The FDA ap­proved an oral liq­uid for­mu­la­tion of the drug zon­isamide, orig­i­nal­ly made by Eton Phar­ma­ceu­ti­cals and cur­rent­ly owned by Azu­ri­ty Phar­ma­ceu­ti­cals.

The nod gives Azu­ri­ty the abil­i­ty to mar­ket Zon­isade as an ad­junc­tive ther­a­py for treat­ing par­tial seizures in adults and kids 16 years and old­er who have epilep­sy. The green light comes af­ter three dou­ble-blind and place­bo-con­trolled clin­i­cal stud­ies of the drug, which is ad­min­is­tered once or twice a day. Zon­isamide was orig­i­nal­ly ap­proved in the ear­ly 2000s as a cap­sule for treat­ing par­tial epilep­tic seizures and has been mar­ket­ed by a va­ri­ety of com­pa­nies, in­clud­ing the for­mer Irish biotech Elan Phar­ma­ceu­ti­cals, Japan­ese drug­mak­er Ei­sai and Sum­it­o­mo Dainip­pon. In 2010, Elan and Ei­sai agreed to pay $214.5 mil­lion to re­solve al­le­ga­tions of off-la­bel mar­ket­ing of Zone­gran.

Eton sold the oral liq­uid for­mu­la­tion of the drug to Azu­ri­ty as part of a Feb­ru­ary 2021 deal, worth up to $45 mil­lion in pay­ments, in­clud­ing $5 mil­lion when the drug is launched.

“This is now the eighth prod­uct ap­proval that our team has con­tributed to, and we are ex­cit­ed for Azu­ri­ty to bring the prod­uct to pa­tients. The pro­ceeds from the launch mile­stone will be used to fur­ther grow our rare dis­ease port­fo­lio,” Eton CEO Sean Bryn­jelsen said in a state­ment. For Azu­ri­ty, the nod adds to a long list of FDA-ap­proved prod­ucts across car­dio­vas­cu­lar, CNS, en­docrinol­o­gy and or­phan dis­eases. — Kyle LaHu­cik

PMV Phar­ma­ceu­ti­cals will test its small mol­e­cule tar­get­ing p53 in com­bi­na­tion with Mer­ck’s Keytru­da as part of the biotech’s on­go­ing Phase I/II PYN­NA­CLE tri­al in pa­tients with ad­vanced sol­id tu­mors.

The com­bo arm will en­roll about 36 pa­tients whose sol­id tu­mors have a p53 Y220C mu­ta­tion. PMV will lead the tri­al and Mer­ck will pro­vide its an­ti-PD-1 ther­a­py.

Shares of the Cran­bury, NJ-based biotech sky­rock­et­ed in late May when PMV said ini­tial da­ta on the monother­a­py arm of the tri­al showed a par­tial re­sponse in 3 out of 10 pa­tients in the high­er dose co­hort. At AS­CO in ear­ly June, the com­pa­ny pre­sent­ed more de­tailed da­ta show­ing six con­firmed par­tial re­spons­es among 25 pa­tients. Two more pa­tients had un­con­firmed par­tial re­spons­es. — Kyle LaHu­cik

Jonathan Lim’s can­cer play Eras­ca, which is fund­ed by some deep VC pock­ets, an­nounced on Mon­day that it has net­ted a clin­i­cal tri­al col­lab­o­ra­tion with Eli Lil­ly to test an­oth­er one of its can­di­date along­side Lil­ly’s an­ti-EGFR an­ti­body Er­bitux (ce­tux­imab).

The deal will see Eras­ca, which stands for “erase can­cer,” get sup­port for its on­go­ing Phase I/IIb tri­al, a proof-of-con­cept tri­al eval­u­at­ing its can­di­date ERAS-601, an oral SHP2 in­hibitor, alone and with Er­bitux for both the treat­ment of triple wild-type metasta­t­ic col­orec­tal can­cer and HPV-neg­a­tive ad­vanced head and neck squa­mous cell car­ci­no­ma.

For the tri­al, Lil­ly is sup­ply­ing Er­bitux at no cost.

This is not the first deal that Eras­ca has net­ted with larg­er phar­mas as the biotech has pre­vi­ous­ly signed sim­i­lar agree­ments with Lil­ly and Pfiz­er, re­spec­tive­ly, to eval­u­ate Er­bitux and Braftovi (en­co­rafenib) in com­bi­na­tion with Eras­ca’s ERK1/2 in­hibitor.

