Boehringer Ingelheim

Boehringer, Seqster team-up on patient-centric, real-world studies

Seqster has attracted another pharma partner for its patient data technology, which aims to improve care through better access and understanding of patient-level real-world data (RWD). Boehringer Ingelheim has signed a three-year agreement with the US startup for its Seqster operating system (SeqsterOS) and Digital Front Door platform, a portal that gathers together a patient’s …

Boehringer, Seqster team-up on patient-centric, real-world studies Read More »

Boehringer takes on antimicrobial resistance with Evotec, bioMérieux JV

A Franco-German joint venture company – Aurobac Therapeutics – has been formed to try to tackle the rising threat of antimicrobial resistant (AMR) infections. The JV has been formed German pharma companies Boehringer Ingelheim and Evotec with in vitro diagnostics specialist bioMérieux, with the objective of developing new antimicrobial drugs backed by diagnostics to quickly …

Boehringer takes on antimicrobial resistance with Evotec, bioMérieux JV Read More »

Boehringer takes option on masked cytokine specialist Trutino

Boehringer Ingelheim must like what it has seen in its two-year-old R&D collaboration with Trutino Biosciences to develop cytokine therapies – it has just taken an option to buy the company outright. The German pharma group originally teamed up with San Diego-based Trutino on a project to apply its drug discovery and development platform to …

Boehringer takes option on masked cytokine specialist Trutino Read More »

Boehringer sells drug safety software to ArisGlobal

German drugmaker Boehringer Ingelheim has sold an artificial intelligence-powered software platform it developed to monitor drug safety data to ArisGlobal, which provides cloud software to life sciences companies. The platform – called BRASS (Benefit-Risk Analytic System) – was developed by Boehringer to unlock hidden patient safety signals from large data sets, and will be layered …

Boehringer sells drug safety software to ArisGlobal Read More »

AZ bites back at rivals with new Farxiga data in heart failure

AstraZeneca’s SGLT2 inhibitor Farxiga has hit the mark in a phase 3 heart failure trial that brings it back into contention with its main rival Jardiance from Boehringer Ingelheim and Eli Lilly. Top-line results from the DELIVER trial showed that Farxiga (dapagliflozin) was able to reduced the risk of cardiovascular deaths or worsening heart failure …

AZ bites back at rivals with new Farxiga data in heart failure Read More »

Boehringer plans €25bn R&D spend, fuelled by Jardiance

Boehringer Ingelheim says it is planning to invest a hefty €25 billion ($27 billion) in its pipeline over the next five years, as it reinvests healthy sales revenue from Eli Lilly-partnered SGLT2 inhibitor Jardiance. The German group has just reported a 28% increase in Jardiance (empagliflozin) sales to €3.9 billion in 2021, buoyed by new …

Boehringer plans €25bn R&D spend, fuelled by Jardiance Read More »

Jardiance pulls ahead of Forxiga with heart failure approval in EU

Boehringer Ingelheim and Eli Lilly’s SGLT2 inhibitor Jardiance has become the first drug in the class to be approved in the EU for all adults with symptomatic chronic heart failure (CHF), giving the drug an edge in its battle for market share with AstraZeneca’s rival Forxiga. The European Commission has expanded the label for Jardiance …

Jardiance pulls ahead of Forxiga with heart failure approval in EU Read More »

Stage set for Jardiance to become universal heart failure drug

Boehringer Ingelheim and Eli Lilly have published data for their SGLT2 inhibitor Jardiance in acute heart failure, setting them on course to position the drug across the spectrum of patients with the condition. The results of the EMPULSE trial showed that adults hospitalised for acute heart failure were 36% more likely to see an improvement …

Stage set for Jardiance to become universal heart failure drug Read More »

FDA approves Jardiance (empagliflozin) for wider range of patients with heart failure

