Archive


Category: AbbVie

  • Aldeyra builds case for troubled dry eye drug reproxalap

    Prospects for Aldeyra’s dry eye disease candidate reproxalap were hit last month after the drug failed to hit its primary objective in a phase 3 trial, but the company isn’t giving up, and has new data showing an improvement over Novartis rival therapy Xiidra. Patients treated with reproxalap reported significantly less eye discomfort and itching […]

  • FDA gives AbbVie’s c-Met lung cancer ADC a breakthrough tag

    The FDA thinks an antibody-drug conjugate (ADC) developed by AbbVie could set new standards in treatment for certain patients with lung cancer, awarding the drug breakthrough status. Teliso-V (telisotuzumab vedotin) is pitching to become the first targeted cancer treatment for people with non-small cell lung cancer (NSCLC) whose tumours overexpress c-Met. The c-Met protein thought […]

  • Leo puts target on Dupixent in US as FDA clears tralokinumab

    Sanofi and Regeneron have another challenger to their big-selling drug Dupixent for atopic dermatitis, now that the FDA has approved Leo Pharma’s rival antibody tralokinumab. IL-13 inhibitor tralokinumab has been cleared by the US regulator as Adbry as a treatment for moderate-to-severe atopic dermatitis in adults who can’t control symptoms using topical prescription therapies. The […]

  • AbbVie prices first presbyopia drug Vuity at $80 per month

    AbbVie has ended speculation about what it will charge for its newly-approved Vuity therapy for  presbyopia, a sight condition characterised by difficulty in focusing on near objects. The company told CBS it will charge around $80 for a 30-day supply of Vuity, a once-daily eyedrop formulation of muscarinic cholinergic agonist pilocarpine intended as an alternative […]

  • 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, […]

  • AbbVie’s Humira tops ICER’s list of unwarranted price hikes again

    With drug pricing controls back on the legislative table in the US, the influential Institute for Clinical and Economic Review (ICER) has published its third report on “unsupported” price increases – with AbbVie’s Humira top of the list. ICER estimates that price hikes for Humira (adalimumab) increased US healthcare spending by $1.4 billion in 2020, […]

  • 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, […]

  • Pharma group will develop ‘digital endpoint’ for atopic dermatitis

    The development of digital medicine requires valid endpoints that can be used in clinical trials, and a consortium of pharma companies has just identified a new one for atopic dermatitis. Working with the Digital Medicine Society (DiMe), the drugmakers – AbbVie, Janssen, Novartis, Pharma and UCB – will work on the development of nocturnal scratch […]

  • AbbVie claims first FDA okay for presbyopia drug therapy

    The FDA has approved the first and so far only pharmacological treatment for presbyopia, a sight condition that typically starts in middle age and involves difficulty in focusing on near objects. The approval has been granted to Vuity (formerly AGN-190584), a one-daily eyedrop formulation of muscarinic cholinergic agonist pilocarpine developed by AbbVie’s Allergen unit that […]

  • PharmaShots Weekly Snapshots (October 25 – 29, 2021)

    ADC Reports EMA’s Validation of MAA for Zynlonta to Treat R/R Diffuse Large B-Cell Lymphoma Published: 29 Oct, 2021 | Tags: ADC, EMA, MAA, Zynlonta, R/R Diffuse Large B-Cell Lymphoma Impact Receives US FDA’s IND Clearance for IMP9064 to Treat Solid Tumor Published: 29 Oct, 2021 | Tags: Impact, US, FDA, IND, IMP9064, Solid Tumor […]

  • AbbVie preps filings after ABBV-951 tops oral Parkinson’s drugs in trial

    AbbVie has reported that a subcutaneous infusion of Parkinson’s disease candidate ABBV-951 was more effective than standard oral therapy in a phase 3 trial, paving the way for regulatory filings. ABBV-951 is based on foslevodopa and foscarbidopa – delivered via a subcutaneous device once a day – with the aim of providing full 24-hour control […]

  • 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: […]

  • 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 […]

  • 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, […]

