Frank Pallone (D-NJ), House Energy and Commerce Committee chair (Kevin Dietsch/Pool via AP Images)

House com­mit­tee unan­i­mous­ly ad­vances FDA user fee leg­is­la­tion with ac­cel­er­at­ed ap­proval tweaks

The House En­er­gy and Com­merce Com­mit­tee on Wednes­day of­fered a rare show of bi­par­ti­san sup­port for a bill that would pro­vide the FDA with user fees for the next five years.

The com­mit­tee vot­ed 55-0 to ad­vance the quin­quen­ni­al user fee bill to the full House floor, which if ap­proved, will al­low the FDA to use bio­phar­ma funds to hire new re­view­ers, and hit new marks as out­lined in the user fee deals that the FDA and bio­phar­ma com­pa­nies forged over the past sev­er­al years.

While the reau­tho­riza­tion of these fees usu­al­ly sticks to just the FDA-in­dus­try agree­ments, the bill that ad­vanced out of the House com­mit­tee on Wednes­day fea­tures mul­ti­ple new pro­vi­sions, in­clud­ing ac­cel­er­at­ed ap­proval re­forms, man­u­fac­tur­ing in­spec­tion tweaks at the FDA, and oth­ers.

On the ac­cel­er­at­ed ap­provals, com­mit­tee chair Frank Pal­lone (D-NJ) said at the markup Wednes­day that he heard from FDA of­fi­cials that some drugs ap­proved via the ac­cel­er­at­ed path­way take years to start their con­fir­ma­to­ry tri­als, and if the spon­sor fails to show ben­e­fit, it can take even more time to pull the drugs from the mar­ket.

Ex­am­ples of both sce­nar­ios can be seen with Sarep­ta’s DMD drug eteplirsen, which took al­most 4 years to be­gin its con­fir­ma­to­ry tri­al af­ter its ac­cel­er­at­ed ap­proval, and the con­tro­ver­sial preterm birth drug Mak­e­na, which the FDA is still try­ing to pull from the mar­ket af­ter its failed tri­al in 2018.

But the Sen­ate draft of its own user fee bill, un­veiled yes­ter­day, did not in­clude many of these same pro­vi­sions like the ac­cel­er­at­ed ap­proval re­forms, and in­stead looks to ramp up FDA reg­u­la­tion of cos­met­ics, nu­tri­tion­al sup­ple­ments, and in vit­ro di­ag­nos­tics.

Both In­di­ana Re­pub­li­can Lar­ry Buc­shon and Col­orado De­mo­c­rat Di­ana DeGette said Wednes­day that they’re pleased to see the Sen­ate in­clud­ed the VALID Act in its user fee reauth bill, but DeGette said she would pre­fer to work with Pal­lone to in­clude this di­ag­nos­tic test­ing reg­u­la­tion in­to the House bill.

“The time is now to an­swer the call and ad­dress the pit­falls that ex­ist in the cur­rent reg­u­la­to­ry frame­work sur­round­ing lab­o­ra­to­ry de­vel­oped tests,” Buc­shon said.

With­out re­veal­ing whether he would budge on LDTs, Pal­lone re­spond­ed with, “When­ev­er the Sen­ate takes ac­tion on any­thing, we have to take no­tice.”

Vas Narasimhan (Photographer: Jason Alden/Bloomberg via Getty Images)

No­var­tis de­tails plans to axe 8,000 staffers as Narasimhan be­gins sec­ond phase of a glob­al re­org

We now know the number of jobs coming under the axe at Novartis, and it isn’t small.

The pharma giant is confirming a report from Swiss newspaper Tages-Anzeiger that it is chopping 8,000 jobs out of its 108,000 global staffers. A large segment will hit right at company headquarters in Basel, as CEO Vas Narasimhan axes some 1,400 of a little more than 11,000  jobs in Switzerland.

