MiMedx is in trou­ble, again; Pfiz­er's Avastin biosim­i­lar wins FDA ap­proval

→ The con­tro­ver­sial MiMedx has dug it­self a deep­er hole. Se­nior of­fi­cials at the wound care com­pa­ny, which has long been crit­i­cized for its busi­ness prac­tices, are aware of at least fifty in­stances of pa­tient com­pli­ca­tions as­so­ci­at­ed with the use of MiMedx’s skin grafts or in­jec­tions, Bloomberg re­port­ed on Thurs­day, cit­ing sources and doc­u­ments. The Ma­ri­et­ta, Geor­gia-based com­pa­ny, counts vet­er­ans and mil­i­tary hos­pi­tals as its cus­tomers and is still reel­ing from a 15-month long sweep­ing in­ter­nal in­ves­ti­ga­tion that paint­ed a sor­did pic­ture of MiMedx’s scan­dalous past, in­di­cat­ing the com­pa­ny’s for­mer C-suite spied on em­ploy­ees, lied to reg­u­la­tors and mis­led in­vestors.

Pfiz­er‘s $PFE biosim­i­lar for Roche‘s block­buster on­col­o­gy drug Avastin has been ap­proved by the FDA. The copy­cat, called Zirabev, can be used for the treat­ment of five types of can­cer: metasta­t­ic col­orec­tal can­cer; un­re­sectable, lo­cal­ly ad­vanced, re­cur­rent or metasta­t­ic non-squa­mous non-small cell lung can­cer; re­cur­rent glioblas­toma; metasta­t­ic re­nal cell car­ci­no­ma; and per­sis­tent, re­cur­rent or metasta­t­ic cer­vi­cal can­cer. Am­gen‘s $AMGN Avastin copy, Mvasi, was ap­proved by the US agency in 2017.

→ Af­ter re­port­ing pos­i­tive da­ta from its Eu­ro­pean piv­otal study in March, Aim­mune Ther­a­peu­tics $AIMT sub­mit­ted an ap­pli­ca­tion to mar­ket its peanut al­ler­gy ther­a­py in Eu­rope on Fri­day. The drug de­vel­op­er has es­sen­tial­ly leapfrogged its arch-ri­val DBV Tech­nolo­gies $DB­VT in the Unit­ed States.

Paul Hudson, Getty Images

UP­DAT­ED: Sanofi CEO Hud­son lays out new R&D fo­cus — chop­ping di­a­betes, car­dio and slash­ing $2B-plus costs in sur­gi­cal dis­sec­tion

Earlier on Monday, new Sanofi CEO Paul Hudson baited the hook on his upcoming strategy presentation Tuesday with a tell-tale deal to buy Synthorx for $2.5 billion. That fits squarely with hints that he’s pointing the company to a bigger future in oncology, which also squares with a major industry tilt.

In a big reveal later in the day, though, Hudson offered a slate of stunners on his plans to surgically dissect and reassemble the portfoloio, saying that the company is dropping cardio and diabetes research — which covers two of its biggest franchise arenas. Sanofi missed the boat on developing new diabetes drugs, and now it’s pulling out entirely. As part of the pullback, it’s dropping efpeglenatide, their once-weekly GLP-1 injection for diabetes.

“To be out of cardiovascular and diabetes is not easy for a company like ours with an incredibly proud history,” Hudson said on a call with reporters, according to the Wall Street Journal. “As tough a choice as that is, we’re making that choice.”

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De­vel­op­ment of the Next Gen­er­a­tion NKG2D CAR T-cell Man­u­fac­tur­ing Process

Celyad’s view on developing and delivering a CAR T-cell therapy with multi-tumor specificity combined with cell manufacturing success
Overview
Transitioning potential therapeutic assets from academia into the commercial environment is an exercise that is largely underappreciated by stakeholders, except for drug developers themselves. The promise of preclinical or early clinical results drives enthusiasm, but the pragmatic delivery of a therapy outside of small, local testing is most often a major challenge for drug developers especially, including among other things, the manufacturing challenges that surround the production of just-in-time and personalized autologous cell therapy products.

New trade deal knocks out long-sought patent pro­tec­tions for drug­mak­ers

House Democrats negotiating with the Trump Administration on a new North American trade deal settled early on four issues: enforcement, labor and environmental standards and drug pricing.

On drug pricing, Politico reports, Trump crumbled within weeks of heightened negotiations.

