Chris Newmarker

The NIH today announced that a clinical trial is underway to study whether people who are highly allergic or have a mast cell disorder are more likely to develop an allergic reaction to the Moderna or Pfizer-BioNTech COVID-19 vaccines. Reports of severe allergic reactions to COVID-19 vaccines have made headlines since the rollout to the…

Life sciences software company Insightful Science (Bishop’s Stortford, U.K.) recently announced that it has acquired Dotmatics (San Diego) and its cloud-based scientific R&D data management platform. The financial terms of the deal were not disclosed. Integrating Insightful Science’s software applications into Dotmatics cloud-first enterprise data management service will enable an end-to-end scientific research platform, the…

Moderna (Nasdaq: MRNA) announced today that it has started dosing the first participants in its Phase 2/3 KidCOVE study evaluating its COVID-19 vaccine among children between the ages of 6 months and 12 years. The NIH’s National Institute of Allergy and Infectious Diseases (NIAID) and HHS’s Biomedical Advanced Research and Development Authority (BARDA) are collaborating…

MIT researchers are touting a new machine-learning technique called DeepBAR that can quickly calculate the binding affinities between drug candidates and their targets. DeepBAR produces precise calculations in a fraction of the time compared to conventional techniques, according to the researchers. They think the software could potentially accelerate drug discovery and protein engineering. “Our method…

Vertex Pharmaceuticals announced today that FDA has granted fast track designation for its VX-880, an investigational human stem cell-derived islet cell therapy for type 1 diabetes. Vertex has begun a clinical trial for VX-880 (formerly known as STx-02) in patients with type 1 diabetes (T1D) with severe hypoglycemia and impaired hypoglycemia awareness. “Ours is the only…

The NIH announced today that it has launched the last of three Phase 3 clinical trials to evaluate blood thinners to prevent life-threatening blood clots in adults with COVID-19. As part of the  Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) initiative, the trial will study the use of Bristol Myers Squibb/Pfizer’s Eliquis blood thinner in…

The NIH announced today that it has halted a clinical trial of COVID-19 convalescent plasma among ER patients with mild-to-moderate symptoms after the trial found no significant benefit from the treatment. An independent data and safety monitoring board (DSMB) recommended on Feb. 25 that NIH’s stop enrolling new patients. The Clinical Trial of COVID-19 Convalescent…

Abbott announced today that a team including its scientists has uncovered a rare group of Democratic Republic of Congo residents who are HIV positive but have almost nonexistent viral loads without using antiretroviral treatments. This group of “HIV elite controllers” opens up a new area for researchers to discover biological trends that could inform the…

Health Canada today authorized the COVID-19 vaccine developed by AstraZeneca and Oxford University — the third vaccine for the novel coronavirus authorized in Canada. “This is very encouraging news. It means more people vaccinated, and sooner. Because for AstraZeneca, just like we were for Pfizer and Moderna, we are ready to get doses rolling,” said…

Pfizer/BioNTech and Moderna are testing whether a third dose of their COVID-19 vaccines could better protect against new virus variants. Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) announced today that participants from their Phase 1 study will be offered the opportunity to receive a 30-µg booster of the current vaccine 6 to 12 months after receiving their initial two…

Verana Health (San Francisco), which has expertise in turning clinical data into real-world evidence, announced today that it has inked a research collaboration agreement with Johnson & Johnson‘s Janssen Research & Development. The research with Janssen will have an ophthalmology and urology focus. In the ophthalmology space, Verana Health will analyze the American Academy of…

Johnson & Johnson (NYSE:JNJ) posted fourth-quarter results today that beat the consensus forecast on Wall Street — with the company predicting a return to strong sales growth in 2021. The New Brunswick, N.J.–based pharma, medical device and consumer products giant reported profits of $1.7 billion, or 65¢ per share, on sales of $22.5 billion for the…

Merck (NYSE:MRK) announced today that it is discontinuing the development of its two COVID-19 vaccine candidates, with the Kenilworth, N.J.-based pharma company focusing on two therapeutic candidates instead. Merck officials say they made the decision after Phase 1 clinical studies that showed the V590 and V591 vaccine candidates produced an immune response that was inferior to…

Moderna (NSDQ:MRNA) announced today that it will start a Phase 1 study in the U.S. of an emerging variant vaccine booster candidate against a new COVID-19 variant out of South Africa. The company will also test an additional booster of its present vaccine. The Cambridge, Mass.–based company said it has observed a sixfold reduction in neutralizing…

Private equity firm SFW Capital Partners recently announced the recapitalization of lab equipment maker Caron Products and Services. The financial terms of the deal were not disclosed. Owned by the Christy family and management, Caron (Marietta, Ohio) manufactures a line of environmental testing chambers, incubators and growth chambers. The equipment goes toward FDA-required QA/QC stability…

The United Kingdom today approved its first COVID-19 vaccine, created through a partnership between Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX). The Medicines and Healthcare products Regulatory Agency (MHRA) approval came after a “rolling review” in which assessment takes place as the packages of data become available from ongoing studies on a staggered basis. The idea is to…

Moderna (NSDQ:MRNA) announced today that it will apply for emergency authorization from U.S. FDA and the European Medicines Agency for its COVID-19 vaccine candidate. The company said it has already initiated the rolling review process with the EMA, Health Canada, SwissMedic, the United Kingdom Medicines and Healthcare products Regulatory Agency, Ministry of Health in Israel, and…

Merck (NYSE: MRK) recently announced that it will pay $425 million in cash to acquire privately-held biopharmaceutical company OncoImmune and its potential COVID-19 treatment. OncoImmune’s CD24Fc is a first-in-class recombinant fusion protein that targets the innate immune system. OncoImmune recently announced positive top-line findings from an interim efficacy analysis of a Phase 3 study evaluating…

Pfizer (NYSE:PFE) and its partner BioNTech (NSDQ:BNTX) announced that they will submit a request today with FDA for an EUA of their mRNA vaccine candidate, BNT162b2, against SARS-CoV-2. If all goes as planned, the companies predict that high-risk populations in the U.S. could start receiving the vaccine by mid- to late-December. Vaccine distribution could start within…

Qosina (Ronkonkoma, N.Y.) is touting the variety of SmartSite swabbable needle-free injection sites that it offers. The needle-free injection sites feature an ergonomic design and a smooth, flat top that can be easily disinfected, according to Qosina. Said the company: ” These components are equipped with a valve, that when activated, forms an airtight seal […]

U.S. HHS and DoD will pay $375 million to buy 300,000 doses of bamlanivimab 700 mg from Eli Lilly and Co. (NYSE:LLY) as part of Operation Warp Speed initiatives to stockpile experimental COVID-19 treatments for distribution, pending FDA authorization. HHS plans to allocate 300,000 doses of the monoclonal antibody immediately, according to an announcement from…

HHS Secretary Alex Azar has been reportedly discussing the removal of Dr. Stephen Hahn as FDA commissioner, according to Politico. The Politico report cited a half dozen current and former administration officials. FDA spokesperson Michael Felberbaum in an email to Drug Discovery‘s sister site MassDevice denied an Azar-Hahn feud: “Commissioner Hahn enjoys a good relationship…

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…

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…

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…