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Gene editing and gene therapies that disseminate systemically can have unforeseen liability, but in vitro assays paired with advanced molecular diagnostics can be used to assess potential off-target toxicity.
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Today’s Big NewsJun 28, 2024 |
| By James Waldron Rocket Pharmaceuticals’ flight path to approval for Kresladi has been delayed again after the FDA issued a complete response letter (CRL) requesting additional manufacturing information. |
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By James Waldron In the latest sign that biotech’s return to the public markets remains somewhat lackluster, Alumis has downsized its IPO as the company prepares to list on the Nasdaq this morning. |
By Nick Paul Taylor GeNeuro reported the near-total failure of its phase 2 long COVID trial Friday, telling investors it saw no effect on the primary endpoint and most secondary goals. The biotech responded by laying off staff and seeking strategic alternatives. |
Sponsored by Cardinal Health CGT companies should consider developing a market access strategy early in clinical development, ideally more than three years prior to launch. |
By Gabrielle Masson Ensho Therapeutics has emerged with an inflammatory disease therapy portfolio from Eisai’s GI subsidiary EA Pharma, including a phase 2-ready clinical program in ulcerative colitis (UC). |
By Gabrielle Masson,Andrea Park Longtime biopharma leader Salomon (Sam) Azoulay, M.D., has joined endocrine and metabolic disorder-focused MBX Biosciences, where he’ll serve as chief medical officer. |
By Helen Floersh Ethris GmbH’s mRNA-based treatment to prevent viral infections in people with uncontrolled asthma so far appears to be safe and increases expression of its target protein, early data suggest. |
By Angus Liu An antibody-drug conjugate patent arbitration fight that Seagen waged against Daiichi Sankyo has officially ended in a win for the Japanese company. |
By Conor Hale After announcing a plan to reduce “labor expenses” by at least 25% in early May, the synthetic biology company disclosed this week that it will be letting go of more than a third of its workers. |
By Noah Tong Sen. Ron Wyden, not letting PBMs out of his sights, is urging CMS to better enforce rules that could curb unfair practices by Express Scripts and other major PBMs. |
By Zoey Becker Rovi's potential CDMO unit sale has attracted buyout offers, the company confirmed. The unit generated 409 million euros last year. |
By Conor Hale The TB-focused project with the FDA follows up on the Gates Foundation's interest in breath biopsy tests developed by Owlstone Medical. |
By Angus Liu The FDA rejected Daiichi Sankyo and Merck's HER3 antibody-drug conjugate. Novo Nordisk's weight-loss star Wegovy secured approval in China. After two large licensing deals, Takeda's CEO is open to more partnerships with Chinese biotechs. And more. |
Fierce podcastsDon’t miss an episode |
| | In today’s episode of "The Top Line," Fierce Biotech’s Annalee Armstrong and James Waldron discuss what they think are the best and smartest biopharma acquisitions in recent years. |
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| WhitepaperThe definitive report on the state of our industry. Readers will gain an understanding of key indicators to monitor, future predictions, and guidance for investors and founders navigating the therapeutic enabling tools and services, healthtech and techbio sectors through 2024 and beyond. Sponsored by: AVANT BIO |
| WebinarWatch our on-demand webinar video to learn more about the challenges in pDNA manufacturing for gene and cell therapy and how to resolve many of these barriers by partnering with our experts through the adoption of vital manufacturing technologies and strategies. Sponsored by: Aldevron |
| WhitepaperNew molecular formats are gaining momentum in today’s market. Characterizing these products and developing robust manufacturing processes can help to usher them to market and provide new treatment options for diseases which are currently challenging to treat. Read this white paper to learn more. Presented by: Lonza |
| WhitepaperThis detailed case study shows how Fresenius Medical Care achieved 25 times faster insights to help kidney disease patients, launching the world’s largest global database of dialysis care with fully anonymized patient data. Sponsored by: Privacy Analytics, an IQVIA company |
| WhitepaperThis paper outlines the challenges, pitfalls, & solutions associated with adding rare disease therapies to a biopharma company’s portfolio. Sponsored by: AIM, the strategic leader in life science supply chains |
On Helix Date: 4 July 2024 - Location: Babraham Research Campus, Cambridge UK |
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