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ENDPOINTS 06/04/2020 16:52
Inovio was one of the first vaccine developers to snag attention for a jab that their execs said promised to end the Covid-19 pandemic. Using their own unique DNA tech, CEO Joseph Kim said it took just 3 hours to work it out. But while rivals are racing to the finish line to of with billions of dollars of deals, Inovio is still stuck at the starting line on manufacturing. — which has yet to develop a single approved product in 4 decades — says it currently has been stymied by a standoff with its longterm contract manufacturer. And Inovio filed a lawsuit to free itself from the relationship and move on to new partners who can make hundreds of millions of doses — if it passes muster. The problem, Inovio claims in its lawsuit, is that a Korean.
ENDPOINTS 06/04/2020 12:30
Back during the lead up to the $74 billion buyout of Celgene, the big biotech’s leadership did a little housecleaning with a major pact it had forged with Jounce. Out went the $2.6 billion deal and a collaboration on ICOS and PD-1. Celgene, though, also added a $530 million deal…
ENDPOINTS 06/04/2020 10:32
Before remdesivir amid the coronavirus crisis, Gilead’s filgotinib was the tapped to rake in billions competing with other JAK inhibitors made by rivals including AbbVie and Eli Lilly. Now, long term data on the drug — discovered by Gilead’s partners at Galapagos and posted as part of a virtual medical conference — have solidified the durability and safety of filgotinib in patients with rheumatoid arthritis, spanning data from three late-stage trials.
ENDPOINTS 06/04/2020 10:05
→ GlaxoSmithKline is its cell therapy R&D chief to a partner. Immatics hired Cedrik Britten, who had been head of GSK’s oncology cell therapy research unit, as CMO. In February, GSK an up-to $600 million deal with Immatics ($50 million upfront) to use their bi-specific T-cell receptor platform. Immatics’ current CMO Carsten Reinhardt will become chief development officer. → Switzerland-based Ferring and Spain’s Igenomix have a maternal health and reproductive medicine research pact. The pact will see the two companies create a research hub in Boston in an effort to discover new targets and disease mechanisms for infertility and other pregnancy-related conditions. → The big players in MacroGenics’ pipeline are the HER2-targeting margetuximab.
ENDPOINTS 06/04/2020 07:30
In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval. Al Roy Lupus Alliance Research. Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including , as well as defeats in and . One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Ro.
ENDPOINTS 06/04/2020 07:30
There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s. The field has been a disaster over the past decade. Amyloid — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors. Which brings me to Athira, a little, Seattle-based biotech that caught my attention with a heads-up that they’re announcing an $85 million round today to fund their Phase II/III quest for Alzheimer’s. Athira’s team has been on a long.
ENDPOINTS 06/04/2020 06:36
During a Senate Committee on Finance hearing Tuesday, officials from the FDA responded to criticism from senators and a new report from the Government Accountability Office (GAO) on its oversight of foreign drug manufacturers. The hearing follows FDA’s move to halt most foreign inspections in March as a result of the coronavirus disease (COVID-19) pandemic. Much of the criticism centered on the agency’s practice of giving foreign facilities advanced notice of inspections while most domestic surveillance inspections are unannounced, as well as US reliance on foreign drug manufacturing. Opening the hearing, Chairman Chuck Grassley (R-IA) pointed out that most manufacturing sites for finished drugs and active pharmaceutical ingredients (API) a.
ENDPOINTS 06/03/2020 14:40
A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed,. Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the and is now the furthest along of any US effort; J&J, which has not gone into trials but received around earlier this year; the joint AstraZeneca-Oxford venture which was granted two weeks ago; Pfizer, which has been working with the mRNA biotech ; and Merck, which and expects to put their two vaccine candidates into humans la.
ENDPOINTS 06/03/2020 11:17
→ Forbion for Prilenia Therapeutics to fund two late-stage trials in Huntington’s disease and amyotrophic lateral sclerosis. Michael Hayden, the former Teva R&D chief who’s been serving as chairman, will now take over as CEO to oversee the program for pridopidine, which agonizes the sigma-1 receptor (S1R). Morningside and Sectoral Asset Management also joined, as did Talisman Capital Partners and Genworks 2. → Australia’s CSL Behring is teaming up with Seattle Children’s Research Institute to develop stem cell for rare primary immunodeficiency diseases, starting with Wiskott-Aldrich Syndrome and X-linked Agammaglobulinemia. They are among 400 primary immunodeficiency diseases, in which the human immune system is dysfunctional. “Expanding ou.
ENDPOINTS 06/03/2020 10:30
After pharma partner Novartis boosted its IPO with a , Pliant Therapeutics has wrapped its journey to the Nasdaq on a high note. Bernard Coulie. Pliant had penciled in a back in May. But as has become the norm in recent months, that initial number has turned out to be a mere placeholder, making way for the final haul of $144 million. The South San Francisco biotech did so by pricing at $16, the high end of the range, while bringing the number of shares offered up to 9 million. Novartis had led the $100 million Series C that immediately preceded the IPO filing. The two companies are allied on an integrin inhibitor designed to tackle fibrosis related to NASH, based off research done by scientific co-founder Dean Sheppard. But blocking TGF-β ac.
ENDPOINTS 06/03/2020 07:22
Amendments to Canada’s Patented Medicines Regulations will now be put in place 1 January 2021, delaying implementation of the sweeping drug pricing reforms by six months. The new timeline represents a further adjustment from the schedule laid out in 2017, when Health Canada first proposed overhauling its drug pricing review process. Draft pricing promulgated by the government of Canada’s Patent Medicine Prices Review Board (PMPRB) have been available for stakeholder and public consultation since November 2019.
ENDPOINTS 06/02/2020 10:19
→ Novartis is coming in with $10 million to help support the looming IPO of a partner. Pliant Therapeutics posted a new filing with the SEC showing that Novartis is buying the shares at $15, the mid-point of the range. It’s adding several million shares to the offering, bringing the total to around . Biotech companies have been enjoying quite a run on virtual Wall Street, with investors boosting new offerings to some big hauls. → Shares of Tenax Therapeutics , formerly known as Oxygen Bio , shot up on Tuesday after were published on its sole drug, levosimendan . The calcium sensitizer — which is approved for intravenous use in hospitalized patients with acutely decompensated heart failure in 60 countries (not including the United States) —
ENDPOINTS 06/02/2020 09:23
In March, Zeposia became the third oral S1P modulator to for multiple sclerosis. Now, the drug has succeeded in a key ulcerative colitis study. The immunomodulator, akin to others in its class, controls lymphocyte trafficking by limiting the white blood cells to the lymphatic system, in the lymph nodes, and thwarting their ability to jam up lymph nodes — precluding their ability to penetrate the bloodstream and the central nervous system. In the over 1,000 patient trial, christened True North, Zeposia was tested against a placebo as an induction and maintenance therapy in adults with moderate-to-severe ulcerative colitis who did not derive enough benefit from previous therapy. The drug is the to demonstrate benefit in this category of patie.
ENDPOINTS 06/02/2020 06:47
After a more than 15-year run, a California-based biotech is exploring options, including a sale, after its lead experimental therapy failed an exploratory mid-stage study in patients with middle ear infections characterized by a build-up of fluid behind the eardrum. The company, initially called but which subsequently changed its name to Novus Therapeutics in 2017, saw its shares more than halve on Monday after the drug — OP0201— did not pass muster as an adjunct therapy to oral antibiotics in infants and children aged 6 to 24 months with acute otitis media (OM). Otitis media is often caused by a blockage in the passageway that connects the middle ear to the back of the nasal cavity called the Eustachian tube.

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