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Explore BCIQ profiles by entering a target name.
BioCentury | Jan 4, 2025
Market Access
Accelerated approval speed bump will limit access, disincentivize orphan drug development
Penn.-based commercial payer using accelerated approval to justify coverage denials of non-oncology products for 18 months
BioCentury | Dec 11, 2024
Data Byte
November’s FDA approvals include Autolus’ CD19 CAR T
Plus: BridgeBio’s Attruby approved for ATTR-CM, PTC’s gene therapy for AADC deficiency, and Gilead withdrew Trodelvy for urothelial cancer
BioCentury | Dec 2, 2024
Deals
PTC adds $1B up front, ‘more muscle’ for Huntington program via Novartis deal
Biotech retains upside in licensing agreement for oral therapy derived from same splicing platform as SMA drug
BioCentury | Nov 15, 2024
Regulation
PTC wins gene therapy approval based on small, open-label trial
Biotech expects to sell voucher after winning gene therapy’s approval for AADC deficiency based on 13-patient study
BioCentury | Oct 31, 2024
Data Byte
Seven PDUFA dates on FDA’s November calendar
Upcoming decisions include BridgeBio’s
BioCentury | May 3, 2023
Distillery Therapeutics
Blocking LBP suppression of monoamine synthesis for depression
BioCentury | Jan 9, 2023
Deals
Voyager extends cash runway with $175M up front in Neurocrine deal
Second neurology gene therapy deal for partners focused on Parkinson’s disease
BioCentury | Oct 28, 2022
Product Development
Oct. 28 Quick Takes: Gilead returns to $100B market cap on strong earnings
Plus: vaccines stand out for Sanofi, and updates from Outlook, PTC, Y-mAbs, Ascletis, Agios and more
BioCentury | Jul 21, 2022
Finance
July 20 Quick Takes: Multiomics-driven cancer newco Auron raises $48M series A
Plus Section 32 leads BigHat’s $75M round; PTC gains first global approval of brain-infused gene therapy; and more
BioCentury | Oct 14, 2021
Product Development
A year of gene therapy setbacks
And how they’re shifting the development landscape
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