Nancy Crotti

A federal appeals court has ruled that the FDA must regulate a barium sulfate product ingested before imaging as a device rather than a drug. The decision counts as a win for Genus Medical Technologies (St. Louis), maker of the Vanilla SilQ line of contrast agents used to image structures or fluids within the body. Genus…

Pfizer will deliver 10% more of its COVID-19 vaccine to the U.S. by the end of May than originally planned, its CEO tweeted yesterday. The tweet follows the federal government’s decision to recommend a temporary halt in the distribution of Johnson & Johnson’s single-dose vaccine, which has been tied to rare instances of blood clot…

The FDA today released draft guidance designed to make it easier for researchers to seek approvals for drugs designed for individuals with severe genetic diseases. The draft guidance focuses on investigational new drug submissions for antisense oligonucleotide (ASO) products because these are the most common drugs being developed for severely debilitating or life-threatening genetic diseases.…

Once enough people receive effective vaccines against the novel coronavirus, experts say, the end of the pandemic may be in sight. But a new poll of older adults — one of the highest-priority groups for vaccination — suggests an uphill climb lies ahead to reach that goal. In all, 58% of adults aged 50 to…

The Federal Circuit Court has rejected Glaxo Smith Kline’s (NYSE:GSK) petition for a new trial in a patent case brought by British inhaler company Vectura. The circuit court upheld a May 2019 jury verdict in U.S. District Court for the District of Delaware, awarding Ventura $89.7 million damages for the period from August 2016 through December 2018 for an…

Thermo Fisher Scientific (NYSE:TMO) today announced plans to develop two new sterile filling lines in Singapore to extend capacity to the Asia Pacific region for the development and manufacture of therapies and vaccines. Established with the support of the Singapore Economic Development Board (EDB), the $130M facility will be operated by Thermo Fisher and have the…

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…

Five COVID-19 vaccine candidates are going through Phase 3 clinical trials to prove safety and efficacy. Researchers worldwide are testing 132 COVID-19 vaccine candidates, including 42 that are in clinical trials on humans and at least 92 in preclinical or animal trials, according to the New York Times. With the U.S. alone topping 200,000 COVID-19…

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…

Siemens Healthineers (ETR:SHL)  and Novartis (NYSE:NVS) have agreed to jointly design, develop and commercialize diagnostic tests for therapeutic products across Novartis’ therapeutic pipeline, the companies announced today. The first project will be a serum neurofilament light chain (NfL) immunoassay for patients with multiple sclerosis (MS) and other neurological diseases. NfL is a highly specific biomarker for nerve…

CDC director Dr. Robert Redfield told a Senate panel today that the federal government should have enough coronavirus vaccine for Americans to resume “regular life” by the third quarter of 2021, according to a report by CNBC. Redfield said vaccinations could begin November or December of 2020 and that it could take 6 to 9…

A top FDA official has threatened to resign if the Trump administration moves too quickly to approve a vaccine for COVID-19, according to a published report. Peter Marks, director of the agency’s Center for Biologics Evaluation and Research (CBER), made the threat over concerns a vaccine would be approved without being proven safe and effective,…

Massachusetts federal prosecutors today claimed that Teva Pharmaceuticals funneled $300 million from a pair of charitable foundations to subsidize Medicare copayments for a multiple sclerosis drug. Teva Pharmaceuticals and Teva Neuroscience, the maker of Copaxone, simultaneously raised the drug’s price by 329%, allegedly violating the Anti-Kickback Statute and False Claims Act, according to the complaint…

Chinese pharmaceutical company CanSino Biologics‘ COVID-19 vaccine candidate has received a patent from the Chinese government — the first such patent granted in the country. Chinese state media outlet People’s Daily reported Sunday that the country’s National Intellectual Property Administration granted the patent for Ad5-nCoV, which uses a weakened human common cold virus to deliver genetic material that…

The FDA has approved Enspryng (satralizumab-mwge) for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adults with a certain antibody — patients who are anti-aquaporin-4 or AQP4 antibody-positive. NMOSD is a rare autoimmune disease of the central nervous system that mainly affects the optic nerves and spinal cord. Enspryng, made by Genentech, is the…

Becton Dickinson (NYSE:BDX) and Quidel are struggling to fulfill orders for rapid COVID-19 antigen tests as the virus continues to spread, according to a report in the Wall Street Journal. The newspaper reported today that the two companies, which are the only ones that have FDA emergency use authorizations to sell the rapid diagnostics, cannot keep up with…

PerkinElmer (NYSE:PKI) said today that it anticipates sales growth of approximately 12% for the second quarter, fueled by demand for COVID-19 tests and related products. The Waltham, Mass.-based diagnostic and scientific instrument company said demand for its RT-PCR and serology tests, RNA extraction systems and kits and automated liquid handling instrumentation was particularly robust. COVID-19 related…

A new collaboration funded by in part by $1.1 million from the FDA is working on finding new uses for existing drugs for areas of high unmet medical need — with a pilot project focused on treatments for COVID-19. The Critical Path Institute (C-Path) this week announced the launch of the CURE Drug Repurposing Collaboratory…

Lindsay Brownell, Wyss Institute The U.S. Defense Advanced Research Projects Agency (DARPA) has awarded $16 million to Harvard University’s Wyss Institute for Biologically Inspired Engineering to identify and test FDA-approved drugs that could be repurposed to prevent or treat COVID-19. Using its computational drug discovery pipelines and human Organ Chip technologies, the institute has already found multiple…

Respira Technologies (West Hollywood, Calif.) announced the launch of a pharmaceutical-focused commercial development program for its RespiRx drug-delivery device platform. RespiRx is a portable, handheld vibrating mesh nebulizer designed for local and systemic treatment and can operate in any position held by the patient. Current-generation nebulizers are gravity-fed, which limits usage and can lead to…

The FDA has entered an agreement with healthcare analytics company Aetion to research urgent questions about COVID-19. The New York City-based company said the research will support FDA objectives to explore the natural history of the disease, as well as treatment and diagnostic patterns using relevant, novel data sources and analyzing these data according to well-established principles.…

The U.S. Patent and Trademark Office (USPTO) today announced a webpage to help small and micro businesses apply for streamlined consideration for products that require FDA approval for COVID-19 use. The COVID-19 Prioritized Examination Pilot Program, announced May 8, will allow up to 500 qualifying patent applications to be accepted for priority examination and be…

PerkinElmer (NYSE:PKI) is under federal scrutiny for alleged involvement in a scam to bill Medicare for tens of thousands of unnecessary genetic cancer tests, according to a report by Reuters. The news agency cited three unidentified sources and government documents linking the Waltham, Mass.-based diagnostic and scientific instrument company to the probe. PerkinElmer acknowledged that it…

Scientists at the La Jolla Institute for Immunology have documented a robust antiviral immune response to SARS-CoV-2 in a group of 20 adults who had recovered from COVID-19. Their work, published in today’s online edition of Cell, show that the body’s immune system is able to recognize SARS-CoV-2 in many ways, dispelling fears that the…

Gilead Sciences’ (NSDQ:GILD) said Tuesday that it has signed licensing agreements with five generic pharmaceutical manufacturers based in India and Pakistan to further expand supply of remdesivir, the experimental drug being used in the U.S. to treat COVID-19. The non-exclusive, voluntary agreements allow the companies — Mylan (NSDQ:MYL), Cipla, Ferozsons Laboratories, Hetero Labs and Jubilant Lifesciences — to manufacture remdesivir for distribution in 127…