Eli Lilly made a late entry into the checkpoint inhibitor market when it licensed ex-China rights to Innovent’s sintilimab last year, and a new trial in lung cancer will raise its hopes of getting a good return on its investment. PD-1 inhibitor sintilimab has been shown to extend progression-free survival (PFS) in patients with EGFR-mutated …
Good news for Lilly as sintilimab hits the spot in lung cancer again Read More »
Bristol Myers Squibb’s Zeposia (ozanimod) Receives CHMP’s Positive Opinion for Adult Patients with Moderately to Severely Active Ulcerative Colitis Published: 15 Oct, 2021 | Tags: Bristol Myers Squibb, Zeposia, ozanimod, CHMP, Positive Opinion, Adult Patients with Moderately to Severely Active Ulcerative Colitis Gan & Lee Completes P-III Studies of GL-GLA for Patients with T1D & …
PharmaShots Weekly Snapshots (October 11 – 15, 2021) Read More »
BMS Reports EMA’s Validation of MAA for Relatlimab and Nivolumab as 1L Treatment for Unresectable or Metastatic Melanoma Published: Oct 1, 2021 | Tags: BMS, EMA, MAA, Relatlimab, Nivolumab, Metastatic Melanoma Merck and Ridgeback Report Interim Results of Molnupiravir in P-III MOVe-OUT Trial for the Treatment of COVID-19 Published: Oct 1, 2021 | Tags: Merck, …
PharmaShots Weekly Snapshots (September 27 – October 01, 2021) Read More »
The third quarter of 2021 highlights the approvals, clinical data & acquisitions. The new alliance observed in third quarter includes AzurRx signed a reverse triangular merger agreement to acquired First Wave Bio for ~$229M The key highlights of the big acquisition in this quarter includes Merck acquired Acceleron for ~$11.5B, Baxter acquired Hillrom for ~$10.5B, …
PharmaShots’ Key Highlights of Third Quarter 2021 Read More »
Shots: The P-III SURPASS-3 MRI sub-study evaluates the effects of tirzepatide (5/10/15mg, qw) vs titrated insulin degludec on LFC, VAT and ASAT in 296 patients with T2D for 52wks. The study met its 1EPs & 2EPs i.e., (-8.09% from 15.67% vs -3.38% from 16.58%) absolute reduction from baseline in LFC for 10 & 15 mg …
Any lingering hope that Pfizer’s may finally get a regulatory approval for its nerve growth factor (NGF) inhibitor tanezumab looks to have been dashed after the EMA’s human medicines committee rejected the drug. A positive recommendation was already looking like a long shot for after FDA advisors voted 15 to one against approval of the …
EU panel rejects Pfizer’s tanezumab for osteoarthritis pain Read More »
Shots: Twist to receive an up front for each program and $710M in clinical, regulatory, and commercial milestones for the multiple target discovery programs Boehringer Ingelheim obtains global exclusive rights to develop and commercialize any therapeutic Ab discovered under the collaboration The collaboration will utilize Twist’s Ab libraries that derived from human sequences to discover …
Shots: The designation is based on the P-III EMPEROR-Preserved trial evaluates the safety and efficacy of empagliflozin (10mg, qd) vs PBO in 5,988 patients with chronic HFpEF with/out diabetes The results demonstrated a 21% reduction in risk for the composite 1EPs of CV death or hospitalization for adults with HF. The results were presented at …
Forte’s FB-401 Fails to Meet Primary Endpoints in P-II Clinical Trial For the Treatment of Atopic Dermatitis Published: Sept 3, 2021 | Tags: Forte, FB-401, P-II, Clinical Trial, Atopic Dermatitis Novartis Cosentyx (secukinumab) Receives NICE Recommendation for Patients with Plaque Psoriasis Published: Sept 3, 2021 | Tags: Novartis, Cosentyx, secukinumab, NICE Recommendation, Plaque Psoriasis Pfizer …
PharmaShots Weekly Snapshots (August 30 – September 03, 2021) Read More »
Forte’s FB-401 Fails to Meet Primary Endpoints in P-II Clinical Trial For the Treatment of Atopic Dermatitis Published: Sept 3, 2021 | Tags: Forte, FB-401, P-II, Clinical Trial, Atopic Dermatitis Novartis Cosentyx (secukinumab) Receives NICE Recommendation for Patients with Plaque Psoriasis Published: Sept 3, 2021 | Tags: Novartis, Cosentyx, secukinumab, NICE Recommendation, Plaque Psoriasis Pfizer …
PharmaShots Weekly Snapshots (August 30 – September 03, 2021) Read More »
The FDA has concluded its safety review of Pfizer’s JAK inhibitor Xeljanz and Xeljanz XR, requiring revised warnings for the drugs as well as others in the class after finding evidence of elevated risks of serious heart-related events. After looking at the data from Pfizer’s long-term, post-marketing safety study – ORAL Surveillance – the US …
FDA firms up JAK inhibitor warnings after Xeljanz review Read More »
Shots: The P-III EMPEROR-Preserved trial evaluates the safety & efficacy of empagliflozin (10mg, qd) vs PBO in 5988 patients with chronic HFpEF The results demonstrated a 21% reduction in risk for composite 1EPs of CV death or hospitalization for HF. The 2EPs showed a 27% reduction in risk of first & recurrent hospitalizations for HF …
Eli Lilly is entering the field of protein-degrading drugs through a partnership with Lycia Therapeutics, a startup whose technology goes further than the first wave of such drugs. Lilly paid $35 million to begin the alliance, which spans up to five drugs.
