Amgen

ICER says Amgen’s tezepelumab ‘likely to be too expensive’

Amgen and AstraZeneca haven’t won approval or announced a price for their severe asthma therapy tezepelumab should it reach the market, but ICER in the US maintains it will probably not be cost-effective. The cost effectiveness organisation has published a draft evidence report on the first-in-class TSLP inhibitor – which is currently under FDA review …

ICER says Amgen’s tezepelumab ‘likely to be too expensive’ 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 »

Amgen’s Lumakras (sotorasib) Receives Health Canada’s Approval for KRAS G12C-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Shots: The approval is based on P-II CodeBreaK 100 trial evaluating the efficacy and tolerability of Lumakras (PO, qd) in 126 patients with KRAS G12C mutation-positive advanced NSCLC whose disease had progressed after prior treatment with immunotherapy or CT The 1EPs were centrally assessed ORR. Additionally, the therapy demonstrated a positive benefit-risk profile with rapid, …

Amgen’s Lumakras (sotorasib) Receives Health Canada’s Approval for KRAS G12C-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer Read More »

NHS fast tracks access to Amgen’s just-approved KRAS cancer drug

Amgen’s first-in-class KRAS inhibitor Lumykras has been approved in Great Britain and arrives already armed with an agreement to allow early access while its cost-effectiveness is appraised by NICE. The MHRA has approved Lumykras (sotorasib) for patients with previously treated locally advanced or metastatic non-small cell lung cancer (NSCLC) with the KRAS G12C mutation, and …

NHS fast tracks access to Amgen’s just-approved KRAS cancer drug Read More »

AstraZeneca and Amgen’s Tezepelumab Demonstrates 86% Reduction in Exacerbations in Patients with Asthma and Nasal Polyps

Shots: The P-III NAVIGATOR study involves assessing Tezepelumab + SOC vs PBO +SOC in adults (18–80yrs.old) and adolescents (12–17yrs. old) with severe, uncontrolled asthma. The study showed improvements in lung function and nasal polyp symptoms The pre-specified exploratory analysis evaluated the effect of tezepelumab in NAVIGATOR patients with/ out reported nasal polyps (NP+ or NP−) …

AstraZeneca and Amgen’s Tezepelumab Demonstrates 86% Reduction in Exacerbations in Patients with Asthma and Nasal Polyps Read More »

Amgen builds case for severe asthma drug tezepelumab

Amgen and partner AstraZeneca have said their recently filed severe asthma drug tezepelumab has shown impressive results in patients who also have nasal polyps, a common complication of the respiratory disease. Tezepelumab reduced the annualised asthma exacerbation rate (AAER) by 86% in a subgroup of people with severe, uncontrolled asthma and polyps in the NAVIGATOR …

Amgen builds case for severe asthma drug tezepelumab Read More »

PharmaShots Weekly Snapshots (August 23 – 27, 2021)

Ascendis’ Skytrofa (lonapegsomatropin-tcgd) Receives the US FDA’s Approval for Pediatric Growth Hormone Deficiency Published: Aug 27, 2021 | Tags: Ascendis, Skytrofa, lonapegsomatropin-tcgd, US, FDA, Approval, Pediatric Growth Hormone Deficiency Amgen Presents Results of Repatha (evolocumab) in P-III HUYGENS Study for the Treatment of Acute Coronary Syndrome at ESC 2021 Published: Aug 27, 2021 | Tags: …

PharmaShots Weekly Snapshots (August 23 – 27, 2021) Read More »

Amgen Presents Results of Repatha (evolocumab) in P-III HUYGENS Study for the Treatment of Acute Coronary Syndrome at ESC 2021

Shots: The P-III HUYGENS study evaluates Repatha + optimized statin therapy vs optimized statin therapy alone in patients with ACS for 52wks. The study met its 1EPs i.e., improvement in the features of plaque morphology by increasing the fibrous cap thickness (75% vs 39%) as measured by OCT. The therapy also improved all 2EPs includes …

Amgen Presents Results of Repatha (evolocumab) in P-III HUYGENS Study for the Treatment of Acute Coronary Syndrome at ESC 2021 Read More »

Top 20 Immunology Companies Based on 2020 Immunology Segment Revenue

Immunology deals with physiological functioning of the immune system in states of both health and disease as well as malfunctions of the immune system in immunological disorders With the new advancement in immune sector, global pharmaceuticals continue to grow in the field despite the disruption during the COVID-19. As in 2019, Abbvie again secured the …

Top 20 Immunology Companies Based on 2020 Immunology Segment Revenue Read More »

PharmaShots Weekly Snapshots (July 26 – 30, 2021)

