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… Read More »PharmaShots Weekly Snapshots (Apr 19 – 23, 2021)
Shots: The approval is based on P-III ENVISION I study that involves assessing the efficacy, safety, and PK of Humira (SC) in pediatric patients aged 4-17yrs. with mod. to sev. UC The study met its co-1EPs of clinical remission @8wks, patients who responded @8wks, achieved… Read More »AbbVie’s Humira (adalimumab) Receives Health Canada’s Approval for Pediatric Patients with Active Ulcerative Colitis
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… Read More »PharmaShots’ Key Highlights of First Quarter 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 |… Read More »PharmaShots Weekly Snapshots (Apr 05 – 09, 2021)
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… Read More »Top 20 BioPharma Companies based on 2020 Total Revenue
Shots: The submission is based on two P-III studies KEEPsAKE-1 & -2 studies involves assessing Skyrizi (150mg) vs PBO in adult patients with active PsA who had an inadequate response or intolerant to biologic therapy and/or non-biologic DMARDs respectively The 1EP and 2EP of both… Read More »AbbVie Submits Regulatory Applications to the US FDA and EMA for Skyrizi (risankizumab) to Treat Psoriatic Arthritis
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… Read More »PharmaShots Weekly Snapshots (Mar 29 – Apr 02, 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… Read More »PharmaShots Weekly Snapshots (Mar 01 – 05, 2021)
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… Read More »AbbVie Signs a Purchase Right Agreement to Acquire Mitokinin
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… Read More »PharmaShots Weekly Snapshots (Feb 22- 26, 2021)
Shots: The approval is based on P-III ENVISION I study that involves assessing Humira (SC) vs PBO in pediatric patients aged 4-17yrs. with mod. to sev. UC The study demonstrated that 60% of patients taking the higher dosage achieved clinical remission per PMS @8wks induction… Read More »AbbVie’s Humira (adalimumab) Receives the US FDA’s Approval to Treat Pediatric Patients with Ulcerative Colitis
Shots: The P-III U-ACCOMPLISH induction study involves assessing upadacitinib (45 mg, qd) vs PBO in patients with mod. to sev. UC The study met its 1EPs @8wks. i.e, patients achieved clinical remission (per Adapted Mayo Score) (31% vs 4%); met its 2EPs i.e clinical response… Read More »AbbVie Report Results of Rinvoq (upadacitinib) in Second P-III Induction Study for Ulcerative Colitis
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… Read More »PharmaShots Weekly Snapshots (Feb 08 – 12, 2021)
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… Read More »Top 20 Biopharma Deal Terminations of 2020 Based on Total Deal Value
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… Read More »AbbVie Signs a License Agreement with Caribou Biosciences for CAR-T Cell Therapies
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… Read More »FDA holds back from action over Xeljanz safety study
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… Read More »PharmaShots Weekly Snapshots (Jan 25- 29, 2021)
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)… Read More »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)… Read More »Bad news for Pfizer as blockbuster Xeljanz flunks safety study
Shots: The approval is based on data from three pivotal clinical trials P-II SELECT-PsA 1& 2 and P-II/III SELECT-AXIS 1 involves assessing of Rinvoq in patients with PsA and AS. The studies demonstrated that it met all 1EPs & 2EPs with a safety profile consistent… Read More »AbbVie’s Rinvoq (upadacitinib) Receives the EC’s Approval for Psoriatic Arthritis and Ankylosing Spondylitis
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… Read More »AZ says Calquence is a safer drug than Imbruvica
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… Read More »Top 20 Life Sciences Deals of 2020 by Total Deal Value
In its report released last Tuesday, a nonprofit drug pricing research group claims that seven drugs have prices that do not align with any newly discovered increase in clinical benefit, leading to over $1.2 billion in excess drug spending in 2019, alone.