Eli Lilly and Boehringer Ingelheim’s blockbuster diabetes drug Jardiance (empagliflozin) has been granted approval by the US Food and Drug Administration (FDA) for a wider range of heart failure patients.  The approval builds upon previously secured indications, including the use of Jardiance to reduce the risk of cardiovascular death plus hospitalisation for heart failure with …

FDA approves Jardiance (empagliflozin) for wider range of patients with heart failure Read More »

PureTech challenges Roche’s Esbriet in head-to-head IPF trial

Roche’s idiopathic pulmonary fibrosis (IPF) therapy Esbriet is already being squeezed by its main rival in the market, and could come under renewed pressure if another competitor from PureTech Health gets approved. PureTech is developing a modified version of the active ingredient in Esbriet (pirfenidone) that has just been shown to be less likely to …

PureTech challenges Roche’s Esbriet in head-to-head IPF trial Read More »

Boehringer’s spesolimab data raises hope for serious skin disease

Fresh from being awarded a fast-track review from the FDA, Boehringer Ingelheim’s spesolimab has shown encouraging efficacy in a phase 2 trial in generalised pustular psoriasis (GPP), a rare and life-threatening skin disorder. GPP is very different from the more common plaque psoriasis, not least because it causes episodes (flares) of widespread eruptions of painful …

Boehringer’s spesolimab data raises hope for serious skin disease Read More »

Boehringer invests again in AI diagnosis specialist Brainomix

UK digital health company Brainomix has raised £16 million ($21.5 million) that will be used to extend the use of its artificial intelligence-based medical imaging software for stroke to new therapeutic areas. The Oxford University spinout – which has said that AI and machine learning is set to become the “driving force” behind imaging diagnostics …

Boehringer invests again in AI diagnosis specialist Brainomix Read More »

Boehringer-backed digital health academy set for launch in UK

An online training academy that aims to raise the digital skills of NHS health and care workers is due to open its virtual doors next March, according to the Organisation for the Review of Care and Health Apps (ORCHA). The Digital Health Academy – developed with pharma company Boehringer Ingelheim – is part of a …

Boehringer-backed digital health academy set for launch in UK Read More »

Legal requirement, ethical duty: How to develop compliant, useful lay summaries

New lay summary guidelines walk sponsors through their obligations under EU regulation No. 536/2014, due to come into force in February next year. Patient involvement is key, they say. The sooner patients are involved in developing and publishing lay summaries, which will soon be a legal requirement in the European Union, the better. That was …

Legal requirement, ethical duty: How to develop compliant, useful lay summaries Read More »

PharmaShots Weekly Snapshots (November 08 – 12, 2021)

Eisai Presents Results of Lecanemab in P-IIb Study 201 Study for the Treatment of Alzheimer’s Disease at CTAD 2021 Published: Nov 12, 2021 | Tags: Eisai, Lecanemab, P-IIb, Study 201 Study, Alzheimer’s Disease, CTAD 2021 Novo Nordisk’s Wegovy (semaglutide) Receives CHMP’s Recommendation for Approval to Treat Obesity Published: Nov 12, 2021 | Tags: Novo Nordisk, …

PharmaShots Weekly Snapshots (November 08 – 12, 2021) Read More »

Boehringer Ingelheim and Eli Lilly Report the US FDA’s Acceptance of sNDA and Granted Priority Review for Jardiance (empagliflozin) to Treat HFpEF

Shots: The sNDA is based on P-III EMPEROR-Preserved trial evaluates the safety and efficacy of Jardiance (10mg, qd) vs PBO in 5,988 patients with chronic HFpEF with/out diabetes The results showed a 21% vs 40% reduction in relative risk for the composite 1EPs of CV death or hospitalization in adults with HF with LVEF The …

Boehringer Ingelheim and Eli Lilly Report the US FDA’s Acceptance of sNDA and Granted Priority Review for Jardiance (empagliflozin) to Treat HFpEF Read More »

Insights+ Key Biosimilars Events of October 2021

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients During the month of October, Bio-Thera expanded its partnership with Pharmapark to …

