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Puerto Rico offers top-notch talent, smart tax incentives & a robust supply chain, making it a bioscience powerhouse. With the highest concentration of pharma & medical device talent in the U.S., & extensive tax benefits, it’s the top destination for innovation. Visit our booth at BIO to learn more.
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Today’s Big NewsJun 6, 2024 |
| By Annalee Armstrong The docs for Eli Lilly’s donanemab advisory committee meeting are in: the FDA has raised concerns about the use of tau PET imaging during the clinical trials, the cessation of dosing after amyloid clearance and whether the small risk of brain bleeds in patients taking antithrombotics outweighs the benefits. |
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By Fraiser Kansteiner Orano Med—which is working on targeted alpha therapies for cancer—on Thursday inaugurated its first Alpha Therapy Laboratory (ATLab) in Brownsburg near Indianapolis, Indiana. The site marks the world’s first industrial-scale facility dedicated to production of lead-212-based radioligand therapies, the company said. |
By Zoey Becker Italy's antitrust agency is going after Novartis, Genentech, Biogen and Samsung Bioepis for allegedly working together to delay the launch of a Lucentis biosimilar in Italy. |
By Nick Paul Taylor Some slap downs from the PMCPA hit harder than others. The U.K. drug marketing body twisted the knife in its latest ruling against Otsuka, accusing the drugmaker of an unacceptable failure “to provide a full and frank disclosure.” |
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Wednesday, June 12, 2024 | 11am ET / 8am PT If you are a company developing gene therapies, don’t miss this opportunity to learn about containment and aseptic filling solutions – how to prepare for fill finish early and ensure products are ready to ship immediately upon approval, providing life-saving drugs to patients as quickly as possible. Register now.
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By Conor Hale Edwards Lifesciences presented five-year data showing similar safety rates for its Sapien valve regardless of the size of a patient’s aortic annulus or their sex. |
By Eric Sagonowsky England-based rare disease drug maker Cycle Pharmaceuticals revealed an $8-per-share offer for Vanda, representing a total buyout offer of $466 million. Vanda recently rejected a buyout offer worth up to $7.75 per share. |
By Gabrielle Masson Biopharma investment trends continue to shift, with venture funding jumping to $7.4 billion across 188 deals for the first quarter of the year. This compares to $6.3 billion across 248 deals the previous quarter and demonstrates an increase in deal value despite declining deal count, according to PitchBook. |
By Andrea Park While many campaigns for plaque psoriasis treatments focus on erasing the external effects of the condition, Sun Pharma’s latest Ilumya push is emphasizing the importance of looking inward, too. |
By Conor Hale Eko's fundraising follows an FDA clearance unlocking its AI program for detecting cases of low ejection fraction, a key indicator of heart failure. |
By Kevin Dunleavy Seven years after buying land in Des Plaines, Illinois, that housed a Salvation Army campus, German CDMO Vetter Pharma is finally ready to build on the property. Thursday, the 74-year-old private company revealed plans to move and expand its fill-finish site in Chicago suburb Skokie to Des Plaines, which is 10 miles west. Vetter also said that it is expanding its footprint in its home country, with plans to build a plant in Saarlouis. |
By Fraiser Kansteiner AbbVie announced that Elahere—also known as mirvetuximab soravtansine—met its primary endpoint in the midstage PICCOLO trial, triggering an objective response rate of 51.9%. |
By Nick Paul Taylor After taking 11 months to get to know Elsie Biotechnologies' oligonucleotide platform, GSK is ready to tie the knot with a $50 million deal to acquire the West Coast biotech. |
By Fraiser Kansteiner In an eight-observation Form 483, the FDA chided Hengrui for a laundry list of manufacturing missteps, including poor contamination controls, subpar cleaning protocols, failure to promptly hand over documentation to inspectors and quality control shortfalls. |
By Nick Paul Taylor Deerfield Agency has opened its wallet again, buying up the healthcare marketing and advertising firm Embedded to further extend its offer to life science companies. |
Fierce podcastsDon’t miss an episode |
| In this week's episode of "The Top Line," two journalists from the Fierce Biotech team share key insights from their four-part series on the challenges and breakthroughs in cell therapy. |
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Wednesday, June 19, 2024 |10am ET / 7am PT Join us for a one-hour discussion on oral cyclic peptide drug development. Learn about key breakthroughs that demonstrate results. Register now.
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| 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 |
| eBookTo make every rare disease trial count, we design patient-centric, relevant strategies for sponsors and caregivers to produce impactful results every time. Sponsored by: Emmes 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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