Search Results for “FDA” – Page 126 – media

NeoImmuneTech bags orphan drug tag for IL-7 acute radiation syndrome treatment

The US Food and Drug Administration (FDA) awarded an orphan drug designation to NeoImmuneTech’s investigational drug for the treatment of acute radiation syndrome (ARS). The purpose of FDA orphan designation is to advance treatments for rare diseases like ARS. According to the Centers for Disease Control and Prevention (CDC), current treatments are geared towards preventing subsequent infections and treating infections and injuries. NT-17 (efineptakin alfa) (rhIL-7-hyFc) is a long-acting human IL-7 fusion protein designed to exceed the developmental and functional capabilities of endogenous IL-7 and comparatively amplify and enhance the T cell immune response. The drug, currently in preclinical development as a monotherapy, is expected to promote T-cell recovery by restoring lymphocyte levels and fortifying the body’s immune system after individuals are exposed to ionizing radiation. The clinical-stage biotechnology company is collaborating with the National Institute of Allergy and Infectious Diseases (NIAID) to evaluate the efficacy of NT-17 in treating ...
- Source: drugdu
- 93
- November 22, 2023
Senate Democrats press Sanofi and AZ for answers as ‘unprecedented’ demand spurs shortage of RSV antibody Beyfortus

The shortage of Sanofi and AstraZeneca’s new respiratory syncytial virus (RSV) antibody Beyfortus continues to confound doctors and patients, with the Centers for Disease Control and Prevention (CDC) last week fast-tracking tens of thousands of extra doses into circulation to deal with a tough RSV season. Now, several Senate Democrats are pressing the drugmakers to get to the bottom of the issue. In a letter sent to the drugmakers Friday, Sen. Tammy Duckworth, D-Illinois, lamented that Sanofi and AZ “seem to have vastly underestimated” the amount of Beyfortus—also known nirsevimab—needed to protect young kids during this disease season. The partners’ immunization, approved back in July, has quickly run into supply problems, with the CDC last month issuing an advisory for doctors to prioritize available Beyfortus 100-mg doses for infants at the highest risk of severe RSV. At the time, Sanofi attributed the shortfall to “higher than anticipated demand,” which has ...
- Source: drugdu
- 186
- November 22, 2023
Merck Expands Keytruda’s Label as a First-Line Option for Gastric Cancer

By Tristan Manalac Pictured: Merck Research Laboratories building in California The FDA on Thursday approved Merck’s anti-PD-1 blockbuster Keytruda (pembrolizumab) for the first-line treatment of adult patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. Thursday’s label expansion is Keytruda’s seventh approval in gastrointestinal cancer and its 38th indication overall in the U.S., according to Merck’s announcement. This latest approval covers patients with HER2-negative cancers and authorizes the use of the PD-1 blocker in combination with fluoropyrimidine- and platinum-containing chemotherapy. Previously, Keytruda was indicated for gastric cancer only in patients who had progressed after at least two prior lines of systemic therapy, including fluoropyrimidine- and platinum-containing chemotherapy. Marjorie Green, senior vice president and head of late-stage oncology, global clinical development at Merck Research Laboratories, in a statement called Keytruda’s label expansion an “important milestone” in the care of gastric or gastroesophageal junction adenocarcinoma. Data from the Phase ...
- Source: drugdu
- 97
- November 21, 2023
Eli Lilly Plans New $2.5B Manufacturing Site in Germany for Injectable Meds

The German manufacturing site is the latest capital infrastructure move for Eli Lilly, which has already made $11 billion in investments in its global manufacturing capabilities in the past three years. The new site will help Lilly meet strong demand for its diabetes and obesity drugs. By FRANK VINLUAN Eli Lilly’s cardiometabolic drug portfolio is expanding with newly approved therapies. To meet demand for those therapies and additional products to come, the company is building a new $2.5 billion manufacturing site in Germany. Construction on the new plant is on track to begin next year. Lilly expects the site will start operations in 2027, becoming its sixth manufacturing site in Europe. The company said it has invested more than $11 billion in its global manufacturing capabilities in the past three years to support the production of medicines across its portfolio. Some of Lilly’s capital investments have been closer to the ...
- Source: drugdu
- 101
- November 21, 2023
China’s NMPA grants conditional approval for Apollomics’ NSCLC drug

The National Medical Products Administration (NMPA) of China granted conditional approval to biotech Apollomics for the commercialisation of its non-small cell lung cancer (NSCLC) treatment. Velbretinib (APL-101) is an orally bioavailable small molecule that treats NSCLC patients with MET exon 14 skipping alterations by inhibiting c-Met. This is a protein that is key in the tumour growth pathway. MET exon 14 skipping mutations occur in approximately 3% of cases of NSCLC. This condition is most diagnosed in adults aged over 70 with a smoking history. China’s NMPA grants conditional approvals to treatments for diseases that are severely life-threatening and there is no effective treatment method. Under the terms of an agreement, the company’s Chinese partner, Avistone, holds the drug’s exclusive rights in China, Hong Kong and Macau. Apollomics holds the rights for the US and all other countries. California-headquartered Apollomics is also in active discussions with the US Food and ...
- Source: drugdu
- 103
- November 21, 2023
CDC rushes extra doses of Sanofi, AZ’s Beyfortus to ease supply shortfall

