The director of the gastrointestinal oncology program at the University of Chicago Medical Center has been charged by the US attorney in Chicago with insider trading after he made more than $134,000 from stock trades based on an early look at the results of a Five Prime Therapeutics trial.
The US attorney’s office said yesterday that back in early November 2020, Daniel Catenacci, a University of Chicago associate professor with more than a decade of experience who worked with Five Prime on early trials, purchased more than 8,700 shares of the company the morning before it announced positive results from a Phase II trial in treating advanced gastric/gastroesophageal cancer.
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CALQUENCE is a registered trademark of the AstraZeneca group of companies.
At the 2021 American Society of Hematology (ASH) Annual Meeting & Exposition, blood cancer researchers from around the world gathered virtually to discuss the progress that has been made in the field of hematology. Over the past decade, that progress has been tremendous. We’ve seen not only breakthrough approaches to care, but also significant improvement upon existing novel treatments and exploring combinations within those medicines.1 These advances have transformed expectations of what a blood cancer diagnosis now means for patients. While we’ve come a long way, I believe the most exciting scientific discovery is yet to come, and that future advances will truly transform patient care.
Michel Vounatsos, Biogen CEO (Credit: World Economic Forum/Valeriano Di Domenico)
In a surprise move, Biogen announced Monday that it will cut the price of its controversial Alzheimer’s drug Aduhelm in half, slashing the cost from $56,000 to $28,000.
The sudden discount marks a sudden turnaround for the big biotech as it struggles to turn around a drug whose stuck-in-the-mud sales and political ramifications have sent the company into turmoil and triggered the ousting of its longtime chief scientist. Biogen’s leadership had resisted calls since June to reduce the price of the drug.
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Graphic: Alexander Lefterov for Endpoints News
Drug pricing reform has been a political football for years, with both Donald Trump and Joe Biden championing changes during their presidencies. Little has moved the needle on Capitol Hill, however, thanks in part to the drug industry’s powerful lobbyists.
In the most recent example, Democrats tried to allow Medicare to negotiate drug prices — an immediate non-starter for biopharma proponents. After months of negotiation, the measure fell apart in favor of provisions on a small subset of drugs that passed the House but marked a far cry from Biden’s promises and what many activists had hoped for. The bill, included as part of Biden’s broad social policy agenda, now appears dead after Democrats failed to secure 50 votes in the Senate.
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Angie You and Volker Schellenberger, Amunix
Sanofi is crashing the year-end M&A party with a deal of its own.
Immuno-oncology is the name of the game as it swallows Mountain View, CA-based Amunix for $1 billion upfront and up to $225 million in biobucks, tagging a suite of T cell engagers and cytokine therapies as well as a tech platform for making ‘conditionally activated biologics.’
‘The Amunix technology platform utilizes a next generation smart biologics approach to precisely tailor-deliver medicines to become active only in tumor tissues while sparing normal tissues,’ said Sanofi R&D chief John Reed, ‘thus bringing the promise of more effective and safer treatment options for cancer patients.’
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An injectable treatment for the prevention of HIV has been given the go-ahead by the FDA for use in adults and children weighing at least 77 pounds.
Apretude is first given as two injections given a month apart from each other, and then every two months after. Patients are given the option to start treatment with Apretude or the oral cabotegravir Vocabria for four weeks to assess how well to tolerate the drug.
A young man with Duchenne muscular dystrophy has died in Pfizer’s Phase Ib trial of its mini-dystrophin gene therapy, triggering a halt in screening and dosing — and a clinical hold imposed by the FDA.
Pfizer informed the Parent Project Muscular Dystrophy of the death in a community letter. The patient was participating in the non-ambulatory cohort of the trial, the company wrote, adding:
At this time, we do not yet have complete information and are actively working with the trial siteinvestigator to understand what happened.
Right as the new Omicron variant is poised to increase rapidly across the US, the federal government has effectively run out of the only monoclonal antibody treatment that works against it, and at least one major hospital system is now halting all mAb infusions.
Late last month, the federal government paused shipments of GlaxoSmithKline and Vir’s mAb treatment sotrovimab in order to conserve supplies of the only treatment that might work against the Omicron variant. Last week, however, HHS told Endpoints News that the move to hold back sotrovimab was unrelated to Omicron, and due to a surplus of Eli Lilly mAbs, which aren’t effective against Omicron.
One of Pfizer’s new vaccine TV commercials never mentions its vaccine brand Comirnaty. In fact, it doesn’t mention vaccines or Covid-19 at all and doesn’t show people wearing masks or social distancing. Yet it’s clear the ad is talking about the pharma’s Covid-19 vaccines.
The ad’s voiceover talks about the unremarkable moments and routines that matter, like getting a coffee refill at a diner or Sunday grocery shopping. The images shift from those everyday moments to a scientists and purple lidded glass vials spinning off a production line and being packed into freezers.
Sen. Joe Manchin (D-WV) at the Capitol on Friday, Dec. 17 (J. Scott Applewhite/AP Images)
Sen. Joe Manchin on Sunday derailed President Biden’s trillion-dollar spending package, effectively halting the Democrats’ best chance yet to allow Medicare to negotiate drug prices, among a bevy of other health-related provisions tacked onto the Build Back Better Act.
White House press secretary Jen Psaki, stunned by Manchin’s announcement on Fox News, said in a statement: ‘Senator Manchin claims that this change of position is related to inflation, but the think tank he often cites on Build Back Better — the Penn Wharton Budget Institute — issued a report less than 48 hours ago that noted the Build Back Better Act will have virtually no impact on inflation in the short term, and, in the long run, the policies it includes will ease inflationary pressures.’
https://endpts.com/doj-charges-former-five-prime-trialist-with-securities-fraud-after-134k-in-insider-trading-profits/
