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Pharma News

With FDA nod for Lumryz, Avadel is set to Jazz up the narcolepsy market
With FDA nod for Lumryz, Avadel is set to Jazz up the narcolepsy market
Waking up in the middle of the night to take a pill is the onerous way patients take the world’s top-selling narcolepsy drug, Jazz Pharmaceuticals’ Xyrem.
AstraZeneca FDA vote worth potentially US$500mln annual peak sales
AstraZeneca FDA vote worth potentially US$500mln annual peak sales

AstraZeneca PLC forecasts for its major Lynparza drug are expected to be trimmed following an advisory vote against full approval in the US. 

Teva, MedinCell win FDA approval for slow-release schizophrenia drug Uzedy
Teva, MedinCell win FDA approval for slow-release schizophrenia drug Uzedy
After 20 years developing technology for slow-release injectable drugs, MedinCell of France has won its first FDA approval.
FDA turns back Ascendis' hormone drug over manufacturing issues
FDA turns back Ascendis' hormone drug over manufacturing issues
After the FDA threw a wrench in Ascendis’ hypoparathyroidism drug application by flagging deficiencies in the filing, the agency has now issued a manufacturing-related complete response letter to...
Danaher’s Aldevron unit plots mRNA manufacturing expansion
Danaher’s Aldevron unit plots mRNA manufacturing expansion
Aldevron, a subsidiary of Danaher, unveiled plans to expand its mRNA manufacturing operations to include lipid nanoparticle (LNP) encapsulation and aseptic fill-finish capabilities. ...
Labeling error forces Teva to recall 13 lots of fentanyl buccal tablets
Labeling error forces Teva to recall 13 lots of fentanyl buccal tablets
A labeling problem has forced Teva to recall 13 lots of fentanyl buccal tablets. Safety updates on the product insert were omitted, leaving the possibility of misuse that “could lead to life-thre...
FDA approves drug which helps to slow progression of rare form of MND
FDA approves drug which helps to slow progression of rare form of MND
The Food and Drug Administration (FDA) in the US has authorised the first approved drug for a rare form of motor neurone disease (MND) based on the results of a Phase 3 clinical trial completed at ...
National Institute for Health and Care Excellence approves expanded use of Yescarta and Tecartus
National Institute for Health and Care Excellence approves expanded use of Yescarta and Tecartus
Kite – a Gilead Sciences spin out company – has announced that the National Institute for Health and Care Excellence (NICE) has recommended additional uses for their two CAR T-cell therapies. ...
CHMP recommends approval for GSK’s RSV vaccine candidate
CHMP recommends approval for GSK’s RSV vaccine candidate

The CHMP’s positive opinion was supported by data obtained from a pivotal Phase II AReSVi-006 trial.

Eli Lilly raises annual profit forecast on strength of diabetes drug
Eli Lilly raises annual profit forecast on strength of diabetes drug
Eli Lilly and Co  on Thursday raised its annual revenue and profit forecasts after topping first-quarter sales estimates on demand for its closely watched diabetes drug Mounjaro, ahead of a d...
Sun Pharma pauses US drug exports from India plant after FDA scolding
Sun Pharma pauses US drug exports from India plant after FDA scolding

Sun Pharma says it's responding to increased pressure from the FDA following a plant inspection last August. 

The EU outlined its plan to equalize drug access and lower prices. Pharma firms are not happy
The EU outlined its plan to equalize drug access and lower prices. Pharma firms are not happy
The EU’s proposal for the biggest shake-up in pharma rules for decades has finally arrived, but companies say they could simply take their innovative medicines elsewhere. ...
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