Like most things in healthcare, clinical trials have been slow to evolve in recent decades. But the COVID-19 pandemic has forced clinical trial research teams to become more efficient, patient-centered and inclusive. Much is at stake as the pandemic has already caused significant clinical trial disruption. EY estimates that the COVID-19 impact on Phase 3 […]
Gilead Sciences
FDA approves remdesivir as a COVID-19 treatment
The FDA announced that it fully approved the use of remdesivir as a treatment for COVID-19 requiring hospitalization in all adult and some pediatric patients. Remdesivir is only to be administered in a hospital or healthcare setting capable of providing acute care comparable to inpatient hospital care. The drug, also referred to by the FDA […]
MedTech 100 roundup: Another high as stocks tick up
For the third consecutive week, stocks in the medtech industry reached heights not yet seen since the COVID-19 pandemic began. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — sat at 89.65 points at the end of last week (Aug. 7). Overall, medtech stocks saw a 0.72% increase from […]
Pfizer to make Gilead’s remdesivir COVID-19 treatment
Pfizer (NYSE:PFE) announced today that it entered into a multi-year agreement with Gilead Sciences (NSDQ:GILD) to manufacture and supply its antiviral remdesivir treatment. The investigational antiviral remdesivir will be manufactured by Pfizer under the agreement as the company becomes one of the multiple external manufacturing organizations supporting efforts to scale up the supply of the investigational treatment for […]
Insitro raises $143m Series B
Machine-learning-driven drug discovery and development company Insitro announced today that it raised $143 million in an oversubscribed Series B financing round. San Francisco-based Insitro said in a news release that it plans to use the funds to build its foundations of technology and automation, enabling data generation at a larger scale, expanding its capabilities for […]
Gilead licenses remdesivir production to 5 generic drugmakers
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 — […]
BREAKING: FDA grants emergency use of drug to treat COVID-19
The FDA this afternoon issued an emergency use authorization for the investigational antiviral drug remdesivir to treat severely ill COVID-19 patients. The authorization for the drug, made by Gilead Sciences’ (NSDQ:GILD), will allow both adults and children to be treated with the remdesivir, the first drug believed to have any effect on the virus that has […]
Fauci: Hundreds of millions of COVID-19 vaccine doses could be ready in January
Dr. Anthony Fauci said this morning that hundreds of millions of doses of a vaccine for COVID-19 could be ready by January. In an interview on the Today Show, the director of the National Institute of Allergy and Infectious Diseases said that a vaccine candidate is in the first phase of a clinical trial. If […]
Here are the pharma companies accused of blocking generic competition
To prove a generic drug is as safe and effective as the branded version, pharmaceutical companies have to hand over upwards of 1,000 doses of the product to a generic developer. But if the manufacturer creating the generic drug cannot get its hands on enough sample, the development and testing process slows down. It could […]
Gilead inks $90m deal with Verily to create “molecular map” of inflammatory disease
Gilead Sciences (NSDQ:GILD) is reportedly slated to pay Alphabet’s Verily Life Sciences $90 million over three years to analyze cells from patients with rheumatoid arthritis, inflammatory bowel disease and lupus-related diseases. By probing immune cells from patients involved in Gilead’s clinical trials, the companies hope to glean a better understanding of the immunological signatures of RA, IBD and […]
This company helps cell therapies travel around the world
With Gilead Sciences (NSDQ:GILD) and Novartis (NYSE:NVS) leading the way, cell therapies are moving on to the market and into the clinics for patients that have no other option. Companies making CAR-T therapies use a patient’s own cells to genetically engineer a cancer-killing cellular therapy that is then delivered back to the patient. We are so grateful that we […]