BioXcel Therapeutics Inc. shares were up 11% to $22 after the company said the U.S. Food and Drug Administration has approved Igalmi dexmedetomidine sublingual film for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults.
The biopharmaceutical company said Igalmi can be self-administrated by patients under the supervision of a healthcare provider.
BioXcel said it is prepared to launch Igalmi in the U.S. in the second quarter of 2022.
The FDA approval of Igalmi is based on data from two placebo-controlled, parallel group Phase 3 trials evaluating Igalmi for the acute treatment of agitation associated with schizophrenia, or bipolar I or II disorder.
The primary endpoint was the mean change from baseline in the Positive and Negative Syndrome Scale-Excited Component total score assessed at two hours following dosing. The key secondary endpoint was the earliest time where efficacy, measured by the change from baseline in score, was statistically separated from placebo.
In both trials, Igalmi said that it met the primary endpoint at two hours after the first dose in patients treated with the 120 mcg and 180 mcg doses, demonstrating statistically significant improvements from baseline. Igalmi also met the key secondary endpoint, demonstrating a rapid onset of action, with statistically significant separation from placebo, the company said.
Boehringer Ingelheim says it is planning to invest a hefty €25 billion ($27 billion) in its pipeline over the next five years, as it reinvests healthy sales revenue from Eli Lilly-partnered SGLT2 inhibitor Jardiance.
The German group has just reported a 28% increase in Jardiance (empagliflozin) sales to €3.9 billion in 2021, buoyed by new approval in heart failure, which was accompanied by a 25% gain for pulmonary fibrosis therapy Ofev (nintedanib) to €2.5 billion.
The cash flow afforded by its top two sellers allowed it to invest €4.1 billion in its R&D last year as it pursues a goal of bringing 15 new products to market by 2025, the highest spend in its 137-year history and one which rivals some much larger big pharma groups.
Heading that list is spesolimab, its IL-36-targeted antibody already filed for approval as a treatment for generalised pustular psoriasis (GPP), a rare and sometimes life-threatening disease with no approved therapies.
Boehringer also highlighted its oral PDE4B inhibitor BI 1015550 for idiopathic pulmonary fibrosis, which has just picked up a breakthrough designation from the FDA after a positive phase 2 trial, and Gly-T1 inhibitor BI 425809, which breakthrough status for cognitive impairment caused by schizophrenia.
Its long-heralded push into oncology is still a couple of years away from fruition at least, but is headed by MDM2-p53 antagonist BI 907828 in phase 2/3 testing for alone and in combination with Boehringer’s experimental PD-1 inhibitor ezabenlimab in advanced solid tumours.
On the digital health front, Boehringer also shone a spotlight on Click Therapeutics-partnered digital therapeutic CT-155, a cognitive behavioural therapy app intended as an adjunct to drug treatment for patients with schizophrenia.
Boehringer’s ambitions rest in part on the continued success of Jardiance, which was launched for heart failure with reduced ejection fraction (HFrEF), catching up with its main rival Farxiga (dapagliflozin) from AstraZeneca, and then overtaking it last month when it was approved for heart failure with preserved ejection fraction (HFpEF) as well.
GlobalData thinks Jardiance can now overtake Farxiga in the heart failure category, although AZ’s drug retains an edge in other areas as it is also approved for chronic kidney disease (CKD), while Jardiance is still in phase 3 for that indication.
Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases announced that the National Medical Products Administration (NMPA) has approved Pemazyre®(pemigatinib) for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement as confirmed by a validated diagnostic test that have progressed after at least one prior line of systemic therapy.
Pemazyre®, discovered by Incyte and licensed to Innovent for development and commercialization in Mainland China, Hong Kong, Macau and Taiwan markets, is the first selective tyrosine kinase inhibitor approved for the treatment of cholangiocarcinoma, a type of biliary tract cancer, in China, representing a new milestone following its approval in Hong Kong market in January 2022, and in the Taiwan market in June 2021.
Vijoice is first approved treatment to specifically address the root cause of PROS conditions in select patients 2 years of age and older1
PROS is a spectrum of rare conditions and is characterized by atypical overgrowths and anomalies in blood vessels, the lymphatic system and other tissues2,3
Approval based on real-world data from EPIK-P1 study, which showed patients treated with Vijoice experienced reduction in the size of PROS lesions and improvement of PROS-related signs and symptoms
Novartis to offer robust patient support program that includes assistance to access medication, financial resources for eligible patients and continued education
BeiGene, Ltd. (NASDAQ:BGNE) today announced that marketing authorization applications (MAA) for tislelizumab, submitted by Novartis, the license holder in Europe, have been validated for regulatory review by the European Medicines Agency (EMA) for patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy and for patients with non-small cell lung cancers (NSCLC) including:
As monotherapy for the treatment of locally advanced or metastatic NSCLC after prior chemotherapy in adults,
In combination with carboplatin and either paclitaxel or nab-paclitaxel for the first-line treatment of locally advanced or metastatic squamous NSCLC in adults, and
In combination with pemetrexed and platinum-containing chemotherapy for the first-line treatment of locally advanced or metastatic non-squamous NSCLC in adults whose tumors have no EGFR or ALK positive mutations.
