The FDA approved an oral liquid formulation of the drug zonisamide, originally made by Eton Pharmaceuticals and currently owned by Azurity Pharmaceuticals.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