Zai Lab nabs speedy Chi­na reg­u­la­to­ry re­view for PARP drug Ze­ju­la

Chi­nese reg­u­la­to­ry of­fi­cials are sig­nal­ing that they’re ready to whisk Ze­ju­la through the reg­u­la­to­ry process.

Zai Lab $ZLAB said this morn­ing that the Cen­ter for Drug Eval­u­a­tion of Chi­na’s Na­tion­al Med­ical Prod­ucts Ad­min­is­tra­tion has of­fered a pri­or­i­ty re­view for this drug, the PARP ther­a­py ni­ra­parib in-li­censed from Tesaro. They’re look­ing for an OK in Chi­na to mar­ket the drug for ovar­i­an can­cer.

Zai Lab nabbed a fast OK for Ze­ju­la in Hong Kong at the end of 2018, al­low­ing them to be­gin rolling it out in the huge Asian na­tion.

Chi­nese of­fi­cials have been ramp­ing up speedy drug ap­provals, look­ing to ad­van­tage com­pa­nies like Zai Lab, home­grown out­fits that have been snap­ping up late-stage and com­mer­cial prod­ucts look­ing to build quick com­mer­cial port­fo­lios. Pri­or­i­ty re­views and the promise of swift ac­tion af­ter low­er­ing the bar on da­ta re­quire­ments have shak­en up the Asian mar­ket.

Once the $5 bil­lion Tesaro buy­out goes through at GSK, Zai Lab will be part­nered with the phar­ma gi­ant, which has large op­er­a­tions in­side Chi­na and has had for years.


Im­age cred­it: Lon­car Funds

The Advance Clinical leadership team: CEO Yvonne Lungershausen, Sandrien Louwaars - Director Business Development Operations, Gabriel Kremmidiotis - Chief Scientific Officer, Ben Edwards - Chief Strategy Officer

How Aus­tralia De­liv­ers Rapid Start-up and 43.5% Re­bate for Ear­ly Phase On­col­o­gy Tri­als

About Avance Clinical

Avance Clinical is an Australian owned Contract Research Organisation that has been providing high-quality clinical research services to the local and international drug development industry for 20 years. They specialise in working with biotech companies to execute Phase 1 and Phase 2 clinical trials to deliver high-quality outcomes fit for global regulatory standards.

As oncology sponsors look internationally to speed-up trials after unprecedented COVID-19 suspensions and delays, Australia, which has led the world in minimizing the pandemic’s impact, stands out as an attractive destination for early phase trials. This in combination with the streamlined regulatory system and the financial benefits including a very favourable exchange rate and the R & D cash rebate makes Australia the perfect location for accelerating biotech clinical programs.

Covid-19 roundup: Janet Wood­cock steps aside — for now — as FDA drug czar; WHO hits the brakes on hy­droxy study af­ter lat­est safe­ty alarm

The biopharma industry will soon get a look at what the FDA will look like once CDER’s powerful chief Janet Woodcock retires from her post.

Long considered one of the most influential regulators in the agency, if not its single most powerful official when it counts, Woodcock is being detached to devote herself full time to the White House’s special project to fast-forward new drugs and vaccines for the pandemic. The move comes a week after some quick reshuffling as Woodcock and CBER chief Peter Marks joined Operation Warp Speed. Initially they opted to recuse themselves from any FDA decisions on pandemic treatments and vaccines, after consumer advocates criticized the move as a clear conflict of interest in how the agency exercises oversight on new approvals.

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Af­ter de­cou­pling from Re­gen­eron, Sanofi says it’s time to sell the $13B stake picked up in the mar­riage

With Regeneron shares going for a peak price — after doubling from last fall — Sanofi is putting a $13 billion stake in their longtime partner on the auction block. And Regeneron is taking $5 billion of that action for themselves.

Sanofi — which has been decoupling from Regeneron for more than a year now — bought in big in early 2013, back when Regeneron’s stock was going for around $165 a share. Small investors flocked to the deal, buzzing about an imminent takeover. The buyout chatter wound down long ago.

