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ENDPOINTS 09/18/2019 15:59
As part of efforts to prepare for the continued rise in data-rich applications and to help fill the gap separating scientific advances and new therapies, the FDA on Wednesday unveiled its Technology Modernization Action Plan (TMAP). Near-term modernization in computer hardware and software technologies are the focus of the FDA’s TMAP, which offers a broad overview of how the agency needs to adapt.
ENDPOINTS 09/18/2019 13:10
Chemotherapy and radiotherapy are the current gladiators of cancer treatment, and it comes with well-known limits and side-effects. The emergence of immunotherapy — a ferocious new titan in oncologist’s tool box — takes the breaks off the immune system to kill cancer cells with remarkable success in some cases, but the approach has its own drawbacks. What makes certain forms of cancer so resilient? Scientists may have finally pieced together a tantalizing piece of the puzzle, and a new biotech is being launched on the back of this new finding. For long, scientists have theorized that cells — which tend to be viewed in isolation — are interdependent and function in unison. For instance, cells work together in the heart to produce a heartbeat.
ENDPOINTS 09/18/2019 11:08
The pharmaceutical industry has been merging like Porsches on the autobahn of late, raising concerns from unions and consumer groups that a growing oligopoly is promoting anti-competitive practices. Now the mergers have provoked the ire of US lawmakers as eight Democratic senators and one wily-haired independent have written a letter to the Federal Trade Commission asking the regulatory agency to crackdown and specifically scrutinize two pending deals: AbbVie’s for Allergan and Bristol-Myers Squibb proposed of Celgene. “The industry consolidation is occurring against a backdrop of ever-rising prescription drug spending and reports that one in four people taking prescription drugs have difficulty affording their medication,” the senators, le.
ENDPOINTS 09/18/2019 10:51
The idea that flushing senescent cells — those old, fatigued cells that cease to divide — from the body may rid the body of harmful proteins has been one of the prominent proposals in the anti-aging sphere. Having generated a stream of animal data to support the hypothesis, the Mayo Clinic now has results from an early human study suggesting they have found drugs that can do exactly that. Latonya Hickson. To be sure, the main goal of the Phase I trial wasn’t to show the effects of decreasing senescent cells in the body; rather, the scientists were keen to prove that a senolytic regimen they’ve tested in mice works the same way in humans. This is significant because despite the publication of first-in-human data in January, “so far, there has.
ENDPOINTS 09/18/2019 10:46
→ vTv Therapeutics — focused on the development of oral small molecule drug candidates — additional positive data from its Phase II Simplici-T1 study in patients with type 1 diabetes (T1D). CSO Carmen Valcarce presented new continuous glucose monitor (CGM) and insulin dose data from patients with complete CGM profiles in the completed Phase II – Part 1 of the study, which includes:. “TTP399 treatment (n=6) increased Time in Range from baseline to end of treatment by 11% (2.7 hours) (p=0.055) per day (24 hours), and by 12% (1.7 hours) (p=0.04) during the critical waking hours (7am-9pm) relative to placebo (n=9). TTP399 treatment reduced the total daily mealtime bolus insulin dose by 23% compared to 4% for placebo while significantly improving.
ENDPOINTS 09/18/2019 07:15
About a dozen drugmakers and industry groups recently offered their opinions on a revised FDA draft guidance related to population pharmacokinetics (PK) analyses submitted as part of new drug applications and biologic license applications. The comments largely seek specific tweaks to the 23-page revised draft, which was , although some of the comments also seek further clarity and new additions to the guidance. Industry group PhRMA, for instance, recommends that the FDA add more specific examples or literature references throughout "to provide detail to the high-level recommendations and to support the technical statements."
ENDPOINTS 09/18/2019 07:10
The FDA on Tuesday unveiled a new initiative whereby its Oncology Center of Excellence (OCE) will work to approve new cancer drugs alongside Australia’s Therapeutic Goods Administration (TGA) and Health Canada. The collaboration, dubbed , was launched with the FDA’s decision with TGA and Health Canada to grant accelerated approval to Eisai’s Lenvima (lenvatinib) in combination with Merck’s Keytruda (pembrolizumab) for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), and who have disease progression following prior systemic therapy but are not candidates for curative surgery or radiation. All three regulators said they collaboratively worked.
ENDPOINTS 09/18/2019 07:05
Flush with cash from a $102 million round in July, preclinical biotech IGM Biosciences and its enriched squad of cancer-focused antibodies are scurrying onto an upsized Nasdaq debut. The Mountain View, California-based company in August unveiled plans for a $100 million IPO — on Tuesday it disclosed it had raised by selling about 10.9 million shares for $16/share.
