Amgen invests $650 million on expansion of US manufacturing network

Amgen has invested over $40 billion in manufacturing and research and development in US since 2017

Enhertu improved in invasive disease-free survival in early breast cancer in DB-05

Second positive Phase III trial of AstraZeneca and Daiichi Sankyo’s Enhertu in HER2-positive early breast cancer reinforces its potential to become a foundational treatment option in curative-intent setting

Lilly opens biotech in San Diego

82,514 sq ft facility to host up to 15 biotech companies, fueling the development of next-generation medicines

DINAMIQS inaugurates new cGMP viral vector manufacturing facility in Switzerland

The new site enables end-to-end production of viral vector gene therapies

Fujifilm Biotechnologies opens cell culture manufacturing site in North Carolina

Represents one of the largest cell culture biomanufacturing sites in North America, which will employ 1,400 people by 2031

The Lancet Regional Health publishes pivotal phase 3 clinical study on Miqnaf

FDA approves Alembic’s Paroxetine ER tablets

Paroxetine Extended-Release Tablets USP, 25 mg and 37.5 mg, are indicated for the treatment of major depressive disorder

DMMA warns regulatory burden threatening Gujarat’s pharma MSMEs

The association called for an end to the constant issuance of regulatory circulars that make operations unpredictable and capital-intensive.

Pi Health to deliver clinical research services for GSK’s Phase 2 oncology trial

Physician-led Pi Health has demonstrated capabilities to dramatically reduce clinical trial timelines and administrative burden, while increasing data quality

Lupin receives FDA tentative approval for Bictegravir, Emtricitabine, and Tenofovir Alafenamide tablets

Bictegravir, Emtricitabine, and Tenofovir Alafenamide Tablets are indicated for the treatment of human immunodeficiency virus infection in adults and pediatric patients weighing at least 25 kg