Roche eyes April FDA verdict on Polivy as first-line lymphoma therapy
The FDA has started a review of Roche’s Polivy for people with previously untreated diffuse large B-cell lymphoma (DLBCL), as the drugmaker tries to move […]
Roche
What is the Potential for Digital Twins in Healthcare?
David Talby, CTO, John Snow Labs Digital twins are virtual representations of an object or system that spans its lifecycle, is updated from real-time data, […]
Roche adds to pipeline with Poseida, Kiniksa deals
Roche has announced a pair of licensing deals with Poseida Therapeutics and Kiniksa Pharmaceuticals that bolster its pipeline in cancer and inflammatory diseases. The agreement […]
Pressure rises on Lucentis, as Coherus biosimilar gets FDA nod
The US FDA has approved a new biosimilar of Roche and Novartis’ blockbuster ophthalmology therapy Lucentis – Coherus BioSciences’ Cimerli – which its developer claims […]
AC Immune tries to resurrect crenezumab with new data delve
In May, another amyloid targeting drug for Alzheimer’s disease – AC Immune and Roche’s crenezumab – missed the mark in another clinical trial and looked […]
Roche’s fast-growing eye drug Vabysmo set for EU approval
Roche has been trumpeting the rapid uptake of its new eye disease drug Vabysmo as it takes on Regeneron and Bayer’s mighty Eylea in the […]
Roche CEO Severin Schwan to stand down after 14 years
Long-serving Roche chief executive Severin Schwan is stepping down, to be replaced next March by Thomas Schinecker, currently head of diagnostics at the Swiss group. […]
AZ, Daiichi challenge Roche with EU okay for earlier use of Enhertu
AstraZeneca and Daiichi Sankyo have claimed approval in the EU for Enhertu as a second-line therapy for HER2-positive metastatic breast cancer, moving the drug up […]
Byondis cues up US, EU decisions on breast cancer ADC in 2023
Byondis has filed its HER2-targeting antibody-drug conjugate (ADC) trastuzumab duocarmazine in the US and Europe, setting up possible approvals next year and a showdown with […]
Roche rings Bicycle bell again, grabbing another cancer target
Roche’s Genentech unit has gone all in on its collaboration with UK biotech Bicycle Therapeutics, taking up an option on a second additional target in […]
Beyond the pill in an outcomes-based world
Going beyond the pill is proving to be a win/win for patients and pharma alike – because improved outcomes are better for everyone. With growing […]
Roche pays $55M for late-stage drug for rare kidney disease with no approved treatment
An Ionis Pharmaceuticals drug has positive Phase 2 results in immunoglobulin A nephropathy, leading Roche to exercise its option to license the rights to the […]
Novo Nordisk’s concizumab hits mark in haemophilia, but dosing questioned
Novo Nordisk has reported phase 3 results with its concizumab drug for haemophilia A or B, showing efficacy in the prevention of bleeding events that […]
Sanofi trumpets data with haemophilia treatment duo at ISTH
Sanofi R&D in its core haemophilia category is advancing on three fronts – engineered proteins, RNA interference drugs and gene therapies – and highlighted results […]
FDA to decide on Roche’s lymphoma drug Lunsumio before year-end
The FDA has granted a priority review to Roche’s T-cell engager Lunsumio as a treatment for follicular lymphoma (FL), setting up a decision on the […]
Liver injuries prompt clinical hold on Sanofi BTK drug
One of the main assets of Sanofi’s $3.7 billion buyout of Principia Biopharma has run into trouble, after the FDA placed it on partial clinical […]
Another amyloid miss in Alzheimer’s as Roche’s crenezumab fails trial
The litany of failed trials of amyloid-targeting drugs for Alzheimer’s disease has added another verse, as Roche concedes that its crenezumab candidate was unable to […]
Roche bispecific drug Lunsumio lands European nod in follicular lymphoma
Follicular lymphoma patients in Europe now have a new treatment option. The European Commission approved Roche drug Lunsomio, a bispecific antibody designed to go after […]
Roche’s Tecentriq extends lead over Keytruda in adjuvant NSCLC
While Merck & Co’s Keytruda is the undisputed leader of the non-small cell lung cancer (NSCLC) category, there’s one category where it lags behind Roche’s […]
EU first to clear Roche’s lymphoma bispecific mosunetuzumab
Roche has secured its first regulatory approval for mosunetuzumab, a first-in-class CD20xCD3 bispecific antibody, as a treatment for patients with follicular lymphoma (FL) in the […]
Repare relinquishes cancer drug to Roche, gets $125M to finance growing pipeline
Roche’s deep oncology pipeline is adding a drug candidate from Repare Therapeutics that works by interfering with a DNA repair mechanism of cancer cells. Repare […]
FDA nod for Roche drug expands its use to babies with spinal muscular atrophy
Roche drug Evrysdi, one of three FDA-approved treatments for spinal muscular atrophy, is now approved for treating those younger than age 2. The regulatory decision […]
Roche puts pressure on SMA rivals with new FDA approval
Roche and PTC Therapeutics’ Evrysdi for spinal muscular atrophy (SMA) has been approved by the FDA for younger children with the rare disease, extending its […]
ASCO 2022 ahead: Clinical trial updates and data readouts to watch for
The American Society of Clinical Oncology’s annual meeting begins this week, including the presentation of more than 2,800 abstracts. Amgen, Roche, and Sierra Oncology are […]
Roche trumpets new glofitamab data in lymphoma at ASCO
Roche will present the new data at next week’s ASCO congress showing that its bispecific antibody glofitamab can achieve high and durable responses in patients […]
NICE finds solution to making Keytruda available for TNBC
Around 100 patients in England and Wales with triple negative breast cancer (TNBC) that has spread to other parts of the body could soon access […]
GSK, iTeos take stock after Roche’s TIGIT setback
iTeos Therapeutics has said it is evaluating with partner GlaxoSmithKline whether to conduct additional clinical trials of TIGIT drug EOS-448 following the failure of a […]
Closely watched Roche drug fails a second pivotal test in lung cancer
Roche reported that its drug tiragolumab failed to achieve one of two main goals of a Phase 3 study in non-small cell lung cancer. The […]
Roche’s TIGIT ambitions take another blow
Roche’s anti-TIGIT antibody tiragolumab has failed a second phase 3 trial, dousing expectations for the programme and its hopes of finding a companion to its […]
Roche extends Kaiku digital monitoring partnership again
Roche has elevated a longstanding alliance with Finland’s Kaiku Health focusing on digital patient monitoring and management (DPMM) to the level of a strategic partnership. […]
Roche breast cancer drug fails in Phase 2 following similar stumble by rival Sanofi
Experimental Roche drug giredestrant failed to meet the main goal of a Phase 2 study in advanced breast cancer. The disappointing results allow competitors to […]
Roche’s oral SERD giredestrant fails breast cancer trial
Roche revealed in its first-quarter results statement that giredestrant missed the mark in the phase 2 acelERA trial in advanced breast cancer, in what appears […]
CHMP backs Roche’s lymphoma bispecific mosunetuzumab
Roche is on the brink of its first regulatory approval for what could be the first bispecific antibody targeting CD3 and CD20 – mosunetuzumab – […]
