Gilead Sciences

Gilead files first hepatitis delta therapy with FDA

Gilead Sciences has submitted its marketing application for bulevirtide, its antiviral therapy for rare hepatitis delta virus (HDV) infections, to the FDA. If approved, bulevirtide will be the first drug to be approved in the US for HDV, a virus that exists only as a co-infection with hepatitis B virus (HBV). It occurs in around …

Gilead files first hepatitis delta therapy with FDA Read More »

Gilead moves closer to Chinese filing for Trodelvy in TNBC

Gilead Sciences’ Trodelvy has met its objectives in a phase 2b trial in triple-negative breast cancer (TNBC) carried out in China by its partner Everest Medicines, moving it closer to a regulatory filing in the world’s second-largest pharma market. Antibody-drug conjugate Trodelvy (sacituzumab govitecan) is already approved in the US for TNBC, and was licensed …

Gilead moves closer to Chinese filing for Trodelvy in TNBC Read More »

Shoreline Biosciences secures $140M for off-the-shelf NK cell therapies for cancer

Gilead Sciences and BeiGene, which started research alliances with Shoreline Biosciences earlier this year, are among the investors in the biotech’s latest financing. The preclinical-stage company technology develops cell therapies for cancer by using natural killer cells.

Gilead tags Merck for first-line triple negative breast cancer trial

Take two recently-approved immunotherapies for triple negative breast cancer (TNBC), put them together, and what do you get? Hopefully a new standard of care for the aggressive disease, according to partners Gilead Sciences and Merck & Co. Gilead’s Trop-2 targeting antibody-drug conjugate Trodelvy (sacituzumab govitecan) will be paired with Merck’s PD-1 inhibitor Keytruda (pembrolizumab) in …

Gilead tags Merck for first-line triple negative breast cancer trial Read More »

Kite claims a first for CAR-T Tecartus in adult leukaemia

The FDA has approved Kite Pharma’s Tecartus as a treatment for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL), making CAR-T therapy an option for an entirely new group of patients. The regulator cleared Tecartus (brexucabtagene autoleucel) for the new indication after a swift review that focused on the ZUMA-3 trial, which …

Kite claims a first for CAR-T Tecartus in adult leukaemia Read More »

Galapagos’ long-serving CEO Onno van de Stolpe to retire

After 22 years at the helm of Belgian biotech Galapagos, chief executive Onno van de Stolpe has decided it is time to retire and hand the reins to new leadership. He will stay in his role until a successor is found, according to the company, which has kicked off a search for a new CEO. …

Galapagos’ long-serving CEO Onno van de Stolpe to retire Read More »

Appeals court reverses $1.2bn judgment against Gilead in BMS CAR-T case

Gilead Sciences’ Kite Pharma has won a key victory on appeal in its long-running dispute with Bristol-Myers Squibb over patents relating to CAR-T therapies, overturning a $1.2 billion fine levied last year. In December 2019, a jury found that Kite infringed on a patent owned by Juno Therapeutics, a division of BMS acquired through its …

Appeals court reverses $1.2bn judgment against Gilead in BMS CAR-T case Read More »

Kite takes the ‘Appian way’ to off-the-shelf cell therapies for cancer

Gilead Sciences’ Kite Pharma has mapped out another route to the development of allogeneic or ‘off-the-shelf’ cell therapies for cancer, using technology developed by Appia Bio, a US startup focusing on haematopoietic stem cells (HSCs). The partnership will combine Kite’s experience in chimeric antigen receptor (CAR) therapies with Appia’s platform, which involves using HSCs to …

Kite takes the ‘Appian way’ to off-the-shelf cell therapies for cancer Read More »

Arcus’ CMO Grossman jumps ship to join Gilead’s cancer push

Gilead Sciences just forged even closer ties with its cancer drug partner Arcus Biosciences, enticing the biotech’s chief medical officer Bill Grossman to a new role as its head of oncology clinical research. The two companies entered into a 10-year alliance last year, with Gilead claiming certain rights to Arcus clinical and preclinical immuno-oncology candidates …

Arcus’ CMO Grossman jumps ship to join Gilead’s cancer push Read More »

BioNTech grows in cell therapies, buying Kite’s TCR platform

BioNTech has found a use for some of the windfall cash it has raked in from its COVID-19 vaccine, agreeing a deal to buy Kite Pharma’s entire neoantigen T cell receptor (TCR) platform for solid tumours, and an associated manufacturing plant. There’s no value attached to the deal – even though BioNTech is a publicly …

BioNTech grows in cell therapies, buying Kite’s TCR platform Read More »

Trials leave Galapagos’ SIK programme looking under the weather

Galapagos has had to send its SIK inhibitor programme back to the drawing board after its lead compound GLPG3970 has failed two of three clinical trials, adding to a string of disappointments for the Belgian biotech.  Results from a phase 1b study in psoriasis and two phase 2a studies in ulcerative colitis and rheumatoid arthritis …

Trials leave Galapagos’ SIK programme looking under the weather Read More »

