Bayer

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 …

Trial closes gap between Bayer’s Nubeqa and rivals in prostate cancer Read More »

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 …

Bayer, One Drop launch AI tool for heart disease prevention Read More »

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 …

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

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 …

FDA clears Roche’s Susvimo implant for eye disease wet AMD Read More »

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 …

Bayer teams up with Huma to apply AI to lung cancer diagnosis Read More »

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 …

PharmaShots Weekly Snapshots (September 20 – 24, 2021) Read More »

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 Signs a License and Research Agreement with Gubra to Develop Novel Peptide Therapeutics for Cardiorenal Diseases Read More »

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 …

Bayer’s eliapixant hits the right notes in PAGANINI cough study Read More »

Bayer Reports Results of Eliapixant in P-IIb PAGANINI Study for Patients with Refractory Chronic Cough

Shots: The P-IIb PAGANINI study involves assessing the efficacy, safety & tolerability of eliapixant (25, 75 or 150mg, bid) vs PBO in 310 patients with RCC for 12wks. and it lasted for 18wks. in total The study met its 1EPs i.e. reduction in the 24hrs. cough count of up to 27% with 75mg dose and …

Bayer Reports Results of Eliapixant in P-IIb PAGANINI Study for Patients with Refractory Chronic Cough Read More »

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) Read More »

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) Read More »

Bayer Initiates P-III OASIS Program of Elinzanetant for the Treatment of Vasomotor Symptoms During Menopause

Shots: The company initiates P-III OASIS program to evaluate the efficacy and safety of elinzanetant (120mg, qd) in 1300 patients with vasomotor symptoms during menopause at 200+ centers across 20+ countries The design and dosing of the P-III clinical development program is based on the results from two P-II studies i.e., P-Ib/IIa RELENT-1 & P-IIb …

Bayer Initiates P-III OASIS Program of Elinzanetant for the Treatment of Vasomotor Symptoms During Menopause Read More »

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 …

Insights+: The US FDA New Drug Approvals in July 2021 Read More »

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 Read More »

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 Read More »

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 …

PharmaShots Weekly Snapshots (Aug 02 – 06, 2021) Read More »

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 to Acquire Vividion for ~$2B Read More »

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 …

Bayer bolsters R&D platform with $2bn Vividion takeover Read More »

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 …

Chasing Merck & Co, Bayer builds case for cough drug eliapixant Read More »

Bayer Reports Results of Eliapixant (BAY1817080) in P-IIb Study for the Treatment of Refractory Chronic Cough

Shots: The P-IIb clinical trial involves evaluating the efficacy and safety of eliapixant (25/75/150mg, PO, bid) vs PBO in 300 patients with refractory chronic cough for 12wks. The trial met its 1EPs that showed an improvement in 24hrs. cough counts @12wks. of treatment. The results showed a favorable safety and tolerability profile of the therapy …

Bayer Reports Results of Eliapixant (BAY1817080) in P-IIb Study for the Treatment of Refractory Chronic Cough Read More »

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 starts review of Roche’s eye disease drug, setting up 2022 verdict Read More »

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 …

FDA gives speedy review to Bayer’s Parkinson’s stem cell therapy Read More »

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 …

PharmaShots Weekly Snapshots (July 12 – 16, 2021) Read More »

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 …

Bayer’s finerenone gets FDA nod for diabetic kidney disease Read More »

Bayer’s Kerendia (finerenone) Receives the US FDA’s Approval for the Treatment of Chronic Kidney Disease Associated with Type 2 Diabetes

Shots: The approval is based on a P-III FIDELIO-DKD study evaluating finerenone (10/20mg) + SoC vs PBO + SoC in ~ 5700 patients with CKD & T2D. Patients were followed for a median of 2.6yrs. Results: reduction in the incidence of the primary composite EPs of a sustained decline in eGFR of ≥40%, reduction in …

Bayer’s Kerendia (finerenone) Receives the US FDA’s Approval for the Treatment of Chronic Kidney Disease Associated with Type 2 Diabetes Read More »

Bayer kidney disease drug gets FDA nod, pitting it against AstraZeneca, J&J meds

The FDA has approved Bayer’s Kerendia to treat chronic kidney disease in patients with type 2 diabetes. The drug is the first in its class, giving the pharma giant an alternative way to compete against medicines already marketed by AstraZeneca and Bayer.

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’ Key Highlights of Second Quarter 2021 Read More »

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 …

PharmaShots Weekly Snapshots (June 07 – 11, 2021) Read More »

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’s two-pronged cell/gene therapy assault on Parkinson’s enters clinic Read More »

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 …

Bayer props up sagging radionuclide business with Noria acquisition Read More »

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 …

Novartis halts three trials of Beovu eye drug on safety concerns Read More »

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 …

PharmaShots Weekly Snapshots (May 24 – 28, 2021) Read More »

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 backs Ada Health’s symptom checker app in $90m financing Read More »

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, …

Bayer Seeks Approval of Larotrectinib for Advanced Solid Tumors in China Read More »

Bayer’s BlueRock Therapeutics widens cell therapy scope to the eye under new pact

BlueRock Therapeutics, a Bayer subsidiary, is teaming up with Opsis Therapeutics and Fujifilm Cellular Dynamics in an R&D pact focused on developing stem cell therapies for eye diseases. BlueRock is paying its new partners $30 million up front to kick off the alliance.

