CEO in­ter­rupt­ed: No­var­tis chief Narasimhan looks to new ethics czar to clean up af­ter the lin­ger­ing Co­hen mess

Strug­gling to shed a bad rep for a string of ethics scan­dals capped by the ex­plo­sive ac­cu­sa­tions of sev­er­al US Sen­a­tors that com­pa­ny ex­ecs re­cent­ly mis­rep­re­sent­ed the cozy re­la­tion­ship be­tween for­mer CEO Joe Jimenez and Pres­i­dent Don­ald Trump’s per­son­al at­tor­ney Michael Co­hen, No­var­tis is once again look­ing to clean up its act.

CEO Vas Narasimhan has re­cruit­ed a promi­nent Ger­man at­tor­ney to lead their ethics, risk and com­pli­ance ef­forts.

Klaus Moos­may­er will now be charged with keep­ing the com­pa­ny clear of any new ethics scan­dals, which have come fast and fre­quent­ly at the phar­ma gi­ant. The lawyer has spent the past few years as chief com­pli­ance of­fi­cer at Siemens and chairs the An­ti-Cor­rup­tion Task­force of the Busi­ness and In­dus­try Ad­vi­so­ry Com­mit­tee at the Or­ga­ni­za­tion for Eco­nom­ic Co-op­er­a­tion and De­vel­op­ment.

Moos­may­er is tak­ing the place of Shan­non Thyme Klinger, new­ly pro­mot­ed to group gen­er­al coun­sel in the wake of Fe­lix Ehrat’s abrupt res­ig­na­tion dur­ing the cri­sis that hit No­var­tis as it strug­gled with rev­e­la­tions about their $1.2 mil­lion in pay­ments to Co­hen.

No­var­tis’ ex­pla­na­tion — echoed by new­ly re­tired CEO Jimenez — was that this was a sim­ple way to gain in­sights in­to Trump’s new ad­min­is­tra­tion and its health­care poli­cies. But some com­pa­ny in­sid­ers viewed it more like a sim­ple way to pay for ac­cess.

A few weeks ago, a group of De­moc­rats in the Sen­ate re­leased their own quick re­port, con­clud­ing that the com­pa­ny’s con­tention that top ex­ecs had on­ly a brief, in­con­se­quen­tial ex­change with Co­hen and were forced to pay out the con­tract mis­rep­re­sent­ed the nu­mer­ous con­tacts Jimenez had with Co­hen.

“What he was sell­ing was a line of ac­cess to the Trump ad­min­is­tra­tion,” said Sen. Ron Wyden in an in­ter­view with ABC News in Ju­ly. “That would be how I would char­ac­ter­ize it.” Wyden and his col­leagues out­lined nu­mer­ous con­tacts Jimenez had with Co­hen.

Af­ter ini­tial­ly be­moan­ing the need to do bet­ter in fol­low-up meet­ings with staff, Narasimhan and his top staff now in­sist that the whole is­sue is be­hind them. 

The 600-pound go­ril­la, though, re­mains in the room, even if it’s not re­ferred to in the com­pa­ny’s state­ment on its new hire.

Not help­ing much is that No­var­tis shook up its ethics and com­pli­ance op­er­a­tions last fall in the wake of kick­back and bribery ac­cu­sa­tions. A Ko­re­an in­ves­ti­ga­tion de­ter­mined com­pa­ny ex­ecs had been con­duct­ing a kick­back scheme in that coun­try while No­var­tis al­so faced cor­rup­tion charges in Greece.

The chain of scan­dals has se­vere­ly in­ter­rupt­ed Narasimhan’s cam­paign to make over No­var­tis’ rep and present the com­pa­ny as a gi­ant ea­ger to do right by pa­tients and health­care sys­tems, pur­su­ing the lat­est in dig­i­tal strate­gies to im­prove care.

“As we as­pire to reimag­ine med­i­cine, we must hold our­selves to (the) high­est eth­i­cal stan­dards and al­ways aim to win and main­tain the trust of so­ci­ety and our many stake­hold­ers,” the CEO said in a state­ment. “Klaus has ex­ten­sive ex­pe­ri­ence in lead­ing Com­pli­ance for large glob­al or­gan­i­sa­tions and is in­ter­na­tion­al­ly rec­og­nized in his field.”


Im­age: Klaus Moos­may­er. SIEMENS

Charles Baum, Mirati CEO

Mi­rati plots a march to the FDA for its KRAS G12C drug, breath­ing down Am­gen’s neck with bet­ter da­ta

Mirati Therapeutics $MRTX took another closely-watched step toward a now clearly defined goal to file for an approval for its KRAS G12C cancer drug adagrasib (MRTX849), scoring a higher response rate than the last readout from the class-leading rival at Amgen but still leaving open a raft of important questions about its future.

Following a snapshot of the first handful of responses, where the drug scored a tumor response in 3 of 5 patients with non-small cell lung cancer, the response rate has now slid to 45% among a pooled group of 51 early-stage and Phase II patients, 43% — 6 of 14 — when looking solely at the Phase I/Ib. Those 14 patients had a median treatment duration of 8.2 months, with half still on therapy and 5 of 6 responders still in response.

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In his­toric Covid-19 ad­comm, vac­cine ex­perts de­bate a sea of ques­tions — but of­fer no clear an­swers

The most widely anticipated and perhaps most widely watched meeting in the FDA’s 113-year history ended late Thursday night with a score of questions and very few answers.

