Pharmafile Logo
Pharmafocus logo
Advanced Search

Pierre Fabre Laboratories receives CHMP positive opinion for BRAFTOVI  in combination with MEKTOVI  for the treatment of adult patients with advanced non-small cell lung cancer  NSCLC) with a BRAFV600E mutation

July 29, 2024
Clinical Trial Services BRAF mutation, CHMP, EMA, Oncology, Pierre Fabre Laboratories, colorectal cancer, european studies, non-small cell lung cancer

Pierre Fabre Laboratories has announced a positive opinion from the European Medical Association’s (EMA) Committee for Medicinal Products Human use …

News

CHMP gives positive opinion for Merck’s KEYTRUDA for unresectable or metastatic urothelial carcinoma

July 29, 2024
Research and Development ADC, CHMP, Merck, Oncology, Urology, keytruda, metastatic urothelial carcinoma, unresectable urothelial carcinoma

Merck (known as MSD outside of the US and Canada) has announced that its anti-PD-1 therapy, in combination with Padcev …

News

Calliditas Therapeutics announces positive phase 2b data in Primary Biliary Cholangitis trial

July 26, 2024
Research and Development Calliditas, Hepatology, clinical trials, elevated liver stiffness, primary biliary cholangitis

 Calliditas Therapeutics AB today announced that the phase 2b TRANSFORM trial met its primary endpoint. The trial showed statistically significant …

News
alzheimers_brain

AC Immune’s pTau-targeting immunotherapy awarded Fast Track designation by FDA

July 26, 2024
Research and Development AC Immune, Alzheimer's disease, Neurology, clinical trials, fast track designation, immunotherapy, tau protein

Clinical-stage biopharmaceutical company AC Immune announced that the US Food and Drug Administration (FDA) has granted its Alzheimer’s disease (AD) …

News

BioAtla gains FDA Fast Track Designation for ozuriftamab vedotin

July 25, 2024
Medical Communications BioAtla, FDA, Oncology, fast track designation, ozuriftamab vedotin

BioAtla has announced that the US Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to ozuriftamab vedotin, …

News
robina-weermeijer-ihfopazzjhm-unsplash_5

Eisai and EcoNaviSta enter dementia collaboration

July 25, 2024
Business Services EcoNaviSta, Eisai, Neurology, collaboration, dementia

Eisai and EcoNaviSta have announced that they have entered into a business alliance agreement, initiating their collaboration intended to build …

News

Agilent to acquire BIOVECTRA for $925m

July 24, 2024
Business Services Agilent, CMDO, Pharmacy, acquisition

Agilent Technologies has announced that it has signed a definitive agreement to acquire BIOVECTRA, a leading specialised contract development and …

News

J&J seeks FDA approval of Spravato as monotherapy for treatment-resistant depression

July 24, 2024
Medical Communications J&J, Johnson & Johnson, Neurology, Spravato, treatment-resistant depression

Johnson & Johnson (J&J) has announced that it has submitted a supplemental New Drug Application (sNDA) to the US Food …

News

ViiV Healthcare shares data for two-drug regimen for HIV-1 maintenance therapy

July 23, 2024
Research and Development GSK, HIV, HIV/AIDS, ViiV Healthcare, maintenance therapy

GSK has announced that ViiV Healthcare, a specialist HIV company predominantly owned by GSK with Pfizer and Shionogi as shareholders, …

News

ViroCell Biologics signs Master Services Agreement with NCI-designated cancer centre

July 23, 2024
Business Services Cancer, Oncology, ViroCell Biologics, agreement

ViroCell Biologics has announced that it has signed a five-year Master Services Agreement (MSA) with a prominent US-based NCI-designated cancer …

News

60 Degrees Pharmaceuticals signs clinical trial agreements with sites for babesiosis study

July 22, 2024
Medical Communications 60 Degrees Pharmaceuticals, Pharmacy, babesiosis, clinical trials

60 Degrees Pharmaceuticals has announced that it has signed clinical trial agreements with all three of its planned trial sites …

News

Results from Sanofi’s ALTUVIIIO XTEND-Kids phase 3 trial published in NEJM

July 22, 2024
Research and Development Altuviiio, Haematology, Sanofi, haemophilia

Sanofi has announced that full results from the XTEND-Kids phase 3 study were published in The New England Journal of …

News

GSK’s application for Blenrep for MM treatment accepted for EMA review

July 19, 2024
Medical Communications Blenrep, EMA, GSK, Oncology

GSK has announced that the European Medicines Agency (EMA) has accepted the marketing authorisation application (MAA) for Blenrep (belantamab mafodotin) …

News

Brainomix and Boehringer Ingelheim enter strategic partnership

July 19, 2024
Research and Development Boehringer Ingelheim, Brainomix, Pharmacy, fibrosing lung disease, partnership

Brainomix has announced that it has entered into a strategic partnership with Boehringer Ingelheim for a collaborative programme surrounding the …

News

FDA accepts Atara Biotherapeutics’ Tab-Cel for priority review

July 18, 2024
Medical Communications Atara Biotherapeutics, FDA, Virology, priority review

Atara Biotherapeutics has announced that the US Food and Drug Administration (FDA) has accepted the filing of its Biologics License …

News

China’s NMPA accepts Everest Medicines’ Nefecon supplementary application

July 18, 2024
Medical Communications China, Everest Medicines, NMPA, Nephrology

Everest Medicines has announced that China’s National Medical Products Administration (NMPA) has accepted the submission of a supplemental New Drug …

News

Loci Orthopaedics announces €12.8m series A financing

July 17, 2024
Business Services Financing, Musculo-skeletal disorder, investment, loci orthopaedics

Loci Orthopaedics has announced the successful closing of an oversubscribed €12.8m series A financing, which was led by new investors …

News

Renalys Pharma closes ¥6bn series A financing for kidney disease treatments in Asia

July 17, 2024
Business Services Financing, Nephrology, kidney disease, renalys Pharma

Renalys Pharma has announced that it has completed ¥6bn series A financing, which was led by Catalys Pacific and SR …

News

Camurus shares phase 3 results from ACROINNOVA 2 study

July 16, 2024
Research and Development Camurus, Pharmacy, acromegaly, clinical trial, injection

Camurus has announced positive results from its 52-week phase 3 open-label ACROINNOVA 2 study, which assessed the safety and efficacy …

News

NICE recommends digital tech for ADHD diagnosis in children and young people

July 16, 2024
Medical Communications ADHD, Diagnostics, NICE

The National Institute for Health and Care Excellence (NICE) has announced that its diagnostics advisory committee has recommended the QbTest …

News
The Gateway to Local Adoption Series

Latest content

Just – Evotec given Gates Foundation grant to increase global biotherapeutics access

January 8, 2026

Johnson & Johnson submits robotic surgical system for De Novo classification

January 8, 2026

EA Pharma announces phase 3 trial for new schizophrenia treatment in Japan

January 7, 2026

Eleva appoints Erich Rajkovic as Chief Business Officer

January 7, 2026

MedPharm announces US FDA inspection of North Carolina manufacturing facility

January 6, 2026