Despite the growing concerns about the potential for the community spread of COVID-19 in the U.S., the FDA-FTC public workshop on competition in the biologics marketplace went ahead as scheduled March 9, playing to a full house with some audience members sitting in an overflow room. And all the invited speakers and people registered to speak during the open public hearing session showed up.
DUBLIN – Could a recombinant human protein drug rejected by Glaxosmithkline plc in 2019 benefit patients with COVID-19 infection? Apeiron Biologics AG disclosed Wednesday Feb. 26 that an investigator-initiated pilot study of APN-01 is getting underway in Guangzhou, China.
Under steady pressure to accelerate development of vaccines against SARS-CoV-2 and treatments for COVID-19 as the global death toll reached 3,085 people on the afternoon of March 2, biopharma companies continued to detail progress, including in updates at a White House meeting between pharmaceutical executives and administration officials, including President Donald Trump.
DUBLIN – Could a recombinant human protein drug rejected by Glaxosmithkline plc in 2019 benefit patients with COVID-19 infection? Apeiron Biologics AG disclosed Wednesday Feb. 26 that an investigator-initiated pilot study of APN-01 is getting underway in Guangzhou, China.
DUBLIN – Immatics Biotechnologies GmbH is banking $50 million up front and could earn up to $550 million more in per-product milestones from an adoptive cell therapy deal in solid tumor indications with Glaxosmithkline plc, which initially involves two autologous cell therapies engineered to express T-cell receptors (TCRs) that bind novel cancer targets. Immatics would receive royalties on sales of any approved therapies.
Even as the volume of mergers and acquisitions in 2019 reached the highest level in the last 10 years, multiple big pharma companies are looking to get smaller, spinning off units into separate entities.
No matter how effective it is, a drug is worthless if the people who need it can’t afford it. That’s been almost an anthem for patients and policy wonks testifying before U.S. Congress on drug prices.
The National Institute of Allergy and Infectious Diseases has stopped a late-stage HIV vaccine study it sponsored after an interim review by the trial's independent data and safety monitoring board (DSMB) found the regimen failed to prevent HIV.
Significant progress is being made in the development of next-generation treatments for multiple myeloma. For that reason, investors and industry analysts alike will be anxiously awaiting the abstracts for the upcoming American Society of Hematology (ASH) annual meeting.
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.