The largest pharma company in Europe calls for interoperability
Ehab Youssef, area head of Europe North at Roche Pharmaceuticals, tells us why European countries need interoperability to ensure a more effective overall European healthcare […]
Roche hit by failure of TIGIT drug tiragolumab in lung cancer
Roche has suffered a setback with its much-anticipated pairing of anti-TIGIT antibody tiragolumab and PD-L1 inhibitor Tecentriq in small cell lung cancer (SCLC), in a […]
Roche closes in on first-line use for lymphoma drug Polivy in Europe
Roche has moved a step closer to extending the use of its B-cell lymphoma therapy Polivy into the first-line setting, after getting a recommendation for […]
Merck fights back against Roche in adjuvant lung cancer therapy
Merck & Co’s Keytruda is poised to move even earlier in the treatment of patients with non-small cell lung cancer (NSCLC) after showing efficacy when […]
AZ pays $775m to settle patent dispute with Chugai over Ultomiris
AstraZeneca has resolved a lingering liability following its takeover of Alexion with an agreement to pay $775 million to settle a patent dispute with Chugai […]
Sanofi takes a hit as hotly tipped breast cancer drug fails trial
Shares in Sanofi were on the slide this morning after the drugmaker revealed that one of its top pipeline prospects – selective oestrogen receptor degrader […]
Precision Medicine Startup Prenosis Raises $20M for Acute Care Solutions, Starting with Sepsis
What You Should Know: – Prenosis, Inc., a precision medicine company, announced a venture investment from PACE Healthcare Capital, an early-stage investment firm committed to improving health outcomes. This investment brings total funding […]
Scenic Bio raises $31m for genetic modifier platform
18 months after signing its first partnering deal with Genentech, Scenic Biotech has raised $31 million in first-round financing that it will use to take […]
Sanofi’s hemophilia A data set stage for regulatory filings, matchup with Roche
An experimental hemophilia A therapy from Sanofi and partner Sobi has met the goals of a pivotal study, and the pharmaceutical giant is now planning […]
Sanofi, Sobi eye filings for once-weekly haemophilia A therapy
Sanofi and Sobi’s haemophilia partnership has been under competitive pressure from new therapies like Roche’s antibody Hemlibra, so the two companies are hoping a new […]
BrightInsight & UCB Partner to Build Digital Care Solutions for Rare Diseases
What You Should Know: – BrightInsight, provider of the leading global platform for biopharma and medtech regulated digital health solutions, announced a partnership with global […]
BMS carves out a neoadjuvant niche for Opdivo in NSCLC
Bristol-Myers Squibb’s Opdivo has been playing second fiddle to Merck & Co’s Keytruda in the non-small cell lung cancer (NSCLC) market for years, but now […]
Roche starts new four-year trial of Alzheimer’s drug gantenerumab
With prospects of an early, accelerated approval for Roche’s Alzheimer’s disease candidate gantenerumab looking diminished, the drugmaker has launched a new four-year trial in the […]
Olumiant benefits additive to other drugs in severe COVID patients
Eli Lilly and Incyte’s JAK inhibitor Olumiant reduced the risk of death by 13% in hospitalised COVID-19 patients when added to other drugs, according to […]
How new data capabilities can supercharge clinical research
The UK’s health research data capabilities are rapidly evolving. For example, during the height of the pandemic, NIHR’s integrated health research system was able to […]
Dupixent falls short in phase 3 chronic spontaneous urticaria trial
Sanofi and Regeneron have reported disappointing results in a trial of Dupixent in people with chronic spontaneous urticaria (CSU) who don’t respond to the only […]
COVID kits boosted Roche last year, but 2022 will be tougher
Roche has warned that revenue growth will come under pressure in the coming year as sales of its COVID-19 testing kits start to slow, exposing […]
Roche grabs FDA okay for would-be blockbuster eye drug faricimab
The FDA has approved Roche’s much-anticipated faricimab for two major causes of blindness, setting up a market clash with Bayer and Regeneron’s market leading drug […]
4th Treg Directed Therapies Summit 2022
Turbocharge the Development of Best-In-Class Treg-Directed Therapies, Maximising Stability and Function to Deliver Safe, Scalable and Efficacious Therapies Globally As Biopharma turn their focus to autoimmune drug […]
US vs EU: How can Europe translate home-grown innovation into biotech success?
We have seen a boom in biotech initial public offerings over the last two years, but many of Europe’s offerings have migrated to the United […]
Decentralised trials: beyond the pandemic
The adoption of decentralised activities was a major factor in allowing clinical trials to continue during the early stages of the pandemic. Ben Hargreaves examines […]
Roche debuts smart glucose monitor for hospital use
Roche has launched what it says is a first-of-its kind handheld glucose management device, backed up by a digital platform that aims to simplify the […]
Freenome gets $290M from Roche as it preps blood-based cancer test’s next steps
A month after Freenome closed $300 million in financing, Roche has invested another $290 million in the diagnostics developer. The cash infusion comes as Freenome […]
Chasing Roche, Merck unveils adjuvant lung cancer data for Keytruda
Merck & Co’s Keytruda is the undisputed market leader in immunotherapy for non-small cell lung cancer (NSCLC), but was leapfrogged by Roche’s Tecentriq in the […]
PureTech challenges Roche’s Esbriet in head-to-head IPF trial
Roche’s idiopathic pulmonary fibrosis (IPF) therapy Esbriet is already being squeezed by its main rival in the market, and could come under renewed pressure if […]
Biogen looks beyond Spinraza in SMA with Ionis deal
Spinal muscular atrophy (SMA) therapy Spinraza has been a key earner for Biogen in recent years, but with sales now heading into reverse, the company […]
Blow for Novartis as ligelizumab can’t top Xolair in phase 3
Novartis’ big-selling IgE inhibitor Xolair has been a mainstay of treatment for chronic spontaneous urticaria (CSU) for many years, but with biosimilars looming the company […]
Roche builds case for TIGIT combo in untreated lung cancer
Roche’s closely-watched combination of anti-TIGIT antibody tiragolumab and PD-L1 inhibitor Tecentriq has shown long-term efficacy in an ongoing trial in lung cancer, adding to the […]
AI specialist Recursion nabs multibillion-dollar Roche partnership
Roche has formed a decade-long alliance with Recursion Pharma that will focus on using machine learning and “industrialised” drug discovery to find new neuroscience and […]
EU approves Roche’s Actemra for severe COVID-19
The European Commission has moved swiftly to grant full approval to Roche’s Actemra/RoActemra as a treatment for severe COVID-19, clearing the drug within 24 hours […]
After Scotland says no, NICE backs Lilly’s Retsevmo for lung cancer
Eli Lilly’s RET inhibitor Retsevmo can now be prescribed on the NHS for people with RET fusion-positive advanced non-small cell lung cancer (NSCLC) in England […]
ASH abstract drop backs Roche’s Polivy in first-line lymphoma
Roche trumpeted a top-line results of the POLARIX trial of its Polivy therapy in previously-untreated B-cell lymphoma, and a first look at the data suggests […]
