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ENDPOINTS 08/19/2019 09:53
→ India’s Glenmark in April launched domestically a new SGLT2 inhibitor called — marking the first-ever launch of the diabetes drug, which was partly developed by GSK . SGLT2 inhibitors, such as Forxiga, Invokana and Jardiance , work by preventing the kidneys from reabsorbing glucose back into the blood. Remogliflozin will now also be sold in India, Glenmark said on Monday. → GeneCentric Therapeutics , whose technology is engineered to isolate genetic signatures that could help identify appropriate populations that will respond to oncology treatments, has Select ImmunoGenomics , which assists immuno-oncology drug makers by providing advanced immunogenomic, data analysis and biomarker development services. The combined entity is positioning
ENDPOINTS 08/19/2019 09:36
As Bloomberg notes, that cover Sarepta are an upbeat bunch, ready to cheer on the team when it comes to their Duchenne MD drugs, or offer explanations when an odd setback occurs — as happened recently with a safety signal that was last week. Ritu Baral Cowen. So it’s no wonder that Cowen’s Ritu Baral gives Sarepta a 90% chance of an approval today — which is about as high as a percentage bet like this can get — as we hit D-day for the agency’s decision of Vyondys53. Why should Sarepta worry?
ENDPOINTS 08/19/2019 09:24
and — both biotech spinouts that have closed B rounds in April — are loading up with IPO cash to boost their respective late-stage plans. SpringWorks. Lara Sullivan. Bain-backed SpringWorks is the better-known company of the two, and it’s gunning for a larger windfall of $115 million to add to $228 million from previous financings.
ENDPOINTS 08/19/2019 08:56
Data reveal that different racial and ethnic groups — by nature and/or nurture — can respond differently in terms of pharmacokinetics, efficacy, or safety to therapeutics, but this disparity is not necessarily accounted for in clinical trials. A fresh analysis of the last decade of US cancer drug approvals suggests the trend continues, cementing previous research that suggests oncology trials are woefully under-representative of the racial makeup of the real world. The , published in the journal JAMA Oncology , evaluated 230 trials to see whether sponsors reported the racial composition of the patients enrolled in their studies, and how minorities were represented (versus their actual population prevalence) in clinical trials that led to ca.
ENDPOINTS 08/19/2019 07:55
Back in the year, Vanda Pharmaceuticals served up a hot stew of mixed data for a slate of endpoints related to what they called clear evidence that their melatonin sleep drug Hetlioz (tasimelteon) could help millions of travelers suffering from jet lag. Never mind that they couldn’t get a planned 90 people in the study, settling for 25 instead; Vanda CEO Mihael H. Polymeropoulos said they were building on a body of data to prove it would help jet-lagged patients looking for added sleep benefits.
ENDPOINTS 08/19/2019 05:40
The EMA and FDA concur more than 90% of the time in their decisions to approve new drugs, according to a new from EMA and FDA officials that looked at 107 applications from 2014 to 2016. In just eight of the 107 applications, the FDA initially declined to approve a new drug or biologic while the EMA approved it, although in all eight of those cases, the FDA ended up approving that drug or biologic.
ENDPOINTS 08/19/2019 02:00
Earlier this year, an executive from Juvenescence-backed AgeX predicted the field of longevity will eventually “dwarf the dotcom boom.” Greg Bailey, the UK-based anti-aging biotech’s CEO, certainly hopes so. Gregory Bailey. On Monday, Juvenescence completed its $100 million series B round of financing. The company is backed by British billionaire — who wrote his 400-page guide to investing in the field of longevity shortly after launching the company in 2017. Bailey, who served as a board director for seven years at Medivation before Pfizer the biotech for $14 billion, is joined by Declan Doogan, an industry veteran with stints at Pfizer and Amarin. The business of anti-aging is gaining steam — Bank of America has forecast the market will ba.
ENDPOINTS 08/16/2019 14:53
Another big drug approval came through on Friday afternoon as the FDA OK’d AbbVie’s upadacitinib — an oral JAK1 inhibitor that is hitting the rheumatoid arthritis market with a black box warning of serious malignancies, infections and thrombosis reflecting fears associated with the class. It will be sold as Rinvoq and will likely soon face competition from a drug that AbbVie once controlled — and spurned. AbbVie was widely expected to gain an approval, but there will be growing doubts about the drug’s ability to live up to execs’ high-flying expectations of megablockbuster sales in the $6 billion-plus range.
ENDPOINTS 08/16/2019 09:59
ICER has some strong words for PTC, Sarepta and the FDA as the US drug price watchdog that as currently priced, their respective new treatments for Duchenne muscular dystrophy are decidedly not cost-effective. The final report — which cements the conclusions of a draft issued in May — incorporates the opinion of a panel of 17 experts ICER convened in a public meeting last month.
ENDPOINTS 08/16/2019 08:42
There’s nothing quite like a big patent win when it comes to burnishing your prospects in the pipeline. And for Amgen, which seems to have rescued Enbrel for a run to 2029, the cheering section on Wall Street is now fixed on AMG 510 and a key rival. And it didn’t take much data to do it. There was the first snapshot of a handful of patients, with a 50% response rate. Then came word that Amgen researchers are also tracking responses in different cancers, at least one in colorectal cancer and appendiceal too. Never mind that the drug doesn’t actually have to lose out in a clinical study to be discounted — a significant drop in responses in a bigger group would be enough to disillusion investors. Let’s remember . But for now, this landscape is.
ENDPOINTS 08/15/2019 15:24
Just ahead of schedule the FDA has come through with a key approval for Genentech’s entrectinib — now headed to the market as Rozlytrek. Regulators approved the drug for ROS1-positive, metastatic non-small cell lung cancer as well as adult and pediatric patients (12 years of age and older) with solid tumors that have a NTRK gene fusion. Roche lined up this approval once it struck a deal to buy Ignyta for $1.7 billion back in late 2017.
ENDPOINTS 08/15/2019 10:38
→ After posting the results of a testing its cancer drug, little Deciphera Pharmaceuticals is raising gross proceeds of in an offering as it preps its marketing application. Late on Wednesday, the Waltham, Massachusetts-based drug developer said it is offering about 10.8 million shares at a price of $37/share, which is a discount of about 2.3% to its Wednesday close. → Former Forest Labs CFO, , is joining SpringWorks Therapeutics — which launched in the fall of 2017 with a whopping $103 million round and Pfizer assets — in the same capacity.
ENDPOINTS 08/15/2019 10:21
Regeneron is finalizing its grand plans for an expansive new campus designed to support its rapid growth bolstered by the blockbuster Eylea franchise. First in 2013 and last September, the campus in East Greenbush, Rensselaer County — two hours north of Regeneron’s headquarters in Tarrytown, New York — is an $800 million project expected to add at least 1,500 jobs to the area.
ENDPOINTS 08/15/2019 09:23
Embattled Mallinckrodt — tarnished by a as well as its controversially expensive Acthar gel — will enjoy its sliver of optimism that comes with a positive pivotal trial. The UK drugmaker on Thursday unveiled data from a late-stage trial testing the drug, terlipressin, in patients with a life-threatening, progressive rare complication of liver disease that triggers kidney failure called hepatorenal syndrome type 1 (HRS-1), which affects an estimated 30,000 to 40,000 in the United States each year, the company said, adding that patients face a poor prognosis, with a median survival time of less than two weeks and more than 80% mortality within three months. Patients with HRS experience a constriction of the blood vessels that feed the kidneys.

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