Global Markets Archives - Page 9 of 41 - BioProcess InternationalBioProcess International

J&J: ‘We’re working with – but not dependent on – Emergent’

Talks are ongoing with troubled CDMO Emergent, but a robust production network means J&J is still on track to produce a billion doses of its COVID vaccine this year. In February, Johnson & Johnson (J&J) became the third firm to receive Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for a COVID-19 vaccine. The single shot offering received European authorization the following month. However, the vaccine has hit several snags. Questions around potential blood clots saw…

Biogen Alzheimer’s mAb approval to be a boon for bioprocess space

by Dan Stanton

The approval of Aduhelm (aducanumab) will have a significant knock-on effect for the bioproduction services space, increasing the annual growth rate several percentage points. Yesterday, the US Food and Drug Administration approved Aduhelm ending years of regulatory turbulence for Biogen. The drug, a monoclonal antibody that breaks down amyloid plaque buildup that is thought to worsen Alzheimer’s disease, marks a turning point in Biogen’s fortunes. The firm has seen falling revenues as competition challenges its lead products – Tecfidera (dimethyl…

Back to business? Demand for trials returning, says Icon

by Gareth Macdonald

Icon says demand is recovering with bookings for its own services as well as those of soon-to-be acquired PRA continuing to climb in the second quarter. The Dublin, Ireland headquartered contract research organization (CRO) saw bookings increased 27% in the first quarter, versus the first three months of 2020, with book-to-bill ratio – roughly the value of new contracts divided by revenue – of 1.28. And the momentum has continued, according to CFO Brendan Brennan who spoke at Jefferies’ Healthcare…

Sepragen skids to help Serum Institute ramp up vaccine production

by BPI Staff

Sepragen has delivered two chromatography skids to the Serum Institute of India to help increase monthly production of COVID-19 vaccines from 40 million to 200 million doses. Bioprocess equipment manufacturer Sepragen Corporation recently shipped out two 125 liters/minute QuantaSep chromatography skids, with integrated inline buffer blending capabilities, to the Serum Institute, located in Pune, India. “These skids will allow the vaccine manufacturer to increase their production from 40 million doses per month to 200 million doses per month,” a Sepragen…

Alvotech latest to challenge AbbVie on US Humira exclusivity

by Dan Stanton

AbbVie is confident that no biosimilar will challenge Humira sales in the US until 2023 despite a legal challenge from Alvotech seeking to end the monopoly. Humira (adalimumab) is the world’s top selling drug, pulling in $19.8 billion in revenues for AbbVie in 2020. Of this, $16.1 billion was from the US, a region currently protected from adalimumab competition due to AbbVie’s web of patents and legal agreements with numerous biosimilar makers. But while the likes of Amgen, Samsung Bioepis,…

N-SIDE launches app to optimize clinical manufacturing supply chain

by Dan Stanton

The Production App has already saved one biopharma firm €10.5 ($12.8) million by optimizing manufacturing planning within the uncertainty of the R&D process, says N-SIDE. N-SIDE has a suite of software aimed at optimizing the entire clinical trial supply chain management process from production planning through to protocol design and delivery of supplies to patients. The latest offering, known as ‘The Production App,’ focuses on helping biopharma firms manage the complexities and uncertainties of manufacturing clinical material and according to the…

CDMOs need to invest in innovation to make complex meds, says Resilience CEO

by Gareth Macdonald

Biopharma CDMOs need to rethink production according to Resilience CEO Rahul Singhvi, who says industry must learn to make a new generation of complex products. Advances in biological science in recent years are helping the biopharmaceutical industry to start unlocking the potential of cell and gene therapies. For example, in the past few months the US FDA has approved two cell based cancer meds – Abecma (idecabtagene vicleucel) and Breyanzi (lisocabtagene maraleucel) – further underlining the cell therapy sector’s potential.…

Survey highlights lack of minority leadership in life science space

by Dan Stanton

The lack of ethnic minorities and women in leadership roles is the biggest problem with diversity and inclusion in the life sciences space, according to a survey from Informa Connect. Over 480 people working across the life sciences space responded to a survey entitled ‘Diversity, Equity and Inclusion in the Life Sciences 2021,’ conducted by Informa Connect in March, and the results are now in. While respondents stressed that a combination of many problems plagued our industry, over a third…

GSK says 47% drop in Shingrix sales is down to COVID-19

by Millie Nelson

The coronavirus pandemic and rapid rollout of COVID vaccines in the US has led to a decline in sales of shingles vaccine, Shingrix. For the quarter, GlaxoSmithKline (GSK) reported its non-live, recombinant subunit vaccine for the prevention of shingles (herpes zoster), Shingrix sales have declined by 47%, which the firm predicted during its last quarterly earnings call. “The prioritization of the public health systems to focus on pandemic vaccination deployment has led to significant disruption in Shingrix prescriptions,” Luke Miels,…

Biosimilars: Roche and Biogen talk competition, price, opportunities

by Gareth Macdonald

The complexity of the biosimilar market was much in evidence last week with Roche and Biogen both citing competition as challenges in Q1. Roche saw group revenues of CHF 14.9 billion ($16.3 billion) in the first three months of 2021, up 3% year-on-year. The contribution from diagnostics grew 55% to CHF 4.5 billion due to a surge in demand for COVID-19 testing. In contrast, revenue from medicines fell 9% to CHF 10.6 billion. Roche said the decline was mainly because…