Biogen (NASDAQ:BIIB) posted third-quarter results today that beat the consensus forecast on Wall Street — but cut its outlook for the rest of the year, citing the emergence of generic versions of its Tecfidera drug for multiple sclerosis. The Cambridge, Mass.–based neurological therapies company reported profits of $702 million, or $4.46 per share, on sales…
Purdue Pharma reaches $8B federal settlement over opioid abuse crisis
The U.S. Department of Justice today announced a roughly $8 billion resolution with Purdue Pharma relating to its role in the U.S. opioid abuse crisis. The agreement — which is pending approval in bankruptcy court in Southern New York as part of Purdue’s ongoing Chapter 11 process — has the company paying a criminal fine…
U.K. to reportedly conduct human challenge trials with COVID-19 vaccines
British researchers plan to deliberately infect healthy volunteers with lab-grown COVID-19 viruses in order to test potential vaccines, according to a report today in The Washington Post. U.S. researchers have seen so-called human challenge trials as too risky, but U.K. scientists think it’s worth the risk if the challenge trials speed up the development of…
Moderna CEO sees EUA for COVID-19 vaccine in December
The CEO of Moderna (NSDQ:MRNA) thinks the FDA could grant an EUA for its COVID-19 vaccine candidate in December, depending on whether it sees positive interim clinical results in November. Moderna CEO Stéphane Bancel’s comments — made during The Wall Street Journal’s annual Tech Live conference yesterday and reported in the newspaper — suggest that the…
NIH launches drug trial for deadly cytokine storm
The National Institutes of Health today launched a Phase 3 clinical trial to evaluate three immune modulator drugs in hospitalized adults with COVID-19. Some COVID-19 patients experience an immune response in which the immune system unleashes proteins that trigger inflammation, otherwise known as a cytokine storm, which can lead to acute respiratory distress syndrome, multiple…
Pfizer expects to apply for COVID-19 vaccine EUA in late November, CEO says
Pfizer (NYSE:PFE) chairman & CEO Albert Bourla penned an open letter today setting an expected timeline for the company’s COVID-19 vaccine candidate. The vaccine candidate, being developed in collaboration with BioNTech (NSDQ:BNTX), is among the top COVID-19 vaccines currently undergoing Phase 3 clinical trials and nearing potential regulatory authorization, should they prove safe and effective. Once the…
FDA approves first Ebola virus treatment
The FDA granted approval to Inmazep, a mixture of three monoclonal antibodies, making it the first FDA-approved treatment for Ebola virus. Regeneron Pharmaceuticals (NSDQ:REGN) received the approval, having recently been in the news for providing its investigational COVID-19 therapeutic to President Donald Trump. Inmazeb targets the glycoprotein that is on the surface of the Ebola virus.…
Sanofi to launch COVID-19 vaccine trial in Q4
Sanofi (NYSE:SNY) and Translate Bio (NSDQ:TBIO) announced today that a Phase 1/2 clinical trial for its COVID-19 vaccine candidate is set for the fourth quarter of 2020. Preclinical results for MRT5500, the COVID-19 vaccine candidate under development by the two companies, demonstrated a favorable immune response profile against SARS-CoV-2, the virus causing coronavirus, which supports the selection…
Report: Eli Lilly halts COVID-19 treatment trial
Eli Lilly (NYSE:LLY) reportedly paused a clinical trial testing its COVID-19 antibody treatment candidate because of a “potential safety concern.” The New York Times reported that Eli Lilly’s testing site researchers were notified of the pause by emails sent by government officials (it is a government-sponsored trial) and the company later confirmed it. A spokesperson from…
J&J halts COVID-19 vaccine trial due to illness
Johnson & Johnson (NYSE:JNJ) announced that it temporarily paused further dosing in its COVID-19 vaccine candidate clinical trials. The pause in the trials conducted by J&J’s Janssen Pharmaceuticals subsidiary follows an unexplained illness arising in a study participant, according to a news release. Under the company’s guidelines, the illness is being reviewed and evaluated by internal…
FDA funds studies of 6 rare-disease drugs
The FDA announced that it awarded six new clinical trial research grants to principal investigators totaling more than $16 million over four years. Awarded through the Congressionally-funded Orphan Products Grants Program, the research grants seek to enhance the development of medical products for patients with rare diseases, according to a news release. More than 90…
EU orders 200M J&J COVID-19 vaccine doses
Johnson & Johnson (NYSE:JNJ) announced today that its set to provide 200 million doses of its COVID-19 vaccine candidate to Europe. The European Commission, on behalf of the European Union, approved an advance purchase agreement in which J&J subsidiary Janssen Pharmaceutical, which is developing the vaccine candidate, would supply the doses to EU member states following…
FDA defies Trump on vaccine approval timeline
The FDA today told COVID-19 vaccine developers that it needs two months’ worth of safety data before it will consider emergency approvals. The agency’s move cast further doubt on a vaccine against SARS-COV-2 being ready by election day, November 3 — a notion mentioned repeatedly by President Trump in attempts to pressure the agency to…
The top 10 medical disruptors of 2021
For the past 18 years, the Cleveland Clinic has predicted what the top 10 medical disruptors will be for the following year. The list of technologies, cultivated by a panel of physicians and scientists at the clinic, was led by Dr. Will Morris, executive medical director of Cleveland Clinic Innovations, and Dr. Akhil Saklecha, managing…
FDA’s Hahn insists a COVID-19 vaccine approval will not be rushed
FDA Commissioner Dr. Stephen Hahn used a virtual conference appearance today to repeat that a COVID-19 vaccine approval will be up to the agency’s scientists — not political pressure. “We want to make sure that any vaccine we approve is safe and effective according to our criteria,” Hahn said during The Virtual Medtech Conference held…
How could holographic displays boost drug discovery?
