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ENDPOINTS 02/28/2020 15:57
The FDA posted a new generic drug approval Friday afternoon, and this one arrived with a little extra relish added to the customary pronouncement. The agency has given Cerovene the green light to sell generic Daraprim, Martin Shkreli’s treatment for toxoplasmosis that detonated a world class brouhaha over drug pricing that has tainted the industry.
ENDPOINTS 02/28/2020 10:49
Before she boarded the plane, Cristina Ghenoiu spent most school day afternoons at Bucharest’s National Museum of Natural History, studying endangered animals Romanian scientists had brought back from around the country, or the world. The communist government sponsored a wide range of programs for kids so both parents could work. Her sister danced; Ghenoiu fell in love with biology. And she was good, at least good enough to win several national awards and then, at 15, win a spot as Romania’s representative to an international school in Canada that accepted about one person per country. “That really marked me,” Ghenoiu told Endpoints News . “In Romania we didn’t really have the funds to do proper science. If you were interested in science, y.
ENDPOINTS 02/28/2020 09:59
Months after at Verastem Oncology, Brian Stuglik has a plan to take the biotech in a "new strategic direction" — but not before some layoffs. Left out of an upbeat press release spelling out its clinical plans, and buried below news of a $100 million private placement in an SEC filing, is a planned restructuring that will claim 31 jobs.
ENDPOINTS 02/28/2020 06:55
A coronavirus fear-induced bloodbath on the Nasdaq has not stopped Passage Bio from making a public debut — and an exuberant one. James Wilson. By pricing an upsized offering at $18, the top of the range, the gene therapy biotech bagged $216 million from its IPO, 72% more than it’s originally . The proceeds likely reflected confidence in Jim Wilson, who gathered all the tools he’s built over decades of gene therapy research to assemble the startup and teamed up with Frazier and OrbiMed to hone its focus on rare, monogenic disorders of the central nervous system.
ENDPOINTS 02/27/2020 18:18
While the fate of Biogen’s resurrected Alzheimer’s drug aducanumab remains uncertain, the Cambridge, MA-based drugmaker is joining forces with genome editing company Sangamo Therapeutics to develop a range of therapies for neurological conditions. Sangamo is set to receive a meaty in cash and stock and is eligible to receive up to $2.37 billion in milestone payments, in addition to royalties.
ENDPOINTS 02/27/2020 17:42
Seven years after spinning out of Yale, Biohaven has entered the ranks of commercial-stage biotechs. The FDA handed down its OK for its CGRP drug, rimegepant, as an acute treatment. Dubbed Nurtec, the orally dissolving pill will join Allergan’s (soon to be AbbVie’s) and Lilly’s Reyvow on the market amid a new wave of migraine therapies reshaping the disease space. In a pivotal Phase III trial, Nurtec hit the co-primary endpoints on pain freedom and freedom from most bothersome symptoms at two hours post dose, proving superior to placebo. In the real world, it will be competing with existing generic medicines such as triptans — available at low cost but with a transient effect. “Millions of people suffering from migraine are often not satisf.
ENDPOINTS 02/27/2020 10:46
Zogenix has had a troubling 2020 so far. Earlier this month, its experimental seizure drug met the main goal in a pivotal study in patients with Lennox-Gastaut Syndrome, but the company saw its shares plummet after the magnitude of the therapy’s effect . On Thursday, the drug developer said that the FDA had extended the review of the drug in patients with Dravet syndrome by three months. Last April, Zogenix said the FDA had for Dravet patients in a refuse-to-file letter, citing the lack of certain non-clinical studies key for the assessment of chronic administration of the drug as well as an incorrect version of a clinical dataset. In November, the FDA accepted the company’s resubmitted application, and the agency was expected to make its f.
