What You Should Know: – Northwestern Memorial Hospital is the first in the nation to deploy FDA-cleared AI-guided ultrasound by Caption Health, including measurement of ejection fraction – the most widely used measurement to assess cardiac function. – Caption Health’s AI-guided cardiac ultrasound enables clinicians… Read More »Northwestern to Deploy FDA-Cleared Deploy AI-Guided Cardiac Ultrasounds
Stocks for Exact Sciences leaped 33% after it announced the acquisition of liquid biopsy rival Thrive and UK start-up Base Genomics. Exact Sciences said it has agreed to buy Thrive for a cash and stock deal worth up to $2.15 billion, positioning it as a… Read More »Exact Sciences buys cancer detection company Thrive for $2.15 billion
Daiichi Sankyo Initiates P-I Study of DS-1055 for Relapsed/Refractory Advanced or Metastatic Solid Tumors
Shots: The P-I dose-escalation study will assess the safety, tolerability, and preliminary efficacy of DS-1055 in adult patients with r/r advanced or metastatic head and neck, gastric and esophageal cancers, and other tumor types The focus of the study is to determine the maximum tolerated… Read More »Daiichi Sankyo Initiates P-I Study of DS-1055 for Relapsed/Refractory Advanced or Metastatic Solid Tumors
As recently as June, NICE was minded not to back routine NHS of MSD’s Keytruda as a first-line treatment for advanced head and neck cancer, but it has had a partial change of heart on the drug after the company submitted new data. Just-published draft… Read More »NICE changes stance on Keytruda for first-line head and neck cancer
Cancer doesn’t end when treatment stops – it’s a lifelong journey and people need support throughout, says patient advocate Megan-Claire Chase. No one gets through cancer unscathed. People are usually left with a mixture of treatment aftereffects, toxic positivity, and lingering anger to deal with.… Read More »Toxic positivity and grief: The reality of living through cancer
Two years after quietly forming cancer start-up Nuvation Bio, ex-Axovant and Medivation CEO David Hung has agreed a big merger that will take it public – and provide more than $850 million in funding to boot. Hung’s new company is merging with Panacea Acquisition Corp,… Read More »David Hung’s Nuvation Bio seals merger with blank cheque firm Panacea
The FDA has granted a fast review for AstraZeneca’s Tagrisso oncology drug in certain patients with early-stage lung cancer. Results from the phase 3 ADAURA trial were the talk of this year’s American Society of Clinical Oncology (ASCO) conference in summer and the regulator has… Read More »FDA grants fast review for AstraZeneca’s Tagrisso in early-stage lung cancer
Bristol-Myers Squibb could be mere months away from claiming a second US approval for an Opdivo-based combination immunotherapy that will help defend its first-line kidney cancer franchise. The FDA has started a priority review of PD-1 inhibitor Opdivo (nivolumab) alongside Exelixis’ tyrosine kinase inhibitor Cabometyx… Read More »FDA kicks off review of second kidney cancer combo based on BMS’ Opdivo
What You Should Know: – Nearly three-quarters of hospital leaders are either moderately (52%) or extremely (22%) concerned about the financial viability of their organizations without an effective treatment or vaccine for COVID-19, according to a new report from Kaufman Hall entitled, “2020 State of… Read More »Impact of COVID-19: 2020 State of Healthcare Performance Improvement Report
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
Jerry Carlson, Product Support Manager, BG DI BU IC Sales, Dunlee As the COVID-19 pandemic creates surges in acute care, many imaging departments are experiencing a decrease in volume, due to patients deferring or canceling non-urgent appointments and surgeries. The impact of this makes it… Read More »Thriving in a Value-Based Care Environment: Impacting Outcome-to-Cost Ratio
The company has received FDA approvals for two cancer drugs in less than 12 months and announced partnerships with Merck last month for a Phase II antibody-drug conjugate and a marketed drug.
