Tag: BioPharma

Apellis Drug Becomes First Approved Therapy for Vision-Loss Disorder Geographic Atrophy

Apellis Drug Becomes First Approved Therapy for Vision-Loss Disorder Geographic Atrophy

MedCity News

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…

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Chiesi Wins FDA Approval for First Drug to Treat Ultra-Rare Enzyme Deficiency

Chiesi Wins FDA Approval for First Drug to Treat Ultra-Rare Enzyme Deficiency

MedCity News

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,…

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The Adderall Shortage

The Adderall Shortage

MedCity News

The current Adderall shortage is of serious concern to both patients who have attention deficit hyperactivity disorder (ADHD) and clinicians. This shortage cannot be quickly alleviated by a simple increase in the amount of medication manufactured, unless the upper limit to the amount of Adderall’s active ingredient that can be manufactured in a given year is raised by the Drug Enforcement Agency (DEA). The limit has been imposed because the active ingredient can be abused as a recreational drug. It is necessary to control the supply of any medication with abuse liability, but this must be achieved without compromising the legitimate…

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Moderna Flu Vax Prompts Response to More Common Strains, But Misses in Influenza B

Moderna Flu Vax Prompts Response to More Common Strains, But Misses in Influenza B

MedCity News

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…

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Cell Therapy Biotech Talaris Ends Two Kidney Transplant Trials, Restructures

Cell Therapy Biotech Talaris Ends Two Kidney Transplant Trials, Restructures

MedCity News

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…

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Report: Pharma R&D ROI Falls to Lowest Level in 13 Years

Report: Pharma R&D ROI Falls to Lowest Level in 13 Years

HIT Consultant

What You Should Know:– Deloitte Centre for Health Solutions releases its thirteenth annual report, ‘Seize the Digital Momentum: Measuring the return from pharmaceutical innovation 2022’ that explores the performance of the biopharmaceutical industry (bio Pharma) and its ability to generate returns from investment in innovative new medicines.– Since 2021, much of the world has successfully adjusted to life where COVID-19 is more endemic as vaccines and treatments reduced the risk and severity of illness, however geopolitical turmoil and a global cost-of-living crisis have continued to drive serious instability in the health landscape.Pharmaceutical Innovation – Trends and Insights At a GlanceThis is…

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Digital as the Differentiator for Biopharma and Medtech

Digital as the Differentiator for Biopharma and Medtech

MedCity News

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…

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Blood Biotech Grifols Cuts Deep in the U.S. to Find €400M in Savings

Blood Biotech Grifols Cuts Deep in the U.S. to Find €400M in Savings

MedCity News

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…

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MD Anderson’s Tech Puts Replay on Fast Path to Clinic With TCR NK Cell Therapies

MD Anderson’s Tech Puts Replay on Fast Path to Clinic With TCR NK Cell Therapies

MedCity News

A slew of biotech companies are pursuing research that could overcome limitations of current cell therapies. Startup creator Replay has a new subsidiary pushing toward the front of the pack with a therapeutic candidate on track to start its first human test this summer—about one year after Replay emerged from stealth. It owes this rapid progress to a cell therapy pioneer’s technology that has already been de-risked by a big pharmaceutical company.
Replay calls itself a genome writing company. With operations split between San Diego and London, the private equity-backed business launched last July with $55 million and a suite of technologies…

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GSK’s Covid-19 Valentine to Vir Biotech: ‘You Can Go Your Own Way’

GSK’s Covid-19 Valentine to Vir Biotech: ‘You Can Go Your Own Way’

MedCity News

Vir Biotechnology’s Covid-19 research may yield more drugs and perhaps a vaccine, but no longer with the financial support of GSK. The collaboration agreement the two companies struck up in the early days of the pandemic has been amended, leaving Vir to either find another partner or continue its coronavirus research on its own.
The alliance did successfully develop the Covid-19 drug sotrovimab. GSK and Vir will continue to share responsibilities for that drug, which is available under the brand name Xevudy in more than 40 countries. The U.S. is no longer one of them. Last April, the FDA withdrew emergency authorization…

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