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Thomas Schall, ChemoCentryx CEO (file photo)

Chemo­Cen­tryx plunges as FDA rais­es ques­tions about rare dis­ease drug ahead of ad­comm

ChemoCentryx’s stock price on Wednesday was cut in half by the release of FDA briefing documents ahead of a Thursday adcomm, raising questions on the company’s clinical data to support avacopan as a treatment for adults with a rare and serious disease known as anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis.

ANCA-associated vasculitides (AAV) affect small to medium-size blood vessels that can be fatal in less than a year if left untreated, according to FDA. Only Roche’s Rituxan is currently FDA-approved for the treatment of AAV, while glucocorticoids are approved for the broader indication of vasculitis.

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Mer­ck lays out vi­sion for wom­en's health spin­out Organon, with some spe­cial plans for its $9B wind­fall

As Merck prepares to launch its women’s health spinoff Organon next month, the leadership teams at both companies showed off their business development plans Monday. And based on the way Merck tells it, there’s a lot to like for the newco, even if it’s not quite for them.

Organon’s products while as a Merck subsidiary accounted for roughly $6.6 billion in 2020 sales, Merck said Monday, led by efforts in contraceptive and biosimilar franchises. That figure will likely stay the same for 2021, falling in the estimated $6.1 to $6.4 billion range.

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Re­gen­eron’s gold­en goose Eylea may stave off biosim­i­lar com­pe­ti­tion un­til 2024 or be­yond

Almost 10 years have passed since its first FDA approval and Regeneron’s macular degeneration injection Eylea continues to pile up sales to the tune of about $5 billion per year, or more than half of Regeneron’s annual revenues.

Those billions are not expected to go anywhere anytime soon thanks to competition, even as Novartis subsidiary Sandoz announced Monday that it’s beginning a Phase III trial for an Eylea biosimilar in 460 patients across 20 countries.

The Covid-19 pan­dem­ic can't hold down glob­al drug spend­ing, IQVIA re­ports, with cash ex­pect­ed to keep flow­ing

Despite its long-reaching effects in global markets, the Covid-19 pandemic is not expected to broadly impact global sales on medicines in the near-term future, according to a new report from IQVIA.

Over the next five or so years, through 2025, global spending will grow at an estimated 3% to 6% rate annually and reach $1.6 trillion in sales. Notably, that figure does not include an additional $157 billion expected to be spent on Covid-19 vaccines, which will mostly come from now through the end of 2022.

Bio­gen won’t ex­plain why FDA slapped down their bid for new Tysabri for­mu­la­tion

When it submitted a supplemental Biologic License Application to the FDA, Biogen hoped they could offer patients with multiple sclerosis an easier way of receiving and administering their therapy Tysabri. But Thursday, it received a CRL denying the approval of its filing, and it isn’t offering any explanation behind it.

The company turned down a request for further explanation from Endpoints News Friday.

Bris­tol My­er­s' Op­di­vo scores pri­or­i­ty re­view in com­mon blad­der can­cer, mark­ing lat­est win in PD-1 bat­tle with Keytru­da

Two months after Bristol Myers Squibb announced Opdivo nearly doubled the average length of time patients with a common bladder cancer lived without disease recurrence, regulators have said they’ll give the PD-1 blockbuster an expedited look.

The FDA has granted priority review to Opdivo as an adjuvant treatment in muscle-invasive urothelial cancer, Bristol Myers said on Friday, marking the latest win in the pharma’s bid to outshine Merck’s superstar I/O Keytruda. The agency tapped Sept. 3 for a PDUFA date.

Pascal Soriot, AstraZeneca CEO (Raphael Lafargue/Abaca/Sipa USA; Sipa via AP Images)

As­traZeneca's non-prof­it vac­cine is, for now, cost­ing them mon­ey

For the first earnings report of the year, AstraZeneca invented a new metric: the profit they’d have if you didn’t count their Covid-19 vaccine costs.

When AstraZeneca announced last year that they would develop Oxford’s Covid-19 candidate, they said they would sell it on a not-for-profit basis during the pandemic. The terms fulfilled the vaccine’s academic inventors’ desire to see their shot deployed cheaply around the world, while also allowing the drugmaker to do some good and, potentially, secure a massive PR coup.

Janet Woodcock (AP Images)

More in­fo on drug re­view time­lines? HHS and FDA pull Trump HHS’ last-minute pledge

HHS and FDA on Friday said they’re withdrawing a notice published just days before former President Donald Trump left office, which would’ve required the FDA to publish redundant information on the timelines for reviewing drug applications.

In addition to the FDA being entirely left out of the decision to publish the initial notice, the decision to pull the notice came as HHS and FDA said it did not account for what’s already publicly available about FDA’s review of drug applications.

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Nick Leschly, bluebird bio CEO (Jeff Rumans)

Bob­bing on a sea of crises, blue­bird's Nick Leschly sees his pay cut in half as the biotech pre­pares to split

It wasn’t so long ago that bluebird bio and CEO Nick Leschly were the darling of biotech, using a lentiviral vector approach that looked to change the game in gene therapy. But after a series of setbacks and a looming split of the business, Leschly has watched his star rapidly fall — and his pay to boot.

With bluebird on its way to a split between its gene therapy and oncology units, Leschly saw his pay in 2020 plummet to just over $6 million — a more than 50% cut from the previous year — as the biotech struggled through regulatory setbacks and an exodus of its leadership team, according to a proxy filing.

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Richard Gonzalez, AbbVie CEO (Chris Kleponis/picture-alliance/dpa/AP Images)

House com­mit­tee to grill Ab­b­Vie CEO next month on sup­press­ing Hu­mi­ra com­pe­ti­tion

AbbVie CEO Richard Gonzalez will be in the hot seat on May 18, again defending the company’s mammoth blockbuster drug Humira before the House Oversight Committee as competition for the world’s best-selling drug isn’t likely to hit American shores for about two years.

Oversight Committee Chairwoman Carolyn Maloney (D-NY) has been zeroing in on AbbVie for months now, even threatening to issue a subpoena last September for documents as part of her committee’s ongoing investigation into drug pricing practices.