Manufacturing
The Pierre Fabre-partnered allogeneic T-cell immunotherapy is already available in Europe but hopes of a US approval have been hit by a complete response letter citing problems at a third-party manufacturing facility.
Productive talks with the US FDA after securing Regenerative Medicine Advanced Therapy designation haves speeded up development of bemdaneprocel, which is about to go into a registrational trial to see if it can slow down or even stop progression of the neurodegenerative disease.
PE firms Advent and Carlyle drove the biggest M&A deals in human and animal pharmaceuticals in India during 2024, a year that also saw Lupin strike deals with Eli Lilly and Boehringer Ingelheim to further its ambitions in the fast-growing diabetes space. Which segments look hot and what are the expected trends for deal making in 2025?
Following promising Phase II data presented at ASH on the company's allogenic leukemia-derived dendritic cell vaccine, Mendus has secured support from the FDA and the EMA for pivotal studies starting later this year.
The biopharma sector has once again experienced highs and lows this year. With just a week left, and in no particular order, Scrip takes a look at five of the biggest stories of 2024.
Merck’s India head for process solutions and Aragen Bioscience’s CEO talk about an incubator set-up and AI-led drug discovery to enable India’s research ecosystem, US tariffs on China, ADC and GLP-1 development, funding path for Goldman Sachs-investee Aragen and more in this video interview
Sanofi's EVP, manufacturing and supply, Brendan O’Callaghan, tells Scrip how modular concept manufacturing at a new site in Singapore can drive efficiencies and minimize downtime, with technologies such as digital twins expected to further improve operational metrics.
The San Diego-based firm had aggressively pursued Evotec, but the service provider based in Hamburg, Germany appeared uninterested in a buyout.
Sun and other major Indian firms outline how things are shaping up for products and manufacturing in China - while it’s a mixed bag, the wider outlook is upbeat. M&A and GLP-1 plays were among other key areas discussed during Q2 earnings.
The US firm wants to hook up with the German group to create a global innovative services company but its €11.00 per share cash offer looks unlikely to sway Evotec shareholders.
Indian firms Lupin and Aurobindo lay out global plans for GLP-1 agonists, as Aurobindo also updates on its biosimilar ambitions as they report results for fiscal Q2.
The new company, Rhine Pharma, hopes to avoid the isotope production issues that have dogged other radiopharmaceutical developers.
Breaking with convention, Thomas Schinecker has said allowing the $16.5bn acquisition to go ahead would be “the wrong decision”. Novo Nordisk says otherwise.
In a video interview, Nandini Piramal, chairperson of Piramal Pharma, speaks with Scrip about a focus on on-patent products, an integrated ADC offering, a measured approach to the proposed BIOSECURE Act and the company’s strategy to double revenue to about $2bn
Emerging Company Profile: The Maryland-based biotech is working on a functional cure for type 1 diabetes that is similar to Vertex’s VX-880 – but with some key differences.
Indian CMOs, CDMOs and CRDMOs are expanding capacity and making leadership moves ahead of the BIOSECURE Act, anticipating demand from big pharma and budding biotechs. Scrip brings details on leading Indian firms which could be potential go-to suppliers for US companies affected by the proposed Act
The drug maker will spend $4.5bn on a “Lilly Medicine Foundry” that it said would provide extra manufacturing capacity as well as research ways to improve manufacturing processes.
In a video interview with Scrip, Syed Husain, CEO of the US-based cell therapy CDMO BioCentriq, talks about the company’s role in parent GC’s growth strategy and business priorities, the cell and gene therapy manufacturing market and his views on the US BIOSECURE Act.
The biotechnology and pharmaceutical sectors outsource much of their drug discovery and clinical development efforts to contract organizations. Investors’ reduced appetite for biotech is now impacting those contractors.
A redistribution of pharma outsourcing activities, both ex-China and also a wider shift in CDMO work from North America down the line may be in store. A senior McKinsey executive discusses with Scrip these trends in the CDMO sector amid geopolitical tensions, the spurt in customer queries at Indian firms and also facets of the deals scenario.