March 18, 2024
Via: PMLiVEThe regulator’s decision specifically applies to adult patients with relapsed or refractory disease who have received at least two prior lines of therapy, including a Bruton tyrosine kinase inhibitor and a B-cell lymphoma 2 inhibitor. CLL is one of the […]
March 18, 2024
Via: PMLiVEThe authorisation specifically applies to adult patients with unresectable or metastatic ESCC after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor. Oesophageal cancer is the sixth most common cause of cancer-related deaths globally and ESCC accounts for almost […]
March 14, 2024
Via: World Pharma NewsAstraZeneca announced that it has entered into a definitive agreement to acquire Amolyt Pharma, a clinical-stage biotechnology company focused on developing novel treatments for rare endocrine diseases. The proposed acquisition will bolster the Alexion, AstraZeneca Rare Disease late-stage pipeline and […]
March 13, 2024
Via: Biopharma DiveTwo cellular medicines for multiple myeloma were associated with an increased risk of early death in clinical testing, raising questions about whether they should be earlier in a patient’s disease, Food and Drug Administration scientists wrote in a briefing document […]
Clinical Trials, Research and Development
March 12, 2024
Via: Biopharma DiveFor Rick Bedlack, director of the ALS clinic at Duke University, tough times come with the job. He and his team treat about 500 people with the rare, fatal disorder that rapidly erodes nerve cells. Friday, though, was particularly difficult. […]
Manufacturing, Research and Development
March 11, 2024
Via: Biopharma DiveAs the manufacturing landscape changes, it opens the door to pursuing hybrid opportunities that push the boundaries of technological advancement in the field. As an Industry Leader in two key domains: flow chemistry and biocatalysis, Asymchem has developed an innovative […]
Clinical Trials, Research and Development
March 11, 2024
Via: Drugs.comFollowing disappointing trial results, the maker of a controversial ALS drug may pull the medication off the market. In a statement issued Friday, Amylyx Pharmaceuticals said that Relyvrio failed to help patients in a large follow-up study, but the company […]
March 7, 2024
Via: Biopharma DiveWith national polls showing Biden trailing former President Trump, Thursday’s State of the Union address is taking on outsized importance. Biden will be working to remind Americans of his accomplishments in office and persuade them that he can get even […]
Cell and Gene Therapy, Clinical Trials, Industry, Research and Development
March 6, 2024
Via: PMLiVEAffecting an estimated one in 10,000 infants globally, SMA is a rare, genetic neuromuscular disease and a leading genetic cause of infant death. Caused by the lack of a functional SMN1 gene, the most severe forms of SMA result in […]
Clinical Trials, Research and Development
March 5, 2024
Via: Biopharma DiveThe study results represent the first human data from Apogee, which last year became one of the rare preclinical biopharmaceutical companies to succeed in a tough market for initial public offerings. After launching in late 2022, Apogee raised $300 million […]
March 4, 2024
Via: Biopharma DiveFor the second time in less than a month, a federal court has rejected a pharmaceutical industry lawsuit challenging the drug pricing powers Medicare was granted by the Inflation Reduction Act. The U.S. District Court for the District of Delaware […]
FDA, Industry, Regulations, Vaccines
March 4, 2024
Via: Drugs.comAs new outbreaks of measles — a once nearly eliminated illness in the United States — continue to emerge, experts remind Americans that there’s an easy way to stop infection: Get vaccinated. “Measles spreads so easily that if one person […]
February 28, 2024
Via: PMLiVEThe antibiotic combination has been approved for adults with cUTIs, including the kidney infection pyelonephritis, which is most commonly caused by gram-negative bacteria. UTIs are a common infection and typically require antibiotics for treatment. Accounting for approximately 19% of all […]
February 28, 2024
Via: Drugs.comPFAS “forever” chemicals, increasingly linked to health risks, will no longer be added to food packaging handled by American consumers, the U.S. Food and Drug Administration announced Wednesday. “Grease-proofing materials containing per- and polyfluoroalkyl substances [PFAS] are no longer being […]
February 27, 2024
Via: Biopharma DiveThe FDA’s decision sets back many years of effort by Minerva to secure approval of its drug for schizophrenia, called roluperidone and designed to treat so-called negative symptoms of the condition. The company, which licensed rights to roluperidone from Mitsubishi […]
February 27, 2024
Via: PharmaphorumThe round was led by Pfizer’s investment arm Pfizer Ventures, with Columbus Venture Partners and British Patient Capital joining the round along with prior investors Advent Life Sciences and Epidarex Capita. The proceeds will be used to develop Curve’s Microcycle […]
February 26, 2024
Via: Biopharma DiveFounded in 2007, NGM took a broad approach to its drug research, assembling a pipeline that spans from solid tumors to retinal diseases to liver and metabolic disorders. NGM raised a few hundred million dollars in private funding before going […]
February 22, 2024
Via: PharmaphorumIn an unusual move, United Therapeutics has filed a lawsuit against the FDA which claims the regulator is sidestepping established norms in allowing rival Liquidia to file for approval of a competitor to its Tyvaso product. The suit claims that […]
February 21, 2024
Via: Biopharm InternationalOn Feb. 15, 2024, FDA’s Center for Drug Evaluation and Research (CDER) released its report, Drug Safety Priorities FY23. The report describes the center’s key safety programs and activities involved in promoting and protecting public health and dealing with the […]
Clinical Trials, Research and Development
February 20, 2024
Via: Biopharma DiveAnalysts have followed Rapt as they view its drug, an oral pill dubbed zelnecirnon, as a possible competitor to Dupixent in conditions like eczema. Dupixent, which was developed by Sanofi and Regeneron, is a multibillion-dollar product approved for a range […]