Don­ald Trump promis­es to slash drug prices by bil­lions, pledg­ing ag­gres­sive fed­er­al bid­ding process

The phar­ma in­dus­try came in for a one-two punch from pres­i­dent-elect Don­ald Trump to­day, who used a press con­fer­ence to promise that the fed­er­al gov­ern­ment will use its full pow­er to over­come the lob­by­ing in­flu­ence of the in­dus­try and slash drug prices through new bid­ding pro­ce­dures.

Here’s the ex­cerpt:

“We have to get our drug in­dus­try com­ing back. Our drug in­dus­try has been dis­as­trous. They’re leav­ing left and right. They sup­ply our drugs but they don’t make them here, to a large ex­tent. And the oth­er thing we have to do is cre­ate new bid­ding pro­ce­dures for the drug in­dus­try. They’re get­ting away with mur­der. Phar­ma has a lot of…lob­by­ists and a lot of pow­er and there’s very lit­tle bid­ding on drugs.

“We’re the largest buy­er of drugs in the world, and yet we don’t bid prop­er­ly. We’re go­ing to start bid­ding. We’re go­ing to save bil­lions of dol­lars over a pe­ri­od of time.”

Dur­ing the elec­tion Trump sug­gest­ed that Medicare could be giv­en the right to ne­go­ti­ate drug prices, a very sen­si­tive is­sue for phar­ma, which lob­bied Con­gress to make it im­pos­si­ble for the fed­er­al agency to lever­age low­er prices through ne­go­ti­a­tions. Drug prices have been large­ly opaque in the US, and with more than half of the US pop­u­la­tion tak­ing a pre­scrip­tion drug, ris­ing prices have be­come a po­tent po­lit­i­cal is­sue.

Many in the drug in­dus­try would re­ply that there is a pro­ce­dure for Medicare to ex­tract dis­counts for whole­sale prices through ben­e­fit man­agers who can ne­go­ti­ate prices. But oth­ers would ar­gue that if Medicare could open­ly ne­go­ti­ate prices, they could es­tab­lish a pub­lic bench­mark for all pay­ers, which would be enor­mous­ly in­flu­en­tial in set­ting prices for every­one.

Dur­ing the elec­tion Hillary Clin­ton took the lead in at­tack­ing phar­ma and drug prices, leav­ing many in the in­dus­try hope­ful that Trump would be friend­lier to bio­phar­ma. Trump, though, stuck with a pop­ulist theme dur­ing the press con­fer­ence, paint­ing the in­dus­try as the vil­lain in this dra­ma. That’s type­cast­ing that the in­dus­try des­per­ate­ly want­ed to avoid.

Com­mu­ni­cat­ing the val­ue of pre­ci­sion med­i­cine

By Natasha Cowan, Content Marketing Manager at Blue Latitude Health.
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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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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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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

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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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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.

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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.