Category: Amgen

  • Amgen eyes swift move to ph3 for cardiovascular drug olpasiran

    Amgen is planning to push its olpasiran candidate for reducing lipoprotein(a) into phase 3 as quickly as possible as it tries to catch up with a rival programmes at Novartis. The US biotech has just reported phase 2 trial results with the small, interfering RNA (siRNA) gene silencing drug showing that it an cause a […]

  • Mirati heads for FDA verdict on KRAS drug with new data

    Mirati Therapeutics will hear from the FDA on its KRAS inhibitor adagrasib later this year, hoping to compete with first-to-market rival Lumakras from Amgen. However, new data due to be presented at ASCO suggest that could be challenging. In a phase 2 trial, adagrasib achieved an overall response rate of 43% in 112 patients with […]

  • AACR: Novartis joins the KRAS clan, eyeing swift move to phase 3

    Novartis has joined the select cadre of drugmakers developing KRAS inhibitors for cancer, opening its account with phase 1b data on JDQ443 showing efficacy in KRAS-mutated non-small cell lung cancer (NSCLC). The results – presented at the American Association of Cancer Research (AACR) congress – set Novartis off in pursuit of Amgen, whose Lumakras (sotorasib) […]

  • NICE ends UK access disparity to osteoporosis drug Evenity

    NICE has reversed its stance on UCB and Amgen’s severe osteoporosis therapy Evenity, saying out can be prescribed on the NHS for women with the disease in England and Wales who are at high risk of fractures. The move – which comes after an agreement by UCB to reduce the price of the drug – […]

  • Amgen eyes pancreatic cancer use for its pathfinder KRAS drug

    Armed with new clinical trial results, Amgen is expanding studies of its KRAS inhibitor Lumakras in pancreatic cancer, as it tries to extend the label for the first-in-class drug beyond its current use in non-small cell lung cancer (NSCLC). Data from the CodeBreaK 100 phase 1/2 trial showed “encouraging and clinically meaningful anticancer activity” for […]

  • Amgen grabs EU approval for pathfinder KRAS drug Lumykras

    Amgen now has regulatory approval on both sides of the Atlantic for Lumykras, the culmination of many years of effort to bring a drug to market that inhibits KRAS – a cancer target that for a long time was considered “undruggable”. The European Commission has approved Lumykras (sotorasib) as a monotherapy for adults with advanced […]

  • Amgen pledges $1.9bn to alliance with AI specialist Generate

    Fresh from a sizeable funding round that raised $370 million, artificial intelligence-based drug discovery firm Generate Biomedicines has just signed its first major partnering deal with Amgen. The machine learning specialist – founded by venture capital firm Flagship Pioneering in 2018 – is getting $50 million upfront to kick off the alliance, with another £370 […]

  • Novartis bags elusive US approval for cholesterol drug inclisiran

    At its second attempt, Novartis has won FDA approval for its cholesterol lowering drug inclisiran, which can reduce levels with just two injections a year. The FDA has approved the drug under the Leqvio trade name as an adjunct to maximum-dose statin drugs for people who need further LDL-cholesterol reduction to reach targets, a year […]

  • Amgen builds Otezla’s psoriasis label as rival BMS looms large

    Amgen has won FDA approval for a stronger label for its oral plaque psoriasis therapy Otezla, as it prepares for competition from Bristol-Myers Squibb’s much-touted rival deucravacitinib, which could make its debut next year. The agency has cleared Otezla (apremilast) for the treatment of adult patients with plaque psoriasis, regardless of the severity of their […]

  • Relief for AZ, Amgen as FDA okays severe asthma hope tezepelumab

    The FDA has approved AstraZeneca and Amgen’s severe asthma hope tezepelumab, exonerating the drugmakers’ decision to press ahead with a regulatory filing despite a failed phase 3 trial. Another phase 3 study supported the efficacy of the first-in-class TSLP inhibitor as an add-on treatment for people aged 12 and over with severe asthma, as did […]

  • FDA sets Sept review date for BMS’ psoriasis drug deucravacitinib

    The FDA has kicked off its review of Bristol-Myers Squibb’s psoriasis therapy deucravacitinib, setting an action date of 1 September next year, as the EU and Japanese regulators also start their appraisals of the drug. If approved, deucravacitinib would become the first tyrosine kinase 2 (TYK2) inhibitor approved for the treatment of any disease, said […]

  • PharmaShots Weekly Snapshots (November 15 – 19, 2021)

    Jazz’ Sunosi (solriamfetol) Receives NICE Recommendation for the Treatment of Excessive Daytime Sleepiness Caused by Narcolepsy Published: Nov 19, 2021 | Tags: Jazz, Sunosi, solriamfetol, NICE, Recommendation, Excessive Daytime Sleepiness, Narcolepsy Antengene’s Selinexor (ATG-010) Receives NMPA’s IND Approval for P-I/II SWATCH Study to Treat Non-Hodgkin Lymphoma Published: Nov 19, 2021 | Tags: Antengene, Selinexor, ATG-010, […]

  • Merck’s oral PCSK9 drug matches injectables in early trials

    Injectable antibodies targeting PCSK9 have failed to take off as expected in the cholesterol-lowering market, but Merck & Co hopes to do much better with an oral alternative. MK-0616 has been shown to reduce LDL cholesterol by a similar margin to injectables sold by Amgen and Sanofi/Regeneron – as well as Novartis’ longer-lasting RNAi therapy […]

  • 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, […]

  • Failed IBD trial dents confidence in BMS’ deucravacitinib

    Bristol-Myers Squibb’s hopes of extending the use of its highly-anticipated psoriasis pill deucravacitinib into inflammatory bowel disease (IBD) have been hit by a mid-stage failure in ulcerative colitis. Confidence in the first-in-class tyrosine kinase 2 inhibitor has been riding high after a pair of phase 3 trials hit the mark in psoriasis, setting up regulatory […]

  • Allied with Amgen and backed by $500M, Neumora brings data science to brain drugs

    Neumora Therapeutics unveiled $500 million in capital and a research partnership with Amgen. The startup analyzes neurological data to inform its drug research and development; President and Chief Operating Officer Lori Lyons-Williams said researching psychiatric drugs and neurodegenerative drugs within the same company allows brain insights from one area to inform the other.

  • Amgen Signs a R&D Collaboration with Neumora to Advance Novel Precision Therapies for Neuropsychiatric and Neurodegenerative Diseases

    Shots: Neumora has received a $100M as an equity investment and obtains an exclusive global right to develop and commercialize Amgen programs targeting casein kinase 1 delta and glucocerebrosidase for neurodegenerative diseases The collaboration will utilize Neumora’s precision neuroscience platform with Amgen’s deCODE human genetics capabilities to boost innovative therapies for the treatment of brain disease Neumora’s […]

  • 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’ 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 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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, […]

  • 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 […]

  • 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−) […]

  • 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 […]

  • 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: […]

  • 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 […]

  • 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 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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: […]

  • 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 […]

  • 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 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 […]

  • 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: […]

  • 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 […]

  • 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 + […]

  • 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

    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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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: […]

  • 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 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 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% […]

  • 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) […]

  • 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 | […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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, […]

  • 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 […]

  • 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 […]

  • 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. […]

  • 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 […]

  • 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 […]

  • 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, […]

  • 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 […]

  • 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, […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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, […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]