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ENDPOINTS 06/13/2019 10:09
→. AbbVie is touting new positive data comparing their aging blockbuster Humira with their hoped-for blockbuster upadacitinib . Over 48 weeks a larger proportion of patients taking the experimental drug experienced clinical remission than in the control arm with Humira. Their drug brought in $20 billion last year, topping the scales in the number 1 slot. →Gilead has turned to Vancouver-based AbCellera for its latest discovery deal . AbCellera will use its know-how in “single-cell screening of natural immune sources” to find antibody candidates for Gilead to pursue in the infectious disease field. The deal includes an upfront and milestones. →Mereo BioPharma $MREO notes that Celgene has informed the company that they won’t be licensing etig.
ENDPOINTS 06/13/2019 09:13
Rudolph "Rudy" Tanzi Harvard. The Washington Post managed to whip up the quickest industry consensus I’ve ever seen that one of its reporters was purveying overblown nonsense with a story that Pfizer was sitting on data suggesting that Enbrel could be an effective treatment for Alzheimer’s. In covering that bit of anti-Big Pharma fantasy — there are lots of reasons to go after pharma, but this piece was ludicrous — I noted comments in the story from some prominent people in the field criticizing Pfizer for not publishing the data.
ENDPOINTS 06/13/2019 08:36
Anyone looking for a few simple reasons why the gene therapy field has caught fire with the pharma giants need only look at the new list of the 10 most expensive therapies from GoodRx. Two recently approved gene therapies sit atop this list, with Novartis’ Zolgensma crowned the king of the priciest drugs at $2.1 million .
ENDPOINTS 06/13/2019 08:30
As artificial intelligence and machine learning loom ever larger in drug discovery and development, a biotech operating at the "nexus" of technology and neurosciences has cashed in with $76 million in fresh financing. The big idea at BlackThorn Therapeutics is to do for neurobehavioral disorders what genetically targeted therapy has done for oncology: Redefine patient populations by the underlying biology — dysregulated brain circuits, or neurotypes — instead of symptoms, thereby finding the patients who are most likely to benefit at enrollment phase. The challenges that neurosciences drug developers run into, president and COO Bill Martin explained, have a lot to do with how diseases are diagnosed.
ENDPOINTS 06/13/2019 07:18
President Donald Trump has little love for Big Pharma, but there’s at least one new drug that just hit the market which he is enamored with. Trump, evidently, has been reading up on J&J’s new anti-depression drug, Spravato. And the president — who often likes to break out into a full-throated attack on greedy drugmakers — apparently enthused about the therapy in a meeting with officials of Veterans Affairs, which has long grappled with depression among veterans. “Give it to anybody that has the problem, because you have people calling and our folks do a great job on the phone — but it’s a telephone,” Trump said, according to a report from Bloomberg . “You have people calling for help and if those people had that, I’m hearing like instantane.
ENDPOINTS 06/13/2019 06:58
Investors are in no mood to hear biotechs tout the success of a “key” secondary endpoint when the pivotal Phase III flunks the primary goal. Just ask Savara. The Texas biotech $SVRA went looking for a silver lining as company execs bluntly conceded that Molgradex, an inhaled formulation of recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF), failed to spur significantly improved treatment outcomes for patients with a rare respiratory disease called autoimmune pulmonary alveolar proteinosis, or aPAP. The p-value was an awful 0.17. Researchers blamed a high placebo effect, teasing out the positive aspects of an improved numerical outcome for secondaries on the 6-minute walk test and a need for whole lung lavage — a pro.
ENDPOINTS 06/13/2019 06:37
These days just about every biotech serious about global development — and not just commercialization — has a China strategy. Tessa Therapeutics, a Baylor associated outfit based out of Singapore, is no exception. Andrew Khoo Tessa. Taking a page out of the CAR-T pioneers’ playbook, Tessa is establishing a joint venture with China-Singapore Guangzhou Knowledge City, which is initially putting down $40 million for a 13% stake with $40 million more to come in a second stage. The biotech, which now retains an 87% control, is also rolling out its own contributions in two phases, starting with $20 million and all its technology license rights for China. The JV will be the sole China licensee of Tessa’s for research, clinical and commercial purpos.
ENDPOINTS 06/12/2019 11:13
→ Clinical trial software provider Medidata is getting acquired in a $5.8 billion deal. The all-cash buyer, Dassault Systemes , is a French technology company that’s historically focused on 3D design and engineering. “Life science is going to go through an accelerated digitization of its own processes, basically,” Dassault CEO Bernard Charles told CNBC . Having powered operations and data analysis for hundreds of biopharma companies, CROs and researcher centers, Medidata’s platform is poised to lead the virtual transformation in the industry, he added. → Swedish rare disease player Sobi is restructuring its operations to focus on hematology and immunology. Discovery, early research and partner R&D programs outside of those core areas are be.
