Merck receives positive European Union CHMP opinion for Gefapixant

The CHMP’s recommendation will now be reviewed by the European Commission for marketing authorization in the European Union

Moderna posts Q1 2024 revenues at US$167 million

GAAP net loss of $1.2 billion and GAAP diluted EPS of $(3.07)

AstraZeneca’s Truqap plus Faslodex recommended for approval in the EU by CHMP for cancer treatment

Recommendation based on CAPItello-291 results which showed the Truqap combination reduced the risk of disease progression or death by 50%

Takeda receives positive CHMP opinion for Fruquintinib in previously treated mCRC

If approved in the European Union, Fruquintinib will be the first novel targeted therapy for Metastatic Colorectal Cancer regardless of biomarker status in over a decade

CHMP adopts positive opinion recommending approval of Bristol Myers Squibb’s Opdivo in combination with Cisplatin and Gemcitabine

If approved, the Opdivo-based regimen would be the first immunotherapy-chemotherapy combination approved for this patient population in the EU

Merck 1Q 2024 sales up 9% to US$ 15.8 billion

Sales reflect continued strong growth in oncology and vaccines

Mac-Chem Products (India)’s Boisar facility renews EU-GMP certification

Briefs: Sun Pharma and Kimia Biosciences

Sun Pharma's Dadra facility receives OAI status from US FDA

USFDA approves Bristol Myers and 2seventy bio’s Abecma for triple-class exposed multiple myeloma

Abecma tripled progression-free survival compared to standard regimens in the Phase 3 KarMMa-3 trial

Truqap plus Faslodex approved in Japan for patients with advanced HR-positive breast cancer

First and only AKT inhibitor approved in Japan for breast cancer patients with specific biomarker alterations