J+D Forecasting, known as the experts in pharmaceutical forecasting, has today announced the launch of EpiCube; the latest addition to its comprehensive suite of pharmaceutical forecasting products. Unlike most standard epidemiological databases available, EpiCube is the first database where the user can choose how to… Read More »J+D FORECASTING LAUNCHES INTELLIGENT DATA
Cancer Insights co-founders, President and CEO Tarun Kumar and CIO Dr. Sharon Hensley Alford, discuss their company’s goals to transform the oncology care continuum.
The FDA has rejected Mesoblast’s Ryoncil cell therapy for children with graft versus host disease, despite a recommendation to approve from a panel of expert advisers. In August the FDA’s Oncology Drugs Advisory Committee voted nine to one in favour of approving Ryoncil (remestemcel-L), making… Read More »Shock as FDA rejects Mesoblast’s Ryoncil in paediatric graft versus host disease
The findings may make it possible to identify a subset of patients who experience poorer outcomes or more serious side effects, especially neurotoxicity.
Bristol-Myers Squibb’s immunotherapy combination of Opdivo and Yervoy has been approved in the US in a new indication for untreated mesothelioma, a rare but aggressive form of cancer that forms in the lining of the lungs. The FDA has approved Opdivo (nivolumab) and Yervoy (ipilimumab),… Read More »FDA approves BMS’ Opdivo and Yervoy combination in first-line mesothelioma
Roche’s Genentech unit has paid $200 million to develop an individualised cancer vaccine with Norwegian biotech Vaccibody, which focuses on targets known as neoantigens that spring up as tumours grow and mutate. The deal with the Oslo-based company is worth up to $715 million, with… Read More »Roche pays $200m for Vaccibody’s cancer vaccine drug
The company hopes to use the money to bring its T-cell antigen coupler cell therapy technology – currently in preclinical development – into human clinical trials. German drugmaker Bayer’s venture capital arm led the round.
The TIGIT checkpoint has gained much attention in recent years due to the number of roles it plays in several malignancies. TIGIT’s diverse function in multiple cell types has made it a lucrative immunotherapy candidate, with an increasing number of candidates being investigated in pre-clinical and clinical… Read More »TIGIT Therapies Digital Summit
GlaxoSmithKline has approval on both sides of the Atlantic for its multiple myeloma drug Blenrep, after getting the nod from the European Commission. Blenrep (belantamab mafodotin) becomes the first BCMA-targeted drug for myeloma to be approved in the EU, and according to its label can… Read More »GSK moves further ahead in BCMA with EU okay for Blenrep
Merck KGaA could be looking at an early 2021 approval for its MET inhibitor tepotinib in lung cancer from the FDA after the US regulator started a priority review of the drug, but could still be beaten to market by a rival drug. Tepotinib has… Read More »FDA starts quick review of Merck’s MET-targeting lung cancer drug
A first-in-class STAMP inhibitor developed by Novartis – asciminib – has outperformed a current drug for chronic myeloid leukaemia (CML) in a head-to-head trial, setting up regulatory filings. The ASCEMBL trial compared asciminib (ABL001) to Pfizer’s Bosulif (bosutinib) in Philadelphia chromosome-positive CML patients who had… Read More »Novartis eyes filings for leukaemia drug asciminib after phase 3 win
With the ink barely dry on a deal to develop Dragonfly’s lead cancer immunotherapy, Bristol-Myers Squibb’s business development team has agreed to buy Canadian biotech Forbius and its pipeline of drugs for cancer and fibrotic diseases. Since its foundation in 2011, privately-held Forbius has been… Read More »BMS swoops on Forbius, snaring another immuno-oncology player
Could collecting, understanding, and disseminating patient-reported outcomes during trials be the key to advancing oncology treatments and improving cancer outcomes? With our understanding of cancer accelerating at an unprecedented rate, and personalised medicines on the cusp of becoming mainstream, regulatory bodies need new ways to… Read More »Sharing oncology trial PROs to build the treatment of the future
Novartis’ hopes of catching up with other companies in immuno-oncology have been dented after PD-1 inhibitor spartalizumab failed a phase 3 trial in skin cancer. Novartis had hoped the COMBI-i trial would allow it to file for approval of the ‘me-too’ PD-1 inhibitor before the… Read More »Blow for Novartis as PD-1 drug spartalizumab flunks trial
Cambridge, UK-based Biofidelity has raised $12 million in first-round funding for its cancer diagnosis platform, which can detect mutations quicker than current approaches like gene sequencing. The Series A comes just a few months after Biofidelity launched with seed funding from Longwall Ventures and private… Read More »UK cancer mutation testing firm Biofidelity raises $12m
Harnessing the Potential of Macrophage Therapies Using Small Molecule, Antibody & Cell Therapy based Approaches for Oncology and Beyond The $4.9 billion acquisition of Forty Seven by Gilead is an example of the explosive excitement and investment into macrophage-directed therapies, utilizing CD47 checkpoint blockades, repolarization… Read More »2nd Macrophage-directed Therapies Summit
Eli Lilly has doubled down on its partnership with Chia’s Innovent with a licensing deal for ex-China rights to Tyvyt, their PD-1 inhibitor, which some analysts think may be launched at a discount to its rivals. Lilly and Innovent co-developed Tyvyt (sintilimab) in China and… Read More »Latecomer Lilly throws cash at Innovent PD-1 partnership
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.
