Markets & Regulations

Herceptin biosimilar market expands with Celltrion-Teva approval

18-Dec-2018 By Flora Southey

The US regulator has validated Celltrion and Teva’s biosimilar version of Roche’s Herceptin, marking the partnership’s second approval in as many months.

bioProcessUK Conference

Outgoing GSK exec shares four industry mega-trends

17-Dec-2018 By Flora Southey

A number of global ‘mega-trends’, such as dated technology and manufacturing inefficiencies, present major challenges for the drug industry, according to Dave Tudor

BIO EUROPE 2018

European biotech an attractive option for Chinese investment, says VC exec

14-Dec-2018 By Flora Southey

Chinese investors are looking abroad for technology that will provide short-term returns and long-term health benefits to its large patient population, according to Panacea Ventures partner.

Stable 2019 predicted for pharma despite political and regulatory risk, finds credit agency

13-Dec-2018 By Ben Hargreaves

Scope’s report finds biologics likely to be protected from severe biosimilar erosion but sees warning signs for the generics industry.

Hired and retired: Year’s end edition

13-Dec-2018 By Ben Hargreaves

As we move closer to the end of the year, companies are assembling their boardrooms ready for the new year.

Insulin biosimilars? US FDA readies market for entry

12-Dec-2018 By Ben Hargreaves

From March 2020, insulin medication will be regulated as a biologic drug, allowing biosimilar competition in a ‘watershed moment’.

Lonza and GE look to China with development of biologics facility

11-Dec-2018 By Maggie Lynch

Lonza will work with GE Healthcare to establish a biologics facility in Gunagzhou, China.

Europe approves Mundipharma’s Neulasta biosimilar

07-Dec-2018 By Maggie Lynch

The European Commission approved a pegfilgrastim biosimilar from Mundipharma after the network acquired Cinfa Biotech.

Leukemia licensing deal could potentially cost Janssen more than $1.8bn

05-Dec-2018 By Maggie Lynch

Janssen has entered a global licensing agreement with argenx to develop and commercialize a treatment for acute myeloid leukemia.

Samsung BioLogics CEO responds to regulator's accountancy claims

04-Dec-2018 By Ben Hargreaves

CEO remains confident its ‘accounting treatment has been proper’, and the company has filed a lawsuit against the South Korean regulatory body.

AbbVie secures another Humira patent deal

04-Dec-2018 By Flora Southey

AbbVie’s latest adalimumab licensing deal grants Pfizer access to the Humira biosimilar market in the US on November 20, 2023.

Five big pharma deals in Humira market could save UK £300m

30-Nov-2018 By Flora Southey

At least 80% of patients currently taking AbbVie’s blockbuster drug could be switched to “the best value biological medicine” within 12 months, according to the UK National Health Service.

Bayer to shed €600m factor VIII facility and 12,000 staff

30-Nov-2018 By Ben Hargreaves

Bayer looks to boost investor confidence by cutting away its animal health unit, selected consumer health brands and a number of jobs to focus on its life sciences businesses.

EU rules Avastin can be reimbursed for off-label use

30-Nov-2018 By Maggie Lynch

The European Court of Justice has determined that Roche’s Avastin may be reimbursed for ARMD – despite Novartis and Bayer’s challenge.

Celltrion and Teva announce first Rituxan biosimilar approval in US

30-Nov-2018 By Flora Southey

Celltrion and Teva have overcome regulatory hurdles to secure approval for Truxima in the US, a biosimilar to non-Hodgkin’s lymphoma treatment, Rituxan.