Global Markets

Biocon going digital to fix insulin plant hit with another FDA 483

Adopting a digital-based Quality Management System will help Biocon remediate issues at its insulin glargine facility in Malaysia, the firm says. An inspection by the US Food and Drug Administration (FDA) between June 24 and July 5 has resulted in a Form 483 with 12 observations at Indian drugmaker Biocon’s facility in Malaysia. The drug product and drug substance site will produce a follow-on insulin glargine referencing Sanofi’s Lantus intended for the US market. “We believe these 12 observations across…

Teva partnership looks to up its biologics productivity

Teva has teamed with Just Biotherapeutics to develop a high productivity biomanufacturing process as it focuses its efforts towards biopharmaceuticals. The partnership aims to develop methods to lower the cost of biomanufacturing. Just Biotherapeutics – recently acquired by Germany’s Evotec – will design and development a high yielding manufacturing process for one of Teva Pharmaceutical Industries’ complex products. Further details of the process, molecule or the finances of the deal were not answered by either company when contacted by this…

Spark on the evolving commercial cell & gene therapy space

Single-use technologies and CDMO expansions have resolved some of the issues in the cell and gene therapy space but analytical and supply chain challenges still exist, says Spark Therapeutics. Spark Therapeutics is one of a handful of companies to achieve regulatory success with an advanced therapy, specifically its gene therapy for inherited vision loss Luxturna (voretigene neparvovec) which received US approval in December 2017. Speaking as part of a panel discussion at the BPI Theater at BIO in Philadelphia last…

Henlius’ trastuzumab: EU to assess first China-made biosimilar

The European Medicines Agency (EMA) has accepted to review a version of Roche’s cancer drug Herceptin (trastuzumab) developed by Chinese biotech Henlius. The European agency has officially accepted to review the Marketing Authorization Application (MAA) of Shanghai, Henlius’ trastuzumab molecule HLX02, making it he first biosimilar developed and made in China to be up for review. Scott Liu, co-founder and CEO at Henlius, said the review “shows that our clinical, medical, regulatory affairs and quality system capabilities have been internationally…

Biotech money: Global funding down despite spate of IPOs

A decline in venture capital (VC) funding has been offset by a flood of IPOs with growth coming from non-US biotechs, according to a Jefferies analyst. For April and May 2019, biotech funding has declined 6.5% year-on-year to $9.3 billion (€8.3 billion) according to Jefferies analyst David Windley. This, he said in a note, is due to a 46% drop in VC funding as the private market continues to be less kind to biotech over the past few periods. “Both…

Catalent to invest up to $10m into ex-BMS fill/finish site

Catalent will retain all 700 staff and invest up to $10 million into a site in Italy it is acquiring from Bristol-Myers Squibb. The deal, announced this week, will see the contract development and manufacturing organization expand its biologics network outside of the US through the addition of a sterile product manufacturing and packaging facility in Anagni, Italy. Financial details regarding Catalent’s first biologics manufacturing facility in Europe have not been divulged, but a spokesperson told this publication the CDMO…

The scale-X factor: Univercells wins $14m grant to make low-cost measles vaccines

Univercells aims to make affordable measles and rubella vaccines using its NevoLine biomanufacturing platform incorporating the scale-X fixed-bed bioreactor. In a consortium with Batavia Biosciences and Natrix Separations, Belgium-based Univercells has been able to develop a manufacturing platform that has slashed the cost of production of inactivated polio vaccine (sIPV). Now, through a $14.3 million (€12.8 million) from the Bill & Melinda Gates Foundation, the firm is looking to adapt the platform to produce low-cost measles and rubella (M&R) vaccines…

Amgen: ‘We’ve shaved 3 years off development but can do better’

Amgen says it hopes to rapidly develop new medicines from a collaboration with Intermountain Health as its EVP of R&D discusses changing timelines. Wholly-owned Amgen subsidiary deCODE genetics will have access to the genomes of 500,000 Utah-based participants from a study carried out by not-for-profit healthcare provider Intermountain Healthcare. Amgen hopes to use this data to uncover new insights into specific diseases and develop new medicines that reach the right disease targets. Speaking at the Goldman Sachs 40th Annual Global…

America has 20 approved biosimilars but you’ll never believe how many have launched!

With the FDA approving Amgen And Allergan’s version of Roche’s Herceptin (trastuzumab) America’s biosimilar tally has reached 20… But only seven have reached the market. Clickbait headline aside, this week marks another major milestone in the US biosimilar market: the approval of its twentieth biosimilar Kanjinti (trastuzumab-anns), a version of Roche’s cancer monoclonal antibody Herceptin developed by Amgen and Allergan. The approval is the third in Amgen’s portfolio and the second of four biosimilars from an Amgen and Allergan collaboration…

Hitachi supplying gene therapy Zynteglo for bluebird in EU

bluebird bio will use Hitachi Chemical subsidiary apceth Biopharma to commercially manufacture its recently EU approved gene therapy Zynteglo. Earlier this month, the European Medicines Agency (EMA) approved orphan drug Zynteglo (autologous CD34+ cells encoding βA-T87Q-globin gene) – previously known as LentiGlobin – as a one-off treatment for beta-thalassaemia. Zynteglo uses a lentiviral viral vector to add functional copies of a modified β-globin gene into a patient’s own stem cells, addressing the underlying genetic cause of patients for whom a…