EMA en­dors­es Teva's mi­graine drug; Dis­as­ter prone CTI Bio­Phar­ma re­scinds EU ap­pli­ca­tion for pa­cri­tinib

→ The EMA was busy on Fri­day. The Eu­ro­pean drug reg­u­la­tor, which is cur­rent­ly in the process of shift­ing its head­quar­ters to Am­s­ter­dam from Lon­don, rec­om­mend­ed the ap­proval of Te­va’s mi­graine-pre­ven­tion drug, Ajovy. A fi­nal de­ci­sion is ex­pect­ed in the first half of this year, and if ap­proved the treat­ment drug will be the first and on­ly an­ti-CGRP med­i­cine in the EU with both quar­ter­ly and month­ly dos­ing op­tions, the Is­raeli drug­mak­er said. CTI Bio­Phar­ma, how­ev­er, had bad news to re­port on the Eu­ro­pean front for its myelofi­bro­sis drug pa­cri­tinib. The no­to­ri­ous­ly fail­ure-prone drug de­vel­op­er an­nounced it was with­draw­ing an ap­pli­ca­tion to mar­ket the drug in the EU, fol­low­ing dis­cus­sions with the EMA. Last year, Shire backed away from a part­ner­ship with the ill-fat­ed com­pa­ny, fol­low­ing a mixed da­ta read­out from a piv­otal study that was pre­vi­ous­ly put on a full clin­i­cal hold — un­der the be­hest of the FDA — af­ter the death of sev­er­al pa­tients. The com­pa­ny’s shares $CTIC tum­bled more than 15% in ear­ly Fri­day trad­ing.

→ Sep­a­rate­ly on Fri­day, the EMA al­so laid out guid­ance to help bio­phar­ma com­pa­nies pre­pare for Brex­it, so as to en­sure sup­ply is not dis­rupt­ed — on the as­sump­tion the UK will be­come a third coun­try as of 30 March 2019. For pre-sub­mis­sion meet­ings re­gard­ing hu­man and an­i­mal drugs re­quest­ed from last Oc­to­ber, the EMA will en­gage with man­u­fac­tur­ers via tele­con­fer­ence or vir­tu­al meet­ings. Be­tween 11 Feb­ru­ary and 15 March 2019, no such meet­ings for ini­tial mar­ket­ing au­tho­ri­sa­tion ap­pli­ca­tions will take place, while the EMA moves to its new home in Am­s­ter­dam, it said.

→ On Thurs­day at a par­lia­men­tary com­mit­tee meet­ing, UK health and so­cial care sec­re­tary Matt Han­cock said the British gov­ern­ment was pri­or­i­tiz­ing med­i­cines over food if a no-deal Brex­it would make it tricky to im­port prod­ucts in ei­ther cat­e­go­ry of goods. Last year, Han­cock  asked drug sup­pli­ers to keep six weeks worth of med­i­cines stock­piled in ad­di­tion to their buffer stocks and last month the UK’s Med­i­cines and Health­care prod­ucts Reg­u­la­to­ry Agency (MHRA) said that in the event of a no-deal, the UK would be no longer be part of the EMA um­brel­la, and that reg­u­la­to­ry sub­mis­sions for drugs would be made di­rect­ly to the MHRA.

Tal Zaks, Moderna CMO (Moderna via YouTube)

UP­DAT­ED: NI­AID and Mod­er­na spell out a 'ro­bust' im­mune re­sponse in PhI coro­n­avirus vac­cine test — but big ques­tions re­main to be an­swered

The NIAID and Moderna have spelled out positive Phase I safety and efficacy data for their Covid-19 vaccine mRNA-1273 — highlighting the first full, clear sketch of evidence that back-to-back jabs at the dose selected for Phase III routinely produced a swarm of antibodies to the virus that exceeded levels seen in convalescent patients — typically in multiples indicating a protective response.

Moderna execs say plainly that this first stage of research produced exactly the kind of efficacy they hoped to see in humans, with a manageable safety profile.

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Trans­port Sim­u­la­tion Test­ing for Your Ther­a­py is the Best Way to As­sure FDA Ex­pe­dit­ed Pro­gram Ap­proval

Modality Solutions is an ISO:9001-registered biopharmaceutical cold chain engineering firm with unique transport simulation capabilities that support accelerated regulatory approval for biologics and advanced therapeutic medicinal products (ATMP). Our expertise combines traditional validation engineering approaches with regulatory knowledge into a methodology tailored for the life sciences industry. We provide insight and execution for the challenges faced in your cold chain logistics network.

