Sean Whooley

A member of the FDA’s expert panel for nervous system therapies reportedly resigned over the decision to authorize an Alzheimer’s therapy. The FDA controversially authorized Aduhelm (aducanumab) from Biogen on Monday, making it the first novel Alzheimer’s drug treatment in 18 years despite drug companies pumping billions of dollars into more than 400 clinical trials. STAT…

Bayer announced today that its BlueRock Therapeutics subsidiary successfully administered the first dose of its Parkinson’s disease therapies. Berlin-based Bayer said in a news release that BlueRock successfully administered the dose of its investigational pluripotent stem cell-derived dopaminergic neruons, called DA01, to a Parkinson’s disease patient in an open-label Phase 1 clinical safety and tolerability…

  Moderna (Nasdaq:MRNA) announced today that it submitted for full FDA approval of its mRNA COVID-19 vaccine for individuals 18 years of age and older. Cambridge, Mass.-based Moderna initiated the rolling submission process with the FDA for a Biologics License Application (BLA) to license its mRNA COVID-19 vaccine, according to a news release. The move…

Researchers at the University of Texas at Austin are touting chemical probes designed to help identify an enzyme produced by bacterias. The team at UT Austin developed the probes to identify the enzyme produced by some types of E. coli and pneumococcal bacteria that are resistant to treatment because of their ability to break down…

Sanofi and GlaxoSmithKline announced today that they began enrollment in the Phase 3 clinical trial for their COVID-19 vaccine candidate. The companies will evaluate the safety, efficacy and immunogenicity of their adjuvanted recombinant-protein COVID-19 vaccine candidate in a global, randomized, double-blind, placebo-controlled Phase 3 study of more than 35,000 participants aged 18 and older, according…

A partnership with J&J’s Janssen Pharmaceuticals is helping PhysIQ advance with its device-agnostic clinical data collection and analysis platform.  Over the course of the last year and some change, the impact of digital health and the need for it has increased by an immeasurable amount. Virtual care became the norm after the COVID-19 pandemic hit, and, although…

Pfizer CEO Albert Bourla said the company will soon seek full FDA approval and authorization for further age groups for its COVID-19 vaccine. Speaking during the company’s first-quarter earnings call yesterday, transcribed by The Motley Fool, Bourla outlined the regulatory pathways that the company is pursuing for the vaccine it developed with BioNTech, which is…

AI-powered drug discovery company Exscientia announced that it completed a $225 Series D funding round. SoftBank Vision Fund 2 led the funding round, while previous lead investors, Novo Holdings and funds managed by Blackrock, contributed. Other investors included Mubadala Investment Company, Farallon Capital, Casdin Capital, GT Healthcare Capital, Marshall Wace, Pivotal bioVenture Partners, Laurion Capital,…

The FDA and CDC have lifted the pause placed on the Johnson & Johnson (NYSE:JNJ) COVID-19 vaccine after reports of blood clots caused concern. On April 13, the FDA and CDC issued a joint statement recommending the pause in the administration of the J&J (Janssen) COVID-19 vaccine after, among 6.8 million doses delivered in the…

The European Medicines Agency confirmed that the benefits of the COVID-19 vaccine from Johnson & Johnson (NYSE:JNJ) outweigh risks of blood clots. At a meeting today, EMA’s safety committee (PRAC) concluded that there is a link between unusual blood clots with low blood platelets with the COVID-19 vaccine made by J&J’s Janssen Pharmaceuticals unit. PRAC…

The FDA announced today that it approved Opdivo (nivolumab) in combination with chemotherapy to treat gastric cancer, among other diseases. Opdivo, developed by Bristol-Myers Squibb, when used in combination with certain types of chemotherapy is designed to treat advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma. It is now the first FDA-approved…

Thermo Fisher Scientific (NYSE:TMO) announced today that it agreed to acquire PPD (NSDQ:PPD) for $17.4 billion. The boards of directors for both companies approved the definitive agreement which will see Thermo Fisher buy PPD at a price of $47.50 per share, totaling the $17.4 billion, plus the assumption of approximately $3.5 billion of net debt,…

Reports from Italy claim that the European Union Commission won’t renew COVID-19 vaccine contracts next year with AstraZeneca and Johnson & Johnson. According to Reuters, Italian outlet La Stampa reported that sources from the Italian health ministry have said the commission does not want to pursue contract renewals with those two companies once those encompassing the…

