Target $16
Tuesday, September 28, 2021
Sanofi ditches mRNA COVID-19 vaccine after rivals' success
Sanofi is dropping plans for its own mRNA-based COVID-19 vaccine because of the dominance achieved by BioNTech-Pfizer and Moderna in using the technology to fight the pandemic, the company said on Tuesday.
The move highlights the challenges of competing in particular with pioneer BioNTech, which rose from obscurity through its alliance with pharma major Pfizer last year. They have delivered close to 1.5 billion doses so far to become the Western world's largest COVID-19 vaccine maker.
French healthcare group Sanofi will instead focus on efforts with British partner GlaxoSmithKline to bring another COVID-19 vaccine candidate to market based on the more conventional protein-based approach, where mass trials are ongoing.
The decision to drop clinical development of a shot based on mRNA, or messenger RNA, acquired as part of its takeover of Translate Bio, came despite positive Phase I/II study interim results https://www.sanofi.com/en/media-room/press-releases/2021/2021-09-28-08-00-00-2304069 announced on Tuesday, where participants' blood readings showed a strong immune reaction.
But Sanofi said the read-out encouraged it only to pursue the technology as a potential vaccine against influenza and other diseases, giving up on the area of COVID-19 because of the strong market presence of the two approved mRNA shots.
"The results are extremely important as they show us that the platform we acquired works," Thomas Triomphe, head of the Sanofi Pasteur vaccines division, told journalists. He said kicking off final Phase III trials now made no sense.
"Would it, responsibly, be the best use of this wealth of science afforded by mRNA vaccines to make a COVID-19 vaccine and try and bring another mRNA COVID-19 vaccine to people who already today may not want an mRNA COVID-19 vaccine? Clearly not," Triomphe said.
He also dismissed the prospect for annual repeat shots, which has been intensely debated by researchers and pharmaceutical executives, with clear trial results on the need for yearly boosters still to come.
FDA OKs Regeneron Libtayo for Priority Review for Advanced Cervical Cancer
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for PD-1 inhibitor Libtayo® (cemiplimab-rwlc) to treat patients with recurrent or metastatic cervical cancer whose disease progressed on or after chemotherapy. The target action date for the FDA decision is January 30, 2022. The sBLA is also being reviewed under the FDA's Project Orbis initiative, which will allow for concurrent review by participating health authorities in Australia, Brazil, Canada and Switzerland. Additional global regulatory submissions are planned, including in the European Union (EU) by the end of 2021.
The sBLA is supported by results from a Phase 3 trial that enrolled patients irrespective of
PD-L1 expression status and is being conducted with The GOG Foundation, Inc. (GOG), the European Network for Gynaecological Oncological Trial groups (ENGOT) and NRG Oncology-Japan. Detailed results were first presented as part of a European Society for Medical Oncology (ESMO) Virtual Plenary in May 2021.
https://finance.yahoo.com/news/fda-accepts-libtayo-cemiplimab-rwlc-110000129.html
Ocugen-Partnered Covaxin's WHO Clearance Delayed Further
The World Health Organization (WHO) has further delayed the emergency use authorization (EUA) for Covaxin, a COVID-19 vaccine developed in India. Ocugen Inc (NASDAQ: OCGN) is the U.S. partner for the vaccine.
According to sources, the global body has sent more technical queries to its manufacturer Bharat Biotech.
Without EUA, Covaxin would not be considered an accepted vaccine by most countries around the world. WHO's queries for Bharat Biotech come despite the drugmaker asserting that it has submitted all data required for clearance.
The indication of a delay comes merely days after the Union Health Ministry hinted that the global body was likely to give its nod anytime soon.
According to Bharat Biotech, Phase 3 trials of Covaxin had demonstrated an efficacy rate of 77.8%.
Pfizer submits data for COVID-19 vaccine use in younger kids
Pfizer Inc and BioNTech SE on Tuesday submitted initial trial data for their COVID-19 vaccine in 5-11 year olds and said they would make a formal request with U.S. regulators for emergency use in the coming weeks.
The U.S. Food and Drug Administration said earlier this month it would look to complete its data review for this age group as quickly as possible, likely in a matter of weeks rather than months. That could mean an authorization of the shot for children by the end of October, sources have told Reuters.
A decision on the vaccine's use in younger children is eagerly awaited by millions of Americans as coronavirus infections have soared in children to hit their highest point in early September, according to data from the American Academy of Pediatrics.
The vaccine, which is already authorized for 12 to 15 year olds and fully approved for ages 16 and up, induced a strong immune response in the target age group in a 2,268-participant clinical trial, the companies said on Sept. 20.
The Pfizer-BioNTech vaccine was authorized for the 12-15 age group roughly a month after the companies filed for authorization. If the same timeline is followed for this application, younger children could start receiving their shots as soon as late October.
A rapid authorization could help mitigate a potential surge of cases this fall, with schools already open nationwide.
While kids are less susceptible to severe COVID-19, they can spread the virus to others, including vulnerable populations that are more at risk of severe illness.
The companies said they plan to submit the data to the European Medicines Agency and other regulatory authorities. They also plan to submit data from the full late-stage trial for scientific peer-reviewed publication.
The FDA was not immediately available for comment.
Data from the companies' trial showed the two-shot vaccine generated an immune response in children that matched what was previously observed in 16-to-25 year olds. The safety profile was also comparable to the older age group, Pfizer said.
Lilly to cut price of Lispro insulin injection by 40% from Jan. 1
Eli Lilly and Co will lower the list price of its Insulin Lispro Injection in the United States by 40% from Jan. 1, the drugmaker said on Tuesday.
The new list price will be 70% less than the Lispro injection's Humalog U-100 counterparts, Lilly said, reducing costs for those without insurance coverage and those that have not joined the company's affordability programs.
The move would bring down the price of Insulin Lispro Injection to $82.41 for individual vials and $159.12 for a pack of five pens.
Most people using Insulin Lispro Injection are unlikely to see a change in what they pay for their monthly prescription because they have fixed insurance co-pays or already use one of Lilly's affordability programs, it added.
The list price for drugs is not necessarily what patients actually pay, as out-of-pocket costs vary based on the duration of the treatment and individual healthcare plans.
Lilly last year announced a new co-pay scheme that covers most of its insulin products, capping the out-of-pocket cost for insulin to $35 per month.
About one in three prescriptions for Lilly's U-100 mealtime insulin – Lilly's most commonly used insulin formulation – is for Insulin Lispro Injection, the drugmaker said.
https://finance.yahoo.com/news/1-lilly-cut-price-lispro-112701230.html
Impel NeuroPharma launches migraine nasal spray
Trudhesa is the First and Only Therapeutic to Use POD® Technology to Deliver Dihydroergotamine Mesylate (DHE)—a Proven, Well-Established Therapeutic—to the Vascular-Rich Upper Nasal Space
Trudhesa is Available Through Trudhesa Direct™, Which Will Provide Hassle-Free Prescribing, Savings and Home Delivery Facilitated by Digital Pharmacy Partners Carepoint Pharmacy and Phil, Inc.
Eligible, Commercially-Insured Patients Will Be Automatically Enrolled in a Patient Savings Program to Obtain Trudhesa
https://finance.yahoo.com/news/impel-neuropharma-announces-trudhesa-dihydroergotamine-123000974.html
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