Insights+ Key Biosimilars Events of October 2021 Read More »

Boehringer Ingelheim and Eli Lilly Present Results of Jardiance (empagliflozin) in P-III EMPEROR-Preserved Trial for HFpEF at ASN Kidney Week 2021

Shots: The P-III EMPEROR-Preserved trial evaluates the safety & efficacy of Jardiance (10mg, qd) vs PBO in 5,988 patients with chronic HFpEF with/out diabetes The results showed a reduction in risk for composite 1EPs of CV death or hospitalization for HF & slowed kidney function decline in adults with HF with LVEF. The new prespecified …

Boehringer Ingelheim and Eli Lilly Present Results of Jardiance (empagliflozin) in P-III EMPEROR-Preserved Trial for HFpEF at ASN Kidney Week 2021 Read More »

PharmaShots Weekly Snapshots (October 18 – 22, 2021)

LEO Reports 16-week Results of Tralokinumab in P-III ECZTRA 6 Trial for the Treatment of Moderate-to-Severe Atopic Dermatitis Published: 22 Oct, 2021 | Tags: LEO, Tralokinumab, P-III, ECZTRA 6 Trial, Atopic Dermatitis Marinomed Biotech Signs a License Agreement with Luoxin to Commercialize Budesolv (budesonide nasal spray) in Greater China Published: 22 Oct, 2021 | Tags: …

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

FDA approves Humira biosimilar as first-ever interchangeable monoclonal antibody

Boehringer Ingelheim has shown biosimilar manufacturers the way to win interchangeability with the world’s highest-grossing drug — but the company’s Cyltezo won’t come out until July 2023. Will future Humira competitors have better luck winning an earlier launch date?

Boehringer Ingelheim Exercised its Option to License Oxford Biomedica’s Lentiviral Vector Technology to Commercialize BI 3720931 for CF

Shots: OXB to receive $4.83M as an option exercise fee & ~$37.96M in development, regulatory & sales milestones along with royalty on sales of a CF gene therapy product under an option & license agreement with Boehringer Ingelheim as reported in Aug’18 Boehringer Ingelheim has also exercised its option to license IP from IP & …

Boehringer Ingelheim Exercised its Option to License Oxford Biomedica’s Lentiviral Vector Technology to Commercialize BI 3720931 for CF Read More »

FDA clears first “interchangeable” Humira biosimilar

Biosimilar competition to AbbVie’s big-selling Humira drug in the US has just been ratcheted up by the FDA approval of Boehringer Ingelheim’s Cyltezo – which can be substituted for the reference drug without any prescriber intervention. Cyltezo has been approved in the US since 2017 for several of the approved indications for Humira (adalimumab) but …

FDA clears first “interchangeable” Humira biosimilar Read More »

NICE changes stance on Sanofi’s Dupixent for severe asthma

18 months after saying “no”  to regular NHS funding for Sanofi and Regeneron’s Dupixent (dupilumab) for severe asthma in initial guidance, NICE has now backed the drug. The final appraisal document for Dupixent (dupilumab) has given the green light to use of the drug as an add-on maintenance therapy for people aged over 12 with …

NICE changes stance on Sanofi’s Dupixent for severe asthma Read More »

Boehringer Ingelheim’s Cyltezo (biosimilar, adalimumab) Receives the US FDA’s sBLA Approval as the 1st Interchangeable Biosimilar for Multiple Chronic Inflammatory Diseases

Shots: The approval is based on the P-III VOLTAIRE-X trial evaluates the effects of multiple switches b/w Humira and Cyltezo in patients with multiple chronic inflammatory diseases The study showed that Cyltezo was equivalent to Humira & demonstrated that switching several times b/w Cyltezo and Humira resulted in no clinical differences in PK, efficacy, immunogenicity, …

