FDA Approves Truvada For PrEP With Bolstered Labeling But No Restricted Distribution Concerned about impeding drug access for HIV treatment, the agency declined to restrict prescribing of Gilead's antiretroviral for pre-exposure prophylaxis to documented evidence of a negative HIV test, although the label's newly revised boxed warning highlights the need for confirmation of HIV-negative status.
HGSI Gets Slightly Increased Buyout Bid, Accepts GSK Offer Of $3.6 Billion After three months of battling, with lupus drug Benlysta still struggling, Human Genome Sciences accepted a modestly increased sales offer from partner GlaxoSmithKline.
Par Acquisition By TPG Allows Competing Marriage Proposals Par will be acquired by private equity firm TPG in $1.9 billion deal if no other suitors come forward with a better offer over the next month.
Reverse Payment Settlements Suffer Reversal Of Fortune At Third Circuit FTC ends its losing streak on patent settlement suits as the Third Circuit says "rule of reason" rather than "scope of patent" analysis should be applied to brand/generic settlements; appeals court reinstates suit by direct purchasers challenging Schering's payments to Upsher-Smith and ESI Lederle.
Sandoz + Fougera = 4 Topical Generics For Tolmar FTC's proposed consent agreement requires the Novartis unit to return marketing rights to calcipotriene topical solution, lidocaine-prilocaine cream and metronidazole topical gel to Tolmar Inc., as well as rights to market a future generic version of Solaraze (diclofenac sodium gel).
Genetic Tests As Physician Fees Or Lab Fees? CMS Asks For Input How much physician "work" is required for the application of genetic tests will determine how CMS begins reimbursing for more than 100 assays in 2013.
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