October

Novartis pays $422m to settle probe

Novartis has agreed to pay $422m to settle charges that it engaged in off-label marketing and financial kickbacks to doctors for a number of its drugs
01 Oct 2010

Teva biosimilar delayed by FDA

The US Food and Drug Administration has requested additional information from Teva before acting on a Biologics License Application for Neutroval
01 Oct 2010

Custirsen to enter second phase III trial

Teva and OncoGenex have announced the initiation of a global phase III trial evaluating custirsen as a therapy for castration-resistant prostate cancer
04 Oct 2010

Fresenius Kabi recalls anastrozole tablets

Fresenius Kabi has commenced a voluntary recall of two batches of anastrozole tablets shipped to the US, after indications of contamination
04 Oct 2010

J&J pain drug delayed

Johnson & Johnson has been informed that additional information for its extended-release tapentadol is needed before US approval
04 Oct 2010

Shionogi ADHD drug wins US approval

Shionogi Inc. has won US Food and Drug Administration approval of extended-release Kapvay for attention deficit hyperactivity disorder in children
04 Oct 2010

FDA to hold biosimilars hearing

The US Food and Drug Administration will hold a public hearing to garner input on the Biologics Price Competition and Innovation (BPCI) Act of 2009
04 Oct 2010

S-A's bid for Genzyme gets hostile

After US biotech Genzyme rejected a 'friendly' offer from sanofi-aventis, the French company has launched a hostile $18.5bn takeover bid
04 Oct 2010

Edelman launches integrated marketing unit

Public relations firm Edelman is launching an integrated marketing unit to provide cross-channel strategy and content to its clients
05 Oct 2010

Tentative approval for generic Reyataz

Mylan has won tentative US approval for its generic version of Bristol Myers Squibb's Reyataz HIV drug under the President's Emergency Plan for AIDS Relief
05 Oct 2010

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