Boehringer Ingelheim’s Cyltezo (biosimilar, adalimumab) Receives the US FDA’s sBLA Approval as the 1st Interchangeable Biosimilar for Multiple Chronic Inflammatory Diseases Read More »

PharmaShots Weekly Snapshots (September 27 – October 01, 2021)

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 »

PharmaShots’ Key Highlights of Third Quarter 2021

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 »

Boehringer Ingelheim Signs an Agreement with Invetx to Develop and Commercialize Novel Veterinary Therapies

Shots: The companies collaborate to develop novel species-specific mAb biotherapeutics targeting a wide range of diseases in the veterinary species with an initial focus on dogs and cats The collaboration will utilize Invetx’s discovery platform, optimization technologies, and Ab expertise to develop veterinary biotherapeutics against selected targets for chronic & serious diseases in animals Boehringer …

Boehringer Ingelheim Signs an Agreement with Invetx to Develop and Commercialize Novel Veterinary Therapies 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 »

Boehringer buys Abexxa, bolstering its immuno-oncology pipeline

Boehringer Ingelheim says it has agreed to buy US biotech Abexxa Biologics, its second acquisition in the cancer immunotherapy area in the space of a year. Texas-based Abexxa has been on the Boehringer’s radar since it was set up, as it provided seed funding for the preclinical-stage company in 2016, buying into its approach of …

Boehringer buys Abexxa, bolstering its immuno-oncology pipeline Read More »

Boehringer Ingelheim Acquires Abexxa to Expands its Immuno-oncology Research

Shots: The acquisition includes upfront, milestones, and other consideration payments. Abexxa will continue to operate in the Arlington The acquisition will allow Boehringer to access Abexxa’s expertise and capabilities in targeting cancer-specific proteins by using its technology to develop cancer immunotherapies and Abs for solid cancers The acquisition also bolsters Boehringer’s commitment to identifying the …

Boehringer Ingelheim Acquires Abexxa to Expands its Immuno-oncology Research Read More »

ESMO21: First combo data with Amgen’s Lumakras hit the mark in CRC

Amgen has made progress with its plans to expand the use of its first-in-class KRAS inhibitor Lumakras, reporting encouraging results when the drug is used alongside its EGFR drug Vectibix in colorectal cancer (CRC). The phase 2 study due to be reported at the ESMO cancer meeting – in patients KRAS G12c-mutated CRC – is …

ESMO21: First combo data with Amgen’s Lumakras hit the mark in CRC Read More »

Boehringer Ingelheim Enters into a Clinical Collaboration with Amgen to Evaluate BI 1701963 + Lumakras (sotorasib) for Locally Advanced or Metastatic NSCLC

Shots: The companies collaborated to evaluate the synergistic effects of BI 1701963 (SOS1::pan-KRAS inhibitor) + Lumakras (KRAS G12C inhibitor) in a P-I trial for adult patients with LA or metastatic NSCLC The companies will jointly share costs & manage the clinical development for combined therapy. Amgen will sponsor the trial The preclinical data showed that …

Boehringer Ingelheim Enters into a Clinical Collaboration with Amgen to Evaluate BI 1701963 + Lumakras (sotorasib) for Locally Advanced or Metastatic NSCLC Read More »

Boehringer Ingelheim Signs a Research Agreement with Twist to Discover Therapeutic Antibodies Against Multiple Targets

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 …

Boehringer Ingelheim Signs a Research Agreement with Twist to Discover Therapeutic Antibodies Against Multiple Targets Read More »

Boehringer Ingelheim and Eli Lilly’s Jardiance (empagliflozin) Receive the US FDA’s Breakthrough Therapy Designation for the Treatment of Heart Failure with Preserved Ejection Fraction

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 …

Boehringer Ingelheim and Eli Lilly’s Jardiance (empagliflozin) Receive the US FDA’s Breakthrough Therapy Designation for the Treatment of Heart Failure with Preserved Ejection Fraction 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 »