For nearly 9 hours, 18 different outside experts listened to public health agencies and foundations present how the United States’ Covid-19 vaccine program developed through October, and they debated where it should go from there: Were companies testing the right metrics in their massive trials? How long should they track patients before declaring a vaccine safe or effective? Should a vaccine, once authorized, be given to the volunteers in the placebo arm of a trial?

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Michel Vounatsos, Biogen CEO (via YouTube)

Bio­gen spot­lights a pair of painful pipeline set­backs as ad­u­canum­ab show­down looms at the FDA

Biogen has flagged a pair of setbacks in the pipeline, spotlighting the final failure for a one-time top MS prospect while scrapping a gene therapy for SMA after the IND was put on hold due to toxicity.

Both failures will raise the stakes even higher on aducanumab, the Alzheimer’s drug that Biogen is betting the ranch on, determined to pursue an FDA OK despite significant skepticism they can make it with mixed results and a reliance on post hoc data mining. And the failures are being reported as Biogen was forced to cut its profit forecast for 2020 as a generic rival started to erode their big franchise drug.

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Dan O'Day, Gilead CEO (Andrew Harnik, AP Images)

UP­DAT­ED: FDA anoints Gilead­'s remde­sivir as the Covid-19 treat­ment win­ner, hand­ing down full ap­proval — de­spite some deep skep­ti­cism

Seven months into the Covid-19 pandemic, the race to develop a treatment for the disease that’s proved to be the biggest health crisis in a century has an officially designated winner: Gilead. And they’re picking up the prize — worth billions in peak sales — despite a major study that concluded the drug was no help in reducing the number of people who die from the virus.

The FDA handed down a thumbs-up for remdesivir, the company announced Thursday afternoon, as the drug becomes the first fully approved treatment for Covid-19 in the US. Remdesivir, to be marketed as Veklury, will come with a label for treatment in adults and children older than 12 in Covid-19 cases that require hospitalization.

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Stephen Hahn, FDA commissioner (AP Images)

As FDA sets the stage for the first Covid-19 vac­cine EUAs, some big play­ers are ask­ing for a tweak of the guide­lines

Setting the stage for an extraordinary one-day meeting of the Vaccines and Related Biological Products Advisory Committee this Thursday, the FDA has cleared 2 experts of financial conflicts to help beef up the committee. And regulators went on to specify the safety, efficacy and CMC input they’re looking for on EUAs, before they move on to the full BLA approval process.

All of this has already been spelled out to the developers. But the devil is in the details, and it’s clear from the first round of posted responses that some of the top players — including J&J and Pfizer — would like some adjustments and added feedback. And on Thursday, the experts can offer their own thoughts on shaping the first OKs.

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UP­DAT­ED: In­di­v­ior's Shaun Thax­ter heads to prison, join­ing In­sys' John Kapoor among jailed opi­oid ex­ecs

Update: An earlier version of this article misidentified the jailed Insys CEO. Former CEO John Kapoor was sentenced to 5.5 years in prison in January. Endpoints News regrets the error.

The Justice Department’s years-long battle with Indivior has arrived at a rare place: the jailing of a pharmaceutical executive.

A US district court sentenced long-running Indivior CEO Shaun Thaxter to 6 months in federal prison for his role in company efforts to mislead a major healthcare provider about the safety and abusability of their opioid addiction drug Suboxone, which generated billions in revenue over the last decade. Thaxter joins former Insys CEO John Kapoor as one of the only two executives to face prison time for their roles in the opioid epidemic.

Biond­Vax stock im­plodes af­ter a big PhI­II gam­ble for its uni­ver­sal flu vac­cine fails

After flying high on Wall Street for the last few months of a pandemic, BiondVax’s stock and dreams of getting approval for its universal flu vaccine hit the windshield.

The Jerusalem-based biotech announced on Friday that its only clinical candidate, M-001, failed both primary and secondary endpoints in a Phase III study. There was no statistically significant difference in reduction of flu illness and severity between the vaccine and placebo groups, according to the company. The vaccine did prove safe, if ineffective, BiondVax said.

David Hung (file photo)

Mas­ter deal­mak­er David Hung re­tools a SPAC sedan in­to a fi­nanc­ing mus­cle ve­hi­cle that leaves his can­cer start­up with $850M and a place on Wall Street

It’s only right that one of the industry’s top dealmakers just completed one of the biggest SPAC-related deals in the pipeline.

David Hung, of Medivation fame, has completed a back flip into the market, merging with EcoR1 Capital’s SPAC Panacea and landing neatly on Wall Street with an $NUVB stock ticker after filling out the blank check in his name. In addition to the $144 million held in the SPAC — provided none of the investors opt out — Hung is getting ahold of $500 million more being chipped in by a slate of institutional investors who feel that Hung could have the keys to another Medivation-style success.

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Roche finds a home for a new, $500M man­u­fac­tur­ing lo­gis­tics hub, promis­ing 500 jobs

Roche is pouring $500 million into its Canadian headquarters in Mississauga, Ontario to set up a new hub that will coordinate logistics for its global supply chain.

Over the 5-year investment, the Swiss pharma giant expects to add 200 jobs over next year and another 300 by the end of 2023.

Introduced as a $190 million global pharmaceutical development site in 2011, the campus currently houses Roche’s Canadian commercial unit as well as product development, global procurement and pharma informatics. The new expansion will see it organize manufacturing across 13 plants and 11 sites, according to FiercePharma.

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