Gilead combs Shoreline for NK cell therapies in $2.3bn alliance

Gilead Sciences’ cell therapy Kite Pharma has bulked up its position in natural killer (NK) cell therapies, pledging up to $2.3 billion for a partnership with Shoreline Bioscience focusing on off-the-shelf therapies for haematological cancers. The two companies will collaborate on the development of targeted NK cell and macrophage cells derived from induced pluripotent stem …

Gilead combs Shoreline for NK cell therapies in $2.3bn alliance Read More »

ASCO21: Gilead sets up first FDA okay for adult ALL with Tecartus data

Novartis’ Kymriah has had the CAR-T therapy market for acute lymphoblastic leukaemia (ALL) to itself so far, but Gilead Sciences’ Kite subsidiary is now looming in the rear view mirror – armed with new data for its already-filed rival Tecartus. Results of the phase 1/2 ZUMA-3 trial of Tecartus (brexucabtagene autoleucel) reported at the ongoing …

ASCO21: Gilead sets up first FDA okay for adult ALL with Tecartus data Read More »

Lilly’s Olumiant flunks COVID-19 trial – or does it?

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 to needing a ventilator or death compared to a placebo …

Lilly’s Olumiant flunks COVID-19 trial – or does it? Read More »

Top 20 BioPharma Companies based on 2020 Total Revenue

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 combat this global crisis. The top 20 companies on the …

Top 20 BioPharma Companies based on 2020 Total Revenue Read More »

Gilead and Novo Nordisk advance NASH collaboration to larger clinical study

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 R&D alliance.

Gilead/Galapagos alliance hit again as IPF drug is binned

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 companies in 2019, and has been advanced into the phase …

Gilead/Galapagos alliance hit again as IPF drug is binned Read More »

Gilead, Galapagos halt IPF study in latest stumble for blockbuster alliance

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.

Gilead says Veklury should work against COVID-19 variants

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 the viral spike protein that have made them more transmissible …

Gilead says Veklury should work against COVID-19 variants Read More »

Top 20 Biopharma M&A of 2020 by Total Deal Value

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 deal value of $39B at a 1-day premium of 45% …

Top 20 Biopharma M&A of 2020 by Total Deal Value Read More »

Oxford BioTherapeutics to research cell therapies for Gilead’s Kite

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 UK firm will try to develop antibodies against them. Kite …

Oxford BioTherapeutics to research cell therapies for Gilead’s Kite Read More »

Gilead to Acquire MYR for ~$1.4B

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 compensated liver disease in Jul’2020. MYR anticipates the submission for …

Gilead to Acquire MYR for ~$1.4B Read More »

Data sets up 2021 filings for Gilead’s twice-a-year HIV drug lenacapavir

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 in a new class of class HIV-1 capsid inhibitor that …

Data sets up 2021 filings for Gilead’s twice-a-year HIV drug lenacapavir Read More »

Gilead Q3 revenue rise bolstered by $873m Veklury sales

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 months to the end of September, helping it to a …

Gilead Q3 revenue rise bolstered by $873m Veklury sales Read More »

Kite cues up first EMA okay for mantle cell lymphoma CAR-T

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 relapsed or refractory MCL setting up a formal approval by …

Kite cues up first EMA okay for mantle cell lymphoma CAR-T Read More »

EU ramps up supply of COVID-19 vaccine, drugs

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 EU, coming after earlier deals with AstraZeneca and Sanofi/GlaxoSmithKline, and …

EU ramps up supply of COVID-19 vaccine, drugs Read More »

Amid mixed messages about his Covid-19 diagnosis, Trump looks like a one-man clinical trial

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.

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 myeloid leukemia.

FDA issues surprise rejection of Gilead, Galapagos rheumatoid arthritis drug

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.

Gilead invests another $145M into expanded oncology pact with Tango Therapeutics

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.

Gilead got a boost from a newly approved PrEP drug. Now, a major insurer is dropping coverage

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 product sales.

Trials of Gilead’s remdesivir in Covid-19 not diverse enough, experts write

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.

Big Pharma plays CMO as Pfizer signs on to produce Covid-19 drug remdesivir for Gilead

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 Kite gains some height after second CAR-T approval in US

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 Tecartus (brexucabtagene autoleucel; formerly KTE-X19) as a treatment for mantle …

Gilead’s Kite gains some height after second CAR-T approval in US Read More »

Gilead eyes takeover of cancer biotech Tizona, despite its ties to AbbVie

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 buy the company outright for another $1.25 billion. Tizona is …

Gilead eyes takeover of cancer biotech Tizona, despite its ties to AbbVie Read More »

Top 20 Prescription Drugs Based on 2019 Revenue

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 therapy area including immunology, cardiology, and neurology but are they …

Top 20 Prescription Drugs Based on 2019 Revenue Read More »

Glympse Bio raises more than $46M in Series B round for biosensor technology

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.

Gilead Covid-19 drug remdesivir benefited from $6.5B in NIH-funded basic research, study finds

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.