Holographic displays company Looking Glass Factory in the early summer integrated its displays with drug discovery software from Schrödinger. The combination, according to Looking Glass Factory officials, enables drug designers to view molecular structures and compositions in true 3D right on their desktops, without having to wear VR or AR headsets. Looking Glass Factory CEO…
J&J closes $6.5B Momenta buy
Johnson & Johnson (NYSE:JNJ) announced today that it successfully completed its $6.5 billion acquisition of Momenta Pharmaceuticals (NSDQ:MNTA). After the all-cash acquisition was agreed upon in August, it officially closed today through a merger of Vigor with and into Momenta, which now operates as a wholly-owned subsidiary of Johnson & Johnson. In connection with the merger, shares…
Novavax launches Phase 3 COVID-19 vaccine trial in UK
Novavax (NSDQ:NVAX) today announced that it has begun its first Phase 3 study to evaluate the efficacy, safety and immunogenicity of its COVID-19 vaccine candidate, NVX-CoV2373. The trial is underway in the UK, in partnership with the UK government’s Vaccines Taskforce. Gaithersburg, Md.-based Novavax said it expects to enroll up to 10,000 individuals between 18…
Report: AstraZeneca Phase III COVID-19 vaccine remains on hold in U.S.
AstraZeneca (NYSE:AZN) is reportedly keeping its COVID-19 vaccine trial in the U.S. on hold as questions remain over patient safety. U.S. Health and Human Services Dept. Secretary Alex Azar told CNBC yesterday that federal investigators are looking for “answers to important questions,” regarding the safety of patients involved in the trial operated by the United Kingdom-based…
J&J launches fourth large-scale COVID-19 vaccine trial
Johnson & Johnson (NYSE:JNJ) has begun enrollment of adult volunteers for a fourth Phase 3 clinical trial of a COVID-19 vaccine candidate. The National Institutes of Health announced today that J&J’s Janssen Pharmaceuticals COVID-19 vaccine candidate (JNJ-78436725) has begun the Phase 3 trial to evaluate if it can prevent symptomatic COVID-19 after a single dose regimen. Get the…
Canada lining up millions of doses of COVID-19 vaccines
Sanofi (NYSE:SNY), GlaxoSmithKline (NYSE:GSK) and Moderna (NSDQ:MRNA) have all agreed to supply Canada with a total of more than 90 million doses of a COVID-19 vaccine. Beginning in 2021, Government of Canada is set to receive up to 72 million doses of an adjuvanted COVID-19 vaccine from Sanofi and GSK, while the country also increased its confirmed…
BARDA awards $12.9M to Ortho Clinical for coronavirus antigen test
Ortho Clinical Diagnostics announced that it received a nearly $12.9 million award from BARDA to support the development of its COVID-19 antigen test. Raritan, N.J.-based Ortho Clinical Diagnostics and the Biomedical Advanced Research and Development Authority (BARDA) are working together under a new contract as part of the government’s ongoing COVID-19 medical countermeasure development efforts,…
Pfizer touts animal trial results for COVID-19 vaccine candidate
Pfizer (NYSE:PFE) announced today that its COVID-19 vaccine candidate protected against infection in preliminary non-human trials. The vaccine, being developed in collaboration with BioNTech (NSDQ:BNTX), was tested in mouse and non-human primate models. In the non-human primate study, the BNT162b2 mRNA-based vaccine candidate protected rhesus macaques against SARS-CoV-2 infection, according to a news release. In a viral…
AstraZeneca puts COVID-19 vaccine trial on hold
AstraZeneca (NYSE:AZN) announced today that it voluntarily paused the trials for its COVID-19 vaccine candidate after an unexplained illness. The company said in a news release that a standard review process was triggered so an independent committee could review safety data surrounding a single event of an unexplained illness that occurred in the UK Phase III…
Drug companies agree not to release COVID-19 vaccine until it’s ready
Executives from nine different drug companies today announced a pledge to ensure safety with a potential COVID-19 vaccine. The CEOs of AstraZeneca (NYSE:AZN), BioNTech (NSDQ:BNTX), GlaxoSmithKline (NYSE:GSK), Johnson & Johnson (NYSE:JNJ), Merck (NYSE:MRK), Moderna (NSDQ:MRNA), Novavax (NSDQ:NVAX), Pfizer (NYSE:PFE) and Sanofi (NYSE:SNY), all of whom are developing vaccine candidates, all signed the pledge, which vows to “uphold the integrity of the scientific process” as…