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US FDA warns Lonza about Walkersville site

25-Apr-2017 - The US FDA has warned Lonza about operations at its facility in Walkersville, Maryland, raising concerns about validation and aseptic process simulations.

Fresenius Kabi to buy Merck KGaA biosimilar candidates

25-Apr-2017 - Fresenius Kabi has announced plans to purchase Merck KGaA’s biosimilars business. 

Samsung Bioepis to take on J&J with FDA approved Remicade biosimilar

24-Apr-2017 - Samsung Bioepis’ Renflexis has become the second biosimilar of rheumatoid arthritis biologic Remicade (infliximab) to be recommended for approval in the US.

UK MHRA announces pre-election quiet period

21-Apr-2017 - Tory Prime Minister Teresa May’s decision to call a snap general election to stymie political opposition of her stewardship of the UK’s withdrawal from the European Union will see the...

Wearable drug delivery tech firm Unilife files for Chapter 11 bankruptcy

20-Apr-2017 - Unilife Corporation has filed for Chapter 11 bankruptcy and confirmed that a key customer for its wearable injectors business has halted a project.

DHL looks to strengthen presence in South American market

18-Apr-2017 - Deutsche Post DHL Group’s contract logistics business, DHL Supply Chain, has announced its intention to acquire Brazilian transport service provider Polar Transportes. 

UK firms should look to global opportunities to offset Brexit woes, says biotech CEO

18-Apr-2017 - UK life science companies must become global to help offset staffing and funding problems potentially caused by Brexit, says Arecor CEO Sarah Howell.

US biosimilars: Quality trumps manufacturing location, say physicians

11-Apr-2017 - American-made biosimilars hold no advantage in the US market according to patient and physician groups which place emphasis on trusted and reputable manufacturers instead.

CBMG completes Wuxi stem cell plant expansion

04-Apr-2017 - Cellular Biomedicine Group Inc (CBMG) has expanded its stem cell manufacturing facility in Huishan High Tech Park in Wuxi, China.

Lonza confirms drug firm was biggest customer in 2016

31-Mar-2017 - Lonza's biopharma business grew faster than other divisions in 2016 with a drug firm becoming the Swiss life science supplier's biggest customer for the first time since 2013

Regeneron and Sanofi's $37,000 per year eczema mAb given US FDA nod

29-Mar-2017 - The US FDA has approved the first systematic treatment for eczema: Sanofi and Regeneron’ monoclonal antibody Dupixent (dupilumab).

UK biopharma industry looks to Switzerland ahead of impending Brexit

28-Mar-2017 - The UK BioIndustry Association will visit Switzerland ahead of Brexit negotiations to learn how to work in Europe without being in the EU.

Amgen targets Roche in Europe with Herceptin biosimilar submission

22-Mar-2017 - Amgen has signalled its intention to take a share of the $6.9bn Herceptin market by filing its trastuzumab candidate in the EU.

Infographic

Biosimilar interchangeability: Do you know your switching from your substitution?

21-Mar-2017 - US FDA interchangeability guidance adds another level of confusion over the concept of biosimilar switching, says Medicines for Europe.

EC says separate GMP for cell and gene therapies is necessary

21-Mar-2017 - The European Commission has rejected PIC/S criticism of a plan to develop GMP for advanced therapies and stressed that separate rules will not mean a lowering of standards.

PIC/S raises concerns about EC plan for advanced therapy GMP

20-Mar-2017 - Separate GMP rules for advanced therapies would put patients at risk according to the PIC/S, which has called on the European Commission (EC) to rethink the idea.

Reader's poll

American-made biosimilars a differentiator in US market, Coherus

15-Mar-2017 - US patients and physicians favour domestically-made biosimilars according to Coherus Biosciences. But if quality is assured should the manufacturing location matter?

FDA grants industry requests for interchangeability guidance comment extension

15-Mar-2017 - The US FDA has extended the comment period for its draft biosimilar interchangeability guidance until May 19.

$62m injection in Hungary is latest boost for GSK vaccine production

14-Mar-2017 - The investment at the Gödöllö manufacturing site adds 104 jobs and comes a week before GSK breaks ground on a $170m meningitis B vaccine facility in Germany.

Biosimilars were ‘plan B,’ says portfolio pumped Merck KGaA

10-Mar-2017 - Germany's Merck has confirmed it is divesting its biosimilars division in order to concentrate on its innovative product pipeline.

Opinion

Roche tops biosimilar defence league by a 'country mile'

08-Mar-2017 - Roche is better positioned than Amgen, AbbVie and Janssen to defend against biosimilar competition, according to this writer and a Twitter poll.

UK High Court rules against AbbVie in Humira indication patent battle

07-Mar-2017 - Biosimilar developers have welcomed a court ruling against AbbVie regarding Humira indication patents, but an IP lawyer warns the judgement is not binding outside the UK.

US FDA lifts hold on Seattle Genetics' blood cancer ADC candidate

07-Mar-2017 - The US FDA has cleared Seattle Genetics to restart trials of its blood cancer candidate vadastuximab talirine that were halted last year after patient deaths. 

Russia approves first ever biosimilar of Serono’s MS drug Rebif

03-Mar-2017 - Russia’s Ministry of Health has awarded Biocad marketing authorisation for a biosimilar version of EMD Serono’s Multiple sclerosis drug Rebif (interferon beta-1a).

Synagis maker MedImmune teams with Sanofi Pasteur on mAb RSV drug

03-Mar-2017 - Sanofi Pasteur and MedImmune have partnered to develop a monoclonal antibody (mAb) based treatment for respiratory syncytial virus.

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