Eli Lilly has bolstered its position the fast-emerging area of protein degrader drugs, agreeing a $1.6 billion-plus deal with Lycia Therapeutics spanning up to five drug targets. The drugmaker has looked close to home for its latest entry into the category, as Lycia’s founder Prof Carolyn Bertozzi has held a seat on its board of …
Lilly taps Lycia for protein degrader tech in $1.6bn deal Read More »
Janssen Presents Results of Rybrevant (amivantamab-vmjw) in P-I CHRYSALIS Study for Advanced NSCLC with METex14 Mutations at WCLC Published: Aug 20, 2021 | Tags: Astellas, FibroGen, Evrenzo, Roxadustat, EC, Approval, Symptomatic Anemia, Chronic Kidney Disease Astellas and FibroGen’s Evrenzo (roxadustat) Receive EC’s Approval for Symptomatic Anemia Associated with Chronic Kidney Disease Published: Aug 20, 2021 …
PharmaShots Weekly Snapshots (August 16 – 20, 2021) Read More »
Shots: The approval is based on the P-III EMPEROR-Reduced trial evaluating the effect of Jardiance (10 mg, qd) vs PBO in 3730 adults with HFrEF with/out T2D The results demonstrated a 25% reduction in the relative risk of the primary composite EPs of time to CV death or hospitalization for HF. The 2EPs demonstrated 30% …
Eli Lilly and Boehringer Ingelheim have claimed FDA approval for their diabetes therapy Jardiance in heart failure with reduced ejection fraction (HFreF), setting up a market tussle with AstraZeneca’s Farxiga. The US regulator has cleared a 10mg daily dose of Jardiance (empagliflozin) to reduce the risk of cardiovascular death plus hospitalisation for heart failure in …
Jardiance gets parity with Farxiga in US as FDA clears use in heart failure Read More »
Eli Lilly is one of the front runners in the bid to follow Biogen and Eisai onto the market with an anti-amyloid drug for Alzheimer’s disease, and its preparing the ground with a restructuring of its business units. As of 5 September, Lilly’s BioMedicines division will be split in two to form Lilly Neuroscience and …
With Alzheimer’s market opening up, Lilly forms neuroscience unit Read More »
Shots: The approval is based on P-III PRONTO-PUMP-2, a treat-to-target study that evaluates the efficacy & safety of Lyumjev (insulin lispro-aabc injection, 100 units/mL) vs Humalog (insulin lispro injection, 100 units/mL) in 432 adults in a ratio (1:1) with T1D for 16wks. The study met its 1EPs i.e., non-inferior A1C reduction from baseline @16wks. Lyumjev …
Eli Lilly had a lot riding on its two phase 3 trials of IL-13 inhibitor lebrikizumab in atopic dermatitis (AD) – and it now looks like it has backed a winner. The company has claimed across-the-board wins against primary and secondary measures of efficacy in the studies, and while the data hasn’t been revealed yet, …
Look out Dupixent, Lilly’s lebrikizumab is on the march Read More »
Junshi and Coherus’s Toripalimab Receive the US FDA’s Breakthrough Therapy Designation as 1L Treatment of Nasopharyngeal Carcinoma Published: Aug 13, 2021 | Tags: Junshi, Coherus, Toripalimab, US, FDA, Breakthrough Therapy Designation, Nasopharyngeal Carcinoma Celltrion’s Regdanvimab (CT-P59) Receives the ANVISA’s EUA for the Treatment of COVID-19 in Brazil Published: Aug 13, 2021 | Tags: Celltrion, Regdanvimab, …
PharmaShots Weekly Snapshots (Aug 09 – 13, 2021) Read More »
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 immunological disorders With the new advancement in immune sector, global pharmaceuticals continue to grow in the field despite the disruption during the COVID-19. As in 2019, Abbvie again secured the …
Top 20 Immunology Companies Based on 2020 Immunology Segment Revenue Read More »
After rejecting Eli Lilly’s Verzenio for breast cancer therapy earlier this year, NICE has relented, recommending the drug for routine NHS use alongside hormonal therapy fulvestrant. A final appraisal document from the health technology assessment (HTA) agency backs the use of Verzenio (abemaciclib) alongside fulvestrant for the treatment of women with hormone receptor-positive, HER2-negative breast …
NICE changes stance on Lilly’s breast cancer dug Verzenio Read More »
AstraZeneca’s Forxiga has become the first SGLT2 inhibitor to be approved in Europe for use in people with chronic kidney disease, extending its lead over rival drugs in the class. The European Commission has cleared Forxiga (dapagliflozin) for CKD in adults with or without diabetes, and the drug becomes the first new drug treatment for …
AZ gets European approvals for Forxiga in chronic kidney disease Read More »
Shots: The P-III ORIENT-11 study evaluates the efficacy & safety of sintilimab (200mg) + pemetrexed and platinum CT vs PBO + CT in 397 patients in a ratio (2:1) as 1L treatment for advanced or metastatic nonsq. NSCLC without sensitizing EGFR mutations or ALK rearrangements The results demonstrated an OS benefit with a median follow-up …
Eli Lilly and Incyte have another rival in the rear-view mirror for Olumiant in alopecia areata after Pfizer reported that its ritlecitinib improved scalp hair regrowth in a late-stage trial. In the phase 2b/3 ALLEGRO trial, JAK inhibitor ritlecitinib hit its primary objective of improving the area of scalp covered by hair in people with …
Lilly has a bad hair day as Pfizer rival hits the mark in alopecia Read More »
The FDA’s approval of Biogen’s Aduhelm for Alzheimer’s disease emboldened Eli Lilly to move forward plans to file its own candidate donanemab later this year, although it has acknowledged it will have to overcome reservations about anti-amyloid drugs. Lilly’s chief scientific officer Dan Skovronsky said on the company’s second-quarter results call that the results of …
Lilly sets out its stall on donanemab as filing approaches Read More »
In an interview with PharmaShots, Dr. Lotus Mallbris, M.D., Ph.D., Vice President of Immunology Development at Lilly shared her views on the abstracts demonstrating data on the use of Taltz and Olumiant in rheumatic diseases, including psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA) for Taltz, and rheumatoid arthritis (RA) for Olumiant. Shots: Lilly reported that key data from Taltz (ixekizumab) & Olumiant (baricitinib) is highlighted at the …
Eli Lilly is beginning a research alliance discovering and developing small molecules that stimulate immune responses against cancer. If drugs from the partnership reach the market, Kumquat could earn up to $2 billion in milestone payments.
Eli Lilly Signs an Agreement with Banner Alzheimer’s Institute to Evaluate Donanemab in P-III TRAILBLAZER-ALZ 3 Trial for Alzheimer’s Disease Published: July 16, 2021 | Tags: Eli Lilly, Banner Alzheimer’s Institute, Donanemab, P-III, TRAILBLAZER-ALZ 3 Trial, Alzheimer Disease AcelRx Signs a License Agreement with Aguettant to Commercialize Dzuveo in EU and for Two Pre-Filled Syringe …
PharmaShots Weekly Snapshots (July 12 – 16, 2021) Read More »
Shots: Eli Lilly to acquire Protomer Technologies for ~$1B, with the achievement of future development and commercial milestones Earlier, Lilly led an equity investment in Protomer along with JDRF T1D fund that provides Lilly with 14% ownership of promotor and is currently acquiring the remaining shares of Protomer beyond the initial investment The acquisition will …
Eli Lilly to Acquire Protomer Technologies for ~$1B Read More »
Eli Lilly has Protomer Technologies, a preclinical startup developing next-generation insulin that senses blood glucose levels and adjusts its activity accordingly. The technology could eliminate the need for multiple insulin injections throughout the day.
