Fraiser Kansteiner

1 week ago | fiercepharma.com | Fraiser Kansteiner

Despite hiring a commercial chief and sponsoring disease awareness efforts last year, Savara will have to wait a while longer for a potential approval of its inhaled lung disease asset molgramostim. The FDA has slapped Savara with a refuse to file (RTF) letter after the biotech in March applied for approval of molgramostim in the rare disease autoimmune pulmonary alveolar proteinosis (aPAP).

2 weeks ago | fiercepharma.com | Fraiser Kansteiner

After meeting the mark alongside Keytruda in PD-L1-positive breast cancer earlier this year, Gilead Sciences' antibody-drug conjugate Trodelvy has impressed in a solo showing in a similar indication. In the late-stage Ascent-03 trial, Trodelvy bested standard-of-care chemotherapy at extending the time before disease worsening or death in certain patients with previously untreated metastatic triple-negative breast cancer (TNBC).

2 weeks ago | fiercepharma.com | Fraiser Kansteiner

In the wake of the COVID-19 pandemic, which acclimated many workers to at-home or hybrid work models, French drugmaker Sanofi concluded that the traditional office paradigm was on its way out. Now, following efforts by the company to modernize its workspaces in France and beyond, nearly 2,000 employees have moved on up to Sanofi’s new flagship U.S. offices in New Jersey.

2 weeks ago | fiercepharma.com | Fraiser Kansteiner

While GSK’s Nucala may not have earned the distinction of becoming the first FDA approved biologic for chronic obstructive pulmonary disease (COPD), the British drugmaker is confident its IL-5 antibody still has a major role to play in tackling the traditionally tough-to-treat respiratory condition. And now, following an unexpected delay earlier this month, the company has a fresh FDA green light to put its thesis to the test.

2 weeks ago | fiercepharma.com | Fraiser Kansteiner

In a bid to allay conflict-of-interest concerns, Korean manufacturing giant Samsung Biologics is decoupling from its biosimilars development unit. Starting later this year, Samsung Bio will devote itself fully to contract manufacturing under a plan to spin off a new investment holding company that will oversee the drugmaker’s biosimilar subsidiary Samsung Bioepis. The spinoff of the new company—tentatively named Samsung Epis Holdings—is expected to take place on Oct.