FRANKFURT, Germany — It is no secret that the CDMO arm of one of South Korea’s largest conglomerates has been expanding in 2022. Samsung Biologics, towards the middle of the year, was going to see a bump in funding from the Samsung group and now has committed to boosting its presence in both South Korea and beyond.
The company has kicked off operations at its latest manufacturing site in South Korea, called Plant 4, after breaking ground 23 months ago. So far, the plant can produce around 60,000L of manufactured materials, and it will have the ability to produce around 240,000L when fully operational in 2023.
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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.
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.
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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.
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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.
Pfizer suffered its first quarterly revenue dip since its BioNTech-partnered Covid vaccine was authorized in 2020, CEO Albert Bourla revealed on Tuesday. And if that isn’t bad enough, he expects patent expiries to cost the company around $17 billion between 2025 and 2030.
Which is why, he emphasized on the Q3 call, “It’s all about what’s next.”
Bourla outlined ambitious plans to bring 19 new products or indications to market over the next year and a half.
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“Where’s Juan?” a soccer player asks while nervously eyeing the goal. “Covid, again,” a teammate responds while holding up a text message. The referee blows the whistle.
That’s the introduction to one of the Department of Health and Human Services’ latest Covid-19 ads designed to convince those who are disproportionately affected by the pandemic to roll up their sleeves for updated vaccines. The ad, titled “Don’t Miss the Game,” aired on Oct. 24 as part of HHS’ broader “We Can Do This” campaign.
Bristol Myers Squibb unveiled a surprise victory on Monday for its potential $4 billion-per-year drug Reblozyl, with the biopharma announcing that it hit a primary endpoint for a Phase III trial.
The positive result, defined as a “statistically significant and clinically meaningful improvement” in red blood cell transfusion independence (RBC-TI), or how long a patient with anemia goes without a transfusion, with increasing levels of hemoglobin increasing in patients who require red blood cell transfusions, follows FDA pushback on a third approval in March.
J&J has decided to hit the brakes on one of its partner’s early-stage programs.
The Big Pharma’s Janssen division will halt enrollment in ESSA Pharma’s Phase I trial for a prostate cancer program, ESSA announced Monday morning, due to what the biotech described as “operational recruitment challenges.” An ESSA spokesperson told Endpoints News in an email that it will conduct a Phase I study using the Janssen drugs on its own, but possibly in a different population.
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The time is upon us as the manufacturing world descends on Frankfurt for CPhI. This year’s conference plans to be filled to the brim with the top companies and experts from around the world of pharmaceutical manufacturing. While Endpoints News was not able to attend the conference last year in Milan, we are on the ground this year and plan to deliver all the news of the conference and all the latest trends.
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