Today, we’re sipping a hot cup of caffeinated black, while mulling the rise and fall and, apparently (!), rise again of Luckin Coffee, a chain whose cashless kiosks and discount lattes were once seen as China’s answer to Starbucks, before allegations emerged of widespread accounting fraud. This Bloomberg story has the best quote I’ve read all week, from a former executive (who was not accused of wrongdoing): “Obviously, it was wrong and unlawful to fabricate data. But you still have to acknowledge the great design that was its business model.” Anyway, here’s some news:

The FDA has questions about Eli Lilly’s experimental Alzheimer’s drug, STAT tells us. Documents released in advance of Monday’s advisory committee hearing show regulators are mulling whether donanemab, which slowed cognitive decline in a large study, should be limited to a subset of patients with a key biomarker, called tau, used to screen patients for Lilly’s trial. They also want to know if the drug’s benefits justify the risk of severe brain swelling and bleeds seen in the study.

The FDA took the rare step of publicly explaining why it rejected a drug, Endpoints relays. The agency put out a notice about the application to approve Vanda Pharmaceuticals’ sleep disorder drug Hetlioz as an insomnia medication, saying the company “does not provide substantial evidence of effectiveness” and didn’t show the drug was safe. It asked for a new “well-controlled” trial. Vanda is currently suing the FDA, while facing pressure to accept a takeover bid from Cycle Pharmaceuticals.

Continue to STAT+ to read the full story…

After all, the world continues to spin, although it remains a bit wobbly where we are after losing a Pharmalot ancestor, which explains our recent disappearance. To cope, we are brewing a cup of stimulation. Our choice today is hot buttery rum. As always, you are invited to join us. We hope your day is productive and meaningful. Either way, do keep in touch. …

Almost a dozen pharmaceutical companies have lost sensitive customer data due to a supply chain cyberattack that trickled down from Cencora, TechRadar writes. In late February, the wholesaler — previously known as AmerisourceBergen — disclosed a data breach incident with few details. But 11 drug companies have now submitted almost identical breach notification letters to the California Attorney General’s office claiming a data breach as a result of the Cencora incident. Among them is Novartis, GSK, Bayer, AbbVie, Regeneron Pharmaceuticals, Genentech, Incyte, Sumitomo Pharma America, and Acadia Pharmaceuticals.

A last-ditch effort by World Health Organization member states failed to finish negotiations on a pandemic accord ahead of the World Health Assembly meeting this week, The New York Times reports. The key articles in the draft text that remained unresolved included the thorny formula for global sharing of vaccines and medicines during international health emergencies. Among the most contentious issues in the draft treaty is a section called Pathogen Access and Benefits Sharing, under which countries would be required to swiftly share genetic sequences and samples of emerging pathogens. These data are crucial for rapid development of diagnostic tests, vaccines, and treatments.

Continue to STAT+ to read the full story…

While you ponder the sobering possibilities, we invite you to join us for a delightful cup of stimulation. Our choice today is maple bourbon. Remember that no prescription is required and so rebates do not have to be calculated. Meanwhile, here is the latest menu of tidbits to help you on your way. Have a wonderful day, and please do stay in touch. …

Fake studies have flooded publishers of top scientific journals, leading to thousands of retractions and millions of dollars in lost revenue, The Wall Street Journal says. The biggest hit has come to Wiley, which is closing 19 journals, some of which were infected by large-scale research fraud. The sources of the fake science are “paper mills” — businesses or individuals that, for a price, will list a scientist as an author of a wholly or partially fabricated paper. The mill submits the work, generally avoiding the most prestigious journals in favor of publications such as one-off special editions that might not undergo as thorough a review and where there is a better chance of getting bogus work published.

