Stanley Erck, Novavax CEO (Andrew Harnik, AP Images)

No­vavax's vac­cine roll­out crawls amid months of bro­ken promis­es — re­port

For No­vavax, part of the big ques­tion sur­round­ing the biotech was whether it could man­u­fac­ture a Covid-19 vac­cine — its first com­mer­cial prod­uct — prop­er­ly, in suf­fi­cient quan­ti­ty and de­liv­er it on time.

With months of de­lays due to fil­ings and man­u­fac­tur­ing con­cerns, the an­swer to that ques­tion might just be no. The newest de­vel­op­ment for the biotech marks the lat­est in missed dead­lines and bro­ken pledges for the com­pa­ny — and the CEO who has a mul­ti­tude on his record.

As we wrote pre­vi­ous­ly, No­vavax’s CEO Stan­ley Er­ck had told an­a­lysts that “we’re talk­ing weeks here, not months” on a EUA sub­mis­sion to the FDA on Au­gust 5. Three months lat­er, the com­pa­ny changed its tune and punt­ed the time­line to the end of 2021. And on New Year’s Eve? They said they ex­pect to sub­mit a re­quest for EUA in one month — which made that promise a re­al-life ex­am­ple of “third time’s the charm” as they ac­tu­al­ly met that dead­line last week.

And now, there are re­ports of mas­sive ship­ping de­lays.

No­vavax $NVAX is feel­ing the heat from in­vestors — with shares tum­bling down more than 10% this morn­ing af­ter clos­ing yes­ter­day at $94.80 a share and at one point, dip­ping be­low $80 a share.

Amy Speak

On­to the news: No­vavax has on­ly de­liv­ered a tiny per­cent­age of the 2 bil­lion Covid-19 shots it planned to send around the world this year, ac­cord­ing to Reuters — about 10 mil­lion shots in to­tal. The biotech has al­so de­layed first-quar­ter ship­ments in Eu­rope and low­er-in­come coun­tries such as the Philip­pines, which has not re­ceived any of the 30 mil­lion shots it had or­dered.

No­vavax se­nior spokesper­son Amy Speak told Reuters that some ship­ments have been held up by reg­u­la­to­ry process­es and are wait­ing in a dis­tri­b­u­tion ware­house to go to health­care providers.

Ship­ments to the EU, In­done­sia and the Philip­pines were held back by a se­ries of fac­tors, ac­cord­ing to of­fi­cials who spoke with Reuters — in­clud­ing late reg­u­la­to­ry ap­proval from the WHO, ex­port lim­i­ta­tions on No­vavax’s pro­duc­tion part­ner in In­dia, the Serum In­sti­tute, and de­layed ap­proval from Eu­ro­pean reg­u­la­tors for in­di­vid­ual vac­cine batch­es, who must ex­am­ine the shots be­fore they can be dis­trib­uted.

The com­pa­ny has al­so yet to de­liv­er vac­cine dos­es on its largest con­tract for Co­v­ax — with 1.1 bil­lion dos­es ex­pect­ed, which would make No­vavax its third-largest sup­pli­er, Reuters said — cit­ing busi­ness da­ta and an­a­lyt­ics firm Glob­al­Da­ta Plc.

While No­vavax did not pro­vide a time­line for Co­v­ax, the biotech said it ex­pects to de­liv­er around 80 mil­lion dos­es to Co­v­ax by the end of the quar­ter, which is less than 10% of what is list­ed on their con­tract.

The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; and more

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With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Raymond Stevens, Structure Therapeutics CEO

Be­hind Fri­day's $161M IPO: A star sci­en­tist, GPCR drug dis­cov­ery and a plan to chal­lenge phar­ma in di­a­betes

What does it take to pull off a $161 million biotech IPO these days?

In Structure Therapeutics’ case, it means having a star scientist co-founder paired with the computational drug discovery company Schrödinger, $198 million in private funding from blue-chip investors, almost six years of research work on G protein-coupled receptors and a slate of oral, small-molecule drugs, with an eye on the huge and growing diabetes and weight-loss market.

