Regulations

Compounders complain they can’t make these four drugs once they’re deemed biologics

After 23 March, the US FDA won’t allow any more bulk compounding of four oft-compounded drug substances, disrupting patient care, compounders say. Major disruptions in patient access to compounded versions of four bulk drug substances may result from the US Food and Drug Administration’s (FDA’s) decision, announced 5 March, to regulate them beginning 23 March as biologics licensed under the Public Health Service Act, drug compounding industry groups say. The announcement said outsourcing facilities complained four substances on the FDA’s preliminary list would be…

Individualized gene therapy: FDA considering device-like manufacturing approval process

CBER Director Peter Marks said the agency could streamline development by allowing sponsors to depend on an already-approved manufacturing platform and reviewing any modifications that are proposed. Individualized gene therapy approvals at the US Food and Drug Administration (FDA) could speed up using a 510(k)-like process under consideration. Peter Marks, director of the Center for Biologics Evaluation and Research (CBER), said the FDA needs a workable pathway not requiring new authority from Congress to deal with the growing sector. During…

Halozyme eyes major drivers in Roche and Janssen subcutaneous approvals

Potential upcoming approvals and launches of subcutaneous formulations of monoclonal antibodies could prove a boon for Halozyme, which licenses its Enhanze technology to Janssen and Roche, among others. In 2019, Halozyme Therapeutics announced its pancreatic cancer drug candidate PEGPH20 did not meet a Phase 3 study’s main goal of improving how long patients lived. As such, the firm laid plans to restructure, ending its R&D oncology operations in favor of growing its formulation platform offering, Enhanze. The technology consists of…

Manufacturing quality systems first defense against hackers says expert

An effective quality management system is a must for biopharmaceutical firms looking to protect their data assets against hackers according to a leading cybersecurity expert. Increasingly biopharmaceutical manufacturing relies on data. Ensuring optimal conditions are maintained in bioreactors or that chromatography systems are functioning properly depends on monitoring systems that feed information back to control systems. Likewise, data is key to how biopharmaceutical products are tracked through packaging and distribution systems to ensure they get to the correct hospital, pharmacy…

FDA approves Seqirus’ adjuvant cell-based flu vaccine Audenz

Seqirus says it is confident of supply of its newly approved cell-base influenza A (H5N1) vaccine Audenz in the case of a pandemic. The US Food and Drug Administration (FDA) gave the thumbs up to Seqirus for its vaccine Audenz (Influenza A (H5N1) Monovalent Vaccine, Adjuvanted), making it the first adjuvanted, cell-based influenza vaccine approved to protect against influenza A (H5N1) in the event of a pandemic. Seqirus, a subsidiary of CSL Limited, is not planning to market the product…

Akron says biopharma needs GMP framework for ancillary materials

Akron Biotechnology says biopharma needs a common GMP framework for ancillary materials used in the production of advanced therapies Ancillary materials (AMs) are components and reagents used during cell therapy production. They are not supposed to be present in the finished products, but often are which can impact quality and safety. Despite this, at present there are no specific regulations governing the composition, compliance, and qualification of AMs. Instead there are several independent GMP frameworks for such materials. These include…

Potential Oklahoma anti-vax bill danger to health and industry

Oklahoma has introduced a bill intended to ban the state from prescribing, administering, and making medicinal products and vaccines containing human DNA. Introduced on January 15, Senate Bill 1514 is proposing prohibiting vaccine use and supply in the state of Oklahoma. “No medicine, medical product, vaccine or other injection that contains human DNA shall be prescribed, administered, dispensed, used or offered in this state,” the bill states, placing a date of November 1, 2020 as the when it hopes to…

US FDA predicts gene therapy surge and moves to clarify expectations

Gene therapy developers targeting the US market have a clearer idea of what it will take to win approval thanks to new guidance documents issued by the FDA. The US regulator set out its expectations for developers in six documents published last week. There are final guidance documents on gene therapies for hemophilia, retinal disorders and rare diseases. In addition, there are final guidance documents on chemistry, manufacturing and controls (CMC), observational studies and on the assessment of gene therapies…

Biocon receives FDA Form 483 at Bangalore plant

The US FDA has issued Indian drugmaker a 483 with five observations following a pre-approval inspection of an API plant in Bangalore. [Story corrected 01/28 9am ET] – The US Food and Drug Administration (FDA) carried out the inspection at the site in Bangalore, India last week and issued a Form 483 with five observations. “We will respond to the FDA with a Corrective and Preventive Action Plan (CAPA) and are confident of addressing these observations expeditiously. We remain committed…

Phacilitate 2020: FDA commercial cell and gene therapy forecast ‘unlikely’

Manufacturing issues and a scarcity of new commercial products leave predictions that 10-20 cell and gene therapy approvals each year by 2025 somewhat fanciful, says Dark Horse Consulting. In his plenary address at the Phacilitate conference yesterday, Anthony Davies, founder of cell and gene therapy specialist firm Dark Horse Consulting, reflected on the difficulties the sector has faced since the high of 2017 when three products achieved US Food and Drug Administration (FDA) approval: Kymriah (tisagenlecleucel) and Yescarta (axicabtagene ciloleucel),…