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1 week ago | 
biocentury.com | Meredith Durkin Wolfe
DATA GRAPHICS | Data ByteTotal CDER approvals stand at 10 so far this year, 50% less than at this time last year By Meredith Durkin Wolfe, Director of ResearchFDA approved just three NMEs in April, bringing the total for the first four months of the year to 10.
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1 week ago | 
biocentury.com | Meredith Durkin Wolfe
DATA GRAPHICS | Data ByteA next-gen COVID vaccine among eight FDA decisions due in May By Meredith Durkin Wolfe, Director of ResearchAmong the eight PDUFA dates on FDA’s May calendar is a BLA for Moderna’s next-generation COVID-19 vaccine. The agency’s decision on the application will send a strong signal about whether any COVID vaccine can still win approval under the Trump administration. Moderna Therapeutics Inc.
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2 weeks ago | 
biocentury.com | Meredith Durkin Wolfe
DATA GRAPHICS | Data ByteSeven new products get positive opinions in April By Meredith Durkin Wolfe, Director of ResearchEMA’s CHMP recommended seven new drugs at its April meeting: five new orphan medicines, one new “orphan hybrid,” and a non-orphan product under standard review. An orphan hybrid is similar to FDA’s 505(b)(2) application for new formulations.
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1 month ago | 
biocentury.com | Meredith Durkin Wolfe
DATA GRAPHICS | Data ByteXBI and NBI continue to fall more than broader markets By Meredith Durkin Wolfe, Director of ResearchStocks fell again Tuesday, as markets continue to react to tariff policy. The XBI and NBI have lost 17% and 14% since last Friday, March 28, and 11% and 10% since tariffs were announced Wednesday. Their slide outpaces the broader markets, with the S&P500 down 11% since last Friday and 8% since Wednesday.
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1 month ago | 
biocentury.com | Meredith Durkin Wolfe
DATA GRAPHICS | Data BytePreviously a bright spot in 2025 markets, Hong Kong stocks take a sharp downturn By Meredith Durkin Wolfe, Director of ResearchBiopharma stocks listed in Hong Kong fell Monday, following the trendsetting of the U.S. markets on Friday. Of 24 companies with drugs on the market and valuations over US$1 billion at Friday’s close, 17 performed worse that the 13% drop by the Hang Seng Index (HSI). The smallest loss in the group was 8%.
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1 month ago | 
biocentury.com | Meredith Durkin Wolfe
PRESENTATION | Finance1Q25 Wrap: Market backslide hits broad swath of companiesWinners, losers in biotech stock tiers in 1Q25 By Meredith Durkin Wolfe, Director of ResearchApril 4, 2025 10:56 PM UTCLarge-cap biotechs narrowly avoided the downward trajectory of stock markets in 1Q25, treading water with a median gain of 1%. The group, defined as companies that started the year with market capitalizations of $5-$9.9 billion, saw 17 companies gain value and 16 lose value.
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1 month ago | 
biocentury.com | Meredith Durkin Wolfe
DATA GRAPHICS | Data ByteFirst drug for Prader-Willi hyperphagia, first Xolair biosimilar By Meredith Durkin Wolfe, Director of ResearchFDA’s six new product approvals in March included the first drug to treat hyperphagia in Prader-Willi syndrome: Vykat XR diazoxide choline. Soleno Therapeutics Inc. (NASDAQ:SLNO) is launching the ATP-dependent potassium channel (KATP) agonist in April. It will be the company’s first product.
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1 month ago | 
biocentury.com | Meredith Durkin Wolfe
DATA GRAPHICS | Data ByteFDA has at least seven more target action dates coming up in April By Meredith Durkin Wolfe, Director of ResearchFDA’s deadline to complete review of Novavax’s COVID-19 vaccine came and went Tuesday with no response from the agency.
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1 month ago | 
biocentury.com | Meredith Durkin Wolfe
DATA GRAPHICS | Data ByteSeven of 11 $1B+ immunology acquisitions focused on two diseases By Meredith Durkin Wolfe, Director of ResearchBiopharmas cited immunology as the motivation for 11 M&A deals with upfront valuations over $1 billion in 2022-24. Of those, four of the acquired companies had lead products in the rare autoimmune kidney disease IgA nephropathy, while three were testing treatments for inflammatory bowel diseases.
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1 month ago | 
biocentury.com | Meredith Durkin Wolfe
DATA GRAPHICS | Data ByteAt least eight East-to-West licensing deals outside oncology so far this year By Meredith Durkin Wolfe, Director of ResearchWith Tuesday’s announcement that Hengrui is granting Merck & Co. ex-China rights to an oral small molecule lipoprotein(a) inhibitor, this year has brought at least eight deals where a Chinese company licensed products to a Western company in a therapeutic focus other than cancer. Both Jiangsu Hengrui Pharmaceuticals Co. Ltd.