Eli Lilly bought a stake in Protomer Technologies and its glucose-sensing insulin platform last year, and it must like what it has seen in the programme since then – it has just agreed to buy the company outright. Pasadena, California-based Protomer is working on proteins that can sense molecular activators in the body and only …
Lilly grabs glucose-sensing insulin tech, buying Protomer in $1bn deal Read More »
Eli Lilly is partnering with startup Verge Genomics in a move intended to add ALS drugs to its neuroscience pipeline. To date, Verge’s artificial intelligence technology has produced programs internal programs in ALS, Parkinson’s, and frontotemporal dementia.
Boehringer Ingelheim and Eli Lilly have the results they were hoping for in a large-scale study of Jardiance therapy in heart failure with preserved ejection fraction (HFpEF), a form of chronic heart failure associated with high hospitalisation rates, poor quality of life and increased mortality. The results of the much-anticipated EMPEROR-Preserved trial found that SGLT2 …
Boehringer, Lilly hail Jardiance data in hard-to-treat heart failure Read More »
Two months after Eli Lilly began an alliance with MiNA Therapeutics, a startup developing a new type of RNA therapy, the pharmaceutical giant is making a $15 million equity investment in its partner. MiNA is developing a new class of medicines called small activating RNA therapies.
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 agreement with US Government for Molnupiravir to treat COVID-19 The big acquisition took place during the quarter including Microsoft acquired Nuance for ~$19.7B, MorphoSys acquired Constellation for ~$1.7B Our team …
PharmaShots’ Key Highlights of Second Quarter 2021 Read More »
A north-south divide has emerged in UK medicines access after the Scottish Medicines Consortium (SMC) okayed Kyowa Kirin’s Poteligeo for two rare blood cancers, a few weeks after the drug was turned in England by NICE. Poteligeo (mogamulizumab) has been backed by the SMC for adults living with mycosis fungoides (MF) and Sézary syndrome (SS), …
Scotland backs rare blood cancer drug Poteligeo rejected by NICE Read More »
Novo Nordisk is celebrating the FDA approval of its GLP-1 agonist semaglutide as a treatment for obesity, which it believes has the potential to redefine the market for weight-loss medicines. Already approved at a lower dose as Ozempic for treating diabetes, the new 2.4 mg once-weekly formulation – which will be sold as Wegovy – …
FDA ends 7-year obesity drug drought, clearing Novo Nordisk’s Wegovy Read More »
Novo Nordisk is celebrating the FDA approval of its GLP-1 agonist semaglutide as a treatment for obesity, which it believes has the potential to redefine the market for weight-loss medicines. Already approved at a lower dose as Ozempic for treating diabetes, the new 2.4 mg once-weekly formulation – which will be sold as Wegovy – …
FDA ends 7-year obesity drug drought, clearing Novo Nordisk’s Wegovy Read More »
Seelos’ SLS-005 (Trehalose) Receives EC’s Orphan Drug Designation to Treat Amyotrophic Lateral Sclerosis Published: May 28, 2021 | Tags: Seelos, SLS-005, Trehalose, EC, Orphan Drug Designation, Amyotrophic Lateral Sclerosis The US FDA’s EMDAC Supports Provention Bio’s Teplizumab in Delaying Diabetes Published: May 28, 2021 | Tags: US, FDA, EMDAC, Provention Bio, Teplizumab, Delaying Diabetes uniQure …
PharmaShots Weekly Snapshots (May 24 – 28, 2021) Read More »
Concert Pharmaceuticals has started the second of two planned phase 3 trials of its drug candidate for alopecia areata (AA), a common cause of hair loss, and says it hopes to report results in the second half of 2022. The two studies – THRIVE-AA1 and THRIVE-AA2 – are testing oral JAK1/2 inhibitor CTP-543 in adults …
Chasing Lilly, Concert eyes 2023 filing for its JAK drug for alopecia Read More »
Shots: Eli Lilly and Dicerna have reported the US FDA’s IND acceptance of LY3819469 to treat cardiometabolic diseases. The IND acceptance triggers $10M as a milestone to Dicerna under the companies’ 2018 research collaboration and licensing agreement LY3819469 is an investigational GalXC RNAi candidate targeting the LPA gene and is the second clinical-stage candidate to …
Eli Lilly to Initiate P-I Study of LY3819469 for Cardiometabolic Diseases Read More »
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 | Tags: BeiGene, Tislelizumab, CT, P-III, RATIONALE 309 Study, Recurrent, Metastatic Nasopharyngeal Cancer Aurinia to Present Results of Lupkynis (voclosporin) in AURORA 2 Continuation Study for Lupus Nephritis at EULAR …
PharmaShots Weekly Snapshots (May 17 – 21, 2021) Read More »
Eli Lilly has scored five out of five with its phase 3 trials of type 2 diabetes candidate tirzepatide, setting up regulatory filings for a drug that the drugmaker thinks could be the lynchpin of its franchise in the coming years. In SURPASS-4 – the last of Lilly’s registration studies for the dual GLP-1/GIP agonist …
Trial win sets up filings for Lilly’s diabetes blockbuster hope tirzepatide Read More »
Eli Lilly diabetes drug tirzepatide beat long-acting insulin in the last of a series of global studies designed to support regulatory submissions for the type 2 diabetes drug, a potential successor to blockbuster drug Trulicity. The Indianapolis-based drug giant said it expects to file for approval by the end of 2021.
