AbbVie turned to Capsida Biotherapeutics two years ago for help delivering gene therapies into the brain. That partnership is ongoing, but the pharmaceutical giant now wants to leverage its partner’s technology for delivery of…
Continue Reading
In June, the United States Supreme Court abandoned nearly 50 years of precedent and, for the first time in this nation’s history, eliminated a fundamental right: the right to choose. This decision, Dobbs v….
Continue Reading
Editor’s note: This story is based on an interview at Abarca Forward, a conference that was hosted by Abarca Health, a pharmacy benefit manager last week in San Juan, Puerto Rico. MedCity News’ Editor-in-Chief…
Continue Reading
Travere Therapeutics has won FDA approval for a drug that treats a rare autoimmune disorder that is typically first noticed as blood in the urine and can progress over time to end-stage kidney failure.
The…
Geographic atrophy, an eye disorder that starts as a loss of central vision and progressively worsens to total blindness, now has its first treatment. The FDA on Friday approved an Apellis Pharmaceuticals drug that slows the progression of this disease, which affects more than 1 million people in the U.S.
Approval of the Apellis drug, pegcetacoplan, covers all patients with geographic atrophy, a broad label that reflects the representative patient population tested in pivotal studies, Chief Medical Officer Caroline Baumal said during a Friday evening conference call. The Waltham, Massachusetts-based company plans to launch the drug in March, marketing the product under…
A Chiesi Farmaceutici drug for a rare enzyme deficiency is now approved by the FDA, making it the first U.S. treatment for a disorder that leads to a range of cognitive and muscle problems.
The regulatory decision announced late Thursday covers the treatment of children and adults who have alpha-mannosidosis (AM), a disease caused by a genetic mutation that leads to defective or inactive forms of an enzyme called alpha-D-mannosidase. Chiesi’s drug, velmanase alfa, is an engineered version of that enzyme. The privately held Italian company will market its new FDA-approved drug as Lamzede, the same name for the product in Europe,…
A Moderna messenger RNA vaccine for influenza now has preliminary data from a pivotal study showing the shot prompted a strong immune response to the more common strains of the virus but fell short against less common strains.
The results reported Thursday are from one of two pivotal studies for the Moderna vaccine, mRNA-1010, which is assessing the shot for safety and immune response. A separate Phase 3 study is evaluating the shot for efficacy. Results from that study could come as early as next month. Moderna’s vaccine encodes hemagglutinin, a protein on the surface of the influenza virus that is also…
Talaris Therapeutics aimed to transform solid organ transplants with a cell therapy that replaces anti-rejection drugs patients need for the rest of their lives. But after clinical trial setbacks, the biotech has decided to end two kidney transplant studies. Although a separate test of its experimental therapy is continuing in a rare autoimmune condition, Talaris has commenced a restructuring plan that it said could culminate in a merger or sale of the company.
The restructuring announced Thursday will lead to the layoff of about one-third of Talaris’s staff. As of the end of the third quarter of 2022, the Louisville, Kentucky-based biotech…
With the Inflation Reduction Act now on the books, the U.S. Centers for Medicare & Medicaid Services (CMS) will begin negotiating drug prices with the pharmaceutical industry. That, combined with other headwinds such as increased competition from me-too drugs, and ever-present pricing pressure from payers, means that pharma players now more than ever need a new and powerful tool to differentiate their products. We believe the next decade of transformation is digital.
Learning from the auto industry Almost every industry has had to confront a fundamental existential question: What is our product? Consider the automotive industry, which once was largely about hardware…
Grifols, a company that turns blood plasma into therapies for immunological disorders and other conditions, is laying off about 2,000 U.S. workers as part of a corporate restructuring projected to yield up to €400 million in annual cost savings, the biotech announced Wednesday.
The layoffs represent about 8% of the Barcelona-based company’s global workforce, but they will happen mainly in its U.S. plasma operations. That’s notable because as a company that relies on plasma, the U.S. is vital to its business. The starting point for Grifols’s therapies is blood plasma. Key to its drug-making process is fractionation, in which the protein components…
