A potential $1.9 billion-plus deal with Amgen Inc. in hand, Generate Biomedicines Inc. CEO Michael Nally said his firm’s approach “can take a couple of years off traditional complex protein design” by way of combining in silico work with wet lab capabilities. The pact brought $50 million up front for Cambridge, Mass.-based Generate, with the bigger money possible on the back end plus royalties on any resulting products.
With licensed Humira (adalimumab) biosimilar competition a little more than a year away in the U.S., Abbvie Inc. is trying to fend off competitors that have not signed an agreement with the North Chicago-based company.
A lead clinical trial investigator for Five Prime Therapeutics Inc.’s flagship cancer drug, bemarituzumab, is facing SEC and criminal charges related to insider trading.
The FDA has approved Astrazeneca plc and Amgen Inc.’s first-in-class biologic, tezepelumab, for the add-on maintenance treatment of adults and children ages 12 and older with severe asthma, adding further competition to a hotly contested market. An injection marketed under the brand name Tezspire, tezepelumab inhibits the action of thymic stromal lymphopoietin (anti-TLSP). This is a signaling molecule at the top of several cascades influencing allergic, eosinophilic and other types of airway inflammation associated with severe asthma, including airway hyperresponsiveness.
There was no slowing of biopharma innovation in 2021, even as industry directed significant resources to, while feeling the impact of, the ongoing COVID-19 pandemic. The year saw big wins for developers of DNA vaccines and biosimilars, while CAR T expanded its reach and a drug target once considered undruggable was finally conquered. And as 2021 gives way to 2022, other potentially game-changing technologies and therapeutics are waiting in the wings.
In trials name-checking some of the world’s highest peaks, longest rivers and most famous seas, Astrazeneca plc has long sought the best use of its CTLA4 inhibitor tremelimumab. Now, after a disappointing cruise along the first-line bladder cancer trial Danube and travails in non-small-cell lung cancer with the trials Mystic, Neptune and Arctic, a trek to the endpoint of its phase III trial Himalaya has yielded top-line success. A single, high priming dose of tremelimumab added to the company's immune checkpoint inhibitor, Imfinzi (durvalumab), led to a statistically significant overall survival (OS) benefit vs. Nexavar (sorafenib, Bayer AG and Amgen Inc.) in the first-line treatment for patients with unresectable hepatocellular carcinoma.
Neumora Therapeutics Inc., a neuroscience startup aiming to launch precision medicines for brain diseases, said Oct. 7 it has raised more than $500 million, including a $100 million equity investment from Amgen Inc. and a series A financing led by Arch Venture Partners. The company launches with a portfolio of eight clinical, preclinical and discovery-stage programs from internal discovery efforts, the acquisitions of multiple private companies and a new license agreement with Amgen.
Amgen Inc. will pay $900 million in cash to acquire privately held Teneobio Inc. In exchange for the cash, Amgen gets all of Teneobio’s outstanding shares, which could end up paying out quite a bit as contingent milestone payments to Teneobio’s equity holders could be worth up to $1.6 billion.
The FDA took Amgen Inc. to task for promotions claiming Neulasta (pegfilgrastim) Onpro on-body injector is more effective than pegfilgrastim delivered via a prefilled syringe.
U.S. Rep. Carolyn Maloney (D-N.Y.) came out swinging against the biopharma industry’s innovation talking point July 8 when she released a House Oversight Committee staff report on U.S. drug prices and the games drug manufacturers play to delay competition.
