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.
7th February 2019
Latest news
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.
7th February 2019
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.
5th February 2019
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.
5th February 2019
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.
5th February 2019
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.
5th February 2019
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.
5th February 2019
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).
5th February 2019
Isatuximab shows positive results in Phase III trial for multiple myeloma
A Phase III trial of Sanofi's isatuximab’s has proven successful, showing that the drug achieved the primary endpoint of prolonging progression free survival in patients with relapsed/refractory multiple myeloma.
5th February 2019
Boots to launch specialist pharmacist practitioner role
Boots UK has announced plans to introduce a new specialist pharmacist practitioner role.
5th February 2019
Polypharmacy reviews becoming ‘increasingly important’
The Royal Pharmaceutical Society (RPS) has published guidance on polypharmacy for pharmacists and all healthcare organisations involved with medicines.
5th February 2019
Mapping of oesophageal cancer gene mutations leads to new drug targets
Mutations that cause oesophageal adenocarcinoma (OAC) have been mapped in unprecedented detail, unveiling good news that more than half could be targeted by drugs currently already in trials for other cancer types.
5th February 2019
FDA rejects Alkermes' depressive disorder drug
The US Food and Drug Administration (FDA) has rejected Alkermes' filing for ALKS 5461 in major depressive disorder (MDD), asking for more clinical data.
4th February 2019
Migraine treatment Ajovy among CHMP’s six endorsed medicines
Six medicines have taken a giant leap toward winning approval in Europe having won the backing of the European Medicines Agency’s (EMA) human medicines committee (CHMP).
4th February 2019
Forxiga receives positive EU CHMP for type I diabetes in adults
AstraZeneca’s Forxiga has been recommended by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) as an oral adjunct treatment to insulin in adults with type I diabetes.
4th February 2019