  • AbbVie’s Qulipta cleared for migraine prevention, setting up Biohaven clash

    AbbVie has added a third drug to its arsenal in the crowded migraine market, getting FDA approval for Qulipta – its once-daily oral preventive therapy for episodic migraines. Qulipta (atogepant) is AbbVie’s second oral CGRP inhibitor after Ubrelvy (ubrogepant) – which was approved for the acute treatment of migraine attacks in 2019 – and rounds […]

  • ObsEva files uterine fibroid drug in US, chasing AbbVie, Myovant

    Swiss biopharma company ObsEva has filed its oral GnRH antagonist linzagolix for the treatment of uterine fibroids in the US, hoping to expand the number of women eligible for this type of therapy. If approved, linzagolix will be the only drug in the class with a dosing regimen intended for women with uterine fibroids who […]

  • AbbVie spies potential in Regenxbio eye disease gene therapy

    AbbVie has expanded its ophthalmology pipeline via a licensing deal with Regenxbio, paying $370 million upfront to get its hands on a gene therapy for wet age-related macular degeneration (AMD) and other eye diseases. The partnership centres on RGX314, which delivers a gene coding for an antibody against VEGF – a well-established approach to treating […]

  • FDA firms up JAK inhibitor warnings after Xeljanz review

    The FDA has concluded its safety review of Pfizer’s JAK inhibitor Xeljanz and Xeljanz XR, requiring revised warnings for the drugs as well as others in the class after finding evidence of elevated risks of serious heart-related events. After looking at the data from Pfizer’s long-term, post-marketing safety study – ORAL Surveillance – the US […]

  • 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 7 Pharma Industry Leaders in 2020 By the Numbers

    Pharmaceutical companies play a vital part in our lives and in helping us to live healthier lives. The pharmaceutical industry finds, develops, manufactures, and promotes medicines or pharmaceutical drugs for usage as medications that are administered (or self-administered) to patients in order to cure, vaccinate, or relieve symptoms. Pharmaceutical companies may deal in both generic […]

  • AbbVie’s Rinvoq is first JAK drug cleared in EU for atopic dermatitis

    The FDA may be reluctant to trust JAK inhibitors, but the European Commission is more willing, and has just handed a first-in-class approval in atopic dermatitis to AbbVie’s Rinvoq. The EU regulator has cleared Rinvoq (upadacitinib) as an oral treatment for moderate to severe atopic dermatitis in adults and adolescents 12 years and older, either […]

  • 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 (Aug 09 – 13, 2021)

    Junshi and Coherus’s Toripalimab Receive the US FDA’s Breakthrough Therapy Designation as 1L Treatment of Nasopharyngeal Carcinoma Published: Aug 13, 2021 | Tags: Junshi, Coherus, Toripalimab, US, FDA, Breakthrough Therapy Designation, Nasopharyngeal Carcinoma Celltrion’s Regdanvimab (CT-P59) Receives the ANVISA’s EUA for the Treatment of COVID-19 in Brazil Published: Aug 13, 2021 | Tags: Celltrion, Regdanvimab, […]

  • 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 […]

  • AbbVie Terminates its License Agreement with Molecular Partners for Abicipar Pegol

    Shots: AbbVie has terminated the license agreement for abicipar pegol to treat nAMD and DME. Additionally, Molecular Partners will reacquire the development and commercial rights of abicipar globally Molecular Partners will put a special committee to assess the program & figure out the next steps. Additionally, the companies will continue the ongoing discovery collaboration to […]

  • FTC drops AbbVie antitrust case, but fires a parting shot at the firm

    AbbVie will not be pursued any further by the US government over allegations that it used ‘sham’ litigation to keep competition to its AndroGel testosterone replacement product off the market. The Federal Trade Commission (FTC) sad it had dropped its antitrust complaint against the company after the US Supreme Court declined to review a lower […]

  • 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 | […]

  • AbbVie, Calico raise their age-related disease alliance funding to $3.5bn

    AbbVie and Alphabet spin-out Calico Life Sciences have agreed to fund their seven-year-old partnership seeking treatments for diseases of ageing with another $500 million apiece. The collaboration with Google sister company Calico – formed in 2014 with $1.5 billion in funding and extended in 2018 with another $1 billion top up – has already resulted […]