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With loom­ing su­per­bug cri­sis, Iterum miss­es in a key an­tibi­ot­ic tri­al — and its shares tum­ble

A raft of antibiotic makers have crashed and burned recently despite getting their drugs across the finish line. Iterum Therapeutics hopes that its lead drug sulopenem, which has an outpatient focus in addition to hospitals and a plan to target areas with the highest levels of drug-resistant infections, will avert some of those reimbursement challenges. On Tuesday, however, the company stumbled in a late-stage study, diminishing its shot at FDA approval it first requires.

Lit­tle Leo Phar­ma steps to­ward the prize-fight ring with pos­i­tive PhI­II atopic der­mati­tis da­ta. Now they just have to beat Dupix­ent

A day after new Sanofi CEO Paul Hudson staked his reputation and the future of the pharma giant on making Dupixent a megasuccess story, little Leo Pharma is throwing down the gauntlet on atopic dermatitis.

Three years ago Leo paid AstraZeneca $115 million to buy up rights to use tralokinumab against atopic dermatitis — with $1 billion more on the table in milestones — the Danish company says their drug has swept up positive results for all primary and secondary endpoints in three Phase III trials. Now they plan to start the final push for regulatory approvals so they can challenge the heavyweight champions in this slugfest.

Otello Stampacchia. Omega Funds

Af­ter sev­er­al high pro­file start­up launch­es, om­niv­o­rous Omega Funds clos­es $438M fund to pur­sue more deals

Omega Funds likes to work backwards. It invests with the end game — denoted by the Greek letter in its name — in mind, and it keeps tabs on the number of marketed medical products that culminate from its ventures: 37 in 16 years.

So when founder and managing director Otello Stampacchia declares it’s the most exciting time to be investing in life sciences in a generation, it’s perhaps only natural that Omega has closed its largest fund to date. With $438 million in total commitments for Fund VI, the firm will continue injecting capital into a broad swath of companies across the US and Europe.

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Janet Woodcock (Credit: CQ Roll Call/AP)

For­eign drug in­spec­tions de­cline as FDA hir­ing strug­gles con­tin­ue

The US reliance on imported pharmaceuticals and ingredients is rising as foreign drug facility inspections decreased by about 10% from 2016 to 2018. Part of the reason for the decline: The US Food and Drug Administration (FDA) said it’s still struggling to hire new inspectors.

Testifying before a House subcommittee on Tuesday, Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, defended the agency’s approach and discussed some of the vulnerabilities of its foreign inspection program. She said FDA is looking to hire 50 new inspectors, but there are difficulties.

Paul Hudson, Sanofi

Paul Hud­son promis­es a bright new fu­ture at Sanofi, kick­ing loose me-too drugs and fo­cus­ing on land­mark ad­vances. But can he de­liv­er?

Paul Hudson was on a mission Tuesday morning as he stood up to address Sanofi’s new R&D and business strategy.

Still fresh into the job, the new CEO set out to convince his audience — including the legions of nervous staffers inevitably devoting much of their day to listening in — that the pharma giant is shedding the layers of bureaucracy that had held them back from making progress in the past, dropping the duds in the pipeline and reprioritizing a more narrow set of experimental drugs that were promised as first-in-class or best-in-class.  The company, he added, is now positioned to “go after other opportunities” that could offer a transformational approach to treating its core diseases.

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Left top to right: Mark Timney, Alex Denner, Vas Narasimhan. (The Medicines Company, Getty, AP/Endpoints News)

In a play-by-play of the $9.7B Med­Co buy­out, No­var­tis ad­mits it over­paid while of­fer­ing a huge wind­fall to ex­ecs

A month into his tenure at The Medicines Company, new CEO Mark Timney reached out to then-Novartis pharma chief Paul Hudson: Any interest in a partnership?

No, Hudson told him. Not now, at least.

Ten months later, Hudson had left to run Sanofi and Novartis CEO Vas Narasimhan was paying $9.7 billion for the one-drug biotech – the largest in the string of acquisitions Narasimhan has signed since his 2017 appointment.

The deal was the product of an activist investor and his controversial partner working through nearly a year of cat-and-mouse negotiations to secure a deal with Big Pharma’s most expansionist executive. It represented a huge bet in a cardiovascular field that already saw two major busts in recent years and brought massive returns for two of the industry’s most eye-raising names.

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