Buy­out buzz: No­var­tis has been kick­ing the tires at AAA as FDA re­views Lu­tathera — re­port

Af­ter work­ing through some sna­fus on its ap­pli­ca­tions for its ex­per­i­men­tal can­cer drug Lu­tathera, Bloomberg is re­port­ing that No­var­tis has been kick­ing the tires at France’s Ad­vanced Ac­cel­er­a­tor ap­pli­ca­tions with an in­ter­est in mak­ing a bid for the com­pa­ny.

No one is say­ing that No­var­tis has bid for the com­pa­ny, and Bloomberg’s piece notes that oth­ers may step in — the kind of sto­ry that nev­er hurts your stock price $AAAP.

Vas­ant Narasimhan, No­var­tis

The com­pa­ny’s stock surged 10% on the buy­out buzz, boost­ing a mar­ket cap that closed Wednes­day at $2.7 bil­lion.

That kind of val­u­a­tion is well with­in the range of No­var­tis, which has se­lect­ed $2 bil­lion to $5 bil­lion bolt-ons as its sweet spot un­der CEO Joe Jimenez. This new deal — if this is ac­cu­rate — would pre­sum­ably have to pass muster with de­vel­op­ment chief Vas Narasimhan, now tran­si­tion­ing to the helm in ear­ly 2018.

Last fall AAA not­ed that the FDA had trou­ble an­a­lyz­ing da­ta from its study of Lu­tathera for gas­troen­teropan­cre­at­ic neu­roen­docrine tu­mors and a CRL fol­lowed in De­cem­ber. The ther­a­py tar­gets tu­mors with ra­di­o­la­beled so­mato­statin ana­logue pep­tides. The FDA ac­cept­ed the re­sub­mit­ted ap­pli­ca­tion at the end of Au­gust, set­ting a PDU­FA date of Jan­u­ary 26, 2018.

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.

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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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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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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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.

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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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.

Roche beefs up di­ag­nos­tic arm with an­oth­er bet on faster, cheap­er DNA se­quenc­ing

While Roche pours half a billion dollars into its Covid-19 antibody test, the Swiss company is quietly beefing up the rest of their diagnostics arm.

Roche today acquired Stratos Genomics, a Seattle-based developer of a new DNA technology designed to make genetic strands more easy to read. Roche said it will use the Stratos technology, alongside its existing efforts, to develop a nanopore sequencing device that can quickly and cheaply read patients’ DNA in clinics to diagnosis disease and assess the risk of developing one.

Covid-19 roundup: CanSi­no beats Mod­er­na to pub­li­ca­tion of first-in-hu­man da­ta for a coro­n­avirus vac­cine

China’s CanSino Biologics has released results from the Phase I trial of its Covid-19 vaccine — data that have propelled its entry into Phase II more than a month ago.

In a paper published in the Lancet, the biotech reported that their adenovirus-based vaccine was “tolerable and immunogenic at 28 days post-vaccination” among the 195 volunteers enrolled in the trial. In addition to antibody responses, T cell responses were also observed.

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