Search Results for “FDA” – Page 117 – media

European Commission greenlights Mirati’s Krazati in KRAS-mutated NSCLC

Mirati Therapeutics has received conditional marketing authorisation from the European Commission for Krazati (adagrasib), a targeted treatment for patients with KRASG12C-mutated advanced non-small cell lung cancer (NSCLC). Mirati filed a marketing authorisation application to the European Medicines Agency (EMA) for Krazati in this indication in May 2022. In November 2023, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) granted conditional marketing authorisation to the therapy. In October 2023, pharma-giant Bristol Myers Squibb acquired Mirati for a total value of $4.8bn. The deal is expected to close by the end of Q1 2024. Krazati was the company’s lead marketed drug and significant driver for potential revenues. According to GlobalData’s Pharma Intelligence Center, Krazati is forecast to generate $1.24bn in sales in 2029. Krazati is a small molecule RAS inhibitor which suppresses cancer cell signalling and prevents cell proliferation by inhibiting mutant KRAS, a signalling protein which acts as a molecular ...
- Source: drugdu
- 173
- January 13, 2024
Menstrual Blood Testing Technology Eliminates Need for Finger Prick or Lab Blood Draw

Traditional methods of blood testing require invasive procedures administered by medical professionals, and can be time-consuming as well as expensive. Not everyone has the time, access, and financial means to get laboratory results for blood work, however, billions of women globally have their period every single month. Until now, menstrual samples had never previously been explored as a diagnostic source for health information. Now, for the first time, a safe and simple technology allows menstrual blood samples to be used as an alternative to traditionally collected venous blood draws. This breakthrough provides an opportunity for testing important biomarkers for millions of menstruating women across the world. Qvin (Menlo Park, CA, USA) has proved the clinical relevancy of menstrual blood for several important biomarkers. The company’s Q-Pad technology uses menstrual blood to gain health insights in a non-invasive, convenient manner and can be used for testing anywhere in the world. The ...
- Source: drugdu
- 91
- January 13, 2024
AcelRx becomes Talphera, adopting new name to reflect pain pivot

AcelRx Pharmaceuticals wants to put a tough few years behind it. After failing to crack the pain market, the biotech has shifted its focus to a pipeline led by a blood thinner and adopted a new name, Talphera, to reflect the revised strategy. The value of AcelRx has fallen sharply in recent memory, dropping 62% over the past year and 98% over the past five years to leave the company with a market cap of below $15 million. The five-year time frame covers the period after the approval of the sublingual pain drug Dsuvia. AcelRx won approval in 2018 but failed to turn the opioid into a major product, generating sales of $1.8 million in 2022. Alora Pharmaceuticals acquired the drug for $1.1 million last year, moving AcelRx away from its earlier focus on pain. Following the transaction, AcelRx’s goals were to win approval tforhe pre-filled ephedrine syringe, Fedsyra, and ...
- Source: drugdu
- 128
- January 12, 2024
Multi-Cancer Early Detection Solution to Address Unmet Medical Needs in Clinical Diagnosis

Early detection, diagnosis, and treatment can significantly improve the survival and quality of life of cancer patients. Tumors continuously release fragmented genomic DNA into the bloodstream, although existing testing methods may find the signal too weak to be picked up in the early stages. Now, a revolutionary multi-cancer early detection solution leverages highly sensitive multi-omics technology to detect early cancer signals as well as predict the tissue of origin (TOO). Geneseeq Technology Inc.’s (Toronto, Canada) CanScan multi-cancer early detection solution is designed to enhance the early detection, diagnosis, and treatment of various cancers. This innovative solution harnesses the power of low-depth whole-genome sequencing (WGS) applied to circulating cell-free DNA (cfDNA) from a single tube of peripheral blood. It efficiently extracts genetic and fragmentomic features to identify early cancer signals with a high specificity of 99% and accurately predicts the TOO of cancers, thereby informing subsequent diagnostic and treatment strategies. Particularly ...
- Source: drugdu
- 161
- January 11, 2024
Pfizer PARP inhibitor Talzenna nabs EU combo nod

• Pfizer’s PARP inhibitor Talzenna has gained European approval when used in combination with Pfizer and Astellas’ Xtandi to treat adult patients with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated. This approval makes Talzenna the first PARP inhibitor in Europe to be licensed in combination with Xtandi in mCRPC, Pfizer said in a release. The European Commission approved Pfizer’s application based on data from the phase 3 TALAPRO-2 trial, which showed that the combo cut the risk of disease progression or death in patients with mCRPC compared with placebo and Xtandi. Last June, the FDA approved the combination to treat adults with HRR gene-mutated mCRPC. • In another regulatory win for Pfizer, the FDA is reviewing the company’s full approval application on Genmab-partnered Tivdak. Under its priority review timeline, the FDA is assessing whether to convert Tivdak’s accelerated approval into a full nod to treat ...
- Source: drugdu
- 119
- January 11, 2024
Merck expects $20B+ in new cancer sales thanks to Daiichi ADC deal, Moderna vaccine

