Eisai and Purdue Pharma have announced six-month results from the SUNRISE 2 Phase III clinical study evaluating the efficacy and safety of lemborexant.
News
NICE makes Canadian partnership to offer scientific advice
The National Institute for Health and Care Excellence (NICE) is working with the Canadian Agency for Drugs and Technology in Health (CADTH) to offer parallel scientific advice to the life sciences industry.
Cablivi gets FDA OK for blood clotting disorder
The US Food and Drug Administration (FDA) has approved Sanofi’s Cablivi as the first treatment for adult patients with a rare blood clotting disorder, acquired thrombotic thrombocytopenic purpura (aTTP).
GSK posts Q4 profit
GlaxoSmithKline (GSK) has released its fourth-quarter 2018 results, reporting prescription drug sales of £4.8 billion – a 6% increase on the prior year period – and profit of £1.4 billion, marking an increase of £442 million.
Zogenix submits new drug application to FDA for Fintepla
Zogenix has completed its rolling submission of a New Drug Application in the US and submitted a marketing application in Europe for Fintepla for the treatment of seizures associated with Dravet syndrome.
Roche to treat 1,500 hemophilia A patients in developing countries
Roche has announced that it has joined the World Federation of Hemophilia (WFH) Humanitarian Aid Program, a landmark initiative leading the effort to change the lack of access to care and treatment for people with inherited bleeding disorders in developing countries.
Fasenra granted Orphan Drug Designation by FDA
AstraZeneca’s Fasenra has been awarded Orphan Drug Designation in the US for the treatment of hypereosinophilic syndrome (HES).
Mundipharma launches Pelmeg biosimilar in Europe
Mundipharma has announced the launch of Pelmeg (pegfilgrastim), a biosimilar of Neulasta, following its European Commission (EC) approval in November 2018.
Scottish researchers link 100 variants and 269 genes to depression
More than 100 independent variants and 269 genes have been linked to depression by scientists in Edinburgh.
Taking home a Pharma
Tatiana Doldonova, winner of the Experienced CRA category in last year’s PharmaTimes Clinical Researcher of the Year – The Americas competition, reflects on her role in clinical research and what it means to win a Pharma.
Medical professionals urge MP Matt Hancock to give funding for prostate cancer research
A group of doctors is calling on health secretary Matt Hancock to stream some of the recently announced £75 million funding for prostate cancer into greater provision of a new method for diagnosing the condition.
Merck and GSK join forces for difficult to treat cancers
Germany’s Merck and GlaxoSmithKline have announced a global alliance to jointly develop and commercialise M7824, a novel immunotherapy with potential in multiple difficult to treat cancers, in a deal worth up to 3.7 billion euros.
FDA accepts two of MSD’s new drug applications
MSD has announced that the US Food and Drug Administration (FDA) has accepted for review New Drug Applications (NDA) for two of its antibacterial agents.
Roche submits FDA supplemental biologics license application for Kadcyla
Roche has submitted a supplemental biologics license application in the US seeking to expand the use of Kadcyla to include the adjuvant treatment of people with HER2-positive early breast cancer with residual disease after neoadjuvant treatment.
AZ’ RSV drug bags EMA PRIME, FDA Breakthrough statuses
AstraZeneca’s MEDI8897 has been granted access to both the European Medicines Agency (EMA) PRIME (PRIority MEdicines) scheme, and the US Food and Drug Administration’s (FDA) Breakthrough Therapy Designation (BTD).
