UPDATE: Pfizer, Sarepta team with fellow DMD gene therapy makers to get to the bottom of adverse events Sponsored: Q&A: Steve Thompson on Compliant, Hands-Free Validation Sponsored: mRNA Unlocked: How Technology Convergence Is Driving the Next Wave 'We just don’t have the studies': New report details critical diversity shortcomings in US clinical research Flagship Pioneering unfurls cell and gene therapy company Sonata Therapeutics With lead gene therapy nearing the clinic, SwanBio leans heavily on Syncona to close $56M series B Barber buzzes into Aquestive CEO post as Kendall leaves amid FDA delay Applied Molecular Transport’s co-founder exits along with 40% of staff as early pipeline activity paused Reaction Biology bolsters executive team with new commercial, HR heads Researchers develop battery-free, smart contact lens that delivers glaucoma drugs on demand J&J partner Aspen, with no orders for its COVID shot, warns low demand sends 'bad message' NIH scientists use machine learning AI to narrow down risk factors for long COVID Online mental health startup Cerebral will stop prescribing controlled substances Pfizer holding on tight to supplies of COVID-19 drug Paxlovid, limiting the prospect of combination research: report Featured Story | By Annalee Armstrong The four companies working on gene therapies for Duchenne muscular dystrophy have had another thing in common besides the modality and disease they’re working on: serious adverse events. Pfizer, Sarepta, Genethon and Solid Biosciences teamed up for a pooled safety analysis that was presented this week at the American Society of Gene and Cell Therapy meeting. read more |
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| Sponsored By: ValGenesis Inc. AR-driven hands-free validation isn’t just a futuristic concept. It’s available now, and it has the power to transform the life sciences. Read more. read more |
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| Sponsored By: Danaher Corporation The Life Sciences companies at Danaher are setting the template for end-to-end creation of new mRNA medicines, with innovations in plasmid DNA, RNA oligonucleotides, lipid nanoparticles and more. read more |
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Top Stories By Annalee Armstrong “We just don’t have the studies” became a familiar refrain for Kirsten Bibbins-Domingo, M.D., Ph.D., chair of the Committee on Improving Representation of Women and Underrepresented Minorities in Clinical Trials and Research. A new report from the committee shines a light on the “critical shortcoming” in clinical research conducted in the U.S.: a lack of representation in clinical trials. read more By James Waldron,Annalee Armstrong Life sciences VC firm Flagship Pioneering has unveiled a new company called Sonata Therapeutics to develop cell and gene therapies for oncology, fibrosis, and autoimmune disorders. Flagship founded Sonata this year by combining two of the VC’s existing ventures: Inzen Therapeutics and Cygnal Therapeutics. read more By Nick Paul Taylor Syncona is continuing to bet big on gene therapy. While setbacks at other biotechs have taken the sheen off the modality, the investor is keeping the faith in SwanBio Therapeutics, stepping up to provide the lion’s share of a $56 million series B round that will support an early-phase clinical trial. read more By Nick Paul Taylor Aquestive Therapeutics is shuffling its deck of executives as it awaits an FDA decision on its seizure drug, parting company with CEO Keith Kendall and promoting Daniel Barber to fill the gap created by the exit. read more By Gabrielle Masson It’s been less two years since Applied Molecular Transport’s IPO, but time has not been kind. The company is slashing 40% of its workforce and a co-founder will exit, while early-stage pipeline activities are put on pause. read more By Gareth Macdonald Discovery services contractor Reaction Biology has further expanded its executive team, framing the appointments as the next phase of the firm’s development. read more By Conor Hale Researchers in China have put forward early studies of a smart contact lens for treating glaucoma. It aims to sense rising fluid pressures within the eye and automatically deliver medication as needed. read more By Fraiser Kansteiner Late last year, Johnson & Johnson’s COVID production partner Aspen Pharmacare touted the game-changing potential of its “monumental” licensing deal to make and sell J&J’s single-dose shot in Africa. Five months later, and two months after Aspen’s start of production, the effort has encountered a problem currently familiar to all pandemic vaccine developers. read more By Andrea Park While it may seem that there’s no clear rhyme or reason to long COVID diagnoses, researchers from the National Institutes of Health are determined to suss out a pattern that could shed at least a little light on the factors that put a person at higher risk of developing the condition. read more By Heather Landi Mental health startup Cerebral said this week it will no longer prescribe most controlled substances to patients, citing the eventual expiration of telehealth waivers that allowed online prescriptions for drugs like Xanax and Adderall. read more By Zoey Becker Pfizer is keeping a tight fist around supplies of its blockbuster COVID-19 drug, Bloomberg reports. Researchers aren't able to get their hands on the pills for combination studies, which they say could help them fight the looming problem of drug resistance. read more Resources Sponsored by: Catalent In this executive summary, we describe the benefits of controlled release, look at how to determine whether a drug is suitable for controlled release, review the application of PBPK modelling in controlled release formulation development and discuss how modified release products can be developed to deliver optimal patient outcomes. Sponsored by: Merit Solutions Quality operations guide your organization through regulatory compliance processes and safeguard your products, processes, and reputation. But your team is capable of so much more. Quality incident data and processes can be a driver of significant business value if shared with other stakeholders. Sponsored by: Blue Matter, strategic consultants in the life sciences Recent trends are driving big changes in Medical Affairs. This paper explores why, and what MA teams can do to stay ahead of the curve. Sponsored by: PwC Don’t miss these critical considerations when evaluating your HCP interactions management program. 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