Search Results for “Johnson ” – Page 9 – media

J&Js Rybrevant plus Lazcluze combination gets FDA approval in NSCLC

Johnson & Johnson’s (J&J) Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib) has secured US Food and Drug Administration (FDA) approval as a first-line treatment for patients with some types of non-small cell lung cancer (NSCLC). The indication covers patients with locally advanced or metastatic NSCLC with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test. The approval is based on data from the Phase III MARIPOSA study (NCT04487080), which compared the Rybrevant/Lazcluze combination to AstraZeneca’s Tagrisso (osimertinib). Data showed that Rybrevant plus Lazcluze reduced the risk of disease progression or death by 30% compared to Tagrisso alone. Additionally, the median duration of response was nine months longer with the combination therapy compared to Tagrisso. The study met its primary endpoint of progression-free survival (PFS) and additional secondary endpoints, including participant race, type of EGFR mutation, and history of brain metastasis. These ...
- Source: drugdu
- 84
- August 22, 2024
Adcendo and Multitude ink ADC deal potentially worth $1bn

The antibody drug conjugate (ADC) dealmaking trend has seen yet another example as Adcendo has signed a licencing agreement potentially worth over $1bn with China-based Multitude for its tissue factor-targeting ADC candidate. The Danish company will acquire the global rights for the development and commercialisation rights for ADCE-T02, except in the Greater China region, including mainland China, Hong Kong Special Administrative Region, Macao Special Administrative Region, and Taiwan. The companies were light on financial details noting that upfront and milestone payments will “total over $1bn”. The deal also has the option for “single digit to low double digit” tiered royalties. “We are highly impressed by the deep science behind Multitude Therapeutics’ linker/payload platforms and are delighted about our licensing agreement on ADCE-T02, which perfectly complements our existing unique first-in-class ADC pipeline and allows Adcendo to become a clinical-stage biotech company in Q4 2024,” said Adcendo CEO, Michael Pehl. “The highly ...
- Source: drugdu
- 77
- August 22, 2024
CMS Touts First Negotiated Drug Prices, But Greater Impact Expected in Future Rounds

The first 10 drugs selected for Medicare price negotiations now have new prices set to take effect in 2026. Industry observers note that most of these drugs are older products facing generic competition soon, so greater industry impact will come as the program expands to more drugs in years to come. By Frank VinluanMedicare has unveiled prices for the first 10 drugs selected for its negotiation program, resulting in discounts of as much as 79% off of list prices. Taxpayers will save an estimated $6 billion, the White House said in a Thursday announcement of the new prices. The savings won’t happen right away. New pricing for these products won’t take effect until Jan. 1, 2026 for those with Medicare Part D prescription drug coverage. But these 10 widely used products in therapeutic areas such as diabetes and autoimmune disorders represent the first of many drugs on a path to ...
- Source: drugdu
- 105
- August 19, 2024
FDA Awards Accelerated Approval to Gilead Sciences Drug for Rare Liver Disease

Livdelzi is now FDA-approved for treating the rare liver disease primary biliary cholangitis. Gilead Sciences added the drug to its pipeline via the $4.3 billion acquisition of CymaBay Therapeutics earlier this year. By Frank Vinluan A Gilead Sciences drug acquired earlier this year in a multi-billion dollar deal is now FDA approved as new treatment for primary biliary cholangitis (PBC), a rare liver disease that can lead to liver failure. The approval announced Wednesday for the drug covers the treatment of adults whose disease is inadequately managed by the standard of care PBC drug as well as those who cannot tolerate that drug. The Gilead therapy, seladelpaar, will be marketed under the brand name Livdelzi. PBC is a rare, progressive autoimmune condition that leads to inflammation and scarring of the liver’s bile ducts. The chronic disorder, which impairs liver function, mainly strikes women over 40 years of age. Gilead estimates that ...
- Source: drugdu
- 77
- August 16, 2024
Chinese CAR-T Pioneer Legend Biotech in Profile

Chinese player Legend Biotech reached a new turning point last month when its Johnson & Johnson-partnered Carvykti became the first BCMA-targeted CAR-T cell therapy to be approved by the FDA for second-line treatment of multiple myeloma. From its original roots in China to its first FDA approval in 2022, the company has remained uniquely focused on CAR-T cells targeting the BCMA protein. Humble Beginnings and a Breakthrough Approval Back in 2014, a team of Chinese scientists began investigating cell therapies for cancer under the banner of the “Legend Project,” operating in what the company calls “a room the size of a freight elevator.” After making the decision to focus its research solely on chimeric antigen-receptor T-cells (CAR-T) targeting the BCMA protein in 2015, Legend began conducting its first clinical trials in 2016. The pioneering biotech landed its first major vote of confidence from the global life sciences community in 2017, ...
- Source: drugdu
- 75
- August 9, 2024
Buyout of China’s drug companies by global pharma giants sparks national security fears

