It’s a tie: Sanofi and No­vo come in neck-and-neck at the FDA with two new di­a­betes com­bo OKs

Sanofi and No­vo Nordisk tried might­i­ly to beat each oth­er to the fin­ish line first with a com­bi­na­tion of their long-last­ing in­sulin with their GLP1 drugs. But the FDA de­cid­ed to call it a draw.

Olivi­er Brandi­court, Sanofi CEO

Reg­u­la­tors in the US si­mul­ta­ne­ous­ly ap­proved No­vo’s Xul­to­phy — a com­bi­na­tion of Tre­si­ba and Vic­toza on the mar­ket in Eu­rope for the past two years — and Sanofi’s Soli­qua, which com­bines Lan­tus and Lyx­u­mia.

Xul­to­phy’s edge en­cour­aged an­a­lysts to project a blend­ed $1.2 bil­lion an­nu­al sales pro­jec­tion for 2021, as tracked by Thom­son Reuters, while Sanofi may not hit half that amount.

Both of these com­pa­nies rep­re­sent the top ranks of big play­ers which dom­i­nate the di­a­betes mar­ket. In­tense­ly com­pet­i­tive, reg­u­la­tors tend to work at a slow and steady pace when it comes to their re­views. As a re­sult, Sanofi squan­dered its $245 mil­lion pri­or­i­ty re­view vouch­er on Soli­qua, forced to take ex­tra time to an­swer the agency’s ques­tion on its de­liv­ery de­vice.

Both of these com­pa­nies have had to suf­fer through de­clin­ing ex­pec­ta­tions for their di­a­betes fran­chis­es. In Sanofi’s case, the set­back on di­a­betes helped push them to part­ner close­ly with Re­gen­eron in oth­er ar­eas. But (rel­a­tive­ly) new CEO Olivi­er Brandi­court was left stand­ing at the al­tar in his bid for Medi­va­tion and the part­ners’ first com­mer­cial prod­uct in PC­SK9 has called far, far be­hind ini­tial ex­pec­ta­tions as pay­ers con­tin­ue to refuse re­im­burse­ment.

You can ex­pect both com­pa­nies to hit the ground run­ning in 2017. The US mar­ket re­mains the most im­por­tant are­na in the glob­al drug mar­ket. And in di­a­betes, speed and com­pet­i­tive zeal is para­mount. In ad­di­tion, nei­ther phar­ma com­pa­ny can af­ford to be lax in pur­su­ing new sales.

Com­mu­ni­cat­ing the val­ue of pre­ci­sion med­i­cine

By Natasha Cowan, Content Marketing Manager at Blue Latitude Health.
Many stakeholders are confused by novel precision medicines, including patients and healthcare professionals. So, how can industry help them to navigate this complexity?

Precision medicine represents a new paradigm in healthcare. It embodies the shift from treating many patients with the same therapy, to having the tools to identify the best treatment for every patient.

Spe­cial re­port: Twen­ty ex­tra­or­di­nary women in bio­phar­ma R&D who worked their way to the top

What differentiates a woman leader in biopharma R&D from a man?

Not much, except there are fewer of them in senior posts. Data suggest women are not more risk-averse, family-oriented or less confident than their male counterparts — indeed the differences between the two sexes are negligible. But a glance at the top R&D positions in Big Pharma leaves little doubt that upward migration in the executive ranks of biopharma R&D is tough.

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GSK's asth­ma bi­o­log­ic Nu­cala scores in rare blood dis­or­der study

GlaxoSmithKline’s asthma drug Nucala, which received a resounding FDA rejection for use in chronic obstructive pulmonary disease (COPD) last year, has shown promise in a rare blood disorder.

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Mer­ck buys a fledg­ling neu­rode­gen­er­a­tive biotech spawned by an old GSK dis­cov­ery al­liance. What’s up with that?

Avalon Ventures chief Jay Lichter has a well-known yen for drug development programs picked up in academia. And what he found in Haoxing Xu’s lab at the University of Michigan pricked his interest enough to launch one of his umbrella biotechs in San Diego.
Xu’s work laid the foundation for Avalon to launch Calporta, which has been working on finding small molecule agonists of TRPML1 (transient receptor potential cation channel, mucolipin subfamily, member 1) for lysosomal storage disorders. And that pathway, they believe, points to new approaches on major market neurodegenerative diseases like Parkinson’s, ALS and Alzheimer’s.

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FDA slaps a hold on an AML tri­al as Mark­er scraps a fail­ing ovar­i­an can­cer pro­gram, sink­ing shares

The FDA has placed a hold on a Phase II AML trial from the small immuno-oncology biotech Marker Therapeutics. Marker disclosed the issue two weeks after responding to FDA concerns, adding it to the Q3 release Tuesday. The company also announced it was scrapping a Phase II ovarian cancer program it determined was unlikely to succeed.

The agency’s concern centers around two reagents used in manufacturing for their trial for acute myeloid leukemia patients who have received a stem cell transplant. The reagents are from third parties and not present in the final product, Marker said.

Eli Lil­ly-backed biotech grabs $100M to dis­patch an­ti­body-oligonu­cleotide con­ju­gates af­ter mus­cu­lar dy­s­tro­phy

Hold up your hand. Make a fist. Now open it. And again.

If you can do it fully and with ease, then the proteins in your hand are likely working properly. If you can’t then they may not be. In people with myotonic muscular dystrophy, something more atomic is going on.

In those folks, the problem is RNA. Certain base pairs repeat far beyond normal, up to 11,000 superfluous letters in some cases. The extended strands form “clumps.” Proteins misform and can’t function properly. They often allow one movement but not the reverse, a condition called myotonia that gives the dystrophy its name.

As­traZeneca sets stage for mar­ket­ing ap­pli­ca­tion with promis­ing piv­otal lu­pus drug da­ta

After fumbling in its first late-stage lupus study, AstraZeneca disclosed that a second pivotal trial testing its experimental drug, anifrolumab, had met the main goal, in August. Earlier this week, the British drugmaker broke out the numbers from its successful study.

Last year, anifrolumab failed to meet the main goal of diminishing disease activity in the 460-patient TULIP I study, a 52-week trial that tested two doses of the drug versus a placebo. But in the 373-patient TULIP II study, the higher dose (300 mg) was compared to patients given a placebo — patients in both arms were on baseline standard care.

FDA Vas­cepa re­view spot­lights new safe­ty sig­nals, pos­si­ble min­er­al oil spoil­er as Amarin hunts a block­buster ap­proval

An in-house FDA review of Amarin’s Vascepa raises a set of hurdles the biotech will have to clear if the biotech expects to get the long-awaited FDA approval that could set it on a path to superstar status. But it appears that Amarin has survived another potential setback without introducing a major new threat to its prospects.

The stakes don’t get much higher, with analysts saying a win this week for Amarin could lead to billions in new sales — provided the agency stamps it with an OK. And investors liked what they say in the FDA review this morning, bumping the stock $AMRN 17%.

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FDA puts Sol­id Bio’s lead gene ther­a­py pro­gram on hold — again — af­ter an­oth­er pa­tient is hurt by SGT-001

Solid Biosciences continues to be plagued by safety issues.

Close to 18 months after the gene therapy biotech was able to quickly shed an FDA hold on their lead Duchenne muscular dystrophy program for SGT-001, regulators have stepped back in to force another halt after another patient was hit hard by a set of serious adverse events remarkably similar to the first set.

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