| | | Three unique groups share all they learned about sample collection for COVID-19 testing and research. From a pop-up COVID-19 testing lab to a vehicle catching on fire with COVID-19 samples aboard, read their stories and recommendations. Download Now. 
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Today's Big News Sep 13, 2022 Encouraging Oramed phase 2 data ‘paint an exciting picture’ in rocky NASH landscape Akero hits endpoints in midphase NASH trial, linking candidate to improvements in fibrosis Rubius makes hard pivot after reviewing clinical data, dumping lead assets and laying off 75% of staffers Acelyrin scores series C that brings total raised in less than a year past $500M Gene interaction analysis predicts existing drugs that could be repurposed for autism Biden looks to beef up US biomanufacturing amid pressure from China Chinese vaccine developer Recbio taps OCT Clinical for COVID-19 shot trial Adagio goes for name rebrand as it tries to shake off bad run with COVID hopeful FAK inhibitors block breast cancer brain metastasis in mice Ra Medical lines up reverse merger with Catheter Precision after layoffs, stock crash Most physicians unclear on 'life-threatening emergencies' under abortion bans: survey Siemens Healthineers' Corindus surgical robot clears brain aneurysm study | By Gabrielle Masson Oramed Pharmaceuticals has posted encouraging phase 2 results for its oral insulin candidate designed to treat diabetes and non-alcoholic steatohepatitis. The company now awaits phase 3 readouts for the candidate that holds potential to become the first commercial oral insulin capsule for treating diabetes. |
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By Nick Paul Taylor Akero Therapeutics has delivered the strongest evidence yet that its nonalcoholic steatohepatitis candidate can improve liver fibrosis. After impressing investors with liver scarring data in phase 2a, the biotech has followed up with a primary endpoint hit against fibrosis in a larger midphase study. By Nick Paul Taylor Rubius Therapeutics has torn up its strategy. After reviewing human data on its lead candidates, the cell therapy biotech concluded investment in its two clinical prospects “is no longer justified,” leading it to stop studies and lay off 75% of its workforce. Shares in Rubius fell 25% to $0.80. Sponsored By Danaher Corporation The rapidly evolving field of genomic medicines has manufacturers scrambling to scale up the production of complex medicines. Flexible, automated and integrated technologies are the solution. By James Waldron Any biotech that can rake in half a billion dollars from investors in 12 months is clearly doing something right. The $300 million series C funding round Acelryin announced this morning means the inflammatory-disease-focused drug developer has reached that marker and now has its sights set on entering late-stage trials. By Helen Floersh By using a series of analyses to predict how gene protein products interact, researchers from Norway’s University of Oslo have homed in on existing drugs that they believe warrant testing in people with ASD. The results, published Monday in Frontiers of Pharmacology, indicate four possible meds: anti-diarrheal loperamide, dopamine D2 receptor agonist bromocriptine, the female hormone progesterone and the progestin birth control pill drospirenone. By Fraiser Kansteiner The Biden Administration, after setting its sights on America’s pharmaceutical supply chains last winter, is telegraphing its next move to restore the United States' drugmaking prowess. By Joseph Keenan Chinese biotech Recbio Technology is partnering with European CRO OCT Clinical to operate a phase 3 trail for a SARS-CoV-2 vaccine. By Ben Adams Adagio Therapeutics burst onto the scene in 2020 led by biotech veteran Tillman Gerngross, Ph.D., and in direct response to the COVID pandemic. But in the intervening years, much has changed at the company, and now a new name is reflecting this new reality. By Helen Floersh After seeing brain metastases retreat in a new preclinical mouse model for metastatic breast cancer, a group of scientists based at the University of Lausanne and the University of Fribourg in Switzerland is making the case for testing small molecule focal adhesion kinase inhibitors, or FAK inhibitors, in patients with the condition. By Andrea Park Just a few months after beginning a review of “strategic alternatives” to its existing business plan—and proceeding to lay off around two-thirds of its full-time employees—Ra Medical has plotted a new route to potential financial success. By Annie Burky Most doctors are confused about what constitutes a "life-saving emergency" to overrule state abortion bans, a recent Sermo poll found. In the poll, 70% indicated they were unclear about what constitutes a “life-threatening emergency” allowing a physician to legally perform an abortion in states where the procedure is otherwise banned. Currently, 12 states have banned the procedure entirely, with Georgia and Ohio instituting six-week bans. By Conor Hale The CorPath GRX Neurovascular System successfully completed 94% of its robotic-assisted procedures without the surgeon having to switch to a manual approach during the operation. Fierce podcasts Don't miss an episode | This week on "The Top Line," we discuss Sarepta's phase 2 Duchenne muscular dystrophy clinical trial that was green-lit earlier this week after a clinical hold in June. We also chat the opposing results on either side of the pond for Illumina quest for Grail. |
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| Tuesday, September 27, 2022 | 11am ET / 8am PT By standardizing core, repeatable IRT modules, clinical trial organizations can realize consistency and efficiency for all trials. Join The Secrets of Successful IRT Standardization and learn how Bayer did it. Register now. 
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