Regulations

Trump’s ‘reckless’ drug pricing Executive Order threatens innovation, BIO chief

The US is doing more in the COVID-19 space than anywhere in the world due to the strength of its innovative ecosystem, says Michelle McMurry-Heath, head of trade group BIO. But such innovation is under threat due to “reckless” orders coming out of the White House. As part of an exclusive interview filmed for Xconomy’s Xcelerate’s Keynote Series at Biotech Week Boston next week, Michelle McMurry-Heath, president & CEO of life sciences advocacy group Biotechnology Innovation Organization (BIO), criticized Executive…

As COVID disrupts FDA inspections, will liso-cel approval be further delayed?

Coronavirus-related constraints mean the US FDA has not yet inspected manufacturing facilities in Washington and Texas, risking a delay in the approval of Bristol-Myers Squibb’s lymphoma CAR-T candidate liso-cel. Bristol-Myers Squibb added anti-CD19 targeting lymphoma candidate lisocabtagene maraleucel (liso-cel) to its pipeline through the $74 billion acquisition of Celgene. In May, the action date of the Biologics License Application (BLA) for the chimeric antigen receptor (CAR) T-cell therapy was extended by three months by the US Food and Drug Administration…

Samsung Bioepis: Govs and biopharma must work on post-COVID supply chain security

With biopharma operations still affected by coronavirus, governments and industry must look ahead to ensure the security of manufacturing resources and supply chain structures, says Samsung Bioepis. Like other companies, 2020 has been a challenge for Samsung Bioepis with the global coronavirus pandemic laying waste to ‘normal’ business procedures and supply chain management. “We’ve supplied more than 18 million units of product worldwide since 2016 without experiencing any supply shortages in providing our products to customers and patients,” Kevin Jack,…

Calculated risk is key to rapid COVID-19 vaccine development says CEPI

Taking calculated risks will accelerate SARS-CoV-2 vaccine development according to CEPI, which says traditional techniques are too slow. Developing a vaccine usually takes between six to 11.5 years according to the Gates Foundation backed Coalition for Epidemic Preparedness Innovations (CEPI). In traditional development models target identification can take six months to two years, followed by preclinical testing and up to a decade of clinical development. Manufacturing scale up also takes years. But the COVID-19 pandemic calls for a different approach…

Pfizer blasts Trump’s pricing plans, threatens to pull US investments

CEO Albert Bourla says Pfizer will rethink plans to invest in US R&D and manufacturing after lambasting four executive orders aimed at reducing drug prices unveiled last week. Like most areas of society, Big Pharma’s relationship with US President Donald Trump has been tumultuous. Initial fears of a clampdown on drug pricing through promises to ‘drain the swamp’ were abated through Trump cozying up with the sector once in office. And reforms passed by Congress in 2017 through the ‘Tax Cuts…

Kite flies high with second CAR-T approval

Gilead’s Kite has won US FDA approval for Tecartus (brexucabtagene autoleucel), a CAR-T cell therapy for the treatment of mantle cell lymphoma (MCL). Tecartus becomes the third chimeric antigen receptor (CAR) T-cell therapy to be granted approval by the US Food and Drug Administration after Novartis’ Kymriah (tisagenlecleucel) and Kite’s Yescarta (axicabtagene ciloleucel), both of which were approved in 2017. Tecartus is designed to target CD19, a protein found in high amounts in cancerous B cells, and the regulatory decision…

WHO drafting regulatory convergence white paper on cell and gene therapies

Regulators in high-income countries have a responsibility to help health authorities in low- and medium-income countries develop regulatory frameworks for cell and gene therapy products to ensure these treatments are available to all, asserts the US FDA’s biologics center’s director Peter Marks. The World Health Organization plans to soon issue a white paper proposing a harmonized regulatory framework for cell and gene therapy products, according to Peter Marks, director of the US Food and Drug Administration’s Center for Biologics Evaluation…

US FDA says platforms can speed COVID-19 jab development

COVID-19 focused drug and vaccine firms need to keep a close eye on the US FDA according to lawyers who predict manufacturing and trial rules will continue to change. The US Food and Drug Administration (FDA) issued its latest guidance for firms developing vaccines against SARS-CoV-2 – the virus that causes COVID-19 – last week. The document sets out what trial data vaccine firms will need to supply. It also makes clear developers will have to seek approval the traditional…

Manufacturing pace key for COVID-19 vaccines hoping to jump to ‘Warp Speed’

Ease of manufacturing scale up may determine which candidates advance furthest in the US government’s partnership with industry to speed COVID-19 vaccines to patients. Senior government officials also discussed approval standards, how a vaccine would be distributed, and how much the government and Americans could pay in a 16 June press call. The ability for a COVID-19 vaccine to be manufactured quickly and at scale will be a key factor in determining which potential candidates advance through Operation Warp Speed,…

US FDA warns Takeda about Hikari plant

The US FDA has warned Japanese drug firm Takeda about its plant in Hikari, Japan after an inspection conducted last November. According to a letter from the regulator, inspectors who visited the site identified a number of problems with the facility’s quality control unit. The agency wrote, “Our inspection found that your Quality Unit (QU) did not take appropriate steps prior to resumption of aseptic manufacturing after a shutdown that included multiple significant activities that compromised cleanroom control.” It also…