Category: Bayer

  • Bayer bails on $670m CAR-T partnership with Atara

    In February, Atara Biotherapeutics paused enrolment into a trial of a CAR-T cell therapy for mesothelioma after a patient death. Now, its partner Bayer has backed out of a partnership covering two mesothelin-directed CAR-Ts signed in 2020. Bayer licensed rights to the two CAR-Ts in a deal worth up to $670 million, including $60 million […]

  • Bayer reloads Leaps with €1.3 billion to step up investments in biotech innovation

    Bayer is committing another €1.3 billion to Leaps by Bayer, the company’s investment arm, to support additional investments in companies developing innovative technologies in healthcare and agriculture. In addition to backing companies developing cell and gene therapies, Leaps has also deployed its cash to startups developing artificial intelligence technologies for a range of applications.

  • Chasing rivals, Bayer files Nubeqa for new prostate cancer use

    Bayer has filed for approval to extend the use of its prostate cancer therapy Nubeqa as it tries to achieve labelling parity with rival drugs from Pfizer/Astellas and Johnson & Jonson, and fulfil its aim of €3 billion in peak sales for the drug. Nubeqa is already making headway in the market as a treatment […]

  • Astellas’ eyes filings for menopause drug fezolinetant after ph3 win

    Astellas looks to be in pole position to bring a new non-hormonal therapy for symptoms of menopause to market, after its candidate fezolinetant cleared a phase 3 safety study. The SKYLIGHT 4 was investigating the safety and tolerability of fezolinetant – an orally-active neurokinin-3 (NK3) receptor antagonist – over 52 weeks in women with vasomotor […]

  • EU clears Bayer’s chronic kidney disease drug Kerendia

    Bayer has claimed EU approval for Kerendia, its new drug for chronic kidney disease (CKD) in people with type 2 diabetes, as the company tries to build a role of the drug alongside rival therapies from AstraZeneca and Johnson & Johnson. The approval is based on the phase 3 FIDELIO-DKD trial, in which Kerendia (finerenone) […]

  • Bayer triples sales forecast for prostate cancer drug Nubeqa

    Bayer now says it expects to make €3 billion in sales for its prostate cancer treatment Nubeqa, up from an earlier estimate of €1 billion, after reviewing new data for the drug in metastatic hormone-sensitive tumours. The optimistic assessment of the revenue potential for androgen receptor inhibitor Nubeqa (darolutamide) follows the publication of the results […]

  • Oxurion reports stronger data for diabetic eye disease drug

    Belgian biotech Oxurion has revealed new data from a phase 2 trial of its plasma kallikrein inhibitor THR-149, in development for people with diabetic macular oedema (DME) who don’t respond to standard therapy. New results from the first of two stages in the KALAHARI study of THR-149 showed that patients treated with the drug had […]

  • FDA fast tracks Bayer’s oral anticoagulant asundexian

    The FDA has granted fast-track status to Bayer’s oral Factor Xia inhibitor asundexian, which is in phase 2 testing as an anticoagulant that could offer safety advantages over current drugs. Asundexian (also known as BAY2433334) will be given a speedy review by the US regulator as a secondary preventative treatment for people with ischaemic stroke, […]

  • Bayer’s pipeline takes a hit as it drops eliapixant

    Bayer has abandoned development of its investigational P2X3 receptor antagonist eliapixant, despite promising efficacy data in clinical trials, on what appears to be safety grounds. The decision comes right on the heels of the FDA’s rejection of Merck & Co’s rival oral P2X3 antagonist gefapixant, which was also attributed to concerns about the safety of […]

  • Bayer-led project on AI in trials eyes ‘virtual’ placebo groups

    Last year, Bayer launched a project to explore the use of artificial intelligence in clinical trials, working with Finland’s Aalto University to find ways to use the technology to support decentralised trials and streamline the testing process. Now, an extension of the work is starting that will see if AI can be used to reduce […]

  • 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 Eylea. The US regulator has given the green light to the bispecific antibody – now called Vabysmo – for both neovascular or ‘wet’ age-related macular degeneration (AMD) and diabetic macular […]

  • FDA stifles Merck’s cough drug gefapixant, asking for more data

    The FDA has issued a complete response letter (CRL) to Merck & Co’s gefapixant candidate for refractory chronic cough, delaying the programme and giving Bayer an opportunity to close the gap with its rival eliapixant drug. Gefapixant is still out in front in the non-narcotic, orally administered selective P2X3 receptor antagonist class – having secured […]

  • Pfizer, Bayer each strike up deals to add in-vivo gene editing to pipeline mix

    As the annual J.P. Morgan HealthCare Conference kicked off Monday, two pharma giants unveiled deals that expand give them access to in-vivo gene editing technologies. Pfizer is teaming up with Beam Therapeutics to develop new base-editing therapies while Bayer hopes to develop new medicines with the in-vivo CRISPR editing tools of Mammoth Biosciences.