The first phase of the work is almost done, the company says in a statement to Endpoints News. Now it’s on to phase two. In the statement, Novartis says:

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Peter Marks (Jim Lo Scalzo/Pool via AP Images)

FDA's VRB­PAC votes in fa­vor of adapt­ing the Covid-19 vac­cine to the lat­est Omi­cron vari­ant

The FDA’s Vaccine and Related Biological Products Advisory Committee on Tuesday gave the thumbs up — by a vote of 19-2 — that the FDA should require an Omicron-related component in this next season’s booster dose for Covid-19, which both Pfizer/BioNTech and Moderna are hard at work on.

And while neither booster will likely be ready to go with adequate supplies for all American adults by the beginning of the next school year, the situation is still complex and fluid, with CBER Director Peter Marks telling the committee that it’ll take companies at least three months to ready their supplies for this expected next wave.

Bob Nelsen (Lyell)

UP­DAT­ED: As bear mar­ket con­tin­ues to beat down biotech, ARCH clos­es a $3B ear­ly-stage fund

One of the biggest names in biotech investing has a whole lot of new money to spend.

ARCH Venture Partners closed its 12th venture fund early Wednesday morning, the firm said, bringing in almost $3 billion to invest in early-stage biotechs. The move comes about a year and a half after ARCH announced its previous fund, for almost $2 billion back in January 2021.

In an interview with Endpoints News, ARCH managing director and co-founder Bob Nelsen brushed off concerns about the broader market troubles, saying the downturn that’s seen several biotechs downsize and the XBI fall back to almost pre-pandemic levels won’t impact ARCH’s mindset too much because it typically focuses on company formation.

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Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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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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Aurobindo Pharma co-founders P. V. Ram Prasad Reddy (L) and K. Nityananda Reddy

Au­robindo Phar­ma re­ceives warn­ing let­ter from In­di­a's SEC fol­low­ing more FDA ques­tion marks

Indian-based generics manufacturer Aurobindo Pharma has been in the crosshairs of the FDA for several years now, but the company is also attracting attention from regulators within the subcontinent.

According to the Indian business news site Business Standard, a warning letter was sent to the company from the Securities Exchange Board of India, or SEBI.

The letter is related to disclosures made by the company on an ongoing FDA audit of the company’s Unit-1 API facility in Hyderabad, India as well as observations made by the US regulator between 2019 and 2022.

Sanofi to cut in­sulin prices for unin­sured from $99 to $35, match­ing the in­sulin cap com­ing through Con­gress

As the House-passed bill to cap the monthly price of insulin at $35 nationwide makes its way for a Senate vote soon, Sanofi announced Wednesday morning that beginning next month it will cut the monthly price of its insulins for uninsured Americans to $35, down from $99 previously.

The announcement from Sanofi, which allows the uninsured to buy one or multiple Sanofi insulins (Lantus, Insulin Glargine U-100, Toujeo, Admelog, and Apidra) at $35 for a 30-day supply effective July 1, follows House passage (232-193) of the monthly cap in March, with just 12 Republicans voting in favor of the measure.

Ankit Mahadevia, Spero CEO

Spero’s UTI can­di­date gets the CRL ham­mer as the com­pa­ny falls in­to pen­ny stock sta­tus

Spero Therapeutics has been struggling in the past few years, dealing with FDA holds and staff reductions amidst a rough biotech market, and the latest news from the Massachusetts-based company confirms what it anticipated in May: a CRL.

The company was slapped with the no-go for its NDA, the biotech disclosed Monday. The company was seeking approval for tebipenem HBr oral tablets, intended for the treatment of adult patients with complicated urinary tract infection, or cUTI, including pyelonephritis. The FDA had set a PDUFA date of June 27.

State bat­tles over mifepri­s­tone ac­cess could tie the FDA to any post-Roe cross­roads

As more than a dozen states are now readying so-called “trigger” laws to kick into effect immediate abortion bans following the overturning of Roe v. Wade on Friday, these laws, in the works for more than a decade in some states, will likely kick off even more legal battles as states seek to restrict the use of prescription drug-based abortions.

Since Friday’s SCOTUS opinion to overturn Americans’ constitutional right to an abortion after almost 50 years, reproductive rights lawyers at Planned Parenthood and other organizations have already challenged these trigger laws in Utah and Louisiana. According to the Guttmacher Institute, other states with trigger laws that could take effect include Arkansas, Idaho, Kentucky, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas, and Wyoming.

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