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Outside Biogen's headquarters in Cambridge, MA (Steven Senne/AP Images)

How cozy is too cozy? FDA and Bio­gen of­fer up a test case

As the saga over how to pay for Aduhelm plays out, biopharma companies are now looking closely at how Biogen was able to keep such a special relationship with FDA officials ahead of the drug’s accelerated approval, and whether or not they might be able to leverage those takeaways into their own relationships with the agency.

What makes Biogen unique, however, is how deep its relationship with the FDA ran, and the way in which FDA’s neuroscience head Billy Dunn worked alongside the company for years prior to Aduhelm’s quick OK. For instance, back in 2017, Dunn co-chaired a data sharing initiative at the nonprofit C-Path Institute alongside Biogen SVP Samantha Budd Haeberlein, as first reported by the New York Times. In 2018, Dunn and Budd Haeberlein also jointly presented on strengthening communication across the Alzheimer’s drug development community.

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FDA re­jects pro­fes­sor’s pe­ti­tion seek­ing to pull ‘dan­ger­ous’ Ot­su­ka kid­ney dis­ease drug

The FDA on Monday denied a petition from an emeritus professor at Ohio State University who had sought to revoke the approval of Otsuka’s kidney disease drug tolvaptan, which he said is “dangerous” and offered “negligible efficacy.”

Approved by the FDA in 2018 to treat the genetic disease known as autosomal dominant polycystic kidney disease, Otsuka’s tolvaptan — marketed in the US as Jynarque — faced a long and rocky road to marketing but quickly amassed more than $700 million in worldwide sales in 2020, up almost 40% from 2019.

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Terms of mega opi­oid set­tle­ment set to be dis­closed this week — re­port

Years after talks between drugmakers, distributors and five US states began surrounding the opioid crisis, the final terms of a $26 billion settlement holding the companies responsible for fueling the epidemic is expected to be announced this week, Bloomberg reports.

J&J, McKesson Corp., Cardinal Health and AmerisourceBergen are expected to disclose the final terms of a multibillion dollar settlement for thousands of lawsuits surrounding the companies’ role in the opioid crisis.  Each state has the option to accept just J&J’s offer, or the combined distributors’ proposal, and the companies will pay bonuses for each local government that signs up, according to Bloomberg.

Rendition of the new learning center (Credit: Merck KGaA)

Mer­ck KGaA for­ti­fies its ‘site of the fu­ture’ with $319M re­search, staff train­ing cen­ters

Everything began in 1668, in Darmstadt, Germany — so goes Merck KGaA’s description of its global headquarters. And the conglomerate has been clear that it’s not going anywhere else, unveiling plans in 2019 to lavish $1.18 billion on the site over the coming years.

Merck KGaA has just mapped out another substantial chunk of that investment package.

The next stage involves pouring $319 million into two new institutions: a translational science center for scientists in its healthcare business unit, as well as a new learning center to onboard new employees.

Janet Woodcock, acting FDA commissioner (Bill Clark/CQ Roll Call via AP Images)

UP­DAT­ED: FDA’s do­mes­tic bio­phar­ma in­spec­tions re­turn to nor­mal as agency faces back­log of 8,000+

For the first time since March 2020, the FDA’s inspections of US-based biopharma sites have returned to normal, FDA acting commissioner Janet Woodcock said Monday at a small business regulatory event.

“I’m pleased to say that as of this month, we’ve begun transitioning back to standard operations for domestic inspections while continuing to prioritize mission-critical work for foreign inspections,” Woodcock said.

As­traZeneca earns an­oth­er ap­proval in jam-packed Chi­nese PD-(L)1 mar­ket, this time in late-stage lung can­cer

One of the first entrants in the PD-(L)1 market in China, British drugmaker AstraZeneca is now looking to cement its advantage there with another approval for checkpoint inhibitor Imfinzi.

Imfinzi was approved by China’s NMPA as a combination with platinum-based chemotherapy for first-line use in “extensive-stage” small cell lung cancer, an advanced form of the disease associated with particularly poor outcomes for patients, the drugmaker said Monday.

Andrew Cuomo, AP Images

Re­gen­eron, al­ready an in­sti­tu­tion in NY, earns Cuo­mo's back­ing for a $1.8B ex­pan­sion at Tar­ry­town hive

As the feather in New York’s life sciences cap, Regeneron has maintained a warm relationship with the state’s foremost political family, the Cuomos. Legendary Gov. Mario Cuomo had a hand in getting Regeneron on its feet early, and now his son will pave the way for the drugmaker’s future.

Regeneron plans to spend $1.8 billion and hire 1,000 new workers as part of an ambitious, two-phase expansion at its Tarrytown, NY campus to flesh out its preclinical manufacturing unit and provide some more elbow room for its lab and office staff, according to Gov. Andrew Cuomo’s office.

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Giovanni Caforio, AP Images

Bris­tol My­ers Squibb takes an­oth­er late-stage loss for Op­di­vo-Yer­voy com­bo in head and neck can­cer

Bristol Myers Squibb has worked overtime to hunt down an edge for its PD-(L)1 blocker Opdivo over rival Keytruda from Merck, including taking a bold combo strategy with CTLA4 inhibitor Yervoy. But in head and neck cancer, the combo keeps dropping duds.

Opdivo plus Yervoy failed to show clinical benefit in extending the lives of first-line patients with recurrent or metastatic squamous cell carcinoma of the head and neck, according to topline results from the Phase III CHECKMATE-651 study revealed Friday.

Pfiz­er set­tles EpiPen price hike law­suits for $345M

Pfizer has agreed to pay $345 million as part of a settlement related to a 5-year-old lawsuit over the company’s price hikes on the lifesaving EpiPen.

Plaintiffs across the country raised concerns over the price of the autoinjector 2-pack, which they said spiked from about $100 in 2007 to $608 in 2016 — an increase of over 600%.

“Were the price increases attributable to market conditions, increases in manufacturing costs, or shortages in the supply of epinephrine? Absolutely not. They were driven solely by unaccountable executives and companies who sought to profit off of human misery and fear,” the consolidated class action complaint from 2017 alleged.

UP­DAT­ED: Safe­ty con­cerns push FDA ad­comm to vote over­whelm­ing­ly against ap­proval for Fi­bro­Gen ane­mia drug

The FDA’s Cardiovascular and Renal Drugs Advisory Committee on Thursday afternoon voted 12 to 2 against approving AstraZeneca and FibroGen’s anemia drug roxadustat as a treatment of anemia due to chronic kidney disease in adult patients on dialysis, and the committee voted 13-1 against approval for patients not on dialysis.

Overall, adcomm members raised questions related to the cardiovascular safety of the drug and a lack of a signal related to quality-of-life improvements, under-representation of African Americans in the global trials, as well as concerns with the company’s planned post-marketing study and dosing changes.

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