As gene ther­a­py ri­vals ad­vance, Bio­gen moves clos­er to spin­ning out he­mo­phil­ia drugs, R&D

Lest any­one for­get, Bio­gen is fo­cused pri­mar­i­ly on neu­ro­science. And it’s mov­ing at a steady clip to spin off its he­mo­phil­ia busi­ness in a tac­tic de­signed to un­der­score that strat­e­gy. Bio­gen to­day says the busi­ness will launch as Biover­a­tiv in ear­ly 2017 and trade as $BIVV.

The busi­ness at Biover­a­tiv will start by fo­cus­ing on con­tin­u­ing to com­mer­cial­ize Eloc­tate and Al­pro­lix, which were de­vel­oped in part­ner­ship with Stock­holm-based So­bi. And there’s a pipeline of new projects look­ing at ex­pand­ing their use while adding new ef­forts on gene ther­a­pies and more for he­mo­phil­ia A and B.

An­a­lysts, though, may well be won­der­ing what kind of a fu­ture awaits Biover­a­tiv. Bio­Marin re­cent­ly pro­duced some jaw-drop­ping re­sults for a po­ten­tial­ly once-and-done gene ther­a­py for he­mo­phil­ia A. And there are a va­ri­ety of oth­er ef­forts un­der­way that are al­so look­ing to cure he­mo­phil­ia.

Bio­gen, mean­while, has been con­cen­trat­ing heav­i­ly on its mul­ti­ple scle­ro­sis port­fo­lio, where it makes the bulk of its mon­ey, and a high risk, high re­ward ef­fort in the clin­ic for Alzheimer’s. The com­pa­ny has been un­der in­tense pres­sure for a year now to strike some ma­jor de­vel­op­ment deals as its rev­enue fore­casts have erod­ed as Tec­fidera’s for­tunes start to slide. And it may be hard for the com­pa­ny’s deal­mak­ers to find more promis­ing neu­ro­science work in late-stage de­vel­op­ment.

John Cox

John Cox, a Bio­gen vet who will take the helm at Biover­a­tiv, plans to be among the lead­ers. Cox had this to say in a state­ment:

As an in­de­pen­dent and fo­cused com­pa­ny, we be­lieve that Biover­a­tiv will be unique­ly po­si­tioned to dri­ve progress and ad­vance the stan­dard of care for peo­ple liv­ing with he­mo­phil­ia. Work­ing close­ly with the he­mo­phil­ia com­mu­ni­ty, we hope to trans­form lives by ac­cel­er­at­ing in­no­va­tion for peo­ple and care­givers liv­ing with he­mo­phil­ia.

Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; and more

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Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

No­var­tis' ap­proved sick­le cell dis­ease drug fails to beat place­bo in PhI­II

Novartis’ sickle cell drug, approved in 2019 and branded as Adakveo, has failed an ongoing Phase III, according to preliminary results.

The Swiss pharma giant unveiled early data from the ongoing STAND Phase III study on Friday, saying that crizanlizumab showed no statistically significant difference between the drug at two different dose levels compared to placebo in annualized rates of vaso-occlusive crises that lead to a healthcare visit over the first year since being randomized into the trial.

Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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FDA ap­proves an­oth­er in­di­ca­tion for Keytru­da, this time in the ad­ju­vant NSCLC set­ting

Merck’s blockbuster cancer treatment Keytruda has been handed another indication by the FDA.

The US regulator announced on Thursday that it has approved Keytruda to serve as an adjuvant treatment for non-small cell lung cancer (NSCLC), which is its fifth indication in NSCLC and 34th indication overall.

According to a Merck release, the approval is based on data from a Phase III trial, dubbed Keynote-091, which measured disease-free survival in patients who received chemotherapy following surgery. The data from Merck displayed that Keytruda cut down on the risk of disease recurrence or death by 27% versus placebo.

Ying Huang, Legend CEO

J&J, Leg­end say Carvyk­ti beat stan­dard ther­a­py in ear­li­er-line blood can­cer

J&J and Legend Biotech’s next step in turning their CAR-T therapy Carvykti into a potential megablockbuster has succeeded, the companies said Friday.

Carvykti achieved the primary endpoint — progression-free survival — in an open-label Phase III study testing the treatment in second- to fourth-line multiple myeloma patients. The CARTITUDE-4 trial, for which there aren’t any hard data yet, represents the biggest development for Carvykti’s ability to compete with Bristol Myers Squibb’s Abecma since its approval last February.

Dutch biotech starts liq­ui­da­tion af­ter end­ing PhI­II in GVHD

A 13-year-old Dutch biotech is going through a liquidation process after an unexpected end to its Phase III trial testing whether its combination of two monoclonal antibodies was superior to Incyte’s Jakafi.

Xenikos had hoped to prove its investigational therapy, named T-Guard, was better than Jakafi at garnering a complete response in patients experiencing life-threatening complications in which new cells from a hematopoietic stem cell transplant begin to fight the body. Jakafi was approved for the indication, steroid-refractory acute graft-versus-host disease, in May 2019.

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Eliot Forster, F-star CEO (Rachel Kiki for Endpoints News)

F-star gets down to the wire with $161M sale to Chi­nese buy­er as na­tion­al se­cu­ri­ty con­cerns linger

With the clock ticking on F-star Therapeutics’ takeover by a Chinese buyer, the companies are still scrambling to remove a hold on the deal from the US government’s Committee on Foreign Investment in the United States.

F-star and invoX Pharma said they are “actively negotiating” with CFIUS “about the terms of a mitigation agreement to address CFIUS’s concerns regarding potential national security risks posed by the transaction.”

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