Regulations

EMA selects candidates for pilot scheme to advance ATMPs

The European Medical Agency (EMA) has selected three candidates for a non-profit pilot scheme to develop advanced therapy medicinal products (ATMPs).  Hospital Clínic de Barcelona, Fondazione Telethon, and Berlin Center for Advanced Therapies were selected out of 11 candidates. The agency will provide these organizations with enhanced support.   Launched in 2022, the scheme aims to support basic research developments into medicines to treat patients in the European Economic Area (EEA). The pilot is open to academic sponsors and non-profit organizations…

Iovance: Price and time could hinder Amtagvi rollout

Iovance Biotherapeutics’ cell therapy Amtagvi received US FDA approval last week, but with a hefty price tag and a manufacturing process that takes 22-days, BioProcess Insider discusses if these factors could affect its rollout.   Last week, the US Food and Drug Administration (FDA) approved Amtagvi (lifileucel), the first one-time cell therapy for patients with advanced melanoma. Amtagvi is a tumor-derived autologous T-cell immunotherapy, which consists of a patient’s own T-cells. The firm claimed it offers a “new” cell therapy…

Iovance wins FDA approval for solid tumor cell therapy

The US Food and Drug Administration (FDA) has approved Amtagvi (lifileucel), the first one-time cell therapy for patients with advanced melanoma. After 40 years in the making, Iovance Therapeutics’ Amtagvi was approved by the FDA through the Accelerated Approval pathway last Friday. The cell therapy is a tumor-derived autologous T-cell immunotherapy, which consists of a patient’s own T-cells. Amtagvi aims to treat adults with unresectable or metastatic melanoma (skin cancer), which has previously been treated with a PD-1 blocking antibody,…

Aduhelm: Biogen calls time on controversial Alzheimer’s mAb

Two-and-a-half years after approval, Biogen is dropping the Alzheimer’s treatment after failing to find strategic partners or outside funding. Aduhelm (aducanumab) won US Food and Drug Administration (FDA) accelerated approval in June 2021. However, following authorization, the monoclonal antibody (mAb) drug suffered from limited availability due to questions surrounding its efficacy and access barriers imposed by the US government’s Centers for Medicare & Medicaid Services (CMS) program. However, the monoclonal antibody (mAb) drug has suffered from limited sales due to…

Insider’s out? Evotec ‘immediately’ reported ex-CEO share trading

Biologics CDMO Evotec says it immediately disclosed share transactions made by former CEO Werner Lanthaler and has since refined its insider trading policies. After 15 years at the helm, contract development and manufacturing organization (CDMO) Evotec earlier this month announced the stepping down of Werner Lanthaler citing personal reasons. But during a business update call this week, the firm made reference to Lanthaler’s departure in combination with “his late disclosure of transactions in company shares” made over a period of…

Patient advocate slams FDA decision for CAR-T warning labels

The US FDA has come under criticism after demanding CAR-T therapies must have black box warnings (BBWs) on their labels to signify the risk of T-cell malignancies. In November 2023, the US Food and Drug Administration (FDA) safety material about the risk of T-cell malignancies concerning individuals who are receiving chimeric antigen receptor (CAR) T cell therapies for the treatment of specific blood cancers. This week, the agency issued safety and availability communications to the following companies regarding their respective CAR-T therapies:…

Alvotech receives another 483 at biosimilar plant

Biosimilar versions of Humira and Stelara are on course for approval despite a further observation at its Reykjavik, Iceland facility, says Alvotech. The US Food and Drug Administration (FDA) has concluded a reinspection of the Iceland plant, which began on January 10, resulting in a Form 483 with one observation being issued to Alvotech. “We believe that the observation is readily addressable, and we intend to respond as quickly as possible,” Robert Wessman, CEO of Alvotech, said in a statement.…

Oligo Factory MA plant given GMP greenlight

Oligo Factory’s Holliston, Massachusetts facility has received GMP compliance, which it said has reinforced its commitment to the therapeutics sector and its customers. In March 2023, contract development manufacturing organization (CDMO) Oligo Factory opened the doors to its 13,00 square-foot Holliston facility and increased its oligonucleotide synthesis capability 12-fold. Now, the firm said it is compliant with current Good Manufacturing Practices (GMP). According to Oligo, this “milestone” further reinforces the CDMO’s commitment to global regulatory standards, customer service, and quality…

Astellas: CDMO issues cause FDA to reject gastric cancer mAb

The US FDA has rejected Astellas’ cancer candidate zolbetuximab due to “unresolved deficiencies” at a third party manufacturer. Zolbetuximab is an investigational, chimeric IgG1 monoclonal antibody (mAb) that targets and binds to transmembrane protein claudin 18.2 (CLDN18.2). The drug is in trials for gastrointestinal adenocarcinomas and pancreatic tumors, but Astellas has hit a setback receiving a complete response letter from the US Food and Drug Administration (FDA). “The FDA stated that the agency cannot approve the BLA [Biologics License Applications]…

Bayh-Dole Act nurtures medical innovation, says Nobel Prize winning mRNA researcher

US patent law that – proponents argue – incentivized development of the mRNA vaccine tech used to fight COVID-19, continues to foster collaboration between academia and biopharma. The Bayh-Dole Act – which was enacted in 1980 – gave universities, non-profit research institutions and small businesses the right to own, patent and commercialize inventions developed under federally funded research programs. It also prompted a 40-year debate over appropriate incentives for innovation and the scope of the government’s authority. The pandemic intensified…