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 (May 10 – 14, 2021) Read More »

Bayer Reports Results of Finerenone in P- III FIGARO-DKD CV Outcomes Study for Chronic Kidney Disease and Type 2 Diabetes

Shots: The P-III FIGARO-DKD study involves assessing the efficacy and safety of finerenone (10/20mg, PO, qd) + SoC vs PBO + SoC in ~7400 patients with CKD and T2D at 1,000+ sites across 47 countries globally The study resulted in meeting its 1EPs i.e reduction in the composite risk of time to the first occurrence …

Bayer Reports Results of Finerenone in P- III FIGARO-DKD CV Outcomes Study for Chronic Kidney Disease and Type 2 Diabetes Read More »

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 (Apr 12 – 16, 2021) Read More »

Bayer Reports Results of Aliqopa (copanlisib) + Rituximab in P-III CHRONOS-3 Study for Relapsed Indolent Non-Hodgkin’s Lymphoma

Shots: The P-III CHRONOS-3 study involves assessing Aliqopa (IV) + rituximab vs PBO + rituximab in 458 patients with relapsed iNHL in extending PFS who have received at least one or more lines of prior rituximab-containing treatment Results: @median follow-up of 19.2mos., mPFS (21.5 vs 13.8 mos.), ORR (80.8% vs 47.7%), CR (33.9% and 14.6%), …

Bayer Reports Results of Aliqopa (copanlisib) + Rituximab in P-III CHRONOS-3 Study for Relapsed Indolent Non-Hodgkin’s Lymphoma Read More »

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 …

PharmaShots Weekly Snapshots (Mar 22 – 26, 2021) Read More »

Bayer’s Vitrakvi Receives MHLW’s Approval for the Treatment of NTRK Fusion-Positive Advanced or Recurrent Solid Tumors

Shots: The approval is based on the P-III NAVIGATE trial in adult and adolescent patients and P- I/II pediatric SCOUT trial involves assessing Vitrakvi for NTRK fusion-positive advanced or recurrent solid tumors The P-III NAVIGATE trial showed ORR (65.2%), CR (16.9%), and P-I/II SCOUT trial showed ORR (88.9%), CR (22.2%). In general, the studies demonstrated …

Bayer’s Vitrakvi Receives MHLW’s Approval for the Treatment of NTRK Fusion-Positive Advanced or Recurrent Solid Tumors Read More »

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 …

The US FDA New Drug Approvals in January 2021 Read More »

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 …

No cooling off for pharma digital transformation in 2021 Read More »

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 …

UK patient group warns COVID could limit access to Novartis’ new eye drug Read More »

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 …

PharmaShots Weekly Snapshots (Jan 18 – 22, 2021) Read More »

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 …

FDA approves Bayer/Merck & Co heart failure drug Read More »

Bayer and Merck’s Verquvo (vericiguat) Receives the US FDA’s Approval to Treat Chronic Heart Failure

Shots: The approval is based on pivotal P-III VICTORIA trial involves assessing of Verquvo (2.5mg, 5mg & 10mg) vs PBO in 5,050 adult patients with symptomatic CHF and LVEF less than 45%, following a worsening HF event The study met the primary efficacy objective based on a time-to-event analysis & showed a 4.2% reduction in …

Bayer and Merck’s Verquvo (vericiguat) Receives the US FDA’s Approval to Treat Chronic Heart Failure Read More »

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 Snapshots (Jan 11 – 15, 2021) Read More »

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, …

PharmaShots Weekly Snapshot (Jan 4-8, 2020) Read More »

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 …

Bayer Collaborates with CureVac for CVnCoV Against COVID-19 Read More »

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

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

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

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 …

Bayer joins the COVID-19 vaccine push, backing CureVac shot Read More »

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’ Most Read News of 2020 Read More »

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, …

PharmaShots Weekly Snapshots (Dec 7-11, 2020) Read More »

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 …

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

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 …

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

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, …

PharmaShots Weekly Snapshot (Nov 16-20, 2020) Read More »

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 to Fund Five New Startup Companies as Part of G4A Digital Health Partnerships Program Read More »

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 …

Bayer provides funding to five more digital health start-ups Read More »

Bayer’s Finerenone Demonstrates Positive Outcomes in Patients with Chronic Kidney Disease and Type 2 Diabetes

Shots: The P-III FIDELIO-DKD study in CKD and T2D enrolled over 13,000 patients with early kidney damage and more advanced stages of kidney disease. The data were presented at the ASN Kidney Week 2020 and published in the NEJM based on which Bayer submitted finerenone for marketing authorization in the US and the EU Results: …

