FDA warns Amazon again for selling unapproved drugs online – Endpoints News

Slow­ly but sure­ly the FDA is crack­ing down on the vast, il­le­gal on­line sale of drugs made pos­si­ble by be­he­moths like Ama­zon.
In a warn­ing let­ter dat­ed Oct. 28, the FDA told Ama­zon CEO Andy Jassy that the com­pa­ny sold and dis­trib­uted drugs with un­de­clared ac­tive in­gre­di­ents that were mar­ket­ed as di­etary sup­ple­ments.
The FDA said it con­firmed via lab analy­ses that the “Ar­tri Ajo King,” “Or­ti­ga Mas Ajo Rey,” and “Ar­tri King Re­forza­do con Or­ti­ga y Omega 3” pur­chased on Ama­zon.com con­tained the API of the NSAID pain drug di­clofenac, which is not list­ed on the prod­uct la­bels.
The let­ter fol­lows a no­tice from last Jan­u­ary in which the FDA warned the pub­lic not to pur­chase these prod­ucts, which are pro­mot­ed and sold for joint pain and arthri­tis. The FDA wrote at the time:
NSAIDs may cause in­creased risk of car­dio­vas­cu­lar events, such as heart at­tack and stroke, as well as se­ri­ous gas­troin­testi­nal dam­age, in­clud­ing bleed­ing, ul­cer­a­tion, and fa­tal per­fo­ra­tion of the stom­ach and in­testines. This hid­den drug in­gre­di­ent may al­so in­ter­act with oth­er med­ica­tions and sig­nif­i­cant­ly in­crease the risk of ad­verse events, par­tic­u­lar­ly when con­sumers use mul­ti­ple NSAID-con­tain­ing prod­ucts.
The FDA ran ad­di­tion­al lab analy­ses re­veal­ing in April that cer­tain Ar­tri and Or­ti­ga prod­ucts al­so con­tained dex­am­etha­sone, a cor­ti­cos­teroid, and the mus­cle re­lax­ant metho­car­bamol, which can cause se­da­tion, dizzi­ness and low blood pres­sure. And in an up­date on its Jan­u­ary warn­ing, the agency said it has re­ceived ad­verse event re­ports linked to these Ar­tri King prod­ucts, in­clud­ing of liv­er tox­i­c­i­ty and death, since the agency is­sued its first warn­ing.
This is the sec­ond time this year that the FDA has sent a warn­ing let­ter to Jassy, with the first com­ing in Au­gust for sell­ing mole re­moval prod­ucts over-the-counter even though they were un­ap­proved prod­ucts.
In both cas­es, the FDA pur­chased the drugs from Ama­zon.
September marked the 12th anniversary of Moderna’s founding, when we set out to study whether it is possible to instruct a patient’s own cells to produce proteins that may have the potential to treat a wide range of conditions with mRNA.
Since then, we have built a diverse clinical portfolio of mRNA vaccines and therapeutics across seven modalities. We have pioneered the development of our mRNA platform and have expanded our mRNA pipeline to 47 programs in development including 31 in clinical studies.
Australian pharma giant CSL is making a late bid for mRNA glory, and they’ve lined up one of the also-ran US Covid-19 biotechs touting their own particular tech twist to partner with.
CSL Seqirus, the big vaccines arm of the global player, is shelling out $200 million in cash and putting up another $4.3 billion in milestones — including a hefty $1.3 billion for development goals — to ally itself with Arcturus Therapeutics. Joe Payne’s San Diego-based biotech — where Payne had to mount a counter-coup to wrest back control of the company from some rebellious board members in 2018 — is just coming off a $63 million BARDA contract, where they’re putting their mRNA tech to work on the flu.
Unlock this story instantly and join 152,600+ biopharma pros reading Endpoints daily — and it’s free.
Artiva Biotherapeutics has elected not to move forward with an IPO. The San Diego cell therapy developer quietly disclosed its plans not to wade into the murky public waters in an SEC filing on Tuesday.
With an IND clearance for its second oncology asset just six weeks ago, Artiva has decided to back out of its plans, which have been in the making since early 2021. The natural killer, or NK, cell therapy company originally penciled in a $100 million offering in April 2021, less than a full year after coming out of stealth with $78 million.
Almost half of adults with type 1 diabetes say they felt like quitting sports as a kid because of their health condition – and one in five ended up doing so. Now Dexcom wants to encourage the next generation to stick with sports, so it’s lined up a first-ever name, image, likeness (NIL) college athlete program to showcase 14 players living with type 1 diabetes.
The mostly Division I men and women athletes who crisscross a range of sports — from baseball, basketball and football to cheerleading, lacrosse and swimming — all use Dexcom’s continuous glucose monitoring devices. Called Dexcom U, the program aims to bring on a new class of athletes every year who will co-create content on social media and serve as role model advocates for others living with diabetes. They’ll post about their day-to-day lives, how they train and prep for game day and how they use the Dexcom CGM to understand their diabetes state.
Unlock this story instantly and join 152,600+ biopharma pros reading Endpoints daily — and it’s free.
In the waning days of the Covid-19 pandemic, one penny stock biotech is reporting a close miss for its sole approved drug. But alas, a close miss is still a miss.