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… Read More »PharmaShots Weekly Snapshots (Jan 11 – 15, 2021)
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… Read More »PharmaShots’ Key Highlights of Fourth Quarter 2020
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… Read More »Amgen’s Enbrel heads ICER list of unjustified US price rises
Shots: The P-III ADVANCE & MOTIVATE studies involves assessing of Risankizumab (600/1200mg) vs PBO in adult patients with mod. to sev. CD who had an inadequate response/ were intolerant to conventional and/or biologic therapy & patients who had responded inadequately or were intolerant to biologic… Read More »AbbVie Reports Results of Skyrizi (risankizumab) in P-III Induction Studies for Crohn’s Disease
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:… Read More »PharmaShots Weekly Snapshot (Jan 4-8, 2020)
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’… Read More »AbbVie scores crucial phase 3 wins with Humira follow-up Skyrizi
Shots: The two P-III studies KEEPsAKE-1 & -2 involves assessing Skyrizi (150mg) vs PBO followed by risankizumab (150mg, @24wks.) in patients with active PsA who had an inadequate response or intolerant to at least one biologic therapy and/or non-biologic DMARDs respectively Results: ACR20 (57% &… Read More »AbbVie Reports Results of Skyrizi (Risankizumab) in P-III Studies for Active Psoriatic Arthritis
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… Read More »AbbVie begins trials of COVID-19 antibody therapy
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… Read More »5 big healthcare lawsuits of 2020
Shots: AbbVie reported pooled analysis and long-term integrated analysis of the P-lll RESONATE-2 and ILLUMINATE study evaluating Imbruvica as 1L treatment of high-risk patients with CLL. The data is presented at ASH 2020 Results from an integrated analysis of two clinical trials ~6.5 yrs. of… Read More »AbbVie Reports Results of Imbruvica (ibrutinib) in Two P-III Studies as 1L Treatment for Chronic Lymphocytic Leukemia
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… Read More »ASH: Lilly builds case for its BTK drug LOXO-305 in lymphoma
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… Read More »PharmaShots Weekly Snapshot (Nov 30 – Dec 04, 2020)
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… Read More »AbbVie Collaborates with Frontier Medicines to Develop Novel Therapies and E3 Degraders Against Difficult-to-Drug Targets
Shots: The approval of additional indication is based on a P-lll study involve the assessing the efficacy and safety of Humira targeting the patients with active ulcers in Japan who were diagnosed with PG but were not sufficiently effective with local treatment, or who were… Read More »AbbVie and Eisai’s Humira (adalimumab) Receives MHLW’s Approval for Pyoderma Gangrenosum
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… Read More »NICE backs chemo-free CLL combination from AbbVie and Roche
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,… Read More »AbbVie Reports Results of SKYRIZI (risankizumab) in P-III LIMMitless Study in Patients with Moderate to Severe Plaque Psoriasis
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… Read More »PharmaShots’ Key Highlights of Third Quarter 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… Read More »PharmaShots Weekly Snapshot (Oct 19 – 23, 2020)
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… Read More »Top 20 Immunology Companies Based 2019 Immunology Segment Revenue
Shots: The company submitted applications to the US FDA & EMA seeking approval for Rinvoq (upadacitinib) for adults (15mg/30mg, qd) and adolescents (15mg, qd) with moderate to severe AD. The submission is based on three pivotal P-III studies and was studied without TCS in Measure… Read More »AbbVie Submits Regulatory Applications to the US FDA and EMA for Rinvoq (upadacitinib) to Treat Atopic Dermatitis
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… Read More »FDA grants full approval for Roche/AbbVie’s Venclexta in AML combination therapies
Shots: The approval is based on P-lll VIALE-A & VIALE-C studies and updated data from the P-Ib M14-358 and the P-I/II M14-387 studies. The P-III studies involve assessing of Venclexta (400mg & 600mg, qd) + azacitidine & LDAC vs PBO + azacitidine & LDAC in… Read More »AbbVie and Roche’s Venclexta (venetoclax) Receive the US FDA’s Approval for Acute Myeloid Leukemia
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… Read More »PharmaShots Weekly Snapshot (Sept 28 – Oct 1, 2020)
Shots: AbbVie and Harvard University enter a $30M research alliance to study & develop novel therapies against emergent viral infections with an initial focus on coronavirus and the viruses leading to hemorrhagic fever The focus of the collaboration is to integrate fundamental biology into the… Read More »AbbVie and Harvard University Collaborate to Develop Novel Therapies Against Emergent Viral Diseases
Shots: Morphic will receive a $20M as license fee and is eligible to receive milestones and royalties on sales of any commercialized therapy while AbbVie has exercised a license option under the companies’ R&D collaboration agreement to develop Morphic’s αvβ6 integrin inhibitors for fibrotic diseases… Read More »AbbVie Exercises its Option to License Morphosys’ αvβ6 Integrin Inhibitor Program for Fibrotic Disease
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… Read More »AbbVie Terminates Tau and ASN Agreement with Voyager Signed in 2018 and 2019
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.
Shots: The P-III AD Up study involves assessing Rinvoq (15/30mg) + TCS vs PBO + TCS in patients (aged≥12) with the mod. to sev. AD who are candidates for systemic treatment. Patients receiving PBO + TCS were switched to either upadacitinib (15/30mg) + TCS @16wks.… Read More »AbbVie Report Results of Rinvoq (upadacitinib) in a P-III AD Up Study for Patients with Atopic Dermatitis
Shots: The P-III Measure Up 2 study involves assessing of Rinvoq (15/30mg) vs PBO in adults and adolescents aged 12-18yrs. or older with mod. to sev. AD who are candidates for systemic treatment. Placebo patients were switched to either upadacitinib (15/30mg) @16wks. The study met… Read More »AbbVie Reports Results of Rinvoq (upadacitinib) as Monotherapy in a P-III Measure Up 2 Study for Atopic Dermatitis
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… Read More »Gilead eyes takeover of cancer biotech Tizona, despite its ties to AbbVie
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… Read More »Gilead to Acquire Tizona’s Stakes for $300M
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… Read More »Top 20 Prescription Drugs Based on 2019 Revenue