The FDA has accepted Eli Lilly and China’s Innovent filing for their latecomer immunotherapy sintilimab, which is expected to compete on price with rivals such as Merck & Co’s Keytruda. The companies filed for approval for the PD-1 inhibitor in untreated nonsquamous non-small lung cancer in combination with pemetrexed and platinum chemotherapy. It’s the first …
FDA review of Lilly/Innovent’s sintilimab paves way for cut-price immunotherapy option Read More »
Shots: The submission is based on a P-III ORIENT-11 study assessing sintilimab (200mg) + pemetrexed and platinum CT vs PBO + CT as a 1L treatment for 397 patients in a ratio (2:1) with advanced or metastatic nonsq. NSCLC, with no sensitizing EGFR mutations or ALK rearrangements The anticipated PDUFA date for this application is …
UK biotech Arecor Therapeutics has announced plans to float on the London stock market, to fund plans to develop novel formulations of insulins and other biological drugs with enhanced properties. Based in Cambridge, Arecor has proprietary formulation technology and plans to licence out drugs to big pharma companies, looking for milestone payments and royalties as …
Arecor hopes London stock market float will raise profile of insulin products Read More »
UK biotech MiNA Therapeutics has signed up another big pharma partner for its small activating RNA (saRNA) platform, which upregulates the activity of proteins, with Eli Lilly the latest to get in on the action. While most RNA-based drugs are intended to reduce the activity of proteins that are over-expressed, saRNAs work in the opposite …
Lilly buys into MiNA’s protein-boosting RNA tech in $1.25bn deal Read More »
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 care for diabetes patients in markets outside the US The 4 companies will provide diabetes management platforms that are well-suited with Lilly’s Tempo Pen and Tempo Smart Button to help …
What We Should Know: – Glooko Inc., a provider of remote patient monitoring and data management solutions for diabetes and other chronic conditions announced a strategic collaboration with Eli Lilly and Company for people with diabetes that use Lilly’s connected insulin pen solutions. – The technology collaboration will ease insulin management for people with diabetes …
Glooko Integrates with Eli Lilly’s Connected Insulin Pen Solutions in Global Markets Read More »
AstraZeneca is already seeing sales rocket for its SGLT2 inhibitor Farxiga in heart failure, and is expected to gather even more momentum after claiming FDA approval in chronic kidney disease (CKD). The US regulator has cleared Farxiga (dapagliflozin) to reduce the risk of kidney damage, end-stage kidney disease, cardiovascular, death and hospitalisation for heart failure …
AstraZeneca’s Farxiga claims first SGLT2 kidney disease OK from FDA Read More »
Shots: The new analyses of the P-III BREEZE-AD5 trial and an extended safety analysis across multiple trials for Olumiant (2mg, qd) vs PBO in patients with AD showed improvements in the severity and extent of AD and patient outcomes, other key symptoms, and QoL as early as 1wks. Olumiant has also evaluated in patients with …
Eli Lilly has walked away from a major indication for its blockbuster hopeful mirikizumab, shelving plans to file it for psoriasis as the market is getting much too congested. The decision – announced in the company’s first-quarter results statement – comes shortly after Lilly reported positive phase 3 results with mirikizumab in ulcerative colitis. The …
Crowded psoriasis market cuts Lilly’s mirikizumab ambitions Read More »
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 Muscular Atrophy in Adults and Children Published: Apr 16, 2021 | Tags: Roche, Evrysdi (risdiplam), Receives, Health Canada, Approval, Spinal Muscular Atrophy, Adults, Children GSK Discontinues the P-II Trials of …
PharmaShots Weekly Snapshots (Apr 12 – 16, 2021) Read More »
Shots: Lilly to receive up front, milestones, as well as royalties on the products developed and commercialize by SciNeuro. Lilly retains all rights outside Greater China SciNeuro to get an exclusive license to develop and commercialize alpha-synuclein targeted therapies in Greater China includes mainland China, Hong Kong, Macau, And Taiwan Alpha-synuclein directed therapies help to …
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 »
In an interview with PharmaShots, Marie Schiller Vice President of Product Development for Connected Care and Insulins at Lilly shared her views on its collaboration with Welldoc to integrate Welldoc’s insulin management technology into Lilly’s connected insulin solutions. Shots: Lilly and Welldoc are teaming up to create a new version of Welldoc’s BlueStar app which will be …
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 Presents Results of Sotatercept in P-II PULSAR Trial for the Treatment of Pulmonary Arterial Hypertension, Published in NEJM Published: Apr 2, 2021 | Tags: Acceleron, Presents, Results, Sotatercept, P-II PULSAR …
PharmaShots Weekly Snapshots (Mar 29 – Apr 02, 2021) Read More »
Shots: The P-II BLAZE-4 study involves assessing bamlanivimab as monothx. and bamlanivimab (700mg) + VIR-7831 (500mg) vs PBO in 1000 participants with symptomatic low-risk COVID-19 in the outpatient setting across the US and Puerto Rico Results: The dual regimen met its 1EPs i.e. 70% relative reduction in persistently high viral load (> 5.27; cycle threshold …
Two antibodies targeting different parts of the COVID-19 virus spike protein, from Eli Lilly and GlaxoSmithKline/Vir Biotech, can cut viral load dramatically within a week. The BLAZE-4 trial found that co-administration of Lilly’s bamlanivimab – already granted emergency approval as a COVID-19 treatment – and GSK/Vir’s experimental antibody VIR-7831 reduced virus levels by 70% after …
Lilly and GSK/Vir antibody pairing offers resistant COVID-19 hope Read More »
Regeneron has posted findings from a large trial its COVID-19 antibody cocktail showing it reduced risk of hospitalisation or death by 70%. The US pharma said that the results were a landmark as they “conclusively” demonstrated that REGEN-COV (casirivimab+imdevimab) can significantly reduce death in an outpatient setting. Data from the phase 3 trial will also …
Regeneron’s antibody cocktail cuts COVID hospitalisation in large trial Read More »
After a long and troubled development the fate of Pfizer/Lilly’s tanezumab painkiller injection is in the balance ahead of a key meeting of advisers later this week. Safety has been an issue throughout development and in 2012 the FDA put tanezumab on clinical hold because of a class-related issue with joint destruction, which was finally …
FDA worried about Pfizer/Lilly pain drug safety ahead of key meeting Read More »
Takeda Collaborates with Anima to Discover and Develop mRNA Translation Modulators for Neurological Diseases Published: Mar 19, 2021 | Tags: Takeda, Collaborates, Anima, Discover, Develop, mRNA Translation Modulators, Neurological Diseases Kiniksa’s Arcalyst (rilonacept) Receives the US FDA’s Approval for the Treatment of Pericarditis Published: Mar 19, 2021 | Tags: Kiniksa, Arcalyst (rilonacept), Receives, US, FDA, …
PharmaShots Weekly Snapshots (Mar 15 – 19, 2021) Read More »
Takeda Collaborates with Anima to Discover and Develop mRNA Translation Modulators for Neurological Diseases Published: Mar 19, 2021 | Tags: Takeda, Collaborates, Anima, Discover, Develop, mRNA Translation Modulators, Neurological Diseases Kiniksa’s Arcalyst (rilonacept) Receives the US FDA’s Approval for the Treatment of Pericarditis Published: Mar 19, 2021 | Tags: Kiniksa, Arcalyst (rilonacept), Receives, US, FDA, …
PharmaShots Weekly Snapshots (Mar 15 – 19, 2021) Read More »
Shots: The P-II TRAILBLAZER-ALZ study involves assessing donanemab vs PBO in 272 patients with early symptomatic AD who were selected based on cognitive assessments in conjunction with amyloid plaque imaging and tau staging by PET imaging The study met its 1EPs, showed a slowing of decline by 32% @76wks. as measured by the iADRS. The …
The UK regulator has authorised Eli Lilly’s targeted cancer drug Retsevmo for tumours with RET fusion positive lung cancers and thyroid cancers, which the company said could herald a new era of genomic medicine for the NHS. The UK Medicines and Healthcare products Regulatory Agency (MHRA) granted conditional approval for Retsevmo (selpercatinib) as monotherapy for …
New era of genomic medicine begins as UK approves Lilly’s Retsevmo Read More »
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 Breakthrough Designation is granted to the drug candidates as monotherapy or in combination with other drugs intended to treat serious or life-threatening diseases and has shown substantial improvement over available …
Insights+: Breakthrough Therapy Designation by the US FDA in 2020 Read More »
Eli Lilly reported data from a second group in a Phase 3 study testing its combination antibody drug for Covid-19 showing that the treatment reduced the risk of hospitalization and death by 87%. That’s better than the data that supported the emergency authorization that the FDA granted last month.