Roche Publishes the Results of Evrysdi (risdiplam) in FIREFISH Study to Treat of Type 1 SMA at NEJM Published: July 30, 2021 | Tags: Roche, Evrysdi, risdiplam, FIREFISH Study, Type 1 SMA, NEJM BeiGene Reports Results of Brukinsa (zanubrutinib) in P-III SEQUOIA Trial for the Treatment of Chronic Lymphocytic Leukemia Published: July 30, 2021 | …

PharmaShots Weekly Snapshots (July 26 – 30, 2021) Read More »

PharmaShots Interview: Guardant Health’s Justin Odegaard Shares Insight on the US FDA’s Approval of Guardant360 CDx for Amgen’s Lumakras

In an interview with PharmaShots, Justin Odegaard, Vice President of Clinical Development at Guardant Health shares his views on the Guardant360 CDx approval as the first & only liquid biopsy companion diagnostic for Amgen’s Lumakras (sotorasib) KRASG12C inhibitor for use in advanced NSCLC. Shots: Guardant Health received the US FDA’s approval for Guardant360 CDx liquid …

PharmaShots Interview: Guardant Health’s Justin Odegaard Shares Insight on the US FDA’s Approval of Guardant360 CDx for Amgen’s Lumakras Read More »

Amgen to Acquire Teneobio for ~$2.5B

Shots: Amgen to acquire all outstanding shares of Teneobio for $900M as up front and $1.6B in cash as contingent milestones to Teneobio equity holders. The transaction is expected to be closed in H2’21 The acquisition will boost Amgen’s abilities to develop innovative therapies and expand its portfolio with the addition of early-stage oncology assets …

Amgen to Acquire Teneobio for ~$2.5B Read More »

Amgen adds antibody assets and R&D tech with $900M Teneobio acquisition

Amgen is paying $900 million up front to acquire Teneobio, a biotech with technology for discovering and developing antibody drugs. Though Amgen already has its own antibody platform, the company says Teneobio’s technology and drug assets will complement its own.

PharmaShots Weekly Snapshots (July 05 – 09, 2021)

Lysogene Receives the US FDA’s Fast Track Designation for LYS-GM101 Gene Therapy to Treat GM1 Gangliosidosis Published: July 9, 2021 | Tags: Lysogene, US, FDA, Fast Track Designation, LYS-GM101 Gene Therapy, GM1 Gangliosidosis Jazz’s Vyxeos (daunorubicin and cytarabine liposome) for Injection Receives Health Canada Approval for the Treatment of High-risk Acute Myeloid Leukemia Published: July …

PharmaShots Weekly Snapshots (July 05 – 09, 2021) Read More »

AstraZeneca and Amgen Report the US FDA’s Acceptance of BLA and Priority Review of Tezepelumab for the Treatment of Asthma

Shots: The BLA is based on PATHFINDER clinical program, including P-III NAVIGATOR study evaluating Tezepelumab + SOC vs PBO + SOC in 1,061 adults (18–80yrs.) & adolescents (12–17yrs.) with severe & uncontrolled asthma who receive treatment with medium/high dose ICS + at least 1 additional controller medication with/out OCS The results demonstrated superiority in 1EP …

AstraZeneca and Amgen Report the US FDA’s Acceptance of BLA and Priority Review of Tezepelumab for the Treatment of Asthma Read More »

AZ, Amgen get speedy FDA review for asthma drug tezepelumab

The FDA has started a priority review of AstraZeneca and Amgen’s severe asthma antibody tezepelumab, setting a date for a decision in the first quarter of 2022. If approved, TSLP inhibitor tezepelumab could reach the market with a broader label than currently-used asthma antibodies, which are approved to treat patient with severe asthma characterised by …

AZ, Amgen get speedy FDA review for asthma drug tezepelumab Read More »

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 »

Insights+: The US FDA New Drug Approvals in May 2021

The US FDA has approved 4 NDAs and 1 BLAs 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 29 novel products in 2021. Additionally, last year in 2020, the US FDA …

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

Dermavant raises $200m to ease launch of Otezla rival tapinarof

Dermavant is in line to make some big payments to GlaxoSmithKline if its topical psoriasis drug tapinarof reaches the market, and it has just cut a deal to defray those costs. The Roivant group company has raised $160 million from investors plus a $40 million credit facility that it can draw on if – and …

Dermavant raises $200m to ease launch of Otezla rival tapinarof Read More »

PharmaShots Weekly Snapshots (May 31 – June 4, 2021)

