J&J wins FDA OK for their nasal spray ver­sion of a par­ty drug, now ap­proved for treat­ment-re­sis­tant ma­jor de­pres­sion

There it is. 

De­spite some se­ri­ous clin­i­cal fail­ures, the FDA has ap­proved J&J’s new drug es­ke­t­a­mine for ma­jor de­pres­sion, which will now hit the mar­ket as Spra­va­to.

An in­tranasal for­mu­la­tion of ke­t­a­mine, a horse tran­quil­iz­er that is bet­ter known in par­ty cir­cles as Spe­cial K, the drug won a warm as­sess­ment by FDA in­sid­ers as well as an over­whelm­ing vote in its fa­vor by a pan­el of out­side ex­perts or­ga­nized by the FDA.

The ex­perts and reg­u­la­tors were won over by the fact that most were aware of ke­t­a­mine’s years-long rep­u­ta­tion for deal­ing quick­ly with the most se­vere kinds of de­pres­sion. J&J tout­ed the da­ta that they had ac­quired in late-stage re­search, down­play­ing the fail­ures. But in de­pres­sion physi­cians are al­ready well used to deal­ing with hit-and-miss ther­a­peu­tic strate­gies, armed with a hap­haz­ard set of de­pres­sion drugs that of­ten don’t work.

This drug will be giv­en on­ly un­der care­ful su­per­vi­sion and a black box warn­ing re­gard­ing the risk of se­da­tion and dis­so­cia­tive be­hav­ior. It is one of J&J’s top late-stage pro­grams, tapped as a po­ten­tial block­buster.

“There has been a long-stand­ing need for ad­di­tion­al ef­fec­tive treat­ments for treat­ment-re­sis­tant de­pres­sion, a se­ri­ous and life-threat­en­ing con­di­tion,” said Tiffany Far­chione, the act­ing di­rec­tor of the Di­vi­sion of Psy­chi­a­try Prod­ucts in FDA’s Cen­ter for Drug Eval­u­a­tion and Re­search. “Con­trolled clin­i­cal tri­als that stud­ied the safe­ty and ef­fi­ca­cy of this drug, along with care­ful re­view through the FDA’s drug ap­proval process in­clud­ing a ro­bust dis­cus­sion with our ex­ter­nal ad­vi­so­ry com­mit­tees, were im­por­tant to our de­ci­sion to ap­prove this treat­ment. Be­cause of safey con­cerns, the drug will on­ly be avail­able through a re­strict­ed dis­tri­b­u­tion sys­tem and it must be ad­min­is­tered in a cer­ti­fied med­ical of­fice where the health care provider can mon­i­tor the pa­tient.” 

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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David Ricks, Eli Lilly CEO (David Paul Morris/Bloomberg via Getty Images)

Eli Lil­ly set to in­vest $2.1B in home state man­u­fac­tur­ing boost

Eli Lilly is looking to expand its footprint in its home Hoosier State by making a major investment in manufacturing.

The pharma is investing $2.1 billion in two new manufacturing sites at Indiana’s LEAP Lebanon Innovation and Research District in Boone County, northwest of Lilly’s headquarters in Indianapolis.

The two new facilities will expand Lilly’s manufacturing network for active ingredients and new therapeutic modalities, including genetic medicines, according to a press release.

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Pfiz­er and CD­MOs ramp up Paxlovid man­u­fac­tur­ing with Kala­ma­zoo plant ex­pan­sion lead­ing the way

As the Covid-19 pandemic continues to evolve, pharma companies and manufacturers are exploring how to step up production on antivirals.

Pfizer is planning to expand its Kalamazoo-area facility to increase manufacturing capabilities for the oral Covid-19 antiviral Paxlovid, according to a report from Michigan-based news site MLive. The expansion of the facility, which serves as Pfizer’s largest manufacturing location, is expected to create hundreds of “high-skilled” STEM jobs, MLive reported. No details about the project’s cost and timeline have been released, but according to MLive, Pfizer will announce the details of the expansion at some point in early June.

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FDA spells out the rules and re­stric­tions for states seek­ing to im­port drugs from Cana­da

The FDA is offering more of an explanation of the guardrails around its program that may soon allow states to import prescription drugs in some select circumstances from Canada, but only if such imports will result in significant cost reductions for consumers.

While the agency has yet to sign off on any of the 5 state plans in the works so far, and PhRMA’s suit to block the Trump-era rule allowing such imports is stalled, the new Q&A guidance spells out the various restrictions that states will have to abide by, potentially signaling that a state approval is coming.

Pfizer CEO Albert Bourla at the World Economic Forum (Gian Ehrenzeller/Keystone via AP Images)

All about ac­cess: Pfiz­er moves to a non-prof­it mod­el for drug sales in 45 low­er-in­come coun­tries

Leading the way to increase access to cheaper drugs worldwide, Pfizer said Wednesday it will provide all current and future patent-protected medicines and vaccines available in the US or EU on a not-for-profit basis to about 1.2 billion people in 45 lower-income countries.

Rwanda, Ghana, Malawi, Senegal and Uganda are the first five countries to sign on to this accord, which will also seek to blaze new paths for quick and efficient regulatory and procurement processes to reduce the usual delays in making new medicines and vaccines available in these countries.

US sees spike in Paxlovid us­age as Mer­ck­'s mol­nupi­ravir and As­traZeneca's Evusheld are slow­er off the shelf

New data from HHS show that more than 162,000 courses of Pfizer’s Covid-19 antiviral Paxlovid were administered across the US over the past week, continuing a streak of increased usage of the pill, and signaling not only rising case numbers but more awareness of how to access it.

In comparison to this week, about 670,000 courses of the Pfizer pill have been administered across the first five months since Paxlovid has been on the US market, averaging about 33,000 courses administered per week in that time.

Te­va, Al­ler­gan reach yet an­oth­er opi­oid set­tle­ment — ef­fec­tive­ly end­ing WV tri­al

Teva and Allergan have reached settlements with multiple states over their involvement in the opioid crisis. Their latest is worth 9 figures.

West Virginia attorney general Patrick Morrisey announced the newest settlement, worth $161.5 million, at a press conference on Wednesday. The deal would resolve claims that the companies helped fuel the state’s opioid epidemic. If it goes through, it could become the largest state-negotiated settlement in West Virginia’s history, according to Reuters.

Roche un­veils three new mon­key­pox tests as cas­es rise

Health experts maintain that the current monkeypox situation is a stark contrast to Covid. Even so, a handful of biotechs have sprung to action, including Roche, who quickly developed a set of three tests to detect the virus.

Roche and subsidiary TIB Molbiol unveiled their Lightmix Modular Virus test kits on Wednesday — three unique test kits that can help track the spread of monkeypox.

The first kit detects orthopoxviruses, including all monkeypox viruses originating from the West African and Central African forms of the virus. The second kit is a specific test that detects monkeypox viruses only, while the third simultaneously tests for both orthopoxviruses and monkeypox viruses.

New law­suit ac­cus­es GSK of 'de­vice hop­ping' to block gener­ic in­haler com­pe­ti­tion

Despite inhalers being on the market for decades, many patients still can’t afford them. A new lawsuit filed in Missouri federal court puts the blame on GSK.

Last week, plaintiff Elliot Conrad Dale — who’s paid for GSK’s Ventolin and Arnuity Ellipta inhalers — filed a class-action lawsuit against the pharma giant, accusing it of scheming to block generic versions of its brand-name inhalers.