Roche, Blueprint’s RET cancer drug Gavreto cleared in EU
Roche and Blueprint Medicines have opened a second front in their rivalry with Eli Lilly in RET-mutated cancers, after getting approval for Gavreto from the […]
NICE reaches a deal with Roche on access to oral SMA drug Evrysdi
Roche’s oral treatment Evrysdi for the rare genetic disease spinal muscular atrophy (SMA) will be made available on the NHS in England, after NICE reached […]
Pfizer files oral COVID pill in US, signs access deal for 95 countries
Armed with impressive new data for its oral antiviral Paxlovid, Pfizer has filed for emergency use authorisation as a COVID-19 treatment in the US – […]
PharmaShots Weekly Snapshots (November 08 – 12, 2021)
Eisai Presents Results of Lecanemab in P-IIb Study 201 Study for the Treatment of Alzheimer’s Disease at CTAD 2021 Published: Nov 12, 2021 | Tags: […]
COVID antibodies from Roche, Celltrion backed for approval in EU
The EMA’s human medicines committee has recommended approval of Roche’s Ronapreve and Celltrion’s Regkirona for use in COVID-19, the first antibody-based therapies for coronavirus to […]
PharmaShots Weekly Snapshots (November 01 – 03, 2021)
Lonza Collaborates with Codiak to Acquire its Exosomes Manufacturing Facility in Lexington, Massachusetts (US) Published: Nov 3, 2021 | Tags: Lonza, Codiak, Acquire, Exosomes Manufacturing […]
Novartis is cashing out of Roche for $21B, 20 years after mega-merger that never happened
Novartis’s equity stake in Roche, shares acquired 20 years ago in a strategy to build up to a potential mega-merger, will be sold back to […]
Novartis finally sells Roche stake, for almost $21 billion
After more than 20 years, Novartis has finally decided to sell its substantial share in fellow Swiss pharma group Roche for $20.7 billion, a decent […]
Roche Entered into a Clinical Trial Supply Agreement with Galecto to Evaluate GB1211 + Tecentriq (atezolizumab) in P-IIa Trial for 1L Treatment of NSCLC
Shots: The companies collaborated to evaluate the safety, tumor shrinkage, clinical activity & immune biomarkers of Galecto’s GB1211 (galectin-3 inhibitor) + Roche’s Tecentriq (PD-L1 checkpoint […]
Merck gets EU approval for Keytruda in triple-negative breast cancer
Merck & Co has claimed EU approval for Keytruda in triple-negative breast cancer (TNBC), a particularly hard-to-treat form of the disease. The European Commission has […]
FDA clears Roche’s Susvimo implant for eye disease wet AMD
Roche’s Genentech unit has won FDA approval for Susvimo, an implant for eyesight-robbing disease wet age-related macular degeneration (AMD) that gives patients an alternative to […]
Delta variant keeps Roche diagnostics sales sky high
High demand for COVID-19 diagnostics driven by the delta variant has led to rocketing sales at Roche’s diagnostics division, allowing the company to raise its […]
HLTH21: Roche, Ibex Medical Partner to Develop AI-Powered Digital Pathology Apps
What You Should Know: – Ibex Medical Analytics, the pioneer in AI-based cancer diagnostics, today announced that it has signed a deal with Roche, the […]
Roche scores early adjuvant lung cancer approval for Tecentriq
Roche has claimed an earlier-than-expected FDA approval for its checkpoint inhibitor Tecentriq in non-small cell lung cancer (NSCLC), giving the drug a lead in early-stage […]
Prenosis, Roche Partner to Combat Hospital Sepsis Using Precision Diagnostics
What You Should Know: – Prenosis Inc., a precision diagnostics company transforming clinical diagnosis with artificial intelligence, announced today the expansion of an existing partnership […]
Actemra shortage spills over to include Sanofi’s rival Kevzara
Roche’s Actemra has been in high demand since its value in treating severe COVID-19 was established, leading to shortages. Now, Sanofi’s rival therapy Kevzara has […]
Enhertu nabs speedy FDA review for earlier use in breast cancer
Hard on the heels of impressive new data for Enhertu as a second-line therapy for breast cancer, AstraZeneca and Daichi Sankyo have claimed FDA breakthrough […]
NICE clears NHS use of Roche’s Tecentriq in bladder cancer
NICE has recommended routine NHS access to Roche’s cancer immunotherapy Tecentriq for some bladder cancer patients, four years after it was first made available via […]
Innovaccer, Roche Partner to Develop Clinical Decision Support Solutions
What You Should Know: – Innovaccer Inc. the Health Cloud company, announced it has entered into a three-year collaboration with Roche to partner in the […]
PharmaShots Weekly Snapshots (September 20 – 24, 2021)
Everest’s SPR206 Receives the NMPA’s IND Approval for the Treatment of MDR Gram-Negative Bacterial Infections Published: Sept 24, 2021 | Tags: Everest, SPR206, NMPA, IND, […]
Roche builds evidence for Evrysdi’s benefits younger SMA patients
Roche has highlighted new data with its oral treatment for spinal muscular atrophy (SMA) – Evrysdi – showing its benefits when given to pre-symptomatic babies […]
Roche Presents Results of Evrysdi (risdiplam) in RAINBOWFISH Study for the Treatment of Neuromuscular Disorder at WMS 2021
Shots: The RAINBOWFISH study evaluates the efficacy and safety of Evrysdi in babies aged birth to 6wks. with pre-symptomatic SMA The results showed that 4 […]
FDA OKs first biosimilar of Roche’s blockbuster AMD drug Lucentis
Samsung Bioepis and Biogen have claimed the first FDA approval for a biosimilar version of Roche and Novartis’ Lucentis (ranibizumab) for leading causes of blindness, […]
ESMO21: Enhertu brings it’s A game to second-line breast cancer
AstraZeneca and Daiichi Sankyo were clearly excited by data from a trial pitting their HER2 antibody-drug conjugate (ADC) Enhertu against Roche’s rival Kadcyla when they […]
ESMO21: Roche’s giredestrant takes stage in battle of the oral SERDs
Roche has revealed the first phase 2 clinical data with giredestrant, one of a clutch of new selective oestrogen receptor degraders (SERDs) hoping to provide […]
Roche Collaborates with Temedica to Launch Brisa App for the Treatment of Multiple Sclerosis
Shots: The companies collaborated to launch a digital companion app i.e., Brisa to treat patients with MS. The app will be offered free of charge […]
Roche to Acquire TIB Molbiol for Bolstering its Molecular Diagnostics Portfolio
Shots: Roche has signed a purchase agreement to acquire 100% of the outstanding shares of the TIB. The transaction is expected to close in Q4’21 […]
Roche inks $3B deal; Owlstone raises $58M; FDA approves OCS heart system; Google, Mayo Clinic build brain-mapping AI algorithm
Roche’s Genentech taps Adaptimmune for T-Cell Therapy Collaboration for USD 3 Billion A collaboration valued more than USD 3 billion, Genentech, a member of the […]
Roche bets $300M on Adaptimmune tech for off-the-shelf cell therapies for cancer
Roche is partnering with Adaptimmune Therapeutics to develop allogeneic cell therapies based on Adaptimmune’s technology. In addition to these “off-the-shelf” products, the partners will also […]
Roche dives further into cancer cell therapy with Adaptimmune deal
Roche has largely been a spectator on the side lines as other drugmakers have embraced cell therapies for cancer, but it has made a big […]
AC Immune claims half a win for tau drug in Alzheimer’s trial
Shares in AC Immune leaped today after the company said its tau-targeting Alzheimer’s disease candidate semorinemab hit one of its objectives in a phase 2 […]
PharmaShots Weekly Snapshots (August 23 – 27, 2021)
