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Litigation

In Exit Message, FTC Consumer Protection Chief Urges Return Of 13(b) Monetary Relief Authority

“We have made significant strides in finding new ways to return money to consumers, but a fix to our 13(b) authority is badly needed,” says Sam Levine.

MSN Hit With Temporary Pause On Entresto Generic As US Patent Runs Its Course

A lot can happen in 24 hours, as Novartis can attest. The Swiss originator has managed to win a court order temporarily putting the brakes on MSN’s Entresto ANDA product – just hours after a lower court refused a similar request.

FTC Proposed Rule Change Targeting Direct Sellers Gets Direct Challenge From Incoming GOP Majority

FTC seeks comment on three proposals to “strengthen the agency’s tools to curb deceptive earnings claims in industries where they are pervasive: multi-level marketing programs and money-making opportunities.” However, Republican members say they’ll reconsider the proposals as a majority after Trump takes office.

Teva Leapfrogs One ANDA Sponsor But Faces Decade Wait On US Firdapse Opportunity

Catalyst saw its share price jump by around 14% after striking what the market termed a favorable patent-litigation settlement agreement with ANDA sponsor Teva over its rare disease drug Firdapse.

European UPC Ruling Refuses Block On Soliris Biosimilars

Alexion has been refused in its bid for injunctions to block the sale of Samsung Bioepis and Amgen’s European Soliris biosimilars, following a decision by the Court of Appeal of Europe’s Unified Patent Court.

Sandoz Pays Another $275m Over Price-Fixing

Sandoz announced a $275m settlement to resolve class action antitrust litigation over price-fixing allegations and disclosed that the company made a further provision of $265m linked to the case.

Sandoz Forks Out Another $275m Over Price-Fixing

Sandoz has announced a $275m settlement to resolve with end payers class action antitrust litigation in the US over historical price-fixing allegations, as well as disclosing that it has made a further provision of $265m linked to the case.

BeiGene Blocks US Rival To Brukinsa Blockbuster Until 2037

MSN Laboratories has struck a patent-litigation settlement deal with BeiGene that will allow it to launch its zanubrutinib generic rival to Brukinsa in the US from 2037.

Skinny Label Limits: Supreme Court Denies Norwich Bid For US Xifaxan Reprieve

Removing the patent-protected indication from the label of Norwich Pharmaceuticals's proposed generic for Xifaxan did not convince the US Supreme Court to hear its petition to review a case from Bausch Health that blocked approval until 2029.

Supreme Court Denies Norwich Bid For US Xifaxan Reprieve

The US Supreme Court has failed to come to the aid of Norwich Pharmaceuticals in its legal battle over a generic version of Xifaxan (rifaximin) that has a patented indication carved out of its label. An earlier decision over the generic thus bars approval and launch until 2029.