FDA issues CRL to PharmaTher’s ketamine ANDA
The US FDA has issued a complete response letter (CRL) to PharmaTher concerning its ketamine abbreviated new drug application (ANDA).
TerSera acquires global rights to MacroGenics’ MARGENZA for breast cancer treatment
MacroGenics has granted global rights to the breast cancer drug MARGENZA to TerSera Therapeutics. TerSera will pay MacroGenics $40m upon closing.
Samsung Biologics signs $1.24bn manufacturing deal with Asian pharma company
CDMO Samsung Biologics has secured a contract manufacturing deal valued at $1.24bn with an Asia-based pharmaceutical company.
Novartis gets positive CHMP opinion for Kisqali in early breast cancer
Novartis has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), recommending marketing authorisation for Kisqali (ribociclib)
AscellaHealth acquires specialty pharmaceutical wholesaler CHAPPER healthcare
AscellaHealth has acquired CHAPPER healthcare, a specialty pharmaceutical wholesaler, distributor and services provider, for undisclosed amount.
Astria Therapeutics’ navenibart gains orphan medicinal status from EC
Astria Therapeutics received the European Commission's orphan medicinal product designation (OMPD) for navenibart to treat hereditary angioedema (HAE).
RTI partners with Codetta Bio to boost healthcare innovation
RTI International has announced a strategic collaboration with Codetta Bio, a multi-omics company, to fast-track healthcare innovation.
Samsung Biologics launches biopharmaceutical platform S-HiCon
Samsung Biologics has launched S-HiCon, a new formulation platform designed to enhance the development and manufacturing of high-dose drugs.
Stealth’s elamipretide gains FDA advisory committee support for Barth syndrome
Stealth Biotherapeutics elamipretide has received a favourable vote from the FDA Cardiovascular and Renal Drugs Advisory Committee (CRDAC).
Volixibat gains FDA breakthrough therapy designation
Mirum Pharmaceuticals has announced that the US FDA has granted breakthrough therapy designation to its drug candidate, volixibat,
Volixibat gains FDA breakthrough therapy designation
Mirum Pharmaceuticals has announced that the US FDA has granted breakthrough therapy designation to its drug candidate, volixibat,
insitro collaborates with Lilly on metabolic disease treatments
Drug discovery and development company insitro has executed three agreements with Lilly to advance new treatments for metabolic diseases.
PsychoGenics secures NIH contract to identify new pain therapeutics
PsychoGenics has received an award from the US NIH to conduct the testing and identification of new investigational therapeutics aimed at treating pain.
Neuvivo files NDA seeking FDA approval for ALS treatment
Neuvivo has filed a new drug application (NDA) with the US FDA seeking approval for NP001 for treating amyotrophic lateral sclerosis (ALS).
AstraZeneca to license CSPC Pharmaceutical’s lipid-lowering therapy
AstraZeneca has signed an exclusive agreement to license CSPC Pharmaceutical’s new lipid-lowering therapy, YS2302018, for patients with dyslipidaemia.
FDA grants priority review for AstraZeneca’s Calquence sNDA
The US FDA granted priority review to AstraZeneca's sNDA for Calquence for the treatment of adult patients with mantle cell lymphoma (MCL).
FDA grants fast track status for Volastra’s VLS-1488 to treat ovarian cancer
The US FDA granted fast track designation for Volastra Therapeutics’ VLS-1488 to treat patients with platinum-resistant high-grade serous ovarian cancer.
FDA grants approval for Fresenius-Formycon’s biosimilar Otulfi
The US Food and Drug Administration (FDA) has granted approval for Fresenius Kabi and Formycon’s Otulfi (ustekinumab-aauz).
AbbVie seeks FDA approval for non-small cell lung cancer treatment
AbbVie has filed a BLA with the US FDA seeking accelerated approval for telisotuzumab vedotin (Teliso-V) in adult NSCLC patients.
Acumen Pharmaceuticals extends collaboration with Lonza for sabirnetug
Acumen Pharmaceuticals has announced the extension of its collaboration with Lonza to facilitate the anticipated commercial launch of sabirnetug.
MITEM PHARMA acquires global rights to injectable medicine from Novartis
MITEM PHARMA has acquired worldwide rights to DESFERAL, an injectable medicine of major therapeutic interest in haematology, from Novartis.
Amgen’s TEPEZZA gets Japan’s MHLW approval for thyroid eye disease treatment
Amgen has announced the receipt of approval from the Japan’s MHLW for TEPEZZA to treat active or high clinical activity score thyroid eye disease (TED).
FDA grants fast track designation for Elevation Oncology’s EO-3021
The US FDA has granted fast track designation for Elevation Oncology’s EO-3021 for gastric and gastroesophageal junction (GC/GEJ) cancer.
FDA grants fast track designation for Elevation Oncology’s EO-3021
The US FDA has granted fast track designation for Elevation Oncology’s EO-3021 for gastric and gastroesophageal junction (GC/GEJ) cancer.