The FDA is to review data supporting AstraZeneca’s Imfinzi (durvalumab) cancer immunotherapy in a new four-week regimen that will halve the number of required clinic visits for patients with lung and bladder cancer. The regulator has granted a faster six-month Priority Review for the fixed… Read More »AZ aims to cut cancer clinic visits with new Imfinzi regimen
Bristol-Myers Squibb has signed an agreement worth $475 million to develop a new form of cancer immunotherapy drug with US biotech Dragonfly Therapeutics. BMS is best known as an early pioneer of checkpoint inhibitor therapies, which work by flipping a biochemical switch on tumour cells… Read More »BMS signs $475m cancer immunotherapy deal with Dragonfly
What You Should Know: – CancerIQ raises $5M in Series A funding led by HealthXVentures to accelerate the growth of its genetic cancer risk assessment platform to identify and manage patients at high risk of cancer. – CancerIQ’s technology enables hospitals to use genomics to… Read More »CancerIQ Raises $5M to Expand Genetic Cancer Risk Assessment Platform
Screening women for breast cancer in their 40s rather than their 50s could save lives, say the authors of a new Lancet Oncology study, although that finding has been challenged by other experts. Lowering the age that women start to routinely get mammograms was associated… Read More »UK medical journals spar over breast cancer screening study
The FDA has accepted TG Therapeutics’ filing for its lymphoma drug umbralisib, which if approved could compete against a combination therapy from Bristol-Myers Squibb and Roche. TG’s filing covers previously treated marginal zone lymphoma (MZL) and follicular lymphoma (FL), competing against a combination of BMS’… Read More »FDA to decide on TG Therapeutics’ lymphoma drug early next year
The Chicago-based startup company plans to use the funding to further growth of its product offering and integration with EHRs and genetic testing partners.
