Please login to the form below

Not currently logged in
Email:
Password:

drug approval

This page shows the latest drug approval news and features for those working in and with pharma, biotech and healthcare.

Neoantigen player Achilles gets OK for first clinical trial

Neoantigen player Achilles gets OK for first clinical trial

Will test the candidate in advanced NSCLC patients. Achilles Therapeutics is now a clinical-stage biotech after getting regulatory approval to start a phase 1/2 trial of its lead lung ... Approval of our first [clinical trial application] represents an

Latest news

More from news
Approximately 6 fully matching, plus 840 partially matching documents found.

Latest Intelligence

  • China’s clinical trial shake-up China’s clinical trial shake-up

    Chinese authorities have supported the local R&D boom and made the country more attractive for overseas companies by overhauling clinical trial and drug approval processes. ... A drug control institute or third-party laboratory tests drug samples to

  • Alnylam’s big moment: bringing groundbreaking RNAi drugs to Europe Alnylam’s big moment: bringing groundbreaking RNAi drugs to Europe

    Alnylam was also forced to abandon one of its first pipeline drugs, revusiran, after it was linked to deaths in trials, but persisted, developing a safer and more potent drug delivery ... platform. Led by founder and CEO John Maraganore, Alynlam finally

  • China: AstraZeneca’s new engine for growth and innovation China: AstraZeneca’s new engine for growth and innovation

    In March 2017, AZ’s targeted lung cancer drug Tagrisso was one of the first medicines to gain approval through the Chinese Food and Drug Administration (CFDA)’s Priority Review pathway, ... This means the out-of-pocket cost for healthcare has fallen,

  • The rise of real-world evidence The rise of real-world evidence

    Using real-world evidence. RWE has distinct applications pre- and post-approval. Before a drug comes to market, sponsors use the resource to evaluate unmet needs, identify subpopulations of patients and ... Once a therapy wins approval, companies turn to

  • Finding the patient voice Finding the patient voice

    probability of the drug getting approval. ... Mr Whitley went on to volunteer at an NGO, working with pharma companies to make drug trials simpler for patients.

More from intelligence
Approximately 0 fully matching, plus 32 partially matching documents found.

Latest appointments

  • Anthony Zook resigns as Vivus CEO Anthony Zook resigns as Vivus CEO

    shareholders became unhappy with the way Vivus handled the launch of its obesity drug Qsymia (phentermine/ topiramat). ... Pharmaceuticals. Vivus also failed in a bid to win approval for the drug in Europe.

  • CytomX makes senior changes following Pfizer deal CytomX makes senior changes following Pfizer deal

    During his time at Affymax, Dr Polu headed several areas, including clinical sciences, clinical operations and drug safety/pharmacovigilance. ... He was also one of the key figures behind the development and approval of Affymax' first drug Omontys

  • Kite Pharma appoints Zelboraf scientist as CMO Kite Pharma appoints Zelboraf scientist as CMO

    At Plexxikon, he also led the filing of eight investigational New Drug Applications in cancer. ... Dr Nolop's vast experience in drug development from conception to approval will be instrumental to advancing Kite's eACT products through multi-center

  • Sweden’s Tomas Salmonson to chair EMA’s CHMP Sweden’s Tomas Salmonson to chair EMA’s CHMP

    Commenting on his election Salmonson said: “The regulation of medicines has become much more proactive over the past few years, and we must embrace the tools we have to shape drug ... development pre- and post-approval, for example by providing

More from appointments
Approximately 0 fully matching, plus 4 partially matching documents found.

Latest from PMHub

  • Pharma and free medicines: a different perspective

    Pfizer have recently announced that they will provide the breast cancer drug, palbociclib, free of charge to patients. ... Recently, there has been increasing discussion about the use of progression-free survival as a clinically relevant endpoint in

  • Pharma Market Research Report - Predictions for 2016

    Secondly, although patient populations for each disease in every market are small, if the drug gains approval across a number of indications, the manufacturer can increase its potential revenue.

  • Can rare diseases be a viable option for the pharma industry?

    Market research with many of the industry leaders involved with the development of orphan drugs has indicated the main influential drivers to pursuing an orphan drug approval as the reasons shown ... In an environment where a successful Health Technology

  • NEW FROM GOWER

    Arthur G. Cook's second edition of Forecasting for the Pharmaceutical Industry is now available. The book is a definitive guide for forecasters as well as the multitude of decision makers and executives who rely on forecasts in their decision making

More from PMHub
Approximately 1 fully matching, plus 3 partially matching documents found.

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
dna Communications

Healthcare communications with unique thinking, insight and attitude...

Latest intelligence

NHS regional footprints
What to expect from 2019...
Not another weight-loss ad
Christmas is over and the gyms are packed, it’s a never-ending tale. But why do we do it to ourselves every year?...
China’s clinical trial shake-up
As many of the obstacles to running clinical trials in China fall away, the country is proving to be a better research location...

Infographics