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FDA ap­proves 5 new cost­ly drugs well ahead of PDU­FA dates

Since 21 October, the FDA has been on a tear in approving five new drugs (all with list prices of more than $100,000 per year) months ahead of when they were expected to be approved.

For instance, the FDA signed off on Vertex Pharmaceuticals’ Trikafta (elexacaftor/ivacaftor/tezacaftor), a new treatment for those with the most common cystic fibrosis mutation, after only three months of review and well ahead of its 19 March 2020 user fee action date.

Feds add fraud charges to the mul­ti­tude of ac­cu­sa­tions made against for­mer MiMedx ex­ecs

You can add federal charges of accounting fraud to the steadily growing mound of accusations faced by former top executives of MiMedx Group.

The Justice Department has indicted ex-CEO Parker Petit and ex-President William Taylor on fraud charges related to overstating revenue and misleading investors of the tissue repair company. And the SEC followed up with a civil suit outlining a claim that Petit, Taylor and former CFO Michael Senken engaged in accounting fraud over a 4-year period stretching from 2013 to 2017.

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Aque­s­tive nabs FDA OK for oral film ver­sion of gener­ic ALS drug

The FDA has given Aquestive Therapeutics the green light to market Exservan, its oral film formulation of a decades-old treatment for amyotrophic lateral sclerosis.

Back in 1995 riluzole became the first FDA-approved therapy for ALS, which remains incurable. Its exact mechanism of action is unknown but it’s been proposed that the drug blocks the release of glutamate from nerve cells, thereby alleviating glutamate-induced deterioration. As a result, the original drug was shown to delay symptoms and even death.

FDA re­leas­es 81 prod­uct-spe­cif­ic guid­ances

The FDA on Thursday released product-specific guidance documents for 81 active pharmaceutical ingredients to aid generic drug development, including 28 new draft guidances and 53 revised draft guidances.

The guidances, when finalized, are intended to promote generic competition by clarifying the FDA’s expectations for the studies required to demonstrate that a generic drug is equivalent to a reference listed drug. So far, the FDA has issued nearly 1,800 product-specific guidances.

Muzammil Mansuri. Sanofi

Sanofi's strat­e­gy head to re­tire by month end, as com­pa­ny gears up for De­cem­ber strate­gic up­date

While speculation that Sanofi is considering options for its consumer healthcare unit erupts ahead of a planned strategic update next month, it looks like the French drugmaker is losing a senior executive in charge of strategy.

Muzammil Mansuri, executive vice president of strategy, and business development — and member of Sanofi’s executive committee — is set to leave the company by the end of November, Reuters reported on Friday, citing an internal memo.

Ahead of strate­gic up­date, new Sanofi CEO mulls op­tions for con­sumer health­care arm — re­ports

Big pharma has made moves to sharpen its focus on developing new medicines, while slow-growing consumer health divisions fall by the wayside. Looks like another large drugmaker is considering a similar move. On Thursday, reports citing sources indicated that Sanofi is reportedly mulling a joint venture, sale, or a public listing of its consumer health arm.

The French group is in discussions for options that could value the division at $30 billion, Bloomberg and Reuters reported, citing sources familiar with the matter.

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David Ricks. Eli Lilly

Eli Lil­ly touts $400M man­u­fac­tur­ing ex­pan­sion, 100 new jobs to much fan­fare in In­di­anapo­lis — even though it's been chop­ping staff

Eli Lilly is pouring in $400 million to beef up manufacturing facilities at its home base of Indianapolis. The investment, which was lauded by the city’s mayor, is expected to create 100 new jobs.

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Badrul Chowdhury. FDA via Flickr

As­traZeneca los­es an­oth­er ex­ec­u­tive to biotech, as Badrul Chowd­hury moves to Savara

Another executive is migrating from the echelons of Big Pharma to the corridors of small biotech.

In April 2018, Badrul Chowdhury took his more than two decades of experience at the FDA to AstraZeneca, where he took on the role of senior vice president and chief physician-scientist for respiratory, inflammation and autoimmunity late-stage development in biopharmaceuticals R&D.

After about a year and a half in this role, Chowdhury is moving to a small Texas biotech called Savara, where he will serve as chief medical officer.

Elizabeth Warren speaks during the Nevada Democrats' "First in the West" event at Bellagio Resort & Casino on November 17, 2019 in Las Vegas, Nevada (Getty Images)

Eliz­a­beth War­ren pro­pos­es us­ing com­pul­so­ry li­cens­ing, an­titrust ac­tions to break bio­phar­ma’s con­trol of drug pric­ing — and here are the block­busters she’s tar­get­ing first

Nancy Pelosi’s drug pricing bill may have sparked some industrial strength headaches on the money side of biopharma, but Elizabeth Warren seems determined to become biopharma’s Nightmare on Pennsylvania Avenue.

Warren, one of the top-ranked candidates for the Democratic presidential nomination backing Medicare for all, is circulating a new plan that promises to break the industry’s grip on drug prices — and she has some very specific examples of how she would do it.

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Image: Associated Press

Af­ter a late-stage miss, No­var­tis touts an­oth­er En­tresto analy­sis to con­vince the FDA to ex­pand the block­buster's la­bel

Fresh after getting its keenly watched sickle cell treatment endorsed by the FDA, Novartis is pulling out all the stops to expand the use of heart therapy Entresto using a raft of analyses after the drug “narrowly” failed a crucial late-stage test.

Entresto is a top seller for Novartis and is currently approved for HFrEF (formerly known as systolic heart failure) — in these patients the heart muscle does not contract effectively, reducing the level of oxygen-rich blood pumped into to the body. The drug is administered twice daily and is designed to cut the strain on the failing heart.

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