Pharma News - Chemdiv

FDA Pauses IND Submission for Duchenne Therapy ENTR-601-44

In preclinical studies, ENTR-601-44 has demonstrated a robust ability to skip exon 44 in the muscles of nonhuman primates and full-length human DMD mice.

AbbVie’s Vraylar Gets Expanded Approval for Major Depressive Disorder

The FDA has expanded its approval for AbbVie’s blockbuster antipsychotic drug Vraylar (cariprazine), this time as an adjunctive treatment along with antidepressants to treat adults with major dep...

EU regulators issue guidance on decentralised trials

The EU has published new recommendations aiming to encourage the use of decentralised clinical trials (DCTs) – and to make sure patients who participate in them have their wellbeing safeguarded. ...

FDA Expands Approval for Cytalux Imaging for Lung Cancer Detection

The FDA has approved a new indication for pafolacianine (Cytalux) to aid surgeons in detecting lung cancer lesions in adult patients with known or suspected lung cancer. ...

FDA Approves First Gene Therapy for Specific Form of Bladder Cancer

The FDA has approved Ferring’s gene therapy Adstiladrin to treat adults with high-risk Bacillus Calmette-Guérin-unresponsive non-muscle-invasive bladder cancer — the first gene therapy approv...

Vanda Loses Hetlioz Patent Case

Vanda Pharmaceuticals has vowed to appeal a federal judge’s dismissal of several patent infringement claims aimed at Teva Pharmaceuticals and Apotex over their generic forms of its sleep disorder...

Neurophth Receives IND Clearance from FDA for AAV-ND1 Gene Therapy of LHON

Neurophth Therapeutics, Inc. today announced receiving the U.S. Food and Drug Administration (FDA) clearance of its investigational new drug (IND) application on the in-vivo gene replacement therap...

Kintara’s VAL-083 Gets Orphan Drug Status for Rare Childhood Cancer

The FDA has granted Orphan Drug status to Kintara Therapeutics’ VAL-083 candidate for the treatment of diffuse intrinsic pontine glioma, a rare, very aggressive and hard to treat childhood brain...

Centrient API Plant Receives Warning Letter

Centrient Pharmaceuticals’ active pharmaceutical ingredient (API) facility in Punjab, India, received a warning letter from the FDA for multiple deficiencies including lax records, test validatio...

Prime to Cover Biosimilars Alongside Humira

A decision is anticipated in early January about which of the now eight Humira biosimilars will be included.

AstraZeneca's Alexion hopes to extend dominance in PNH as Big Pharma competitors close in

For years, Alexion has been the only name in the game for a blood disease called paroxysmal nocturnal hemoglobinuria (PNH).

Intranasal Therapy for Major Depressive Disorder Gets Fast Track Status

The Food and Drug Administration (FDA) has granted Fast Track designation to PH10 for the treatment of major depressive disorder (MDD).