  • Bayer trumpets $1bn CRISPR deal with Mammoth Bio

    Bayer has bolstered its cell and gene therapy platform by securing access to a CRISPR-based gene-editing platform developed by US biotech Mammoth Biosciences. The German group is paying $40 million upfront to kick off the alliance, which is focusing on the development of up to five CRISPR drugs that can be delivered in vivo for […]

  • Trial closes gap between Bayer’s Nubeqa and rivals in prostate cancer

    Bayer’s Nubeqa is making headway as a treatment for castration-resistant prostate cancer (CRPC), but could be on track to expand the eligible patient population for the drug thanks to new phase 3 data. Just released results from the ARASENS trial show that adding Nubeqa (darolutamide) to docetaxel chemotherapy and androgen deprivation therapy (ADT) to switch […]

  • Bayer, One Drop launch AI tool for heart disease prevention

    Bayer’s two-year-old digital health collaboration with One Drop has borne its first fruit, an artificial intelligence-powered software module for preventing cardiovascular disease (CVD). The German pharmaceutical company has been working with New York-based One Drop on digital health products that span multiple therapeutic areas, including oncology and women’s health as well as CVD in the […]

  • WTF Health: Inside the One Drop – Bayer Collaboration: New Cardiovascular Disease Product Is Just the Beginning

    By JESSICA DaMASSA, WTF Health Bayer’s $98M co-development-plus-investment in One Drop from August 2020 has yielded its first new product: a highly-personalized, AI-powered digital program aimed at preventing cardiovascular disease. While the solution itself is impressive in terms of its predictive analytics and integration into One Drop’s chronic condition precision health platform, what’s really remarkable […]

  • 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 regular injections into the eye. Susvimo has the same active ingredient as Roche’s big-selling therapy Lucentis (ranibizumab), a VEGF inhibitor administered once a month that has been approved by the […]

  • Bayer teams up with Huma to apply AI to lung cancer diagnosis

    A research project between Bayer and digital health company Huma will use artificial intelligence to detect lung cancer in CT scans – and determine which type a patient has, in order to direct treatment. AI is already being applied by a number of groups, with some studies indicating it can even be more effective than […]

  • 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, Approval, MDR Gram-Negative Bacterial Infections GE Healthcare to Acquire BK Medical for ~ $1.45B Published: Sept 24, 2021 | Tags: GE Healthcare, Acquire, BK Medical, ~ $1.45B Roche Presents Results […]

  • Bayer Signs a License and Research Agreement with Gubra to Develop Novel Peptide Therapeutics for Cardiorenal Diseases

    Shots: Gubra to receive ~ $253.4M as up front, development, and commercialization milestones The collaboration will combine Gubra’s peptide drug discovery capabilities with Bayer’s expertise to develop innovative medicines to treat cardiorenal diseases The collaboration also use Gubra’s streaMLine which is an ML based peptide drug discovery platform & is used for fast screening and […]

  • Bayer’s eliapixant hits the right notes in PAGANINI cough study

    Bayer has released the data in its phase 2b trial of eliapixant in refractory chronic cough, as it tries to close the gap with Merck & Co’s rival drug gefapixant. The drugmaker said last month that the PAGANINI study hit its main objective, which was to reduce the average cough frequency compared to placebo after […]

  • PharmaShots Weekly Snapshots (August 30 – September 03, 2021)

    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)

    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 […]

  • Insights+: The US FDA New Drug Approvals in July 2021

    The US FDA has approved 6 NDAs in 2021, 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 43 novel products in 2021 Additionally, last year in 2020, the US FDA has approved 121 […]

  • Novartis says trials back Beovu safety in diabetic eye disease

    There is plenty of evidence that Novartis’ ophthalmology drug Beovu can match its rivals when it comes to efficacy, with less frequent dosing, but the big question facing the company is whether it is less safe. Data from phase 3 trials of the drug in diabetic macular oedema (DMO) provide some encouragement for Novartis on […]