J+D Forecasting strike the balance between simplicity and complexity when modelling for the liquid tumour market The Challenge Identify a clear, transparent, and logical way to structure a forecast model to identify the potential for a new therapy in leukaemia. The model would be complex… Read More »J+D Forecasting strike the balance for the liquid tumour market
What You Should Know: The FDA and Syapse announce research collaboration expansion to address urgent public health challenges including supporting FDA’s goal of rapid understanding of COVID-19. As part of the research, Syapse is partnering with FDA’s Oncology Center of Excellence to investigate methods to… Read More »FDA, Syapse Expand Research to Generate Real-World Data Related to COVID-19 and Cancer
US biotech Pieris Pharmaceuticals has begun a collaboration and supply agreement with Eli Lilly, trialling its cancer drug PRS-343 in combination with the big pharma’s Cyramza (ramucirumab). PRS-343 is a bispecific drug targeting the 4-1BB and HER2 receptors, which the companies hope will work well… Read More »Pieris begins gastric cancer combination trial with Lilly’s Cyramza
Bristol-Myers Squibb’s Opdivo has improved survival in a trial involving patients with mesothelioma, a form of lung cancer, getting one up over rival checkpoint inhibitor Keytruda from Merck & Co. The results of the CheckMate-743 trial showed that a combination of Opdivo (nivolumab) with low-dose… Read More »BMS’ Opdivo aces trial in asbestos-linked lung cancer
What You Should Know: – Siemens Healthineers and Varian Medical announce a $16.4B deal in an all-cash transaction on 2nd August 2020. – Deal expected to close in 1H 2021. – Varian Medical will maintain its brand name and operate “independently” – Siemens AG will… Read More »M&A Analysis: 3 Benefits of Siemens Healthineers’ $16.4B Acquisition of Varian Medical
Roche’s hopes of extending the use of its PD-L1 inhibitor Tecentriq in triple-negative breast cancer (TNBC) have been dashed by a late-stage trial failure looking at the drug in combination with chemotherapy. Adding Tecentriq to treatment with paclitaxel as a first-line treatment for TNBC patients… Read More »Roche’s Tecentriq flunks triple-negative breast cancer trial
Pfizer has taken a big step towards positioning Lorbrena as a worthy heir to its big-selling Xalkori drug in lung cancer, after beating its parent in a phase 3 trial. The CROWN trial pitted Lorbrena (lorlatinib) against Xalkori (crizotinib) in patients with previously-untreated ALK-positive non-small… Read More »Will new data make Pfizer’s Lorbrena a ‘no-brainer’ in early lung cancer?
Blenrep, an antibody-drug conjugate, is the first drug approved for multiple myeloma that targets the antigen BCMA. Several other companies are also developing BCMA-targeting therapies for the blood cancer, including CAR-T cells and bispecific antibodies.
The FDA has approved GlaxoSmithKline’s multiple myeloma drug Blenrep, a first-in-class potential blockbuster that will be used in advanced disease. Blenrep (belantamab mafodotin) has been approved in patients who have received at least four therapies including an anti-CD38 such as Darzalex, a proteasome inhibitor and… Read More »FDA approves GSK’s Blenrep for advanced multiple myeloma
The company said the study of Kymriah in follicular lymphoma met its primary endpoint, though it did not disclose the trial data. It plans to submit approval applications to the FDA and EMA next year.
Amplified Sciences emerged as the winner of the diagnostics track for the MedCity INVEST conference’s Pitch Perfect contest with PanCystPro, the test it is developing to address the problems encountered when determining whether pancreatic cysts are cancerous.
The FDA approved Monjuvi for second-line diffuse large B-cell lymphoma. Though the drug has the same antigen target as approved CAR-T cell therapies, it is designed for patients unable to tolerate such intensive treatments.
Incyte and Morphosys’ Monjuvi antibody therapy has been approved for certain patients with lymphoma, as the companies hope to provide a more convenient alternative to expensive and cumbersome CAR-T therapy. At the beginning of the year Incyte paid $750m to Morphosys for the CD-19 targeting… Read More »Incyte/Morphosys take on CAR-Ts as lymphoma antibody Monjuvi approved in US
Roche’s tumour-agnostic therapy Rozlytrek has been approved in the European Union for people with tumours with the NTRK mutation, meaning Bayer’s class rival faces competition in Europe for the first time. Last September Bayer’s Vitrakvi became the first NTRK inhibitor class drug approved in Europe… Read More »Roche’s NTRK tumour-agnostic therapy Rozlytrek approved in Europe
