Pharmaceutical Technology

DECEMBER 11, 2022

Due to the rarity of the disease, no FDA-approved therapy exists specifically for RT, and these patients are treated using regimens derived from the DLBCL treatment paradigm and other small-scale clinical trials. In the pirtobrutinib safety cohort, only 2.6% of patients discontinued treatment due to adverse events.

FDA 59

FDA Patients Safety Pharmaceutical 59

Pharmaceutical Technology

AUGUST 16, 2022

Enhertu has already achieved regulatory approval as a second-line therapy for metastatic or recurrent HER2-positive breast cancer, as well as HER2-positive gastric or gastroesophageal junction adenocarcinoma, with annual sales for these indications alone expected to exceed $1.3bn by 2028.

Food and Drug Administration 59

Food and Drug Administration Sales Patients Food 59

Pharmaceutical Technology

OCTOBER 28, 2022

The vaccine demonstrated a similar safety profile to Pfizer’s marketed 20-serotype shot Prevnar 20 at all assessed doses, and showed non-inferior efficacy. In June 2021, the FDA approved Pfizer’s Prevnar 20 for adult use, although a nod for paediatric use is pending. billion and $812 million in 2028. Further plans in the making.

Training 64

Training Marketing Competition FDA 64

PM360

SEPTEMBER 21, 2023

Under the pathway, manufacturers can use safety and efficacy data from existing products in their applications for their own products. In March, the FDA approved several new naloxone products using the pathway, including one from Amphastar, which will compete with other intranasal on the market.

Management 105

Management Manufacturing Sales Competition 105

Contrarian Sales Techniques

FEBRUARY 10, 2023

According to various market research reports, the global non-invasive medical devices market was valued at approximately USD 45 billion in 2020 and is expected to grow at a compound annual growth rate (CAGR) of over 6% from 2021 to 2028. This growth is driven by several factors, including: 1.

Healthcare 52

Healthcare Healthcare Manufacturing Medical 52

European Pharmaceutical Review

FEBRUARY 14, 2023

Robust analytical methods are needed to establish safety, potency, and purity of mRNA therapeutics in large-scale manufacturing. Sarah Bundra, Pharmaceutical Analyst at GlobalData also warned about patient safety: “introducing mRNA carries the risk of activating the immune system.”

Food and Drug Administration 89

Food and Drug Administration Medicine Safety Consulting 89

Medico Reach

OCTOBER 17, 2022

million by 2028. From procedure efficacy and cost to safety and training, there are still several challenges to overcome before robot-assisted surgery becomes standard practice. Quite recently, the Food and Drug Administration (FDA) marked a historical moment when it approved Patient Specific Talus Spacer 3D-printed implants in 2021.

Medical 98

Medical Food and Drug Administration Healthcare Healthcare 98