Regulations

Novartis awaiting Italian plant inspection for FDA’s Leqvio decision

Novartis is confident of maintaining a December 2020 action date for its high cholesterol siRNA therapy Leqvio despite common COVID-related regulatory delays of three to five months. Earlier this month, Novartis received positive opinion from the European Medicines Agency (EMA) for Leqvio (inclisiran), a small interfering RNA (siRNA) therapy for the treatment of adults with hypercholesterolemia or mixed dyslipidemia. The Swiss pharma giant is hoping for the same in the US, with a PDUFA date set for December 31 2020…

EMA committee nod for Orchard’s Libmeldy positive for AGC Biologics

AGC Biologics looks set to start making Orchard Therapeutics’ Libmeldy after an EMA panel recommended the gene therapy be approved. The agency’s the Committee for Medicinal Products for Human Use (CHMP) recommended approval last week, explaining Libmeldy (cryopreserved autologous CD34+ cells encoding the arylsulfatase-A, or ARSA, gene) slows down progression of the lysosomal storage disease, metachromatic leukodystrophy (MLD). Orchard CEO Bobby Gaspar welcomed the recommendation. He said it “brings us closer to delivering a one-time, potentially transformative therapy for eligible…

Tech used for new Ebola drug key to COVID-19 fight, Regeneron

Regeneron says rapid response technologies pioneered to combat Ebola are helping accelerate efforts to create COVID-19 countermeasures. Last week Regeneron won US FDA approval for Inmazeb (atoltivimab, maftivimab and odesivimab-), its treatment for Zaire Ebola. The product is made from three monoclonal antibodies that target the Ebola glycoprotein, preventing the virus binding and infecting cells. Regeneron created Inmazeb using the same rapid response manufacturing platform it is currently using for RGEN-COV2, its COVID-19 treatment candidate. Shawn Lawrence, senior director, cell…

J&J trial pause does not bode well for viral-vector COVID vaccines, analyst

Johnson & Johnson says the pausing of dosing in trials of its COVID-19 candidate is not unusual, but one analyst believes this could have significant negative impact for viral-vector based vaccines. Johnson & Johnson announced at the beginning of the week it has temporarily paused further dosing in all its COVID-19 vaccine candidate clinical trials due to an unexplained illness in a study participant. This included the Phase III ENSEMBLE trial of JNJ-78436735, also known as Ad26.COV2-S, recombinant, which is…

SQZ Biotech lines up $75m IPO for cell therapy R&D

SQZ Biotechnologies says its technology can produce cell therapies in less than 24 hours compared to a month or more for current products and is looking to use IPO proceeds toward the completion of Phase I development of its lead therapeutic candidate. In paperwork filed with securities regulators late last week, SQZ set a preliminary $75 million goal for its IPO. The Watertown, MA-based biotech has applied for a listing on the New York Stock Exchange under the stock symbol “SQZ.” SQZ…

Regeneron and Pfizer sued for ‘unauthorised’ reagent use

Allele Bio says Regeneron and Pfizer’s use of a labelling reagent during COVID-19-related vaccine and therapeutics development infringed on its IP. The San Diego biotech made the claim in lawsuits filed lawsuits against Regeneron and Pfizer this week. It said “both complaints address the infringement of Allele’s patented mNeonGreen reagent.” mNeonGreen is a fluorescent protein used in biological assays. Like Green Fluorescent protein, when mNeonGreen binds a specific molecule it gives off a fluorescent signal that can be used to…

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…