Facing the global threat of antimicrobial resistance (AMR), the EMA issued a final revised guideline on the evaluation of new antibiotics. In accordance with an agreement with the U.S. FDA and Japan’s Pharmaceuticals and Medical Devices Agency, the EMA’s guideline aligns as much as possible with the data requirements of those regulators so drug developers can design clinical trials that meet the evidence needs of all three agencies, the EMA said.
Not satisfied with the findings of a World Trade Organization (WTO) dispute panel, Turkey informed the WTO April 28 that it has initiated arbitration proceedings to review those findings, which involve an EU complaint about measures Turkey employs concerning the production, importation and marketing of prescription drugs.
Janssen Pharmaceutical Cos, Inc.’s CAR T-cell therapy, Carvykti (ciltacabtagene autoleucel), looks set for approval in Europe after endorsement by regulators for advanced multiple myeloma. At its monthly meeting, the EMA’s Committee for Medicinal Products for Human Use recommended Carvykti for adults with relapsed and refractory disease who have received at least three prior therapies and whose cancer has worsened since their last treatment.
As it settles a patent dispute with Japan’s Chugai Pharmaceutical Co. for $775 million, the U.K.’s Astrazeneca plc is looking to bring intellectual property in-house by snapping up a new generation of talented scientists.
With the World Health Organization’s COVAX facility having more COVID-19 vaccine doses available than have been requested by the countries it was designed to help, industry groups are pushing back against the proposed TRIPS waiver for COVID-19 vaccines.
LONDON – Antibody-drug conjugate specialist Heidelberg Pharma AG has secured a route into Asia and a fresh injection of much-needed capital, in a licensing and equity deal with Huadong Medicine Co. Ltd. worth up to €930 million (US$1.1 billion).
The EU initiated a dispute complaint with the World Trade Organization over China’s intellectual property (IP) enforcement allowing Chinese courts to block infringement litigation worldwide. The Feb. 18 complaint, posted by the WTO last week, takes issue with Chinese courts issuing global injunctions barring patent holders from asserting their rights through legal proceedings in other countries until the case is settled in China.
It is acknowledged that the huge bias toward individuals of European ancestry means studies of the contribution of genetics to disease may not translate well to other ethnicities. That point is underlined in the first large-scale investigation of the population structure and demographic history of British Pakistanis, which shows an increased number and length of regions of homozygosity inherited from a common ancestor, and greatly elevated identity by descent, compared to the population at large.
LONDON – Conflicting data from around the world on the extent to which the Delta variant of SARS-CoV-2 is reducing the effectiveness of vaccines is generating uncertainty over the need, or not, for booster programs.
Samsung Bioepis Co. Ltd. has emerged as the first company to obtain marketing authorization from the EMA for a biosimilar of Lucentis (ranibizumab), a significant development for the Korean biosimilar specialist. The approval comes less than two months after the company received a positive opinion from the EMA’s CHMP for Byooviz (ranibizumab), formerly called SB-11.