Tonix Pharmaceuticals Presents Results of TNX-102 SL in P-III RELIEF study for the Management of Fibromyalgia at ASCP 2021 Published: June 4, 2021 | Tags: Tonix Pharmaceuticals, TNX-102 SL, P-III, RELIEF Study, Fibromyalgia, ASCP 2021 Dermavant Submits NDA to the US FDA for Tapinarof Cream to Treat Plaque Psoriasis Published: June 4, 2021 | Tags: …

PharmaShots Weekly Snapshots (May 31 – June 4, 2021) Read More »

Insights+ Key Biosimilars Events of May 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 May, Samsung initiated patient enrollment in the P-III …

Insights+ Key Biosimilars Events of May 2021 Read More »

Amgen pays Kyowa $400m upfront for OX40 eczema drug

Amgen has made a play in a hot area of immunology R&D, paying $400 million upfront to claim rights to an OX40-targeting drug from Kyowa Kirin that is ready for phase 3 testing for atopic dermatitis or eczema.  The deal gives Amgen rights to the KHK4083 antibody in all countries except Kyowa’s home market of …

Amgen pays Kyowa $400m upfront for OX40 eczema drug Read More »

Eying eczema, Amgen pays $400M to co-develop Phase 3-ready Kyowa Kirin drug

Amgen is paying Kyowa Kirin $400 million to share in the development of a drug that could offer a new approach to treating atopic dermatitis, a form of eczema. The deal comes months after Japan-based Kyowa Kirin reported positive preliminary Phase 2 data for its antibody.

Amgen and Kyowa Kirin Collaborate to Develop and Commercialize KHK4083 for Atopic Dermatitis

Shots: Kyowa Kirin to receive ~$400M up front and an additional ~$850M as milestones along with royalties on future global sales. Both companies will share global development costs (Ex- Japan & the US) Amgen will responsible for the development, manufacturing, and commercialization of KHK4083 for all markets globally (Ex-Japan, where Kyowa Kirin will retain all …

Amgen and Kyowa Kirin Collaborate to Develop and Commercialize KHK4083 for Atopic Dermatitis Read More »

Amgen nabs speedy approval for first-ever KRAS drug sotorasib

After decades of mostly unsuccessful R&D, Amgen has claimed the first ever regulatory approval for a drug that inhibits KRAS – a cancer target that for a long time was all-but written off as “undruggable”. The FDA’s conditional approval for Lumakras (sotorasib; formerly AMG-510) as a second-line treatment for KRAS G12c-mutated non-small cell lung cancer …

Amgen nabs speedy approval for first-ever KRAS drug sotorasib Read More »

Amgen’s Lumakras (sotorasib) Receives the US FDA’s Approval as the First KRAS Blocking Cancer Therapy

Shots: The approval is based on the CodeBreaK 100 trial evaluating the efficacy & tolerability of Lumakras (960mg, qd) in 124 patients with KRAS G12C mutation-positive NSCLC whose disease had progressed after prior treatment with immunotherapy or CT Results: ORR (36%); DCR (81%); mDoR (10 mos.); durable response with a positive benefit-risk profile, 9% showed …

Amgen’s Lumakras (sotorasib) Receives the US FDA’s Approval as the First KRAS Blocking Cancer Therapy Read More »

Amgen lands first FDA approval for drug targeting elusive mutation in lung cancer

FDA approval of Amgen drug sotorasib (Lumakras) makes the small molecule the first compound authorized by the regulator for treating cancers characterized by a KRAS G12C mutation. Mutated KRAS proteins had long been regarded “undruggable” targets.

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 »

AstraZeneca and Amgen Present Results of Tezepelumab in P-III NAVIGATOR Study for Severe Asthma at ATS2021

Shots: The P-III NAVIGATOR study involves assessing Tezepelumab + SOC vs PBO + SOC in adults (18–80 yrs.) & adolescents (12–17 yrs.) with severe uncontrolled asthma The results demonstrate superiority in 1EP & 2EP in a broad population i.e., 77% reduction in AAER with blood eosinophil counts (≥300 cells/ microlitre) and FeNO levels (≥25 parts/ …

AstraZeneca and Amgen Present Results of Tezepelumab in P-III NAVIGATOR Study for Severe Asthma at ATS2021 Read More »

AstraZeneca and Amgen Submit BLA to US FDA for Tezepelumab to Treat Severe Asthma

Shots: The submission is based on PATHFINDER clinical program including P-III NAVIGATOR that involves assessing Tezepelumab + SOC vs PBO + SOC in 1061 adults (18–80yrs.) & adolescents (12–17yrs.) with severe and uncontrolled asthma The study demonstrated 56% reduction in AAER @52wks. in the overall population. The study also met 1EPs in the subgroup of …

