Regeneron’s COVID-19 antibody EUA reduced to lower dose by FDA
June 7, 2021Sales and Marketing
The FDA has updated the Emergency Use Authorisation (EUA) for Regeneron Pharmaceuticals’ COVID-19 antibody cocktail, REGEN-COV, halving the dose from …
Pharmafile.com’s top 10 news stories of the week
June 4, 2021Medical Communications
Among our ten most-read stories this week: NICE rejects risdiplam for treating spinal muscular atrophy; The EU wants to Fine …
Novartis’s 177Lu-PSMA-617 reduces prostate cancer death risk by 38%
June 4, 2021Medical Communications
Novartis’s 177Lu-PSMA-617 has shown to significantly improve overall survival and radiographic progression-free survival for men with metastatic castration-resistant prostate cancer …
BMS announce new positive data from oesophageal cancer study
June 4, 2021Medical Communications Cancer, oncology
Bristol Myers Squibb (BMS) has announced results from the Phase III CheckMate -648 trial in which nivolumab plus chemotherapy and …
Phase III trial shows Olaparib reduces breast cancer recurrence by 42%
June 4, 2021Medical Communications
Results from OlympiA’s Phase III trial has shown that its Olaparib (Lynparza) in the adjuvant treatment of patients with germline …
J&J’s Tremfya sees positive results for post-TNFi psoriatic arthritis
June 4, 2021Medical Communications J&J, JJ
Johnson & Johnson’s interleukin-23 (IL-23) Tremfya (guselkumab) has shown positive results in Phase IIIb trials, in post-tumour necrosis factor (TNF) …
WHO approves China’s Sinovac COVID-19 vaccine
June 3, 2021China’s Sinovac COVID-19 vaccination has received an emergency use listing (EUL) from the WHO. This decision means the jab can …
Vaccine patch outperforms needle-and-syringe jabs in pre-clinical study
June 3, 2021COVID-19, Vaccine, technology
Vaxxas, an Australian clinical-stage biotechnology company, has announced positive results from pre-clinical trials into its novel high-density microarray patch (HD-MAP) …
Phase III traumatic brain injury trial does not meet primary endpoint
June 3, 2021vasopharm GmbH has announced that its NOSTRA III traumatic brain injury (TBI) Phase III clinical trial of ronopterin did not …
Novartis report longest median OS in breast cancer study
June 3, 2021Novartis, breast cancer, trials
Novartis has announced updated median overall survival (OS) results for Kisqali (ribociclib), in combination with fulvestrant, in postmenopausal women with …
Organon launches as women’s health company
June 3, 2021Organon has today launched through a spinoff from Merck as a global company focusing on women’s health. The new team …
Biosimilars and Brexit: What’s in store for UK’s biosimilar market?
June 2, 2021Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing biosimilars, brexit
It’s been 15 years since the first biosimilar entered the market, and the impact of these drugs on the healthcare …
The importance of representation in clinical trials
June 2, 2021Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Representation, clinical trials
Before any kind of new medicine can be made available to the market, it has to go through a strictly …
Softbox brings in Sean Austerberry as new Director
June 2, 2021Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing
Softbox Systems has appointed Sean Austerberry as its Research and Product Development Director. Sean will be responsible for all of …
Sharp adds Robert O’Beirn to its Global Clinical Services Business
June 2, 2021Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing
Sharp has appointed Robert O’Beirn as SVP and Managing Director of its global Clinical Services business. In early 2019 Mr …
Debra Hussain new CCO of Acacia Pharma
June 2, 2021Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing
Acacia Pharma has appointed Debra Hussain as Chief Commercial Officer. She is a highly experienced commercial leader having spent over …
Redx installs Natalie Berner as Non-Executive Director
June 2, 2021Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing
Redx Pharma has appointed Natalie Berner as a Non- Executive Director, she will represent RM Special Holdings 3 LLP on …
NICE rejects risdiplam for treating spinal muscular atrophy
June 2, 2021Research and Development
NICE has issued draft guidance today which does not recommend Roche’s risdiplam (Evrysdi) for treating the rare genetic disorder spinal …
FDA approves Novartis’s Cosentyx for severe plaque psoriasis
June 2, 2021Research and Development
The FDA has approved Novartis’s Cosentyx for the treatment of children and adolescents with moderate to severe plaque psoriasis. The …
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