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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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.
Eli Lilly is beefing up its fleet of vehicles being deployed to carry drugs to the brain.
Enlisting Canada’s Entos Pharmaceuticals, Eli Lilly has grabbed rights to a suite of proteo-lipid vehicles (PLVs) as part of a research collaboration that spans multiple programs focused on diseases of the central and peripheral nervous system. Entos will receive an upfront of $50 million, part of it as an equity investment, to start developing PLVs for Lilly’s selection.
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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.
After showcasing clinical data at #ASH21 for a sickle cell disease candidate, Sanofi has decided to throw in the towel on its 8-year partnership with collaborator Sangamo — and return its rights to the candidate.
The gene editing biotech announced the ‘transition’ this morning, several days after Sanofi told Sangamo that the biotech was backing out of the deal. The Paris-based pharma giant will be returning its rights and obligations on SAR445136, a zinc finger nuclease gene-edited cell therapy back to Sangamo by the end of June.
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.
Mike Nally, Generate Biomedicines CEO
Amgen is approaching the new year the same way it tackled 2021: swinging deals. But now it’s aiming to bring AI capabilities into the fold.
The big biopharma is partnering with Flagship’s Generate Biomedicines on five therapeutic programs, the companies announced Thursday morning, in a collaboration that seeks to pair Generate’s machine learning algorithms with Amgen’s drug development capabilities. Amgen will pay $50 million upfront and up to $370 million in milestones for each program, which could total $1.9 billion when all is said and done.
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