AstraZeneca and Amgen Submit BLA to US FDA for Tezepelumab to Treat Severe Asthma Read More »

PharmaShots Weekly Snapshots (May 03 – 07, 2021)

AstraZeneca Reports Results of Imfinzi (durvalumab) and Imfinzi + Tremelimumab in P-III POSEIDON Study as 1L Treatment for Stage IV Non-Small Cell Lung Cancer Published: May 7, 2021 | Tags: AstraZeneca, Imfinzi, durvalumab, Tremelimumab, P-III, POSEIDON Study, Stage IV Non-Small Cell Lung Cancer Merck and Fusion Pharmaceuticals Enter into a Clinical Collaboration for FPI-1434 + …

PharmaShots Weekly Snapshots (May 03 – 07, 2021) Read More »

Amgen Reports the US FDA’s Acceptance of sNDA for Review of Otezla (apremilast) to Treat Mild-To-Moderate Plaque Psoriasis

Shots: The acceptance is based on a P-III ADVANCE trial assessing the efficacy of Otezla (30 mg, bid) vs PBO in 595 patients in a ratio (1:1) with mild-to-moderate plaque psoriasis for the first 16wks. All patients then received Otezla during an OLE phase through week 32. Results: @16wks., improvement in its 1EPs of sPGA …

Amgen Reports the US FDA’s Acceptance of sNDA for Review of Otezla (apremilast) to Treat Mild-To-Moderate Plaque Psoriasis Read More »

Ex-Merck R&D chief Perlmutter takes reins at drug discovery startup Eikon

A new drug discovery firm, Eikon Therapeutics, has launched with former Merck & Co research chief Roger Perlmutter at the helm. Eikon is backed with $148 million in Series A financing led by The Column Group, with Foresite Capital, Innovation Endeavors and Lux Capital also joining. The California-based company said it aims to use super-resolution …

Ex-Merck R&D chief Perlmutter takes reins at drug discovery startup Eikon Read More »

Ex-Merck R&D chief Perlmutter takes reins at drug discovery startup Eikon

A new drug discovery firm, Eikon Therapeutics, has launched with former Merck & Co research chief Roger Perlmutter at the helm. Eikon is backed with $148 million in Series A financing led by The Column Group, with Foresite Capital, Innovation Endeavors and Lux Capital also joining. The California-based company said it aims to use super-resolution …

Ex-Merck R&D chief Perlmutter takes reins at drug discovery startup Eikon Read More »

Amgen Launches Amgevita (biosimilar, adalimumab) for the Treatment of Multiple Chronic Inflammatory Diseases in Canada

Shots: The company reports the availability of Amgevita, referencing Humira to treat 11 chronic inflammatory conditions in Canada Amgevita is available as a prefilled syringe and a prefilled pen (SureClick autoinjector) with a broad range of pack sizes to support dosing for each indication and available in a citrate-free formulation. Amgevita is reimbursed on the …

Amgen Launches Amgevita (biosimilar, adalimumab) for the Treatment of Multiple Chronic Inflammatory Diseases in Canada Read More »

BMS’ deucravacitinib psoriasis pill could launch next year after outperforming Amgen’s rival

Bristol-Myers Squibb has phase 3 data from its deucravacitinib psoriasis pill, showing it outperformed Amgen’s rival Otezla in patients with moderate to severe disease. The company thinks the data from the first-in-class tyrosine kinase 2 inhibitor are strong enough to file with regulators, setting up a potential launch next year. Competition regulators required Celgene to …

BMS’ deucravacitinib psoriasis pill could launch next year after outperforming Amgen’s rival Read More »

PharmaShots’ Key Highlights of First Quarter 2021

The first quarter of 2021 highlights new approvals, M&A, and the clinical data of COVID-19 vaccines. The companies expand their working in COVID-19 by targeting South African & Brazil variants along with other emerging variants Starting with the latest acquisition, Amgen acquired Five Prime for $1.9B, Jazz acquired JW while Boston acquired Preventice. This quarter …

PharmaShots’ Key Highlights of First Quarter 2021 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 »

PharmaShots Weekly Snapshots (Mar 29 – Apr 02, 2021)

Pfizer and BioNTech Report Results of BNT162b2 to Prevent COVID-19 Published: Apr 2, 2021 | Tags: Pfizer and BioNTech, Report, Results, BNT162b2, Prevent, COVID-19 Acceleron Presents Results of Sotatercept in P-II PULSAR Trial for the Treatment of Pulmonary Arterial Hypertension, Published in NEJM Published: Apr 2, 2021 | Tags: Acceleron, Presents, Results, Sotatercept, P-II PULSAR …