Ascendis’ Skytrofa (lonapegsomatropin-tcgd) Receives the US FDA’s Approval for Pediatric Growth Hormone Deficiency Published: Aug 27, 2021 | Tags: Ascendis, Skytrofa, lonapegsomatropin-tcgd, US, FDA, Approval, […]
Top 7 Pharma Industry Leaders in 2020 By the Numbers
Pharmaceutical companies play a vital part in our lives and in helping us to live healthier lives. The pharmaceutical industry finds, develops, manufactures, and promotes […]
Roche Signs a License Agreement with Shape to Advance AAV-based RNA Editing Technology for Neuroscience and Rare Disease
Shots: Shape is eligible to receive $3B+ including initial payment, development, regulatory, and sales milestone along with royalties on sales of therapies resulting from the […]
Europe has its first Lucentis biosimilar, Samsung Bioepis’ Byooviz
Novartis and Roche’s big-selling eye drug Lucentis has its first biosimilar competitor in Europe, after the European Commission approved Samsung Bioepis’ copycat drug Byooviz. Byooviz […]
BMS gets FDA nod for Opdivo as first adjuvant bladder cancer therapy
Bristol-Myers Squibb has scored a win in its drive to get Opdivo into earlier lines of cancer therapy, getting FDA approval for the drug for […]
Roche’s Ventana MMR RxDx Panel Test Receives the US FDA’s Approval as First CDx to Detect dMMR Solid Tumor
Shots: The FDA has approved the Ventana MMR RxDx Panel test as a CDx to identify patients with dMMR advanced solid tumors, who may be […]
PROVENT trial puts AZ COVID antibody combo back on track
AstraZeneca’s AZD7442 has shown that it can prevent COVID-19 infection when given to healthy patients – the first time this has been demonstrated by a […]
Amid Actemra shortage, WHO asks Roche to ensure equitable access
Roche’s arthritis drug Actemra has become a key treatment for people with severe COVID-19, leading to shortages, and the World Health Organisation (WHO) wants the […]
Top 20 Immunology Companies Based on 2020 Immunology Segment Revenue
Immunology deals with physiological functioning of the immune system in states of both health and disease as well as malfunctions of the immune system in […]
HER2 heats up as Seagen licenses RemeGen ADC for $2.6bn
Seagen is a specialist in antibody-drug conjugates, but has looked to Chinese biotech RemeGen for a HER2-targeting candidate that could challenge rival drugs from AstraZeneca/Daiichi […]
Armed with ph3 trial, Roche preps filing for Polivy in first-line DLBCL
Roche has the results it was hoping for in a phase 3 trial of Polivy in newly diagnosed diffuse large B-cell lymphoma (DLBCL) – an […]
PharmaShots Weekly Snapshots (Aug 02 – 06, 2021)
Medtronic to Acquire Intersect ENT for ~$1.1B Published: Aug 6, 2021 | Tags: Medtronic, Intersect ENT, ~$1.1B Kite Signs a License Agreement with Appia to […]
Roche gets fast FDA review for Tecentriq in adjuvant lung cancer
Roche is preparing for a December verdict form the FDA on adjuvant use of its PD-L1 inhibitor Tecentriq as an adjuvant treatment for some patients […]
Roche Reports the US FDA’s Acceptance of BLA and Priority Review of Tecentriq (atezolizumab) as an Adjuvant Treatment for NSCLC
Shots: The application is based on the P-III IMpower010 study evaluating the efficacy & safety of Tecentriq vs BSC in 1005 patients in a ratio […]
PharmaShots Weekly Snapshots (July 26 – 30, 2021)
Roche Publishes the Results of Evrysdi (risdiplam) in FIREFISH Study to Treat of Type 1 SMA at NEJM Published: July 30, 2021 | Tags: Roche, […]
Roche Publishes the Results of Evrysdi (risdiplam) in FIREFISH Study to Treat of Type 1 SMA at NEJM
Shots: The company has reported the results from Part 2 of the FIREFISH study evaluating the efficacy and safety of Evrysdi in 41 infants aged […]
FDA starts review of Roche’s eye disease drug, setting up 2022 verdict
The FDA has started a priority review of Roche’s bispecific antibody faricimab for two major causes of blindness, preparing for a market showdown with Bayer […]
Roche Reports the US FDA’s Acceptance of BLA for Faricimab to Treat Diabetic Macular Edema and Neovascular Age-Related Macular Degeneration
Shots: The BLA submission is based on four P-III studies i.e TENAYA, LUCERNE, YOSEMITE & RHINE evaluating the efficacy & safety of faricimab vs aflibercept […]
Angelman syndrome Pipeline: Unmet needs call for a robust pipeline
The necessity of a robust Angelman syndrome pipeline is indispensable at the current moment because of a shortage of any approved therapy option available in […]
Roche ‘talking to FDA’ as Alzheimer’s drug moves towards 2022 readout
Phase 3 results with Roche’s amyloid-targeting Alzheimer’s drug gantenerumab may not be due until the second half of last year, but the company is already […]
AstraZeneca bags Imfinzi okay in big Chinese lung cancer market
China has approved AstraZeneca’s PD-1/PD-L1 inhibitor Imfinzi to treat small-cell lung cancer (SCLC), an aggressive form of the disease that accounts for around 15% of […]
PharmaShots Weekly Snapshots (July 05 – 09, 2021)
Lysogene Receives the US FDA’s Fast Track Designation for LYS-GM101 Gene Therapy to Treat GM1 Gangliosidosis Published: July 9, 2021 | Tags: Lysogene, US, FDA, […]
Roche Enters into a Clinical Collaboration with Treos Bio for PolyPEPI1018 + atezolizumab in P-I/II Trial to Treat Late Stage Microsatellite Stable Metastatic Colorectal Cancer
Shots: The companies collaborated to evaluate Treos’ PolyPEPI1018 (Polypeptide cancer immunotherapy) + Roche’s atezolizumab (PD-L1-inhibitor) in P-I/II trial in patients with late-stage MSS mCRC which […]
Roche Enter into a Collaboration with Mimetas to Develop Human Disease Models for Drug Development
Shots: Mimetas is eligible to receive up front and milestones while Roche will get an option to exclusively license specific disease models and assays for […]
Roche to Present New data of Hemlibra (emicizumab) in P-IIIb STASEY Study for Hemophilia A at ISTH 2021
Shots: The company will present data from the final analysis of P-IIIb STASEY study of Hemlibra (emicizumab) reinforcing the safety & efficacy of Hemlibra in […]
PharmaShots’ Key Highlights of Second Quarter 2021
The second quarter of 2021 witnesses major acquisitions, approvals, and clinical data. There are major alliances in this quarter which include Merck signed ~$1.2B supply […]
Roche antibody gets FDA authorization for treating hospitalized Covid-19 patients
The FDA has granted emergency use authorization to a Roche antibody as a treatment for hyperinflammation in patients hospitalized with severe Covid-19. The drug, Actemra, […]
Atea Pharma Secures $50M Milestone Payment with Roche in the Development of AT-527 for COVID-19
Shots: Atea Pharma achieved a milestone related to the development of AT-527 and is expecting to receive a related payment of $50M under its license […]
Ambrx tries another IPO as it chases down HER2 rivals
California biotech Ambrx Biopharma is hoping to raise $126 million from a listing on the New York Stock Exchange (NYSE) that will be used in […]
PharmaShots Weekly Snapshots (June 07 – 11, 2021)
Vertex and CRISPR Therapeutics Present New Data of CTX001 from 22 Patients with TDT and SCD at EMA 2021 Published: June 11, 2021 | Tags: […]
Roche Reports New Interim Data of JEWELFISH & RAINBOWFISH Studies for Evrysdi (risdiplam) to Treat Spinal Muscular Atrophy
Shots: The new interim data from two studies i.e JEWELFISH open-label study evaluating Evrysdi in people aged 1 to 60 yrs previously treated with another […]