Boehringer Ingelheim and Eli Lilly Present Results of Jardiance (empagliflozin) in P-III EMPEROR-Preserved Trial for the Treatment of HFpEF at ESC 2021

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 …

Boehringer Ingelheim and Eli Lilly Present Results of Jardiance (empagliflozin) in P-III EMPEROR-Preserved Trial for the Treatment of HFpEF at ESC 2021 Read More »

PharmaShots Weekly Snapshots (August 16 – 20, 2021)

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 »

Boehringer Ingelheim and Eli Lilly’s Jardiance (empagliflozin) Receive the US FDA’s Approval for the Treatment of Heart Failure with Reduced Ejection Fraction

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% …

Boehringer Ingelheim and Eli Lilly’s Jardiance (empagliflozin) Receive the US FDA’s Approval for the Treatment of Heart Failure with Reduced Ejection Fraction Read More »

Jardiance gets parity with Farxiga in US as FDA clears use in heart failure

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 »

AZ gets European approvals for Forxiga in chronic kidney disease

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 »

Boehringer takes alteplase to phase 3 for COVID, but drops antibody

Boehringer Ingelheim’s latecomer antibody therapy for COVID-19 has been side-lined, as the company focuses its attention on its thrombolytic drug alteplase, heading into a phase 3 programme later this year. The decision to discontinue development of BI 767551, an inhaled antibody, has been taken because of the “evolving landscape” in managing the pandemic including the …

Boehringer takes alteplase to phase 3 for COVID, but drops antibody Read More »

ImaginAb Signs a Multi-Year Non-Exclusive License Agreement with Boehringer Ingelheim for CD8 ImmunoPET Technology

Shots: ImaginAb to receive license fees for providing ongoing technical, clinical, and regulatory support to facilitate the successful implementation of its CD8 ImmunoPET technology Following the new agreement, ImaginAb will supply clinical doses of 89Zr CD8 Immuno-PET technology to Boehringer Ingelheim for use in the clinical development of its novel oncology therapeutics throughout North America …

ImaginAb Signs a Multi-Year Non-Exclusive License Agreement with Boehringer Ingelheim for CD8 ImmunoPET Technology Read More »

Boehringer, Lilly hail Jardiance data in hard-to-treat heart failure

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 »

Turning words into actions with patient engagement

Boehringer Ingelheim’s Carinne Brouillon tells us how the company co-created its recent Global Patient Partnership Summit with patients and how the meeting brought representatives together to design actionable projects for pharma-patient engagement. This article appears in our free digital magazine Deep Dive: Market Access 2021. Read a preview below: As pharma seeks new and better …

Turning words into actions with patient engagement Read More »

Turning words into actions with patient engagement

Boehringer Ingelheim’s Carinne Brouillon tells us how the company co-created its recent Global Patient Partnership Summit with patients and how the meeting brought representatives together to design actionable projects for pharma-patient engagement. This article appears in our free digital magazine Deep Dive: Market Access 2021. Read a preview below: As pharma seeks new and better …

Turning words into actions with patient engagement Read More »

Scotland backs rare blood cancer drug Poteligeo rejected by NICE

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 »

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 »

Boehringer Ingelheim’s BI 425809 Receives the US FDA’s Breakthrough Therapy Designation for Cognitive Impairment Associated with Schizophrenia

Shots: The BTD is based on P-II 1346.9 clinical trial, which demonstrated that BI 425809 improved cognition in adult patients with schizophrenia Moreover, the company has initiated the P-III CONNEX program assessing the safety and efficacy of BI 425809 vs PBO for improving cognition in adults with schizophrenia over a 26wks. treatment period Additionally, Boehringer …

Boehringer Ingelheim’s BI 425809 Receives the US FDA’s Breakthrough Therapy Designation for Cognitive Impairment Associated with Schizophrenia Read More »

