Tag: featured

March 26, 2024

The Dallas, Texas-based biotech said it plans to submit a dossier to the FDA later this year after its MCO-010 (sonpiretigene isteparvovec) gene therapy achieved almost all its primary and secondary efficacy objectives in the phase 2b RESTORE trial. Approximately […]

March 25, 2024

Lonza announced on March 20, 2024 that is has signed an agreement to acquire from Roche its Vacaville, Calif., site, a large-scale biologics manufacturing site, for $1.2 billion. Beyond the acquisition, Lonza plans to invest approximately CHF 500 million (US$557 […]

March 25, 2024

The U.S. Food and Drug Administration approved Duvyzat (givinostat) oral medication for the treatment of Duchenne Muscular Dystrophy (DMD) in patients six years of age and older. Duvyzat is the first nonsteroidal drug approved to treat patients with all genetic […]

March 21, 2024

On March 19, 2024, Cytiva and White Raven, a Belgium-based contract development and manufacturing organization (CDMO), announced that White Raven has selected Cytiva’s SA25 Aseptic Filling Workcell for its fill/finish site. The installation of the workcell will complete White Raven’s […]

March 20, 2024

Gene therapy makers like Orchard are counting on insurers to recognize the value proposition of their products. Unlike traditional pharmaceuticals that might be taken regularly for the rest of a person’s life, gene therapies carry the promise of a long-lasting […]

March 19, 2024

The U.S. Food and Drug Administration has approved the first drug to treat yeast ear infections in dogs. DuOtic is also the first ear infection medication that does not contain an antibiotic, the FDA said in its approval announcement. The […]

March 18, 2024

The 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

The 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

AstraZeneca 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

Two 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 […]

March 12, 2024

For 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. […]

March 11, 2024

As 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 […]

March 11, 2024

Following 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

With 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 […]

March 6, 2024

Affecting 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 […]

March 5, 2024

The 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

For 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 […]

March 4, 2024

As 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

The 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

PFAS “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 […]