  • Novartis says trials back Beovu safety in diabetic eye disease

    There is plenty of evidence that Novartis’ ophthalmology drug Beovu can match its rivals when it comes to efficacy, with less frequent dosing, but the big question facing the company is whether it is less safe. Data from phase 3 trials of the drug in diabetic macular oedema (DMO) provide some encouragement for Novartis on […]

  • 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 Develop Allogeneic Cell Therapies for the Treatment of Cancer Published: Aug 6, 2021 | Tags: Kite, Appia, Allogeneic Cell Therapies, Cancer Polpharma & Bioeq Report BLA Submission to the US […]

  • Bayer to Acquire Vividion for ~$2B

    Shots: Vividion to receive $1.5B up front & $500M milestone while Bayer to get full rights to Vividion’s discovery platform which consists of chemoproteomic screening technology, a data portal, and a chemistry library. The transaction is expected to close in Q3’21 The acquisition will strengthen Bayer’s drug discovery capabilities & expand it into new modalities. […]

  • Bayer bolsters R&D platform with $2bn Vividion takeover

    Bayer headlined its second-quarter results this morning by unveiling a deal to buy Vividion Therapeutics, saying it will boost its ability to develop medicines against targets once considered “undruggable.” Bayer is paying $1.5 billion upfront to claim ownership of Vividion‘s drug discovery platform, which uses chemoproteomics to identify new binding sites on proteins and find […]

  • Chasing Merck & Co, Bayer builds case for cough drug eliapixant

    Bayer says its drug candidate for chronic cough – eliapixant – has hit the mark in a phase 2b trial, putting it in hot pursuit of Merck & Co’s gefapixant, which was filed for approval in March. The orally-active P2X3 receptor antagonist, also known as BAY1817080, hit the main objective of the study, which was […]

  • 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 and Regeneron’s market-leading Eylea. The US regulator will review the drug for both neovascular or ‘wet’ age-related macular degeneration (AMD) and diabetic macular oedema (DME), as well as diabetic retinopathy […]

  • FDA gives speedy review to Bayer’s Parkinson’s stem cell therapy

    Bayer subsidiary BlueRock Therapeutics has been granted a fast-track review by the FDA for DA01, its stem cell-based therapy for Parkinson’s disease which is currently in early-stage clinical testing. The FDA designation allows for benefits such as more frequent meetings and communication with the regulator during clinical development, and a truncated six-month review time. Those […]

  • PharmaShots Weekly Snapshots (July 12 – 16, 2021)

    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 […]

  • Bayer’s finerenone gets FDA nod for diabetic kidney disease

    Bayer’s big investment in time and money on the development of finerenone for chronic kidney disease (CKD) in diabetics has paid off with an FDA approval, although it could face stiff competition in the market.  The oral, non-steroidal mineralocorticoid receptor (MR) antagonist has been approved as Kerendia in the US – its first world market […]

  • 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 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 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: Vertex, CRISPR Therapeutics, CTX001, TDT, SCD, EMA 2021 AbbVie Reports Results of Four-Year Follow-Up Analysis in P-III CLL14 Trial for Venclyxto/Venclexta to Treat Chronic Lymphocytic Leukemia Published: June 11, 2021 […]

  • Bayer’s two-pronged cell/gene therapy assault on Parkinson’s enters clinic

    Bayer subsidiary BlueRock Therapeutics has dosed the first Parkinson’s disease patient in a phase 1 trial of its cell-based therapy DA01, which aims to replenish the neurons lost in people with the neurodegenerative disorder. At the same time, the German group’s Asklepios BioPharma (AskBio) unit has started recruiting patients for a phase 1b trial of […]

  • Bayer props up sagging radionuclide business with Noria acquisition

    Bayer has agreed to buy Noria Therapeutics and its subsidiary PSMA Therapeutics, adding to its pipeline of radionuclide drugs for cancer as sales of its lead product in the category – Xofigo – continue to decline.  Just over three years ago, Bayer was forced to concede that its blockbuster expectations for Xofigo (radium Ra 223 […]

  • Novartis halts three trials of Beovu eye drug on safety concerns

    Prospects for Novartis’ ophthalmology drug Beovu have taken another dive after the drugmaker reported toxicity issues in a new phase 3 trial in wet age-related macular degeneration (AMD). On the plus side, Beovu (brolucizumab) met its efficacy objectives in the MERLIN study, but that was offset by higher rates of inflammatory reactions in the eyes […]