With so many novel drug candidates for Alzheimer’s disease failing in clinical development, researchers in the US have started using artificial intelligence (AI) to screen already-approved therapies for activity against the neurodegenerative disorder. A team based at Massachusetts General Hospital and Harvard Medical School has come up with an AI algorithm – called DRIAD (Drug …
AI platform says Olumiant could be repurposed for Alzheimer’s Read More »
Last year, Belgium’s ExeVir Bio raised 23 million euros ($27 million) to finance development of llama antibodies – and now it is ready to begin clinical development of a potential treatment that could be effective against emerging COVID-19 variants. Regeneron and Eli Lilly have already got antibody therapies on the market following emergency approvals by …
ExeVir ready for clinic with variant-targeting llama antibody Read More »
The EMA’s human medicines committee has said two Eli Lilly antibodies are effective in people with COVID-19 who are at risk of developing severe disease, clearing the way for use in EU member states. The CHMP says bamlanivimab (LY-CoV555) can be given alone or administered together with etesevimab (LY-CoV016) to treat at-risk patients aged 12 …
EMA backs emergency use of Lilly’s COVID antibodies Read More »
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 and Incyte, Report, Results, Olumiant (baricitinib), P-III, BRAVE-AA2, Study, Severe, Alopecia Areata Takeda Reports NDA Submission to Import and Distribute Moderna’s mRNA-1273 in Japan Published: Mar 5, 2021 | Tags: …
PharmaShots Weekly Snapshots (Mar 01 – 05, 2021) Read More »
Eli Lilly’s JAK inhibitor Olumiant has become the first drug in the JAK inhibitor class to be recommended for NHS use in England and Wales as a treatment for atopic dermatitis, also known as eczema. Olumiant (baricitinib) has been backed by cost-effectiveness agency NICE to treat moderate to severe atopic dermatitis in adults who haven’t …
Lilly’s Olumiant is first JAK drug backed by NICE for eczema Read More »
Eli Lilly has become the latest drugmaker to have a go at developing RIP kinase inhibitors, a new class of drugs with potential in autoimmune and inflammatory disease, paying $125 million upfront for rights to a lead candidate from Rigel Pharma. Rigel’s clinical-stage R552 is the main asset in the deal – which also includes …
Lilly cuts a $960m deal with Rigel on RIP kinase Read More »
Eli Lilly is paying $125 million up front to team up with Rigel Pharmaceuticals on drugs that block a signaling protein involved in inflammation. With the alliance, Lilly joins Sanofi and Denali Therapeutics in the pursuit of drugs that block this protein.
“Patent losses could sink Allergan”.1 “Drug prices to plummet in wave of expiring patents”.2 “Price decay after loss of brand exclusivity”.3 These are just three headlines that come up when you Google “drug patent expiry”.4 It’s no wonder “loss of exclusivity (LOE)” or “the patent cliff” is an ominous prospect for drug manufacturers – shrouded …
Three strategies for managing loss of exclusivity successfully Read More »
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, US, FDA, EUA, Use, CLIA, Waived, Settings Takeda Collaborates with Ensoma to Accelerate Next-Generation In Vivo Gene Therapies Published: Feb 12, 2020 | Tags: Takeda, Collaborates, Ensoma, Accelerate, Next-Generation, Vivo Gene …
PharmaShots Weekly Snapshots (Feb 08 – 12, 2021) Read More »
The biopharma industry saw numerous deal terminations in 2020. Clinical and regulatory results, change in control limitations, and strategic reprioritizations were among the most common reasons for deal termination. Sanofi and Hanmi’s agreement in 2015 ranked first under which Hanmi regained WW rights to its protein/peptide discovery technology, lapscovery. The second position goes to the …
Top 20 Biopharma Deal Terminations of 2020 Based on Total Deal Value Read More »
The EUA for Eli Lilly brings to patients a second antibody cocktail, following the FDA’s fall authorization of an antibody combination from Regeneron Pharmaceuticals. Lilly is working with Amgen to ramp up manufacturing of its newly authorized therapy.
