Signage is seen outside the U.S. Food and Drug Administration (FDA) headquarters in White Oak, Maryland, on August 29, 2020.
Andrew Kelly | Reuters
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The U.S. Food and Drug Administration approved 50 new drugs at the end of 2024, clearing a wave of long-awaited treatments.
This is according to the agency official statistics The total number of drugs approved for new treatments that have not been previously approved or marketed in the United States is down slightly from 55 in 2023, but the FDA approved some first-in-class drugs and other notable drugs last year.
These include the first treatment for metabolic dysfunction-associated steatohepatitis (MASH), a common and potentially fatal liver disease that affects millions of people worldwide. This drug Rezdiffra comes from Madrigal Pharmaceuticalsand now it’s succeeding in disease areas where big companies have failed or are still trying to get into it.
The FDA also approved the first two treatments for a rare, progressive genetic disorder called Niemann-Pick disease type C. Inability to transport cholesterol and other fatty substances properly within cells, leading to accumulation of these substances in the body.
For the first time, the agency approved a mipril method from Zefra Therapeuticsreached the finish line on its second try after being rejected in 2021.
The FDA also approved several drugs last year aimed at treating common diseases in new ways.
For example, Bristol-Myers SquibbCobenfy is the first new treatment approved to treat schizophrenia in decades. It is the first drug in a new class that does not directly block dopamine to improve symptoms.
Bristol-Myers Squibb’s Cobenfy drug
Courtesy: Bristol-Myers Squibb
PfizerThe new drug to treat hemophilia A or B, an inherited bleeding disorder, is also the first to target a specific protein involved in the clotting process. treat, Hempavcithe first drug approved specifically to treat hemophilia in the United States management Use a prefilled auto-injector pen.
MerckWinrevair becomes the first medicine to target the root cause of pulmonary arterial hypertension, a progressive and life-threatening lung disease. Other available medications only help control symptoms.
At the same time, the FDA approved AmgenTreatment with Imdelltra as second-line or late-stage treatment for patients with advanced small cell lung cancer. It is the first and only so-called T-cell engagement therapy approved to treat this deadly form of lung cancer.
Amgen’s drug is specifically designed to redirect the immune system’s T cells to recognize and kill cancer cells.
Other noteworthy FDA approvals include Eli Lilly and CompanyA long-awaited drug to treat early symptomatic Alzheimer’s disease has hit several hurdles on its way to market. Kisunla therapy is expanding the limited treatment options in the United States for conditions that cause mental degeneration.
It’s worth noting that many of the FDA’s approvals are for products from lesser-known public and private companies, such as Allecra Therapeutics, John Vance biotherapeutics and Bridge Bio Pharmaceuticals. This suggests that smaller biotech companies prefer to bring products to market on their own rather than partnering with or being acquired by Big Pharma.
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The latest in healthcare technology: Transcarent to take Accolade private for $621 million
On Wednesday, digital health startup Transcarent declare it will get honor The deal is worth approximately $621 million.
Transcarent, which earned a spot on CNBC’s Disruptor 50 list last year, provides self-insured employers with a risk pricing model to help their employees quickly access care and benefits. As of May, the company has raised approx. $450 million Valuation is $2.2 billion.
Accolade provides care services, navigation and advocacy services. The company went public in 2020 during the coronavirus pandemic and investors began pouring billions into the digital health space, but its stock has essentially been in freefall in the years since. Accolade is the latest in a series of digital health companies to exit the public markets as the industry realigns after the coronavirus pandemic.
Transcarent will pay $7.03 per share in cash for Accolade, a premium of approximately 110% to its closing price on Tuesday, Transcarent said. The deal is expected to close next quarter, subject to shareholder and regulatory approval.
“Combining Transcarent’s complex care experience with Accolade’s employees and 16 years of healthcare data, we will create a more personalized healthcare experience for people while improving outcomes and Reduce costs.
Evercore served as Transcarent’s financial advisor on this transaction. Morgan Stanley advised Accolade.
Transcarent CEO Glen Tullman is no stranger to flashy deals in digital health. Tullman previously ran Livongo, which was acquired by virtual care provider Teladoc in 2020 at a valuation of $18.5 billion.
When Teladoc acquired Livongo, the combined enterprise value of the two companies was $37 billion. Teladoc’s market capitalization is currently approximately $1.7 billion.
“I think the power of digital health care has been lost a bit since Livongo,” Turman told CNBC on Wednesday. “We’re now creating an experience that people not only like, but actually enjoy.”
Tullman said Transcarent and Accolade have “very similar visions.” Accolade has extensive expertise in medical opinion, primary care and patient advocacy services, which he said Transcarent’s customer base is seeking.
“I think it’s a perfect fit,” Turman said.
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