Roche’s SARS-CoV-2 Antigen Test Receives CE mark For Self Testing of COVID-19 at Home
Shots: Roche received a CE mark for its SARS-CoV-2 Ag self-test nasal at home setting for COVID 19. The test will be available in countries […]
NICE ‘no’ to Roche’s risdiplam for SMA not unexpected, says patient group
NICE has rejected routine NHS funding for Roche’s Evrysdi (risdiplam) for spinal muscular atrophy drug in draft guidance, a decision which doesn’t come as a […]
PharmaShots Weekly Snapshots (May 17 – 21, 2021)
BeiGene Reports Results of Tislelizumab + CT in P-III RATIONALE 309 Study as 1L Treatment for Recurrent or Metastatic Nasopharyngeal Cancer Published: May 21, 2021 […]
Genentech Reports Results of Tecentriq in P-III IMpower010 Study for 1L Treatment of NSCLC
Shots: The P-III IMpower010 involves assessing Tecentriq + BSC in 1,005 participants in a ratio (1:1) with Stage IB-IIIA NSCLC, following surgical resection and up […]
Roche Receives the US FDA’s EUA for cobas SARS-CoV-2 Test to Suspect COVID-19
Shots: Roche’s cobas SARS-CoV-2 test to be use on high-throughput cobas 6800/8800 systems has received the US FDA’s EUA for testing individuals without symptoms or […]
Eli Lilly Signs an International Agreements with Four Diabetes Technology Companies for Connected Insulin Pen Solutions
Shots: Eli Lilly collaborates with DexCom, Glooko, myDiabby Healthcare and Roche to integrate the data and technology into connected insulin pen solutions and provide streamlined […]
PharmaShots Weekly Snapshots (May 03 – 07, 2021)
AstraZeneca Reports Results of Imfinzi (durvalumab) and Imfinzi + Tremelimumab in P-III POSEIDON Study as 1L Treatment for Stage IV Non-Small Cell Lung Cancer Published: […]
Roche’s Tecentriq gets fourth European lung cancer indication
Roche’s cancer immunotherapy Tecentriq has been granted a new use by European regulators, for the first-line treatment of certain patients with metastatic non-small cell lung […]
Roche’s Tecentriq Receives EC’s Approval as 1L Treatment for Metastatic Non-Small Cell Lung Cancer
Shots: The approval is based on P-III IMpower110 study assessing the efficacy and safety of Tecentriq vs CT in 572 PD-L1-selected, CT-naïve participants in a […]
ODAC votes to keep bladder cancer labels for Keytruda, Tecentriq
Merck & Co’s Keytruda and Roche’s Tecentriq should stay on the market as first-line treatments for bladder cancer, at least until new clinical data becomes […]
FDA looks at pulling speedy approvals for three cancer drugs
FDA advisors will scrutinise three cancer immunotherapies granted conditional approvals at a three-day meeting this week, to see if they should stay on the market. […]
CHMP backs Roche’s Enspryng for rare nerve disease NMOSD
Roche’s Enspryng has been recommended for approval in the EU for treating neuromyelitis optica spectrum disorder (NMOSD), extending the treatment options for people with the […]
PharmaShots Weekly Snapshots (Apr 19 – 23, 2021)
BMS’ Opdivo + Yervoy and Onureg Receive EC’s CHMP Positive Opinion for MPM and AML Published: Apr 23, 2021 | Tags: BMS, Opdivo, Yervoy, Onureg, […]
Roche Receives the US FDA’s Approval for First CDx to Identify Endometrial Cancer Patients Eligible for Immunotherapy
Shots: The US FDA has approved Ventana MMR RxDx panel to identify endometrial cancer patients who are eligible for treatment with GSK’s Jemperli (monothx.) that […]
PharmaShots’ Key Highlights of First Quarter 2021
The first quarter of 2021 highlights new approvals, M&A, and the clinical data of COVID-19 vaccines. The companies expand their working in COVID-19 by targeting […]
Roche axes two pipeline COVID drugs as pandemic hits Q1 pharma sales
Roche has axed two mid-stage COVID drugs from its development pipeline, according to a first quarter results statement showing the pandemic has hit sales in […]
PharmaShots Weekly Snapshots (Apr 12 – 16, 2021)
ThermoFisher to Acquire PPD for ~$17.4B Published: Apr 16, 2021 | Tags: ThermoFisher, Acquire, PPD, ~$17.4B Roche’s Evrysdi (risdiplam) Receives Health Canada’s Approval for Spinal […]
Roche’s Evrysdi (risdiplam) Receives Health Canada’s Approval for Spinal Muscular Atrophy in Adults and Children
Shots: The approval is based on two studies i.e. FIREFISH & SUNFISH. The FIREFISH study involves assessing Evrysdi in infants aged 2-7mos. with symptomatic Type […]
Evrysdi has ‘real world impact’ on lives of babies with severe SMA, says Roche
Roche’s Genentech unit has released further data from a key trial of Evrysdi, its oral treatment for spinal muscular atrophy (SMA), the rare muscle wasting […]
Roche and Biocorp Launch Mallya Smart Insulin Pen for Patients with Diabetes in France
Shots: The companies launched the Mallya smart insulin pen device in France to support patients with diabetes. The smart insulin pen is available in pharmacies […]
Race for hepatitis B drug intensifies as Antios raises $96m for phase 2 trial
Antios has raised $96 million in Series B financing to support the ongoing phase 2 development of its hepatitis B drug candidate, ATI-2173. There are […]
Regeneron, Roche injectable antibody drug shows efficacy in preventing Covid-19
A Regeneron Pharmaceuticals antibody cocktail currently authorized for treating Covid-19 now has additional clinical data showing it reduces the risk of infection spread. The drug […]
Roche Report Results of Ab Cocktail (Casirivimab + Imdevimab) in P-III REGN-COV 2069 Trial for Symptomatic COVID 19 Infection
Shots: The P-III REGN-COV 2069 trial involves assessing the efficacy and safety of Ab cocktail (casirivimab (1200 mg, SC) + imdevimab (1200 mg, SC) vs […]
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 […]
PharmaShots Weekly Snapshots (Mar 29 – Apr 02, 2021)
Pfizer and BioNTech Report Results of BNT162b2 to Prevent COVID-19 Published: Apr 2, 2021 | Tags: Pfizer and BioNTech, Report, Results, BNT162b2, Prevent, COVID-19 Acceleron […]
TG Therapeutics completes FDA filing for Roche challenger in CLL
TG Therapeutics has completed its rolling FDA filing for its U2 combination therapy consisting of the antibody ublituximab with the oral drug Ukoniq (umbralisib) as […]
Roche’s Tecentriq Receives CHMP’s Positive Opinion for 1L Treatment for Metastatic Non-Small Cell Lung Cancer
Shots: The CHMP’s recommendation is based on Phase III IMpower110 study assessing Tecentriq vs CT in 572 PD-L1-selected, CT-naïve participants in a ratio (1:1) with […]
PharmaShots Weekly Snapshots (Mar 22 – 26, 2021)
Pfizer and BioNTech Initiate COVID-19 Vaccine Trial in Children Under 12 Published: Mar 26, 2021 | Tags: Pfizer and BioNTech, Initiate, COVID-19 Vaccine Trial, Children, […]
Roche Launches New Configurations for Cobas Pro to Increase Testing Efficiency
Shots: Roche launches eight new configurations for Cobas pro integrated solutions in countries accepting the CE mark and is designed to address the individual needs […]
Roche stops dosing in trial of Huntington’s disease hopeful tominersen
Roche has stopped dosing in a phase 3 trial of tominersen, a potential Huntington’s disease (HD) drug developed with Ionis, after a pre-planned review by […]
Roche Pauses Dosing of Tominersen in P-III GENERATION HD1 for Manifest Huntington’s Disease
Shots: Roche discontinue the dosing in the P-III GENERATION HD1 study that assesses Tominersen (120 mg, every 2mos./120 mg every 4mos., IT) in 791 participants […]