A U.S. lawmaker is accusing Amgen of “putting profits before patients” over its decision to continue marketing a high dose of a pricey cancer treatment instead of a lower dose that is less expensive and not as toxic to patients, STAT reports. At issue is a medication called Lumakras, which is used to treat non-small cell lung cancer and which won conditional regulatory approval three years ago. At the time, the Food and Drug Administration required Amgen to run a trial confirming earlier test results, as well as a so-called post-marketing study to examine safety and effectiveness at different dosages, in order to gain full approval.

Continue to STAT+ to read the full story…

Sabatini, who has denied harassing anyone and filed litigation over the claims, has been working since last October in a senior research position at the Institute of Organic Chemistry and Biochemistry, in the Czech Republic capital of Prague, investigating scientific questions in the areas of cell growth and metabolism, similar to his past research at Whitehead.

The Czech institute, known as IOCB Prague, is realizing a long-held ambition to expand into the Boston biotech hub, confirmed the institute’s director, Jan Konvalinka.

Continue to STAT+ to read the full story…

And here is our regular feature in which we highlight a different person each week. This time around, we note that Recludix Pharma hired Ajay Nirula as executive vice president and head of R&D. Previously, he worked at Eli Lilly, where he was senior vice president and the immunology therapeutic area head.

But all work and no play can make for a dull head of R&D.

Continue to STAT+ to read the full story…

We may also hold a listening party, where the rotation may include this, this, this and this. And what about you? This is a lovely time of year to enjoy the great outdoors. Perhaps you can catch a view of some cherry blossom trees while there is still time. You could stroll city streets to take in the sights. Life is with people, as they say. Or you could hold your breath and spend time catching up on the news of the world. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …

Cigna plans to make copies of AbbVie’s Humira arthritis drug available with no out-of-pocket payment to eligible patients in the U.S. using its Accredo specialty pharmacy beginning in June, Reuters writes. Cigna said it will stock high- and low-concentration versions from Boehringer Ingelheim, Teva Pharmaceutical, and Alvotech, which will be priced at about 85% lower than the $6,922.62 monthly list price of Humira. Deals were made with the manufacturers as well as its distributor Quallent to bring the out-of-pocket cost down to $0. Cigna said the move should save around $3,500 on average per year for some of the 100,000 Accredo patients using either Humira or biosimilar.

The World Health Organization says new evidence shows the extensive overuse of antibiotics during the Covid-19 pandemic worldwide, which may have exacerbated “silent” spread of antimicrobial resistance. While only 8% of hospitalized patients with Covid-19 had bacterial co-infections requiring antibiotics, some 75% of patients have been treated with antibiotics “just in case” they help. Overall, antibiotic use did not improve clinical outcomes for patients with Covid-19. The highest rate of antibiotic use was seen among patients with severe or critical Covid-19, with a global average of 81%. In mild or moderate cases, there was a considerable variation across regions.

Continue to STAT+ to read the full story…

We recall a bit of insight from the Morning Mayor, who taught us that “Every new day should be unwrapped like a precious gift.” To celebrate the notion, we are brewing still more cups of stimulation and inviting you to join us. Our choice today is pistachio creme. Remember, a prescription is not required. So no need to mess with rebates. Meanwhile, here are a few items of interest. Hope you have a meaningful and productive day and, of course, do stay in touch. …

A photo shows the WuXi Biologics chief executive officer shaking hands with John Crowley, the incoming head of the Biotechnology Innovation Organization, but three months later, a sister company, WuXi AppTec and BIO, ended their relationship and Crowley openly supported legislation to ban many U.S. biotechs from doing business with the Chinese behemoth, STAT says. The about-face illustrates the difficulty the biotech industry faces in dealing with an issue that, fueled by national security concerns, is moving fast and forcefully. It also tests the ability of Crowley, who lacks a background in politics, to navigate a domestic policy issue that is tangled up in U.S.-China relations.