  • PharmaShots Weekly Snapshots (May 24 – 28, 2021)

    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 […]

  • Bayer backs Ada Health’s symptom checker app in $90m financing

    Ada Health has received another endorsement for its app to help patients diagnose conditions from symptoms, raising an impressive $90 million in funding from investors including the venture capital arm of Bayer.  Leaps by Bayer was joined by Samsung Catalyst Fund, Vitruvian Partners, Inteligo Bank, F4 and Mutschler Ventures in the second-round financing of the […]

  • Bayer Seeks Approval of Larotrectinib for Advanced Solid Tumors in China

    Shots: The NDA submission is based on P-I study of adult patients, the P-II NAVIGATE trial in adult and adolescent patients and the P- I/II pediatric SCOUT trial. These trials evaluated Larotrectinib in 20+ different histologies of solid tumors with NTRK fusion The therapy is already approved in several countries under the brand name Vitrakvi, […]

  • PharmaShots Weekly Snapshots (May 10 – 14, 2021)

    AzurRx BioPharma Reports Positive Interim P-II Data of MS1819 + PERT for Cystic Fibrosis Patients with Severe Exocrine Pancreatic Insufficiency Published: May 14, 2021 | Tags: AzurRx BioPharma, P-II, MS1819, PERT, Cystic Fibrosis, Severe, Exocrine Pancreatic Insufficiency Goldfinch Bio Initiates P-I Clinical Trial of GFB-024 for the Treatment of Severe Insulin Resistant Diabetic Nephropathy Published: […]

  • 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 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 (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, Under 12 Tetra Bio-Pharma Initiates Additional Studies of ARDS-003 in Neuroinflammation and Antiviral Diseases Published: Mar 26, 2021 | Tags: Tetra Bio-Pharma, Initiates, Additional Studies, ARDS-003,  Neuroinflammation, Antiviral Diseases Immunai […]

  • The US FDA New Drug Approvals in January 2021

    The US FDA has approved 4 NDAs in Jan 2021, 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 4 novel products in 2021. Additionally, last year in 2020, the US FDA has approved […]

  • No cooling off for pharma digital transformation in 2021

    COVID-19 has already proved to be a digital accelerant for the pharmaceutical industry, sparking new ideas into life and lighting a fire underneath existing plans that had, in retrospect, yet to burn brightly. After a year in which the need for digital transformation in pharma reached white heat levels, the sector mustn’t cool off in […]

  • UK patient group warns COVID could limit access to Novartis’ new eye drug

    NICE has recommended regular NHS funding for Novartis’ long-acting eye drug Beovu (brolucizumab) in England and Wales – but a patient group warned that access could be limited until the pandemic recedes because of disruption to ophthalmology clinics. In final guidance NICE said trials have shown Novartis’ Beovu has similar efficacy in wet advanced macular […]

  • 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, 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 […]

  • FDA approves Bayer/Merck & Co heart failure drug

    Bayer and Merck & Co’s heart failure drug vericiguat has been approved by the FDA under the brand name Verquvo, in an increasingly competitive market. Verquvo has been approved to reduce risk of cardiovascular death and heart failure hospitalisation in adults with symptomatic chronic heart failure and ejection fraction less than 45%. The drug can […]

  • 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 ,US FDA’s, Breakthrough Designation for Patients , Chronic Spontaneous Urticaria Philips Collaborates with Merck KGaA to Advance Personalized Fertility Treatment Published: Jan 15, 2020 | Tags: Philips, Collaborates, Merck KGaA, […]

  • PharmaShots Weekly Snapshot (Jan 4-8, 2020)

    Almirall and Tyris Collaborate to Develop Next Generation Gene Therapies Published: Jan 7, 2020 | Tags: Almirall, Tyris, Collaborate, Develop, Next Generation, Gene Therapies Sarepta Reports Mixed Results of SRP-9001 (rAAVrh74.MHCK7.micro-dystrophin) in Part 1 of Study 102 for DMD    Published: Jan 7, 2020 | Tags: Sarepta, Reports, Mixed Results, SRP-9001, (rAAVrh74.MHCK7.micro-dystrophin), Part 1, Study 102, […]

