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Home » Newsletters » BioWorld

BioWorld

Dec. 19, 2018

View Archived Issues

Fibrogen, Astrazeneca move roxadustat to first approval in China

In a second first in the same week for China, roxadustat (previously FG-4592), developed by Fibrogen Inc. and partnered in the country with Astrazeneca plc, became the first drug advanced by a global biopharma to receive its initial nod from the National Medical Products Administration (NMPA, formerly the CFDA) before applications were submitted to the FDA and EMA. Read More

Tetra partners up with Shionogi on early asset targeting AD, FXS

After a courtship of more than a year, Tetra Discovery Partners LLC and Shionogi & Co. Ltd. tied the knot to develop and commercialize BPN-14770, Tetra's phosphodiesterase 4D (PDE4D) allosteric inhibitor, for the treatment of fragile X syndrome (FXS), Alzheimer's disease (AD) and other indications marked by cognitive and memory deficits. Read More

Wave of series A rounds place 2018 at an all-time high; five raise a combined $139M

Series A financings are continuing their record pace, with five additional companies raising a combined total of $139 million, placing 2018 at the top for most venture capital money ever flowing into early stage companies, and doubling the amount raised one year prior: $5.4 billion vs. $2.6 billion. Read More

Proposal to require drug prices in TV ads in U.S. lands mixed reviews

Comments on a proposed rule requiring drug companies to disclose pricing information in direct-to-consumer (DTC) TV ads drew both qualified support and strong opposition from predictable quarters in responses posted by the U.S. CMS on Monday. Arguments against the rule from industry and advocates for free commercial speech made clear likely lines of attack while positive feedback suggested in some cases that the rule wouldn't go far enough to clarify true out-of-pocket costs in a complex market. Read More

Haystack soon all needles, Vitrakvi FDA OK highlights need for better screening

Stamford, Conn.-based Loxo Oncology Inc. and partner Bayer AG, of Leverkusen, Germany, recently scored their expected win with the accelerated clearance by the FDA for Vitrakvi (larotrectinib) to treat adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without an acquired resistance mutation. Read More

Innovent Biologics, Incyte ink licensing deal for potential $391.5M

HONG KONG – In a deal involving up to $391.5 million, HKEX-listed Innovent Biologics Inc. (HKG:1801) in-licensed three clinical-stage assets from Incyte Corp. to develop and commercialize them in the Chinese mainland, Hong Kong, Macau and Taiwan. Read More

An inflection point for ATTR: Approvals, data and more

Transthyretin (TTR) amyloidosis (ATTR), a rare disease caused by the misfolding and aggregation of the TTR protein, has reached an inflection point with two drugs approved to treat the disease this year and multiple drugs in development. Read More

Other news to note

Selexis SA, of Geneva, and Menlo Park, Calif.-based Teneobio Inc. said that they have entered into a second services agreement to expand Teneobio's oncology pipeline of human heavy-chain antibodies (Uniabs), a new class of multi-specific biologics. Read More

Clinical data for Dec. 18, 2018

Read More

Regulatory actions for Dec. 18, 2018

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