Jeffrey Stein, Cidara CEO

San Diego an­ti­fun­gal play­er nabs pri­or­i­ty re­view for blood­stream in­fec­tion treat­ment

Cidara Ther­a­peu­tics wants to make its mark in the world of an­ti­fun­gals, and thanks to the FDA, it may get there soon.

The San Diego-based com­pa­ny an­nounced Tues­day that the FDA has giv­en pri­or­i­ty re­view to its an­ti­fun­gal reza­fun­gin for the treat­ment of can­didemia and in­va­sive can­didi­a­sis — com­mon caus­es of se­ri­ous blood­stream in­fec­tions in hos­pi­tal­ized pa­tients, per the CDC. No new ther­a­pies have been ap­proved in over a decade for the two in­fec­tions, the com­pa­ny said in a press state­ment. Reza­fun­gin’s re­view dead­line date is set for March 22, 2023.

The new drug sub­mis­sion was based on re­sults from its glob­al Re­STORE Phase III and STRIVE Phase II tri­als, which showed the drug’s non-in­fe­ri­or­i­ty over caspo­fun­gin, the cur­rent stan­dard of care.

“If ap­proved, reza­fun­gin would rep­re­sent an im­por­tant new treat­ment op­tion for pa­tients at risk of these po­ten­tial­ly dead­ly dis­eases,” said Cidara’s CEO Jef­frey Stein.

Mean­while, the com­pa­ny is cur­rent­ly con­duct­ing a sec­ond Phase III study to ex­am­ine the drug as a pro­phy­lac­tic for in­va­sive fun­gal dis­ease in pa­tients un­der­go­ing al­lo­gene­ic blood and mar­row trans­plan­ta­tion.

In Ju­ly 2022, the com­pa­ny struck a li­cense agree­ment with Melin­ta Ther­a­peu­tics, grant­i­ng the lat­ter an ex­clu­sive li­cense to com­mer­cial­ize reza­fun­gin in the US.

“This trans­ac­tion elim­i­nates the need for Cidara to build com­mer­cial in­fra­struc­ture to launch reza­fun­gin in the U.S.,” Stein said in a Ju­ly 27 press state­ment.

The com­pa­ny li­censed the drug to Mundiphar­ma for oth­er parts of the world ex­cept for Japan, where Cidara con­tin­ues to hold the rights.

A few oth­er com­pa­nies are al­so de­vel­op­ing an­ti­fun­gals. One of those, New Jer­sey-based biotech Scynex­is, is de­vel­op­ing its drug ibrex­a­fungerp to fight fun­gal in­fec­tions in a hos­pi­tal set­ting.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

FDA in­di­cates will­ing­ness to ap­prove Bio­gen ALS drug de­spite failed PhI­II study

Ahead of Wednesday’s advisory committee hearing to discuss Biogen’s ALS drug tofersen, the FDA appeared open to approving the drug, newly released briefing documents show.

Citing the need for flexibility in a devastating disease like ALS, regulators signaled a willingness to consider greenlighting tofersen based on its effect on a certain protein associated with ALS despite a failed pivotal trial. The documents come after regulatory flexibility was part of the same rationale the agency expressed when approving an ALS drug last September from Amylyx Pharmaceuticals, indicating the FDA’s openness to approving new treatments for the disease.

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FDA warns Proc­ter & Gam­ble over NyQuil la­bel's in­gre­di­ent list­ings

The FDA on Tuesday released a warning letter sent earlier this month to the Mason, OH-based site of Procter & Gamble Manufactura, raising questions about the list of ingredients on the label and in the electronic filing.

The warning says that for P&G’s over-the-counter Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion, there’s a “mismatched” list of active ingredients between the labeling and the electronic listing file. The listing file for the active ingredients did not match the active ingredients in the electronic file.

