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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.

Daily Brief: Limited NICE recommendation for Fasenra, Urovant takes aim at an IPO, Xtandi expands use

Daily Brief: Limited NICE recommendation for Fasenra, Urovant takes aim at an IPO, Xtandi expands use

News from pharma, biotech and healthcare. Limited NICE approval for AZ’s asthma drug Fasenra. ... The approval makes Xtandi the first and only oral medication FDA-approved for both non-metastatic and metastatic CRPC.

Latest news

  • NHS England says yes to Roche's Hemlibra NHS England says yes to Roche's Hemlibra

    Roche’s new haemophilia A treatment Hemlibra has gained a valuable market access approval from NHS England. ... The drug gained European approval in February this year for haemophilia A patients with inhibitors, antibodies which mean patients no longer

  • CTI slumps as Servier-partnered lymphoma drug fails CTI slumps as Servier-partnered lymphoma drug fails

    Shares in CTI were suspended as the news broke but slumped after trading resumed as investors came to terms with both a threat to the drug’s EU approval, and little ... The Seattle-based company has said for some time that any development of the drug

  • Gilead’s Biktarvy gets European approval, setting up battle with GSK Gilead’s Biktarvy gets European approval, setting up battle with GSK

    Juluca, marketed by GSK-led ViiV Healthcare is a two-drug combination which received EU approval just last month, putting the companies into direct competition. ... By contrast, Juluca's approval is for patients who have been virologically suppressed for

  • US approval for first ever cannabis-based medicine US approval for first ever cannabis-based medicine

    US approval for first ever cannabis-based medicine. UK company's Epidiolex tipped to be blockbuster. ... GW Pharma has gained an historic approval for its drug Epidiolex, the first ever prescription medicine derived from cannabis.

  • Sanofi’s rare blood disorder drug Cablivi set for European approval Sanofi’s rare blood disorder drug Cablivi set for European approval

    Europe looks set to be the first market for the new drug, ahead of the US where it has not yet been submitted for approval, according to Sanofi. ... changes in the EU, according to Jazz, which got FDA approval for the drug last August.

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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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