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Facilitating applications for paediatric investigation plans
European Commission's guideline is applicable as of today
The European Commission has published a revised guideline on applications for paediatric investigation plans, or PIPs, in the Official Journal of the European Union. The new guideline is expected to facilitate the application process. It is intended for all medicines developers.
Since the European Paediatric Regulation came into force in 2007, pharmaceutical companies have had a legal obligation to develop plans to evaluate medicines in children (known as paediatric investigation plans) as part of the development of all new medicines, unless they obtain an exemption (known as a waiver). In some cases, a similar obligation also applies to medicines that are already authorised in the European Union (EU).
The first guideline describing the format and content of applications for paediatric investigation plans was released in September 2008.The Commission has conducted a review of this guideline to take into account experience gained as well as feedback received from medicines developers.
Amongst other elements, the new guideline:
establishes key elements that should be included in paediatric investigation plans,
introduces increased flexibility into the application process,
incorporates new study concepts, such as extrapolation of results and modelling,
clarifies requirements for the compliance check.
The text of the guideline is available in all EU languages.
European Medicines Agency decision
of 8 August 2013
on the agreement of a paediatric investigation plan and on the granting of a deferral and on the
granting of a waiver for naltrexone (hydrochloride) / bupropion (hydrochloride) (EMEA-001373-PIP01-
12) in accordance with Regulation (EC) No 1901/2006 of the European Parliament and of the Council
This Decision does not constitute entitlement to the rewards and incentives referred to in
Assuming successful completion of the review process and potential approval in the second half of 2014, Orexigen would expect Contrave to be available to physicians and their patients in Europe in early 2015.
Adam Feuerstein Tweet: '$OREX - CHMP has further questions re: Contrave. Co. believes they are addressable, submit response Sept'
The Company believes the CHMP's requests are addressable. However, in regards to the third-party suppliers, in order to have the time to coordinate responses from these suppliers, Orexigen has requested an extension of one month and plans to submit its response to the Day 180 LOI in September.
Celldex had licensed CDX-301 from Amgen (AMGN) in Mar 2009.
We note that Celldex completed a phase I study on CDX-301 in Feb 2013.
Apart from CDX-301, Celldex has several early-stage candidates in its pipeline including varlilumab (lymphoma/leukemia and solid tumors) and CDX-1401 (multiple solid tumors).
Yes but PBYI is $250 with just Phase 2 Puma Biotechnology (PBYI) declared their results for neratinib, they also disclosed their agreement with Pfizer regarding the license for neratinib. According to this agreement, Puma shall pay for the cost of the trials of neratinib which totals to $30 million and Pfizer would have the sales royalty for the drug, not a usual 10-20% but in ‘low to mid teens’. Whether or not Pfizer had complete knowledge of the data for neratinib remains a mystery.
Accelerated approval study (METRIC) evaluating Glembatumumab vedotin (CDX-011) in patients with GPNMB over-expressing triple negative breast cancer. The study is designed to enable Celldex to apply for registration with positive results for either endpoint. An interim analysis (futility assessment) will be conducted after the enrollment of the first 80 patients.
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