PharmaShots Weekly Snapshots (Mar 29 – Apr 02, 2021) Read More »

Insights+: Breakthrough Therapy Designation by the US FDA in 2020

Breakthrough Therapy (BT) Designation is an expedited review program introduced in Section 902 of the Food and Drug Safety and Innovation Act of 2012 The Breakthrough Designation is granted to the drug candidates as monotherapy or in combination with other drugs intended to treat serious or life-threatening diseases and has shown substantial improvement over available …

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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 »

Amgen in $1.9bn swoop for Five Prime and its gastric cancer drug

Amgen is to buy US biotech Five Prime Therapeutics for around $1.9 billion, adding a potential gastric cancer drug to its pipeline. The big pharma swooped in after the California biotech reported promising phase 2 trial results from bemarituzumab in November. The phase 2 FIGHT trial testing bemarituzumab plus chemotherapy as a front-line therapy for advanced gastric …

Amgen in $1.9bn swoop for Five Prime and its gastric cancer drug Read More »

Amgen to Acquire Five Prime for ~$1.9B

Shots: Amgen to acquire all of the outstanding shares of Five Prime for $38.00 /share in cash, representing an equity value of ~ $1.9B. The transaction is expected to close in Q2’21 The acquisition will add Five Prime’s innovative pipeline to Amgen thus expanding its oncology portfolio and supports its international expansion strategy Five Prime’s …

Amgen to Acquire Five Prime for ~$1.9B Read More »

Amgen’s $1.9B Five Prime deal adds to cancer drug pipeline and Asia strategy

The acquisition brings Amgen a novel Phase 3-ready drug for gastric cancers. For Five Prime Therapeutics, the deal is a lifeline following a series of clinical and financial setbacks that left much of the biotech’s fortunes resting on its lead antibody drug.

Amgen Reports Results of Blincyto (blinatumomab) in P-III Study for Relapsed Acute Lymphoblastic Leukemia in Pediatric Patients

Shots: The P-III 20120215 study involves assessing of Blincyto vs SoC consolidation CT before alloHSCT in pediatric patients with high-risk first relapsed B-cell ALL. The findings were published in JAMA Results: @median follow-up 22.4mos., patients that are alive and event-free (69% vs 43%); patients achieved MRD negative remission (93% vs 24%); @36mos. OS was (81.1% …

Amgen Reports Results of Blincyto (blinatumomab) in P-III Study for Relapsed Acute Lymphoblastic Leukemia in Pediatric Patients Read More »

AstraZeneca and Amgen Report Results of Tezepelumab in P-III NAVIGATOR Trial for Severe Asthma

Shots: The P-III NAVIGATOR study involves assessing Tezepelumab + SOC vs PBO + SOC in 1061 adults (18–80yrs.) & adolescents (12–17yrs.) with severe, uncontrolled asthma, who were receiving treatment with medium/high dose ICS + at least 1 additional controller medication with/ out OCS The trial met its 1EPs i.e. 56% reduction in AAER @52wks. in …

AstraZeneca and Amgen Report Results of Tezepelumab in P-III NAVIGATOR Trial for Severe Asthma Read More »

AZ trumpets tezepelumab data as filing for severe asthma looms

AstraZeneca says full data from the NAVIGATOR trial of tezepelumab in severe asthma keep it on course to file for approval in the first half of this year, with a broader indication than rival biologic drugs.  Top-line data were reported last year, but a presentation at the American Academy of Asthma Allergy & Immunology (AAAAI) …

AZ trumpets tezepelumab data as filing for severe asthma looms Read More »

PharmaShots Weekly Snapshots (Feb 22- 26, 2021)

Regeneron Reports IDMC Clearance of Efficacy for REGEN-COV (Casirivimab + Imdevimab) in P-III COVID-19 Outpatient Outcomes Trial Published: Feb 26, 2021 | Tags: Regeneron, Reports, IDMC, Clearance, Efficacy, REGEN-COV (Casirivimab + Imdevimab), P-III, COVID-19, Outpatient, Outcomes, Trial Daiichi Sankyo Collaborates with LYSA-LYSARC-CALYM for Valemetostat in Patients with R/R B-Cell Lymphoma Published: Feb 26, 2021 | …

PharmaShots Weekly Snapshots (Feb 22- 26, 2021) Read More »

Amgen Reports sNDA Submission of Otezla (apremilast) to The US FDA’s for Adults with Mild to Moderate Plaque Psoriasis

Shots: The sNDA filing is based on P-III ADVANCE trial data, assessing Otezla (30 mg, bid) vs PBO in 595 patients in a ratio (1:1) with mild-to-moderate plaque psoriasis The P-III ADVANCE study results: @16wks., improvement in its 1EPs of sPGA score; achieve 2EPs i.e, 75% improvement in BSA, change in PASI score Otezla is …

