Global Markets

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

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

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

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

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…

Chinese CDMO sector growing but unlikely to make global impact

China’s contract manufacturing space is growing at over 15% year-on-year but only WuXi Biologics has seen success in attracting global clients, says BioPlan Associates ahead of CPhI Discover. Third-party drug manufacturing is relatively new in China. Only since 2015 has a market authorization holder (MAH) system been in place, opening the doors through further reforms for commercial contract development and manufacturing organizations (CDMOs) to operate in the country. In 2019, China approved Hodgkin’s lymphoma drug tislelizumab – the first CDMO-made…

Pfizer mRNA risk paying off as it moves to make 3bn doses of COVID jab

Pfizer says it will produce 3 billion doses of its COVID-19 vaccine this year and will further invest in its manufacturing network to support continued global demand. Through its partnership with BioNTech, Pfizer became the first company to bring a messenger RNA-based product to market, namely the COVID-19 vaccine Comirnaty (BNT162b2). Last month, the firm estimated it was set to make around $15 billion from global sales of the vaccine this year, based on production projections of 2 billion doses.…

Thermo Fisher to buy PPD to build in ‘high growth’ clinical services sector

Thermo says buying PPD will position it as leader in the “high growth” CRO sector and help it win more business from new and existing customers. Thermo Fisher Scientific announced its intention to buy contract research organization (CRO) PPD for $17.4 billion in a statement on Thursday, citing demand from pharma and biotechnology sector customers. Thermo Fisher’s CEO Marc Casper said “The acquisition of PPD is a natural extension for Thermo Fisher and will enable us to provide these customers…

COVID-19 and cell and gene sector help to kickstart Pharma 4.0

COVID-19 and the growth of the cell and gene therapy sector have pushed the pharma industry to use new and emerging technologies to solve manufacturing challenges.    Speaking at the recent BPI West virtual conference, co-founder and CEO of Apprentice Angelo Stracquatanio said the coronavirus pandemic has forced companies across the pharma industry to adapt and operate differently, particularly altering how and what technologies it opts to use.  With business “grossly disrupted,” he argued “the industry started to turn to new and emerging technologies to solve a lot of these key challenges that came up in…

Turning a corner in CAR-T: FDA approves ide-cel

The US FDA has approved Abecma (ide-cel); the first CAR-T for a non-CD19 target and the second cell therapy in eight weeks for Bristol-Myers Squibb. This weekend, the US Food and Drug Administration (FDA) approved Abecma (idecabtagene vicleucel, commonly referred to as ide-cel) as the first cell-based gene therapy for the treatment of multiple myeloma. Developed by Bristol-Myers Squibb acquisition Celgene and fellow advanced therapy maker bluebird bio, Abecma is a B-cell maturation antigen (BCMA)-directed genetically modified autologous chimeric antigen…

BIO: Sputnik V should be judged on same data as other COVID jabs

Russia’s Sputnik V COVID-19 vaccine should be judged by the same safety and efficacy standards applied to jabs made by Moderna, Pfizer, AstraZeneca, and J&J according to industry group BIO. The Amsterdam-based EMA began reviewing the vaccine – also called Gam-COVID-Vac – last week after R-Pharm Germany GmbH submitted an approval application. A spokeswoman told us “The CHMP’s decision to start the rolling review of the Sputnik V COVID-19 vaccine is based on results from laboratory studies and clinical studies…