Remove 2015 Remove Communication Remove Labelling
article thumbnail

Health Canada expands Orkambi label to include access to infants

Pharmaceutical Technology

This label expansion makes Orkambi the only disease-modifying CF medication available to patients of this age in Canada. This label expansion follows a similar label change in the US in September 2022. Health Canada is granting this new label expansion based on recent results from a Phase III study.

article thumbnail

Scientific Communication for Pharma Marketing – Quiz

PharmaState Academy

Scientific Communication for Pharma Marketing - Quiz Competition Participate in the Quiz & learn more about the “Scientific Communication for Pharma Marketing” which is significant to Pharma Marketing & Sales professionals. Winner Prize: The Quiz winner will be awarded Amazon Gift card worth Rs.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

FDA AdCom votes in favour of Lundbeck’s/Otsuka’s Rexulti in AAD

Pharmaceutical Technology

Also known as brexpiprazole, the FDA first approved Rexulti as a treatment for adults with schizophrenia and as an add-on treatment for adults with major depressive disorder in July 2015. He added that there is also a need for FDA-approved products that communicate efficacy and safety on their labels.

article thumbnail

PEM POCUS Series: Pediatric Renal and Bladder Ultrasound

ALiEM - Pharm Pearls

Longitudinal view of the right kidney: Left – Probe placement in right mid-axillary line; Right – Unlabeled and labeled ultrasound view Video 1. Cysts will have a more spherical shape and will not “communicate” with one another [5]. Identify the medullary pyramids, calyces, renal cortex, and renal pelvis (Figure 4).

Labelling 177
article thumbnail

It’s a Cruel Summer – Two New OPDP Untitled Letters

FDA Law Blog: Biosimilars

The approved labeling for AUVI-Q includes warnings and precautions regarding emergency treatment, injection-related complications, serious infections at the injection site, allergic reactions associated with sulfite, and disease interactions. The Mirati letter deals with much more nuanced issues than the letter to kaleo.

article thumbnail

NHC Submits Comments on CMS Draft Guidance for IPAY 2028

Putting Patients First Blog

Even well-intentioned policies can create access disparities if communication and operational support are lacking. It is unclear how CMS will communicate this determination or whether stakeholders will be notified and invited to contribute evidence before a new price is set.

article thumbnail

Why security-first design is the fix to stalling AI pilot tools

pharmaphorum

Skip to main content Wednesday 2 July 2025 BlueSky linkedin youtube rss User account menu Subscribe Channels Channels Digital Market Access Oncology Patients R&D Sales & Marketing Spotlight on Content type Content type Digital -News -Views & Analysis -Deep Dive -Webinars -Podcasts -Video -White Papers -Event Market Access -News -Views & (..)