FDA opi­oid ad­comm chair blasts agency for 'will­ful blind­ness that bor­ders on the crim­i­nal'

In scathing re­marks di­rect­ed at the FDA’s han­dling of opi­oid ap­provals, the head of the agency’s ad­vi­so­ry pan­el has lam­bast­ed its “cozy, cozy re­la­tion­ships” with the phar­ma­ceu­ti­cal in­dus­try and called for a halt in con­sid­er­ing any new opi­oids for ap­proval.

Rae­ford Brown

Rae­ford Brown, chair of the FDA’s anes­thet­ic and anal­gesic drug prod­ucts ad­vi­so­ry com­mit­tee, did not pull any punch­es in his in­ter­view with the Guardian:

I think that the FDA has learned noth­ing. The modus operan­di of the agency is that they talk a good game and then noth­ing hap­pens. Work­ing di­rect­ly with the agency for the last five years, as I sit and lis­ten to them in meet­ings, all I can think about is the clock tick­ing and how many peo­ple are dy­ing every mo­ment that they’re not do­ing any­thing. The lack of in­sight that con­tin­ues to be ex­hib­it­ed by the agency is in many ways a will­ful blind­ness that bor­ders on the crim­i­nal.

The FDA’s ten­den­cy to put the in­ter­est of drug­mak­ers ahead of pub­lic health was most re­cent­ly man­i­fest­ed in the con­tro­ver­sial ap­proval of Acel­Rx’s Dsu­via, ac­cord­ing to Brown, an anes­the­si­ol­o­gist, who called it a “ter­ri­ble drug.”

Dsu­via was ap­proved fol­low­ing a 10-3 vote by the pan­el of out­side ex­perts in fa­vor of a green light, one year af­ter it was first re­ject­ed by the FDA. Brown was ab­sent from the ad­vi­so­ry pan­el meet­ing as he was away at a pro­fes­sion­al con­fer­ence.

“There’s no ques­tion in my mind right that they did that on pur­pose,” he told the Guardian. “The FDA has a lack of trans­paren­cy. They use the ad­vi­so­ry com­mit­tees as cov­er.”

The OK drew flak de­spite the lop­sided pan­el re­view vote as crit­ics pounced on the in­tro­duc­tion of an­oth­er pow­er­ful pain med that could be ripe for abuse. In a state­ment, FDA chief Scott Got­tlieb coun­tered his crit­ics by not­ing the need for a non-IV opi­oid as well as the de­fense de­part­ment’s de­mand for a ther­a­py that would be ben­e­fi­cial on the bat­tle­field.

That did lit­tle to con­vince Brown, who ac­cused FDA of­fi­cials of be­ing out of touch with the con­se­quences of the opi­oid epi­dem­ic, which has claimed hun­dreds of thou­sands of lives the in the US and con­tin­ues to be re­spon­si­ble for about 130 deaths every day.

“Noth­ing is fun­da­men­tal­ly be­ing done to ef­fect change in the reg­u­la­tion of opi­oids,” he said. “If the FDA con­tin­ues to en­cour­age the phar­ma­ceu­ti­cal in­dus­try to turn out opi­oid af­ter opi­oid af­ter opi­oid, and the reg­u­la­tion of those opi­oids is no bet­ter than it was in 1995, then we’ll be clean­ing this up for a long time.”

How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Pearl Huang, Dunad Therapeutics CEO (Ken Richardson, PR Newswire)

Long­time biotech leader Pearl Huang takes the reins as CEO of No­var­tis-backed up­start

It has only been a few months since Pearl Huang exited the top seat at Cygnal Therapeutics, but now she’s back at the helm of another biotech.

After taking a few months off — passing an exam in that time to get her captain’s license from the US Coast Guard — she’s been named CEO of Dunad Therapeutics, a biotech focused on developing a small molecule covalent therapies that was founded in 2020. Huang told Endpoints News that two factors attracted her to going back to the c-suite: the company’s technology and its co-founders.

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Laurence Reid, Decibel CEO

Still in pre­clin­i­cal test­ing for ear gene ther­a­pies, Deci­bel touts small snap­shot of chemo-in­duced hear­ing loss drug

Though Decibel Therapeutics has largely pivoted toward gene therapies for the inner ear, its lead clinical candidate simply aims to protect cancer patients from chemotherapy-induced hearing loss. On Tuesday, the biotech presented its first efficacy data for the program, and execs like what they see.

Decibel reported interim results from a Phase Ib study showing the experimental drug, dubbed DB-020, largely protected a small group of patients from losing their hearing. Researchers used a particularly unique study design, administering the compound in one of each patients’ ears before they received cisplatin chemotherapy and placebo in the other.

Alex­ion puts €65M for­ward to strength­en its po­si­tion on the Emer­ald Isle

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

Fed­er­al judge de­nies Bris­tol My­er­s' at­tempt to avoid Cel­gene share­hold­er law­suit

Some Celgene shareholders aren’t happy with how Bristol Myers Squibb’s takeover went down.

On Friday, a New York federal judge ruled that they have a case against the pharma giant, denying a request to dismiss allegations that it purposely slow-rolled Breyanzi’s approval to avoid paying out $6.4 billion in contingent value rights (CVR).

When Bristol Myers put down $74 billion to scoop up Celgene back in 2019, liso-cel — the CAR-T lymphoma treatment now marketed as Breyanzi — was supposedly one of the centerpieces of the deal. After going back and forth on negotiations for about six months, BMS put $6.4 billion into a CVR agreement that required an FDA approval for Zeposia, Breyanzi and Abecma, each by an established date.

Ben Zimmer, Priovant CEO

Roivant un­veils lat­est spin­out as Pfiz­er en­trusts JAK1/TYK2 to Pri­o­vant

In November, Pfizer disclosed it’s spun out the Phase II dual JAK1/TYK2 inhibitor to a startup formed in collaboration with an unnamed, experienced partner.

We now know who the partner is. And as Pfizer and Roivant officially take the wraps off Priovant Therapeutics, the companies reveal that they have started two registrational trials of the drug, brepocitinib, as part of a broader plan to develop a big, first-in-class franchise spanning multiple orphan and specialty autoimmune diseases.

AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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Am­gen takes next step with its Chi­na am­bi­tions, out-li­cens­ing drugs to Fo­s­un Phar­ma

In a bid to increase its market share in China, Amgen has agreed to a partnership with a Shanghai biotech — a collaboration and out-licensing agreement for two of its drugs.

Amgen and Fosun Pharma announced a deal Monday in a bid to increase Amgen’s presence in the country. The stated goal so far is to commercialize Amgen’s blockbuster psoriasis drug Otezla alongside Parsabiv, a drug for secondary hyperparathyroidism in adults with chronic kidney disease and on a specific type of dialysis.