Regulations

FDA guidelines aim to improve quality and lower costs

The US FDA has issued draft guidance intended to promote innovation in pharmaceutical development and manufacturing. Entitled ‘Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality Guidance for Industry,’ the draft guidance has been produced by the US Food and Drug Administration (FDA) to informally recognize voluntary consensus standards relating to pharmaceutical quality for products under the jurisdiction of the Center for Drug Evaluation and Research (CDER). “The overall goal of this program is to promote development…

Phacilitate: Cell & gene industry flocks to Miami

The cell and gene therapy industry congregated in Miami to discuss supply chain strategies, regulatory rationale and the high manufacturing costs of advanced therapies. BioProcess Insider attended the Phacilitate Leaders World Summit, co-located with the World Stem Cell Summit, in Miami, Florida last week. The conference reflected on the first full year where three advanced therapies – Kymriah, Yescarta, and Luxturna – proved themselves on the commercial stage, heralding in a new frontier for regenerative medicines. But industry quickly rose above…

Trastuzumab triple: FDA approves Merck and Samsung Bioepis biosimilar

The FDA has approved Ontruzant, the third version of Roche’s cancer drug Herceptin, and the second US biosimilar approval for Samsung Bioepis. The product will be marketed by Merck & Co. Europe approved Ontruzant in November 2017 as a biosimilar to Roche’s Herceptin (trastuzumab), and 14 months on the US Food and Drug Administration (FDA) has given the oncology biologic the regulatory thumbs up. Ontruzant becomes the seventeenth biosimilar to be approved in the US, and the first of 2019.…

Cell and gene therapies: FDA expects 10 to 20 approvals per year by 2025

The US FDA predicts it will receive more than 200 regenerative INDs per year from 2020 and will add 50 additional staff to review these products. There has been “a large upswing in the number of investigational new drug (IND) applications” for cell and gene therapies received by the US Food and Drug Administration (FDA), commissioner Scott Gottlieb and Peter Marks, director of the Center for Biologics Evaluation and Research (CBER) said in a statement yesterday. The Agency has so…

Biotech patents: How to protect from IP threats

Thomas Wolski, partner at The Webb Law Firm, says biotech firms must file more patent applications earlier to overcome the threats of US legal uncertainty and unclear guidance. Uncertainty in US laws is one of the threats that the biotech industry has and continues to face when it comes to patents. And it seems like every patent case that the Supreme Court takes these days has a strong chance of reversing the Federal Circuit’s decision. To compound the problem, Congress’s…

FDA paves way for insulin biosimilars, but will they be interchangeable?

Sanofi will see its short-acting follow-on insulin Admelog be regulated as a biosimilar from 2020 under US FDA plans to promote competition. But the need for additional studies to show interchangeability could delay any impact, the firm says. The US Food and Drug Administration (FDA) has been actively pursuing efforts to increase adoption of biosimilar products over the past year. In July, the Agency published a ‘Biosimilars Action Plan’ aimed at promoting access to lower-cost biosimilar drugs while maintaining a desire…

MacroGenics clinical hold has no wider implications for bispecifics, say analysts

The US FDA has placed a partial clinical hold on MacroGenics’ CD3 bispecific candidate MGD009 following reports of hepatic adverse events. On December 6, the US Food and Drug Administration (FDA) sent Maryland-based clinical-stage biopharmaceutical company MacroGenics a letter indicating that a partial clinical hold has been placed on its Phase I monotherapy study of MGD009 and a combination study of MGD009 and MGA012 (anti-PD-1). No new patients will be enrolled in either study until the partial hold is lifted…

Pfizer Kansas plant hit by FDA 483 with 8 repeat observations

The US FDA observed potential mold contamination and deficient aseptic processes during an inspection at Pfizer’s fill/finish facility in McPherson, Kansas. The McPherson facility was one of several manufacturing plants added to Pfizer’s network following the $17 billion (€14.9 billion) acquisition of Hospira in 2015. The plant has been subject to various regulatory issues, resulting in a US Food and Drug Administration (FDA) warning letter in February 2017 citing poor aseptic processing and repeat GMP violations. An October 2017 inspection resulted…

EU gives conditional nod for Takeda Shire megamerger

The European Commission (EC) has approved Takeda’s $62 billion acquisition on the proviso the firm divests Shire’s inflammatory bowel disease (IBD) candidate. In May, Japanese firm Takeda struck a deal to acquire Ireland-headquartered rare diseases biopharmaceutical company Shire for $62 billion (€54 billion). Six months on, the merger is one step closer after receiving approval under the EU Merger Regulation, on the condition of divesting Shire’s IBD candidate SHP647. “We can today approve the merger between Shire and Takeda, but…

StemGenex warned as FDA clamps down on stem cell ‘bad actors’

Marketing unapproved stem cell therapies and cGMP deviations have landed California’s StemGenex Biologic Laboratories with a US Food and Drug Administration (FDA) warning letter. The letter cites issues in good manufacturing practice (GMP) and the unlawful marketing of an unapproved stromal vascular fraction (SVF) stem cell therapy, processed from autologous adipose tissue. It was sent on October 31, following an FDA inspection at StemGenex Biologic Laboratories’ (SGBL) facility in San Diego, California in January this year. According to the Agency,…