Eu­ro­pean Union aims to es­tab­lish patent workaround in case of emer­gen­cies while try­ing to strength­en its own IP

The Eu­ro­pean Union is look­ing at ways to by­pass patent pro­tec­tions and make it eas­i­er to make gener­ic drugs in cas­es of emer­gency such as the Covid-19 pan­dem­ic, a new doc­u­ment says.

Nor­mal­ly, un­der WTO reg­u­la­tions, the prac­tice known as “com­pul­so­ry li­cens­ing” is al­lowed in ex­cep­tion­al cir­cum­stances and could be ap­plied as a waiv­er to by­pass patent hold­ers. Wednes­day’s doc­u­ment was pub­lished as part of the EU’s plan to shore up the in­tel­lec­tu­al prop­er­ty rights of its mem­ber states.

“The Com­mis­sion sees the need to en­sure that ef­fec­tive sys­tems for is­su­ing com­pul­so­ry li­cences are in place, to be used as a means of last re­sort and a safe­ty net, when all oth­er ef­forts to make IP avail­able have failed,” the doc­u­ment said.

Reuters was the first to re­port on the plan, writ­ing Wednes­day that some leg­is­la­tors have urged the EU to use the WTO waiv­er to gain ac­cess to po­ten­tial vac­cines and drugs for Covid-19, but the bloc has re­sist­ed un­til this point. In­stead, the Eu­ro­pean Com­mis­sion and oth­er gov­ern­ments on the con­ti­nent have been pur­chas­ing prospec­tive vac­cines and ther­a­pies in bulk.

But Covid-19 is caus­ing the EU to re­think its strat­e­gy, giv­en the ex­tra­or­di­nary na­ture of the pan­dem­ic and need for treat­ments.

The EU out­lines how a pro­ce­dure close­ly linked to patents, known as sup­ple­men­tary pro­tec­tion cer­tifi­cates, are al­so ham­per­ing Eu­ro­pean patent hold­ers. The cer­tifi­cates pro­vide an ex­tend­ed IP pro­tec­tion for prod­ucts that un­der­go clin­i­cal tri­als and reg­u­la­to­ry ap­provals, but due to in­con­sis­tent im­ple­men­ta­tion across Eu­rope, both gener­ic and drug mak­ers have had a dif­fi­cult time im­ple­ment­ing a co­he­sive Covid strat­e­gy.

Ear­li­er this week, Reuters had pre­vi­ous­ly re­port­ed that the bloc was con­sid­er­ing mak­ing ac­cess to gener­ics eas­i­er al­to­geth­er. The goal of the plan is to make drugs more af­ford­able while pre­vent­ing the sup­ply and man­u­fac­tur­ing short­ages seen dur­ing the ear­ly stages of the pan­dem­ic this spring.

A draft of the doc­u­ment re­viewed by Reuters ap­peared to dis­cuss a plan to ap­ply an­titrust poli­cies more rig­or­ous­ly against phar­ma­ceu­ti­cal com­pa­nies, though that does not ap­pear in the fi­nal plan re­leased Wednes­day. The draft al­so men­tioned the pos­si­bil­i­ty of crack­ing down on drug­mak­ers that de­lay the ap­proval of gener­ics, lim­it­ing patent pro­tec­tion for drugs that aren’t made avail­able in all 27 EU coun­tries, and aim­ing to pre­vent drug short­ages across the con­ti­nent.

So­cial: Shut­ter­stock

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In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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Jean-Christophe-Hyvert, Lonza

Lon­za look­ing to build on 'd­if­fer­en­ti­at­ed ad­van­tage' in Covid-19, CD­MO mar­ket­place in 2021

It’s not new for Lonza, the Swiss CDMO nearing its quasquicentennial anniversary, to be in the upper echelon of the biotech manufacturing industry.

But 2020 — as it was for many CDMOs — was a special year even by Lonza’s standards. The company inked a deal to produce 1 billion worldwide doses of Moderna’s Covid-19 vaccine and tapped pharma vet Pierre-Alain Ruffieux to lead its operations, moves which have allowed Lonza to make a myriad of other deals that will continue to ramp up its global production capacity.

Matt Gline (L) and Vivek Ramaswamy

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Over the past 7 years since founding Roivant, Vivek Ramaswamy has been a constant blur of biotech building motion.

He launched his first biotech with an Alzheimer’s drug he picked up cheap, and watched the experiment implode in one of the highest profile pivotal disasters seen in the last decade. But it didn’t slow the 30-something exec down; if anything, he hit the accelerator. Ramaswamy blazed global paths and went on to raise billions to spur the creation of a large lineup of little Vants promising big things at a fast pace. He sold off a section of the Vant brigade to Sumitomo Dainippon for $3 billion. And more recently the relentless dealmaker has been building a computational discovery arm to add an AI-driven approach to kicking up new programs and companies, supplementing the in-licensing drive while pursuing advances that have created more than 700 jobs at Roivant, with $2 billion in reserves.

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Ron Cooper, Albireo CEO

Al­bireo just ad­vanced down to the 10-yard line at the FDA. And Ron Coop­er’s team is get­ting prepped for the next big play

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Hal Barron, GSK via YouTube

What does $29B buy you in Big Phar­ma? In Glax­o­SmithK­line’s case, a whole lot of un­com­fort­able ques­tions about the pipeline

Talk about your bad timing.

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Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

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The Cambridge, MA-based biotech put out word on Monday that in vivo studies indicate their mRNA vaccine works well enough against two strains first detected in the UK and South Africa. But with a six-fold reduction in neutralizing titers observed against the latter strain, the company is launching a new study of a booster version to make sure it can do the job.

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