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BioMarin’s new CEO Hardy says top priority is expansion of dwarfism drug Voxzogo

In his first presentation as the new CEO of BioMarin, Alexander Hardy left no doubt about his mission for the rare and genetic disease specialist. The top priority for the former Genentech CEO is to accelerate and maximize the commercial potential of dwarfism drug Voxzogo, Hardy said Tuesday at the J.P. Morgan Healthcare Conference. His second objective is to ramp up the commercialization of Roctavian, a newly approved gene therapy for hemophilia A. Thirdly, it is up to Hardy to identify BioMarin’s most promising R&D projects and make tough decisions about what to cut. Given his experience heading up Roche subsidiary Genentech for the last five years, Hardy is equipped to take on these challenges. During his time in charge, Genentech launched 10 medicines, including blockbuster macular degeneration drug Vabysmo. The company’s revenue jumped 24% and did so efficiently as profit-per-employee grew by 69%. “Why did I choose BioMarin? I ...
- Source: drugdu
- 97
- January 15, 2024
Hengrui Pharmaceuticals’ “Double Ai” Combination Study for Advanced Lung Adenocarcinoma Featured in The Lancet Supplement

Recently, the results of the prospective, multicenter, single-arm phase II clinical study of carilizumab in combination with apatinib and albumin paclitaxel in advanced lung adenocarcinoma (CAPAP-lung), led by Prof. Wu Lin of Hunan Cancer Hospital, have been published in The Lancet (IF=15.1) and eClinicalMedicine (IF=15.1), which is a subseries of The Lancet. eClinicalMedicine (IF=15.1).1 The results of the study showed that the first-line treatment of advanced lung adenocarcinoma negative for epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutations with karelizumab in combination with apatinib (the “double-Ai” combination) and albumin paclitaxel demonstrated a clinically meaningful antitumor effect. Demonstrated clinically meaningful antitumor activity and a manageable safety profile with low hematological toxicity. This study is the first exploration of advanced non-small cell lung cancer (NSCLC) treated with platinum-free chemotherapy in combination with immunologic agents and anti-vascular drugs, and is expected to provide new options for first-line treatment of EGFR/ALK ...
- Source: drugdu
- 92
- January 15, 2024
In booming obesity field, Novo Nordisk is ‘just getting going,’ CEO says

Despite persistent supply hitches since Wegovy’s launch in 2021, Novo Nordisk has quickly garnered blockbuster sales in the newly untapped obesity market. And to hear Novo’s CEO Lars Fruergaard Jørgensen tell it, the company is “just getting going” in the field. In 2024, Novo Nordisk plans to entrench itself even deeper into the burgeoning obesity market, Jørgensen said Tuesday at the 42nd annual J.P. Morgan Healthcare Conference. To get there, Novo will rely on expanded manufacturing capacity, new cardiovascular outcomes data and a surprise boost from Eli Lilly’s rival weight-loss drug Zepbound, which snagged its own obesity nod in November. Novo’s Wegovy proved immensely popular out the gate. Initially, the company struggled to contend with the unprecedented spike in demand for its new semaglutide-based medicine. But after a sustained manufacturing expansion campaign over the past two years, Jørgensen figures Novo is in a comfortable position moving into 2024. In 2023, ...
- Source: drugdu
- 173
- January 13, 2024
FDA clears penicillin imports from French drugmaker amid Pfizer shortage

With U.S. syphilis cases on the rise and Pfizer’s Bicillin treatment still in short supply, France’s Laboratoires Delbert is stepping in to help with temporary imports. The French drugmaker is working with the FDA to bring in shipments of its Extencilline to the U.S. The product, while not approved in the U.S., is made up of penicillin G benzathine (or benzathine benzylpenicillin), which Pfizer has branded as Bicillin. In a letter (PDF) published by the FDA, Laboratoires Delbert noted that it will import 1,200,000 units of its powdered Extencilline and 2,400,000 units of the diluent version for reconstitution for injection. The meds are manufactured in Italy and both lots have an expiration date of 2025. Bicillin is used for an array of bacterial infections such as strep throat, but it’s the preferred treatment for syphilis and gonorrhea. The FDA first reported a shortage of the treatment in April. In June, ...
- Source: drugdu
- 111
- January 13, 2024
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
Moderna Highlights Respiratory Product Pipeline at JP Morgan Healthcare Conference