  • Bayer Collaborates with CureVac for CVnCoV Against COVID-19

    Shots: Bayer to support the development, supply and key territory operations of CureVac´s COVID-19 vaccine candidate, CVnCoV and will contribute its expertise and established infrastructure in numerous area Curevac will be the MAH for the product while Bayer will support CureVac with country operations within the EU and additional markets. Additionally, Bayer has an option […]

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

    Biopharma merger and acquisition activity in 2020 was mainly filled with late-stage, bolt-on acquisitions, which were orders of magnitude smaller than the mega M&A deals of prior years. AstraZeneca holds the top rank by acquiring Alexion Pharmaceuticals among the top 20 acquisitions with a total deal value of $39B at a 1-day premium of 45% […]

  • Bayer joins the COVID-19 vaccine push, backing CureVac shot

    Shortly after launching large-scale trials of its COVID-19 vaccine candidate, CureVac has the partner it will need to roll the shot out at scale if it works as hoped. Bayer has joined forces with the German biotech to support the development and supply of CVnCoV, an mRNA candidate using a similar technology to the Pfizer/BioNTech […]

  • 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 biotech companies involved in M&A, option & licensing agreements, and gaining approvals. Our team has compiled a list of 30 most read life sciences news on PharmaShots in 2020. 1. […]

  • 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, Support, Suspected, Test, Testing, Volume Chugai In-Licenses Roche’s Antibody Cocktail for COVID-19 in Japan Published: Dec 10, 2020 | Tags: Casirivimab, Chugai, Commercialization, COVID-19, Development, Imdevimab, In-License Agreement, Japan, Roche, […]

  • Bayer Signs an Exclusive Worldwide License Agreement with Atara for Mesothelin-Targeted CAR T-cell Therapies to Treat Solid Tumors

    Shots: Atara to receive $60M upfront and ~$610M as development, regulatory & commercialization milestones + tiered royalties on net sales. The collaboration focuses on off-the-shelf T-cell immunotherapy ATA3271 and ATA2271 Atara will lead to IND and process development for ATA3271 and will continue to be responsible for P-I study of ATA2271 while Bayer will be […]

  • KaliVir, Astellas licensing deal; AbCellera’s IPO; Bayer CAR-T Cell therapy collab with Atara; Aligos, Merck together against NASH

    KaliVir, Astellas Pharma forms a licensing deal for VET2-L2 oncolytic virus KaliVir Immunotherapeutics and Astellas Pharma entered into a worldwide exclusive licensing agreement for the development, research, and commercialization of VET2-L2 to widen the horizon of therapeutic approaches available in the Immuno-Oncology market.  As its lead program, KaliVir is developing VET2-L2 leveraging its unique technology […]

  • 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 Lilly, Emergency Use Authorization, FDA’s, Incyte, receives, Remdesivir Novartis Signs a License Agreement with Mesoblast to Develop and Commercialize Remestemcel-L for ARDS Published: Nov 20,2020 | Tags: Agreement, ARDS, Commercialize, […]

  • Bayer to Fund Five New Startup Companies as Part of G4A Digital Health Partnerships Program

    Shots: The funding focuses on fostering the development of a digital health ecosystem in the fields of cardiometabolic and renal diseases, oncology, and women’s health Bayer G4A partnership program offers 2 digital health collaboration segments. Under its Growth Track, selected early-stage startups receive $118.29M funding to accelerate market uptake and tailored business acceleration clinics and […]

  • Bayer provides funding to five more digital health start-ups

    Bayer has provided funding to five more digital health start-ups as part of its G4A partnering programme, which has already provided backing for more than 150 companies since 2013. The latest crop of recipients in the G4A scheme were selected from more than 400 applications from companies in dozens of countries around the world and […]

  • PharmaShots Weekly Snapshots (Nov 09-13, 2020)

    Qiagen Launches Portable Digital SARS-CoV-2 Antigen Test in the US Published: Nov 13,2020 | Tags: Antigen Test, Digital, Launches, Portable, Qiagen, SARS-CoV-2, US GSK and Medicago Initiate P-II/III Study of its Plant-Derived COVID-19 Vaccine Published: Nov 13,2020 | Tags: COVID-19, GSK, Initiate, Medicago, P-II/III, Plant- Derived study, vaccine BD Acquires the Medical Business Assets of […]

  • Top 20 Animal Health Companies Based on 2019 Revenue

    Healthy animals contribute to the elimination of hunger and sustainable food production. The diseases that affect animal health also affect humans. Tackling them while they are present in animals not only safeguards our health, but it is also easier, more effective, and less expensive to address. Monitoring animal health and preventing animal disease outbreaks is […]

  • 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 cancer. Tecentriq (atezolizumab) can be used with Avastin (bevacizumab) for adults with advanced or unresectable hepatocellular carcinoma (HCC) who have not received systemic therapy. Approval is based on findings of […]

  • Bayer paying up to $4B for gene therapy pioneer AskBio

    The deal, offering $2 billion up front and $2 billion in future milestone payments, includes a gene therapy manufacturing facility and a pipeline that includes treatments for Parkinson’s and congestive heart failure.

