't tolerate that type of asparaginase med.
Parexel, a major US CRO owned by Pamplona Capital, is being bought out for $8.5 billion by EQT Private Equity, a Swedish investment firm, and Goldman Sachs Asset Management.
The CRO sector had a difficult year due to Covid-19, but the sector has bounced back since spring/summer 2020, with most tapping a hybrid siteless approach to keep subjects in testing and to allow the flow of biopharma R&D to run free.
<Policies & Announcements>
FDA revokes Emergency Use Authorizations for certain respirators and decontamination systems as access to N95s increases nationwide (6/30)
The FDA announced it is revoking EUAs of all non-NIOSH (National Institute of Occupational Safety and Health)-approved disposable respirators, which includes imported disposable respirators such as KN95s, along with revoking EUAs for decontamination and bioburden reduction systems.
Today’s actions are consistent with the Centers for Disease Control and Prevention’s (CDC) updated recommendations that health care facilities do not use crisis capacity strategies and should promptly return to conventional practices.
All manufacturers of decontamination and bioburden reduction systems have requested, and the FDA has proceeded with, the revocation of their EUAs, effective June 30, 2021.
Since the beginning of the pandemic, NIOSH has approved more than 875 respirator models or configurations, with some of these manufactured by approximately 20 new, domestic NIOSH-approval holders. In addition, as of today, there are more than 6,400 total respirator models or configurations on the NIOSH-certified equipment list which have met the NIOSH-approved EUA criteria and thus are FDA-authorized.
FDA releases Cyclospora Prevention, Response and Research Action Plan (7/1)
As part of our ongoing efforts to combat foodborne illness and aligned with our New Era of Smarter Food Safety initiative, the FDA released the Cyclospora Prevention, Response and Research Action Plan, the plan focuses on improving prevention, enhancing response activities and filling knowledge gaps in order to help prevent Cyclospora contamination of foods and to help prepare for responding to future outbreaks.
Cyclosporiasis is a foodborne intestinal illness caused by Cyclospora cayetanensis. The most common symptoms of cyclosporiasis are diarrhea, weight loss, nausea and fatigue.
The plan can be found here.
HHS announces rule to protect consumers from surprise medical bills (7/1)
The Biden-Harris Administration issued “Requirements Related to Surprise Billing; Part I,” an interim final rule that will restrict excessive out of pocket costs to consumers from surprise billing and balance billing.
Surprise billing happens when people unknowingly get care from providers that are outside of their health plan’s network and can happen for both emergency and non-emergency care. Balance billing, when a provider charges a patient the remainder of what their insurance does not pay, is currently prohibited in both Medicare and Medicaid. This rule will extend similar protections to Americans insured through employer-sponsored and commercial health plans.
The interim final rule:
Bans surprise billing for emergency services.
Bans high out-of-network cost-sharing for emergency and non-emergency services.
Bans out-of-network charges for ancillary care (like an anesthesiologist or assistant surgeon) at an in-network facility in all circumstances.
Bans other out-of-network charges without advance notice.
The full fact sheet can be found here.
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