Amgen Reports sNDA Submission of Otezla (apremilast) to The US FDA’s for Adults with Mild to Moderate Plaque Psoriasis Read More »

The Paradox of Rare: Chalking out Challenges in the Rare Disease Market

How is a Rare disease defined? Well, it depends on the geography in question, since there is no universal definition, even so, the definition revolves around the point of prevalence or incidence of rare disease. However, despite the changing attributes in the definition, there is one common ground every country faces‒challenges in mapping the patient …

The Paradox of Rare: Chalking out Challenges in the Rare Disease Market 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 »

PharmaShots Weekly Snapshot (Feb 01-05, 2021)

Reistone Report Results for SHR0302 in P-II Study to Treat Ulcerative Colitis Published: Feb 5, 2020 | Tags: Reiston, Report, Result, SHR0302, P-II, Study, Treat, Ulcerative Colitis Enzene Receives Marketing Authorization for Teriparatide (biosimilar) in India Published: Feb 5, 2020 | Tags: Enzene, Receives, Marketing Authorization, Teriparatide (biosimilar), India Johnson & Johnson Reports EUA Submission …

PharmaShots Weekly Snapshot (Feb 01-05, 2021) Read More »

Amgen’s Sotorasib Receives NMPA’s Breakthrough Therapy Designation in China for the Treatment of Advanced NSCLC With KRAS G12C Mutation

Shots: The BT designation is based on P-II CodeBreaK 100 study assessing Sotorasib in 126 patients with KRAS G12C-mutated locally advanced or metastatic NSCLC who have received at least one prior systemic therapy. The findings will be presented at the IASLC 2020 WCLC Presidential Symposium The company is currently recruiting in a P-III study (CodeBreaK …

Amgen’s Sotorasib Receives NMPA’s Breakthrough Therapy Designation in China for the Treatment of Advanced NSCLC With KRAS G12C Mutation Read More »

PharmaShots Weekly Snapshots (Jan 25- 29, 2021)

Roche Collaborate with Cambridge Quantum Computing to Develop Quantum Algorithm for Drug Discovery and Development Published: Jan 29, 2020 | Tags: Roche, Collaborate, Cambridge Quantum Computing, Develop, Quantum Algorithm, Drug, Discovery, Development Janssen Reports Results of Amivantamab in P-I CHRYSALIS Study for Metastatic or Unresectable NSCLC and EGFR Exon 20 Insertion Mutations Published: Jan 29, 2020 …

PharmaShots Weekly Snapshots (Jan 25- 29, 2021) Read More »

Amgen Report Results of Sotorasib in P-II Study for KRAS G12C-Mutated Advanced NSCLC

Shots: The P-II cohort of the CodeBreaK 100 clinical study involves assessing Sotorasib (AMG 510, 960mg, qd) in 126 patients with KRAS G12C-mutated advanced NSCLC. The findings will be presented at the IASLC 2020 WCLC Results: @median follow up of 12.2 mos., ORR (37.1%); DCR (80.6%); mDoR (10 mos.), PFS (6.8 mos.). Median tumor shrinkage …

Amgen Report Results of Sotorasib in P-II Study for KRAS G12C-Mutated Advanced NSCLC Read More »

Insights+ Key Biosimilars Events of December 2020

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. Hence, the providers are more likely to adopt biosimilars as a “reference …

Insights+ Key Biosimilars Events of December 2020 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 »

Amgen’s Enbrel heads ICER list of unjustified US price rises

US cost effectiveness watchdog ICER found 10 examples of substantial price rises for top-selling medicines in 2019, and concluded that seven of those were not backed by any clinical evidence. The cost to the American taxpayer from those increases? Around $1.2 billion for the seven drugs alone, says the organisation, which also found that for …

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Amgen Collaborates with Evoq to Develop Novel Therapies for Autoimmune Disorders

Shots: Evoq to receive ~$240M up front & milestones along with royalties on the sales of therapies emerges from the collaboration The companies collaborated on preclinical development, while Amgen will be responsible for clinical development and commercialization The collaboration will bolster Amgen’s autoimmune offerings as its portfolio contains innovative medicines, including Otezla and Enbrel, and …

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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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Amgen hands off leprosy, TB candidate to Australian non-profit

Amgen has decided that a drug for leprosy and tuberculosis it inherited as part of its acquisition of Celgene’s psoriasis blockbuster Otezla last year would fare better in the hands of a non-profit company, dedicated to bringing affordable medicines to poorer countries. AMG 634 – a PDE4 inhibitor being investigated for TB and leprosy complication …

