Purdue’s multi-billion dollar settlement in jeopardy after federal judge tosses deal; BioMarin announces global gene therapy collaboration

Well, Pur­due Phar­ma’s mul­ti-bil­lion dol­lar opi­oid set­tle­ment is now in jeop­ardy — a fed­er­al judge just said no.

Colleen McMa­hon, a judge on the US Dis­trict Court for the South­ern Dis­trict of New York, said that the set­tle­ment, which would dis­solve Pur­due Phar­ma and was ap­proved in Sep­tem­ber by a bank­rupt­cy judge, should not go for­ward be­cause it re­leas­es the com­pa­ny’s own­ers, mem­bers of the bil­lion­aire Sack­ler fam­i­ly, from li­a­bil­i­ty in civ­il opi­oid-re­lat­ed cas­es.

There was a sub­stan­tial amount of crit­i­cism of the deal when it was ap­proved by judge Robert Drain, with crit­ics say­ing it didn’t go far enough in hold­ing the Sack­lers ac­count­able. As part of the deal, the fam­i­ly agreed to pay about $4.5 bil­lion over the next nine years in ex­change for pro­tec­tion, and Pur­due Phar­ma was to be con­vert­ed in­to a pub­lic ben­e­fits com­pa­ny aimed at fight­ing the opi­oid cri­sis, which has led to more than 500,000 deaths in the US alone.

The Sack­lers al­so would for­feit own­er­ship of Pur­due, but the crux of the is­sue was that in­di­vid­ual fam­i­ly mem­bers could ef­fec­tive­ly be scot-free.

In her rul­ing, McMa­hon all but in­vit­ed the U.S. Court of Ap­peals for the Sec­ond Cir­cuit to weigh in — in her 142-page as­sess­ment, McMa­hon wrote that ‘the low­er courts des­per­ate­ly need a clear an­swer’ be­cause of ap­pel­late courts dis­agree­ment.

While some peo­ple cheered the rul­ing, such as Con­necti­cut’s at­tor­ney gen­er­al William Tong, Pur­due said it would ap­peal. Steve Miller, the com­pa­ny’s chair, told The New York Times the rul­ing ‘will de­lay, and per­haps end, the abil­i­ty of cred­i­tors, com­mu­ni­ties, and in­di­vid­u­als to re­ceive bil­lions in val­ue to abate the opi­oid cri­sis.’

Bio­Marin and Sky­line an­nounce glob­al AAV gene ther­a­py deal — with fo­cus on car­dio­vas­cu­lar dis­ease

Bio­Marin and Shang­hai biotech Sky­line Ther­a­peu­tics are pair­ing up to dis­cov­er, de­vel­op and com­mer­cial­ize ade­no-as­so­ci­at­ed virus (AAV) gene ther­a­pies to treat ge­net­ic car­dio­vas­cu­lar dis­eases.

The part­ner­ship, which the two com­pa­nies an­nounced yes­ter­day, will lever­age Sky­line’s AAV gene ther­a­py plat­form, which fo­cus­es on hered­i­tary heart con­di­tions called ge­net­ic di­lat­ed car­diomy­opathies (DCM), the com­pa­nies said.

Un­der the agree­ment, Bio­Marin and Sky­line will col­lab­o­rate on dis­cov­ery and re­search through IND. Each com­pa­ny will ad­vance the pro­grams through clin­i­cal de­vel­op­ment in their pre-de­fined ter­ri­to­ries.

Fi­nan­cial­ly, Sky­line will re­ceive an undis­closed up­front pay­ment and an eq­ui­ty in­vest­ment from Bio­Marin, along with undis­closed mile­stones for R&D, reg­u­la­to­ry and com­mer­cial mile­stones. Plus, Sky­line will be el­i­gi­ble to re­ceive roy­al­ty pay­ments on fu­ture sales from Bio­Marin in its ter­ri­to­ries.

On the oth­er hand, Bio­Marin will have the rights to com­mer­cial­ize ther­a­peu­tic prod­ucts re­sult­ing from the col­lab­o­ra­tion in its ter­ri­to­ries, in­clud­ing the US, Eu­rope, and Latin Amer­i­ca. Sky­line Ther­a­peu­tics will be re­spon­si­ble for com­mer­cial­iza­tion in the Asia-Pa­cif­ic re­gion.

