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…

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…

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 any number of biosimilar medicines in the U.S.

This connection is crucial to the sudden jump in Hyrimoz prescriptions. How so? On April 1, CVS Caremark, which is one of the largest pharmacy benefit managers in the U.S., removed Humira from its major national formularies for health plans that cover about 30 million lives. Then, Hyrimoz was added to the formularies, which are the lists of medicines that are covered by health insurance.

Continue to STAT+ to read the full story…

Contineum Therapeutics plans to spend most of its IPO cash on clinical testing of a lead drug candidate in development for idiopathic pulmonary fibrosis and multiple sclerosis. This small molecule blocks a competitive target pursued by several other companies, including Bristol Myers Squibb and AbbVie.

The post J&J-Partnered Contineum Corrals $110M From IPO for Clinical Trials in Fibrosis & MS appeared first on MedCity News.

The rotation will likely include this, this, this, this and this. And what about you? If it is true that spring has sprung — and we are still awaiting definitive evidence — you might want to enjoy the great outdoors and watch the trees and flowers slowly come to life. If huddling inside your castle is preferable, there is always the option of staring at the telly and binge-watching a few things. Or if you prefer old-fashioned contact sports, reach out to someone special. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …

Boehringer Ingelheim will lay off an undisclosed number of sales reps due to poor U.S. sales of its biosimilar version of AbbVie’s blockbuster arthritis treatment Humira, STAT reports. The drugmaker will switch to a hybrid model that mixes in-person and virtual sales by June 30, in large part because pharmacy benefit managers kept Humira on their formularies. That led to less uptake of biosimilar versions of Humira in the U.S., including Boehringer’s Cyltezo. Boehringer launched Cyltezo last July but has only managed to sell 1,487 prescriptions, according to IQVIA data. Almost 2.8 million Humira prescriptions have been written during that time.

An unprecedented crisis looms in India over supplies of injectable poliomyelitis vaccine, or IPV — a crucial tool in efforts to eradicate polio — now that Sanofi has shut its manufacturing plants in the country, The Economic Times reports. Sanofi, which is a leading supplier of the vaccine, ceased production of its IPV vaccine in December 2023, triggering concerns among health experts about an imminent supply disruption that may hobble the country’s most ambitious immunization campaign. IPV is made by only two companies — Sanofi Pasteur and Serum Institute of India, which started its supplies in 2021. Sanofi is believed to cater to over 80% of India’s IPV dose requirements.

Continue to STAT+ to read the full story…

After two decades on the U.S. market, Humira (adalimumab) last year began facing competition from multiple less-expensive biosimilar versions of the blockbuster therapy. Cyltezo is one of the only biosimilars that can be substituted for Humira at the pharmacy counter without a doctor’s permission, so it is in a better competitive position than most others. 

The price of Humira rose 470% in the 20 years following its launch in 2003 to reach upward of $84,000 annually. List prices of Humira biosimilars are as much as 85% lower. 

Continue to STAT+ to read the full story…

Meanwhile, here is the latest menu of tidbits for you to digest. We hope you have smashing day and conquer the world. And do keep in touch. We enjoy the missives very much. …

Top European prosecutors are investigating allegations of criminal wrongdoing in connection with vaccine negotiations between European Commission President Ursula von der Leyen and the Pfizer chief executive officer, Politico reports. Investigators from the European Public Prosecutor’s Office have in recent months taken over from Belgian prosecutors investigating von der Leyen over “interference in public functions, destruction of SMS, corruption and conflict of interest.” No one has yet been charged in connection with the case. The probe was originally opened by Belgian judicial authorities in early 2023 after a criminal complaint was lodged by a local lobbyist.

The net prices that health plans paid for medicines — after subtracting rebates, discounts, and fees — fell by 2.8% in last year’s fourth quarter, STAT writes, adding this is the largest decline ever measured by SSR Health, a research firm that tracks the pharmaceutical industry and its pricing trends. A key reason for the big drop — which dwarfed the 0.4% decline seen at the same time a year earlier — was pricing pressure on the Humira treatment for rheumatoid arthritis and psoriasis from biosimilar versions of the medicine. The Humira net price fell to roughly $29,800 at the end of last year from $48,000 at the end of 2022, a nearly 38% drop.

Continue to STAT+ to read the full story…

A key reason for the big drop — which dwarfed the 0.4% decline seen at the same time a year earlier — was pricing pressure on the Humira treatment for rheumatoid arthritis and psoriasis. Over the past year, nine biosimilar versions of the medicine were launched by other companies seeking favorable placement on formularies, the lists of drugs for which health insurance coverage is available.

As these companies battled to win placement, the Humira net price fell to roughly $29,800 at the end of last year from $48,000 at the end of 2022, a nearly 38% drop, the SSR analysis found. In fact, the entire category of rheumatoid arthritis medicines saw a 30% decline in annual net pricing, the largest such drop among all type of drugs. Meanwhile, net prices for psoriasis treatments fell nearly 10%.

Continue to STAT+ to read the full story…

New biotech newsletter launching this Thursday. Don’t miss out.

Hello, everyone. Damian here with a look at a pivotal FDA approval, good news for a small biotech company, and why not all buyouts are worth writing home about.

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