The Irish poet W.B. Yeats wrote of sailing to an imagined Byzantium because his was “no country for old men.” The pandemic has proven that the United States is no country for the young.
Many of us have lamented the terrible damage done to younger children by school closures and mask mandates — years of learning loss that may never be made up. Now we learn that the isolation and anxiety that accompanied school shutdowns have taken a heavy toll on adolescents.
The CDC found that more than a third of US high-school students reported poor mental health during the pandemic. Nearly half — 44% — said they felt sad or hopeless. A horrifying near-20% said they had seriously considered suicide in the previous 12 months.
The lifeline for those who made it through unscathed? Per the CDC data, it’s an obvious one: a feeling of “school connectedness.”
Teens who felt connected to both adults and their school buddies were far less likely to experience those feelings of sadness or despair: 35% vs 53%.On suicidal thoughts, the numbers are even starker, with 14% who felt connected having such thoughts vs. 26% of those who didn’t. And when it comes to actual suicide attempts, 6% of those who felt connected made the attempt vs. 12% of those who didn’t.
The CDC found that more than a third of US high-school students reported poor mental health during the pandemic.Getty Images/iStockphoto
These kids were twice as likely to attempt suicide if they felt disconnected.
It turns out that feeling connected to your friends and teachers is actually a matter of life and death. This is obvious to any parent of a teen and, indeed, to anyone who remembers being a teenager.
And — more news of the obvious — school closures played a major role in destroying those feelings of connectedness, paving the way for the depression epidemic now overwhelming our kids.
The CDC admitted this, if only glancingly, in its report on the findings. What it doesn’t admit is its own role in creating this epidemic.
“The COVID-19 pandemic has created traumatic stressors that have the potential to further erode students’ mental well-being,” chirped the body’s acting principal deputy director, Dr. Debra Houry, about the new data.
But those “stressors” were, in large part, created by the CDC.
Remember that the agency served as the legitimating body for a series of absolutely catastrophic public-health measures. Of these, school closures may well prove to be the one with the worst and longest-lasting consequences — consequences borne by the most vulnerable among us, our children.
That the body co-operated with educrats like union chief Randi Weingarten, giving the American Federation of Teachers line-editing authority to weaken its reopening guidance, both adds to the shame and proves beyond any doubt that its decisions had nothing to do with public health and everything to do with power politics.
The CDC’s acting principal deputy director said the “COVID-19 pandemic has created traumatic stressors that have the potential to further erode students’ mental well-being.”Getty Images/iStockphoto
Power politics, it must be noted, aimed at those with no direct electoral voice and no meaningful economic strength.
And that’s to say nothing of the fact that the real risks of COVID to young people — which are statistically negligible for those under 18, barring serious comorbidities — were consistently overstated by the public-health powers-that-be.
The CDC using distant, clinical language to indict school closures as a cause of this mental-health crisis is like a serial arsonist soberly pointing out that the fires he set have decreased the stock of affordable housing in the area.
The study found that 14% of students felt connected to suicidal thoughts compared to 26% who didn’t.Matthew McDermott
All without the faintest whiff of an apology.
That, however, is the standard operating procedure for our public-health establishment. Officials have made no acknowledgment of the manifold errors the CDC and other bodies made (on surface disinfection, air travel and many other subjects). Let alone any admission of responsibility for the social damage caused by the policies they endorsed — policies often described, in the hideous language of therapy, as “guidance.”
All this suggests that if we parents want our children to be both physically and mentally healthy, we need to loudly, ceaselessly and publicly demand that the CDC be held accountable.
The study found that 6% of teenagers who felt connected to suicide made an attempt to end their life.Education Images/Universal Image
But the people who did this to our children are still in positions of power and influence. The next time a health crisis arises, they are going to try to do it again.
The Food and Drug Administration is investigating why hundreds of consumers have reported becoming ill after eating Lucky Charms cereal, The Post has learned.
On Friday, The Post reported that the sugary cereal made by General Mills is believed to be making people sick, with consumers complaining that they began vomiting and experiencing diarrhea after eating a bowl of Lucky Charms.
Since then, more than 400 people have flooded iwaspoisoned.com — a website that tracks foodborne illnesses. Some have complained that their poop turned green.
Now the Food and Drug Administration said it’s aware of the reports “and is looking into the matter,” the agency told The Post.
“The FDA takes seriously any reports of possible adulteration of a food that may also cause illnesses or injury,” an FDA spokesperson said in a statement, adding, “Depending on the seriousness of the problem, an FDA investigator may visit the person who made the complaint, collect product samples, and initiate inspections.”
“The complaints are also discussed with company management during these inspections,” the spokesperson added, declining to say whether the FDA had contacted General Mills.
General Mills told The Post last week that it did not believe its cereal was making people sick, but it conceded that there is an “ongoing review” of the matter.
Nearly 140 people from July 2021 to March 2022 reported via Iwaspoisoned.com that they got sick after eating Lucky Charms.
General Mills did not immediately respond to a request for comment on Tuesday.