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AZ, Amgen’s asthma hope tezepelumab flunks phase 3 trial

AstraZeneca and Amgen looked on course to cruise to approval of their severe asthma drug tezepelumab with a pair of positive clinical trials, but the failure of a third threatens to derail the programme. The new study – called SOURCE – was supposed to back up the encouraging readouts from the phase 3 NAVIGATOR trial …

AZ, Amgen’s asthma hope tezepelumab flunks phase 3 trial Read More »

PharmaShots Weekly Snapshots (Dec 14-18, 2020)

Sandoz to Launch Hyrimoz (biosimilar, adalimumab) in Canada Published: Dec 17, 2020 | Tags: Authorization, Biosimilar, canada, health, Humira, Hyrimoz, Launch, receives, Sandoz Amgen’s Riabni (biosimilar, rituximab) Receives the US FDA’s Approval for Multiple Diseases Published: Dec 17, 2020 | Tags: Adult, Amgen, approval, Biosimilar, CLL, GPA, MPA, NHL, patients, receives, RIABNI, Rituxan, Rituximab, rituximab-arrx, …

PharmaShots Weekly Snapshots (Dec 14-18, 2020) Read More »

Amgen’s Riabni (biosimilar, rituximab) Receives the US FDA’s Approval for Multiple Diseases

Shots: The approval is based on trial assessing Riabni (375 mg/m2, IV) vs Rituxan once weekly for 4wks. followed by dosing @12wks. & 20wks. in 256 patients in a ratio (1:1) with grade 1, 2, or 3a follicular B-cell NHL & low tumor burden The WAC of Riabni will be 23.7% lower than the Rituxan …

Amgen’s Riabni (biosimilar, rituximab) Receives the US FDA’s Approval for Multiple Diseases Read More »

Amgen files KRAS trailblazer sotorasib with FDA for lung cancer

Amgen has filed its groundbreaking KRAS inhibiting drug sotorasib with the FDA for a group of lung cancer patients with an aggressive form of the disease. The drug was the first targeted at the mutation known as KRAS to show activity in the clinic and provided the biggest talking point at the American Society of …

Amgen files KRAS trailblazer sotorasib with FDA for lung cancer Read More »

Amgen Reports NDA Submission of Sotorasib to the US FDA for Advanced/Metastatic NSCLC With KRAS G12C Mutation

Shots: The NDA submission is based P-II CodeBreaK 100 study assessing Sotorasib in patients with KRAS G12C-mutated NSCLC prior treated with CT and immunotherapy The study provided durable anticancer activity with a positive benefit-risk profile The US FDA has reviewed the NDA under RTOR pilot program, which aims to explore efficient review process that ensures …

Amgen Reports NDA Submission of Sotorasib to the US FDA for Advanced/Metastatic NSCLC With KRAS G12C Mutation 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 »

Amgen’s Sotorasib Receives the US FDA’s Breakthrough Therapy Designation for Advanced or Metastatic NSCLC with KRAS G12C Mutation

Shots: The BT designation is based on P-II CodeBreaK 100 study assessing Sotorasib in patients with advanced NSCLC with KRAS G12C mutation whose cancer had progressed despite prior treatment with CT and/or immunotherapy The company is currently recruiting in a P-III study (CodeBreaK 200) assessing sotorasib vs docetaxel in patients with KRAS G12C-mutated NSCLC. Amgen …

Amgen’s Sotorasib Receives the US FDA’s Breakthrough Therapy Designation for Advanced or Metastatic NSCLC with KRAS G12C Mutation Read More »

Member of COVID R&D Alliance Report the First Patient Enrollment in COMMUNITY Study

Shots: Amgen, UCB, and Takeda reported that the first patient has been enrolled in the COMMUNITY trial. The study will test whether Amgen’s Otezla, Takeda’s lanadelumab, and UCB’s zilucoplan can reduce the severity of COVID-19 in hospitalized patients by moderating the immune system’s response to the disease The focus of the trial is to identify …

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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 »

AstraZeneca and Amgen Report Results of Tezepelumab in P-III NAVIGATOR for Asthma

Shots: The P-III NAVIGATOR study involves assessing Tezepelumab + SOC vs pbo + SOC in adults (18–80yrs.) & adolescents (12–17yrs.) with severe, uncontrolled asthma, who were receiving treatment with medium/high dose ICS + at least 1 additional controller medication with or without OCS Trial met its 1EPs i.e. reduction in AAER @52wks. in the overall …

AstraZeneca and Amgen Report Results of Tezepelumab in P-III NAVIGATOR for Asthma Read More »

