→ UK’s NICE has en­dorsed the use of Akcea’s in­ot­ersen (brand­ed as Tegse­di) to treat pa­tients with a rare in­her­it­ed con­di­tion called hered­i­tary transthyretin-re­lat­ed amy­loi­do­sis (hAT­TR), af­ter the Io­n­is $IONS sis­ter com­pa­ny of­fered the agency an “im­proved com­mer­cial agree­ment.” This counts as a win for Akcea, which has been com­pet­ing against Al­ny­lam’s $AL­NY On­pat­tro, al­though the dataset sup­port­ing its ap­proval is seen as a run­ner up to On­pat­tro. The UK has rough­ly 150 hAT­TR pa­tients, ac­cord­ing to NICE.

→ Last week, the EMA asked doc­tors to lim­it the use of Sanofi’s $SNY Lem­tra­da to adults with re­laps­ing-re­mit­ting mul­ti­ple scle­ro­sis that is high­ly ac­tive de­spite treat­ment with at least two dis­ease-mod­i­fy­ing ther­a­pies or in pa­tients that can­not take any oth­er treat­ments. The health reg­u­la­tor is re­strict­ing the drug’s use while it in­ves­ti­gates re­ports of im­mune-me­di­at­ed con­di­tions and prob­lems with the heart and blood ves­sels with the med­i­cine, in­clud­ing fa­tal cas­es.

→ Charles Riv­er Lab­o­ra­to­ries $CRL and the CH­DI Foun­da­tion have ex­tend­ed their long run­ning al­liance on Hunt­ing­ton’s dis­ease by an­oth­er 5 years, they said last week. They ini­tial­ly be­gan work to­geth­er back in 2005 and are now adding mul­ti­dis­ci­pli­nary ac­tiv­i­ties to the pact.

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

San Francisco-based biotech 89bio announced on Friday that it expects to rake in $275 million on a stock offering. The raise comes after 89bio announced on Tuesday results of a Phase II study showing that its drug was better than placebo at lessening fibrosis without worsening nonalcoholic steatohepatitis, or NASH.

To run a Phase III study, 89bio CEO Rohan Palekar told Endpoints News that the biotech “would need to raise additional capital.” 89bio offered over 16 million shares of its common stock at $16.25 per share, and expects the offering closes on March 28.