Medical Communications

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fda

FDA releases biosimilars labelling guidance

April 1, 2016 Manufacturing and Production, Medical Communications, Research and Development FDA, biosimilars

The US Food and Drug Administration (FDA) has issued draft guidance on the labelling of biosimilar drugs. The guidance states …

Sanofi and Regeneron announce positive Phase III trial results for chronic skin disease treatment

April 1, 2016 Medical Communications, Research and Development Dupilumab, Regeneron, Sanofi, atopic dermatitis, phase III, skin disease

Sanofi (NYSE: SNY) and Regeneron Pharmaceuticals (NASDAQ: REGN) have announced positive top line results for dupilumab in Phase III clinical …
samsung_bioepis

Samsung Bioepis’ Remicade biosimilar set for CHMP verdict

March 31, 2016 Medical Communications, Sales and Marketing Flixabi, Remicade, Samsung Bioepis, biosimilars, infliximab

Samsung Bioepis has confirmed that the European Commission’s scientific committee, the CHMP, is this week discussing the approval of its …
valeant

Valeant’s outgoing CEO subpoenaed by US congressional committee

March 29, 2016 Medical Communications, Research and Development Drug pricing, Michael Pearson, US, Valeant, committee, pearson, pharma, price hikes, senate aging committee, subpoena, subpoenaed

The US Senate Aging Committee has announced the issuing of a subpoena to the outgoing CEO of Valeant Pharmaceuticals, Michael …
msd

MSD teams up with Harvard to develop new leukaemia treatments

March 24, 2016 Medical Communications, Research and Development AML, Harvard, MSD, leukaemia

MSD has entered a new collaboration with Harvard University aimed at developing innovative new small-molecule therapeutics for leukaemia and other …
novartis_pic

Novartis settles bribery charges in China for $25m

March 24, 2016 Medical Communications, Sales and Marketing Novartis

Novartis will pay $25 million to the US Government’s Securities and Exchange Commission to settle charges that it bribed healthcare …
sovaldi-web

Federal jury rules in MSD’s favour in Gilead blockbuster hepatitis C drug dispute

March 23, 2016 Medical Communications, Research and Development Gilead, MSD, blockbuster, federal court, federal jury, hit, patents, sales, sales hit, sofosbuvir, sovaldi

Gilead’s dominance of the hepatitis C market is under severe threat after a federal jury ruled in favour of MSD …
fda_sign_web

FDA announces strongest warnings for opioid pain medications

March 23, 2016 Medical Communications, Research and Development FDA, abuse, addiction, boxed, label, misuse, opioids, public health, restrictions, safety, warnings

The US Food and Drug Administration has announced class-wide safety labelling changes for immediate release (IR) opioid pain medications. The …
fda_building

FDA bans clinical trial co-ordinator who faked patient samples and stole funds

March 22, 2016 Manufacturing and Production, Medical Communications FDA, HIV, clinical trials, faked, forgery, mcquerry, prison

The US Food and Drug Administration has permanently banned a clinical trial co-ordinator who was found to have falsified patient …
christa_wirthumer-hoche

European Medicines Agency elects Christa Wirthumer-Hoche as new chair of management board

March 21, 2016 Medical Communications, Research and Development Christa Wirthumer-Hoche, EMA, European Medicines Agency, chair, chairperson, wirthumer-hoche

Christa Wirthumer-Hoche has been elected chair of the management board of the European Medicine’s Agency. She has served as vice …
janssen_stairs_1

J&J says psoriasis drug Stelara shows positive results in trials for Crohn’s disease

March 18, 2016 Medical Communications, Research and Development Crohn’s disease, J&J, JJ, Stelara, crohn's disease

Johnson & Johnson (NYSE: JNJ) on Friday said a second late-stage trial of its psoriasis drug Stelara (ustekinumab) has shown effectiveness …
abraxane0058

Wales approve pancreatic cancer drug for use despite NICE rejection in England

March 18, 2016 Medical Communications, Research and Development Abraxane, Celgene, England, NHS, NICE, Wales, approval

Celgene (Nasdaq: CELG) has announced that Abraxane, in combination with gemcitabine, will continue to be an available treatment option for …
shutterstock_92671375

Indian govt set to ban 1,200 fixed-dose combination drugs, reports

March 18, 2016 Business Services, Medical Communications, Sales and Marketing Abbott Laboratories, Pfizer, cough drug, pharma

Indian regulators are set to ban an additional 1,200 fixed-dose combinations, sent for probe by Drug Controller General of India …
clinical_trial-web

OncoMed initiates Phase Ib immuno-oncology combination clinical trial

March 18, 2016 Medical Communications, Research and Development Merck, OncoMed, clinical trial, demcizumab, immuno-oncology, immuno-oncology combination, pembrolizumab, phase ib

OncoMed (NASDAQ: OMED) has announced the beginning of its Phase Ib clinical trial to investigate if the combination of demcizumab …
allergan

Allergan files ANDA for generic version of Celgene’s breast cancer treatment

March 18, 2016 Business Services, Medical Communications, Sales and Marketing Abraxane, Allergan, Celgene, breast cancer, generic

Allergan (NYSE: AGN) said it is seeking regulatory approval for a generic version of biotech firm Celgene’s (Nasdaq: CELG) breast …
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