We’re talking weeks here, not months. — Stanley Erck, CEO of Novavax, to analysts on August 5.
In the U.S., we expect to submit our complete regulatory package to the FDA before the end of this year. — Erck on November 4.
Novavax expects to submit a request for EUA for the vaccine in the U.S. in one month… — Novavax statement on December 31.
You can add one more broken promise from Novavax $NVAX on its Covid-19 vaccine application to the FDA.
Unlock this story instantly and join 126,700+ biopharma pros reading Endpoints daily — and it’s free.
Knowing the patient recruitment journey and why and when they ‘disappear’ is vital for clinical success.
TrialWire is a Digital Patient Recruitment Platform custom-built on Salesforce Health Cloud that can start recruiting in under 24 hours. It has prioritized security and patient privacy while leveraging the latest algorithm and AI technology to rapidly match patients with studies. TrialWire engages with patients in real-time online when they are researching medical conditions so they are motivated and highly responsive. TrialWire allows eligible people to find and connect with their nearest participating site in less than a minute. Study Coordinators, Sponsors, and CROs have private and secure Dashboards showing relevant patient referral updates. Study Coordinators also have a built-in SMS system to quickly connect with patients. TrialWire successfully recruits for site-based and DCT studies in APAC, EU, Canada and the US.
Michel Vounatsos, Biogen CEO
A Korean business publication reported Wednesday that Samsung is in the process of making a buyout bid for Biogen, raising equal parts skepticism and anticipation around a possible deal.
The report from the Korea Economic Daily says that the Samsung Group – which has a long-term biosimilar partnership with Biogen – has offered to acquire Biogen for some $42 billion, a 20% improvement over the $35 billion recorded ahead of the report. That’s far less than what Biogen was trading for when hopes of a major windfall from their controversial Alzheimer’s drug Aduhelm still percolated.
Unlock this story instantly and join 126,700+ biopharma pros reading Endpoints daily — and it’s free.
With the clock ticking through the final hours of an eventful 2021, FDA regulators took the opportunity to squeeze in one more drug approval.
This time the nod went to Xeris for a rare disease treatment known as levoketoconazole, now approved for sale as Recorlev. The drug is designed to treat hypercortisolemia in patients suffering from Cushing’s syndrome. In late stage studies, researchers tracked a drop and normalization in cortisol levels in patients.
Unlock this story instantly and join 126,700+ biopharma pros reading Endpoints daily — and it’s free.
BridgeBio CEO Neil Kumar had all but reserved the champagne to celebrate the success of its big Phase III study for acoramidis, designed to stabilize transthyretin and slow or halt the progression of TTR amyloidosis. They had bought out full rights to the drug in late 2020 and borrowed the first $450 million of a $750 million loan, adding to a hefty debt load while confidently predicting a straight march to the FDA in 2022.
Unlock this story instantly and join 126,700+ biopharma pros reading Endpoints daily — and it’s free.
Five years after little Leo Pharma put up its dukes and $115 million in cash to acquire and advance tralokinumab for atopic dermatitis, the Danish biotech has crossed the regulatory finish lines with a year-end approval at the FDA.
The drug will be sold as Adbry and there’s no immediate word on pricing.
This is the 50th new drug approval from CDER this year, totting up to 60 for the year if you add 10 major biologic OKs to the mix. That marks a record number of new approvals from the agency, tipping the scales after hitting 59 in 2020 and 2018. And it’s an indication that despite a long litany of setbacks in CMC in other areas, the drumbeat of new approvals continues at chart-topping levels after the long and disastrous dry spell of the early 2000s — despite a global pandemic.
Unlock this story instantly and join 126,700+ biopharma pros reading Endpoints daily — and it’s free.
Indian CDMO Yapan Bio has landed an investment from Piramal Pharma, the company announced, to help enhance its manufacturing arm.
Yapan provides biologic and vaccine scale-up and manufacturing services, including RNA, DNA, recombinant vaccines, gene therapies and monoclonal antibodies. With the investment, Piramal takes on a 27.78% stake in the company and will help Yapan keep up the quick pace of the rapidly expanding CDMO space. It will combine its antibody drug conjugation capabilities with Piramal’s fill-finish services.
Patrick Lu, Sirnaomics CEO
A low-profile small interfering RNA player has managed to squeeze in its IPO before the year ends, adding another listing to the Hong Kong stock exchange’s tally.
Sirnaomics is making its HKEX debut with a modest raise of slightly over $50 million, with the potential of adding about $10 million if the over-allotment option is exercised in full.
CEO Patrick Lu founded the biotech all the way back in 2007, setting up an early discovery operation in Gaithersburg, MD after a transition from research at Georgetown into industry — first working for Novartis then co-founding another company called Intradigm. Through it all, he was focused on what he calls nucleic acid drug development.
Unlock this story instantly and join 126,700+ biopharma pros reading Endpoints daily — and it’s free.
The FDA on Thursday authorized another new pill to treat the Omicron variant, this time from Merck.
While Pfizer’s antiviral may prove to be more effective, and Merck’s pill has left some scientists questioning the dangers behind its mechanism of action, molnupiravir will be another weapon in the armamentarium of Covid-19 treatments for the US in a time of need, as two mAb treatments from Regeneron and Eli Lilly are no longer effective against Omicron, and as supplies of a third mAb from Vir/GlaxoSmithKline are very limited.
It’s time for our holiday break here at Endpoints News, and like a lot of you, we’ve been prepping for 2022.
Anyone who’s spent some time in industry can tell you the past decade has shoved the drug-hunting field into the forefront of the world’s view of things, garnering tens of billions in investment as new technologies look to change the landscape of R&D. And anyone who qualifies for first-in-class and best-in-class can clean up.
Unlock this story instantly and join 126,700+ biopharma pros reading Endpoints daily — and it’s free.
https://endpts.com/novavax-breaks-another-pledge-for-its-covid-19-vaccine-and-the-us-is-reportedly-fretting-about-global-goals-now/