PharmaShots Weekly Snapshot (Nov 02-06, 2020)

AstraZeneca’s Brilinta (ticagrelor) Receives the US FDA’s Approval to Reduce the Risk of Stroke in Patients with an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack Published: Nov 6, 2020 | Tags: AstraZeneca, Brilinta, ticagrelor, Receives, US FDA, Approval, Acute, High,Risk, Transient, Ischaemic, Stroke Novo Nordisk to Acquire Emisphere Technologies for $1.8B Published: Nov 6, …

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Novartis’ Aimovig tops topiramate in migraine face-off

Novartis’ injectable migraine prevention antibody Aimovig has been shown to be more effective than topiramate – a go-to oral therapy for people with chronic migraine – in a head-to-head trial. The HER-MES trial found that Aimovig (erenumab) was more effective at preventing migraine attacks and also better tolerated than topiramate, a generic epilepsy drug which …

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BMS’ deucravacitinib psoriasis pill outperforms Amgen’s Otezla in phase 3

Bristol-Myers Squibb could be on the verge of a major coup in psoriasis after its deucravacitinib pill outperformed Amgen’s rival Otezla. BMS had to sell off Otezla (apremilast) as a condition of its merger with Celgene and made Amgen pay $13.4 billion in cash for the popular pill treatment, which is not quite as effective …

BMS’ deucravacitinib psoriasis pill outperforms Amgen’s Otezla in phase 3 Read More »

Top 20 Immunology Companies Based 2019 Immunology Segment Revenue

Immunology is an important branch of science which deals with the study of the immune system. The immune system is a highly regulated and balanced system and when the balance is disturbed, the disease can result. A lot of this work has importance in the development of new therapies and treatments that can handle or …

Top 20 Immunology Companies Based 2019 Immunology Segment Revenue Read More »

Amgen Report Mixed Results of Omecamtiv Mecarbil in P-lll GALACTIC-HF Study for Heart Failure

Shots: The P-lll GALACTIC-HF study involves the assessing of Omecamtiv mecarbil (25mg, bid with the maintenance dose of 50 mg, 37.5mg, or 25mg, bid) vs PBO in 8,256 patients with HFrEF Result: The study met its 1EPs of reduction in CV death or HF events (HF hospitalization and other urgent treatment for HF) while the …

Amgen Report Mixed Results of Omecamtiv Mecarbil in P-lll GALACTIC-HF Study for Heart Failure 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 »

Amgen announces ‘positive’ Phase II lung cancer results for cancer drug with hard-to-reach target

The company did not provide data, but said results for patients who received sotorasib at the 960mg dose were consistent with those seen in the Phase I portion of the Phase I/II study, which showed an overall response rate of 35.3%. ……

Amgen Report Results of Sotorasib in P-II CodeBreaK 100 Study for Advanced Non-Small Cell Lung Cancer

Shots: The P-ll CodeBreaK 100 study involves assessing of Sotorasib (proposed INN for AMG 510, 960mg) in 126 patients with KRAS G12C-mutant advanced NSCLC, whose cancer had progressed despite prior treatment with CT and/or immunotherapy Result: ORR is consistent with previously reported P-I study while other measures of efficacy including DoR are promising and 50%+ …

Amgen Report Results of Sotorasib in P-II CodeBreaK 100 Study for Advanced Non-Small Cell Lung Cancer Read More »

Amgen Report Five Year Data of Aimovig (erenumab-aooe) in Open-Label Treatment Period of P-II Study for Episodic Migraine

Shots:   The OLE P-II study involves assessing of Aimovig monthly (70mg) vs PBO in 383 eligible adult patients with an episodic migraine for 12wks. 250 patients increasing their dosage to 140mg monthly after a protocol amendment to assess the long-term safety of the higher dose The results of the OLE study showed the therapy helped …

Amgen Report Five Year Data of Aimovig (erenumab-aooe) in Open-Label Treatment Period of P-II Study for Episodic Migraine Read More »

Platform study designed to rapidly screen potential Covid-19 drugs enrolls first patients

Three of the companies making drugs used in the Phase II I-SPY COVID-19 study – Amgen, AbbVie and Takeda – announced the patient enrollments Monday. The study, which will enroll up to 1,500 critically ill patients, could test around 10 drugs.

Top 20 Prescription Drugs Based on 2019 Revenue

The average life expectancy span of Human Beings are increased due to better medical facilities and drugs developed by Biopharma companies. Pharmaceutical products or drugs or medicines are being produced for a wide range of medical sectors. It includes the lifesaving drugs or the major therapy area including immunology, cardiology, and neurology but are they …

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