FDA expand Paragraph IV Patent Certifications List for generic drugmakers
June 19, 2019Research and Development FDA, Hatch-Waxman act, generic drugs, generics, pharma
The FDA has said that it is expanding a database used by generic drugmakers to get information on when their …
EU approval for MSD and AZ’s Lynparza in first-line BRCA-mutated advanced ovarian cancer
June 18, 2019Manufacturing and Production, Sales and Marketing AstraZeneca, Cancer, MSD, lynparza, ovarian cancer, pharma
AstraZeneca and MSD’s jointly-developed therapy Lynparza (olaparib) has scored its third EU approval, the pair announced, with authorisation for the …
Roche secures world first with Japanese Rozlytrek approval in advanced recurrent solid tumours
June 18, 2019Manufacturing and Production, Sales and Marketing Cancer, Japan, Roche, Rozlytrek, pharma
Roche’s personalised cancer therapy Rozlytrek (entrectinib) has seen its first approval: the drug has been approved in Japan for the …
MHRA recall M&A Pharmachem’s paracetamol due to fungal contamination
June 18, 2019Manufacturing and Production Contamination, MHRA, fungal, paracetamol, pharma
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has issued a recall of M&A Pharmachem’s 500mg paracetamol tablets. The …
FDA approves Novo Nordisk’s Victoza for children with type 2 diabetes
June 18, 2019Manufacturing and Production GLP-1, Novo Nordisk, Victoza, diabetes, liraglutide
The FDA has approved Novo Nordisk’s Victoza (liraglutide) for paediatric patients aged 10 years and older with type 2 diabetes. …
Pfizer buy Array BioPharma for $11.4 billion
June 18, 2019Manufacturing and Production
Pfizer has said it will acquire Colorado-based cancer specialist Array BioPharma for $11.4 billion. Pfizer has announced that it has …
Boehringer Ingelheim open new plant in Catalonia
June 17, 2019Sales and Marketing Boehringer Ingelheim, Catalonia, Sant Cugat de Valles, barcelona, pharma
Boehringer Ingelheim has opened a new manufacturing facility in the town of Sant Cugat del Vallès near Barcelona. The new …
Dr Reddy’s sells of two migraine treatments to Upsher-Smith Laboratories in deal worth $110 million
June 17, 2019Sales and Marketing
Indian firm Dr Reddy’s has agreed to sell two migraine treatments to American firm Upsher-Smith Laboratories in a deal worth …
WHO decide not to declare global emergency
June 17, 2019Sales and Marketing Ebola, UN, WHO, global emergency, health, pharma
The WHO has decided not to declare the Ebola crisis in the Congo a global emergency. While the WHO said …
Drugmakers sue Trump over prices in TV ads
June 17, 2019Sales and Marketing Amgen, Eli Lilly, HHS, MSD, Merck, Trump, pharma
Amgen, Eli Lilly and MSD have sued the Trump administration to try and block measures to force pharma companies to …
Patient dies after receiving faecal transplant
June 17, 2019Sales and Marketing Adverse Event, E.Coli. AMR, FDA, faecal transplant, pharma
A person has died after experiencing an adverse event related to a faecal transplant. The FDA has warned that two …
The missing link: Blockchain in clinical data management
June 14, 2019Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Big Data, blockchain, data, data management, pharma, supply chain
Louis Goss explores the potential uses for the much-hyped technology blockchain as a tool to tackle the data management challenges …
Gilead inks deal with Canadian antibody discovery firm AbCellera
June 14, 2019Medical Communications AbCellera, Gilead, monoclonal antibodies, pharma
Gilead has entered into an agreement with Canadian monoclonal antibody discovery firm AbCellera. The two firms will take part in …
Top Ten most popular articles on Pharmafile.com this week!
June 14, 2019Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Astellas, GSK, J&J, JJ, Otsuka, Pfizer, Purdue, Sanofi, Vertex, pharma
Pfizer supressed research showing their arthritis drug Enbrel reduced the risk of Alzheimer’s. This was the big revelation this week! …
FDA ask MSD to join blockchain supply chain network
June 14, 2019Medical Communications FDA, MSD, Merck, blockchain, supply chain
The FDA has asked MSD to join a shared permission blockchain network to help track and trace prescription medicines and …
Teva recall heart drug after carcinogen found in API
June 14, 2019Medical Communications API, Contamination, NMDA, Teva, carcinogen, pharma, recall
Teva Pharmaceuticals has expanded its recall of losartan potassium tablets after detecting a possible carcinogen in an active pharmaceutical ingredient …
GSK sets up new CRISPR lab with UC, Berkeley
June 13, 2019Medical Communications GSK, UC, berkely, crispr, genetics, pharma
GSK has struck a $67 million deal with the University of California, Berkeley. British multinational GlaxoSmithKline will collaborate with UC, …
GSK tech exec joins Institute of Cancer Research
June 13, 2019Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing
The Institute of Cancer Research (ICR) has said GlaxoSmithKline’s Dr Adrian Cottrell will join as the institute’s new Chief Information …
Catalyst Pharma sues FDA after agency approves Jacobus’ LEMS drug
June 13, 2019Business Services, Manufacturing and Production FDA, Jacobus, catalyst, firdapse, pharma, ruzurgi
Florida firm Catalyst Pharmaceuticals is suing the FDA after the agency approved a rival’s drug. The lawsuit alleges the approval …
FDA offer priority review for Genentech’s Rituxan in children
June 13, 2019Research and Development
The FDA will offer priority review to Genentech’s supplemental biologics-license application (sBLA) application for Rituxan for children with two rare …
Latest content
Major funding opportunity opens for early cancer diagnostics
Androlabs receives UK authorisation for new Testavan presentation
CEPI backs African-led Bundibugyo Ebola vaccine development
Cytomos appoints life sciences executive to board