The FDA has granted an emergency licence for Eli Lilly’s COVID-19 antibody combination therapy, to reduce chances of high-risk patients progressing from mild to moderate disease to more severe symptoms that may need hospital treatment. The FDA granted an Emergency Use Authorization (EUA) covering patients aged 12 years and over for investigational bamlanivimab (LY-CoV555) 700 …
FDA grants emergency licence for Lilly’s COVID-19 antibody combo Read More »
Shots: The FDA authorized EUA for bamlanivimab (700 mg) and etesevimab (1400 mg) for the treatment of mild to mod. COVID-19 patients aged ≥12yrs. who are at high risk for progressing to severe COVID-19 and/or hospitalization The EUA is based on P-III BLAZE-1 trial in ≥1,000 COVID-19 patients showed 70% reduction in hospitalizations. Lilly plans …
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, Develop, Quantum Algorithm, Drug, Discovery, Development Janssen Reports Results of Amivantamab in P-I CHRYSALIS Study for Metastatic or Unresectable NSCLC and EGFR Exon 20 Insertion Mutations Published: Jan 29, 2020 …
US drugmaker Eli Lilly – still waiting for an FDA decision on one non-opioid pain drug – has just added another to its pipeline via a licensing agreement with Japan’s Asahi Kasei worth up to $410 million. Lilly is paying $20 million upfront for exclusive rights to AK1780, a P2X7 receptor antagonist in early-stage clinical …
Lilly adds to pain pipeline with Asahi Kasei licensing deal Read More »
US drugmaker Eli Lilly – still waiting for an FDA decision on one non-opioid pain drug – has just added another to its pipeline via a licensing agreement with Japan’s Asahi Kasei worth up to $410 million. Lilly is paying $20 million upfront for exclusive rights to AK1780, a P2X7 receptor antagonist in early-stage clinical …
Lilly adds to pain pipeline with Asahi Kasei licensing deal Read More »
Regeneron is considering an emergency filing for its antibody cocktail REGEN-COV to protect people against COVID-19 after early trial results showed it conferred 100% protection against symptomatic infection. The announcement came after Eli Lilly posted results from its rival antibody cocktail, showing hospitalisations were reduced by 70% in high-risk patients. Regeneron’s results are based on …
Regeneron and Lilly post new data backing COVID antibody cocktails Read More »
Shots: The P-II/III BLAZE-1 trial involves assessing of Bamlanivimab + Etesevimab (2800 mg) vs PBO in 1035 patients recently diagnosed with COVID-19 in the ambulatory setting The results demonstrated an 70% reduction in risk of COVID-19 related hospitalizations and deaths in high-risk patients and improvements in all 2EPs including reductions in viral load and accelerated …
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, Alunbrig, (brigatinib), Receives, MHLW, Approval,1L and 2L, Treatment, ALK+ Advanced or Recurrent NSCLC MTPA and Aquestive Sign a License and Supply Agreement for Exservan (riluzole) to Treat ALS in the …
PharmaShots Weekly Snapshots (Jan 18 – 22, 2021) Read More »
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 partnerships in 2020 Artios partnered with Merck with an option to license up to 8 oncology programs proving to be the highest valued deal of 2020 with a total deal …
Top 20 Life Sciences Deals of 2020 by Total Deal Value Read More »
Shots: The P-III BLAZE-2 COVID-19 prevention trial involves assessing bamlanivimab (4,200mg) vs PBO in residents and staff at skilled nursing and assisted living facilities. The 965 &132 COVID-19 negative & positive participants were included in the analysis of 1EPS & 2EPs for assessing prevention & in exploratory analyses respectively The results demonstrated an 80% reduction …
Always a big player in oncology, Eli Lilly has fallen behind some of its rivals when it comes to cancer immunotherapy, but a new R&D alliance with Dutch biotech Merus is further evidence of its fightback. Lilly is tapping into Merus’ expertise in bispecific antibodies, specifically antibodies that target cancer cells with one end of …
Lilly bolts on cancer bispecifics with $1.6bn Merus alliance Read More »
South Korea’s Celltrion has announced encouraging top-line results for its potential antibody therapy for COVID-19, with the first part of a phase 2/3 trial showing it could cut recovery times and chances of progression from moderate to more severe disease. Several other companies are also working on antibody therapies and Eli Lilly’s bamlanivimab gained an …
Celltrion closes in on COVID-19 antibody market after trial success Read More »
When Eli Lilly reported results for donanemab in Alzheimer’s disease earlier this week it was hailed as a rare win for the amyloid hypothesis, although there’s no shortage of candidates that have failed despite positive mid-stage trial results. Some analysts have intimated that given the small size of the study at just over 270 patients, …
Could Lilly’s donanemab readout in Alzheimer’s boost Biogen’s prospects? Read More »
Boehringer and Eli Lilly have moved closer to a heart failure indication for their SGLT2 inhibitor Jardiance, as the FDA starts a fast-track review of the drug in its first use beyond diabetes. The US regulator is looking at data from the EMPEROR-Reduced trial of Jardiance (empagliflozin), which found that the drug achieved a 25% …
Boehringer, Lilly’s Jardiance ties to match AZ’s Farxiga with heart failure label Read More »
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 »
Our planet is facing a major pandemic outbreak due to COVID-19 and health agencies are taking every measure to stop it. The COVID-19 virus has been named “SARS-CoV-2” (severe acute respiratory syndrome coronavirus and the disease it causes has been named “Coronavirus Disease 2019” (COVID-19). The outbreak of the respiratory disease was first detected in …
Insights+: COVID-19 Healthcare News Monthly Updates – December 2020 Read More »
The lawsuit follows action by at least a half-dozen drug companies to rein in what they see as waste and abuse in the program, overseen by the Department of Health and Human Services. Meanwhile, the Hospital plaintiffs have a potentially powerful ally in the person picked to head the department under the incoming Biden administration.