Boehringer Ingelheim to Develop Dicerna’s GalXC RNAi Candidate for NASH

Shots: Boehringer Ingelheim has accepted a GalXC RNAi candidate (DCR-LIV2) for advancement under the existing agreement b/w the companies for the discovery and development of novel therapies for chronic liver diseases Dicerna will receive $170M as development and commercial milestones related to DCR-LIV2 and is eligible to receive royalties on net sales of the therapy …

Boehringer Ingelheim to Develop Dicerna’s GalXC RNAi Candidate for NASH Read More »

Insights+ Key Biosimilars Events of April 2021

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients During the month of April, Biocon and Viatris received EC’s approval for …

Insights+ Key Biosimilars Events of April 2021 Read More »

AstraZeneca’s Farxiga claims first SGLT2 kidney disease OK from FDA

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 »

Deep Dive: Market Access

It’s fair to say this is the most interesting time ever for market access. Not only has COVID forced companies, governments and healthcare systems to work towards approving drugs and vaccines in record times, the sector is also facing an influx of digital therapeutics and advanced drugs that don’t fit neatly into existing access frameworks. …

Deep Dive: Market Access 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 »

Boehringer Ingelheim and MD Anderson Expand their Collaboration to Accelerate Targeted Therapies for Lung Cancer

Shots: Boehringer Ingelheim and MD Anderson expand their 2019 joint VRDC to explore new molecules from Boehringer Ingelheim’s KRAS and TRAILR2 portfolios for lung cancer, particularly NSCLC The joint research will continue for 5 additional years. The extended collaboration follows successful preclinical studies in GI cancers via joint VRDC The expanded agreement allows the partners …

Boehringer Ingelheim and MD Anderson Expand their Collaboration to Accelerate Targeted Therapies for Lung Cancer Read More »

Boehringer and MD Anderson extend KRAS cancer collaboration

Boehringer Ingelheim and The University of Texas MD Anderson Cancer Center have extended and expanded a collaboration exploring medicines targeting lung cancer with KRAS mutations.  The collaboration was launched in 2019 and in its next phase will explore new molecules from Boehringer’s KRAS (Kirsten rat sarcoma) and TRAILR2 (TNF-related apoptosis-inducing ligand receptor 2) portfolios, with a …

Boehringer and MD Anderson extend KRAS cancer collaboration Read More »

Top 20 BioPharma Companies based on 2020 Total Revenue

Despite having the global pandemic, the biopharma companies were involved in multiple M&A, licensing deals. The major focus of the year remains the production and distribution of vaccines to combat the COVID-19 globally All the companies on our list are on the front line to combat this global crisis. The top 20 companies on the …

Top 20 BioPharma Companies based on 2020 Total Revenue Read More »

COVID-19 drives Boehringer’s R&D spend to record level in 2020

Boehringer Ingelheim invested €3.7 billion on R&D last year, the highest spend in its history, as it mobilised its scientists to seek out new therapies for COVID-19. Not all those efforts have been successful. Boehringer abandoned BI 764198, an inhibitor of TRPC6 in phase 2 for acute respiratory distress syndrome (ARDS) in patients hospitalised for …

COVID-19 drives Boehringer’s R&D spend to record level in 2020 Read More »

PharmaShots Weekly Snapshots (Mar 01 – 05, 2021)

Eli Lilly and Incyte Report Results of Olumiant (baricitinib) in P-III BRAVE-AA2 Study for Severe Alopecia Areata Published: Mar 5, 2021 | Tags: Eli Lilly 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 »

G1 Therapeutics and Boehringer Ingelheim Launch Cosela (trilaciclib) in the US

Shots: On Feb 12, 2021, the US FDA has approved Cosela to decrease the incidence of CT induced myelosuppression in adult patients when administered before a platinum/etoposide-containing regimen or topotecan-containing regimen for ES-SCLC The launch is supported by the “One Patient Support Program” which is designed to provide access and affordability solutions to eligible patients …

G1 Therapeutics and Boehringer Ingelheim Launch Cosela (trilaciclib) in the US Read More »

