December 18, 2019 | Reuters
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The U.S. Securities and Exchange Commission on Wednesday proposed changes to its decades-old definition of a professional investor in order to allow more Americans to buy shares in private companies. The agency hopes the changes will boost retail investorsâ€™ access to the swelling pool of companies that are staying private for longer and longer, but it has sparked worries among some investor advocates who say even seasoned investors struggle to spot problems with private companies.
Under current SEC rules, individuals who wish to put their money into the high-risk, high-yield private markets must earn an individual annual income over $200,000, or a combined $300,000 in shared annual income between spouses.
Alternatively, an individual may hold at least $1 million in assets, excluding oneâ€™s home.
These standards constitute the â€œaccredited investorâ€ designation.
Wednesdayâ€™s proposed changes, which are subject to public consultation, would broaden the definition to include a test of an investorâ€™s sophistication level â€œbased on professional knowledge, experience, or certifications,â€ the agency said.
September 7, 2019 | Los Angeles Times
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Dr. Janet Woodcock, director of the FDAâ€™s Center for Drug Evaluation and Research, says there is a disconnect between discoveries in the laboratory and medicines that reach the clinic. At first, it sounded like a breakup.
â€œItâ€™s not working, and it wonâ€™t work in the future,â€ said Dr. Janet Woodcock, the U.S. Food and Drug Administrationâ€™s top drug regulator.
She was speaking to an audience of about 150 researchers who are toiling to discover new medicines that will save lives. The room was silent.
â€œI donâ€™t want to bum everyone out,â€ she said. â€œThe science is fabulous, but thatâ€™s not enough.â€
To be sure, Woodcock wasnâ€™t looking to sever ties with the researchers, who work at universities, research institutes and pharmaceutical companies. But she did call for major reforms in the scientistsâ€™ relationships with regulators, doctors and one another. Without a wide-ranging overhaul, she said, their successes in the lab wonâ€™t make it to the patients who need them most.
Also see Q&A with Dr. Janet Woodcock at https://www.latimes.com/science/story/2019-09-05/future-of-medicine-fda-janet-woodcock
September 2, 2019 | WIRED
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Alex Zhavoronkov, CEO of Insilico Medicine, a startup that generates potential drugs using artificial intelligence, was recently given a challenge by one of his pharma company partners. His team would see how quickly Insilicoâ€™s AI could identify new molecules that bind with a protein associated with tissue scarring. Then theyâ€™d put the molecules to the test, synthesizing a few of them in the lab to see if the AI was onto something, or only dreaming.
Why the rush? It now costs $2.6 billion, by one estimate, to get a new drug to market, and pipelines are only getting slower and more expensive. Thereâ€™s hopeâ€”and hypeâ€”that AI could help chip away at that figure by reducing the time and labor before a drug starts clinical trials. The idea is that the same techniques used to generate realistic deepfakes and deftly play Go might be able to decipher the complex rules of drug design and generate molecules from scratch.
There are signs AI has potential. In December, Alphabetâ€™s DeepMind debuted AlphaFold, an algorithm designed to predict protein foldingâ€”an important step for identifying potential disease targets. It beat the longstanding competition in the pharmaceutical industry, handily. Still, some experts remain skeptical of whether AI can dream up molecules that are both effective and truly practical.
August 20, 2019 | Reuters
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Elanco Animal Health agreed to buy Bayerâ€™s veterinary drugs unit on Tuesday in a cash and stock deal valued at $7.6 billion, creating the second largest maker of medicines for pets and livestock and expanding Elancoâ€™s reach online.
The deal is the latest in the fast-growing animal health market, which has recently seen Elanco floated by Eli Lilly and Co and rival U.S. drugmaker Pfizer also spinning off its veterinary medicine business.
It also adds to the list of assets sold by Bayer, as the German company looks to slash debt from its $63 billion takeover of seed maker Monsanto last year and as it braces for a potential settlement of lawsuits over an alleged cancer-causing effect of weedkiller Roundup.
July 29, 2019 | FDA News Release
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The U.S. Food and Drug Administration today issued a revised draft guidance, Rare Pediatric Disease Priority Review Vouchers â€“ Guidance for Industry. The revised draft guidance incorporates public comments received on the initial draft and provides FDAâ€™s thinking regarding the provisions of the Advancing Hope Act of 2016, which updated the definition of a rare pediatrics disease as one that is a rare disease and one where the disease is serious or life-threatening with the serious or life-threatening manifestations primarily affecting individuals from age zero to 18.