ENDPOINTS 09/18/2019 05:23
As Themis gears up for a Phase III trial of its chikungunya vaccine, the Vienna-based biotech has closed out €40 million ($44 million) to foot the clinical and manufacturing bills. Erich Tauber. Its heavyweight partners at Merck — which signed a pact around a mysterious "" last month — jumped into the Series D, led by new investors Farallon Capital and Hadean Ventures.
ENDPOINTS 09/18/2019 01:00
The process is grinding and often terminal, like a fine car with a transmission patched up a dozen times but still jamming and in dire need of replacement. Patients with late-stage chronic liver disease will decompensate (lose organ function) and though that instance can be treated, each time is like another jolt on the gears. Eventually, the car won’t drive. There are transplants, but over half of the patients die waiting for those. Meriam Kabbaj. A new method from Swiss biotech Versantis wouldn’t cure chronic liver disease but it promises to give far better immediate care and offer a treatment for a couple rare forms of liver disease that currently leave patients without good options short of a transplant. The company just took in $16 mill.
ENDPOINTS 09/17/2019 10:48
An explosion started a fire at a Russian research center that houses smallpox and Ebola, blowing out glass windows and inflicting third-degree burns on one worker, although state-run media said that there is no danger to the general population. The State Research Center of Virology and Biotechnology, also known as the Vector Institute, is one of only two places in the world that still houses the smallpox virus, after the WHO declared the disease eradicated in 1980.
ENDPOINTS 09/17/2019 10:35
More than three years after making a , Sienna Biopharmaceuticals has filed for bankruptcy. The company’s shares — which once crossed the $24 mark — have recently been languishing in penny stock territory — the stock never quite recovered from the of its experimental skin drug, SNA-001, in acne patients in 2017 (although the therapy is still being evaluated as an approach for laser hair removal). This January, the company executed a restructuring plan to focus its resources on its lead product candidate, SNA-120, for psoriasis and the associated pruritus — culling 20 jobs in the process.
ENDPOINTS 09/17/2019 10:29
→ Amgen has enlisted Hummingbird Bioscience on a new , turning over some novel targets to see if the smaller player’s “systems biology” platform can yield better therapeutics. Starting with two initial programs with the potential to add 10 more over the next six years, Amgen has exclusive options to license the resulting antibodies for $100 million per project. Hummingbird, which has offices in Houston, South San Francisco and Singapore, is also receiving an undisclosed upfront and research payments. → Enthusiastic insiders have encouraged IGM Biosciences to propose a much bigger IPO, increasing the proposed raise from $100 million to . The preclinical biotech is still eyeing a price range of $15 to 17, but the number of shares being offere.
ENDPOINTS 09/17/2019 09:39
As part of its work to improve and modernize the quality assessment of drug applications, the FDA is developing a new, more standardized system, to be known as the Knowledge-aided Assessment & Structured Application (KASA), according to an article authored by officials from the FDA’s Center for Drug Evaluation and Research and published in the latest issue of the International Journal of Pharmaceutics. The authors describe KASA as a new system that captures and manages information in a structured format about the inherent risk and control approaches for product design, manufacturing and facilities. The system is meant to help the FDA address challenges related to its quality assessments.
ENDPOINTS 09/17/2019 09:03
A San Diego couple has been charged with stealing trade secrets from a US hospital and opening a business based off those secrets in China, as the controversial industry-wide crackdown on alleged corporate espionage continues. On the same day, the Department of Justice announced they had arrested Beijing representative Zhongsan Liu for allegedly trying to obtain research visas for government recruiters. Li Chen, 46, and her husband Yu Zhou, 49, were accused by federal prosecutors of conspiring to, attempting and successfully stealing secrets related to exosome research from Nationwide Children’s Hospital in Columbus, Ohio, where they worked for 10 years. Liu, head of the China Association for International Exchange of Personnel (CAIEP-NY),
ENDPOINTS 09/17/2019 08:59
Right after jumping on Michael Milken’s on Monday, the newly departed FDA commissioner is back today with news about another life sciences board post that gives him a ringside chair to cheer on a lead player in the real-world evidence movement — one with very close ties to the FDA. Aetion is reporting this morning that Gottlieb is joining their board, a group that includes Mohamad Makhzoumi, a general partner at New Enterprise Associates, where Gottlieb returned after stepping out of his role at the FDA 2 years after he started. Gottlieb — one of the best connected execs in biopharma — knows this company well.

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