  • AbbVie, Calico raise their age-related disease alliance funding to $3.5bn

    AbbVie and Alphabet spin-out Calico Life Sciences have agreed to fund their seven-year-old partnership seeking treatments for diseases of ageing with another $500 million apiece. The collaboration with Google sister company Calico – formed in 2014 with $1.5 billion in funding and extended in 2018 with another $1 billion top up – has already resulted […]

  • Allergen builds case for first drug therapy for presbyopia

    If you are in middle aged and find you have to hold your phone at arm’s length to read, you may have presbyopia – a difficulty focusing on close objects that is usually corrected using glasses, contact lenses or laser eye surgery. Now, there could be another alternative, in the form of eye drops administered […]

  • AbbVie Presents Results of AGN-190584 in P-III GEMINI 1 Study for Presbyopia at 2021 ASCRS

    Shots: The P-III GEMINI 1 study involves assessing AGN-190584 (pilocarpine 1.25%, qd) ophthalmic solution in 323 patients in a ratio (1:1) with presbyopia for 30days. The study demonstrated that AGN-190584 met both its 1EPs & 2EPs with patients achieving near & intermediate vision gains. In addition, AGN-190584 showed no loss of distance vision, rapid onset […]

  • PharmaShots Weekly Snapshots (June 14 – 18, 2021)

    Lineage Signs an Exclusive Option Agreement with Amasa Therapeutics to Supply and Use of Clinical-Grade Hystem Published: June 18, 2021 | Tags: Lineage, Option Agreement, Amasa Therapeutics, Clinical-Grade Hystem BioNTech Reports First Patient Dosing in P-II Clinical Trial of BNT111 to Treat Advanced Melanoma Published: June 18, 2021 | Tags: BioNTech, P-II, Clinical Trial, BNT111, […]

  • PharmaShots Weekly Snapshots (June 07 – 11, 2021)

    Vertex and CRISPR Therapeutics Present New Data of CTX001 from 22 Patients with TDT and SCD at EMA 2021 Published: June 11, 2021 | Tags: Vertex, CRISPR Therapeutics, CTX001, TDT, SCD, EMA 2021 AbbVie Reports Results of Four-Year Follow-Up Analysis in P-III CLL14 Trial for Venclyxto/Venclexta to Treat Chronic Lymphocytic Leukemia Published: June 11, 2021 […]

  • AbbVie Reports Results of Four-Year Follow-Up Analysis in P-III CLL14 Trial for Venclyxto/Venclexta to Treat Chronic Lymphocytic Leukemia

    Shots: The P-III CLL14 trial assessing the efficacy & safety of a combined regimen of Venclyxto/Venclexta + obinutuzumab vs obinutuzumab and chlorambucil in 432 patients with previously untreated CLL Results: @median follow-up of 52.4 mos., PFS rate (74% vs 35.4%) after 1 yr. fixed-duration treatment, 67% reduction in risk of disease progression or death; OS […]

  • ASCO21: AZ seeks to supplant Imbruvica in CLL with new Calquence data

    AstraZeneca has thrown down the gauntlet to AbbVie and Johnson & Johnson with new data for Calquence in chronic lymphocytic leukaemia (CLL) that it says show a safety advantage over Imbruvica – currently dominating the BTK inhibitor market. In the ELEVATE-RR study, Calquence (acalabrutinib) matched Imbruvica (ibrutinib) when it came to keeping adults with previously […]

  • 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 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 […]

  • FDA clears Myovant’s relugolix for uterine fibroids, setting up AbbVie clash

    Myovant has chalked up a second approval for its flagship drug relugolix from the FDA, becoming the first once-daily oral drug in the US to treat heavy menstrual bleeding associated with uterine fibroids.  The drug will be sold as Myfembree (relugolix) for the uterine fibroids indication, and is already available to treat prostate cancer under […]

  • AbbVie’s Venclyxto Receives the EC’s Approval for Patients with Newly Diagnosed Acute Myeloid Leukemia who are Ineligible for Intensive Chemotherapy

    Shots: The approval is based on P-III VIALE-A and P-Ib M14-358 studies. The P-III study involves assessing Venclyxto + azacitidine in patients with newly diagnosed AML who were ineligible for intensive CT and demonstrated OS (14.7mos. vs 9.6mos.), CCCR (66.4% vs 28.3%), CR (36.7% vs 17.9%) The P-Ib M14-358 trial involves assessing in Venclyxto + […]

