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Jazz Phar­ma­ceu­ti­cals push­es to ex­pand la­bel on Xy­wav; FDA eyes Oc­to­ber for de­ci­sion on Seagen's lat­est ADC

Eight and a half months since its last OK for Xywav, Jazz Pharmaceuticals has won priority review for a new indication with the drug.

The FDA granted the expedited inspection Monday morning, Jazz announced, as the biotech looks to expand Xywav into adult idiopathic hypersomnia patients. Regulators have set a PDUFA date of Aug. 12.

Back in July 2020, Xywav notched its first approval to treat cataplexy and excessive daytime sleepiness associated with narcolepsy in patients older than 7. At the time, the drug joined Sunosi and Xyrem in the company’s sleeping disorder-related portfolio.

Seat­tle-based Remiges Ven­tures to launch in­cu­ba­tor af­ter heavy in­vest­ment from Japan; Schrödinger signs lease on new home in Man­hat­tan

After closing $95 million in funding, Remiges Ventures has announced the launch of RDiscovery, a life sciences incubator to advance early-stage therapeutics.

RDiscovery will operate as a subsidiary of Remiges Ventures and allow for seamless transition of projects from start to finish, a release said. The incubator is set to expand Remiges’ capability to harness science from Japanese academia and launch it on a patient-centered path. Remiges Ventures founder Taro Inaba said in a statement:

Bio­gen ac­quires rights for po­ten­tial Actem­ra biosim­i­lar; Roy­al­ty Phar­ma buys lumasir­an roy­al­ty stream for up to $240M

Biogen has a new partner to help develop an experimental IL-6 biosimilar.

The Cambridge, MA-based company announced Thursday it has teamed up with Chinese firm Bio-Thera Solutions to develop, manufacture and commercialize BAT1806. Currently undergoing Phase III studies, the drug is an IL-6 receptor monoclonal antibody that could prove to be a biosimilar for Roche’s Actemra.

Biogen is on the hook for $30 million upfront, while milestone and royalty terms of the deal were not disclosed. The agreement provides licensing rights for Biogen to market the program in all countries outside China.

Vac­citech con­fi­den­tial­ly files for Nas­daq IPO — re­port; Sanofi recom­mits to so­cial caus­es, launch­es glob­al non­prof­it

Another biotech is reportedly headed to Nasdaq, one that plays a prominent role in the Covid-19 vaccine race.

Coming from the shores of Britain, Vaccitech confidentially filed for an IPO on Wednesday, per a report from the Financial Times. The company hasn’t filed any paperwork with the SEC just yet, and it’s unclear what kind of raise they’re estimating. FT noted that the company could price as early as this month, however.

In 1-2 punch, Mol­e­c­u­lar Tem­plates cuts first-gen can­di­date and los­es a Big Phar­ma part­ner; Charles Riv­er teams up with Va­lence to pro­vide AI dis­cov­ery plat­form

It’s been several months since a treatment-related death led the FDA to put a partial hold on Molecular Templates’ only first-generation engineered toxin body (ETB) candidate. Now the company is nixing the program, and Takeda is returning the rights to one of its next-gen candidates.

MT-3724, Molecular’s EBT in development for non-Hodgkin lymphoma, will be no more, the company said on Monday morning. The FDA first placed a partial hold on the candidate in November, following the death of a Phase II patient who experienced Grade 5 capillary leak syndrome.

Watch out, Bris­tol My­ers — J&J is right be­hind you; Blake By­ers leaps out from GV to do his own thing

We’ve learned that J&J has now finished its rolling application for the BCMA-targeted cilta-cel, which one analyst believes will put them about 8 or 9 months behind Bristol Myers Squibb and their partners at bluebird, which just won a delayed OK at the FDA for ide-cel.

Legend included word of the wrap-up during Q1 in its 20F filing with the FDA, and analysts were quick to conclude that should allow for an approval by the end of this year.

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Unit­ed Ther­a­peu­tics bags a new OK on Ty­va­so, with block­buster ex­pec­ta­tions; Gilead goes back to Ab­Celler­a's well with a set of fresh tar­gets

As expected, United Therapeutics {UTHR} snagged an OK from the FDA to sell the inhaled version of its blockbuster drug Tyvaso for a new indication: pulmonary hypertension associated with interstitial lung disease. And as expected, they immediately launched their new marketing effort after carefully laying the groundwork.

United COO Michael Benkowitz noted:

We’ve already expanded our field-based teams by 40% to educate the ILD community on the benefits of Tyvaso and how to properly diagnose PH-ILD. We expect rapid uptake of Tyvaso in this indication and expect to double the number of patients on Tyvaso therapy by the end of 2022, barring any COVID-related delays.

Bausch Health sells off Amoun for $740M; Achilles de­buts on Nas­daq with $175.5M IPO

Looking to pay down debt ahead of the big Bausch + Lomb spinoff, Bausch Health CEO Joseph Papa has struck a deal to sell one of its units in Egypt for $740 million.

Abu Dhabi-based holding company ADB is handing over the cash for Amoun Pharmaceutical, which makes and markets branded generics and animal health products, will be the new owner.

“The sale of Amoun marks significant progress in our efforts to reduce overall Bausch Health debt as we continue to pursue all opportunities to drive value for our shareholders, including preparing for the spinoff of Bausch + Lomb,” said Joseph Papa, chairman and CEO, Bausch Health.

For­ma sees da­ta 'sup­port­ing' sick­le cell ther­a­py dos­ing lev­els; Lian­Bio teams with Tar­sus for eye ir­ri­ta­tion in Chi­na

Looking to make a splash in sickle cell, Forma Therapeutics presented new data they hope can improve their shot at an eventual FDA OK.

As part of an ongoing Phase I study, Forma said its FT-4202 program showed enough hemoglobin increases to support the doses selected in the upcoming Phase II/III trial, which is currently enrolling. Data from two cohorts illustrated 10 of 14 patients taking the once-daily therapy saw a hemoglobin increase of at least 1 g/dL from baseline over the two-week treatment period.

Tem­pest Ther­a­peu­tics jumps on­to Nas­daq in merg­er with strug­gling Mil­len­do Ther­a­peu­tics; Bio­haven hits $100M mile­stone as it gears up for a late-stage study in mi­graine pa­tients

Less than a month after landing a Big Pharma partner on one of its lead oncology programs, Tempest Therapeutics is backflipping onto Nasdaq through a reverse merger with Millendo Therapeutics.

Back in January, Millendo shut down the sole remaining early-stage study for its NK3R antagonist MLE-301 — just nine months after pulling the plug on a pivotal study for its lead drug livoletide. The biotech planned some deep cuts for the remaining staff, while looking for a sale or merger.