Pharmaceutical Executive Editorial Staff Moderna’s vaccine revenue dropped from $18.4 billion in 2022 to $6.7 billion in 2023, however the company anticipates profitability this year powered by COVID-19 vaccine sales and the launch of its mRNA-based respiratory syncytial virus vaccine. Sales of Moderna’s COVID-19 vaccine dropped from $18.4 billion in 2022 to $6.7 billion in 2023, which was ultimately above projections, the company announced in a business update presented at the at 42nd annual JP Morgan Healthcare Conference. The significant decline in people seeking immunizations for COVID-19 products last year comes at a time when the virus is still surging worldwide. The decline resulted in shares of Moderna dropping by approximately 45% last year; however, the shares are up more than 60% following a drop to approximately $70 per share in November 2023. Moderna projected that it would reach the lower end of its forecast range of $6 billion to ...
- Source: drugdu
- 95
- January 13, 2024
FDA Accepts New Drug Application for Shorla Oncology’s Novel Treatment for Breast, Ovarian Cancer

Pharmaceutical Executive Editorial Staff SH-105 eliminates the need for powder reconstitution, which Shorla stated will bolster the novel product’s efficiency and lower the risks associated with drug preparation. The FDA has accepted Shorla Oncology’s New Drug Application (NDA) for SH-105 to treat patients with breast and ovarian cancers. The NDA was given a Prescription Drug User Fee Act action date of June 29, 2024. “This innovative drug will offer hospital pharmacists and patients access to a differentiated, ready to administer, injectable product with unique characteristics that’s expected to facilitate rapid adoption once approved,” said Orlaith Ryan, Shorla Oncology chief technical officer and cofounder, in a press release. The novel therapy is a formulation of a well-established freeze-dried powder medication that has been in use dating back to the 1950s. The ready-to-dilute liquid formulation eliminates the need for powder reconstitution, which Shorla stated will bolster the product’s efficiency and lower the ...
- Source: drugdu
- 204
- January 13, 2024
New Blood Test Identifies Neuroendocrine Subtype of Advanced Prostate Cancer

Roughly 10-15% of individuals with metastatic castration-resistant prostate cancer (CRPC) eventually develop neuroendocrine prostate cancer (NEPC), a challenging cancer subtype. This transformation is marked by a change from androgen-dependent cancer cells to those that no longer respond to androgens. Diagnosing NEPC typically involves a biopsy from a metastatic tumor, but this can be uncertain due to timing issues and the heterogeneous nature of metastatic tumors. Now, researchers have developed a blood test that can reliably detect NEPC and differentiate it from CRPC-adenocarcinoma (CRPC-adeno). In previous research, an international team of researchers from Dana-Farber Cancer Institute (Boston, MA, USA and the University of Trento (Trento, Italy) examined biopsy tissue samples to identify genetic and epigenetic shifts accompanying this shift from cancer cells that are dependent on hormones called androgens to cancer cells that no longer even recognize androgens. They discovered distinctive genome-wide epigenetic alterations, particularly in DNA methylation, that differentiate CRPC-adeno ...
- Source: drugdu
- 96
- January 13, 2024
Livanova to close loss-making circulatory support business

Dive Brief Livanova is closing its circulatory support unit to focus on larger, faster-growing cardiopulmonary and neuromodulation opportunities. The advanced circulatory support (ACS) business sells the Lifesparc device, which pumps blood during cardiovascular surgeries, but sales have fallen and then flatlined since peaking in 2021. In a note to investors, Stifel analysts said they supported the decision to wind down the unit by the end of 2024, predicting it will benefit revenue growth and profitability and increase focus at the company. Dive Insight Livanova expanded its circulatory support offering by acquiring Tandemlife for $200 million upfront in 2018 and received 510(k) clearance for Lifesparc the next year. ASC remained a small part of the broader business, though. Over the first nine months of last year, ASC brought in $30.2 million, almost exclusively in the U.S., and accounted for about 4% of total sales. The unit has contracted in recent years. ...
- Source: drugdu
- 89
- January 12, 2024
FDA Fast Tracks SELLAS Life Sciences’ CDK9 Inhibitor for Acute Myeloid Leukemia

Pharmaceutical Executive Editorial Staff SELLAS Life Sciences Group, Inc’s CDK9 inhibitor SLS009 is being evaluated in an ongoing Phase I/II study in combination with Venclexta and Vidaza for patients with relapsed or refractory acute myeloid leukemia. The FDA has granted Fast Track Designation to SELLAS Life Sciences Group, Inc’s CDK9 inhibitor SLS009 for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML). The regulatory action was based on safety and efficacy data for the drug, which is being evaluated in an ongoing Phase I/II study (NCT04588922) in combination with Venclexta (venetoclax) and Vidaza (azacytidine) for patients with AML. “Receiving fast track designation for SLS009 for relapsed or refractory AML, following the recent orphan drug designation for the same indication, underscores the potential for SLS009 and highlights the critical unmet need for patients with AML who face a poor prognosis due to the progressive nature of the disease,” ...
- Source: drugdu
- 157
- January 12, 2024

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