Manufacturing
US President Trump’s threat of a “25% or higher” import tariff on pharmaceuticals sends ripples through an already uncertain environment. With about half of generics sourced from India, captains of industry read between the lines
Patient demand for compounded versions of FDA-approved obesity drugs is unlikely to dissipate, even if semaglutide’s “shortage” status is resolved. The issue likely will continue to be a high-profile concern for the brand industry.
A US tariff on imports from China raises the spectre of similar action against India, but Aurobindo, the largest generics company in the US by prescriptions dispensed, assures it has alternatives in place. While trials for an opthalmology biosimilar are delayed, supply of other biosimilars to Europe is set to begin in Q2 FY26
AstraZeneca CEO Pascal Soriot said it was “fake news” to describe the UK as the worst place in the western world for pharma companies to invest and blamed the decision to pull plans for a new £450m vaccines facility near Liverpool on it simply not being economically viable without more government support.
The FDA placed a clinical hold on the cell therapy firm’s active INDs that affects Ebvallo and ATA3219 and is connected to the recent complete response letter for Ebvallo.
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.