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.

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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.

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Meanwhile, do keep us in mind if you hear anything interesting. We continue to accept — at absolutely no charge to you — postcards and telegrams. And of course, we hope you have a smashing day. …

AbbVie announced that chief executive officer Richard Gonzalez, who has managed its ascent since being spun off from Abbott Laboratories in 2013, will step down in July, STAT notes. Gonzalez previously said he would depart when AbbVie had a plan in place to move on from its best-selling drug, Humira, which is now facing competition from cheaper biosimilars. He will be replaced by chief operating officer Robert Michael, who, like Gonzalez, is a longtime AbbVie executive. Worth noting: Gonzalez, 70, who will become executive chairman of the board of directors, should be a sobering reminder to pharmaceutical industry critics of the resilience of a chief executive officer’s reputation.

Three conservative-led states — Idaho, Kansas and Missouri — lost their bid to intervene in a battle between the Biden administration and conservative physicians over the abortion pill mifepristone, Bloomberg Law writes. The U.S. Supreme Court decision comes ahead of March 26 oral arguments in the case and marks a victory for the Biden administration in defending U.S. Food and Drug Administration safety decisions on the drug that previously were struck down by an appeals court. The state intervention motion was tailored to maintain the litigation should the Supreme Court find that the conservative physicians lacked standing to sue the FDA over its decisions on the pill.

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Pharmalot, and the rotation will likely include this, this, this, and this. And what about you? This is a fine time to enjoy the great indoors. So why not tidy up around your castle? When done, you could park yourself in front of the telly and watch a few moving picture shows. Of if you’re feeling old fashioned, you could pull out the Scrabble board. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …

U.S. Senate health committee chair Bernie Sanders has taken a step toward subpoenaing the chief executive officers at Johnson & Johnson and Merck related to an investigation into high drug prices in the U.S., STAT writes. The step is highly unusual, since the health committee has not issued a subpoena in more than 40 years. Sanders (I-Vt.) invited the J&J and Merck executives, along with Bristol Myers Squibb chief executive officer Chris Boerner, to testify at a Jan. 25 hearing. But only Boerner agreed, and only if at least one other chief executive participated. Instead, Sanders will hold a committee vote on whether to issue the subpoenas and authorize a probe into drug costs on Jan. 31.

But Johnson & Johnson is accusing Sanders of retaliating against the company and others that sued the Biden administration to stop a program to negotiate how much Medicare pays for high-cost drugs, Bloomberg Law reports. The allegation appears in a letter that was written one week before Sanders announced the Senate health committee would vote on whether it would use subpoenas to force J&J and Merck CEOs to testify on U.S. drug prices. The committee’s actions raise “significant concerns that the hearing is intended as retribution” against companies suing the Biden administration over the Medicare negotiation program, the letter says.

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We will draw on 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 invite you to join us. Remember, a prescription is not required. So no need to mess with rebates. Our choice today is crème brûlée. Meanwhile, here are a few items of interest. Hope you have a smashing day and, of course, do stay in touch. …

Starting April 1, CVS Health will no longer offer AbbVie’s Humira to patients in its commercial prescription plans and, instead, will direct them to biosimilar versions of the anti-inflammatory drug that became available last year, Bloomberg News writes. CVS’s Caremark unit is the first major pharmacy benefit manager to announce such a shift. The move is a blow for AbbVie, which managed to keep Humira on PBM lists of covered drugs even when plans added lower-cost biosimilars. CVS’s Cordavis unit will also start selling a version of Humira with AbbVie in the second quarter, though it will not be preferred on CVS commercial drug plans.

The U.S. Food and Drug Administration is evaluating reports of side effects such as hair loss and suicidal thoughts in people taking medications known as GLP-1 receptor agonists, which are approved to treat diabetes or weight loss, CNN reports. These include Ozempic, Rybelsus, Wegovy, Saxenda, Victoza, Mounjaro, and Zepbound. The FDA is “evaluating the need for regulatory action” after its FDA Adverse Event Reporting System or FAERS received reports of alopecia, or hair loss; aspiration, or accidentally breathing in things like food or liquid; and suicidal ideation in people using these medications.

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We trust you have your own busy agendas. So join us as we hoist the ever-present cup of stimulation — our choice today is gingerbread — and attack the fast-growing to-do list. We hope you have a smashing day and, of course, do stay in touch. Our settings are adjusted to accept postcards and telegrams. …

Activist investor Carl Icahn plans to oust directors at Illumina, laying the groundwork for a second board challenge at the gene-sequencing company months after shareholders elected one of his director candidates, Reuters writes. Icahn disclosed his plans without offering details in a letter to other shareholders less than 24 hours after Illumina said it will divest blood test maker Grail. In Monday’s letter, Icahn blamed the Grail acquisition, which has faced regulatory challenges since 2021, for a 75% drop in Illumina’s share price that he says wiped away $55 billion in value for shareholders. The stock was up more than 2% at $130.39 on Monday.

As more data emerge that obesity drugs like Wegovy can reduce complications from heart and kidney problems as well, scientists have been wondering whether these benefits are driven by weight loss alone or also by other mechanisms. A new study suggests that one possible contributor is the drugs’ ability to reduce inflammation independent of weight loss, STAT tells us. In mice experiments, scientists found that the treatments, known as GLP-1-based drugs, acted through the brain to reduce inflammation throughout the body. This was over a short period of time before the mice lost weight, according to the study, published Monday in Cell Metabolism.

