My­lan CEO Bresch hopes to tame the mob with a 50% dis­count for the EpiPen

Buck­ling un­der a storm of protest over its move to sys­tem­at­i­cal­ly raise the price of its life-sav­ing EpiPen by 500%, My­lan an­nounced this morn­ing that it will pro­duce a gener­ic of the au­to-in­jec­tor and sell it for $300, or half price to the brand­ed prod­uct.

CEO Heather Bresch, who has been the cen­ter of an in­tense pub­lic spot­light since the con­tro­ver­sy broke out, once again blamed the whole thing on the in­dus­try sup­ply chain. But that nev­er gar­nered much sym­pa­thy from an out­raged pub­lic, which saw the move as yet an­oth­er ex­am­ple of price goug­ing from an in­dus­try un­fet­tered by fed­er­al pric­ing re­stric­tions. One of the com­pa­ny’s few de­fend­ers was Mar­tin Shkre­li, the dis­graced biotech ex­ec oust­ed from two com­pa­nies and now await­ing tri­al on fraud charges. Hillary Clin­ton and a va­ri­ety of lead­ing politi­cians in Wash­ing­ton, DC, though, coun­tered by call­ing Bresch on the car­pet for prof­i­teer­ing, a hot top in drug in­dus­try cir­cles, which has been treat­ed to a steady se­ries of pric­ing scan­dals from Shkre­li, My­lan and Valeant.

At one point last week the con­tro­ver­sy dent­ed biotech stocks in gen­er­al as in­vestors once again were faced with the po­ten­tial for new fed­er­al pric­ing rules that could hold back reg­u­lar price hikes on ag­ing prod­ucts, an in­dus­try stan­dard in bio­phar­ma that is fol­lowed by a large num­ber of com­pa­nies.

My­lan had at­tempt­ed to quell the the furor with a more ag­gres­sive ef­fort to cov­er out-of-pock­et costs for pa­tients, but that wasn’t go­ing to help every­one who re­lies on the EpiPen to pre­vent a po­ten­tial­ly lethal al­ler­gic re­sponse. This dis­count­ed prod­uct will al­so help counter any oth­er gener­ic threat to the mar­ket.

Here’s what Bresch of­fered ear­ly Mon­day:

“Our de­ci­sion to launch a gener­ic al­ter­na­tive to EpiPen is an ex­tra­or­di­nary com­mer­cial re­sponse, which re­quired the co­op­er­a­tion of our part­ner. How­ev­er, be­cause of the com­plex­i­ty and opaque­ness of to­day’s brand­ed phar­ma­ceu­ti­cal sup­ply chain and the in­creased shift­ing of costs to pa­tients as a re­sult of high de­ductible health plans, we de­ter­mined that by­pass­ing the brand sys­tem in this case and of­fer­ing an ad­di­tion­al al­ter­na­tive was the best op­tion. Gener­ic drugs have a long, proven track record of de­liv­er­ing sig­nif­i­cant sav­ings to both pa­tients and the over­all health­care sys­tem. The launch of a gener­ic EpiPen, which fol­lows the steps we took last week on the brand to im­me­di­ate­ly re­duce pa­tients’ out-of-pock­et costs, will of­fer a long-term so­lu­tion to fur­ther re­duce costs and ease the bur­den and com­plex­i­ty of the process on the pa­tient.”

The dis­count­ed gener­ic will like­ly be seen as lit­tle more than a face-sav­ing move by Bresch, who al­ways had the pow­er to drop the price of the brand­ed EpiPen back to a more ac­cept­able price.

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.

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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In­vestors could emerge from Neil Wood­ford de­ba­cle with £1B loss, in­ter­nal analy­sis re­veals

When Link Fund Solutions announced that it is closing Woodford Equity Income Fund permanently and kicking out Neil Woodford, it was implied that investors probably won’t get back everything they entrusted to the fund manager. But nobody knew just how much they would lose.

An internal analysis commissioned by Link suggested that the collective loss could amount to £1 billion — out of a fund last valued at £3.1 billion — Citywire has revealed.

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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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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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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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.