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Pharma approval

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

Vertex gains EU approval for earlier Orkambi use

Vertex gains EU approval for earlier Orkambi use

The approval by the European Commission brings us one step closer to our goal of bringing treatment to all people living with CF,” said Reshma Kewalramani, Executive Vice President, Global Medicines ... The approval was based on phase 3 data, whereby

Latest news

  • EU approval for Opdivo combo in renal cell cancer EU approval for Opdivo combo in renal cell cancer

    This follows US approval last year, and is the first Immuno-Oncology (IO) combination therapy for patients with this type of cancer in the European Union. ... The European approval is important for BMS, as it seeks to maintain Opdivo’s blockbuster

  • EMA sees approval numbers rise in 2018 EMA sees approval numbers rise in 2018

    The FDA’s faster approval rate is based on its sustained efforts to identify promising innovative drugs earlier, and work more closely with developers, via pathways such as the FDA Breakthrough ... Four medicines gained approval in 2018 following

  • First-line ovarian approval cements AZ’s Lynparza lead First-line ovarian approval cements AZ’s Lynparza lead

    The new FDA approval means that Lynparza (olaparib) can be given to patients who are in complete or partial response to first-line treatment with platinum-based chemotherapy for ovarian, fallopian ... All three are already approved for maintenance in

  • Shire bags US approval for constipation drug Motegrity Shire bags US approval for constipation drug Motegrity

    Approval is boost as Takeda takeover nears completion. Shire has the US approval it needs for Motegrity, a drug for chronic idiopathic constipation (CIC) that will compete with drugs like ... FDA approval makes Motegrity an option for the estimated 35

  • Biogen picks up another drug from wide-ranging Ionis alliance Biogen picks up another drug from wide-ranging Ionis alliance

    It was joined last year by Mitsubishi Tanabe Pharma’s Radicava/Radicut (edaravone) last year, which provides another options, but there is still a desperate need for additional therapies. ... Pharma’s ODM-109 (oral levosimendan) which was advanced to

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Latest Intelligence

  • Drug launches to watch in 2019 Drug launches to watch in 2019

    set to gain approval in both regions in the first half of 2019. ... GW Pharma gained an historic approval for its drug Epidiolex from the FDA in June last year, becoming the first ever prescription medicine derived from cannabis.

  • Change in the pharma industry is inevitable Change in the pharma industry is inevitable

    And then there is the problem of public opinion. “We have a ridiculously low approval rating for an industry that saves so many lives,” remarked the president of one of the ... With a net approval rating of minus 23, pharma sits only marginally above

  • Europe vs the US: New drug product approvals Europe vs the US: New drug product approvals

    Big pharma continues to dominate the approval statistics, with oncology being the most common therapy area represented. ... Oncology and big pharma dominate the approval statistics. Looking at the therapeutic areas, the busiest by far was oncology.

  • Why don’t big pharma brands win creative awards? Why don’t big pharma brands win creative awards?

    We asked some senior people in pharma companies and agencies for their opinions about this paradox. ... Big pharma decision-making discourages creativity. “The approval process makes it harder than ever to get good work through.” - Creative Director.

  • A tailored approach to the BRIC markets A tailored approach to the BRIC markets

    Pharma's emerging market strategies must therefore be tailored to suit local needs. ... But the deals came at a price for pharma: a condition of the approval is that the companies - which include Pfizer and B Braun - commit to the continued production of

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Latest from PMHub

  • 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

  • vector pharma

    vector pharma specialises in the provision of close strategic regulatory support to innovative small to medium-size development-phase pharma companies seeking product approval within the EU. ... vector pharma works very closely with clients on a limited

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