Cerevel Therapeutics, a neuroscience biotech that AbbVie is acquiring, reported that its Parkinson’s disease drug improved motor symptom control as an add-on therapy in a late-stage trial, STAT writes. When AbbVie announced its $8.7 billion acquisition of Cerevel last year, it emphasized a different drug in the biotech’s pipeline, emraclidine, which is being tested for schizophrenia and has potential in dementia-related psychosis in Alzheimer’s disease and Parkinson’s. While tavapadon doesn’t appear to be the key drug AbbVie focused on its acquisition, the new positive results still represent a win for the pharma company as it completes the deal.

Continue to STAT+ to read the full story…

Cerevel Therapeutics, a neuroscience biotech that AbbVie is acquiring, reported that its drug for Parkinson’s disease improved motor symptom control as an add-on therapy in a late-stage trial.

The 27-week study found that patients taking the drug, tavapadon, on top of a common Parkinson’s treatment called levodopa, experienced 1.7 hours of improvement in “on time” without dyskinesia, which is the amount of time patients function well without involuntary movements that can be brought on by levodopa. That compared to 0.6 hours of improvement among patients taking placebo and levodopa.

This difference was statistically significant and clinically meaningful, Cerevel said in a press release Thursday. There was also a statistically significant decrease in “off time,” the amount of time patients experienced symptoms. The full results will be submitted for presentation at future medical meetings.

Continue to STAT+ to read the full story…

Our choice today is maple bourbon. Remember that no prescription is required. Meanwhile, here is the latest menu of tidbits to help you on your way. Have a wonderful day, and please do stay in touch…

Eli Lilly reported positive results for its obesity drug Zepbound in obstructive sleep apnea, giving the medication a new edge in the highly competitive obesity market, STAT tells us. The results also pave the way for Zepbound to potentially become the first approved treatment for obstructive sleep apnea, or OSA, a common disorder characterized by breathing interruptions during sleep. Obesity is a major risk factor of OSA, which is estimated to affect approximately 39 million U.S. adults, though many cases are undiagnosed, according to the National Council on Aging. Getting approval for indications other than weight loss would help Lilly in its attempts to expand insurance coverage.

Sage Therapeutics will stop development of its experimental drug to treat Parkinson’s disease after the treatment failed a mid-stage study, sending the company’s shares tumbling 36% before stock trading opened, Reuters reports. Parkinson’s disease, a progressive movement disorder of the nervous system, affects about 1 million people in the U.S. The failure is the latest hurdle for Sage Therapeutics after the U.S. health regulator last year approved the company’s and partner Biogen’s pill Zurzuvae as a treatment for postpartum depression, but rejected it for clinical depression, which is a much larger market.

Continue to STAT+ to read the full story…

Please feel free to join us. Meanwhile, here are a few items of interest to start you on your journey, which we hope is productive and meaningful. Have a grand day, and do keep in touch. …

The number of new prescriptions written for biosimilar versions of the Humira rheumatoid arthritis treatment, one of the best-selling medicines in the U.S., surged to 36% from just 5% during the first week of April, thanks to the expanding reach that CVS Health has over the prescription drug market, STAT writes. The big jump was attributed to one particular biosimilar called Hyrimoz, which is manufactured by Sandoz, a former unit of Novartis that is a leading supplier of generic and biosimilar medicines. However, Hyrimoz is jointly marketed with Cordavis, a new subsidiary that CVS created last August specifically to sell biosimilar medicines in the U.S.

Shah Capital is seeking a change in leadership at Novavax and wants to appoint two handpicked directors, Pharmaphorum notes. In an open letter, the hedge fund accuses Novavax’s leadership of squandering its “many significant competitive advantages and sizeable market opportunity” due to “self-inflicted problems” under the current team led by chief executive John Jacobs. The bid by Shah Capital – which owns 6.7% of Novavax and is one of its top five shareholders – comes as the company has seen its share price come under massive pressure since the midst of the Covid-19 pandemic, when its shares were trading above $290 and it had a valuation of more than $40 billion.

Continue to STAT+ to read the full story…