Goldfinch Bio Inc. CEO Anthony Johnson told BioWorld that his company's deal with Gilead Sciences Inc. represents "a phenomenal opportunity, because this [kidney disease patient registry] will be the biggest of its type, definitely for the kidney but arguably across other disease areas as well." Read More
DUBLIN – Pfizer Inc. is acquiring rare disease firm Therachon AG for $340 million up front and could pay up to $470 million more in development and commercial milestones linked to the progress of Therachon's achondroplasia therapy, TA-46. Read More
LONDON – The extent to which the EMA's operations are being impaired by its enforced removal from London to Amsterdam is laid bare in the agency's 2018 annual review, published this month. Read More
Adimab LLC announced three deals in a single day Wednesday by disclosing it will transfer its platform to Takeda Pharmaceuticals Co. Ltd., expand on an earlier multitarget research agreement with Regeneron Pharmaceuticals Inc. and up the ante on an agreement with Novartis AG to optimize antibodies against nine targets. Read More
PHILADELPHIA – "Because of our assumption that structure determines function, for a long time [low-complexity domains] were not considered important," J. Paul Taylor told the audience at the American Academy of Neurology (AAN) annual meeting's Frontiers in Neuroscience plenary session. Such low-complexity domains (LCDs) were thought of as junk parts of proteins, in analogy to junk DNA. Read More
HONG KONG – Kolon Tissuegene Inc., of Rockville, Md., has been ordered by the U.S. FDA to halt the phase III trial of its osteoarthritis cell and gene therapy, Invossa-K, as cancerous cell lines might have been used making the product. Read More
SHANGHAI – Comfort given isn't always comfort received, especially in the midst of volatility. But if attendees of the Chinabio Partnering Forum were open to it, they may have found a soothing message regarding the oft-disdained Committee on Foreign Investment in the U.S.: "CFIUS is not as scary as you may think," said Joseph Benkert, a senior advisor in Morrison & Foerster's National Security practice. Read More
SHANGHAI – Biotech entrepreneurs in China pursuing innovative drugs often straddle two, if not three, worlds. They have a deep knowledge of the scientific, regulatory and commercial landscape of China as well as the U.S. And, crucially, they have the ability to envision what the China market of the future will look like. Read More
List prices for prescription drugs may soon become as common a feature in TV ads in the U.S. as all those FDA-mandated warnings about possible side effects. Read More
The U.S. FDA has tangled with industry on more than one occasion over the question of a combination product's primary mode of action (PMOA), and a recent draft guidance resurrects some of the concerns around that topic. Read More
Jazz Pharmaceuticals plc, of Dublin, reported first-quarter revenues of $508.2 million, a 14% increase over revenues of $444.6 million for the same period in 2018. Read More
Curadev Pharma Pvt Ltd., of Uttar Pradesh, India, said it licensed lead small-molecule stimulator of interferon genes, or STING, agonist CRD-5500 and associated intellectual property to Takeda Pharmaceutical Co. Ltd., of Osaka, Japan. Financial terms were not disclosed. Read More
Veracyte Inc., of South San Francisco, said it closed a public offering of about 6.3 million common shares, including 825,000 shares sold by underwriters to exercise in full their overallotment option, at $23.25 apiece for net proceeds of approximately $137.9 million. Read More
The U.S. Court of Appeals for the Federal Circuit Wednesday upheld a lower court ruling that Sandoz Inc.'s biosimilars do not infringe patents protecting Amgen Inc.'s Neupogen (filgrastim) and Neulasta (pegfilgrastim). Read More
