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ENDPOINTS 11/15/2019 10:28
→ Weeks after winning EU approval to start marketing dapagliflozin as Forxiga , AstraZeneca has racked up another OK for a triplet combo involving the SGLT2 diabetes drug. Named , the pill combines Forxiga with the DPP-4 inhibitor Onglyza (saxagliptin) and the bedrock drug metformin in a modified-release format. That 3-in-1 approach proved superior in reducing average blood glucose levels to a number of other dual combinations across 5 Phase III trials, including Forxiga plus metformin , Onglyza with metformin, or glimepiride with metformin. The EU label specifically covers patients whose type 2 diabetes is not adequately controlled by existing therapies, as well as those who are already taking the three drugs separately. FDA regulators wav.
ENDPOINTS 11/15/2019 10:21
As is custom, an EMA panel on Friday issued its on marketing applications submitted by drug developers. This week, the agency backed the use of five new therapies — including two Novartis drugs — but issued no negative reviews. Novartis’ S1P drug for relapsing forms of multiple sclerosis (MS) drug, Mayzent (known chemically as siponimod), which was approved by the FDA in March — has been given the nod by the EMA. The Swiss drugmaker already sells its other MS drug, Gilenya, in both regions. The company has also secured a positive EMA recommendation for Isturisa — known chemically as osilodrostat — for use in Cushing’s syndrome, a disease characterized by the exaggerated production of the hormone cortisol. Earlier this year, Novartis palmed
ENDPOINTS 11/15/2019 09:59
The folks behind Atomwise’s spinout X-37 like to think in cosmological metaphors, and you can think of their AI drug development model as probes sent into space from a central station. That station just got $14.5 million in Series A funding from DCVC Bio, Alpha Intelligence Capital and Hemi Ventures to back those missions. X-37 uses Atomwise’s AI platform to identify drug targets and – unlike the parent company, which largely sticks to computers – bring those into a wet lab and preclinical testing. In addition to AI professionals, it’s led in by part by drug developers from Velocity Pharmaceutical Development. Their business structure is noteworthy and becoming increasingly common for biotechs. Each drug development program is housed as its.
ENDPOINTS 11/15/2019 09:53
Robert Ford Abbott. →. Abbott Laboratories. to CEO. Miles White. after he announced that he was stepping down in March after 21 years of service. Robert Ford. , the company’s COO and president, will take the helm. Ford is known for his work in the $25 billion merger between. St. Jude Medical. into Abbott in January 2017. White will remain with the company as executive chairman of the board. → After. Novartis. ’ Swiss facility, Novartis Center of Excellence, in July,. Lonza. has announced that their CEO,. Marc Funk. ,. for “personal reasons.” Funk has been the CEO of the company for less than a year — brought onto the company back in March. In the meantime, chairman. Albert Baehny. will serve as interim CEO. Marc Funk Lonza. →. Rakuten Medical. — which,. , recei.
ENDPOINTS 11/15/2019 08:58
A month after posting positive top-line data from their first Phase III trial of the IL-17A/17F inhibitor bimekizumab, Belgium’s UCB says they’ve added more upbeat results from their second late-stage test in moderate-to-severe plaque psoriasis. Iris Loew-Friedrich UCB. That leaves the company on track for regulatory submissions in the middle of next year, says CMO Iris Loew-Friedrich. Their drug beat out a placebo on the co-primaries — a 90% improvement in PASI 90 (the Psoriasis Area and Severity Index) and Investigator Global Assessment (IGA) response of clear or almost clear (IGA 0/1) at week 16, compared to placebo. Investigators also boasted of hitting some key secondaries. UCB is angling to enter an increasingly crowded market space. I.
ENDPOINTS 11/15/2019 08:46
The EMA issued a guideline setting its expectations for the clinical development of new urate-lowering therapies (ULT) and anti-inflammatory drugs to treat gout. The 14-page guideline comes less than a year after the EMA’s Committee for Medicinal Products for Human Use (CHMP) released the for consultation and seven years after the agency published a highlighting the need for such guidance. While there are a handful of ULTs available in Europe, the EMA notes that there are some issues with existing treatments.
ENDPOINTS 11/15/2019 08:07
Roche is snapping up a “breakthrough” anti-fibrotic drug in a $1.4 billion buyout. The pharma giant announced Friday that it is acquiring Promedior, primarily to get its hands on PRM-151, a recombinant form of human pentraxin-2 (PTX-2) protein that has nailed down mid-stage clinical data on idiopathic pulmonary fibrosis and demonstrating its potential for a range of fibrotic conditions. The investors will get $390 million in cash with $1 billion of milestones on the table as Roche carries the ball from here. The buyout comes just 6 months after the private, Lexington, MA-based biotech picked up a breakthrough drug designation for its lead drug after boasting about its mid-stage data,. Researchers noted that “patients who were treated with PR.
ENDPOINTS 11/15/2019 07:16
The preparations to serve biopharma’s explosion of gene therapy pipeline candidates continues. Seven months Thermo Fisher put down $1.7 billion for a rising gene therapy contract manufacturer. Catalent quickly followed up with a $1.2 billion deal for gene therapy play of its own, the Maryland-based Paragon Bioservices. And now, Fujifilm is expanding its own capabilities in the field — with the Japanese conglomerate investing $120 million into the field and building a “Gene Therapy Innovation Center” beside its recently completed base in College Station, Texas. The new facility will cost $55 million, employ 100 people and triple the company’s gene therapy manufacturing capacity, Fujifilm said. The company did not say how the other $65 millio.