Tillman Gerngross, Adagio Therapeutics CEO

An­ti­body leg­end Till­man Gern­gross is el­bow­ing his way in­to the Covid-19 R&D cru­sade: 'I don’t see this end­ing any­time soon'

One of the most influential — and outspoken — scientists at work in the field of antibody discovery is jumping into the frenzied race to create new therapeutics to treat and prevent Covid-19. And he’s operating with the conviction that the current outbreak now once again spreading like wildfire will create plenty of demand for what he has in mind.

Dartmouth professor and Adimab CEO Tillman Gerngross tells me he’s raised $50 million from a group of close VCs to spin out a new company — Adagio Therapeutics — with a full C-suite team assembled to hire up a staff and keep rolling toward the clinic.

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Mer­ck KGaA takes its I/O op­tion on F-star Ther­a­peu­tics; Nephron spends $215M, eye­ing spot in Covid-19 vac­cine chain

→Merck KGaA has taken an early option on an immuno-oncology program developed at F-star Therapeutics. This is their second option in the collaboration. And they added a pair of preclinical discovery programs to the alliance as well.

Any biotech going public these days wouldn’t feel right if they didn’t upsize the offering. And that’s just what Phase I biotech Pandion Therapeutics did. The autoimmune company is now selling 7 million shares, a 1.5 million share bump, for $16 to $18 a share.

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Who are the women blaz­ing trails in bio­phar­ma R&D and lead­ing the fight against Covid-19? Nom­i­nate them for End­points' spe­cial re­port

One of the many inequalities the pandemic has laid bare is the gender imbalance in biomedical research. A paper examining Covid-19 research authorship wondered out loud: Where are the women?

It’s a question that echoes beyond our current times. In the biopharma world, not only are women under-represented in R&D roles (particularly at higher levels), their achievements and talents could also be undermined by stereotypes and norms of leadership styles. The problem is even more dire for women of color.

GSK’s Shin­grix leader Guil­laume Pfe­fer has jumped on board Flag­ship to helm a biotech hy­brid as Afeyan’s lat­est CEO-part­ner

After spending 4 years in a senior post with GlaxoSmithKline’s star team positioning Shingrix for a blockbuster approval, Guillaume Pfefer is headed back to the biotech world — in style.

Pfefer has signed on to join Noubar Afeyan’s busy group of partners at Flagship, and he’s taking the helm of an upstart — which today is being merged with another Flagship startup — with some grand plans of its own. The announcement this morning notes that Pfefer will run Kintai Therapeutics, one of the grads of the Flagship labs.

Donald Trump and Anthony Fauci (AP Images)

Covid-19 roundup: Rus­sia hack­ers tar­get US, UK vac­cine and drug re­searchers; Fau­ci fires back at White House cam­paign to un­der­mine him

Russia has tried to steal a Covid-19 vaccine and therapeutics researcher from pharmaceutical and academic institutions in the US, UK and Canada, Britain’s National Cyber Security Centre said Thursday.

The NCSC said that hacking attempts came from a group known as APT129, also known as “Cozy Bear,” that “almost certainly operate as part of Russian intelligence services.” The Canadian Communication Security Establishment, US Department for Homeland Security, the Cybersecurity Infrastructure Security Agency, and the National Security Agency shared the assessment, the NCSC said.

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John Furey, Imvax CEO

A neu­ro­sur­geon spent the past 30 years de­vel­op­ing a neoanti­gen tu­mor vac­cine. Now he has $112M for a piv­otal test

As a neurosurgeon, David Andrews knew there wasn’t much he could do for his glioma patients after resecting — rarely fully — their tumor. Even with the best treatment and care available, median overall survival is just somewhere between 14 and 16 months.

Then in the 1990s, his mentor at Thomas Jefferson University introduced him to Renato Baserga, a pathologist who had been studying the effect of using antisense oligonucleotide to knock out the insulin-like growth factor type 1 receptor in cancers. As IGF-R1 drives tumor growth and metastasis, the preclinical reasoning went, implanting a molecule targeting the receptor together with the tumor material near lymph nodes can slow down the spread of the cancer.

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Full Bril­in­ta study re­sults show the blood thin­ner re­duces rate of sec­ondary stroke

AstraZeneca once projected its Brilinta drug to peak at $3.5 billion in sales, and though the blood thinner never reached that lofty goal, it received the latest positive signs in a string of recent good news.

The pharma released full details from its THALES study Thursday morning, which measured the effects of Brilinta and aspirin against aspirin alone in treating patients who had an acute ischemic stroke or transient ischemic attack. When taken twice daily with once-a-day aspirin for 30 days, the Brilinta combo reduced the risk of stroke and death by 17 percent, meeting the primary endpoint of the study.