Regeneron and Sanofi’s PD-1 inhibitor Libtayo will be tested in tandem with a cancer vaccine developed by BioNTech in melanoma in people who have failed treatment with other checkpoint inhibitors. The two companies will carry out a phase 2 trial of Libtayo (cemiplimab) alongside BioNTech’s… Read More »Regeneron pairs with BioNTech on melanoma immunotherapy
NICE has said a combination of Merck KGaA’s Bavencio and Pfizer’s Inlyta should be available as a first line option for kidney cancer patients for NHS patients in England. The cost-effectiveness body okayed interim reimbursement from the Cancer Drugs Fund (CDF) in final guidance for… Read More »NICE backs kidney cancer combination from Merck KGaA and Pfizer
Roche’s checkpoint inhibitor Tecentriq has been cleared for another new use in the US – in melanoma – but could struggle to displace rival drugs from Bristol-Myers Squibb and Merck & Co. The FDA has approved the PD-L1 inhibitor as a combination with two targeted… Read More »Roche’s Tecentriq claims melanoma OK, but don’t expect a sales surge
Bristol-Myers Squibb and bluebird bio have refiled their CAR-T therapy for multiple myeloma, leaving the outcome of a three drug “bet” with former Celgene shareholders dependent on a fast review from the FDA. BMS gave Celgene’s shareholders a “Contingent Value Right” (CVR) to sweeten the… Read More »BMS ‘bet’ with Celgene shareholders in balance after CAR-T refile
AstraZeneca has beaten analysts’ expectations in its second quarter results, outshining its UK counterpart GlaxoSmithKline, which has been hit by disruption caused by the COVID-19 pandemic. AZ’s second quarter sales increased by 8% compared with the same period last year to just under $6.3 billion.… Read More »AstraZeneca beats expectations in Q2, while GSK struggles during pandemic
The study design is still being finalized, and the company is thus not yet divulging too many details. However, CEO David Daly said it would be significantly larger than the previous DETECT-A, multi-center and would include both men and women.
Shots: The US FDA has granted 510 (k) clearance to HealthMammo for boosting early detection of breast cancer in mammograms The tool utilizes the AI to prioritize and identify suspicious mammograms and is automatically sent to Zebra’s platform, where it gets processed and analyzed for… Read More »Zebra Medical Receives the US FDA’s Approval for its HealthMammo Mammography Tool
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 companies will share development and commercialization of DS-1062 in solid tumors. They already have a similar deal in place, the $6.9 billion agreement signed last year for another ADC, the HER2-positive breast cancer drug Enhertu.
GlaxoSmithKline is closing in on EU approval for its first-in-class BCMA-targeting drug Blenrep, after getting a green light from the EMA’s human medicines committee. Blenrep, based on the antibody-drug conjugate belantamab mafodotin, has been recommended for conditional approval by the CHMP in adult patients with… Read More »CHMP gives nod to GSK’s BCMA drug Blenrep for myeloma
AstraZeneca Signs an Agreement with Daichii Sankyo to Develop and Commercialize DS-1062 Worth Up to $6B
Shots: Daichii Sankyo to receive $1B as upfront of which $350M is due upon execution, $325M after 12mos. and $325M after 24 mos., ~$5B as contingent payment including $1B as regulatory milestones, and $4B as commercial milestones, making a total deal value up to ~6B… Read More »AstraZeneca Signs an Agreement with Daichii Sankyo to Develop and Commercialize DS-1062 Worth Up to $6B
AstraZeneca has begun a new agreement with Daiichi Sankyo to develop and market an antibody to treat cancer, worth up to $6 billion. The deal covers DS-1062, Daiichi Sankyo’s proprietary antibody-drug conjugate targeting trophoblast cell-surface antigen 2 (TROP2). AZ and Daiichi are already collaborating on… Read More »AstraZeneca inks $6bn cancer drug deal with Daiichi Sankyo
Sorrento to Acquire SmartPharm and Develop Pipeline of Gene-Encoded Therapeutic Antibodies Targeting COVID-19 and Cancer
Shots: Sorrento enters into letter of intent to acquire SmartPharm and develops pipeline of gene-encoded therapeutic Ab, initiating with Sorrento’s STI-1499 or COVI-GUARD, currently preclinical studies with an IND submission targeted for Aug’2020. The transaction is expected to be close in Aug’2020. The integration of… Read More »Sorrento to Acquire SmartPharm and Develop Pipeline of Gene-Encoded Therapeutic Antibodies Targeting COVID-19 and Cancer