“We are pleased to en­ter an­oth­er clin­i­cal tri­al col­lab­o­ra­tion with Lil­ly to ex­plore ce­tux­imab in com­bi­na­tion with ERAS-601, our SHP2 in­hibitor, in EGFR-dri­ven can­cers that are high­ly de­pen­dent on RAS/MAPK sig­nal­ing,” Lim said. — Tyler Patchen

When gene editing exploded onto the scene over three decades ago, it brought previously inconceivable disease treatment and potentially curative therapies into view. Today, gene editing remains one of the most gripping topics in biopharma — and a recent wave of partnerships may move the industry even closer to broad, curative treatment for genetic disease.

Discoveries across the natural environment deriving in vivo and ex vivo biotechnologies have ushered a floodgate of development possibilities. With giants like Bayer, Moderna, Vertex and others signaling that gene editing will be a key driver of their future pipelines, how will the industry leverage this new frontier of genomic technology?

Roche CEO Severin Schwan will be moving to the board chairman role in a few months, making room for Thomas Schinecker — the current chief of the diagnostics division — to take the helm of the Swiss pharma conglomerate.

The changeover will take place at the company’s annual general meeting in March as Christoph Franz, chairman since 2014, decided not to seek re-election to the board.

The shuffle at the top comes as Roche has steadily beefed up its early-stage pipeline while vigilantly guarding its position as one of the top drugmakers around the world. By Evaluate’s estimate, it is set to rank second on the list of largest pharmas by 2028, falling just a tad behind AbbVie.

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The room was packed and electric. That’s how it felt hosting an event in person for Endpoints News readers last month in San Diego.

It exceeded all our expectations, which wasn’t a given, with the pandemic changing the nature of live events. We hadn’t done one in over two years. And Endpoints grew a lot during that time. We quickly built a serious virtual events platform and developed big audiences around those online channels. But there’s nothing quite like being with your colleagues at a live event. Endpoints has a tradition of convening our audience of biopharma pros in major hubs worldwide since our start in 2016. And we’re thrilled to jump right back in.

With demand rising for Bavarian Nordic’s smallpox vaccine, European officials have given the thumbs up to expand the label to include monkeypox.

Imvanex, marketed as Jynneos in the US, has been approved in Europe to treat smallpox since 2013. On Friday, the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended adding a monkeypox indication to the label, as global cases surge past 15,000. The label expansion still needs to be approved by the European Commission before it’s official.

How does a cancer drug cross the FDA finish line 3-5 months before its PDUFA date? That’s where the Real-Time Oncology Review comes in.

For the last five years, FDA’s Oncology Center of Excellence under Rick Pazdur has been quietly tapped into RTOR to allow sponsors to provide even earlier, segmented submissions of critical efficacy and safety data, thereby enabling these faster evaluations of applications.

After Olympic gold medalist Lindsey Vonn’s first major knee surgery in 2013, she couldn’t sleep. That was the beginning of a cycle of more injuries, added anxiety and stress snowballing into an eventual diagnosis of insomnia.

Now Vonn’s teaming up with Idorsia Pharmaceuticals on its sleep drug Quviviq as its newest celebrity patient ambassador. Vonn appeared in media interviews this week, including on the Today Show and People magazine, talking about her struggles with sleep, along with overall mental health issues.

Lonza’s recent building spree and contracts have the manufacturer looking positive as it enters the second half of the year.

According to Lonza’s financial report for H1, which was released on Friday, the Swiss manufacturer posted sales of CHF 3 billion, or $3.1 billion, granting them a total of 16.8% growth in sales.

The first half’s core EBIDTA for Lonza also rose 33.1% according to the company. The company is still targeting low to mid-teen sales and EBIDTA growth for the year.

VistaGen Therapeutics’ social anxiety drug flopped in a Phase III trial, the company announced Friday, adding to its list of programs that haven’t panned out.

The trial, which enrolled 209 patients according to clinicaltrials.gov, did not significantly change patient-reported anxiety levels compared to placebo. In the trial, patients diagnosed with social anxiety disorder took either VistaGen’s drug, PH94B, or a placebo, and then were challenged with a five-minute public speaking trial, during which they were asked to rate their anxiety.

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Hiring has always been an issue for the FDA, particularly for those with expertise in pharma and biotech as they can quickly move over to the industry and earn double or triple what they make at the federal agency.

But a recent staff crunch and a surge in the turnover for quality operations inspectors at the FDA this year is becoming particularly noticeable for companies that rely on agency inspections to win approvals, even if the recent case of Novartis and BeiGene missing their PDUFA date due to an inspection was more of an issue with Chinese travel restrictions.

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Bioscience & Technology Business Center The University of Kansas Lawrence, Kansas

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