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Janet Woodcock, director of the Center for Drug Evaluation and Research (AP Images)

Covid-19 roundup: Hit with new con­flict ac­cu­sa­tions, Janet Wood­cock steps out of the agen­cy's Covid-19 chain of com­mand

Two weeks ago, FDA drug chieftain Janet Woodcock was assuring a top Wall Street analyst that any vaccine approved for combating Covid-19 would have to meet high agency standards on safety and efficacy before it’s approved. But over the weekend, after she and Peter Marks took top positions with the public-private operation meant to speed a new vaccine to lightning-fast approvals — they both recused themselves from the review process after an advocacy group argued their roles close to the White House could pose a conflict of interest.

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FDA ap­proves the first gener­ic for Amar­in's Vas­cepa — but is a fish oil price war im­mi­nent?

Late last year, enthusiasm for Amarin’s fish-oil pill Vascepa burgeoned when the FDA signed off on expanding the cholesterol fighter’s label to include the drug’s beneficial impact on cardiovascular risk, but months later the exuberance for the blockbuster-to-be took a big hit when a judge invalidated key patents protecting Vascepa.

Despite Amarin’s $AMRN pledge to appeal — a process that could take months — the ruling opened the door for generic competition. Hikma Pharmaceuticals, one of three challengers in the Nevada suit, on Friday said that its generic copy of pure EPA, the omega-3 fatty acid that constitutes Vascepa, has been approved by the FDA.

Eric Edwards, Phlow president and CEO (PR Newswire)

BAR­DA of­fers a tiny start­up up to $812M to cre­ate a US-based drug man­u­fac­tur­er — and the CEO comes with a price goug­ing con­tro­ver­sy on his ré­sumé

BARDA has tapped a largely unknown startup to ramp up production of a list of drugs that may be at risk of running short in the US. And the deal, which comes with up to $812 million in federal funds, was inked by a CEO who found himself in the middle of an ugly price gouging controversy a few years ago.

The feds’ new partner — called Phlow — won a 4-year “base” contract of $354 million, with another $458 million that’s on the table in potential options to sustain the outfit. That would make it one of the largest awards in BARDA’s history.

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Re­searchers de­fine ex­act­ly what they saw in the first pos­i­tive remde­sivir study for Covid-19. But what's that worth to Gilead?

Remdesivir can work in fighting Covid-19, particularly for patients with less severe cases, but this is just a first step in the journey to finding combos that can do the job much better,

That’s the bottom line from Gilead’s randomized study published in the New England Journal of Medicine. Analysts were quick to draw conclusions about how the big biotech could turn this into a profitable advantage — with widespread expectation of considerable pricing restraint on Gilead’s part. Anyone looking for a new mountain of cash to count as the world grapples with the pandemic is likely to come away disappointed.

As­traZeneca, Mer­ck push block­buster fran­chise to an­oth­er key FDA ap­proval, rel­e­gat­ing a ri­val to sec­ond-fid­dle sta­tus

Prostate cancer patients have another PARP inhibitor option in a matter of days.

Clovis’ Rubraca won its prostate cancer approval on Friday, but data from AstraZeneca and Merck rival Lynparza put a damper on commercial expectations. Now, the FDA has approved Lynparza in the prostate cancer setting, months ahead of its expected decision date.

Lynparza has been approved for patients with metastatic castration-resistant prostate cancer (mCRPC), who carry BRCA or ATM mutations, which account for roughly 20-30% of patients with mCRPC. The approval was based on the late-stage PROfound trial, which found the drug eclipsed the impact of the androgen therapies at reducing the risk of disease progression or death by a sharp 66%.

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An­oth­er NASH de­lay for In­ter­cept frus­trates in­vestors, shares wilt

A previous FDA advisory committee delay for Intercept’s NASH drug may have dampened spirits, but investors perked up after French rival Genfit recently failed to best a placebo with its offering in a keenly anticipated pivotal study. In yet another twist on Friday, the New York drugmaker said the FDA is postponing its adcom again to accommodate the review of additional data it has asked the company to furnish.

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