Rigel Pharmaceuticals — a biotech with only tyrosine kinase inhibitor fostamatinib in its arsenal — reported topline results Tuesday from a Phase III Covid-19 trial in patients without respiratory failure and who had certain, “high-risk prognostic” factors. The drug is only currently indicated to treat chronic immune thrombocytopenia, a blood condition when platelets are low.
In the historic campaign to vaccinate the world against Covid-19, Corbevax was far from the first vaccine to reach the market. While the first mRNA shot became available 326 days after the SARS-CoV-2 virus was sequenced, the journey of Corbevax — which has so far gone into the arms of 75 million kids in India and recently won approval for adults — spanned about 600 days.
But Peter Hotez, one of its co-inventors, believes it could’ve played out differently if his team had received more funding and there was a smoother regulatory path.
“That could have been probably cut in half had we had the support to move faster,” said Hotez, the co-director of the Texas Children’s Hospital Center for Vaccine Development.
There was good reason to go faster. The mad scramble for life-saving shots exposed the stark disparities between the vaccine haves and have-nots. Corbevax, a patent-free vaccine based on older but proven technology, can be affordably produced and distributed to lower-income countries.
The Corbevax story is relevant to a bigger question as the world attempts to strengthen vaccine research and development infrastructure to go even faster and more equitably distribute vaccines. Vexing scientific, regulatory and manufacturing challenges must be solved ahead of the next pandemic, public health experts and advocacy group representatives said in interviews.
The Coalition for Epidemic Preparedness Innovations, or CEPI, which launched in 2017 in the wake of the Ebola outbreak in West Africa, has proposed what it calls a moonshot goal of spurring a vaccine against a new pandemic-causing pathogen in 100 days. The initiative is known as the 100 Days Mission.
Melanie Saville, CEPI’s executive director of vaccine R&D, reckons the group would’ve been “laughed out of the room” if they had told people before the Covid-19 pandemic that a vaccine would arrive within 326 days – but already there’s a path to going faster.
“If you actually put everybody’s innovation together from Covid-19, we already probably could shave off two months by looking meticulously at every step of the process,” she said, citing a CEPI analysis based on interviews with companies, international organizations, regulatory agencies, academia and the media.
To get to 100 days, though, much more needs to be done. The key is to do as much of it upfront as possible, she added, during so-called peacetime, much like decades-long RNA research ushered in the first Covid-19 vaccines.
Unlock this article along with other benefits by subscribing to one of our paid plans.
There are a few big days to recall in the six-year history of Endpoints News. (Actually, six years, four months and 12 days, but who’s counting.)
One was a sit-down I had with Arsalan Arif in New York a few weeks before the launch, when we agreed to some basic values for what we were going to do. That conversation is a regular touchstone for us. We committed to being honest with each other and the staff. We’d give it everything we had, and we would conduct ourselves independently and with integrity.
The number of pharma sponsors taking advantage of the FDA’s expedited programs has skyrocketed in recent years, including the use of multiple designations to hurry a new compound along. Those increases are only expected to continue, according to FDA-authored research published in JAMA on Tuesday.
Over the last three decades, the number of new drugs receiving an orphan drug designation increased four-fold, and more than 90% of new oncology drugs used one of the agency’s expedited programs since 2008.
Unlock this story instantly and join 152,600+ biopharma pros reading Endpoints daily — and it’s free.
Eli Lilly laid blame Tuesday afternoon on President Joe Biden’s Inflation Reduction Act as the reason it scrapped a $40 million cancer drug.
As part of its third quarter update earlier Tuesday morning, the Big Pharma revealed it had removed a Phase I drug licensed from Fosun Pharma, a BCL2 inhibitor that had been undergoing studies for a variety of blood cancers. Though the reasoning had been initially unclear, an Eli Lilly spokesperson told Endpoints News in an email that “in light of the Inflation Reduction Act, this program no longer met our threshold for continued investment.”
Bioscience & Technology Business Center
The University of Kansas
Lawrence, Kansas
© Endpoints Company 2022
If you’re already an Endpoints subscriber, enter your email below for a magic link that lets you log in quickly without using a password. Please note the magic link is one-time use only and expires after 24 hours.
We’ll e-mail you a link to set a new password. Please note this link is one-time use only and is valid for only 24 hours.
ENDPOINTS NEWS Daily at 11:30 AM ET
EARLY EDITION Daily at 7:15 AM ET
ENDPOINTS PHARMA Daily at 2 PM ET
ENDPOINTS MARKETING RX Tue at 2 PM ET
ENDPOINTS FDA+ Wed at 2 PM ET
ENDPOINTS MANUFACTURING Thu at 2 PM ET
ENDPOINTS WEEKLY Sat at 6 AM ET

source

Add a Comment

Your email address will not be published. Required fields are marked *