In response to a supply squeeze for Sanofi and AstraZeneca’s respiratory syncytial virus (RSV) antibody Beyfortus, the U.S. Centers for Disease Control and Prevention (CDC) is fast-tracking tens of thousands of extra doses into circulation. More than 77,000 additional doses will be distributed “immediately” to physicians and hospitals through the CDC’s Vaccines for Children program and commercial routes, the agency said in a Thursday statement. Alongside the FDA, the CDC plans to maintain “close contact” with manufacturers to secure availability of extra supply through the end of this year and early 2024, the CDC added. The supply strain began last month despite Sanofi’s “aggressive” plan that was designed to “outperform past pediatric vaccine launches,” the company said at the time. The company said it was working with AstraZeneca to “explore a number of actions” to extend the manufacturing network. AZ handles manufacturing under the duo’s Beyfortus partnership. Sanofi previously noted ...
- Source: drugdu
- 134
- November 21, 2023
Inari Medical closes LimFlow acquisition

BY SEAN WHOOLEY The LimFlow System. [Illustration courtesy of LimFlow] Inari Medical (Nasdaq: NARI)+ announced that it completed its acquisition of chronic limb-threatening ischemia (CLTI) treatment maker LimFlow. The Irvine, California–based company earlier this month announced plans to acquire LimFlow for up to $415 million. The deal came just weeks after Paris-based LimFlow won FDA premarket approval (PMA) for its breakthrough CLTI treatment. Inari Medical intends to pay a total upfront consideration of $250 million in cash at closing. Contingent consideration of up to $165 million in additional cash payments hinges on certain commercial and reimbursement milestones. Inari Medical expects to pay those tranches out between 2025 and 2027. The company said it funded the acquisition at close from existing cash resources. LimFlow designed its system for transcatheter arterialization of deep veins. It diverts blood from a diseased tibial artery to a tibial vein to deliver oxygen to a patient’s ...
- Source: drugdu
- 99
- November 20, 2023
Q&A With Dr. Mike McCullar, CEO of RegCell

Mike Hollan McCullar discusses his new role as CEO of RegCell. Dr. Mike McCullar CEO RegCell Pharmaceutical Executive: How did you end up as CEO? Dr. Mike McCullar: Prior to joining RegCell as CEO and president, I was a toxicologist by training. I was fortunate to work in multiple operating roles over the years. I ended up working in Japan for a decade, and I was approached by a leading Japanese venture fund and asked if could help them start to migrate leading Japanese companies to the US. RegCell was one of those companies, and I felt it had the potential to have the best-in-class platform in terms of how we think about treating autoimmune disorders. It’s been an interesting journey so far. PE: What are the companies plans for the coming year? McCullar: What we’re focused on right now is launching a first in-human clinical trial. That takes quite ...
- Source: drugdu
- 109
- November 20, 2023
World’s first CRISPR-based gene therapy approved for sickle cell anaemia

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has granted conditional marketing authorisation to Vertex Pharmaceuticals and CRISPR Therapeutics’ Casgevy (exagamglogene autotemcel), marking the world’s first approval of a CRISPR-based gene editing therapy. Casgevy has been approved to treat patients with sickle cell disease with recurrent vaso-occlusive crises and transfusion-dependent beta-thalassemia aged 12 years or older, for whom a human leukocyte antigen (HLA) matched related hematopoietic stem cell donor is not available. Also known as exa-cel, Casgevy is currently being evaluated by the US Food and Drug Administration (FDA). The Prescription Drug User Fee Act (PDUFA) target action date for the drug is set for 8 December in severe sickle cell disease and 30 March 2024 in beta-thalassemia, as per a 16 November press release. Casgevy is a genetically modified autologous CD34+ cell population that contains clustered regularly interspaced short palindromic repeats (CRISPR) edited human haematopoietic stem and progenitor ...
- Source: drugdu
- 102
- November 20, 2023
BMS strengthens NSCLC market share with ROS1 drug Augtyro

The US Food and Drug Administration (FDA) has approved Bristol Myer Squibs’ (BMS) Augtyro (repotrectinib) for adults with non-small cell lung cancer (NSCLC). Augtyro is an orally administered tyrosine kinase inhibitor (TKI) designed to selectively bind to active kinase formations in ROS1-positive NSCLC and suppress uncontrolled cell proliferation and tumor growth caused by ROS1 oncogenic fusions. It is the only FDA-approved TKI for ROS1-positive NSCLC. The FDA approval was based on data from the ongoing Phase I/II TRIDENT-1 (NCT03093116) trial, which is evaluating repotrectinib in 500 patients with advanced solid tumours characterized by ALK, ROS1, or NTRK1-3 fusions. The Phase I portion assessed the safety, tolerability, and pharmacokinetics of repotrectinib. Patients previously treated with a TKI and no chemotherapy demonstrated an overall response rate (ORR) of 38% and a median DOR of 14.8 months. Patients with no prior treatment with a TKI had an ORR of 79% and a median ...
- Source: drugdu
- 97
- November 20, 2023

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