17-Jan-2017 - The US FDA expects biosimilar developers to provide data from switching studies to demonstrate interchangeability with a reference biologic in draft guidance published today.
13-Jan-2017 - Pfizer and industry groups have criticised the US FDA over the randomness of a four-letter suffix demanded in the nonproprietary names of biological products.
12-Jan-2017 - President elect Donald Trump has said he will bring drug manufacturing back to the US and introduce bidding measures to cut the amount the country spends on medicines.
11-Jan-2017 - The US FDA will decide whether to approve Biocon and Mylan’s version of the Roche breast cancer drug Herceptin by the beginning of September.
11-Jan-2017 - Celltrion deal and multi-million Euro German plant will make it a major second and third wave biosimilars player says Teva.
10-Jan-2017 - Merck has announced plans for process and cell line development centres in the US and China citing biopharmaceutical industry demand for integrated services.
10-Jan-2017 - Sanpower Group says Dendreon's in-house manufacturing set-up will remain in place as it looks to increase US and Asian penetration of the prostate cancer cell therapy.
10-Jan-2017 - Kite Pharma has formed a joint venture with Shanghai Fosun Pharmaceutical Industrial Development Company to develop and manufacture its cell therapy axicabtagene ciloleucel in the Chinese market.
06-Jan-2017 - Trump’s presidency could favour US biosimilars in 2017, but the sector will continue to be hampered by a lack of interchangeability guidance and ongoing litigation, say experts.
04-Jan-2017 - The US FDA has published final guidance on the development and use of clinical pharmacology data for drugmakers to demonstrate biosimilarity.
23-Dec-2016 - The US FDA has pushed back the review date Roche’s Ocrevus (ocrelizumab) after asking for more data on processes used to manufacture the candidate MS treatment.
23-Dec-2016 - Over 30 companies are looking to compete against Abbvie in the adalimumab space. Can you find them all in our word search?
20-Dec-2016 - With four biosimilars now approved in the US, the sector is growing in confidence says a BMI Research analyst.
15-Dec-2016 - As the patent war over CRISPR gene editing technology continues, experts suggest a “one-stop” licensing alternative could help accelerate advances in new medicines.
09-Dec-2016 - Emergent BioSolutions has signed a $911m (€862m) follow-on contract to supply nearly 30 million doses of its anthrax vaccine to the US Government.
09-Dec-2016 - The WHO has agreed to source drugs from manufacturers which use sustainable production methods.
07-Dec-2016 - Sanofi and JHL Biotech will sell biosimilars in markets outside China in the long term according to the French drug firm.
06-Dec-2016 - Sanofi has teamed with JHL Biotech to develop biosimilar products, including a version of Rituxan (rituximab), for the Chinese and international markets.
06-Dec-2016 - Takeda was awarded conditional EU marketing authorisation of the small molecule drug Ninlaro, overturning the EMA’s negative opinion on its efficacy against Multiple Myeloma (MM).
06-Dec-2016 - A lack of investment and government support has stunted biomanufacturing in India, but Biocon says this will change through the country’s 'Make in India' programme.
02-Dec-2016 - Bluebird Bio has reported encouraging efficacy and safety data from a Phase I trial of its CAR-T multiple myeloma therapy, bb2121.
30-Nov-2016 - The deaths in a trial of Juno Therapeutics’ JCAR015 are most likely product-specific says the CEO of French CAR-T developer TxCell, who rejected the idea that chemotherapy or the CD19...
29-Nov-2016 - Juno’s CAR T candidate, combatting antimicrobial resistance, and why you should start a biotech in France. Biopharma-Reporter presents the hot topics from last week's 'Labiotech Refresh' event in Paris. ...
25-Nov-2016 - Celltrion is confident that 2017 will bring European approval and a US filing for Truxima, after achieving regulatory success for the Rituxan biosimilar in Korea.
25-Nov-2016 - Antibody developer Kymab has secured $100m from existing backers and new China-based investors Hepalink and ORI Healthcare Fund.