  • Alvotech files lawsuit challenging AbbVie’s Humira patent thicket

    Biosimilars firm Alvotech has filed a lawsuit that challenges AbbVie’s legal defences surrounding the inflammatory disease drug Humira in the US. Alvotech is challenging the patent thicket surrounding Humira, a common ploy in pharma that seems to be particularly effective in the US. Several biological drugs have remained unchallenged on the US market thanks to […]

  • Allergan Aesthetics to Acquire Soliton and its Resonic Device for ~$550M

    Shots: Soliton to receive $22.60 /share in cash for its all outstanding share making the total deal value $550M The acquisition adds Soliton’s Rapid Acoustic Pulse technology platform to Allergan Aesthetics’s portfolio for improvement in appearance of cellulite in the buttocks and thighs by using rapid high-frequency sound waves to disrupt targeted cellular structures and […]

  • PharmaShots Weekly Snapshots (Apr 19 – 23, 2021)

    BMS’ Opdivo + Yervoy and Onureg Receive EC’s CHMP Positive Opinion for MPM and AML Published: Apr 23, 2021 | Tags: BMS, Opdivo, Yervoy, Onureg, Receive, EC, CHMP, Positive Opinion, MPM, AML Gilead Reports NDA Submission of Filgotinib to PMDA for Ulcerative Colitis in Japan Published: Apr 23, 2021 | Tags: Gilead, Reports, NDA, Submission, […]

  • 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 Weekly Snapshots (Apr 05 – 09, 2021)

    Evotec and Exscientia Initiate Human Clinical Trials of their Novel Immuno-Oncology Drug Published: Apr 9, 2021 | Tags: Evotec and Exscientia, Initiate, Human Clinical Trials, Novel, Immuno-Oncology Drug PlantForm Signs Research and Development Agreement with Bio-Manguinhos/Fiocruz to Develop Biosimilar Pembrolizumab Published: Apr 9, 2021 | Tags: PlantForm, Signs, Research, Development Agreement, Bio-Manguinhos/Fiocruz, Develop, Biosimilar Pembrolizumab […]

  • 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 […]

  • 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: […]

  • AbbVie Signs a Purchase Right Agreement to Acquire Mitokinin

    Shots: Mitokinin to receive an up front and will continue to develop its PINK1 activator program through completion of IND enabling studies for its lead compound. If IND-enabling studies are successful, AbbVie will have the option to acquire Mitokinin The focus of the agreement is to advance Mitokinin’s PINK1 activator program to treat PD Mitokinin’s […]

  • 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 08 – 12, 2021)

    Visby’s POC COVID-19 Test Receives the US FDA’s EUA for Use in CLIA Waived Settings Published: Feb 12, 2020 | Tags: Visby, POC, COVID-19, Test, Receives, US, FDA, EUA, Use, CLIA, Waived, Settings Takeda Collaborates with Ensoma to Accelerate Next-Generation In Vivo Gene Therapies Published: Feb 12, 2020 | Tags: Takeda, Collaborates, Ensoma, Accelerate, Next-Generation, Vivo Gene […]

  • 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 […]

  • AbbVie Signs a License Agreement with Caribou Biosciences for CAR-T Cell Therapies

    Shots: Caribou to receive $40M up front in cash & equity investment, ~$300M in development, regulatory, and launch milestones along with additional commercial milestones and global royalties AbbVie will utilize and gets exclusive rights to Caribou’s next-generation Cas12a chRDNA genome editing and cell therapy technologies to develop two new CAR-T cell therapies directed to specified […]

  • FDA holds back from action over Xeljanz safety study

    The FDA has said it will wait for additional results from last week’s trial showing an increased risk of cardiac side effects with Pfizer’s arthritis blockbuster Xeljanz before deciding on further action. The post-marketing ORAL Surveillance safety study showed that JAK inhibitor Xeljanz (tofacitinib) was associated with a higher rate of heart attacks and cancer […]

  • 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 […]