European regulators have recommended a licence for Blueprint Medicines’ Ayvakyt (avapritinib), for adults with stomach tumours with certain mutations. Blueprint specialises in drugs that tackle cancers on the basis of the mutations they harbour, and has already had the drug approved by the FDA at… Read More »European regulators back Blueprint’s Ayvakyt for stomach tumours
What if we could look at cancer treatment from a completely fresh perspective? This is the philosophy GSK’s UK country medical head for oncology, John Fleming, wants to bring to the company as it rethinks its approach to cancer. Fleming joined Novartis in 2015, when… Read More »GSK’s John Fleming on rethinking oncology from the ground up
Roche has announced half-year results showing the COVID-19 pandemic affected sales of its key products, with currency headwinds also weighing on revenues. The Swiss pharma’s figures came shortly after its arch-rival Novartis conceded that it had hit similar problems as the pandemic meant fewer patients… Read More »Pandemic and currency headwinds hurt Roche in first half
As pharmaceutical ingenuity hits new heights, ensuring that patients gain access to innovative medicines requires a unique combination of evidence generation and communication Working with all stakeholders to generate evidence that communicates value, from early phase development to launch and reimbursement, is essential in therapy… Read More »Commercialising innovative new medicines
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
A new whitepaper from Medscape highlights the difficulties haematologists and oncologists face in keeping up with rapid developments in treatment. We speak to the company’s Katie Lucero and Victoria Harvey-Jones to find out how independent medical education is changing to help HCPs increase their confidence… Read More »How to increase haematologists’ and oncologists’ confidence with new treatments
Germany’s Merck KGaA has taken an option on a second cancer immunotherapy drug from its development deal with Anglo-American biotech F-star Therapeutics. The companies signed a deal to develop cancer immunotherapies in summer 2017, where Darmstadt-based Merck KGaA paid $115 million up front, agreeing to further payments during the first two years of… Read More »Merck KGaA takes second option from cancer immunotherapy pact with F-Star
Making treatment decisions is a tough choice for oncologists: a therapy might save or significantly extend one patient’s life but not deliver the desired outcome for another patient. Reaching this decision involves weighing a variety of data – from clinical trials to the patient’s medical… Read More »Clinical decision support tools will help oncologists manage complexity
Shots: NCCN and Pfizer have issued an open RFP that develop and validate enduring approaches to improve the safe, effective, and efficient adoption of biosimilars in oncology The RFP supports approaches to improve the processes related to biosimilar adoption in oncology. Letters of Intent are… Read More »NCCN Collaborates with Pfizer to Explore Adoption of Biosimilars in Oncology
NICE has recommended regular NHS funding for Astellas’ Xospata (gilteritinib) monotherapy for certain adult patients with acute myeloid leukaemia. In final draft guidance NICE said that the drug is recommended for relapse or refractory FLT3 mutation-positive AML, giving patients an alternative to chemotherapy and its unpleasant side effects. However because of… Read More »NICE backs NHS use for Astellas’ Xospata after rethink
Under the deal, Blueprint will additionally be eligible for more than $900M in milestone payments plus royalties for the RET inhibitor pralsetinib. The deal includes exclusive rights for Roche in ex-U.S. markets other than China and shared rights in the U.S.
What You Should Know: – The COVID-19 crisis has significantly impacted the patient care paradigm, and the ripple effects have altered patient behaviors and expectations, requiring a significant change in how life sciences companies engage with and support patients – Accenture surveyed 2700 patients about… Read More »COVID-19 Has Permanently Shifted Patient Behavior Towards Virtual Care
The company is currently running a Phase I study of its lead candidate, the antibody-drug conjugate VLS-101, in patients with lymphomas and leukemias. It has two additional antibody-drug conjugates and a bispecific antibody in preclinical development.
By CHADI NABHAN, MD, MBA, FACP “The goal for me and for my clinical and research colleagues is to put ourselves out of a job as quickly as possible”. This is how Mikkael Sekeres ends his book “When Blood Breaks Down” based on true stories… Read More »“When Blood Breaks Down”: It Can Break Your Heart