This site uses cookies to improve your experience. To help us insure we adhere to various privacy regulations, please select your country/region of residence. If you do not select a country, we will assume you are from the United States. Select your Cookie Settings or view our Privacy Policy and Terms of Use.
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Used for the proper function of the website
Used for monitoring website traffic and interactions
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Strictly Necessary: Used for the proper function of the website
Performance/Analytics: Used for monitoring website traffic and interactions
Subjects who conclude the trial will be qualified for an open-label extension trial. By GlobalData Learn more about Strategic Intelligence The study is assessing the safety and efficacy of 15 mg or 30 mg of the therapy against a placebo, administered once daily for 12 weeks to those with genetically and phenotypically defined MELAS.
While Catalent Inc and PCI Pharma Services are in charge of the solid dose and packaging of Lupkynis, Lonza is manufacturing the small molecule API. In the same month, the EMA expanded the label of Gilead Sciences’ Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) to include its use for virologically suppressed HIV-positive children.
As a vertically integrated company, SHL Medical prides itself on being an end-to-end partner, offering in-house capabilities at every stage – from design, development and production to final assembly, labelling and packaging. Download the whitepaper ‘Charleston, USA: A life sciences hub’ here.
At the 2025 Congress of the European Hematology Association (EHA 2025), held from 12 June 12 to 15 June in Milan, Italy, preliminary dose-escalation and optimisation results from the global, multicentre, open-label, single-arm Phase I/II SYRUS clinical trial (NCT06137118) were presented on the second day.
Based on the individual contract, these CMOs manufacture small molecules or biological active pharmaceutical ingredients (APIs), as well as packaging material, and are charged with other related functions. Sharp Packaging Services is producing the solid dose of the drug and packaging it.
Contract manufacturing organizations (CMOs) not only produce the active pharmaceutical ingredient (API) at the heart of a therapy, but are also responsible for the sterile manufacturing and packaging of liquid and inhalational drug constituents and packaging, depending on the needs of the particular therapy.
By GlobalData Learn more about Strategic Intelligence Corwin added that Elevidys’s label will likely be updated to reflect the risk of ALF. Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. Give your business an edge with our leading industry insights.
Vaccines under political pressure Whilst the label expansion reflects an easing in regulatory tension surrounding mRNA vaccines under the Trump administration, FDA approval does not automatically mean shots enter national immunisation schedules. It also gained FDA approval a year before mRESVIA, giving it first to market advantage.
Originally approved for children in 2021, the FDA updated the drug’s label in January this year to include adults. The mechanism of action of Qelbree, though unclear, is thought to be through inhibiting the reuptake of norepinephrine. ADHD treatments were in the political crosshairs in the US recently.
We organize all of the trending information in your field so you don't have to. Join 11,000+ users and stay up to date on the latest articles your peers are reading.
You know about us, now we want to get to know you!
Let's personalize your content
Let's get even more personalized
We recognize your account from another site in our network, please click 'Send Email' below to continue with verifying your account and setting a password.
Let's personalize your content