ENDPOINTS 06/12/2019 10:05
Back in 2016 Kris Vaddi left a 12-year career at Incyte to start his own effort diving into resistance mechanisms in cancer at Prelude Therapeutics. Three years later, he has a first program to show for it, as well as a $60 million Series B and two new recruits to the C-suite. Kris Vaddi Prelude. Co-led by OrbiMed and another unnamed existing investor, the B round will pay for clinical proof-of-concept studies of Prelude’s PRMT5 inhibitor . PRMT5, or protein arginine methyltransferase 5, is believed to play a central role in several pathways for cancer cell proliferation, cell cycle progression and resistance to apoptosis. An ongoing dose escalation trial is testing PRT543 across solid tumors, myeloid malignancies and lymphomas. David Mauro
ENDPOINTS 06/12/2019 08:50
In the latest update on AstraZeneca’s delay-prone HQ project, the pharma giant revealed that the cost of construction has swelled to £750 million ($956 million) — more than double the original estimate in 2013. The move-in date is still in 2020, the Times reported, after AstraZeneca pushed projected completion from 2016 to 2017, and then to the spring of 2019.
ENDPOINTS 06/12/2019 08:41
Invokana sales may be muted, but the diabetes drug is set to get some love after its maker J&J unveiled data at the American Diabetes Association meeting on Tuesday suggesting the medicine can confer a cardiovascular benefit in patients who do not have preexisting CV disease. Back in April, J&J had reported that in the late-stage CREDENCE study, the SGLT2 drug scored a 30% reduction in the risk of a composite of ailments: a progression to the doubling of serum creatinine, end-stage kidney disease and renal or cardiovascular death.
ENDPOINTS 06/12/2019 07:17
These aren’t the typical slides you’d see at Endpoints — no molecules, clinical programs, or p-values. Instead, we’ll talk digital and internet trends, factors that elite global brands — regardless of industry — must first measure and understand before deploying products into the world. That’s a concept that most of our Big Pharma audience is in tune with. Digital awareness is key to success in the discovery, development, and marketing of new biopharmaceuticals, and most of the majors now have a chief digital officer: Novartis , Sanofi , and Pfizer , just to name a few. Yet when it comes to internet trends and analytics, there’s too much firehose and not enough signal. And if your day job is something a bit more biopharma, like molecules an.
ENDPOINTS 06/12/2019 06:52
For Ginkgo Bioworks, teaming up with Synlogic on a pilot discovery project late 2017 marked its foray into harnessing the therapeutic ability of its cell programming platform. Having since leaped into a new antibiotics effort with Roche, Ginkgo is anting up $80 million to go deeper with Synlogic. Jason Kelly Synbiobeta. The two companies, both based in the Cambridge/Boston hub, are unveiling a new collaboration in which Ginkgo will help optimize the microbial strains that Synlogic — a pioneer in reengineering non-pathogenic bacteria into medicines — has identified as viable drug candidates. Ginkgo is investing roughly $80 million for a 20%-plus stake in Synlogic $SYBX — an approach that CEO Jason Kelly said he likes to take with category def.
ENDPOINTS 06/11/2019 11:41
→ On the heels of a bankruptcy filing, Insys announced that it’s getting delisted from the Nasdaq. Trading of the stock $INSY — relegated to the over-the-market these days — will come to a halt on June 19, 2019. The opioid maker, which agreed to pay $225 million to settle the US government’s investigations into the marketing practices around its fentanyl spray Subsys ,. does not plan on appealing the determination. → Deciphera Pharmaceuticals has found a Chinese partner in Zai Lab, bagging $20 million in upfront cash in exchange for rights to ripretinib in the region. Now tested in Phase III, the drug is a kinase switch control inhibitor designed to treat gastrointestinal stromal tumors and other solid tumors driven by KIT or PDGFRα. → Germa.
ENDPOINTS 06/11/2019 11:21
Now that J&J and Genmab have thrust Darzalex onto the regulatory orbit for first-line use in multiple myeloma, the partners are lining up a deal for a next-gen follow-on to the leading CD38 drug. Janssen — J&J’s biotech unit — has its eyes on HexaBody-CD38, a preclinical compound generated on Genmab’s tech platform designed to make drugs more potent via hexamerization. Genmab is footing the bill on studies in multiple myeloma and diffuse large B-cell lymphoma; once it completes clinical proof of concept, Janssen has the option to license the drug for a $150 million exercise fee.
ENDPOINTS 06/11/2019 10:24
Merck’s checkpoint star is shining a little brighter today with two new approvals in head and neck squamous cell carcinoma. The pharma giant first clinched an accelerated approval to use Keytruda in recurrent or metastatic cases in 2016, targeting patients whose disease progressed on or after platinum-based chemotherapy. Jonathan Cheng Merck. On Tuesday the FDA converted it into a full approval right at the end of a priority review period, and additionally stamped its OK on Keytruda as a frontline treatment for head and neck cancer.

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