Chuck Schumer, US Senate Majority Leader
Amid the spike in positive Covid-19 cases thanks to the Omicron variant, Ascletis will expand its production of the oral tablet ritonavir to produce 100 million doses a year. And the company is ready to increase that number if the market calls for that.
ASC10 targets RNA dependent RNA polymerase, while ASC11 targets 3-chymotrypsin-like protease. Ascletis currently owns the only authorized ritonavir tablet in China, which was approved in September. A low dose ritonavir oral tablet (100mg) is a component of Paxlovid, Pfizer’s drug that recently landed a contract with the Belgian government for 10,000 courses.
‘At the beginning of Covid-19 in 2020, based on its antiviral platform and R&D experience, the company made the firm and rapid decision to invest in oral direct-acting antivirals R&D against RdRp and 3CLpro of SARS-CoV-2,’ CEO Jinzi Wu said in a statement. ‘Meanwhile, the company accelerated the development effort to obtain the approval of ritonavir oral tablets in China and successfully achieved the authorization by China NMPA for ritonavir oral tablets.’
In the US alone, the number of daily cases has jumped from around 170,000 on Dec. 17 to 1 million on Jan. 3. China, where Ascletis is located, has not reported such a spike, but other countries, such as the Philippines and the UK, are experiencing the largest spikes since last year.
Schumer calls for a boost to domestic vaccine supply
US Senate Majority Leader Chuck Schumer wrote a letter to the Department of HHS Wednesday, calling for the fair consideration of an expansion of manufacturing capacity in Oneonta, NY.
The expansion at the Oneonta Life Sciences Facility, owned by Corning Pharmaceutical Technologies, could preserve the existing 150 jobs at the site, and create 275 jobs in manufacturing and construction in what he calls an economically disadvantaged area.
‘Innovation plus federal investment is how we better equip America to deal with health threats,’ he wrote. ‘Corning’s proposed project would be a shot in the arm for the Upstate New York economy, creating hundreds of jobs and would be a booster for the domestic medical supply chain.’
In 2021, Corning got $204 million in federal funding to double its Big Flats facility.
Their Staying Power Lies in their Patient-Centricity
Decentralized clinical trials (DCTs) were traditionally utilized in an isolated fashion prior to the COVID-19 pandemic. To continue their research within the constraints of the pandemic, sponsors and clinical investigators pivoted to a decentralized model out of necessity. At the onset, regulatory agencies offered some guidance on the digital approaches that are acceptable to ensure DCT approaches are applied in a way that maintains patient safety, as well as data quality and integrity.
Patrick Collison, co-founder of Stripe, has become one of Silicon Valley’s biggest advocates for new forms of funding and conducting science (Matt Winkelmeyer/Getty Images for WIRED)
It’s big days for biology.
The pandemic has seen a series of very public scientific breakthroughs: mRNA vaccine, Covid antibodies, CRISPR as therapy. The minds behind these advancements have graced magazine covers and received prestigious awards.
But the last two years have also, far more quietly, seen a series of new experiments in how to fund the next generation of scientific breakthroughs.
Since March 2020, investors, academics, a significant number of Silicon Valley types, at least one Russian billionaire and two crypto billionaires and, most recently, a few West Coast universities have launched a series of grant programs, institutes, NGOs and companies hoping to change how life science research is done. Though unaffiliated and varying greatly in both size and form, they have broadly promised to evade bureaucracy and misaligned incentives and advance both basic and not-so-basic research in ways they say can’t be done in either conventional academia or profit-focused biotech.
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As the FDA is looking to reduce drug shortages further by collecting more data on the volume of drugs and APIs manufactured worldwide, companies like Pfizer, Thermo Fisher, Viatris and industry groups are pushing back on new guidance that seeks to establish how that data should be collected and submitted to the agency.
The technical conformance guide, released last October, spells out the requirements under Section 3112(e) of the CARES Act, which was signed into law in March 2020 and added a new section to the FD&C Act.
Jody Chastain, Ritedose CEO
For 25 years, Ritedose has been a CDMO that’s provided sterile, aseptic production of single-dose medication for more than 8 billion doses. Novo Holdings has taken notice, acquiring the Columbia, GA-based company from AGIC Capital and Humanwell.
‘The investment in Ritedose is perfectly aligned with our deep expertise in pharma services. We see myriad opportunities to have an impact at Ritedose,’ Novo’s head of principal investments Abhijeet Lele said in a statement. ‘We are also particularly excited to be at the vanguard of increasing vaccine availability through the use of blow-fill-seal injectable technology.’
Chris Perkin, Altasciences via Youtube
Altasciences CEO Chris Perkin has gone through several acquisitions in his 45-year career. And if there’s one thing he learned, it’s how not to go through an acquisition.
His company put that knowledge to use on Tuesday when it announced that it had acquired competitor Sinclair research, a preclinical contract research organization in Missouri. With the pickup, Altasciences gains 80 animal rooms, and full-service IND and NDA-enabling toxicology and safety pharmacology services.
Belén Garijo, Merck KGaA CEO (Kevin Wolf/AP Images for EMD Serono)
Bursting at the seams and executing plans for swift expansion to support its manufacturing work for the mRNA vaccine out of Pfizer/BioNTech, Indianapolis-based Exelead has now been scooped up in a $780 million cash buyout deal.
Germany’s Merck KGaA, which bought out another mRNA manufacturer, AmpTec, early last year, has been beefing up its ops around lipids, which, in mRNA vaccines, play a key role in turning human cells into a mini—vaccine factories?
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Jay Bradner, NIBR president (Jeff Rumans)
Alnylam was a few years ahead in the small interfering RNA (siRNA) space when Novartis jumped on the bandwagon in early 2020, licensing the company’s cholesterol-lowering drug Leqvio through its buyout of The Medicines Company. Less than a month after securing an approval, the pharma giant wants more where that came from.
Novartis is joining forces with Alnylam once again for the discovery and development of a regenerative siRNA-based therapy to treat end-stage liver disease, the companies announced on Thursday.
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Sosei Heptares is teaming up with a big-name partner: Alphabet’s Verily.
No financials were disclosed, but the pair will aim to use Verily’s immune profiling and Sosei Heptares’ GPCR drug design capabilities to develop a variety of new therapeutics. The collaboration will focus on GPCR drugs in the immunology, gastroenterology and immuno-oncology spaces, as well as other disorders with immunoprotective or immunopathogenic mechanisms, the companies said.
Salvatore Mascia, Continuus Pharmaceuticals CEO
A spinout from an MIT lab has landed a deal with a Swedish development group to build a $125 million manufacturing facility in Woburn, MA, just 15 miles outside Boston.
Skanska signed a contract with Continuus Pharmaceuticals to renovate and build another 50,000 square foot site up to current Good Manufacturing Practices standards that will produce dry active pharmaceutical ingredients and finished drug products in both sterile injectable and tablets forms.
https://endpts.com/covid-19-roundup-ritonavir-production-to-reach-100m-doses-annually-schumer-calls-for-a-boost-to-domestic-vaccine-supply/
