Bris­tol-My­ers, Ab­b­Vie's mul­ti­ple myelo­ma drug wins sec­ond EU nod as part of triple reg­i­men

Less than a year af­ter the FDA cleared Bris­tol-My­ers Squibb $BMY and Ab­b­Vie’s $AB­BV ap­proved Em­plic­i­ti in­jec­tion for in­tra­venous use in com­bi­na­tion with Cel­gene’s $CELG po­ma­lido­mide (Po­m­a­lyst, or Im­novid, de­pend­ing on which side of the At­lantic you are) and the steroid dex­am­etha­sone for re­lapsed, re­frac­to­ry mul­ti­ple myelo­ma, the Eu­ro­pean Com­mis­sion has fol­lowed suit.

The ap­proval is based on da­ta from the 117 pa­tient-ELO­QUENT-3 tri­al in which the triplet dou­bled both me­di­an pro­gres­sion-free sur­vival (PFS) and over­all re­sponse rate (ORR) among pa­tients with re­lapsed and re­frac­to­ry mul­ti­ple myelo­ma, ver­sus po­ma­lido­mide and low-dose dex­am­etha­sone alone.

Up­dat­ed tri­al da­ta — with a min­i­mum fol­low-up of 18.3 months — were pre­sent­ed at the Eu­ro­pean Hema­tol­ogy As­so­ci­a­tion (EHA) this year. In this ex­plorato­ry analy­sis, a to­tal of 40 (67%) pa­tients were alive in the triplet arm and 29 (51%) pa­tients were alive in the com­para­tor arm, Bris­tol-My­ers not­ed on Tues­day, adding that me­di­an over­all sur­vival was not reached for the triplet arm.

Em­plic­i­ti, an im­munos­tim­u­la­to­ry an­ti­body, was ini­tial­ly ap­proved by the FDA in 2015 in com­bi­na­tion with Cel­gene’s lenalido­mide (Revlim­id) and dex­am­etha­sone for mul­ti­ple myelo­ma pa­tients whose dis­ease has pro­gressed de­spite, one to three pri­or ther­a­pies — Eu­rope came to the same con­clu­sion the year af­ter. In 2018, Em­plic­i­ti was cleared by the FDA for use in com­bi­na­tion with po­ma­lido­mide and dex­am­etha­sone, to treat pa­tients who have re­ceived at least two pri­or ther­a­pies.

In the first half of this year, Em­plic­i­ti earned $174 mil­lion in glob­al sales. Revlim­id gen­er­at­ed about $5.3 bil­lion and Po­m­a­lyst/Im­novid made about $1.2 bil­lion over the same pe­ri­od.

Mul­ti­ple myelo­ma is can­cer of the plas­ma cells — nor­mal plas­ma cells are found in the bone mar­row and func­tion as a key com­po­nent of the im­mune sys­tem. In Eu­rope, about 40,000 peo­ple were di­ag­nosed with the dis­ease in 2015, and this num­ber is pre­dict­ed to climb to al­most 46,000 by 2025, ac­cord­ing to sta­tis­tics cit­ed by Myelo­ma Pa­tients Eu­rope, a Brus­sels-based non-prof­it Myelo­ma pa­tient group.

So­cial im­age: Bone mar­row as­pi­rate cy­tol­ogy of mul­ti­ple myelo­ma, Shut­ter­stock

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

FDA un­veils six ICH guide­lines ahead of meet­ing with Health Cana­da

A sign that the FDA’s non-Covid-related processes are beginning to normalize: The release of six guidelines from the International Council of Harmonisation.

Years in development, the ICH documents offer an international perspective on drug development, with these latest guidelines covering everything from recommendations to support the classification of drug substances, featured in the M9 guidance, to standards for nonclinical safety studies for pediatric medicines in the S11 guideline.

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Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

UP­DAT­ED: Gink­go Bioworks re­sizes the de­f­i­n­i­tion of go­ing big in biotech, rais­ing $2.5B in a record SPAC deal that weighs in with a whop­ping $15B-plus val­u­a­tion

Ginkgo Bioworks execs always thought big. But today should redefine just how big an upstart biotech player can dream.

In the largest SPAC deal to clear the hurdles to Nasdaq, the biotech that envisioned everything from remaking synthetic meat to a whole new approach to developing drugs has joined forces with one of the biggest disruptors in biotech to slam the Richter scale on dealmaking.