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Pharmalot and the rotation will likely include this, this, this, and this. And what about you? With holidays unfolding, you could head to your local temple of consumption and give the economy a boost. You could also plan an end-of-year getaway or, perhaps, you might soak in the great outdoors with a ride in the country or a walk in the park. Well, whatever you do, have a grand time. And be safe. Enjoy, and see you soon. …

After months of deliberation, the Biden administration disclosed plans to sidestep patents in order to lower costs for some pricey medicines that were discovered with taxpayer money. But the move, which must still be finalized by an inter-agency working group, is already causing uncertainty over the extent to which drugmakers may lose valuable monopolies and consumers will save money, STAT explains. This reflects the seemingly contradictory approach the administration has taken toward the controversial concept, as well as open-ended language in the proposal. As a result, there is a mix of fear and doubt as the pharmaceutical industry and patients try to envision the eventual terms.

The $32,000 cost of a crucial drug to treat severe lead poisoning drew ire from U.S. Sen. Amy Klobuchar (D-Minn.), who wrote a letter to Rising Pharmaceuticals seeking answers on how the company reached its price, CNN says. The drug costs almost 10 times more than an imported version of the medicine from France, which the U.S. Food and Drug Administration had allowed to be used in the U.S. while the drug was in shortage. Toxicologists says the price can make it difficult for hospitals to stock the medicine, called calcium disodium EDTA, potentially leading to delays of days when patients need urgent treatment. EDTA is used for the most severe cases of lead poisoning.

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Remember, a prescription is not required. So no need to mess with rebates. Our choice today is chocolate raspberry. Meanwhile, here are a few items of interest. Hope you have a smashing day and, of course, do stay in touch. …

The White House is throwing its support behind a controversial authority that allows the government to claw back patents for certain high-priced medicines, STAT tells us. The move is an early step that could have major ramifications for the pharmaceutical industry, depending on whether and how federal officials actually use the authority. The administration will issue a framework for the U.S. National Institutes of Health to more broadly use march-in rights, a policy that allows it to seize patents from drugmakers whose products rely on federally funded research. The framework will detail when the agency might assert this authority, and endorse using drug prices when deciding.

AbbVie announced plans to purchase Cerevel Therapeutics and its pipeline of experimental neurological and psychiatric medications for $8.7 billion, STAT writes. The deal marks the second billion-dollar acquisition by AbbVie in under a week. Facing the prospect of declining sales from two of its best-selling drugs, the company also acquired Immunogen and its ovarian cancer treatment for $10 billion last week. With this latest deal, AbbVie will acquire several clinical-stage molecules for Parkinson’s, schizophrenia, and epilepsy, among other disorders, many of which previously belonged to one of its biggest rivals.

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Please feel free to join us. Now, though, the time has come to get cracking. So here is the latest assembly line of items of interest for your enjoyment. We hope you find these useful and have a smashing day. Best of luck and, as always, do stay in touch. …

AbbVie will pay $10 billion for Immunogen, acquiring an approved treatment for ovarian cancer and buying into a burgeoning area of oncology, STAT writes. Under the agreement, AbbVie will pay $31.26 per share in cash, a nearly 100% premium. Central to the deal, which is expected to close in the middle of next year, is Elahere, an Immunogen product that won U.S. Food and Drug Administration approval for advanced ovarian cancer in 2022. Elahere is among a surging class of cancer medicines called antibody-drug conjugates, or ADCs, which are designed to deliver a targeted dose of chemotherapy directly to tumor cells while sparing healthy tissues.

Novo Nordisk filed lawsuits against two compounding pharmacies for selling adulterated and misbranded compounded drugs claiming to contain semaglutide, the active ingredient in Wegovy and Ozempic (see here and here). Testing of compounded drugs from these pharmacies revealed unknown impurities up to 33%, the company claims. To date, Novo Nordisk has filed a total of 12 lawsuits against medical spas, weight loss or medical clinics, and compounding pharmacies, claiming the businesses engaged in false advertising, trademark infringement, and unlawful sales of non-FDA approved compounded products that purportedly contain semaglutide.

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To help you along, we have assembled another laundry list of items of interest for you to peruse. Meanwhile, do keep us in mind if you hear anything interesting. We continue to accept — at absolutely no charge to you — postcards and telegrams. And of course, we hope you have a smashing day. …

Making good on a recent threat, the U.S. Federal Trade Commission is challenging more than 100 patents on brand-name medicines that it says were improperly or inaccurately listed by some of the world’s biggest drug companies in a key government registry, STAT writes. The agency notified 10 companies that listings for dozens of patents on such medicines as asthma inhalers and epinephrine autoinjectors are being disputed. The companies that received warning notices included AbbVie, AstraZeneca, and subsidiaries of GSK and Teva Pharmaceutical. The companies have 30 days to withdraw or amend their patent listings, or certify under penalty of perjury the listings comply with federal law.

Activist investor Elliott Investment Management has built a stake in BioMarin Pharmaceutical and and held discussions with the company for months about its future, according to Reuters. The hedge fund, which oversees some $60 billion in assets, has spent over $1 billion on the stake in BioMarin, which focuses on rare genetic disorders and is valued at about $16 billion. BioMarin is trying to find its footing amid a change in chief executives and slow progress in the launch of its drug Roctavian to treat hemophilia. Analysts noted that BioMarin’s hard-to-manufacture therapies and the fact that its entire portfolio is excluded from Medicare prescription drug price negotiations could appeal to buyers.

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