Bayer’s Finerenone Demonstrates Positive Outcomes in Patients with Chronic Kidney Disease and Type 2 Diabetes Read More »

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 …

PharmaShots Weekly Snapshots (Nov 09-13, 2020) Read More »

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 …

Top 20 Animal Health Companies Based on 2019 Revenue Read More »

Bayer Reports Regulatory Submission of Finerenone (BAY 94-8862) to the US and EU for CKD and T2D

Shots: The MAA submitted to the EMA and the NDA to the US is based on P-III FIDELIO-DKD study assessing finerenone (10/20mg, qd) + SOC vs PBO in ~5,700 patients with CKD and T2D Result: reduction in the combined risk of time to kidney failure; a decrease of eGFR (≥ 40%) from baseline @4wks. or …

Bayer Reports Regulatory Submission of Finerenone (BAY 94-8862) to the US and EU for CKD and T2D Read More »

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 …

Europe approves Roche’s Tecentriq liver cancer combination Read More »

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 buys cell & gene therapy firm AskBio for $4 billion Read More »

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 …

Bayer data for kidney disease hope finerenone sets up filings Read More »

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 …

PharmaShots Weekly Snapshot (Oct 19 – 23, 2020) Read More »

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, …

Bayer and 111 Collaborate to Explore the Vast Blue Ocean of Online Healthcare in China Read More »

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, …

PharmaShots Weekly Snapshot (Oct 12-16, 2020) Read More »

Bayer Report Results of Aliqopa (copanlisib) + Rituximab in P-III CHRONOS-3 Study for Relapsed Indolent Non-Hodgkin’s Lymphoma

Shots: The P-III CHRONOS-3 study involves assessing of Aliqopa + rituximab vs PBO + rituximab in 458 patients with relapsed indolent NHL who have received at least one or more lines of prior rituximab-containing treatment The P-II study met its 1EP of prolonged PFS, safety is consistent with previously published data on the individual components …

Bayer Report Results of Aliqopa (copanlisib) + Rituximab in P-III CHRONOS-3 Study for Relapsed Indolent Non-Hodgkin’s Lymphoma Read More »

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 …

Amgen shares down as heart failure drug disappoints in phase 3 trial Read More »

Triumvira Immunologics raises $55M in Series A funding round for new form of cancer cell therapy

The company hopes to use the money to bring its T-cell antigen coupler cell therapy technology – currently in preclinical development – into human clinical trials. German drugmaker Bayer’s venture capital arm led the round.

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 …

PharmaShots Weekly Snapshot (Aug 24 -28, 2020) Read More »

Bayer Reports the NDA Submission to NMPA for Vericiguat to Treat Chronic Heart Failure in China

Shots: The NDA submission was submitted to NMPA’s CDE and is based on P-III VICTORIA study, seeking regulatory approval of vericiguat in China In Oct’2014, Bayer and MSD signed a WW agreement for sGC modulators. The therapy is being jointly developed by both the companies as per the collaboration and has received the US FDA’s …

Bayer Reports the NDA Submission to NMPA for Vericiguat to Treat Chronic Heart Failure in China Read More »

The Bayer Deal: One Drop’s CEO on New $98M & How Data Science Will Fix Chronic Condition Care

By JESSICA DaMASSA, WTF HEALTH One Drop just landed a $98.7M deal with Bayer — and we got the details from CEO Jeff Dachis. The timing of this deal is nothing short of impeccable: less than a year after the life sciences giant led One Drop’s Series B with a $40M investment, and amidst a …

The Bayer Deal: One Drop’s CEO on New $98M & How Data Science Will Fix Chronic Condition Care Read More »

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 strikes $98m deal with digital health firm One Drop Read More »

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 and One Drop Collaborate to Develop Digital Therapies Across Multiple Therapeutic Areas Read More »

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 to Acquire KaNDy Therapeutics for Augmenting its Women’s Healthcare Portfolio Read More »

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 adds menopause drug to pipeline with KaNDy acquisition Read More »

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 …

Bayer slides on €9.5bn loss caused by litigation, COVID-19 impact Read More »

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 …

Roche’s NTRK tumour-agnostic therapy Rozlytrek approved in Europe Read More »

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 27- 31, 2020) Read More »

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 20- 24, 2020) Read More »

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 …

PharmaShots Weekly Snapshot (Jul 13- 17, 2020) Read More »

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 …

FDA grants fast review for Bayer/Merck & Co’s heart failure drug Read More »

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 …

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 Read More »

I believe Roundup gave me cancer. The Monsanto settlement is a slap in the face | Christine Sheppard

I have to inject myself with needles just to stay alive. Still, Bayer will continue to sell Roundup, and refused to label it as carcinogenic Last Wednesday was my 71st birthday, a low-key celebration in these Covid-19 times. Then I heard the news that the pharmaceutical conglomerate Bayer has offered a settlement to resolve several …

I believe Roundup gave me cancer. The Monsanto settlement is a slap in the face | Christine Sheppard Read More »