Soon after becoming the darling of the VC crew and clearing the bar on a $4 billion valuation, Ginkgo — a synthetic biotech player out to reprogram cells with industrial efficiency — has now struck a deal to go public in the latest leviathan SPAC that sets its pre-money valuation at $15 billion. In one swift vault, Ginkgo will combine with Harry Sloan’s Soaring Eagle Acquisition Corp. and leap into the public markets.

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Sanofi, Glax­o­SmithK­line, Boehringer ac­cused of play­ing games, de­stroy­ing emails re­lat­ed to law­suit over con­t­a­m­i­nat­ed Zan­tac

A recent court filing raises new questions about how major pharma companies like Sanofi, GlaxoSmithKline, and Boehringer Ingelheim have dealt with a lawsuit related to recalls of certain over-the-counter heartburn drugs due to the presence of a potentially cancer-causing substance found in them.

More than 70,000 people who took Sanofi’s Zantac and other heartburn drugs containing ranitidine, which have been recalled over the past two years, have sued the manufacturers, including generic drugmakers, and other retailers and distributors as part of a consolidated suit before US District Court Judge Robin Rosenberg in Florida.

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Alvotech takes Ab­b­Vie to court over al­leged patent 'mine­field' sur­round­ing megablock­buster Hu­mi­ra

AbbVie has so far been successful in shooing away competition to its megablockbuster Humira, deploying a number of patents and settlements to keep biosimilars off the US market until 2023. But one Icelandic drugmaker doesn’t want to wait — and on Tuesday, it filed a lawsuit challenging what it called a patent “minefield.”

Alvotech has accused AbbVie of trying to “overwhelm” and “intimidate” it with “an outrageous number of patents of dubious validity,” according to court documents. The company is currently seeking approval for its Humira copycat AVT02, which AbbVie says would infringe upon 62 patents.

A clos­er look at the FDA’s more than 700 pan­dem­ic-re­lat­ed record re­quests to re­place on­site in­spec­tions

As the pandemic constrained the FDA’s ability to travel for onsite manufacturing inspections, the agency increasingly turned to requesting records to fill the gap, even for hundreds of US-based facilities.

FDA explains in its guidance on manufacturing inspections during the pandemic that the agency can request records (not to be confused with the FDA’s remote interactive evaluations) directly from facilities “in advance of or in lieu of” certain onsite inspections. Companies are legally required to fulfill those requests because a denial may be considered limiting an inspection, which could lead to the FDA deeming a drug made at that site to be adulterated.

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UP­DAT­ED: Feds charge an­oth­er CRO staffer with fak­ing da­ta in a Glax­o­SmithK­line pe­di­atric asth­ma study

A Florida woman has been indicted as part of a clinical trial fraud scheme over a GlaxoSmithKline pediatric asthma study, the Justice Department announced Tuesday, the latest development in a case where three individuals have already pleaded guilty.

Jessica Palacio was charged with participating in a plot to falsify medical records, giving off the appearance that trial participants were making their scheduled visits to a Miami CRO and taking an experimental asthma medication as required. Palacio was also charged with lying to FDA investigators about her conduct.

Distribution of Moderna's Covid-19 Vaccine (Photo by Paul Sancya - Pool/Getty Images)

Opin­ion: Ado­les­cents can wait. The US needs to start do­nat­ing Covid-19 vac­cines to needy coun­tries now.

Now that the US is swimming in Covid-19 vaccines and the supply has officially eclipsed the demand, it’s time for America to lead the world and start shipping these excess doses to countries that desperately need them.

Unlike the IP waiver at the World Trade Organization, which Biden now supports and will likely take years to translate into actual shots in arms, the US could easily donate just a tiny fraction of the more than 60 million doses of Pfizer, Moderna and J&J vaccines sitting on American shelves right now.

Chris Garabedian (Xontogeny)

Per­cep­tive Ad­vi­sors, Xon­toge­ny bring the band back and then some with a $515M sec­ond fund sniff­ing out lead com­pounds

When Perceptive Advisors and startup accelerator Xontogeny initially teamed up on an early-stage VC round in 2019, the partners hoped to prove their investments could be a force multiplier for early-stage companies. Now, with that proof of concept behind them, the pair have closed a second VC round worth more than double the money.

Dubbed PXV Fund II and headed by Xontogeny CEO and former Sarepta head Chris Garabedian, the $515 million fund will target 10 to 12 early-stage preclinical companies with Series A rounds in the $20 million to $40 million range with opportunities for Series B follow-ups. The oversubscribed fund is bringing the band back with initial investors from PXVI as well as new investors that include “top-tier” asset managers, endowments, foundations, family offices, and individual investors.

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