Sean Whooley

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,…

Oramed Pharmaceuticals (NSDQ:ORMP) announced today that it is forming a joint venture to develop novel oral COVID-19 vaccines. New York-based Oramed entered into definitive agreements to form Oravax Medical, which is based on Oramed’s proprietary POD (protein oral delivery) technology and Premas Biotech’s novel vaccine technology, according to a news release. Get the full story…

HRS Heat Exchangers announced that it received orders for pharmaceutical heat exchangers for use with the manufacturing of COVID-19 vaccines. Orders were placed by subcontractors working with Pfizer and Moderna, which both have vaccines authorized in the U.S., and Oxford/AstraZeneca, which has been approved across Europe but not yet in the U.S. The orders are…

The Danish Medicines Agency announced that it is investigating the AstraZeneca COVID-19 vaccine after reports of blood clots. In collaboration with the European Medicines Agency, the Danish Medicines Agency launched the investigation as it considers there to be a reason to look into the circumstances further after cases in which citizens developed blood clots shortly…

President Joe Biden is reportedly set to announce plans to purchase an additional 100 million doses of Johnson & Johnson’s (NYSE:JNJ) COVID-19 vaccine. An NBC News report said that Biden is set to announce the purchase of the single-dose vaccines on Wednesday, according to two officials from his administration. The purchase of doses from Johnson &…

Merck (NYSE:MRK) today announced positive results from a Phase 1 study of its subdermal drug-eluting implant for preventing HIV-1 infection. The investigational implant has the potential for extended administration of islatravir for pre-exposure prophylaxis (PrEP) of HIV-1 infection, according to a news release. Get the full story at our sister site, Drug Delivery Business News.

President Joe Biden is reportedly set to announce a partnership in which Merck (NYSE:MRK) will make Johnson & Johnson’s (NYSE:JNJ) recently approved COVID-19 vaccine. The Washington Post reported that the agreement between the two competitors will boost the supply of the single-dose vaccine from J&J’s Janssen subsidiary, which received FDA emergency use authorization last week. Get the full story at…

Kala Pharmaceuticals (NSDQ:KALA) shares dipped this morning on fourth-quarter results that came up short of the consensus forecast. The Watertown, Mass.-based company posted losses of -$31.1 million, or -55¢ per share, on sales of $2.2 million for the three months ended Dec. 31, 2020, for a more than $10 million bottom-line slide on sales growth of…

An FDA analysis found that the single-dose COVID-19 vaccine candidate developed by Johnson & Johnson (NYSE:JNJ) is safe and effective. The analysis comes two days ahead of the FDA’s meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Feb. 26, 2021, to discuss the EUA request for the vaccine. Johnson & Johnson submitted…

Johnson & Johnson (NYSE:JNJ) announced today that it submitted for emergency use listing (EUL) to the World Health Organization (WHO) for its COVID-19 vaccine. New Brunswick, N.J.-based J&J’s Janssen subsidiary’s single-dose COVID-19 vaccine candidate was submitted for EUL with a data package including interim efficacy and safety results from the Phase 3 Ensemble clinical trial, which…

Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) announced today that it dosed the first participants in a trial of its COVID-19 vaccine for pregnant women. The companies, which developed one of the two COVID-19 vaccines to be authorized in the U.S. so far, are conducting a global Phase 2/3 study to evaluate the safety, tolerability and immunogenicity of the…