A 'dis­ori­ent­ed' Pain Ther­a­peu­tics flips out af­ter FDA re­jects ap­peal on Re­moxy

Pain Ther­a­peu­tics has had the last word on its four-time re­ject Re­moxy — and it’s a bit­ter one.

Af­ter a meet­ing with the FDA, the biotech says, “we be­lieve we are no clos­er to­day to prod­uct ap­proval than we were over a year ago” thanks to “sham­bol­ic reg­u­la­tions” at the agency.

Its stock $PTIE prompt­ly fell 20%, tum­bling fur­ther in­to pen­ny­s­tock low­land.

Re­mi Bar­bi­er

The dis­pute here cen­ters around how eas­i­ly Re­moxy — an ex­tend­ed re­lease gel for­mu­la­tion of oxy­codone — can be abused, at a time the dead­ly opi­oid cri­sis has led to calls for height­ened vig­i­lance over ap­proval of new pain drugs.

That con­cern led an ex­pert pan­el to vote over­whelm­ing­ly against the drug be­fore the FDA hand­ed a for­mal slap­down.

Con­trast that with the sol­id en­dorse­ment Acel­Rx re­ceived for its pain med Dsu­via, which was lat­er ap­proved — trig­ger­ing vo­cal crit­i­cism from an ex­pert on the com­mit­tee who ac­cus­es the FDA for lack­ing in trans­paren­cy.

Pain Ther­a­peu­tics con­tend­ed the agency mis­led the ad­vi­so­ry com­mit­tee with “math er­rors, ma­te­r­i­al mis­takes and mis­rep­re­sen­ta­tions,” an al­le­ga­tion that reg­u­la­tors de­nied in their re­cent meet­ing with the com­pa­ny.

Be­fore they go silent about their fu­ture plans for the drug, CEO Re­mi Bar­bi­er of­fered a part-eu­lo­gy that’s most­ly FDA bash­ing:

Re­moxy re­mains an odyssey with­out a home­com­ing. We had hoped for a fair, neu­tral and im­par­tial re­view of the Re­moxy da­ta. In­stead, we walked out of this meet­ing feel­ing a bit dis­ori­ent­ed by FDA’s lack of trans­paren­cy, clar­i­ty or help­ful­ness. It’s a rare oc­ca­sion when two par­ties can’t agree on sim­ple math. We can’t work with sham­bol­ic reg­u­la­tions. This is not how you win sup­port for in­no­va­tion.

As pre­vi­ous­ly re­port­ed, fol­low­ing a re­or­ga­ni­za­tion, the biotech plans to fo­cus its re­main­ing re­sources on a drug for Alzheimer’s, a dis­ease that has de­feat­ed every ther­a­py thrown at it for more than a decade.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

President Donald Trump (via AP Images)

Signs of an 'Oc­to­ber Vac­cine Sur­prise' alarm ca­reer sci­en­tists

President Donald Trump, who seems intent on announcing a COVID-19 vaccine before Election Day, could legally authorize a vaccine over the objections of experts, officials at the FDA and even vaccine manufacturers, who have pledged not to release any vaccine unless it’s proved safe and effective.

In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Trump — who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA — will take matters into his own hands, running roughshod over the usual regulatory process.

#ES­MO20: Push­ing in­to front­line, Mer­ck and Bris­tol My­ers duke it out with new slate of GI can­cer da­ta

Having worked in parallel for years to move their respective PD-1 inhibitors up to the first-line treatment of gastrointestinal cancers, Merck and Bristol Myers Squibb finally have the data at ESMO for a showdown.

Comparing KEYNOTE-590 and CheckMate-649, of course, comes with the usual caveats. But a side-by-side look at the overall survival numbers also offer some perspective on a new frontier for the reigning checkpoint rivals, both of whom are claiming to have achieved a first.

#ES­MO20: Bris­tol My­ers marks Op­di­vo's sec­ond ad­ju­vant win — eye­ing a stan­dard of care gap

Moving into earlier and earlier treatment lines, Bristol Myers Squibb is reporting that adjuvant treatment with Opdivo has doubled the time that esophageal or gastroesophageal junction cancer patients stay free of disease.

With the CheckMate-577 data at ESMO, CMO Samit Hirawat said, the company believes it can change the treatment paradigm.

While a quarter to 30% of patients typically achieve a complete response following chemoradiation therapy and surgery, the rest do not, said Ronan Kelly of Baylor University Medical Center. The recurrence rate is also high within the first year, Hirawat added.

Clay Siegall (Life Science Washington via YouTube)

#ES­MO20: Seat­tle Ge­net­ics eyes 4th ap­proval with new da­ta in a crowd­ed field

Does Seattle Genetics have another approval on its hands?

The last 12 months, not so great for the world, has been great for Seattle Genetics. The company landed two separate FDA approvals, signed a $4.5 billion deal with Merck and watched antibody-drug conjugates — the technology they spent years developing to broad industry skepticism — emerge suddenly as one of the most popular approaches in oncology. And on Monday at ESMO, the company and their partners at Genmab unveiled the data behind the ADC it hopes will provide its next major FDA approval.

Jonathan Rigby, Immune Regulation group CEO

Im­mune Reg­u­la­tion, tak­ing two clin­i­cal pro­grams to 're­set' the im­mune sys­tem, nets $53M+ Se­ries B

A little under two years after a company rebranding, Immune Regulation is taking an even bigger step toward advancing its goals.

Formerly known as Peptinnovate, the British biotech announced a $53.4 million Series B early Monday morning, helping to further advance two clinical programs in rheumatoid arthritis and asthma. Though those are the two initial indications the company is focusing on, CEO Jonathan Rigby told Endpoints News he hopes the candidates can be applied to a broad swath of autoimmune disorders.

Israel Lowy (Regeneron)

#ES­MO20: 'As good as any PD-1 out there': Re­gen­eron flash­es PD-(L)1 lung can­cer da­ta to ri­val Mer­ck

Regeneron entered the PD-(L)1 game late, so they devised a two-pronged strategy to catch up with Big Pharma rivals: They would push it into cancers where PD-1s had yet been tested, and they would prove that it’s as powerful in the big indications as any other on the market.

They cleared a hurdle on the first goal Friday, showing a 31% response in patients with the rare skin cancer basal cell carcinoma. And with the data they’re rolling out Monday, Regeneron cancer chief Israel Lowy is ready to declare success on the second.

UP­DAT­ED: Two wild weeks for Grail end in $8B Il­lu­mi­na buy­out

Grail’s whirlwind two weeks have ended in the wealthy arms of its former founder and benefactors.

Illumina has shelled out $8 billion to reacquire the closely-watched liquid biopsy startup they spun out just 5 years ago and sold off much of its shares just 3 years ago. The deal comes nearly two weeks after the well-heeled startup filed for a potentially massive IPO — one that was disrupted just a week later when Bloomberg reported that Illumina was in talks to buy their former spinout for up to $8 billion.

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Anthony Fauci (AP Images)

A press of­fi­cer at An­tho­ny Fau­ci’s NI­AID was un­masked as a hard-right Covid troll. He just re­tired to­day

William B Crews had been a public affairs specialist at the NIH’s National Institute of Allergy and Infectious Diseases.

That ended today when he informed the agency of his decision to retire, after he was identified as the managing editor at RedState, a prominent Trump loyalist website.

Crews’ RedState duties are performed under the alias streiff. While enjoying the benefits of pseudonymity, he disparaged and worked against NIAID with an incendiary level of rhetoric in the midst of a pandemic.