PharmaShots Weekly Snapshots (Feb 15- 19, 2021)

RedHill Signs a Manufacturing Agreement with Cosmo for Movantik and RHB-204  Published: Feb 19, 2021 | Tags: RedHill, Signs, Manufacturing, Agreement, Cosmo, Movantik, RHB-204 Astellas and Seagen Reports Submission of Two BLA to the US FDA for Padcev (enfortumab vedotin) in Locally Advanced or Metastatic Urothelial Cancer Published: Feb 19, 2021 | Tags: Astellas, Seagen, Reports, Submission, …

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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 »

Boehringer Ingelheim Animal Health Establishes Pawru for its PetPro Portfolio

Shots: The Pawru will accelerate the expansion of Boehringer Ingelheim’s digital animal healthcare platform, k/a PetPro Connect. PetPro portfolio will transition to Pawru branding The Pawru explores the strategic partners to expand its commercial offerings. PetPro Connect provides the service as a mobile app that links them with their veterinarians for telemedicine appointments, prescription refills, …

Boehringer Ingelheim Animal Health Establishes Pawru for its PetPro Portfolio Read More »

Top 20 Biopharma Deal Terminations of 2020 Based on Total Deal Value

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 »

Insights+: Key Deals of JP Morgan Healthcare Conference 2021

This year J.P. Morgan 39th Annual Healthcare Conference was conducted virtually and we witnessed multiple announcements from numerous Biopharma companies An analysis of events and catalysts that were announced at the conference during these days are included in the report. Most of the deals occurred in the first two days of the conference Our PharmaShots …

Insights+: Key Deals of JP Morgan Healthcare Conference 2021 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 »

Boehringer Ingelheim Collaborates with Cure Genetics to Develop Next-Generation Liver-Targeted Gene Therapy

Shots: The companies collaborated to develop AAV vectors deploying Cure Genetics’ VELP platform to develop next-generation gene therapies The focus of the pact is to provide new AAV serotypes for patients. The collaboration integrates Boehringer Ingelheim’s experience in disease biology and gene therapy development with Cure Genetics’ AAV expertise in library construction and in vivo …

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PharmaShots’ Key Highlights of Fourth Quarter 2020

The fourth quarter of 2020 contains multiple initiations of clinical trials, big approvals, and numerous deals. COVID-19 related news remains at the peak in this quarter Multiple companies received regulatory bodies’ EUA for their vaccines and treatments for COVID-19. Initiating with, Regeneron sought the US FDA’s EUA for REGN-COV2 Ab combination while Health Canada accelerated …

PharmaShots’ Key Highlights of Fourth Quarter 2020 Read More »

Boehringer to investigate ‘dark antigens’ with UK cancer specialist Enara

Boehringer Ingelheim has signed a strategic collaboration with UK biotech Enara Bio, focused on finding ways to fight cancer using “dark antigens” in a deal worth up to €876 million ($1.07bn). Dark Antigens represent a new class of cancer-associated antigens that derive from the genomic “dark matter” – the portion of the human genome that …

Boehringer to investigate ‘dark antigens’ with UK cancer specialist Enara Read More »

Boehringer, Lilly’s Jardiance ties to match AZ’s Farxiga with heart failure label

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 »

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 »

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. …

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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 »

Boehringer Ingelheim to Acquires NBE-Therapeutics ~ $1.5B

Shots: Boehringer Ingelheim to acquire all shares of NBE-Therapeutics for ~$1.434B which include contingent clinical and regulatory milestones. The transaction is expected to be closed in Q1’21 The acquisition will add NBE-Therapeutics’ ROR1-directed ADCs including NBE-002 which is currently in P-I studies for TNBC and other solid tumors NBE-Therapeutics’ iADC platform will add exceptional tumor-targeting …

Boehringer Ingelheim to Acquires NBE-Therapeutics ~ $1.5B Read More »