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Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Te­va drops out of in­dus­try trade group PhRMA

Following in AbbVie’s footsteps, Teva confirmed on Friday that it’s dropping out of the industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA).

Teva didn’t give a reason for its decision to leave, saying only in a statement to Endpoints News that it annually reviews “effectiveness and value of engagements, consultants and memberships to ensure our investments are properly seated.”

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Sanofi CFO Jean-Baptiste de Chatillon (L) and CEO Paul Hudson (Romuald Meigneux/Sipa via AP Images)

Sanofi sees downtick in flu sales as it preps for launch of RSV an­ti­body

Sanofi expects its RSV antibody jointly developed with AstraZeneca will be available next season, executive VP of vaccines Thomas Triomphe announced on the company’s quarterly call.

Beyfortus, also known as nirsevimab, was approved in the EU back in November and is currently under FDA review with an expected decision coming in the third quarter of this year. The news comes as the FDA plans to hold advisory committee meetings over the next couple months to review RSV vaccines from Pfizer and GSK.

Christophe Weber, Takeda CEO (Photographer: Shoko Takayasu/Bloomberg via Getty Images)

Take­da fo­cus­es on ‘di­verse’ pipeline prospects on heels of two ac­qui­si­tions

After a whopping $4 billion asset buy from Nimbus Therapeutics, along with a $400 million deal with Hutchmed for a colorectal cancer drug, Takeda executives touted pipeline optimism on its latest earnings call this week.

That’s because the TYK2 inhibitor for psoriasis Takeda is getting from Nimbus, along with the Hutchmed fruquintinib commercialization outside of China, are just two of what it reports are 10 late-stage development programs of promising candidates.

Regeneron CSO George Yancopoulos (L) and CEO Len Schleifer at a groundbreaking for its new Tarrytown, NY facility, June 2022 (Lev Radin/Pacific Press/LightRocket via Getty Images)

In show­down with Roche, Re­gen­eron gears up for po­ten­tial Eylea ex­pan­sion amid Covid de­cline

Regeneron faced a substantial slump in overall revenue last year, but the focus still remains on some of its biggest blockbusters.

The pharma with several high-profile partnerships — Sanofi and Bayer among them — said Friday that Q4 revenue was down 31% for the quarter, and down 24% for the entire year. However, that won’t stop blockbuster expansion plans.

One of those is Eylea, the Bayer-partnered eye disease drug that has been in major competition with Roche’s Vabysmo. While Eylea is currently only approved in a 2 mg dose, the company recently filed for approval to give a 8 mg dose, in hopes of making a longer-lasting treatment.

BeiGene's new website helps direct cancer patients and caregivers to a wide variety of sources for help.

BeiGene re­veals men­tal health and can­cer care gap in study, de­buts dig­i­tal re­sources

One-fourth of cancer patients are living with depression — and another 20% suffer from anxiety. That’s according to new study results from BeiGene, conducted by Cancer Support Community (CSC), about the mental and emotional health of cancer patients.

While the fact that people with cancer are also dealing with depression or anxiety may not be surprising, what is — and was to BeiGene — is that a majority of them aren’t getting support. 60% of respondents said they were not referred to a mental health professional, and even more concerning, two in five who specifically asked for mental health help did not get it. CSC, a nonprofit mental health in cancer advocacy group, surveyed more than 600 US cancer patients.

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One of the paintings from Gilead's latest campaign making AI art to help MBC patients be 'seen and heard.'

Gilead com­bines ar­ti­fi­cial in­tel­li­gence and art to draw at­ten­tion and hope to MBC

What if you could “see” the emotions and feelings of people living with metastatic breast cancer? That’s what Gilead Sciences’ agency VMLY&R Health did last year, using artificial intelligence and sound analytics to turn the interviews of three women living with metastatic triple-negative breast cancer into works of art.

Using the sound waves, a robotic painting device translated their stories of struggle and hope into colors, contours and brush strokes. The result? An art exhibition called “Paintings of Hope” that was first displayed at ESMO in September in Paris, but has since traveled to hospitals and medical conferences in Europe and Spain.

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