News
As part of an ongoing Senate investigation into pharma companies’ tax rates, Sen. Ron Wyden (D-Ore.) has asked Pfizer CEO Albert Bourla to explain irregularities in its reported revenues, losses and taxes paid.
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
Akebia Therapeutics, Inc., a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, granted 12 newly-hired employees options to purchase an aggregate of 97,000 shares of Akebia’s common stock on February 28, 2022, as inducements material to each such employee’s entering into employment with Akebia.
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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.
THE LATEST
$27.8B Amgen-Horizon deal gets FTC clearance with restrictions; the White House names first 10 drugs subject to Medicare price negotiations; Sage Therapeutics axes 40% of staff.
The vaccine was effective against previous COVID-19 variants but lacked efficacy against new ones, the company announced Thursday, leaving the booster no commercially viable options.
Under a consent order agreement announced Friday, Amgen is prohibited from bundling any of its products with Horizon’s Tepezza or Krystexxa, allaying the FTC’s primary concerns.
The antibody-drug conjugate will be pitted against chemotherapy in a heavily treated breast cancer subpopulation, with hopes of challenging AstraZeneca and Daiichi Sankyo’s blockbuster Enhertu.
Two Democratic senators on Thursday sent a letter to the companies’ CEOs informing them that they have until Sept. 15 to disclose the application processes for their insulin assistance programs.
After shoring up quality control at its Reykjavik manufacturing facility, the biotech has resubmitted a BLA to the FDA seeking an interchangeability designation for its Humira biosimilar.
The settlement, announced Wednesday, ends a three-year legal battle allowing Teva Pharmaceuticals to make a generic version of Alkermes’ alcohol and opioid dependence drug Vivitrol.
With a recent study yielding positive results, experts say GLP-1 drugs are making headway in treating Alzheimer’s and other neurodegenerative diseases.
Following the FDA’s recent rejection of zuranolone in major depressive disorder, Sage Therapeutics has launched a strategic reorganization initiative including a 40% reduction in headcount.
Amid a supply shortage of the attention-deficit/hyperactivity disorder and binge-eating disorder medication, the regulator has cleared a slew of generic drugs of Takeda’s Vyvanse pill.