Roche Reports Results of Tecentriq in P-III IMpower010 Study for Patients with Early Lung Cancer
Shots: The P-III IMpower010 study involves assessing Tecentriq vs BSC, in 1,005 participants in a ratio (1:1) with stage IB-IIIA NSCLC, following surgical resection and […]
PharmaShots Weekly Snapshots (Mar 15 – 19, 2021)
Takeda Collaborates with Anima to Discover and Develop mRNA Translation Modulators for Neurological Diseases Published: Mar 19, 2021 | Tags: Takeda, Collaborates, Anima, Discover, Develop, […]
PharmaShots Weekly Snapshots (Mar 15 – 19, 2021)
Takeda Collaborates with Anima to Discover and Develop mRNA Translation Modulators for Neurological Diseases Published: Mar 19, 2021 | Tags: Takeda, Collaborates, Anima, Discover, Develop, […]
Roche launches test to monitor emerging coronavirus variants
Roche has launched a new test that will help monitor emerging variants of the SARS-CoV-2 coronavirus. In a statement the company said the cobas SARS-CoV-2 […]
Roche launches test to monitor emerging coronavirus variants
Roche has launched a new test that will help monitor emerging variants of the SARS-CoV-2 coronavirus. In a statement the company said the cobas SARS-CoV-2 […]
Genentech Reports Two-Year Data of Evrysdi (risdiplam) for People with Type 2 or Type 3 SMA
Shots: Genentech reports the new 2yrs. data from part 2 of SUNFISH study assessing Evrysdi vs PBO in people aged 2-25 years with Type 2 […]
Roche Launches Cobas SARS-CoV-2 Variant Test to Detect Emerging Coronavirus Mutations
Shots: The company has launched the cobas SARS-CoV-2 variant set 1 test to detect spike mutations in virus variants including UK (B.1.1.7), South Africa (B.1.351), […]
Roche’s $1.8B GenMark deal brings a key testing capability for Covid-19 and beyond
Roche already sells a Covid-19 diagnostic. In acquiring GenMark Diagnostics for $1.8B, Roche is adding technology that can detect SARS-CoV-2 along with multiple respiratory diseases […]
Roche expands COVID testing portfolio with $1.8bn GenMark deal
Roche has said it will pay $1.8 billion for molecular testing company GenMark, boosting the Swiss company’s diagnostic capabilities and adding rapid COVID tests to […]
Roche to Acquire GenMark Diagnostics for $1.8B
Shots: Roche to acquire all outstanding shares of GenMark’s for $24.05/ share in cash, making a total deal value of $1.8B with a premium of […]
PharmaShots Weekly Snapshots (Mar 08 – 12, 2021)
PhaseBio Signs a Supply Agreement with BioVectra to Support the Development and Commercialization of Bentracimab Published: Mar 12, 2021 | Tags: PhaseBio, Signs, Supply, Agreement, […]
Insights+: Breakthrough Therapy Designation by the US FDA in 2020
Breakthrough Therapy (BT) Designation is an expedited review program introduced in Section 902 of the Food and Drug Safety and Innovation Act of 2012 The […]
Roche’s Actemra/RoActemra (tocilizumab) + Veklury Fail to Meet its Primary Endpoints in P-III REMDACTA Study for Patients with Severe COVID-19 Pneumonia
Shots: The P-III REMDACTA study involves assessing Actemra/RoActemra (tocilizumab) + Veklury (remdesivir) vs PBO + Veklury in hospitalized patients with severe COVID-19 pneumonia receiving SOC […]
Roche’s Tecentriq loses bladder cancer use as FDA crackdown continues
Roche’s Tecentriq is the latest medicine to fall foul of a crackdown by the FDA on drugs that have failed to live up to their […]
Roche’s Ventana ALK (D5F3) CDx Assay Receives the US FDA’s Approval for the Treatment of ALK-Positive NSCLC
Shots: The US FDA has granted approval of Ventana ALK (D5F3) as a CDx assay to identify ALK+ NSCLC patients eligible for treatment with Pfizer’s […]
Double first for Scotland as it backs Roche’s Rozlytrek, Novartis’ Zolgensma
The Scottish Medicines Consortium (SMC) has said Roche’s Rozlytrek can be used by NHS Scotland for the treatment of solid tumours with NTRK gene fusion […]
Roche withdraws Tecentriq for bladder cancer, pullback comes amid FDA review
Blockbuster Roche drug Tecentriq will be pulled from the U.S. market as a bladder cancer treatment—three years after failing clinical tests required to stay on […]
Roche to Withdraw Tecentriq Indication in Metastatic Bladder Cancer in the US
Shots: The company reported the voluntary withdrawal of the Tecentriq (atezolizumab) indication in the US for prior-platinum treated mUC, bladder cancer The withdrawal was made […]
PharmaShots Weekly Snapshots (Mar 01 – 05, 2021)
Eli Lilly and Incyte Report Results of Olumiant (baricitinib) in P-III BRAVE-AA2 Study for Severe Alopecia Areata Published: Mar 5, 2021 | Tags: Eli Lilly […]
Roche Collaborates with Tempest to Evaluate TPST-1120 in a Combination Study as 1L Treatment for Hepatocellular Carcinoma
Shots: The companies collaborated to evaluate TPST-1120 + Tecentriq (atezolizumab) and Avastin (bevacizumab) in P-Ib/II study in ~60 patients with advanced HCC prior not treated […]
Regeneron’s Ab Cocktail (casirivimab + imdevimab) Receives the CHMP’s Positive Opinion to Treat COVID-19
Shots: The EMA’s CHMP has recommended the use of casirivimab + imdevimab in patients with confirmed COVID-19 who do not require oxygen supplementation and who […]
PharmaShots Weekly Snapshots (Feb 22- 26, 2021)
Regeneron Reports IDMC Clearance of Efficacy for REGEN-COV (Casirivimab + Imdevimab) in P-III COVID-19 Outpatient Outcomes Trial Published: Feb 26, 2021 | Tags: Regeneron, Reports, […]
Roche on COVID-19 healthcare and testing: the pharmaphorum podcast
For episode 30 I spoke with Dr Ashton Harper, who’s head of medical affairs in the UK and Ireland at Roche Diagnostics, about the pressure […]
Roche Report Results of Evrysdi (risdiplam) in FIREFISH Study for Infants with Type 1 SMA
Shots: Roche has reported the data from the dose-finding Part 1 of the FIREFISH study assessing Evrysdi in patients aged 1-7mos. with Type 1 SMA. […]
Roche Concludes the License Agreement with Chugai for AT-527 to Treat COVID-19 in Japan
Shots: Chugai gets exclusive development and commercializing rights for AT-527 in Japan Earlier, Roche and Atea collaborated to jointly develop AT-527. If approved, Atea to […]
PharmaShots Weekly Snapshots (Feb 15- 19, 2021)
RedHill Signs a Manufacturing Agreement with Cosmo for Movantik and RHB-204 Published: Feb 19, 2021 | Tags: RedHill, Signs, Manufacturing, Agreement, Cosmo, Movantik, RHB-204 Astellas and […]
Roche and PatchAi partner on digital tool for cancer patients
Roche’s Italian subsidiary has joined forces with digital health startup PatchAi to roll out an app that aims to support people diagnosed with cancer. Roche […]
Roche’s Receives the US FDA’s Clearance for Urine Sample Type for BK Virus Quantitative Test
Shots: The US FDA 510K clearance for stabilized urine samples to be used with the cobas BKV test on the cobas 6800/8800 systems. It is […]
PharmaShots Weekly Snapshots (Feb 08 – 12, 2021)
Visby’s POC COVID-19 Test Receives the US FDA’s EUA for Use in CLIA Waived Settings Published: Feb 12, 2020 | Tags: Visby, POC, COVID-19, Test, Receives, […]
Roche Reports Results of Faricimab in Four P-III Studies for Diabetic Macular Edema and Age-Related Macular Degeneration
Shots: The P-III YOSEMITE & RHINE studies involve assessing faricimab (6mg at personalized dosing intervals of up to 4mos. and at fixed 2mos. intervals) vs […]
Roche’s Elecsys GDF-15 Assay Receives the US FDA’s Breakthrough Device Designation as a CDX in Cancer Treatment
Shots: The US FDA grants the BDD for Elecsys GDF-15 assay that is intended for measurement of Growth Differentiation Factor-15 (GDF-15) in cachectic patients aged≥18yrs. […]