Eli Lilly has acquired Prevail, a biotech focusing on gene therapies for neurodegenerative diseases including Parkinson’s, in a deal potentially worth more than $1 billion. The big US pharma is to pay up to $1.04 billion to buy Prevail, paying $22.5 per share up front plus a $4 contingent value right (CVR) to sweeten the …
Lilly pays up to $1.04bn for neurology gene therapy biotech Prevail Read More »
Eli Lilly’s decision to throw large amounts of research dollars at its next-generation diabetes drug tirzepatide could be vindicated, according to its first phase 3 trial readout. Results from the phase 3 SURPASS trial showed tirzepatide led to a reduction in both blood sugar and body weight in adults with type 2 disease, compared with …
Lilly surges on positive phase 3 readout from diabetes contender Read More »
Eli Lilly’s buyout of Loxo Oncology last year has already yielded one approved drug, and it now has a path to market for a second after BTK inhibitor LOXO-305 after reporting promising data at the American Society of Haematology (ASH) meeting. Updated results from the phase 1/2 BRUIN trial suggest that LOXO-305 could become a …
ASH: Lilly builds case for its BTK drug LOXO-305 in lymphoma Read More »
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 for its Saragene COVID-19 2-Gene Multiplex Test Published: Nov 26, 2020 | Tags: approval, CDSCO, Co-Diagnostics JV CoSara, COVID-19 2-gene multiplex RT-PCR, India, Manufacture, receives, Saragene, Sell, Test PostEra Collaborates …
Regeneron’s antibody cocktail is the latest COVID-19 drug to receive Emergency Use Authorization in the US, becoming the first therapy of this kind to become available. The cocktail of casirivimab and imdevimab is still being investigated in trials but the FDA has enough data to grant a temporary licence while the pandemic continues. Formerly known …
Regeneron’s COVID-19 antibody cocktail gets US emergency licence Read More »
Doctors in the US are to get another option to treat COVID-19 after the FDA granted an Emergency Use Authorization (EUA) for Eli Lilly’s baricitinib. Baricitinib is the active ingredient in Lilly’s rheumatoid arthritis drug Olumiant and is the latest example of a drug being repurposed to combat COVID-19. Most of the drugs attempt to …
Lilly’s baricitinib granted US emergency use in COVID-19 Read More »
Shots: The EUA is based on ACCT-2 study assessing baricitinib (4mg, qd for 14 days or until hospital discharge) in combination with remdesivir vs PBO with remdesivir in hospitalized patients with/ out oxygen requirements Result: Median time to recovery from 8-7days (12.5% improvement), patients who progressed to ventilation (23% vs 28%), patients who died @day29 …
UK cost-effectiveness agency NICE has said that Eli Lilly’s Emgality can be made available through the NHS for migraine prevention, the second drug in the CGRP inhibitor class to achieve that milestone. The decision means that with two CGRP antibodies now cleared for migraine prevention, the first drug in the class to be approved in …
NICE backs Lilly’s Emgality for migraine, adding pressure on Novartis rival Read More »
Shots: Seed Therapeutics to receive $10M upfront, $10M equity investment, ~$780M as pre/clinical development, regulatory & commercial milestones along with royalties on net sales of products that emerges from the collaboration Seed utilizes molecular glue protein degradation technology to develop potential new therapies The agreement allows Seed to advance its platform to deliver new molecules …
Eli Lilly has said it will start shipping supplies of its COVID-19 drug bamlanivimab immediately, after claiming emergency-use authorisation (EUA) for the antibody. The AbCellera-partnered drug, previously known as LY-CoV555 or LY3819253, can be used to treat mild-to-moderate COVID-19 in patients 12 years and older, who are at high risk for progressing to severe disease …
Lilly to ship COVID-19 drug straight away after FDA green light Read More »
Eli Lilly’s chief information and digital officer (CIDO) Aarti Shah is leaving the company next year after 27 years at the company. Shah is retiring from a role that only became part of the drugmaker’s executive committee in 2017, reflecting the relatively late acknowledgement of the strategic value of information technology in the pharma industry. …
Lilly’s chief digital officer Aarti Shah announces retirement Read More »
Regeneron’s coronavirus antibody cocktail therapy against COVID-19, famously used to treat president Donald Trump, has hit a safety issue after independent safety experts recommended it should not be given to high-risk patients in a late-stage clinical trial. It’s the latest blow for antibody therapies against COVID-19 after Eli Lilly last week announced it won’t resume …
Regeneron’s COVID-19 antibody cocktail therapy hits safety problem Read More »
Our planet is facing a major pandemic outbreak due to COVID-19 and health agencies are taking every measure to stop it. The COVID-19 virus has been named “SARS-CoV-2” (severe acute respiratory syndrome coronavirus 2) and the disease it causes has been named “Coronavirus Disease 2019” (COVID-19). The outbreak of the respiratory disease was first detected …
Insights+: COVID-19 Healthcare News Monthly Updates – October 2020 Read More »
The US government said it will buy 300,000 doses of Eli Lilly’s COVID-19 therapy bamlanivimab for $375 million if the drug gets Emergency Use Authorisation (EUA) – despite the fact its effectiveness has been called into question. The initial agreement is for delivery over the two months following an EUA, and provides the option for …
US buys Lilly COVID antibody, as effectiveness questions remain Read More »
Eli Lilly says no more patients will be treated with its COVID-19 therapy bamlanivimab in a trial run by the US National Institute of Allergy and Infectious Diseases (NIAID), as results to date suggest it is unlikely to be effective. The ACTIV-3 study was comparing bamlanivimab (also known as LY-CoV555 or LY3819253) and placebo when …
NIAID drops Lilly antibody from ACTIV-3 COVID-19 trial Read More »
Shots: The companies present the findings from a new exploratory sub-analysis of the P-III EMPEROR-Reduced study demonstrating that Jardiance (empagliflozin) reduced the risk of adverse CV by 25% and kidney events by 50% in adults with HFrEF with/out diabetes regardless of CKD status at ASN Week 2020 In all patient cohorts participating in the EMPEROR-Reduced …
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 system and when the balance is disturbed, the disease can result. A lot of this work has importance in the development of new therapies and treatments that can handle or …
Top 20 Immunology Companies Based 2019 Immunology Segment Revenue Read More »
Eli Lilly is to buy the private biotech Disarm Therapeutics, which is working on a new class of disease-modifying drugs for neurological diseases, in a deal worth up to $1.36 billion. Massachusetts-based Disarm is focused on treatments for diseases caused by axonal degeneration, such as amyotrophic lateral sclerosis (ALS) and multiple sclerosis. Disarm has discovered …
Lilly to buy private biotech Disarm Therapeutics for up to $1.36bn Read More »
