Feds accuse AstraZeneca of underpaying 318 female and Hispanic employees – Endpoints News

Just a few months af­ter a fed­er­al ju­ry award­ed $2.4 mil­lion in dam­ages to a for­mer As­traZeneca sales man­ag­er who al­leged re­tal­i­a­tion for whistle­blow­ing, the phar­ma is back in hot wa­ter over the way it treats em­ploy­ees — and once again, it’s go­ing to cost the com­pa­ny.
The British phar­ma has agreed to pay $560,000 in back pay and in­ter­est to re­solve al­leged race- and gen­der-based pay dis­crim­i­na­tion af­fect­ing 318 fe­male and His­pan­ic em­ploy­ees.
The al­le­ga­tions sur­faced af­ter a rou­tine fed­er­al com­pli­ance in­ves­ti­ga­tion found that As­traZeneca un­der­paid 23 His­pan­ic em­ploy­ees in pri­ma­ry care sales, and 295 women in spe­cial­ty care sales from Oct. 1, 2015, to Sept. 30, 2016, ac­cord­ing to the US De­part­ment of La­bor.
“The U.S. De­part­ment of La­bor is com­mit­ted to com­bat­ing pay dis­crim­i­na­tion and en­sur­ing fair com­pen­sa­tion for all em­ploy­ees,” Of­fice of Fed­er­al Con­tract Com­pli­ance Pro­grams act­ing re­gion­al di­rec­tor Michele Hodge said in a state­ment. “Fed­er­al con­trac­tors are re­quired by law to com­ply with all equal em­ploy­ment op­por­tu­ni­ty reg­u­la­tions.”
Dur­ing the pan­dem­ic, As­traZeneca struck a $1.2 bil­lion con­tract with the De­part­ment of the Army to sup­port its Covid-19 vac­cine de­vel­op­ment — an ef­fort which has, so far, not turned up an FDA-au­tho­rized shot.
In ad­di­tion to shelling out the back pay and in­ter­est, As­traZeneca has agreed to rem­e­dy cur­rent pay dis­par­i­ties, and iden­ti­fy an in­di­vid­ual re­spon­si­ble for mon­i­tor­ing en­force­ment of Ex­ec­u­tive Or­der 11246, which pro­hibits race and gen­der dis­crim­i­na­tion by fed­er­al con­trac­tors. The com­pa­ny al­so has to sub­mit progress re­ports with com­pen­sa­tion da­ta for at least the next two years.
“While As­traZeneca does not agree with OFC­CP’s find­ings, it is pleased to have re­solved this mat­ter re­lat­ed to al­le­ga­tions from the 2016 au­dit,” a spokesper­son told End­points News. “As­traZeneca is com­mit­ted to fair and eq­ui­table em­ploy­ment prac­tices, and has im­ple­ment­ed ap­pro­pri­ate mea­sures to en­sure the con­tin­u­a­tion of equal em­ploy­ment op­por­tu­ni­ty and eq­ui­table com­pen­sa­tion poli­cies and prac­tices for all em­ploy­ees.”
The news comes about three months af­ter a fed­er­al ju­ry in Ore­gon de­ter­mined that As­traZeneca vi­o­lat­ed the state’s whistle­blow­er statute, award­ing for­mer sales man­ag­er Suzanne Ivie $2.4 mil­lion in dam­ages. Ivie tes­ti­fied that she was fired af­ter re­peat­ed­ly warn­ing As­traZeneca that an ex­ec­u­tive was plan­ning to mar­ket an­ti-in­flam­ma­to­ry drugs for off-la­bel use.
“Suzanne alert­ed As­traZeneca to bad be­hav­ior and, in­stead of fix­ing the prob­lem, the com­pa­ny pun­ished her,” Ani­ta Mazum­dar Cham­bers, a prin­ci­pal of the law firm rep­re­sent­ing Ivie, said in a state­ment.
A spokesper­son said As­traZeneca has filed “post-tri­al mo­tions” in that case, and is await­ing word from the tri­al judge.
Ivie’s com­plaint came sev­er­al years af­ter the phar­ma paid $520 mil­lion back in 2010 to re­solve al­le­ga­tions that it il­le­gal­ly mar­ket­ed the an­tipsy­chot­ic drug Sero­quel for off-la­bel use.
Cor­rec­tion: As­traZeneca has not yet paid the $2.4 mil­lion award­ed in the Suzanne Ivie case. 
Advanced technology is supposed to help sponsors run clinical trials faster. So why are timelines getting longer?