PharmaShots Weekly Snapshots (Jan 25- 29, 2021)
Roche Collaborate with Cambridge Quantum Computing to Develop Quantum Algorithm for Drug Discovery and Development Published: Jan 29, 2020 | Tags: Roche, Collaborate, Cambridge Quantum Computing, […]
Roche Collaborate with Cambridge Quantum Computing to Develop Quantum Algorithm for Drug Discovery and Development
Shots: CQC collaborates with Roche to design and implement noisy-intermediate-scale-quantum (NISQ) algorithms for early-stage drug discovery and development The collaboration will employ CQC’s quantum chemistry […]
Roche targets wet AMD with faricimab and its 16-week regimen
Twin late-stage trials of Roche’s ophthalmology drug faricimab have hit the mark in “wet” age-related macular degeneration trial, as the company’s challenge to rivals from […]
PharmaShots Weekly Snapshots (Jan 18 – 22, 2021)
Takeda’s Alunbrig (brigatinib) Receives MHLW’s Approval as a 1L and 2L Treatment for ALK+ Advanced or Recurrent NSCLC Published: Jan 22, 2020 | Tags: Takeda, […]
Top 20 Life Sciences Deals of 2020 by Total Deal Value
Life sciences companies are gearing up to enter new markets as they look to secure their positions after a spate of M&A, licensing, and research […]
NICE rejects BMS’ Zeposia MS pill in provisional guidance
NICE has said that the NHS should not fund Bristol-Myers Squibb’s multiple sclerosis pill Zeposia (ozanimod) for relapsing multiple sclerosis in first draft guidance. The […]
Insights+: The US FDA New Drug Approvals in December 2020
The US FDA has approved 7 NDAs and 2 BLA in Nov 2020, leading to treatments for patients and advances in the health care industry. The Center for Drug […]
Roche Reports the US FDA’s Acceptance of sNDA and Granted Priority Review for Esbriet (pirfenidone) to Treat UILD
Shots: The sNDA submission is based on a P-II study that involves assessing Esbriet vs PBO in patients aged ≥18-85yrs. with progressive fibrosing UILD for […]
Scotland backs Roche’s Rozlytrek for ROS1 lung cancer
The Scottish Medicines Consortium (SMC) has given a green light to Roche’s Rozlytrek for a rare form of lung cancer, almost seven months after NICE […]
Angelman Syndrome Market: Insights Into The Recent Late-Stage Drug Failures And Novel Approaches To Treating This Rare Neurogenetic Disorder
Angelman syndrome (AS) is a complex genetic rare disorder that affects the nervous system. The first sign of a child suffering from Angelman syndrome is […]
PharmaShots Weekly Snapshots (Jan 11 – 15, 2021)
Novartis’ Ligelizumab (QGE031) Receives the US FDA’s Breakthrough Designation for Patients with Chronic Spontaneous Urticaria Published: Jan 15, 2020 | Tags: Novartis’, Ligelizumab (QGE031), Receives […]
PharmaShots’ Key Highlights of Fourth Quarter 2020
The fourth quarter of 2020 contains multiple initiations of clinical trials, big approvals, and numerous deals. COVID-19 related news remains at the peak in this […]
Roche Reports Updated OS Data of Tecentriq + Avastin in P-III IMbrave150 Study for Unresectable HCC
Shots: The approval is based on P-III IMbrave150 study involves assessing of Tecentriq (1200mg) + Avastin (15 mg/kg) on day 1 of each 21-day cycle […]
RNAi biotech Atalanta debuts with $110m plus Biogen and Roche CNS tie-ups
US biotech Atalanta Therapeutics has come out of stealth mode backed with $110m from Biogen and Roche, who have also signed separate partnerships to develop […]
Roche’s Xofluza Receives the EC’s Approval for the Treatment of Influenza
Shots: The EC has approved Xofluza (baloxavir marboxil) for uncomplicated influenza in patients aged≥12yrs. Additionally, the EC has approved Xofluza for post-exposure prophylaxis of influenza […]
IL-6 drugs do work in COVID-19, says UK, as it plans NHS use
New data means that IL-6 drugs from Roche and Sanofi that had been all-but written off as coronavirus therapies will now be offered routinely to […]
Roche nabs breakthrough tag for TIGIT cancer immunotherapy
Roche’s closely-watched combination of two checkpoint inhibitors – TIGIT-targeting tiragolumab and PD-L1 drug Tecentriq – has claimed breakthrough status from the FDA. Like PD-L1, TIGIT […]
Roche set to file ophthalmology drug faricimab in DME
Roche looks set to mount a challenge to Bayer’s ophthalmology drug Eylea in 2021 after its faricimab antibody showed comparable results in diabetic macular oedema […]
PharmaShots’ Most Read News of 2020
“Lockdown’ declared Collins Dictionary word of the year. The year 2020, well known as COVID-19 year has been a busy year for global pharma and […]
PharmaShots Weekly Snapshots (Dec 21-23, 2020)
Roche’s Phesgo (Perjeta + Herceptin) Receives EC’s Approval for the Treatment of HER2-Positive Breast Cancer Published: Dec 23, 2020 | Tags: (Perjeta + Herceptin), EC’s […]
Moderna, Roche team up to track duration of Covid-19 protection after vaccination
Moderna is using a Roche antibody test in clinical trials of its Covid-19 vaccine. The test can measure the antibodies created through vaccination, offering a […]
Roche’s Phesgo (Perjeta + Herceptin) Receives EC’s Approval for the Treatment of HER2-Positive Breast Cancer
Shots: The approval is based on P-III FeDeriCa study evaluating the pharmacokinetics, efficacy, and safety of Phesgo + CT vs Perjeta + Herceptin (IV) + […]
Roche claims EU okay for Herceptin/Perjeta combination Phesgo
Roche has secured EU approval for Phesgo, a fixed-dose combination of its breast cancer drugs Herceptin and Perjeta that is easier and cheaper to administer […]
Roche Reports Results of Faricimab in Two Global P-III Studies for Diabetic Macular Edema
Shots: The P-III YOSEMITE & RHINE studies assessing faricimab vs aflibercept in 1891 people living with DME. The studies include 3 treatment arms: faricimab (6mg) […]
PharmaShots Weekly Snapshots (Dec 14-18, 2020)
Sandoz to Launch Hyrimoz (biosimilar, adalimumab) in Canada Published: Dec 17, 2020 | Tags: Authorization, Biosimilar, canada, health, Humira, Hyrimoz, Launch, receives, Sandoz Amgen’s Riabni […]
Insights+: The US FDA New Drug Approvals in November 2020
The US FDA has approved 5 NDAs and 1 BLA in Nov 2020, leading to treatments for patients and advances in the health care industry. […]
EUSA Pharma hopes IL-6 drug will succeed in COVID-19 where rivals failed
UK-based EUSA Pharma has begun a late-stage trial of its antibody siltuximab in COVID-19, hoping that the IL-6 inhibitor will succeed where class rivals from […]
Roche Launches Cobas PIK3CA Mutation Test for Patients with Advanced or Metastatic Breast Cancer
Shots: Roche launches the cobas PIK3CA mutation test for patients with advanced/ m-BC in countries accepting the CE mark The IVT test is a real-time […]
Digital Diabetes Market to Reach $1.5B by 2024, Research Finds
What You Should Know: – The digital diabetes market is on track to reach $1.5 billion dollars by 2024, according to a new report by Research2Guidance. […]
PharmaShots Weekly Snapshots (Dec 7-11, 2020)
Roche Launches Elecsys SARS-CoV-2 Antigen Test to Support High-Volume COVID-19 Testing Published: Dec 11, 2020 | Tags: Antigen, COVID-19, High, Laboratory, Launch, patients, Roche, SARS-CoV-2, […]
Chugai In-Licenses Roche’s Antibody Cocktail for COVID-19 in Japan
Shots: Chugai get an exclusive development and commercialization agreement in Japan for Roche’s Ab cocktail of casirivimab and imdevimab to combat COVID-19 Earlier, Roche & […]
