FDA seeks FTC action after rejecting petition to block first generics for decades-old vasopressin – Endpoints News

The FDA on Wednes­day not on­ly ap­proved the first gener­ic ver­sions of the decades-old di­a­betes in­sipidus treat­ment va­so­pressin, but al­so si­mul­ta­ne­ous­ly of­fered a par­tic­u­lar­ly damn­ing re­buke of a cit­i­zen pe­ti­tion at­tempt­ing to block the gener­ic, while promis­ing to pass along the mat­ter to the Fed­er­al Trade Com­mis­sion.
The re­sponse could prove trou­ble­some for the spon­sor of the brand name ver­sion of the drug, En­do’s Par Ster­ile Prod­ucts, which brought in more than $780 mil­lion in 2020 for its brand name ver­sion of the drug Va­sostrict.
Last month, Par’s lawyers at Ax­inn called on the FDA to re­frain from ap­prov­ing any gener­ics for Va­sostrict due to the po­ten­tial for cer­tain sta­bil­i­ty and oth­er spec­i­fi­ca­tions that could cause con­cerns with im­pu­ri­ties or oth­er safe­ty is­sues.
But FDA points out at the top of its re­sponse that va­so­pressin has been mar­ket­ed as a ther­a­peu­tic agent for near­ly a cen­tu­ry.
“Pitressin, a nat­ur­al va­so­pressin prod­uct de­vel­oped as an ex­tract of the bovine pos­te­ri­or pi­tu­itary, was first in­tro­duced in 1928,” the agency said.
What’s more is that Par on­ly won FDA ap­proval for va­so­pressin in the first place, in 2014, be­cause of the FDA’s drug safe­ty ini­tia­tive at the time to en­cour­age man­u­fac­tur­ers to ob­tain the agency’s ap­proval for old, un­ap­proved drugs.
In ad­di­tion to the deny­ing the pe­ti­tion, FDA said that it “does not on its face raise valid sci­en­tif­ic or reg­u­la­to­ry is­sues” and “it ap­pears to have been sub­mit­ted with the pri­ma­ry pur­pose of de­lay­ing ap­proval of Ea­gle’s AN­DA and fails to raise valid sci­en­tif­ic or reg­u­la­to­ry is­sues. The Agency in­tends to re­fer this mat­ter to the Fed­er­al Trade Com­mis­sion (FTC), which has the ad­min­is­tra­tive tools and the ex­per­tise to in­ves­ti­gate and ad­dress an­ti­com­pet­i­tive busi­ness prac­tices.”
This kind of ac­tion from the FDA is rare to see, as lawyer Kurt Karst at Hy­man, Phelps & Mc­Na­ma­ra not­ed on Twit­ter, and it may be part of a wider col­lab­o­ra­tion be­tween the FDA and FTC to put com­pa­nies on no­tice over at­tempts to block fu­ture gener­ics.
With household names like Botox and cancer treatment Keytruda, it’s no surprise that the global injectable drugs market is expected to top $1.2 trillion between 2022 and 2030. With a projected 9% compound annual growth rate (CAGR) in that same period, the market is quickly expanding to provide desperately needed treatments in areas like oncology and orphan disease to psychiatric disorders and immunodeficiencies.
After snapping up Vividion before it could jump onto Nasdaq last August, Bayer’s preclinical ‘arms-length’ subsidiary is betting on a relatively unknown North Carolina upstart in a five-year pact.
The initial focus concerns four targets, but the deal with Durham-based Tavros Therapeutics could balloon by another five targets, which would more than double the terms from $430.5 million in milestones to a whopping $912 million. Either way, the 14-employee Tavros gets $17.5 million upfront.
This article was published prior to the announcement of the 2022 Nobel Prize in Chemistry. Congratulations to Dr. Bertozzi, Dr. Meldal, and Dr. Sharpless.
Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, which is nearly one in six deaths. Recently, we have seen incredible advances in novel cancer therapies such as immune checkpoint inhibitors, cell therapies, and antibody-drug conjugates that have revamped cancer care and improved survival rates for patients.
Groceries, home goods, auto care and … clinical trial recruitment?
Walmart has joined the wave of health and retail conglomerates jumping in on pharmaceutical research, unveiling the new Walmart Healthcare Research Institute (WHRI) on Tuesday. While the retail chain won’t be running actual trials, its initial focus will be on identifying patients who may benefit from studies in chronic conditions, CMO John Wigneswaran told Endpoints News. 
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Novartis’ blockbuster gene therapy Zolgensma has proven to be a major success story as a spinal muscular atrophy treatment, helping children who might not otherwise be able to stand or walk due to the rare condition.
But last week, the journal Nature Biotechnology surfaced a new flaw in the therapy’s earliest phase of development, and despite the authors’ objections, the journal retracted an article from February 2010 noting “multiple inaccuracies in the reported mouse lifespans and in the animal inclusions and exclusions.”
Move over Facebook, pharma marketers are getting hip to TikTok. Amgen and AstraZeneca are two of the newest — with branded work for co-marketed severe asthma med Tezspire — joining the influx of pharma companies piloting marketing efforts on the social video channel.
Amgen and AZ debuted their effort by adopting popular TikTok trends to better connect with users. For instance, the team is using the “Tell me without telling me” trend in its newest post in which a young woman says, “Tell me you have severe asthma without telling me. I’ll go first.” She then runs down a daily checklist including checking air quality, never leaving home without her inhaler and taking the Tezspire her allergist added to her treatment plan.
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Amid what one member of the European Parliament called “SMS-gate,” a Pfizer executive on Monday denied that the company’s vaccine deal with the bloc could have been negotiated via text message.
The news comes months after the European Ombudsman condemned the Commission’s handling of requests for text messages between president Ursula von der Leyen and Pfizer CEO Albert Bourla. The texts reportedly led to Pfizer’s European deal for 1.8 billion vaccine doses, the New York Times reported last April. But upon a public records request, the Commission said it hadn’t located any of the alleged texts.
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After a short, rocky two-year tenure highlighted by an event-killing pandemic, cutbacks and new pricing legislation widely viewed in biotech as a calamity, BIO CEO Michelle McMurry-Heath has gone on leave in what may be a step ahead of her quick exit.
In a statement issued to Endpoints News Sunday, BIO said:
The BIO CEO is currently on leave. BIO does not speculate on rumors relative to employees or personnel. BIO remains vigilant in its advocacy for biotech innovation and the wellbeing of patients.
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A small California biotech emerged from stealth last year to go after drug discovery’s “data problem,” and now the AI outfit has announced its first public partnership.
Terray Therapeutics put out word Wednesday that it reached a deal with Calico Life Sciences, the Google-backed anti-aging biotech co-founded by industry legend,  billionaire and current CEO Art Levinson, the former head over at Genentech and current chairman at Apple.
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