Posts by Trader2112

    http://betaville123.blogspot.c…olding-ag-said-to-be.html




    RARE ALERT: Sonova Holding AG said to be working with M&A bankers to examine 'strategic options'; could lead to sale

    In case you hadn't noticed, there is a pharmaceutical/healthcare dealmaking frenzy at the moment.

    And the latest tale doing the rounds is about a Swiss hearing aid manufacturer Sonova, whose market capitalisation currently stands at CHF 10 billion (circa £7 billion).

    According to my people with the info, Sonova has started working M&A bankers JP Morgan on a 'strategic review', which may lead to a sale of the company.

    Now, at this stage it's not clear who will buy the company as we are still at the early part of the process. Word is, though, the Sonova board is unlikely to accept any offer lower than 180 a share.

    To be clear, this information is RARE verging on BLEU.

    For readers unfamiliar with the RARE, here is the definition:

    Market gossip that hasn't been tested through all formal journalistic channels (public relations executives, bankers etc). The rumour might be total codswallop but then again there may be something in it, so it's worth airing on Betaville.

    However, I have asked well-placed industry sources about the story and come up with something that would seem to vaguely corroborate the gossip.

    Whilst none of these industry sources had heard about JP Morgan's appointment - in fact, Deutsche Bank was mentioned as the company's main relationship adviser - I have been told Sonova recently held a 'beauty parade' (a process when a company asks several banks to pitch for a mandate) for a new M&A adviser to work on a project.

    I asked Sonova Holding AG for a comment. The company politely declined to comment.

    Sind Briefing documents für den 22.1. Heisst nichts definitives aber deutet klar auf eine Zulassungsempfehlung hin....

    FDA POSTS STAFF REPORT ON ASTELLAS/BASILEA'S ISAVUCONAZONIUM

    Bloomberg:


    Astellas/Basilea’s isavuconazonium sulfate is being reviewed for proposed use in treating invasive aspergillosis and mucormycosis, according to FDA staff report.


    * FDA staff report doesn’t raise any specific concerns about


    efficacy or safety of drug


    * Astellas has proposed oral capsule formulation to treat


    aspergillosis and injection form for mucormycosis; both are


    deadly fungal infections that mostly occur in people with


    compromised immune systems


    * Proposed brand name is Cresemba


    * FDA’s Anti-Infective Drugs Advisory Cmte will meet Jan. 22


    to make recommendations; Pdufa date for agency decision on


    approval is March 8


    * Basilea licensed exclusive U.S. and Canadian rights to


    isavuconazium sulfate to Astellas, would get payment on


    approval and sales milestones

    CHMP Oral Hearing

    Hi


    Weiss man eigentlich ob es schlussendlich definitv zu einem Oral Hearing kam gestern? Nur weil es auf der Agenda stand heisst das nicht dass auch ein Hearing nötig war. Gemäss einem Analysten (siehe Text unten) würde es noch 1 Monat dauern bis zur Opinion im Falle eines Hearings. Falls kein Hearing stattfand bzw. nötig war könnte die Opinion allerdings wirklich Morgen kommen.


    Newron-Zambon's safinamide is on the agenda for a possible oral hearing at this week's meeting of EU regulator CHMP, as an add-on therapy in early or mid- to late-stage Parkinson's disease. An oral hearing may lead to an opinion next month. If no hearing takes place, the CHMP may issue an opinion Nov. 20-21. Phase III data showed safinamide improved motor function and fluctuations when added to commonly prescribed drugs.