ENDPOINTS 02/27/2020 10:39
Years after a family of endogenous proteins known as IAP, or inhibitors of apoptosis proteins, was first linked to poor prognosis of cancer, the FDA is helping move along a drug that blocks it. Debiopharm’s Debio 1143 now enjoys breakthrough status at the agency, after Phase II results unveiled at ESMO suggested that adding it to a regimen of chemoradiation therapy boosted locoregional control rate as well as progression-free survival among patients with “high risk” locally advanced squamous cell carcinoma of the head and neck. There have been no newly approved therapies over the last 25 years for this disease, the Swiss biotech noted. While Debiopharm is positioning the drug as a chemo-radio sensitizer here, it contends that blocking IAP —
ENDPOINTS 02/27/2020 10:24
The first 11 coronavirus patients who arrived in Omaha last week, airlifted across the globe after two weeks quarantined on a cruise ship, showed only minor symptoms or none at all. And then one of them — or one of the couple of Americans who arrived later — got worse. She developed pneumonia, a life-threatening complication for coronavirus patients. In a biocontainment room at the University of Nebraska Medical Center on Friday, doctors infused her with an experimental Gilead drug once developed for Ebola, called remdesivir. Or they gave her a placebo. For the first time in the handful of cases the drug’s been used in the US, neither she nor the doctors knew. The first US novel coronavirus trial was underway and with it, a mad dash for an
ENDPOINTS 02/27/2020 09:56
→ Tessa Therapeutics has a Regenerative Medicine Advanced Therapy designation for its experimental CAR-T therapy. The therapy, which showed a 67% complete response rate in two trials covering 27 patients, is being developed for relapsed and refractory Hodgkin’s lymphoma. A pivotal Phase II trial is expected for fall of this year. → Jim Wilson ’s preclinical biotech — focused on developing gene therapies for rare CNS disorders — its proposed share offering for its . It now plans to raise $170 million by offering 10 million shares at a price range of $16 to $18. Previously it had set the goal at $126 million by offering 7.4 million shares within the same price range. At the midpoint, the Philadelphia, PA-based company could command a fully di.
ENDPOINTS 02/27/2020 09:49
That was fast! UK’s cost-effectiveness agency NICE has the use of Celgene’s (now Bristol-Myers’) blockbuster cancer therapy Revlimid for patients with follicular lymphoma who have undergone previous treatment, about two months after the drug in combination with Roche’s MabThera . In contrast, NICE backed Revlimid as the first line of defense in certain patients with multiple myeloma European approval was sanctioned. Revlimid, which generated roughly $9.4 billion in global 2019 sales, has long been Celgene’s keystone treatment, but until recently its use in England had been restrained due to pricing disagreements.
ENDPOINTS 02/27/2020 07:22
BioMarin execs are still staying tight-lipped about their pricing plans for what is poised to be the world’s first hemophilia gene therapy. But as the company enters the final regulatory stretch and approaches a potential launch this summer, they are also dropping more hints to get investors ready. First thing to know: They really, really don’t expect an advisory committee to be convened for valrox, which is under priority review, to pop up before its PDUFA date on August 21. Henry Fuchs Biomarin. “So AdCom, not necessary, not schedule later,” Henry Fuchs, president of R&D, told analysts on an . “And the reason we’re saying it’s not necessary is because what they wrote to us is that this time, we don’t believe that an AdCom would be necessar.
ENDPOINTS 02/27/2020 06:57
Third time’s the charm for Acacia Pharma. The Cambridge, UK-based company on Thursday finally secured FDA approval for its treatment for patients with postoperative nausea & vomiting (PONV), who are symptomatic despite having received prophylactic treatment. The drug, an intravenous formulation of the selective dopamine D2 and D3 antagonist amisulpride, was shown to help patients in four positive pivotal clinical trials by 2017.
ENDPOINTS 02/26/2020 18:18
Gilead is launching its own Phase III trials of remdesivir, the repurposed antiviral that a WHO official called the "one drug right now we think may have real efficacy" against Covid-19 as the novel coronavirus originating from Wuhan, China ravages the world. Merdad Parsey. Announced just a day after the NIH and the University of Nebraska Medical Center their US-based trial online, Gilead’s program will comprise two studies enrolling around 1,000 patients beginning in March.
ENDPOINTS 02/26/2020 11:08
→ Days after a against the FDA over a partial clinical hold on tradipitant , the biotech said the drug has for pruritus associated with atopic dermatitis. While the neurokinin 1 antagonist missed the primary endpoint of reducing itching among all patients, Vanda pointed to “robust” antipruritic effect in the mild AD subpopulation as a reason to remain optimistic and said it will reassess its second, ongoing late-stage study. → Roche’s application seeking approval for a faster way to administer its oncology drugs Perjeta and Herceptin to help breast cancer patients has been . The Swiss drugmaker is looking to market a fixed-dose version of Perjeta+Herceptin with hyaluronidase , administered by subcutaneous (SC) injection in combination with

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