→ Mayo Clin­ic is open­ing up its sprawl­ing clin­i­cal data­base to nfer­ence, the Cam­bridge, MA-based AI start­up it’s long part­nered with and re­cent­ly backed in a $60 mil­lion round. The project aims to dig­i­tize 25 mil­lion tis­sue slides with­in the next 2 to 2.5 years, Fierce­Biotech re­port­ed, in ad­di­tion to an­no­tat­ing, link­ing and tag­ging writ­ten physi­cian notes. Af­ter sort­ing through the da­ta, nfer­ence will use the plat­form to iden­ti­fy new tar­gets and bio­mark­ers as well as ap­ply it in clin­i­cal tri­al re­cruit­ment and re­al-world ev­i­dence gen­er­a­tion.

→ Cypri­um Ther­a­peu­tics, one of the star­tups in­cu­bat­ed by Fortress Biotech, has been grant­ed rare pe­di­atric dis­ease des­ig­na­tion by the FDA for cop­per his­tid­i­nate, al­so re­ferred to as CUTX-101, for the treat­ment of Menkes dis­ease. The drug — which is de­signed to boost blood and brain cop­per lev­els — has al­so gained or­phan and fast track sta­tus.

→ In an ex­pan­sion of its glob­al foot­print, WuXi Bi­o­log­ics has ac­quired a drug prod­uct man­u­fac­tur­ing plant from Bay­er. The fa­cil­i­ty, lo­cat­ed in Lev­erkusen, Ger­many, will al­so serve as a back-up pro­duc­tion site for Bay­er’s Ko­val­try, a he­mo­phil­ia A treat­ment, once WuXi takes over.

→ South Ko­rea’s Cell­tri­on has plans to build a new plant in Chi­na to man­u­fac­ture its biosim­i­lars as it ad­vances a Rem­i­cade copy­cat in the coun­try. Chair­man Jung-jin Seo said at the JP Mor­gan con­fer­ence that the fa­cil­i­ty will have a pro­duc­tion ca­pac­i­ty of 120,000 liters, ac­cord­ing to Yon­hap News Agency.

→ No­var­tis, J&J, Eli Lil­ly, Pfiz­er and GSK are join­ing the Gates Foun­da­tion on a phil­an­thropic com­mu­ni­ty-based pri­ma­ry health­care ini­tia­tive in six African coun­tries led by two char­i­ties. The drug­mak­ers will “con­tribute dis­ease-spe­cif­ic ex­per­tise and ex­pe­ri­ence in the dis­cov­ery and de­vel­op­ment of new tools, which will sup­ple­ment the com­mu­ni­ty health work­er mod­els.” They would al­so each con­tribute $1.5 mil­lion to the project.

Fewer Approvals, but Neurology Rivals Oncology and Sees Major Innovations

This report, the fourth in our Trinity Drug Index series, outlines key themes and emerging trends in the industry as we progress towards a new world of targeted and innovative products. It provides a comprehensive evaluation of the performance of novel drugs approved by the FDA in 2016, scoring each on its commercial performance, therapeutic value, and R&D investment (Table 1: Drug ranking – Ratings on a 1-5 scale).

For start-up biotechnology companies and resource stretched pharmaceutical organisations, launching a novel product can be challenging. Lean teams can make setting a launch strategy and achieving your commercial goals seem like a colossal undertaking, but can these barriers be transformed into opportunities that work to your brand’s advantage?
We spoke to Managing Consultant Frances Hendry to find out how Blue Latitude Health partnered with a fledgling subsidiary of a pharmaceutical organisation to launch an innovative product in a
complex market.
What does the launch environment look like for this product?
FH: We started working on the product at Phase II and now we’re going into Phase III trials. There is a significant unmet need in this disease area, and everyone is excited about the launch. However, the organisation is still evolving and the team is quite small – naturally this causes a little turbulence.

Every few years, a public health crisis (think Ebola, Zika) spurred by a rogue pathogen triggers a small-biotech rally, as drugmakers emerge from the woodwork with ambitious plans to treat the mounting outbreak. In most cases, that enthusiasm never quite delivers.

Things are no different, as the coronavirus outbreak in Wuhan, China takes hold. There have been close to 300 confirmed human infections in China, and at least four deaths. Coronaviruses are a large family of viruses, which include MERS and SARS. On Tuesday, the CDC reported the virus was detected in a US traveler returning from Wuhan.

The venture tide might have subsided, the IPO window may be closing and certain listed biotechs may be having a tough time amid Neil Woodford’s well-publicized demised, but there’s still plenty to celebrate in the UK BioIndustry Association’s eyes.

Overall investment in UK biotech last year fell from the record-breaking £2.2 billion levels of 2018 to £1.3 billion — including £679 million in venture capital, a meager £64 million in IPOs plus £596 million when you add up all public financings, according to a new report from the BIA.

→ Blueprint Medicines filed an amendment to its application to get the gastrointestinal stromal tumor (GIST) drug Ayvakit approved in fourth-line GIST, the company disclosed in the prospectus for a new $325 million public offering.  Blueprint got a big accelerated OK on the drug this month in a particular mutation, but because the FDA decided to split their review in two, they didn’t hear on fourth-line GIST. They were supposed to hear before February 14, but this amendment could push that date back by 3 months. Blueprint wrote that the amendment is designed to allow the company to comply with the FDA’s request for data from the Phase III Voyage trial before they give a judgment.

Late last year Novartis abandoned a cardio drug from Ionis’ spinoff Akcea just after the pharma giant snapped up inclisiran, going the RNAi way in guarding against heart disease in the $9.7 billion Medco buyout.

Now the pharma goliath — which is headed down the PCSK9 road with a drug it believes can be used in a mass population — can get a clearer picture of just what they gave up.

Akcea $AKCA and the mother company $IONS put out a statement early Wednesday saying that their Phase II study of AKCEA-APOCIII-LR delivered solid efficacy data, with the high dose clearly outperforming placebo in significantly reducing triglycerides as a means to cutting the risk of cardiovascular disease. In addition, investigators concluded that the drug slashed apoC-III, very low-density lipoprotein and remnant cholesterol while boosting “good” HDL levels.

Update: Nominations open through end of day, Monday, January 27

Two years ago, when we did our first Endpoints 20-under-40, we profiled a set of up-and-comers who promised to help reshape the industry as we know it. Now we’re back and once again looking for the top 20 biopharma professionals under the age of 40. We’ll be profiling folks who have accomplished a lot at a young age but seem on the verge of accomplishing so much more.