  • Bad news for Pfizer as blockbuster Xeljanz flunks safety study

    JAK inhibitor Xeljanz is one of Pfizer’s top-selling drugs, despite a ‘black box’ warning for blood clots and cancers added to its label in 2019. Now, a study designed to prove its safety has achieved the opposite. The post-marketing safety study showed that Xeljanz (tofacitinib) – used to treat rheumatoid arthritis (RA) – was associated […]

  • Bad news for Pfizer as blockbuster Xeljanz flunks safety study

    JAK inhibitor Xeljanz is one of Pfizer’s top-selling drugs, despite a ‘black box’ warning for blood clots and cancers added to its label in 2019. Now, a study designed to prove its safety has achieved the opposite. The post-marketing safety study showed that Xeljanz (tofacitinib) – used to treat rheumatoid arthritis (RA) – was associated […]

  • AZ says Calquence is a safer drug than Imbruvica

    AstraZeneca’s fast-growing BTK inhibitor Calquence is already challenging class leader Imbruvica from Johnson & Johnson/AbbVie in the treatment of chronic lymphocytic leukaemia (CLL). Now, AZ has new data suggesting its drug is less likely to cause a serious cardiac side effect. The latest study in AZ’s ELEVATE trial series showed that Calquence (acalabrutinib) matched Imbruvica […]

  • Top 20 Life Sciences Deals of 2020 by Total Deal Value

    Life sciences companies are gearing up to enter new markets as they look to secure their positions after a spate of M&A, licensing, and research partnerships in 2020 Artios partnered with Merck with an option to license up to 8 oncology programs proving to be the highest valued deal of 2020 with a total deal […]

  • 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’ 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 […]

  • 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 […]

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

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

  • AbbVie scores crucial phase 3 wins with Humira follow-up Skyrizi

    AbbVie is in a race against time as US patent expiry of its Humira inflammatory diseases blockbuster looms in 2023 – but it just scored two crucial phase 3 trial victories that could help rebuild sales when cheaper biosimilars flood the market in two years’ time. The company’s follow-up drug Skyrizi is a key plank […]

  • AbbVie begins trials of COVID-19 antibody therapy

    AbbVie is to begin clinical development of an antibody designed to neutralise the SARS-CoV-2 coronavirus after licensing the therapy in from Harbour BioMed and Utrecht University. In a joint statement, the biotech and the university said that the antibody, dubbed ABBV-47D11, will be developed for prevention and treatment of COVID-19 and related coronaviruses. AbbVie has […]

  • 5 big healthcare lawsuits of 2020

    Some of the biggest legal stories of the year include patients attempting to mount a class action lawsuit against Mayo Clinic after an employee improperly viewed more than 1,600 health records and the Supreme Court hearing opening arguments in a case challenging the constitutionality of the ACA’s individual mandate.

  • ASH: Lilly builds case for its BTK drug LOXO-305 in lymphoma

    Eli Lilly’s buyout of Loxo Oncology last year has already yielded one approved drug, and it now has a path to market for a second after BTK inhibitor LOXO-305 after reporting promising data at the American Society of Haematology (ASH) meeting. Updated results from the phase 1/2 BRUIN trial suggest that LOXO-305 could become a […]

  • PharmaShots Weekly Snapshot (Nov 30 – Dec 04, 2020)

    Richter Acquires Janssen’s Evra Transdermal Contraceptive Patch Assets for $263.5M Published: Dec 3, 2020 | Tags: Asset Purchase Agreement, Evra, Gedeon Richter, Janssen Pharmaceutical, Signs, Transdermal Contraceptive Patch Assets, Treat Jazz Pharma and PharmaMar’s Zepzelca Fail to Meet its Primary Endpoint in P-III ATLANTIS Study for SCLC Published: Dec 3, 2020 | Tags: ATLANTIS, Doxorubicin, […]

  • AbbVie Collaborates with Frontier Medicines to Develop Novel Therapies and E3 Degraders Against Difficult-to-Drug Targets

    Shots: Frontier to receive ~$100M including $55M upfront and remaining as milestones within the first 12mos. of collaboration and is eligible for development & commercial milestone that could exceed $1B, along with royalties on commercialized products Following the completion of pre-clinical development, AbbVie will lead global development and commercialization activities and costs for the programs […]