  • Bayer Acquires Asklepios for ~$4B

    Shots: Bayer acquires AskBio for $2B as upfront and ~2B as milestones with 75% of the milestones to be paid during the next five years. The transaction is expected to be close in Q4’20 The focus of the acquisition is to foster Bayer’s cell and gene therapy platform with the potential to bring treatments to […]

  • Bayer buys cell & gene therapy firm AskBio for $4 billion

    Bayer is making clear its ambitions in cell and gene therapy with a $4 billion acquisition of US biotech Asklepios BioPharmaceutical, also known as AskBio. AskBio’s portfolio includes pre-clinical and clinical stage candidates for the treatment of neuromuscular, central nervous system, cardiovascular and metabolic diseases. Through the acquisition, Bayer will gain full rights to the […]

  • Bayer data for kidney disease hope finerenone sets up filings

    Bayer’s blockbuster ambitions for diabetic kidney disease (DKD) drug candidate finerenone look a lot firmer with the publication of data from the phase 3 FIDELIO-DKD trial. Bayer teased the top-line result from the study back in July, providing the first clue that its sizeable investment in the finerenone programme could pay off, but kept the […]

  • 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, Results, Vadadustat, P-lll, INNO2VATE Global Study, Anemia, Chronic Kidney Disease Sanifit Presents Results of SNF472 for the Treatment of Vascular Calcification at ASN Kidney Week 2020 Published: Oct 22, 2020 […]

  • Bayer and 111 Collaborate to Explore the Vast Blue Ocean of Online Healthcare in China

    Shots: The companies will collaborate on drug commercialization initiatives in China, including the commercialization of innovative drugs & healthcare products for chronic disease management, as well as providing reliable and convenient resources for patient education Bayer will leverage 111’s vast network of pharmacies and healthcare providers to enhance its channel management and patient outreach capabilities, […]

  • PharmaShots Weekly Snapshot (Oct 12-16, 2020)

    Novartis’s Luxturna (voretigene neparvovec) Receives Health Canada Approval as the First Gene Replacement Therapy for Inherited Retinal Disease Published: Oct 15, 2020 | Tags: approval, Canada, health, Inherited Retinal Disease, Luxturna, Novartis, receives, voretigene neparvovec Galapagos & Servier’s GLPG1972/S201086 Fails to Meet its Primary Endpoint in P-II ROCCELLA Study for Knee Osteoarthritis Published: Oct 15, […]

  • Amgen shares down as heart failure drug disappoints in phase 3 trial

    Shares in Amgen were down nearly 7% after close of trading yesterday after the company’s heart failure drug omecamtiv mecarbil disappointed in a large phase 3 trial. Take a look at Amgen’s portfolio and it becomes apparent how important this potential new drug is: the company is relying on its ageing inflammatory diseases drug Enbrel […]

  • PharmaShots Weekly Snapshot (Aug 24 -28, 2020)

    1. Taysha Gene Therapies’ TSHA-101 Receives the US FDA’s Orphan Drug Designation and Rare Pediatric Disease Designation for GM2 Gangliosidosis Published: Aug 27, 2020 | Tags:  Taysha Gene Therapies, TSHA-101, Receives, US, FDA, Orphan Drug Designation, Rare Pediatric Disease Designation, GM2 Gangliosidosis 2. Bayer Reports the NDA Submission to NMPA for Vericiguat to Treat Chronic […]

  • Bayer strikes $98m deal with digital health firm One Drop

    Bayer has taken a further stake in New York-based One Drop to support its plans to become a digital health business by developing new integrated care services for patients. The German pharmaceutical company will work with One Drop on digital health products that span multiple therapeutic areas, with Bayer citing oncology, cardiovascular diseases and women’s […]

  • Bayer and One Drop Collaborate to Develop Digital Therapies Across Multiple Therapeutic Areas