ENDPOINTS 11/15/2019 07:02
Safety concerns linked with Shionogi’s antibiotic were put to bed by an expert panel to the FDA, who for complicated urinary tract infections (cUTI) last month. On Friday, the US regulator followed suit, granting the treatment official approval. The drug, branded Fetroja, will be used in patients whose (cUTI) is suspected to have been caused by Gram-negative pathogens, which are increasingly growing resistant to standard therapies. The tsunami of antibiotic resistance is an acute global threat. In the United States, at least 2.8 million people get an antibiotic-resistant infection each year, and more than 35,000 people die, according to a recent report by the CDC. Shionogi’s marketing application largely relied on the results of the pivotal.
ENDPOINTS 11/14/2019 16:47
Weeks after Amgen took a $2.7 billion stake in BeiGene, the Beijing-based biotech has secured its first-ever FDA approval for zanubrutinib, a BTK inhibitor, months ahead of schedule. BeiGene’s drug, branded as Brukinsa, has secured accelerated approval for adult patients with mantle cell lymphoma who have received at least one prior therapy. The approval is based on a single-arm, 86-patient trial that was designed to measure how many patients experienced complete or partial shrinkage of their tumors after treatment (overall response rate).
ENDPOINTS 11/14/2019 11:34
→ After its rare disease drug to Allievex , BioMarin on its ongoing Phase II study of vosoritide in children with achondroplasia. The study showed that in “over 54 months, children in cohort 3 (N=10) of the study, at a dose of 15 µg/kg/day, achieved a statistically significant (p < 0.005) cumulative additional mean height gain of 9 cm compared to children, matched for age and gender, in a new natural history achondroplasia dataset (N=619).” The company plans to release the data from its Phase III study by the end of the year. → Thermo Fisher, which last month with microbiome product manufacturer Arranta Bio, on Thursday said it has opened a in Shanghai, China — following the announcement of a Biosciences customer exploration center in Shang.
ENDPOINTS 11/14/2019 11:32
First comes the $62 billion buyout. Then comes the asset auction and reorganization to pay down debt. Now comes the detailed pledge of a bigger, brighter future in drug development. That’s where Takeda finds itself on R&D day today, about 11 months after closing on their . R&D chief Andy Plump is joining CEO Christophe Weber and other top members of the team to outline a new set of priorities in the greatly expanded pipeline at Takeda, which has jumped into the top ranks of the world’s pharma giants in the wake of the Shire deal.
ENDPOINTS 11/14/2019 11:27
Having tasted early success in treating a number of muscular dystrophies with gene therapy, Sarepta is setting itself up to tackle more rare diseases. The Boston-based biotech has picked StrideBio for a partnership evidently designed to run years, kicking things off with $48 million upfront and four central nervous system targets.
ENDPOINTS 11/14/2019 11:06
The short seller Muddy Waters is taking aim at Japan’s most profitable biotech, projecting a slide for a company that has skyrocketed over the last four years. Meanwhile, the firm tweeted out an analysis accusing FibroGen of manipulating data to obscure safety concerns in their latest reveal, although some investors seem satisfied by the biotech’s explanation. Muddy Waters shorted PeptiDream, a Japanese biotech-for-hire that leveraged its peptide library into partnerships with some of the world’s largest pharmaceutical companies, a 50% profit margin and $6 billion valuation. The firm noted that despite its esteem, PeptiDream has failed to bring a drug to market 13 years after its 2006 launch (although this is not especially rare for biotech.
ENDPOINTS 11/14/2019 10:33
Having served in Afghanistan, the navy veteran leading California-based EpicentRx wants to leave no patient behind with his arsenal of anti-cancer drugs. On Thursday, the company was given a $35 million boost to further its mission. The injection of funds will be used to shepherd its late-stage CD47 drug, RRx-001, to the FDA for marketing, and its oncolytic virus program into the clinic. RRx-001, engineered as an agent that makes tumor cells more sensitive to therapy, is in a Phase III trial in combination with chemotherapy for use in third-line and beyond small cell lung cancer (SCLC). The drug has been granted orphan drug designation from FDA for SCLC, neuroendocrine cancer and glioblastoma. In a 26-patient preceding the pivotal SCLC stud.
ENDPOINTS 11/14/2019 09:16
AstraZeneca’s R&D group doesn’t take failure lying down. Hit with pivotal setbacks for their MEK 1/2 inhibitor selumetinib in several cancer studies, they regrouped and included it in their $8.4 billion alliance with Merck as the therapy was steered into a Phase II for rare cases of neurofibromatosis type 1, or NF1. That data gave the pharma giant a breakthrough drug designation in the spring, and now they are on track for a Q2 2020 PDUFA after the FDA added a priority review to the gift package today. By inhibiting the MEK enzyme in the RAS/MAPK pathway investigators have demonstrated that the drug can control errant signaling that controls cell growth — at least relevant to NF1. Back in 2018, when Ned Sharpless was running the National Ca.

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