Andy Plump, Takeda R&D chief (Jeff Rumans for Endpoints News)

What kind of PhI­Ib da­ta is worth $4B cash? Take­da’s Andy Plump has some thoughts on that

A few months back, when Takeda caused jaws to drop with its eye-watering $4 billion cash upfront for a mid-stage TYK2 drug from Nimbus, it had already taken a deep dive on the solid Phase IIb data Nimbus had assembled from its dose-ranging study in psoriasis.

Now, it’s rolling that data out, eager to demonstrate what inspired the global biopharma to go long in a neighboring, but new, disease arena for the pipeline. And the most avid students of the numbers will likely be at Bristol Myers Squibb, who will have a multi-year head start on pioneering the TYK2 space with Sotyktu (deucravacitinib) as Takeda makes its lunge for best-in-class status.

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No­vo Nordisk re­mains un­der UK scruti­ny as MHRA con­ducts its own re­view in 'in­cred­i­bly rare' case

The UK’s Medicines and Healthcare products Regulatory Agency is now reviewing Novo Nordisk’s marketing violation that resulted in its loss of UK trade group membership last week. Novo Nordisk was suspended on Thursday from the Association of the British Pharmaceutical Industry (ABPI) for two years after an investigation by its regulatory arm found the pharma broke its conduct rules.

MHRA said on Tuesday that its review of the Prescription Medicines Code of Practice Authority (PMCPA) investigation is standard practice. An MHRA spokesperson emphasized in an email to Endpoints News that the situation with Novo Nordisk is “incredibly rare” while also noting ABPI took “swift and proportionate action.”

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FTC says patent bat­tle over Parkin­son's drug could have 'sig­nif­i­cant im­pli­ca­tion­s' for pa­tients

The Federal Trade Commission has gotten involved in a patent feud over Supernus’ Parkinson’s drug Apokyn, a case the agency said may have ‘‘significant implications” for patients who rely on the drug.

Sage Chemical won the first generic approval for its Apokyn formulation (also known as apomorphine hydrochloride injection) back in 2022. The non-ergoline dopamine agonist is approved to treat Parkinson’s symptoms during “off episodes,” such as difficulty moving, tremors and intense cramping. However, regulators specified that the approval pertained to the generic drug cartridges only, not the injector pen required for administration.

Mar­ket­ingRx roundup: What could a US Tik­Tok ban mean for phar­ma? Pfiz­er, Lil­ly lead phar­ma March Mad­ness ad­ver­tis­ers

Just as pharma marketers finally make moves into TikTok, the threat of a US ban on the social media channel is now looming. Already banned on federal employee phones by an initial Congressional act, more bills and maybe bans are on the way. With rare bipartisan agreement, lawmakers have introduced legislation that would give the US president the power to ban TikTok (although not mentioned by name) and other foreign-owned technology platforms that represent a security threat to the US.

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Chat­G­PT with phar­ma da­ta de­buts for med­ical meet­ings, be­gin­ning with AACR

What do you get when you combine ChatGPT generative AI technology with specific pharma and clinical datasets? A time-saving tool that can answer questions about medical conference abstracts and clinical findings in seconds in one new application from ZoomRx called FermaGPT.

ZoomRx is debuting a public version of its generative AI product specifically for medical conferences beginning this week for the upcoming American Association for Cancer Research (AACR) annual meeting that runs April 14-19.

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Vipin Garg, Altimmune CEO

Al­tim­mune’s shares halved af­ter in­ter­im look at PhII weight loss drug da­ta

Altimmune’s attempt to catch up to Novo Nordisk and Eli Lilly’s GLP-1 drugs hit an investor snag Tuesday after the biotech shared interim Phase II weight loss data.

The Maryland biotech’s pemvidutide is a GLP-1/glucagon dual receptor agonist meant to activate GLP-1 receptors to squash appetite and glucagon to ramp up energy use. The 2.4 mg dose showed a placebo-adjusted weight loss of 9.7% at week 24 of 48, which Jefferies analysts said would be comparable to Novo Nordisk’s semaglutide (Wegovy) and Eli Lilly’s tirzepatide (Mounjaro).

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