Regulations

Second Bluebird gene therapy approval a boon for Minaris

CDMO Minaris says it will be the commercial manufacturer for Skysona (elivaldogene autotemcel, Lenti-D), a second Bluebird Bio gene therapy approved by the European Commission. The European Commission (EC) granted marketing authorization of Skysona for the treatment of early cerebral adrenoleukodystrophy (CALD) yesterday. The one-time gene therapy uses a patient’s own hematopoietic stem cells (HSC) to treat the underlying cause of the neurologic condition CALD. SKYSONA uses ex vivo transduction with the Lenti-D lentiviral vector (LVV) to add functional copies…

Bluebird resumes Zynteglo sales after positive EMA committee review

Bluebird Bio has lifted the voluntary suspension on products containing its Zynteglo gene therapy after the EMA concluded the beta thalassemia therapy’s benefits outweigh its risks. The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) published its findings last week, concluding that there is “no evidence” Zynteglo causes a blood cancer known as acute myeloid leukaemia (AML). The EMA wrote “The PRAC reviewed two cases of AML in patients treated with an investigational medicine, bb1111 [also known as LentiGlobin] in a clinical trial for sickle…

Ins & Outs: Ex-Genentech employees plead guilty to sharing trade secrets with competitors

A former Genentech principal scientist and her husband face jail after pleading guilty to stealing corporate information and sharing it with fellow competitors. Meanwhile, JHL’s former CEO and COO plead not guilty. According to the suit, the story goes back to 2009 where Xanthe Lam and her husband, Allen Lam, conspired to commit stealing trade secret information from Genentech and passing the information to Taiwanese firm JHL Biotech (now Eden Biologics). The husband and wife duo stole confidential property, the…

FDA slams unapproved flu vaccine seller Davati Medical

Offering the sale of unapproved influenza vaccine Fluzalp Quadrivalent has landed Davati Medical Supply with a US FDA warning letter. Fluzalp Quadrivalent is an intramuscular vaccine manufactured by Indian firm Anzalp Pharmasolutions. While Anzalp’s motto is ‘Healthcare with Ethics,’ the same cannot be said for US distributor Davati Medical, which received a US Food and Drug Administration (FDA) warning letter last month for offering the vaccine to US consumers, despite it not being approved in the region. The company claims…

FDA quality concerns land Provention diabetes mAb with a CRL

Provention Bio says the US FDA’s Chemistry, Manufacturing and Controls (CMC) concerns relating to its type 1 diabetes candidate teplizumab are addressable in the short-term. Provention Bio has hit a snag in its Biologics License Application (BLA) for teplizumab (PRV-031), its investigational anti-CD3 monoclonal antibody (mAb) being developed for the delay of clinical type 1 diabetes. On July 2, the firm received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) citing concerns relating to pharmacokinetic/pharmacodynamic…

US FDA aims to clarify reporting rules for biologics CMC changes

Biologic drug makers that tweak manufacturing processes after approval have a better idea of when and how to inform the US FDA of the changes thanks to new agency guidelines. The US regulator issued the final guidance document last week, explaining the aim is to help biologics makers determine which reporting category is appropriate for a chemistry, manufacturing, and controls (CMC) change. The guidance – which applies to biologics, vaccines, cell and gene therapies, plasma-derived medicines but not whole blood…

Novartis and Allergopharma sites get EU OK to make Pfizer COVID vaccine

The European Medicines Agency (EMA) has approved sites in Switzerland and Germany for the fill and finish of Pfizer/BioNTech’s COVID-19 vaccine Comirnaty. At the beginning of the year, Pfizer entered into a deal with fellow Big Pharma firm Novartis for the supply of its COVID-19 vaccine Comirnaty, codeveloped with German firm BioNTech. Novartis is providing aseptic manufacturing services from its Stein, Switzerland, facility under a contract manufacturing agreement that sees the company take bulk mRNA active ingredient from BioNTech and…

Biogen Alzheimer’s mAb approval to be a boon for bioprocess space

The approval of Aduhelm (aducanumab) will have a significant knock-on effect for the bioproduction services space, increasing the annual growth rate several percentage points. Yesterday, the US Food and Drug Administration approved Aduhelm ending years of regulatory turbulence for Biogen. The drug, a monoclonal antibody that breaks down amyloid plaque buildup that is thought to worsen Alzheimer’s disease, marks a turning point in Biogen’s fortunes. The firm has seen falling revenues as competition challenges its lead products – Tecfidera (dimethyl…

Alvotech latest to challenge AbbVie on US Humira exclusivity

AbbVie is confident that no biosimilar will challenge Humira sales in the US until 2023 despite a legal challenge from Alvotech seeking to end the monopoly. Humira (adalimumab) is the world’s top selling drug, pulling in $19.8 billion in revenues for AbbVie in 2020. Of this, $16.1 billion was from the US, a region currently protected from adalimumab competition due to AbbVie’s web of patents and legal agreements with numerous biosimilar makers. But while the likes of Amgen, Samsung Bioepis,…

Biogen Swiss site GMP ready for aducanumab launch

Biogen has received GMP certification at its Solothurn, Switzerland facility ahead of a regulatory decision for potential Alzheimer’s drug aducanumab. Biogen commissioned the CHF 1 billion ($1 billion) monoclonal antibody production facility in Luterbach, Solothurn, in 2015, stating at the time it would offer 144,000 L of stainless-steel capacity, comprising of eight 18,000 L bioreactors with an output of 10 metric tons. Last week, Swiss Agency for Therapeutic Products (SWISSMEDIC) granted the facility a Good Manufacturing Practice (GMP) multi-product license,…