Eli Lilly’s JAK inhibitor Olumiant has missed its main objective in a phase 3 trial in hospitalised COVID-19 patients, but had a significant effect on mortality, a secondary endpoint. The perplexing data showed that patients treated with Olumiant (baricitinib) were 2.7% less likely to progress… Read More »Lilly’s Olumiant flunks COVID-19 trial – or does it?
Despite having the global pandemic, the biopharma companies were involved in multiple M&A, licensing deals. The major focus of the year remains the production and distribution of vaccines to combat the COVID-19 globally All the companies on our list are on the front line to… Read More »Top 20 BioPharma Companies based on 2020 Total Revenue
Clinical tests of drugs from Gilead Sciences and Novo Nordisk have yielded encouraging results in nonalcoholic steatohepatitis (NASH), and the partners now want to see if the drug combinations help patients in a larger mid-stage study. The planned Phase 2b study expands on a 2019… Read More »Gilead and Novo Nordisk advance NASH collaboration to larger clinical study
FDA approval for Yescarta in follicular lymphoma makes it the first approved CAR-T treatment for this type of cancer. It also marks Gilead Sciences’ third approved indication for a CAR-T cell therapy.
Gilead and Galapagos’ much-trumpeted R&D alliance has suffered another setback with the abandonment of ziritaxestat after a late-stage failure in idiopathic pulmonary fibrosis (IPF). Ziritaxestat (GLPG1690) – a first-in-class autotaxin inhibitor – was the flagship asset in the $5.11 billion partnership signed by the two… Read More »Gilead/Galapagos alliance hit again as IPF drug is binned
The decision to discontinue all clinical trials for ziritaxestat is the latest setback in a broad alliance between Gilead Sciences and Galapagos. Last year, the FDA rejected a rheumatoid arthritis drug covered under the partnership.
The therapeutic vaccine will be based on Gritstone Oncology’s technology and will use antigens from Gilead Sciences. It’s the latest in a string of partnerships Gilead has signed in its search for an HIV cure.
Gilead Sciences says its antiviral Veklury should be effective against the new, more contagious COVID-19 variants discovered in the UK and South Africa. According to the US biopharma company, genetic analyses of publicly available sequences for the new variants of SARS-CoV-2 suggest the mutations in… Read More »Gilead says Veklury should work against COVID-19 variants
Biopharma merger and acquisition activity in 2020 was mainly filled with late-stage, bolt-on acquisitions, which were orders of magnitude smaller than the mega M&A deals of prior years. AstraZeneca holds the top rank by acquiring Alexion Pharmaceuticals among the top 20 acquisitions with a total… Read More »Top 20 Biopharma M&A of 2020 by Total Deal Value
Gilead Sciences’ Kite unit has teamed up with the UK’s Oxford BioTherapeutics (OBT) to develop a new clutch of cell therapy products for solid tumours and blood cancers. The partnership covers up to five oncology targets identified by OBT using its discovery platform, and the… Read More »Oxford BioTherapeutics to research cell therapies for Gilead’s Kite
Shots: Gilead to acquire MYR for ~$1.4B in the all-cash transaction along with ~$364.73M as a milestone upon the US FDA’s approval of Hepcludex (bulevirtide) The acquisition will provide Gilead with Hepcludex which has received EMA’s conditional approval for chronic HDV infection in adults with… Read More »Gilead to Acquire MYR for ~$1.4B
A discussion on the different models healthcare stakeholders are developing to cover the cost of costly therapies will be just one of the compelling conversations at the virtual conference from December 9-11. Register today!
Gilead Sciences has the data it was hoping for in a pivotal trial of lenacapavir, an HIV drug that only needs to be dosed by subcutaneous injection every six months, keeping it on course for regulatory filings next year. Lenacapavir (previously GS-6207) is the first… Read More »Data sets up 2021 filings for Gilead’s twice-a-year HIV drug lenacapavir
Gilead Sciences is the first and so far only company to claim FDA approval for a COVID-19 treatment with its Veklury antiviral, and its latest financial results reveal the benefit of that achievement. The US drugmaker sold $873 million-worth of Veklury (remdesivir) in the three… Read More »Gilead Q3 revenue rise bolstered by $873m Veklury sales
Landmark FDA approval of antiviral drug as 1st COVID-19 treatment comes amid conflicting efficacy data
The Food and Drug Administration approved Gilead’s antiviral drug as the first treatment for Covid-19 but just last week a WHO report showed that the drug appeared to have little to no effect on hospitalized patients.
