News
The Federal Trade Commission is supporting the U.S. Patent and Trademark Office’s proposed new rules requiring parties to a patent dispute to disclose all settlement agreements, including pharmaceutical drug settlements.
FEATURED STORIES
Following FDA rejections, Regeneron and Scholar Rock are turning to other facilities to clear regulatory logjams created by quality problems at an ex-Catalent facility in Indiana. Novo Nordisk, meanwhile, has been tight-lipped about whether its own FDA applications have been affected.
As big pharmas including Takeda and Novo Nordisk flee the cell therapy space and smaller biotechs shutter their operations, these players are sticking around to take the modality as far as it can go.
This year has seen the approval of several first-in-class therapies for HAE, but in a fragmented space, experts question whether they will be enough to net their developers a significant share of the entrenched market.
Job Trends
Takeda Pharmaceutical Company Limited provided an update on the status and announced the completion of the acquisition of its own shares, which has been carried out pursuant to the provision of its Articles of Incorporation in accordance with Article 459, paragraph 1 of the Companies Act of Japan, based on the resolution of the Board of Directors’ meeting held on October 28, 2021. Details of the acquisition of shares is below.
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Read our takes on the biggest stories happening in the industry.
Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.
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While Merck lost out to Pfizer earlier this year in snapping up Seagen, this week the company closed a deal worth a potential $22 billion with Daiichi Sankyo—further evidence of the industry’s insatiable appetite for ADC technology.
Tarlatamab achieved a 40% objective response rate in small cell lung cancer patients with advanced disease who had failed two or more prior lines of treatment, the company announced Friday.
The two-part formulation of subcutaneous nivolumab combined with Halozyme’s proprietary recombinant human hyaluronidase achieved two primary endpoints while also showing a noninferior overall response rate.
The non-alcoholic steatohepatitis space is still a “big mystery,” analysts tell BioSpace, but its connection to weight loss could provide an additional opportunity for contenders.
Despite increasing antitrust scrutiny across the biopharma industry, the European Commission on Thursday said it found no competitive issues with Pfizer’s buyout of the antibody-drug conjugate company.
Seeking to deepen its immuno-oncology business, Merck has closed a deal potentially worth $22 billion across three of Daiichi Sankyo’s DXd antibody-drug conjugates for various solid tumor indications.
Sail Biomedicines combines Laronde’s circular eRNA platform with Senda’s nanoparticle delivery technology in the pursuit of a new class of programmable medicines across therapeutic areas.
The trial, which is the first late-stage study of an in vivo CRISPR treatment in the U.S., will start by the end of 2023. Intellia’s NTLA-2001 is a treatment candidate for transthyretin amyloidosis cardiomyopathy.
The contracting COVID-19 market has led to lower third-quarter sales for the Swiss drugmaker, which made the decision to eliminate four clinical programs following underwhelming readouts.
Following a delay and an initial rejection, UCB’s IL-17A/IL-17F blocker bimekizumab was approved for moderate-to-severe plaque psoriasis, which will now be marketed with the brand name Bimzelx.