Roche Launches Elecsys SARS-CoV-2 Antigen Test to Support High-Volume COVID-19 Testing
Shots: Roche has launched Elecsys SARS-CoV-2 Ag test as an aid in the diagnosis of SARS-CoV-2 infections, in the markets accepting the CE Mark. Additionally, […]
Roche Presents Results of Tecentriq (atezolizumab) in P-III IMvigor010 Study for MIUC at ESMO 2020
Shots: Roche reports an exploratory analysis of P-III IMvigor010 study assessing efficacy and safety of adjuvant treatment with Tecentriq vs observation in 809 people with […]
Roche Collaborate with Moderna to include SARS-CoV-2 Ab Test in COVID-19 Vaccine Trials
Shots: Roche allied with Moderna to utilize the Elecsys anti-SARS-CoV-2 S Ab test in mRNA-1273 study. The collaboration will facilitate the quantitative measurement of SARS-CoV-2 […]
Roche Collaborate with Moderna to include SARS-CoV-2 Ab Test in COVID-19 Vaccine Trials
Shots: Roche allied with Moderna to utilize the Elecsys anti-SARS-CoV-2 S Ab test in mRNA-1273 study. The collaboration will facilitate the quantitative measurement of SARS-CoV-2 […]
Roche Highlights its Bispecific Antibody Portfolio Across a Range of Blood Cancers at ASH 2020
Shots: The company presented the new data of its T-cell engaging bispecific Abs, mosunetuzumab, glofitamab and cevostamab at ASH 2020, demonstrating encouraging activity across multiple […]
Roche Reports of Polivy + Bendamustine and MabThera / Rituxan in P-lb/ll GO29365 Study for R/R Diffuse Large B-Cell Lymphoma
Shots: The P-lb/ll GO29365 study involves assessing of Polivy (polatuzumab vedotin) + BR vs BR as monthx. in 106 patients with r/r DLBCL who are […]
Roche Presents Results of Hemlibra Reinforcing the Long-Term Benefits for Hemophilia A at ASH 2020
Shots: The 4 pivotal HAVEN studies (HAVEN-1, 2, 3, 4) included pooled data from 401 people with hemophilia A with/ out factor VIII inhibitors, with […]
Roche Reports Long-Term Benefits of Venclexta/Venclyxto Based Combination for R/R Chronic Lymphocytic Leukemia
Shots: Five-year data from P-III MURANO trial shows sustained PFS with Venclexta/Venclyxto + MabThera/Rituxan vs BR in patients with r/r CLL The data showed a […]
PharmaShots Weekly Snapshot (Nov 30 – Dec 04, 2020)
Richter Acquires Janssen’s Evra Transdermal Contraceptive Patch Assets for $263.5M Published: Dec 3, 2020 | Tags: Asset Purchase Agreement, Evra, Gedeon Richter, Janssen Pharmaceutical, Signs, […]
TG Therapeutics challenges Roche with FDA filing for CLL drug
US biotech TG Therapeutics has begun a rolling filing with the FDA for its combination therapy for chronic lymphocytic leukaemia, in a challenge to Roche. […]
Roche, Blueprint raise pressure on Lilly with new Gavreto approval
The FDA has cleared Roche and Blueprint Medicine’s Gavreto for a new use in RET-mutated thyroid cancer, putting it on a level playing field with […]
Swiss start-up Noema raises $59m to develop neurology drugs offloaded by Roche
Swiss biotech Noema has raised 54 million Swiss francs ($59m) to develop four neurological disorder drugs licensed in from Roche. The company is developing four […]
PharmaShots Weekly Snapshot (Nov 23 – 27, 2020)
Merck Collaborates with Siemens for the Digitalization of Production Published: Nov 26, 2020 | Tags: Agreement, Collaborative, Digitalization, Merck, Siemens, Sign CoSara Receives CDSCO’s Approval […]
FDA approves Roche’s Xofluza to prevent flu spreading in families
The FDA has approved a new use for Xofluza (baloxavir marboxil) from Roche’s Genentech unit, to prevent people developing flu after coming into contact with […]
Roche’s Xofluza (baloxavir marboxil) Receives the US FDA’s Approval for Post-Exposure Prevention of Influenza
Shots: The approval is based on P-III BLOCKSTONE study assessing a single dose of Xofluza vs PBO in household members who were living with someone […]
PharmaShots Weekly Snapshot (Nov 16-20, 2020)
Eli Lilly and Incyte Receive FDA’s EUA for Baricitinib + Remdesivir to Treat Hospitalized Patients with COVID-19 Published: Nov 20,2020 | Tags: baricitinib, COVID-19, Eli […]
Lead Pharma signs $308m deal to develop small molecule drugs with Roche
Lead Pharma has signed a potential 260 million euro ($308 million) deal with Roche to develop small molecule drugs for immune diseases. The deal will […]
Roche Signs a License Agreement with Lead Pharma to Develop Oral Therapies for Immune-Mediated Diseases
Shots: Lead Pharma receives ~$11.86M upfront and is eligible to receive funding and ~$307.9 as research, development, regulatory and commercial milestones along with royalties on […]
Roche’s Xofluza (baloxavir marboxil) Receives CHMP’s Recommendation for Approval to Treat Influenza
Shots: The EMA’s CHMP has recommended the approval of Xofluza (baloxavir marboxil) for the treatment of uncomplicated influenza in patients aged ≥12yrs. Xofluza has also […]
Roche’s Herceptin/Perjeta combo product nears EU approval
The EMA’s human medicines committee has recommended approval of a fixed-dose combination of Roche’s breast cancer drugs Herceptin and Perjeta – part of the company’s […]
NICE okays Roche liver cancer immunotherapy, Sanofi’s rare disease drug
Previously-untreated patients with hepatocellular carcinoma (HCC), a common form of liver cancer, will have an immunotherapy-based treatment option after NICE gave the nod to NHS […]
NICE backs chemo-free CLL combination from AbbVie and Roche
Previously treated patients with chronic lymphocytic leukaemia (CLL) in England will get a chemotherapy-free treatment option after NICE recommended NHS funding for a combination of […]
Sanofi/Alnylan’s haemophilia drug hits another safety speed-bump
Sanofi’s attempt to take on Roche with a ground-breaking approach to treating haemophilia has hit a setback after the company voluntarily placed its late-stage trials […]
PharmaShots Weekly Snapshot (Nov 02-06, 2020)
AstraZeneca’s Brilinta (ticagrelor) Receives the US FDA’s Approval to Reduce the Risk of Stroke in Patients with an Acute Ischemic Stroke or High-Risk Transient Ischemic […]
Europe approves Roche’s Tecentriq liver cancer combination
The European Commission has approved Roche’s Tecentriq immunotherapy, in combination with its established cancer drug Avastin, for patients with the most common form of liver […]
Roche’s Tecentriq in Combination with Avastin Receives China NMPA’s Approval for the Treatment of Unresectable Hepatocellular Carcinoma
Shots: The approval was based on the P-III IMbrave150 study (n=501) assessing the combination of Tecentriq (1200 mg, IV) and Avastin (15 mg/kg, IV) or […]
PharmaShots’ Key Highlights of Third Quarter 2020
The third quarter of 2020 was flooded with major acquisitions in the pharma and biotech industry along with multiple approvals. Starting with the latest acquisitions, […]
PharmaShots Weekly Snapshot (Oct 19 – 23, 2020)
Akebia Presents Results of Vadadustat in P-lll INNO2VATE Program for Anemia Due to CKD at ASN Kidney Week Published: Oct 23, 2020 | Tags: Akebia, […]
Top 20 Immunology Companies Based 2019 Immunology Segment Revenue
Immunology is an important branch of science which deals with the study of the immune system. The immune system is a highly regulated and balanced […]
Roche Collaborates with Atea Pharmaceuticals to Develop AT-527 for COVID-19
Shots: The companies will collaborate to develop, manufacture, and distribute AT-527 to combat COVID-19. If approved, Atea will be responsible for distributing the treatment option […]