While some Merck & Co. investors may still get the heebie-jeebies when thinking about Keytruda’s patent cliff in 2028, but the company’s CEO Rob Davis now thinks “it’s just another year.” Make no mistake, given Keytruda’s size, an overall business decline will likely still hit. But Merck is focused on making “the hill to dip as small as possible and the return to growth as fast as possible,” Davis said Monday at the 2024 annual J.P. Morgan Healthcare Conference. Davis and Merck Research Laboratories President Dean Li, M.D., Ph.D., pointed to the breadth of Merck’s portfolio across oncology, infectious disease, cardiometabolic, immunology and neuroscience to explain Merck’s potential for growth. “I know that the conversation continues to be about Keytruda and 2028,” Davis said. “But increasingly, we’re not focused on 2028. 2028, it’s just another year, it’s just another point. We’re focused on 2030 to 2040.” At last year’s J.P. ...
- Source: drugdu
- 99
- January 11, 2024
J&J Joins the Cancer ADC Dealmaking Spree With $2B Ambrx Acquisition

Johnson & Johnson’s acquisition of antibody drug conjugate developer Ambrx Biopharma comes as Novartis and Merck also unveiled M&A deals on the first day of the J.P. Morgan Healthcare conference. In a report, the investment bank said big pharmas are looking for deals involving de-risked assets. By FRANK VINLUAN Big pharmaceutical companies splashed out big bucks in 2023 to acquire or license antibody drug conjugates, or ADCs. The trend is continuing into the new year with Johnson & Johnson reaching a $2 billion deal to acquire clinical-stage Ambrx Biopharma. According to deal terms announced Monday, J&J will pay $28 cash for each Ambrx share, which is a 105% premium to the biotech’s closing stock price on Friday. In other biopharma deal announcements, Merck is paying $680 million to acquire Harpoon Therapeutics, a developer of targeted cancer therapies, and Novartis is buying autoimmune disease drug developer Calypso Biotech for $250 ...
- Source: drugdu
- 134
- January 10, 2024
Will It Be Different Next Time?

Contract development and manufacturing organizations cannot develop or distribute vaccines alone, but through partnerships, their infrastructure can provide the foundation for delivering life-saving tools swiftly and equitably when a new public health crisis emerges. By MARC FUNK When the Covid-19 pandemic hit, contract development and manufacturing organizations (CDMOs) became indispensable partners to the biopharmaceutical companies that developed vaccines, rapidly producing billions of urgently needed vaccine doses for patients around the globe. But as the health crisis wanes, these organizations risk missing a pivotal opportunity to reinforce preparedness for the next – inevitable – pandemic. CDMOs play an indispensable role in the pharmaceutical ecosystem, acting as key partners to produce medications and vaccines for biopharma companies. By providing specialized manufacturing and development services, CDMOs ensure innovative medicines are produced at scale, meeting global demand and helping enable patient access to vital treatments. This flexible, efficient model proved invaluable when Covid-19 vaccine ...
- Source: drugdu
- 197
- January 9, 2024
With Phase 3 Studies Ongoing in Bladder Cancer, CG Oncology Plots Course for IPO

CG Oncology’s main asset is cretostimogene, an oncolytic virus in late-stage development as a treatment for advanced bladder cancer. The IPO filing follow the report of interim efficacy data showing a 75% complete response rate. By FRANK VINLUAN When bladder cancer does not respond to the current standard of care therapy, the next treatment option is surgery to completely remove the bladder. CG Oncology aims to give patients another choice. The biotech has reached late-stage development with an oncolytic virus and it’s now looking to the public markets to finance clinical testing. Irvine, California-based CG has not yet set financial terms for the planned offering, outlined in paperwork filed with the Securities and Exchange Commission this past week. IPO research firm Renaissance Capital estimates the stock offering could raise up to $100 million. CG has applied for a Nasdaq listing under the stock symbol “CGON.” CG is developing treatments for ...
- Source: drugdu
- 81
- January 9, 2024
Invivyd Seeks EUA for Monoclonal Antibody Designed to Prevent COVID-19 in Immunocompromised Individuals

Pharmaceutical Executive Editorial Staff VYD222 is a broadly neutralizing, half-life extended monoclonal antibody developed specifically to prevent COVID-19 in immunocompromised adults and adolescents. Invivyd, Inc. has filed a request with the FDA for emergency use authorization (EUA) for VYD222, a broadly neutralizing, half-life extended monoclonal antibody developed specifically to prevent COVID-19 in immunocompromised adults and adolescents. The EUA submission was based on positive initial findings from the pivotal Phase III CANOPY clinical trial for VYD222 and data for ongoing in vitro neutralization activity against relevant COVID-19 variants. VYD222 was found to demonstrate a potent response against multiple SARS-CoV-2 variants currently circulating, including the fastest growing variant in the United States, JN.1, as well as HV.1, BA.2.86, XBB.1.5.10/EG.5, and HK.3. “We are tremendously pleased by the fact that VYD222 continues to demonstrate in vitro neutralization activity against the latest dominant variant, JN1, as well as other prevalent SARS-CoV-2 strains,” said Dave ...
- Source: drugdu
- 108
- January 8, 2024

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