Shots: The independent DSMB recommended pausing the enrollment of the ACTIV-3 clinical trial. The trial is evaluating Lilly’s bamlanivimab (LY-CoV555, 7000mg) + remdesivir as a treatment for COVID-19 in hospitalized patients, and is sponsored by the NIAID Lilly trusts the judgment & supports independent DSMB decisions to exercise caution in ensuring the safety of the …
Eli Lilly Pauses Enrollment in ACTIV-3 Clinical Trial Due to Safety Concerns Read More »
Eli Lilly’s Olumiant (baricitinib) has a significant effect on recovery from COVID-19 when combined with Gilead Veklury (remdesivir), according to a large trial backed by funding from the US government. The findings came from additional safety and efficacy data harvested from the US National Institute of Allergy and Infectious Diseases’ (NIAID) ACCT-2 trial. Results in …
Eli Lilly and Gilead’s combination cuts COVID-19 recovery time Read More »
Eli Lilly has asked the FDA for an Emergency Use Authorization for its COVID-19 antibody therapy, after announcing new efficacy data from an ongoing trial. It’s been a big week for this class of therapies – Regeneron’s antibody cocktail was famously used to treat president Donald Trump’s illness and GlaxoSmithKline is expanding research into its …
Lilly asks FDA for emergency clearance for COVID-19 antibody therapy Read More »
Shots: Eli Lilly reports additional data on its SARS-CoV-2 neutralizing Ab programs including interim data on combination therapy in diagnosed patients with mild-to-mod. COVID-19 and plans to make therapies available to patients The new analysis P-II BLAZE-1 study assessing LY-CoV555 (2800mg) + LY-CoV016 (2800mg) vs PBO demonstrated reduced viral [email protected] meeting its 1EPs, reduction in …
Eli Lilly Seeks the US FDA’s EUA for its COVID-19 Antibody Treatment Read More »
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 launched the drug there together last year as a third-line …
Latecomer Lilly throws cash at Innovent PD-1 partnership Read More »
1. Roche’s Evrysdi (risdiplam) Receives the US FDA’s Approval for SMA in Adults and Children Published: Aug 10, 2020 | Tags: Roche, Evrysdi, risdiplam, Receives, US, FDA, Approval, SMA, Adults, Children 2. The US FDA Approves Guardant360 CDx as the First Liquid Biopsy NGS Assay to Identify EGFR Mutations in Non-Small Cell Lung Cancer Published: Aug 07, …
Shots: The NMPA has accepted the sNDA for Tyvyt (sintilimab) in combination with Gemzar (gemcitabine) and platinum as 1L therapy in sq. NSCLC The sNDA is based on P-III ORIENT-12 study assessing sintilimab (200mg) vs PBO in combination with Gemzar and Pt (q3w for up to 4 or 6 cycles), followed by either sintilimab or …
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 with Cyramza, a VEGFR2 antagonist already approved in several types …
Pieris begins gastric cancer combination trial with Lilly’s Cyramza Read More »
Denmark’s Novo Nordisk has beaten profit forecasts in the second quarter after overcoming tough conditions in the diabetes market by improving its productivity. Novo said that COVID-19 has begun to affect sales, with fewer new starts as a result of social distancing measures. The company’s diabetes care products saw an increase in sales during the …
Novo Nordisk beats Q2 profit forecasts by cutting costs Read More »
Shots: Eli Lilly initiates P-III BLAZE-2 study assessing LY-CoV555 to prevent SARS-CoV-2 infection and COVID-19 in residents and staff at long-term care facilities in the US (skilled nursing facilities, commonly referred to as nursing homes, and assisted living facilities) The company will enroll up to ~2400 patients and test whether a single dose of LY-CoV555 …
While the world waits an effective coronavirus vaccine, Eli Lilly has started late-stage human testing an antibody drug as an alternative way to prevent viral transmission in high-risk locations. The US drugmaker is testing the antibody – called LY-CoV555 and developed in collaboration with Canadian biotech AbCellera – in a phase 3 trial to see …
Lilly’s antibody for COVID-19 protection starts nursing home trial Read More »
The FDA’s approval of AstraZeneca’s SGLT2 inhibitor Farxiga in heart failure was a first for the class, but Boehringer Ingelheim and Eli Lilly are closing the gap with a positive pivotal trial for their rival drug Jardiance. Top-line data from the phase 3 EMPEROR-Reduced study have shown that Jardiance (empagliflozin) beat out placebo on the …
Study puts Jardiance in hot pursuit of AZ’s Farxiga in heart failure Read More »
Shots: The P-III EMPEROR Trial involves assessing of Jardiance (10 mg) vs PBO in two studies EMPEROR-Reduced [NCT03057977, N=3,730] & EMPEROR-Preserved [NCT03057951, N=5,990] in patients with HFrEF & HFpEF respectively The EMPEROR-Reduced study meets its 1EPs in reducing the risk for the composite of cardiovascular death or hospitalization due to heart failure while the overall …
Shots: The study involved 1402 patients across 3 cohorts: a) 81 patients in Arizona (34 with AD and 47 without), b) 699 in Sweden (301 with no cognitive impairment, 178 with mild cognitive impairment, 121 with AD dementia and 99 with other neurodegenerative diseases) and c) 622 in Colombia (365 with E280A mutations and 257 …
Shots: Chi-Med to receive 70%-80% of Elunate sales in the form of royalties, manufacturing costs and service payments with no upfront regarding this amendment. Lilly will maintain the exclusive commercialization rights and will continue to consolidate the sales of Elunate in China while Chi-Med retains all rights to fruquintinib outside of China The agreement allows …
The US FDA has approved multiple NDAs and BLAs in Jun 2020, leading to treatments for patients and advances in the health care industry. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 51 novel products so far in 2020, including 8 in Jun 2020. Additionally, …
Insights+ Exclusive: The US FDA New Drug Approvals in June 2020 Read More »
Eli Lilly is a latecomer in the new generation of biologic therapies for psoriasis with its mirikizumab candidate, but a win in a head-to-head trial against Novartis’ big-selling Cosentyx could help close the gap. The pivotal trial with anti-IL-23 antibody mirikizumab – OASIS-2 – delivered a significant improvement over placebo at 16 weeks, achieving its …
Lilly’s mirikizumab tops Novartis’ blockbuster Cosentyx in psoriasis Read More »
Shots: The P-III OASIS-2 study involves assessing mirikizumab vs PBO & Cosentyx (secukinumab) in 1,465 patients with mod. to sev. PsO. The patients were randomized in a (4:4:4:1) ratio to one of the following induction and maintenance period treatments: mirikizumab (250mg) @ 0, 4, 8, 12wks. followed by 250 & 125mg, q8w starting @16wks; 300mg …
Shots: The second P-III LIBRETTO-531 involves assessing of selpercatinib vs physician’s choice of cabozantinib or vandetanib in 400 patients in ratio (2:1) with advanced or metastatic RET-mutant MTC who have received no prior systemic therapy for metastatic disease The study will have efficacy endpoints as progression-free survival (PFS), treatment failure-free survival (TFFS), overall survival (OS), …
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