The FDA and CDC issued a joint statement today recommending the pause in the administration of the Johnson & Johnson COVID-19 vaccine. As of yesterday, more than 6.8 million doses of the J&J single-dose vaccine had been administered in the U.S. Among recipients of those doses, six cases of a rare and severe type of blood…

Intravacc is today touting positive pre-clinical results of its SARS-CoV-2 nasal spray vaccine candidate in non-human subjects. Bilthoven, Netherlands-based Intravacc’s SARS-CoV-2 outer membrane vesicle (OMV)-based recombinant spike protein (rSp) nasal spray candidate was observed in four groups of mice and four groups of hamsters, all of which received two intranasal immunizations on day one and day…

Scientists in Cambridge, Mass. and Chennai, India, are touting self-organizing brain tissue growth in a 3D-printed system. Published results in Biomicrofluidics highlight the work of the Massachusetts Institute of Technology (MIT) and Indian Institute of Technology Madras scientists, who have grown small amounts of the self-organizing brain tissue, known as organoids, in a tiny 3D-printed system that…

MedTech Innovator announced today that its new BioTools Innovator accelerator program has launched. BioTools Innovator is intended to advance life science tools innovation and improve human health by accelerating the growth of startups developing and commercializing a wide range of biotech products, platforms and services, according to a news release. Across a three-month accelerator program,…

Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) announced today that their COVID-19 vaccine produced 100% efficacy among adolescents. In adolescents aged 12 to 15 years old with or without prior evidence of SARS-CoV-2 infection, the BNT162b2 vaccine demonstrated 100% efficacy and robust antibody responses, exceeding those recorded earlier in vaccinated participants between 16 and 25. The vaccine…

Pfizer and BioNTech announced today that European authorities approved storage of their COVID-19 vaccine at a new temperature. Based on data showing stability in standard pharmaceutical freezers, the European Medicines Agency (EMA) approved storage of the vaccine at -25°C to -15°C for a total of two weeks. The FDA’s requirements include two-week storage at the same temperatures,…

Following allegations of sexual harassment, former head of Operation Warp Speed Moncef Slaoui has left roles at two more companies. Yesterday, Slaoui was terminated as the Galvani board of directors’ chair, GlaxoSmithKline’s board of directors announced. The same day, Vaxcyte confirmed in an SEC filing that it had axed Slaoui as its chairman of the…

  GlaxoSmithKline’s board of directors announced today that it terminated Moncef Slaoui as the chair of the Galvani board of directors. Slaoui, who served as the head of Operation Warp Speed — the Trump administration’s program to accelerate COVID-19 vaccine development — was terminated effective immediately, according to a news release from GSK, the majority…

Regeneron Pharmaceuticals (NSDQ:REGN) announced today that its COVID-19 antibody drug reduced hospitalization and death risk by 70% in clinical trials. The definitive Phase 3 outcomes trial in high-risk, non-hospitalized COVID-19 patients met its primary endpoint in displaying that the REGEN-COV (casirivimab with imdevimab) significantly reduced the risk of hospitalization or death by 70% (1,200 mg…

The National Institute of Allergy and Infectious Diseases (NIAID) has announced concerns with data from AstraZeneca’s COVID-19 vaccine trial. NIAID, a wing of the National Institutes of Health (NIH), said in a statement today that it was concerned that information the company released from its AZD1222 vaccine clinical trial may be outdated.In turn, that may…

AstraZeneca announced today that its COVID-19 vaccine demonstrated statistically significant efficacy in preventing COVID-19 in a U.S. trial. AZD1222, developed in a collaboration between London-based AstraZeneca and Oxford University, was 79% effective in preventing symptomatic COVID-19 and 100% effective in preventing severe disease and hospitalization, according to a news release. Efficacy was consistent across ethnicity…

Johnson & Johnson (NYSE:JNJ) unit Janssen Pharmaceutical announced today that it received FDA approval for its Ponvory treatment. Ponvory (ponesimod) is a once-daily, oral selective sphingosine-1-phosphate receptor 1 (S1P1) modulator for treating adults with relapsing forms of multiple sclerosis (MS). It’s areas of treatment include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease,…