Regulations

US House approves bill to take on biosimilar ‚Äėpatent dance‚Äô

The bill aims to reduce US drug prices and could limit IP strategies undertaken by reference biologic makers to ward off biosimilar competition. Having been first introduce to the House in April, H R 2884 was approved by the House Judiciary Committee yesterday as part of four bills aimed at tackling the high prices of drugs in the US. According to the text, the bill ‚Äúlimits in certain instances the number of patents that the manufacturer of a biologic drug…

Biocon hit by FDA 483 with 6 observations at Malaysian plant

Biocon‚Äôs insulin manufacturing facility in Malaysia has received a US FDA Form 483 with six observations but firm says it will not affect commercialization plans in the US. Indian biopharma giant Biocon reported this week it has been issued with a Form 483 by the US Food and Drug Administration (FDA) after the agency conducted an on-site pre-approval inspection (PAI) at its Malaysian ¬†manufacturing plant for its biosimilar insulin product. ‚ÄúThe US FDA conducted a (PAI) of our Malaysian subsidiary…

AstraZeneca vaccines: Further problems at Emergent but FDA okays exports

The US FDA has determined several lots of a COVID-19 vaccine are acceptable to use despite AstraZeneca identifying further¬†manufacturing deviations¬†at¬†CDMO¬†partner¬†Emergent.¬† Efforts to scale up COVID-19 vaccines in the wake of the pandemic have been exceptional, but in April¬†Emergent¬†BioSolution¬†fell afoul of the US Food and Drug Administration (FDA).¬† The¬†contract development and manufacturing organization (CDMO)¬†had been contracted by both Johnson & Johnson and AstraZeneca¬†(AZ)¬†to make their respective COVID-19 vaccines, but an ingredient mix up rendered 15 million doses unusable and landed the…

Tivdak approval marks another ADC success for Seagen

The US FDA has approved a fourth product for Seagen and the twelfth ADC therapeutic in the form of cervical cancer drug Tivdak. First up, it‚Äôs Seagen (previously Seattle Genetics), which received accelerated approval for Tivdak (tisotumab vedotin), an antibody drug conjugate (ADC) for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. On a conference call discussing the approval, Seagen CEO Clay Siegall described the approval as ‚Äúanother significant milestone‚ÄĚ…

Eli Lilly and industry criticize Biden’s drug pricing plan

Eli Lilly says the US Government‚Äôs latest pricing plan will restrict access of drugs to patients and restrict industry innovation. On Thursday, the US Department of Health and Human Services published a plan to address what it describes as prices for prescription drugs that are ‚Äúhigher than any comparable nation.‚ÄĚ The report is based on three guiding principles for drug pricing reform: 1) To make drug prices more affordable and equitable for all consumers and throughout the health care system…

FDA: Drug firms using 24/7 production need more viral safety data

The US FDA has urged protein therapeutics makers using continuous manufacturing to take steps to keep products virus free. The regulator made the suggestion in a recent concept paper along with more general advice on how industry can use 24/7 production to manufacture protein drugs more efficiently. Viral contamination is an issue for all biopharmaceuticals made in processes that use mammalian cell lines. The cells contain sequences that can produce potentially harmful virus-like particles that must be removed from the…

EMA thumbs up to more CDMO sites supporting COVID vaccines

The European Medicines Agency (EMA) has approved a Delpharm plant in France and a Catalent facility in the US to support supply of Pfizer and Moderna‚Äôs COVID-19 vaccines, respectively. The approvals from the EMA‚Äôs human medicines committee (CHMP) this week aim to increase manufacturing capacity and supply of the two COVID-19 vaccines in the EU. The first saw the Agency approve a fill-finish site in Saint Remy sur Avre, France operated by contract development and manufacturing organization (CDMO) Delpharm. The…

Lilly hit by FDA 483 with 7 observations at IN plant

An Eli Lilly aseptic facility in Indianapolis, which fills COVID-19 antibodies along with other drugs, has received a US FDA Form 483 with seven observations. The Form 483 (available below) was published last week and highlights the issues the US Food and Drug Administration (FDA) found after inspecting the facility in Indianapolis, Indiana in February and March this year. Among the seven observations noted, the Agency highlighted failures by Lilly to establish an adequate system for monitoring environmental conditions in…

Novavax: Analytical work keeping vaccine at bay, Fujifilm not to blame

Novavax expects EUA submission for its COVID-19 vaccine to occur in the fourth quarter this year due to analytical work delays. Novavax was one of the forerunners of the COVID-19 vaccine pioneers, attempting to bring its prefusion protein-based vaccine NVX-CoV2373 ‚Äď made using Novavax‚Äô proprietary nanoparticle technology and Matrix‚ÄďM adjuvant ‚Äď to market with help from $1.6 billion of US government assistance through the ‚ÄėOperation Warp Speed‚Äô program. However, while peers such as Pfizer, Moderna, and J&J have achieved regulatory…

Bayview’s back: FDA gives Emergent green light to resume vaccine production

Emergent took a $54 million hit from remediation efforts and inventory write-downs at its Bayview plant and saw a $108 million reduction in its CDMO backlog. But now the firm is free to restart vaccine production for customer J&J. Emergent BioSolution‚Äôs Bayview, Maryland facility had been contracted by both Johnson & Johnson and AstraZeneca to make their respective COVID-19 vaccines, but an ingredient mix up rendered 15 million doses unusable and landed the plant with¬†a Form 483 and a directive…