    Shots: The two partners will jointly enhance the existing platform utilizing One Drop’s know-how and capabilities of the One Drop platform and will co-develop digital health therapies across multiple therapeutic areas                One Drop will receive $98M financing, development fees and commercial milestones while in exchange Bayer will receive royalties on sales. In the future, Bayer […]

  • Bayer to Acquire KaNDy Therapeutics for Augmenting its Women’s Healthcare Portfolio

    Shots: KaNDy to receive $425M upfront, ~$450M milestones until launch followed by additional commercial milestones. The transaction is expected to be completed in Sept’2020 The acquisition will add KaNDy’s menopause drug to Bayer’s portfolio. KaNDy has published results of its NT-814 in P-IIb study that demonstrated positive results in mod. to sev. vasomotor symptoms due […]

  • Bayer adds menopause drug to pipeline with KaNDy acquisition

    Bayer is to buy UK-based KaNDy Therapeutics in a deal worth more than $800 million, adding the biotech’s menopause drug to its women’s health pipeline. Bayer will pay $425 million up front and potential milestone payments of up to $450 million until launch, followed by potential undisclosed “triple digit million” milestone payments once the drug […]

  • Bayer slides on €9.5bn loss caused by litigation, COVID-19 impact

    Bayer counted the cost of its expensive Roundup weedkiller settlement in the second quarter with a €9.5 billion net loss made worse by lower sales in its pharma and consumer health divisions. Group sales were down 2.5% to just over €10 billion, with pharma falling 8.8% to just under €4 billion, “weighed down” by COVID-19 […]

  • Roche’s NTRK tumour-agnostic therapy Rozlytrek approved in Europe

    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 and the first ever drug licensed to tackle tumours solely […]

  • PharmaShots Weekly Snapshot (Jul 27- 31, 2020)

     1.  Oxford Biomedica Signs Three Year Clinical Supply Agreement with Axovant to Manufacture and Supply AXO-Lenti-PD for Parkinson’s Disease  Published: Jul 31, 2020 | Tags: Oxford Biomedica, Signs, Three Year, Clinical Supply Agreement, Axovant, Manufacture, Supply, AXO-Lenti-PD, Parkinson’s Disease 2.  Johnson & Johnson Initiates P-I/IIa Study of its Ad26.COV2.S Against COVID-19 in the US and Belgium […]

  • PharmaShots Weekly Snapshot (Jul 20- 24, 2020)

     1.  Gilead and Galapagos’ Jyseleca (filgotinib) Receive the CHMP’s Positive Opinion for Moderate to Severe Rheumatoid Arthritis  Published: Jul 24, 2020 | Tags: Gilead, Galapagos, Jyseleca, filgotinib, Receive, CHMP, Positive Opinion,  Moderate, Severe, Rheumatoid Arthritis 2.  Synaffix Expands its Existing Collaboration with ADC Therapeutics to Explore Two Additional Programs Published: Jul 24, 2020 | Tags: Synaffix, Expands, […]

  • PharmaShots Weekly Snapshot (Jul 13- 17, 2020)

     1.  Eli Lilly Reports Results of Mirikizumab in P-III OASIS-2 Study to Treat Moderate to Severe Plaque Psoriasis Published: Jul 17, 2020 | Tags: Eli Lilly, Reports, Results, Mirikizumab, P-III, OASIS-2, Study, Treat, Moderate, Severe, Plaque Psoriasis 2.  Oncorus Initiates P-I Study of ONCR-177 in Patients with Advanced / Refractory Cutaneous Subcutaneous or Metastatic Nodal Solid […]

  • FDA grants fast review for Bayer/Merck & Co’s heart failure drug

    The FDA has granted a faster Priority Review for Bayer and Merck & Co’s filing for vericiguat, which is being developed for chronic heart failure with reduced ejection fraction, following a previous heart failure event.  US-based Merck, known as MSD outside North America, has been developing vericiguat with ejection fraction less than 45% following a worsening heart failure […]

  • Merck and Bayer Receive the US FDA’s Priority Review for Vericiguat to Reduce the Risk of CV Death in Patients with Symptomatic Chronic Heart Failure with HFrEF

    Shots: The NDA is based on P-III VICTORIA study assessing vericiguat (qd, (titrated up to 10mg) vs PBO when given in combination with available HF therapies in ~5,050 patients with worsening CHF, reduced left VEF of <45% within 12mos. prior to randomization following a decompensation event The 1EPs is the composite of time to the […]