Alk­er­mes has had a rough go in the past few years, mak­ing the de­ci­sion to slice away a healthy por­tion of its R&D work­force last year af­ter a ma­jor set­back in de­pres­sion. The drug­mak­er placed a lot of hope in an­tipsy­chot­ic drug ALKS 3831 to turn things around, and af­ter a win­ning ad­comm late last year that bet is fi­nal­ly pay­ing off.

The FDA on Tues­day ap­proved Alk­er­mes’ Ly­balvi (olan­za­p­ine and sami­dor­phan) to treat schiz­o­phre­nia and bipo­lar 1 dis­or­der, the com­pa­ny said in a re­lease.

The drug was ap­proved as a main­te­nance monother­a­py, or for the acute treat­ment of man­ic or mixed episodes as a monother­a­py or ad­junct to lithi­um or val­proate, Alk­er­mes said. Ly­balvi is a com­bi­na­tion of nov­el chem­i­cal sami­dor­phan and an­tipsy­chot­ic olan­za­p­ine, an ag­ing an­tipsy­chot­ic con­sid­ered one of the field’s most ef­fec­tive de­spite pre­vi­ous red flags over pa­tients’ weight gain.

But with the new for­mu­la­tion, Alk­er­mes thinks it has cracked the code on those pri­or olan­za­p­ine is­sues. The agency based its re­view on ex­pan­sive da­ta from Alk­er­mes’ EN­LIGHT­EN pro­gram, which in­clud­ed 27 clin­i­cal stud­ies, in­clud­ing 18 stud­ies test­ing Ly­balvi and nine study­ing sami­dor­phan alone, the com­pa­ny said. Among those, EN­LIGHT­EN-2 churned out da­ta show­ing schiz­o­phre­nia pa­tients on Ly­balvi post­ed sig­nif­i­cant­ly less weight gain than pa­tients tak­ing olan­za­p­ine alone.

Alk­er­mes $ALKS shares were trad­ing up about 6% be­fore the bell Tues­day.

Ly­balvi will come with a black box warn­ing for in­creased risk of mor­tal­i­ty in el­der­ly pa­tients with de­men­tia-re­lat­ed psy­chosis, ac­cord­ing to its la­bel. That warn­ing is tied to re­port­ed cas­es of cere­brovas­cu­lar side ef­fects in clin­i­cal tri­als, in­clud­ing stroke and tran­sient is­chemic at­tack. The drug will come with con­traindi­ca­tions for pa­tients tak­ing opi­oids or who are un­der­go­ing acute opi­oid with­draw­al.

The drug­mak­er ex­pects Ly­balvi to hit the mar­ket in the Oc­to­ber/No­vem­ber time­frame and plans to lean on its ex­ist­ing com­mer­cial in­fra­struc­ture from mar­ket­ed an­tipsy­chot­ic Aris­ta­da to grease the wheels for the new drug’s suc­cess­ful launch, ac­cord­ing to a re­lease. The team will add 50 sales reps to that Aris­ta­da “core,” CCO Todd Nichols said on a Tues­day morn­ing call with in­vestors, as it works to ramp up com­mer­cial man­u­fac­tur­ing and fi­nal­ize its pro­mo­tion­al claims pri­or to a full roll­out at launch.

Alk­er­mes didn’t re­lease the list price, say­ing it was wait­ing on pay­er ne­go­ti­a­tions pri­or to launch.

An­tipsy­chotics is an un­usu­al mar­ket, with most first-line scripts dom­i­nat­ed by gener­ics al­though a pro­por­tion of pa­tients even­tu­al­ly cy­cle through those ear­ly drugs. That means the po­ten­tial mar­ket for Ly­balvi will like­ly take a while to de­vel­op, with Alk­er­mes pre­dict­ing around $10 mil­lion in sales by the end of the year.

“We have es­tab­lished a pro­file that there will be a path­way to ac­cess at launch, but it will de­vel­op over time,” Nichols said. “They’re most like­ly go­ing to have to step through one or two gener­ics be­fore ac­cess, and we’re pre­pared for that.”

Ly­balvi, for­mer­ly dubbed ALKS 3831, faced an FDA ad­vi­so­ry com­mit­tee in Oc­to­ber dur­ing which the ques­tion of a po­ten­tial REMS was pro­posed for the drug. The com­mit­tee vot­ed 11-6 that po­ten­tial la­bel­ing was enough to mit­i­gate risk, a big draw for Alk­er­mes in the heav­i­ly reg­u­lat­ed an­tipsy­chot­ic space.

Tadataka Yamada, a towering physician-scientist who made his name in academia before transforming drug development at GlaxoSmithKline and developing vaccines for malaria and meningitis at the Gates Foundation, died unexpectedly of natural causes at his home in Seattle Wednesday morning.

He was 76. Frazier Healthcare Partners’ David Socks confirmed his death.

Known widely by the mononym “Tachi,” Yamada had a globetrotting career and arrived in industry relatively late in life. A 2004 Independent article noted GSK had asked Yamada to stay on beyond his approaching 60th birthday, the company’s usual retirement age. Yamada would continue working for the next 17 years, steering the Gates Foundation’s global health division for 6 years, funding Jim Wilson’s gene therapy work when few would touch it, launching Takeda Vaccines and co-founding a series of high-profile biotechs.

As the US struggles to keep pace with the fast-spreading Delta variant, big companies like Walmart and Disney are imposing vaccine mandates for some workers. It may come as no surprise that Pfizer — the Big Pharma behind the US’ first authorized Covid-19 vaccine — is joining them.

Pfizer will start requiring all US employees and contractors to get vaccinated, or participate in weekly Covid-19 testing, spokesperson Pamela Eisele told Reuters. Workers outside the US are strongly urged to get a vaccine if they can, according to the report. And those with medical conditions or religious objections can seek accommodations.

When Aardvark Therapeutics CEO Tien Lee started his work on the biotech’s lead candidate, appetite suppression was the goal for the small molecule.  Soon after, his team started to see added benefits with lower blood glucose levels and anti-inflammatory activity. On the tail end of that, the company has emerged from stealth mode and announced today that they’ve raised enough cash in the B round to cover mid-stage development work.

When a drugmaker raises the price of a drug in the US by more than 2,000% overnight, and without any particular reason for that increase, nothing typically happens to the company. No fines, no court orders, just business as usual.

Martin Shkreli’s decades-old anti-parasitic drug Daraprim was the perfect example — massive price spike on an old drug, lots of media attention, public outcry, congressional committees dragging his former company through multiple hearings, and at the end of it? Nothing happened to the price or the company (until generic competition came).

Before Valneva garnered the favor of the UK government as a potential supplier of Covid-19 vaccines, the French biotech prided itself on being the first company to bring a chikungunya vaccine into Phase III.

It now has positive pivotal results to back up the breakthrough therapy designation the FDA granted just weeks ago.

There are currently no approved jabs to prevent chikungunya virus infection despite decades of R&D efforts, a fact that underscores just how arduous traditional vaccine development can be, particularly for neglected tropical disease. In a absence of a major commercial market, the US government and NGOs such as CEPI have deployed various grants and incentives to spur on a small crew of academics and industry players, with Merck, via its acquisition of Themis, claiming a spot in that race.