Gilead Sciences’ Kite Pharma unit is closing on approval of its second European approval for a CAR-T for cancer, after the CHMP backed its Tecartus therapy for mantle cell lymphoma. The EMA’s human drugs advisory committee recommended approval of Tecartus (brexucabtagene autoleucel; formerly KTE-X19) for… Read More »Kite cues up first EMA okay for mantle cell lymphoma CAR-T
The European Commission has taken its advance orders for potential COVID-19 vaccines to more than 1.1 billion, after signing a supply deal for up to 400 million doses of Johnson & Johnson’s experimental candidate. The agreement is the third for coronavirus vaccine supply for the… Read More »EU ramps up supply of COVID-19 vaccine, drugs
The findings may make it possible to identify a subset of patients who experience poorer outcomes or more serious side effects, especially neurotoxicity.
While the White House and doctors at Walter Reed have sought to reassure the public that Trump’s condition is improving, he has received numerous drugs for Covid-19, including the steroid dexamethasone, which is typically administered only to those who are critically ill.
The company said it was meeting real-time supply demands for Veklury (remdesivir) in the U.S. and anticipated meeting global demands for the drug worldwide. AmerisourceBergen will continue acting as sole U.S. distributor.
Kronos Bio raises $155M in private financing to advance lead leukemia drug into registration study next year
The company has raised $148 million so far and plans to raise the remaining $7 million by next month. Its lead candidate is entospletinib, a SYK inhibitor acquired as part of a deal with Gilead Sciences last month, under development for patients with biomarker-defined acute… Read More »Kronos Bio raises $155M in private financing to advance lead leukemia drug into registration study next year
While there had been some risks to filgotinib’s approval cited before, analysts expressed surprise at the decision, with one writing it would likely delay approval by at least a year. Shares of both companies fell sharply on the news.
The update to the partnership includes opt-in rights for Gilead on 15 drug targets, up from five under the original 2018 deal. Gilead will pay $125 million upfront and make a $20 million equity investment in Tango, which focuses on synthetic lethality.
UnitedHealthcare sent a notice to plan members stating that it would no longer cover Descovy to prevent HIV, while Truvada – after it goes generic next month – will be covered for free. Gilead reported that Descovy for PrEP had offset a second-quarter fall in… Read More »Gilead got a boost from a newly approved PrEP drug. Now, a major insurer is dropping coverage
In a commentary, physicians and pharmacists wrote that percentages of Black, Latino and Native American patients in two Phase III studies of the drug that the company is using for FDA approval were disproportionate to Covid-19’s incidence in those communities.
Gilead Sciences had said in its second-quarter earnings that it would partner with companies in North America, Europe and Asia to manufacture the antiviral drug, which received an emergency use authorization from the FDA in May.
Gilead’s $11.9 billion purchase of Kite Pharma in 2017 didn’t follow the script, with two big write-downs in the value of the asset since then, but a fresh approval for a CAR-T therapy could claw back some value. Late last week, the FDA approved Kite’s… Read More »Gilead’s Kite gains some height after second CAR-T approval in US
The agency approved Tecartus, previously developed under the name KTE-X19, as the first CAR-T therapy for mantle cell lymphoma. The company had previously won approval for another CAR-T, Yescarta, in 2017, for diffuse large B-cell lymphoma.
Gilead Sciences’ run of oncology-focused deals has continued with an option to buy cancer immunotherapy specialist Tizona – even though the biotech’s lead drug candidate is already partnered with AbbVie. Gilead is paying $300m for a 49.9% stake in Tizona, and taking an option to… Read More »Gilead eyes takeover of cancer biotech Tizona, despite its ties to AbbVie
The average life expectancy span of Human Beings are increased due to better medical facilities and drugs developed by Biopharma companies. Pharmaceutical products or drugs or medicines are being produced for a wide range of medical sectors. It includes the lifesaving drugs or the major… Read More »Top 20 Prescription Drugs Based on 2019 Revenue
The company is developing biosensors, initially for NASH, that could be used in place of liver biopsy and have applicability in development of drugs for the disease.
The study is enrolling 60 healthy volunteers aged 18-45, but the company hopes it will form the basis of trials of the drug as an outpatient treatment for patients who do not require hospitalization. Remdesivir is currently administered via IV.
Research on the drug’s molecular target dates back to the 1950s. A spokesperson for Gilead noted that the company anticipates potentially investing more than $1 billion on the drug this year alone.