Chinese pharmaceutical industry insiders have warned that foreign takeovers may damage the sector and even threaten national security. Since December, five Chinese biotech drug makers have been sold to global pharmaceutical giants. Industry insiders have warned that this could have a negative impact, especially given the risk that the United States could extend its technology sanctions to essential medicines. John Cai, chairman of China Healthcare Innovation Platform Academy, a healthcare think tank in Shanghai, said: “When national conflicts occur and drugs are sanctioned as strategic products, it will affect the health of a country’s population. “Considering that China’s biopharmaceutical and broader healthcare industry are now facing international competition and restrictions, Beijing should act with a sense of urgency.” He also said that research and development was a long process and if innovative products were sold as soon as they were developed, it would be difficult for China to cultivate world-class ...
- Source: drugdu
- 62
- August 8, 2024
Jade Bio’s Launch, Brenig’s Debut, Confo’s Cash & More

Recent financing news includes several companies raising money to advance their research to the clinic. Here’s a look back at funding rounds from companies such as Outpace Bio, GRO Biosciences, and Confo Therapeutics. By Frank VinluanOne challenge for developing drugs for autoimmune diseases is that biologic therapies can spark an immune response against them. Immunology and inflammation research is coming up with new approaches to reduce the risk of such responses. That science is progressing in the hands of new companies raising fresh rounds of capital. Inflammation and immunology figures prominently in recent funding news, which includes several companies approaching the clinic with novel biologic drugs. Here’s a recap of recent biotech financings, grouped according to therapeutic area: Immunology & Inflammation —Abiologics unveiled an artificial intelligence-driven platform technology for designing novel biologic drugs based on non-standard amino acids. The startup, which has been incubating within Flagship Pioneering for the past ...
- Source: drugdu
- 91
- August 6, 2024
New study suggests CAR-T therapy monitoring time could be slashed

The US Food and Drug Administration (FDA)-mandated monitoring time for CAR-T therapy patients could be halved, according to a new study. Chimeric antigen receptor (CAR)-T therapy involves modifying a patient’s T cells to recognise and attack cancer cells. There are three approved therapies to treat diffuse large B-cell non-Hodgkin lymphoma (DLBCL), notably Gilead’s Yescarta (axicabtagene ciloleucel) and Novartis’s Kymriah (tisagenlecleucel), which were approved by the FDA in 2017; and Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel), which won approval in 2021. Safety concerns surrounding CAR-T cell therapies related to cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS), led to strict FDA-mandated monitoring requirements when the therapies were first approved in 2017. To allow for the safe use of these therapies, the FDA established a risk evaluation and mitigation strategy (REMS) programme, which covered these monitoring requirements. Under the REMS programme, patients need to stay near the treatment centre ...
- Source: drugdu
- 87
- July 26, 2024
J&J drops Addex’s epilepsy treatment after flunking in Phase II

Johnson and Johnson (J&J) Innovative Medicine has decided to halt the development of its epilepsy drug, three months after a Phase II trial with the drug failed to meet its endpoints. The therapy was developed in partnership with Addex Therapeutics, which was quick to add that its collaboration with J&J is still ongoing as the companies analyse data from the placebo-controlled Phase II trial (NCT04836559). The drug failed to achieve statistical significance for the primary endpoint of time for patients to reach baseline seizure count. Addex’s stock has not recovered from the 53.3% nosedive it took after the Phase II results were released on 29 April. The company’s stock is now trading at $8.06 on the Nasdaq, down 49.9% from what it was worth before the news of Phase II results was announced. ADX71149 is a positive allosteric modulator (PAM) of metabotropic glutamate receptor-2 (mGlu2 receptor), which plays a key ...
- Source: drugdu
- 91
- July 25, 2024
Tau-Focused Asceneuron Adds $100M as Oral Alzheimer’s Drug Advances to Phase 2 Trial

Novo Holdings led Asceneuron’s $100 million Series C financing. The Merck Serono spinout’s lead program is an oral small molecule designed to prevent aggregation of tau protein in neurodegenerative disorders. By Frank Vinluan Alzheimer’s disease patients can now choose between new two intravenously infused therapies that work by breaking up plaques of amyloid protein in the brain. Asceneuron takes a different approach with oral therapies that address the buildup of tau, a protein that’s also associated with the neurodegenerative disorder. The biotech now has $100 million to advance its lead program to Phase 2 testing. The Series C financing announced Tuesday was led by Novo Holdings, the company that manages the assets of the Novo Nordisk Foundation, the controlling shareholder of metabolic drug giant Novo Nordisk. Using a drug to target and break up pathological proteins associated with Alzheimer’s has been validated by Eisai’s Leqembi, approved by the FDA last year, ...
- Source: drugdu
- 140
- July 18, 2024

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