Regulations

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,…

Bluebird welcomes CHMP nod for CALD gene therapy

Bluebird Bio says Skysona – a treatment for the neurological disease CALD – is a step closer after a thumbs-up from EMA reviewers. The European Medecines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion on the therapy and issued an approval recommendation last week. The CHMP said the advice was based on a study in which Skysona (elivaldogene autotemcel, formerly Lenti-D) preserved motor function and communication ability and improved survival in 90% of patients…

GMP deficiencies disrupt production of ERC’s cell-based vaccine

European regulators have suspended the distribution of autologous and allogeneic cell-based vaccine candidate Gliovac following an inspection at ERC’s site in The Netherlands. The inspection took place on February 25 at the Schaijk facility, located about 75 miles southeast from Amsterdam, and resulted in a statement of non-compliance with good manufacturing practice (GMP) being issued. “ERC The Netherlands B.V. showed a lack of ability to adhere to the principles of Good Manufacturing Practice for ATMPs [advanced therapy medicinal products],” the…

Emergent recognized cross contamination risk at Bayview plant hit with 483

Emergent BioSolutions has defended the manufacture of two different viral products from its Bayview facility as part of the “Herculean task” of tackling the coronavirus pandemic. The Bayview, Maryland drug substance facility has been on the forefront of the fight against COVID-19, with Emergent BioSolutions contracted to make millions of doses of Johnson & Johnson and AstraZeneca’s respective vaccines from the plant. But an ingredient mix up reported in March rendered 15 million doses unusable, and Emergent has now halted…

Lonza’s alleged need for Nestlé staff highlights shortage in biopharma talent

Neither company will confirm reports that Nestlé staff have been commandeered to help Lonza service its Moderna contract but the story highlights biomanufacturing staffing issues. A report by Reuters this week claims contract development and manufacturing organization (CDMO) Lonza is adding staff from fellow Swiss firm Nestlé in order to service a deal to produce drug substance for hundreds of millions of doses of Moderna’s COVID-19 vaccine. The “call for volunteers” following an intervention by the Swiss government aims at…