Boehringer buys NBE for €1.18bn, adding cancer ADC expertise

Boehringer Ingelheim has expanded its oncology focus for the second time this week by buying Swiss biotech NBE-Therapeutics, adding an antibody-drug conjugate (ADC) platform led by a drug for a hard-to-treat form of breast cancer. The German pharma group is paying €1.18 billion ($1.43bn) for all the shares in privately-held NBE, based in Basel, and …

Boehringer buys NBE for €1.18bn, adding cancer ADC expertise 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 »

Boehringer axes IPF deal with South Korea’s Bridge Therapeutics over toxicity concerns

Boehringer Ingelheim and South Korea’s Bridge Therapeutics have decided to axe their collaboration over a potential new drug for idiopathic pulmonary fibrosis (IPF), BBT-877. The German pharma had hoped the drug would be a successor to Ofev (nintedanib), which is one of its most important drugs and is approved for the potentially fatal lung-scarring disease. …

Boehringer axes IPF deal with South Korea’s Bridge Therapeutics over toxicity concerns Read More »

Boehringer Ingelheim Initiates P-II Study of BI 764198 for Patients with Severe Respiratory Illness from COVID-19

Shots: The P-II trial will assess BI 764198 (qd for ~4wks.) in patients hospitalized for COVID-19 with expected enrollment initiation in Oct’2020. The 1EPs will be the percentage of patients who are alive and free of mechanical ventilation at day 29 of treatment while other EPs include clinical improvement, oxygen saturation & ICU admission The …

Boehringer Ingelheim Initiates P-II Study of BI 764198 for Patients with Severe Respiratory Illness from COVID-19 Read More »

Boehringer Ingelheim and Eli Lilly Report Results of Jardiance in Adults with HFrEF Regardless of Chronic Kidney Disease Status

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 …

Boehringer Ingelheim and Eli Lilly Report Results of Jardiance in Adults with HFrEF Regardless of Chronic Kidney Disease Status Read More »

Boehringer, Yale trial digital tech in heart failure

Patients with heart failure often have a dismal prognosis as the condition usually worsens over time, but a new study aims to see if digital health technologies can improve their prospects. The trial – run by Boehringer Ingelheim and Yale University – will test a smart bathroom scale device that has cardiac monitoring built in, …

Boehringer, Yale trial digital tech in heart failure Read More »

NHS looks for digital pioneers to reshape services during pandemic

A fellowship programme is looking for digital pioneers to design and lead service transformation projects in England’s NHS as the COVID-19 pandemic continues. DigitalHealth.London opens applications to its Digital Pioneer Fellowship programme, supporting change makers employed by NHS organisations in London to design and lead transformation projects underpinned by digital innovation. Sponsored this year by …

NHS looks for digital pioneers to reshape services during pandemic Read More »

Boehringer Ingelheim Acquires GST to Boost its Stem Cell Capabilities in Animal Health

Shots: Boehringer Ingelheim has acquired Global Stem cell Technology (GST) focusing to strengthen its portfolio capabilities to accelerate innovation and growth The acquisition follows two years of partnership b/w the companies that brought the first-ever registered stem cell-based veterinary medicine (Arti-Cell Forte) in the EU The acquisition of GST will accelerate the development pipeline of …

Boehringer Ingelheim Acquires GST to Boost its Stem Cell Capabilities in Animal Health Read More »

Redx shares soar after IPF drug licence deal with AstraZeneca

Shares in Redx Pharma were soaring this morning after it licensed its preclinical fibrotic disease drug RXC006 to AstraZeneca. The company’s shares were valued as high as 95p on the London Stock Exchange following the announcement, the highest they had been since 2015. AstraZeneca has bought an exclusive global licence to develop and market RXC006, …

Redx shares soar after IPF drug licence deal with AstraZeneca Read More »

Study puts Jardiance in hot pursuit of AZ’s Farxiga in heart failure

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 »