DUBLIN – Friday marked an important milestone for the EMA as its settles into its new home in Amsterdam. The Dutch authorities formally handed over to the agency the keys to its new building, which is located in the Zuidas district of the city.
HAMBURG, Germany – Monoclonal antibodies and their various derivatives now represent the biotechnology industry's dominant, incumbent technology. Six of the top 10 best-selling drugs are antibodies. Two more top 10 drugs are biologics based on fusion protein designs. In all, there are around a hundred antibodies on the market. Whether cell and gene therapy (CAGT) will ever attain that level of success was the subject of two lively panel discussions – on deal trends and valuation and on collaboration and integrated development of advanced therapies – which closed the 25th anniversary edition of BIO-Europe Wednesday.
HAMBURG, Germany – Like any other sector, biotechnology has to engage with the wider political and economic environment it inhabits, as well as deal with the issues that are specific to it. A BIO-Europe panel discussion on transformative deals in 2019 concluded with a slightly nervous look ahead to what is increasingly looking like an uncertain macroeconomic situation.
HAMBURG, Germany – Despite the biotech industry's recent record-breaking run in terms of fundraising and new drug approvals, the ongoing drug pricing controversy is acting as a drag on biotechnology investment. Since the debate started to heat up about four years ago, the Nasdaq Biotechnology Index is down 14%, while the S&P 500 Index is up by 46% during the same period, David Thomas, vice president, industry research at the Biotechnology Innovation Organization (BIO), told delegates attending the opening plenary session at BIO-Europe. "Something is clearly holding back investors in our space," he said.
DUBLIN – Obseva SA's stock plunged 65% Thursday on news that it was terminating development of its in vitro fertilization (IVF) drug, nolasiban, after it missed the primary endpoint of a confirmatory phase III trial. The result blindsided both Obseva and investors, as the outcome was at odds with that of a previous phase III study, Implant 2, which had demonstrated a statistically significant and clinically relevant improvement in the rate of successful pregnancy at 12 weeks.
DUBLIN – Evotec SE is taking a further crack at kidney disease, through a 50-50 joint venture with Vifor Pharma Group, which is funding an initial drug discovery and preclinical development phase with €25 million (US$27.6 million). The as-yet-unnamed venture aims to capitalize on Evotec's participation in a large-scale U.K. biobank, which is tracking about 4,000 patients with either chronic kidney disease or idiopathic nephrotic syndrome.
DUBLIN – Hamlet Pharma AB is about to embark on the next phase in the clinical development of its novel cancer therapy, a constituent of human breast milk that has a selective effect on disrupting the membranes of cancer cells.
DUBLIN – Zealand Pharma A/S has up to now generated its pipeline of peptide drugs internally, but it has gone hunting in biotech's bargain bin to find its first externally sourced asset.
DUBLIN – Fresh from the recent FDA approval of its smallpox and monkeypox vaccine, Jynneos (smallpox and monkeypox vaccine, live, nonreplicating), Bavarian Nordic A/S has struck a deal with Glaxosmithkline plc to take on ownership of two commercial vaccines, for rabies and tick-borne encephalitis (TBE), in return for €301 million (US$336 million) up front and up to €495 million in milestones. The two products are forecast to attain combined revenues of €175 million this year.
DUBLIN – Merck & Co. Inc. is in line to obtain conditional marketing authorization from the European Union for its live attenuated vaccine for preventing Ebola virus infection, V920 Ebola Zaire vaccine (rVSVDG-ZEBOV-GP live), following a positive recommendation for approval from the EMA's Committee for Human Medicinal Products (CHMP) at its October meeting last week. Formal approval should follow within 67 days, after which the Kenilworth, N.J.-based pharma would market the vaccine as Ervebo.