Sensor-based technology for clinical trial data collection represents the latest medical paradigm shift. There are more than 700 clinical studies involving wearable devices currently underway in the United States. A study from Intel IT projects their inclusion in clinical trials will surge to 70% by 2025.

Apps, biosensors and patient-centered technologies increase visibility of comprehensive patient data. Pharma leaders anticipate the benefits of wearables to include better data (58%), faster results (33%) and lower trial costs (10%).

Richard Pazdur (via AACR)

There’s no denying that Merck’s Keytruda set a high bar for checkpoint inhibitors in development everywhere. But when it comes to the often redundant development of PD(L)-1 antibodies worldwide, FDA’s top cancer doctors Rick Pazdur and Julia Beaver are calling for more industry coordination.

‘Efforts to corral this enthusiasm should focus on increased international partnerships between sponsors of approved checkpoint inhibitors and those developing novel agents to be used with anti–PD-1 and anti–PD-L1 antibodies rather than developing ‘me too’ drugs,’ Beaver and Pazdur wrote Wednesday in the New England Journal of Medicine.

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Remember the sandwich generation? That’s the group of middle-aged people who are caring for both children and aging parents.

It’s a group that pharma companies often market to directly as parents who are making decisions about vaccinations, routine visits or rare conditions, but less often in their roles as caregivers who are making healthcare decisions for older family members.

But maybe they should.

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A Chrysalis Initiative and Intouch Solutions campaign features art depictions of Black women with a white not-equal sign drawn over to point out disparity in breast cancer care.

Jamil Rivers went from metastatic breast cancer patient to advocate to non-profit founder – all in her pursuit of breast cancer healthcare equity for Black women. Her mission began a few years ago when at age 39, she was diagnosed with metastatic breast cancer. As she navigated her care and the health system, she was shocked to find out that Black women die from breast cancer at a 40% higher rate than white women.

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American children under the age of five may not be vaccinated until mid-2022, as Pfizer said Friday that it’s going to now test a third dose of its Covid-19 vaccine in the trial.

The decision comes as Pfizer announced non-inferiority was not met for children between the ages of two and five when compared to older teenagers in the current trial.

Pfizer previously said it might apply for an EUA in this youngest population by the end of December or early next year, but now says that if the three-dose study proves successful, Pfizer and BioNTech expect to submit data to regulators to support an EUA ‘in the first half of 2022.’

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.

Usama Malik, ex-Immunomedics CFO

A couple weeks after facing insider trading allegations, former Immunomedics CFO Usama Malik responded to the charges in a vaguely worded LinkedIn post reflecting on the moment when his ‘world was upended.’

Malik was charged on Dec. 2 over allegations that he tipped off his then-girlfriend and four others that a Phase III study for Immunomedics’ breast cancer drug Trodelvy would be stopped early, the Department of Justice said in a complaint. Those individuals went on to purchase more than 9,000 Immunomedics shares, with one of them selling those shares right after the news broke and the biotech’s stock price doubled.

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The European Medicines Agency announced Friday it recommended the European Commission reject Aduhelm, dealing a new — albeit expected — blow to Biogen’s hopes of finding a widespread market for its struggling Alzheimer’s drug.

The EMA recommendation had been expected for a month, since the EMA’s human medicines committee gave Biogen ‘a negative trend vote’ after an oral presentation from the company. As such Biogen’s stock, which has lost all the stratospheric value it gained after Aduhelm’s approval in June, only ticked down 3% pre-market Friday, from $235.52 to $235.

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Janet Woodcock, acting FDA commissioner (Al Drago/Bloomberg via Getty Images)

Since the pandemic began, the FDA has allowed women to access the abortion drug mifepristone via the mail, making it easier for them and ensuring that they don’t have to go to a clinic to receive the pills.

The FDA’s temporary change became permanent on Thursday afternoon, with the FDA announcing that the REMS on mifepristone (brand name Mifeprex) and its generic versions must be modified by removing this in-person dispensing requirement.
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