  • NICE backs chemo-free CLL combination from AbbVie and Roche

    Previously treated patients with chronic lymphocytic leukaemia (CLL) in England will get a chemotherapy-free treatment option after NICE recommended NHS funding for a combination of AbbVie’s Venclyxto and Roche’s Gazyva. The decision by NICE allows for the 12-month fixed duration treatment option based on data from the phase 3 CLL14 trial. This showed the combination […]

  • AbbVie Reports Results of SKYRIZI (risankizumab) in P-III LIMMitless Study in Patients with Moderate to Severe Plaque Psoriasis

    Shots: The P-III LIMMitless study is designed to evaluate the long-term safety & efficacy assessing risankizumab (150 mg q12wks.) continuous risankizumab with a loading dose in adults with moderate to severe plaque psoriasis. The analysis includes integrated data from five P-II & III studies (ultIMMa-1, ultIMMa-2, SustaIMM, IMMvent and NCT03255382) and the LIMMitless study Results: […]

  • PharmaShots’ Key Highlights of Third Quarter 2020

    The third quarter of 2020 was flooded with major acquisitions in the pharma and biotech industry along with multiple approvals. Starting with the latest acquisitions, Gilead acquired Immunomedics for ~$21B, Illumina acquired GRAIL for ~$8B, J&J acquired Momenta Pharmaceuticals for $6.5B and Nestlé acquired Aimmune Therapeutics for $2.6B, Sanofi acquired Principia Biopharma for ~$3.68B  Apart […]

  • PharmaShots Weekly Snapshot (Oct 19 – 23, 2020)

    Akebia Presents Results of Vadadustat in P-lll INNO2VATE Program for Anemia Due to CKD at ASN Kidney Week Published: Oct 23, 2020 | Tags: Akebia, Results, Vadadustat, P-lll, INNO2VATE Global Study, Anemia, Chronic Kidney Disease Sanifit Presents Results of SNF472 for the Treatment of Vascular Calcification at ASN Kidney Week 2020 Published: Oct 22, 2020 […]

  • 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 […]

  • FDA grants full approval for Roche/AbbVie’s Venclexta in AML combination therapies

    Combination therapies involving Roche and AbbVie’s cancer drug Venclexta have been formally approved by the FDA in acute myeloid leukaemia, following supportive data from late-stage studies. The combination therapies had previously been marketed following accelerated approval in November 2018 on the basis of early stage results. But accelerated approval is only a temporary measure and […]

  • PharmaShots Weekly Snapshot (Sept 28 – Oct 1, 2020)

    Sobi & Selecta Report Results of SEL-212 in P-II COMPARE Study for Chronic Refractory Gout Published: Oct 1, 2020 | Tags: Chronic Refractory Gout, COMPARE Study, Important Clinical Improvement, P-II, patients, reports, results, SEL-212, Selecta Biosciences, Sobi 2. Moderna’s mRNA-1273 COVID-19 Vaccine Demonstrate Immune Responses in Older Adults Published: Oct 1, 2020 | Tags: COVID-19, […]

  • AbbVie Terminates Tau and ASN Agreement with Voyager Signed in 2018 and 2019

    Shots: Voyager retains full rights to the vectorization technology and novel vectorized Abs emerges from the collaboration and has the right to pursue vectorized Ab programs targeting tau and alpha-synuclein alone or in collaboration with another partner As per collaboration agreements, Voyager has received an upfront payment to perform research and preclinical development of vectorized […]

  • Gilead eyes takeover of cancer biotech Tizona, despite its ties to AbbVie

    Gilead Sciences’ run of oncology-focused deals has continued with an option to buy cancer immunotherapy specialist Tizona – even though the biotech’s lead drug candidate is already partnered with AbbVie. Gilead is paying $300m for a 49.9% stake in Tizona, and taking an option to buy the company outright for another $1.25 billion. Tizona is […]

  • Gilead to Acquire Tizona’s Stakes for $300M

    Shots: Gilead invests $300M to obtain 49.9% equity interest in Tizona and receives an exclusive option to acquire remaining stakes of Tizona for up to an additional $1.25B that includes an option exercise fee and milestones. The transaction is expected to be closed in Q3’20 Gilead can exercise its option following the results of a […]

  • 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 […]