pharmaphorum

DECEMBER 9, 2022

Nasdaq: AUTL), a clinical-stage biopharma and a portfolio company of Syncona Ltd., This means that enrolment is now completed for the initial target or morphological cohort to form the basis of a Biological License Application (BLA) submission by the end of CY2023 to the US Food and Drug Administration (FDA). Autolus Therapeutic Plc.

Food and Drug Administration 90

Food and Drug Administration Safety Biopharma Patients 90

PM360

DECEMBER 14, 2023

“We’re now leveraging our expertise in communicating with healthcare professionals to deliver essential information and practical tools to physicians and other healthcare providers to help them address the challenges faced by patients with chronic illness.”

Physicians 52

Physicians Pharma Medical Patients 52

Pharma Marketing Network

MARCH 25, 2022

Members of a multidisciplinary care team may include physicians, nurses, pharmacists, radiologists, dieticians…the list goes on. The FDA has studied the importance of caregivers to drug development and regulatory decision-making. Extension of the patient: expanding the role of caregivers in biopharma development.

Pharma 98

Pharma Education Transportation Training 98

Clarivate

OCTOBER 10, 2022

Based on the TROPICS-02 trial results, Gilead has submitted a supplemental biologics license application (sBLA) to the FDA, seeking a label expansion for TRODELVY in the much larger setting of metastatic HR+/HER2-negative breast cancer. Key ESMO findings. months; HR: 0.321, P<0.001). months; HR: 0.321, P<0.001). Market impact.

Marketing 52

Marketing Safety Patients Competition 52

Clarivate

MAY 24, 2022

Approval pathways have been established that allow manufacturers to bring innovative therapies to market without conducting trials in Mainland China, provided the safety and efficacy of the drugs have been demonstrated through real world data (RWD) in other markets. 3] Rare Diseases at FDA [online]. [4] 10] [11] [12]. 2011; 6:81-82. [3]

Patients 52

Patients Food and Drug Administration Marketing Pharma 52

pharmaphorum

SEPTEMBER 12, 2022

Dr Prasanth Reddy, head of oncology at LabCorp, tells us how the company works with cancer care teams, biopharma partners, and patients as an integral part of the patient journey from testing to treatment. They offer the only diagnostic kit cleared by the US FDA for pan-solid cancer comprehensive tumour profiling using a 500+ gene panel.

Patients 102

Patients Medicine FDA Healthcare 102

Clarivate

OCTOBER 7, 2021

What’s new from ESMO: Interim efficacy and safety analysis from the randomized KEYNOTE-716 study showed that the trial met its primary endpoint of RFS, with patients receiving Keytruda presenting an RFS of 90.5% Kisqali plus letrozole demonstrated a significant OS benefit, but is that enough to displace physician favorite Ibrance?

Patients 91

Patients Safety Marketing Physicians 91