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drug approval

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

J&J files ‘breakthrough’ bladder cancer drug in US

J&J files ‘breakthrough’ bladder cancer drug in US

J&J files ‘ breakthrough’ bladder cancer drug in US. Needed as most patients don't respond to checkpoint inhibitors. ... Johnson &Johnson has filed for approval of a new targeted bladder cancer therapy in the US, setting up a possible approval next

Latest news

  • Teva wins FDA OK for crucial migraine drug Teva wins FDA OK for crucial migraine drug

    Teva has secured US approval for migraine drug Ajovy, a key part of new chief execeutive Kåre Schultz's turnaround plan for the company. ... Teva filed Ajovy in Europe earlier this year, but here it will also lag behind Aimovig as Novartis and Amgen

  • AZ nabs US approval for new leukaemia drug Lumoxiti AZ nabs US approval for new leukaemia drug Lumoxiti

    AZ nabs US approval for new leukaemia drug Lumoxiti. Adds to firm's growing oncology franchise. ... AstraZeneca has chalked up another product approval in its oncology franchise, getting an FDA nod for Lumoxiti, a new CD-22-targeted drug for rare cancer

  • Gilead optimistic about Yescarta deal in UK Gilead optimistic about Yescarta deal in UK

    drug’s marketing approval. ... However there are other factors at play that could influence which drug gains the upper hand.

  • Darzalex powers ahead with frontline myeloma approval in Europe Darzalex powers ahead with frontline myeloma approval in Europe

    Darzalex powers ahead with frontline myeloma approval in Europe. New approval makes Darzalex first antibody drug approved in first line. ... patients. The EU approval follows a nod from the FDA in May, and this frontline use will add extra impetus to the

  • Alnylam gets EU nod for Onpattro amid pricing backlash Alnylam gets EU nod for Onpattro amid pricing backlash

    Alnylam gets EU nod for Onpattro amid pricing backlash. However the drug’s price could be lowered in the EU due to direct competition. ... Alnylam won US approval for the drug earlier this month, but was promptly hit by an Institute for Clinical and

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Latest Intelligence

  • 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.

  • A catalyst for change A catalyst for change

    This was considered a significant step in the internationalisation of the Chinese drug approval process. ... The Policy was a groundbreaking comprehensive instrument that targeted several key issues and fundamentally restructured the entire drug approval

  • The gold standard of scientific evidence The gold standard of scientific evidence

    In addition, securing regulatory approval for a drug can take decades. ... In short, RWE presents a fantastic opportunity to accelerate drug approval, monitor treatment safety and appropriately price medications.

  • Transforming Access to Medicines Through Patient-Centric Solutions Transforming Access to Medicines Through Patient-Centric Solutions

    To do this Inceptua Medicines Access and patient group, HAEi, in association with PMGroup, will host a free webinar on Thursday 14th December that will cover both the pre-approval access ... to medicines and the importance of putting patients at the

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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

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Latest from PMHub

  • NEW FROM GOWER

    NEW FROM GOWER. Arthur G. Cook's second edition of Forecasting for the Pharmaceutical Industry is now available. Arthur G. Cook's eagerly awaited second edition of Forecasting for the Pharmaceutical Industry is here! The book is a definitive guide

  • Pharma and free medicines: a different perspective

    The drug is used in combination with another breast cancer drug, letrozole, which belongs to a different drug class called aromatase inhibitors. ... Recently, there has been increasing discussion about the use of progression-free survival as a clinically

  • 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

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Approximately 1 fully matching, plus 2 partially matching documents found.

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