Peter Chang

[Peter Chang @PChangMD1]

Type 2 Diabetes Drugs Can Skip Cardiovascular Outcome Trials, But Phase III Must Be Longer, Broader https://t.co/pw9Zh9zCIF

[Citeline Awards @Citeline_Awards]

4 Days remain! Listen to our #podcast to find out WHY you should enter the 2019 #CAREAwards! But hurry - entries close on Friday! https://t.co/SLtfTQWjFO

[Sue Sutter @PinkSheetSutter]

Not Another Opana: US FDA Panel Rejects PTI’s Remoxy On Intravenous Abuse Concerns https://t.co/QyURZW34ND

[Peter Chang @PChangMD1]

@StuckInStock @JohnTuckerPhD Thanks. Wondering since bardoxolone may work by reducing mesangial cell contractility, maybe that does allow more albumin through? though without damage. But also raises question how much of the underlying disease process it actually impacts, rather than a reversible impact

[Peter Chang @PChangMD1]

$RETA company says increased ACR with bardoxolone is due to albuminuria increasing as eGFR improves, but since ACR is already a ratio of albumin to creatinine, and creatinine would also change with eGFR, shouldn’t ACR remain stable if no increased albumin leakage?

[Peter Chang @PChangMD1]

$RETA since bardoxolone may work by reducing mesangial cell contractility, maybe that does allow more albumin through?..though without causing damage. But that also raises question how much of the underlying disease process it actually impacts, rather than a reversible impact https://t.co/LBOFu7jYpC

[Peter Chang @PChangMD1]

$RETA company says increased ACR with bardoxolone is due to albuminuria increasing as eGFR improves, but since ACR is already a ratio of albumin to creatinine, and creatinine would also change with eGFR, shouldn’t ACR remain stable if no increased albumin leakage?

[Jack Allen @JohnK_Allen]

ANNEXA-4 $PTLA panelists split on need for control arm to accurately analyze the data, interestingly though the presenter (assumed to be most familiar with the data) seemed to be in the "we need a control arm" camp, let's see what update officials have from FDA communications

[Jack Allen @JohnK_Allen]

ODYSSEY $SNY $REGN CVOT conclusions, suggest recent ACS patients LDL-C targets should be as low as 25mg/dL, also suggest that most applicable subgroup might be patients w/ baseline ≥100mg/dL

Mortality benefit shown in this trial may help expand PCSK9 uptake

$AMGN $MDCO #ACC18

[Jack Allen @JohnK_Allen]

Praluent $SNY $REGN ODYSSEY CVOT hits MACE primary endpoint and MORTALITY BENEFIT (RR=15%) -2.8 yrs, LDL-C change=-55%

Comparison, Repatha $AMGN FOURIER -2.2 yrs, LDL-C change=-59%

Risk Reductions -MACE=15% (CV Death=+5%; MI(All)=27%; Stroke=21%; UA=1%) -Mortality=+4%

#ACC18

[Jack Allen @JohnK_Allen]

My takeaways from #ACC18 day 1:

Praluent ODYSSEY $SNY $REGN CVOT was in line with expectations and physicians excited about PCSK9 mortality benefit

Repatha $AMGN and Praluent viewed as interchangeable

Praluent price drop should expand uptake-> + for $MDCO,- for $ESPR

[Peter Chang @PChangMD1]

Disease-Specific Guidances Reflect US FDA's 'Nimble, Collaborative, Patient-Focused' Approach https://t.co/YQQ9edpbYG

[Peter Chang @PChangMD1]

#ACC18 late-breaker schedule is out https://t.co/O9NbsDZqKR

[Peter Chang @PChangMD1]

Pharma Intelligence analysts Amanda Micklus and Tijana Ignjatovic provide key insight into gene therapies and pricing in @Forbes latest medicine-related article. Read today: https://t.co/tu9kaQ8Hfk

[Citeline Awards @Citeline_Awards]

The #CAREAwards18 entry deadline is edging ever closer. Enter today! https://t.co/9kLZrJVtQp

[Jake Mathon @CitelineJakeM]

Join presenter Jack Allen as he uses the exclusive data from @Biomedtracker and @Datamonitor_HC to look at the upcoming projected market for #dyslipidemia: https://t.co/pg15V1IP7C

[Peter Chang @PChangMD1]

#JPM18 #Spark $ONCE Announced new Pompe disease gene therapy program to improve upon ERT, with gene from Genethon that has advantages over wild type.

[Peter Chang @PChangMD1]

#JPM18 $SRPT at breakout, question about uncertainty still whether Exondys 51 even works (controversial FDA approval)...CEO Ingram noted anecdotal evidence and said physicians feel like they are getting results, including a critic of the company

[Mandy Jackson @ScripMandy]

$CELG On tax reform: get to maintain tax rate we’ve had historically & get to access about 60% of cash we couldn’t access previously #JPM18

[Peter Chang @PChangMD1]

#JPM18 $SRPT Exondys 51 Q4 rev ($57.3M, for full year of $154.6M) on high side of some consensus numbers, with full 2018 guidance ($295-305M) in line. Stock had been down earlier in day but now coming back.