A report from the Tufts Center for the Study of Drug Development (CSDD) found that the clinical phase of new drugs and biologics approved by the FDA between 2008 and 2013 took 83.1 months on average. Between 2014 and 2018, the clinical phase extended to an average of 89.8 months.
According to CSDD director Kenneth Getz, fragmented operating activity is one of the primary factors that contribute to growing timelines. What’s one way to limit fragmentation? Bring more clinical trial functions in-house. By making the most of internal resources, sponsors not only simplify operations, they reduce risk and operational costs.
GlaxoSmithKline is radically downsizing — and the move has nothing to do with their head count.
Spurred by the pandemic-inspired reduction in the need for office space, the pharma giant is giving up its iconic facilities in Philadelphia and Research Triangle Park, and replacing the space with new digs that require only a fraction of what they once used.
Starting early next year, GlaxoSmithKline will be shrinking its office space in Philly by 75% as the pharma leaves their bespoke building in the Navy Yard — moving to the FMC Tower in Philly’s University City district. The company is also moving its offices from RTP to downtown Durham, NC by June, the company said — a downsize of close to 90%.
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Pfizer’s clinical development chief and EVP Rod MacKenzie is retiring from his post at the pharma giant, right on the heels of a historic success.
MacKenzie was one of the leaders in Pfizer’s bold push to take an mRNA vaccine from their partners at BioNTech, and was there with CEO Albert Bourla and R&D chief Mikael Dolsten when they took the wraps off the promising pivotal data that set the stage for a speedy FDA approval following an emergency use authorization.
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Ginkgo Bioworks, a synthetic biology unicorn that has captured investors’ imaginations and trades under Genentech’s hallowed  old $DNA ticker, took a big blow Wednesday after a short seller claimed the company represents “a Frankenstein mash-up of the worst frauds of the last 20 years.”
Scorpion Capital, a hedge fund most recently known for torpedoing the stock of Berkeley Lights $BLI, another company dabbling in synbio, released a hefty investigation it says shows a pattern of fraud at Ginkgo, including posing related-party entities as customers and overhyping a platform without any meaningful IP and with a history of failure.
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Biotech deal cash continued to gush through Q3, but a careful look at the details in aggregate suggests that the rosy tint to the biotech boom has started to lose some of its color.
Once again, deal master Chris Dokomajilar at DealForma has crunched the numbers on all the gauges we use to assess the performance of the biotech sector. And there’s been a distinct cooling of overall activity, particularly around IPOs and venture cash infusions.
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While praising the FDA’s quick, agile and frequent use of the emergency use pathway to authorize Covid-19 tests, drugs and vaccines, the Senate health committee’s top Republican recently explained what, in hindsight, the agency needs to do better.
North Carolina Sen. Richard Burr’s new policy brief on FDA points to early issues for the agency in the pandemic, such as its testing woes, due to the agency’s “overly strict and initially inflexible criteria,” which “did not encourage innovative test development and instead limited the tests available to the public and health care providers to help detect, diagnose, and surveille for COVID-19.” He also pointed to more necessary work around the supply chain, as some drugs and tests fell into shortage early on and were slow to recover.
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After almost two decades of discussions with FDA regarding the development of Takeda’s potential drug for post-transplant cytomegalovirus (CMV), which it bought in its acquisition of Shire in 2019, the agency seems to be offering positive marks for the drug’s safety and efficacy profile ahead of Thursday’s adcomm.
According to FDA’s briefing documents released ahead of the meeting, maribavir proved safe across multiple studies and statistically superior to investigator-assigned treatment (IAT) in a Phase III trial, which Takeda announced earlier this year.
Francis Collins is stepping down from the NIH, the agency announced Tuesday morning, leaving a rich legacy of research accomplishments, initiatives as well as values.
He will leave the post by the end of the year and return to his lab at the National Human Genome Research Institute (NHGRI). A successor has not yet been named.
With a 12-year tenure spanning three presidencies, Collins, 71, has been the longest-serving NIH director. He was first appointed by President Barack Obama in 2009, after serving as director of the NHGRI — which in turn followed an illustrious career hunting for genes at the University of Michigan and leading the Human Genome Project.
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Catalysts play a vital role in drug development, driving complex sequences of chemical reactions to break down molecules or join them together. But until just a couple of decades ago, only two types of catalysts were known to scientists: metals and enzymes.
Metal catalysts are easily destroyed by moisture, so while it’s simple enough to deploy them in a lab, large-scale manufacturing becomes a challenge. Enzymes, on the other hand, consist of hundreds of amino acids, though frequently enough, only a few of those are actually involved in a chemical reaction.
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