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
Merck & Co has built more momentum behind its attempt to depose Pfizer’s blockbuster pneumococcal conjugate vaccine Prevnar 13, with two new phase 3 trials backing its rival shot V114. The two trials are both in adult subjects, a group that has been driving growth… Read More »Adult data back Merck’s challenger to Pfizer’s blockbuster Prevnar 13
Pfizer now has hundreds of thousands of doses of BioNTech’s COVID-19 vaccine coming off the production line at a facility in Belgium, ready for delivery if it clears phase 3 testing. The output of the plant in Puurs should allow the partners to have 100… Read More »Pfizer ‘ready to roll’ if BioNTech COVID-19 shot is approved
The UK government has signed a contract to develop a controversial COVID-19 human challenge trial, where participants will be deliberately infected in a controlled environment with coronavirus to test whether a vaccine is effective. Contract research organisation (CRO) hVIVO, a subsidiary of Open Orphan, has… Read More »UK government signs contract for COVID-19 challenge trial
Pfizer said it will wait until after the US election to file its COVID-19 vaccine with the US regulator, as it waits for important safety data to become available. The vaccine is being developed by Pfizer and development partner BioNTech and will wait until late… Read More »Pfizer to wait until after election to file COVID-19 vaccine in US
Novartis’s Luxturna (voretigene neparvovec) Receives Health Canada Approval as the First Gene Replacement Therapy for Inherited Retinal Disease Published: Oct 15, 2020 | Tags: approval, Canada, health, Inherited Retinal Disease, Luxturna, Novartis, receives, voretigene neparvovec Galapagos & Servier’s GLPG1972/S201086 Fails to Meet its Primary Endpoint… Read More »PharmaShots Weekly Snapshot (Oct 12-16, 2020)
The US FDA has approved 6 NDAs in Sept 2020, 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 85 novel products so far… Read More »Insights+: The US FDA New Drug Approvals in September 2020
Shots: Pfizer will continue to provide sales and marketing support and health system support for Cologuard through the end of 2022 and 2021, respectively. Exact Sciences will compensate Pfizer based on the amount of services provided, along with additional fixed and performance-related fees set forth… Read More »Exact Sciences and Pfizer Announce Extension and Amendment of their Cologuard Promotion Agreement
Shots: The Rolling Submission is based on the preliminary results from pre-clinical and early clinical studies in adults, which shows that BNT162b2 triggers the production of neutralizing antibodies and TH-1 dominant CD4+ and CD8+ T cells that target SARS-CoV-2. BioNTech and Pfizer plan to work… Read More »BioNTech and Pfizer Initiates Rolling Submission to EMA for SARS-CoV-2 Vaccine Candidate, BNT162b2
The European Medicines Agency has begun a second “rolling review” of a potential coronavirus vaccine jointly developed by BioNTech and Pfizer, setting up a race with a rival from AstraZeneca and Oxford University. The announcement comes just days after the regulator said its CHMP scientific… Read More »Race for COVID-19 vaccine hots up as EMA begins review of BioNTech/Pfizer jab
Pfizer Signs an Agreement with SpringWorks to Evaluate Nirogacestat + PF‐06863135 for R/R Multiple Myeloma
Shots: Pfizer to sponsor & conduct P-Ib/II study evaluating the safety, tolerability, and preliminary efficacy of dual regimen and will assume costs of study & other expenses related to IP rights. The companies will form a joint development committee to manage clinical study which is… Read More »Pfizer Signs an Agreement with SpringWorks to Evaluate Nirogacestat + PF‐06863135 for R/R Multiple Myeloma
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)
1. Taysha Gene Therapies’ TSHA-101 Receives the US FDA’s Orphan Drug Designation and Rare Pediatric Disease Designation for GM2 Gangliosidosis Published: Aug 27, 2020 | Tags: Taysha Gene Therapies, TSHA-101, Receives, US, FDA, Orphan Drug Designation, Rare Pediatric Disease Designation, GM2 Gangliosidosis 2. Bayer Reports… Read More »PharmaShots Weekly Snapshot (Aug 24 -28, 2020)
The companies also said their Phase II/III study, slated to enroll about 30,000 participants, had already dosed more than 11,000.
1. BioMarin Reports NDA Submission to the US FDA for Vosoritide to Treat Children with Achondroplasia Published: Aug 20, 2020 | Tags: BioMarin, Reports, NDA, Submission, US, FDA, Vosoritide, Children, Achondroplasia 2. Junshi and Impact to Establish Joint Venture for Senaparib (IMP4297) in China Published:… Read More »PharmaShots Weekly Snapshot (Aug 17 -21 2020)
New insights into smell and taste loss symptoms, artificial intelligence and further encouraging data from a vaccine candidate hit the headlines this week as the COVID-19 coronavirus pandemic continues. Here we highlight the biggest R&D, market access and digital coronavirus news of the past week.… Read More »Coronavirus pharma news round-up 21/08/20
Pfizer and BioNTech have said their COVID-19 vaccine could be ready for regulators to review by October and approved by the end of the year after releasing more favourable data from an early-stage trial. There are no vaccines approved for COVID-19 and governments across the… Read More »Pfizer/BioNTech say COVID-19 jab on track for approval by year-end
Shots: The companies have shared additional P-I safety and immunogenicity data from their ongoing US study of the BNT162b2 against SARS-CoV-2, which has advanced into P-II/III evaluation. Across all populations, BNT162b2 was well tolerated with mild to moderate fever in fewer than 20% of the… Read More »Pfizer and BioNTech Plan for Regulatory Review of its COVID-19 Vaccine in October 2020
1. Roche’s Evrysdi (risdiplam) Receives the US FDA’s Approval for SMA in Adults and Children Published: Aug 10, 2020 | Tags: Roche, Evrysdi, risdiplam, Receives, US, FDA, Approval, SMA, Adults, Children 2. The US FDA Approves Guardant360 CDx as the First Liquid Biopsy NGS Assay to… Read More »PharmaShots Weekly Snapshot (Aug 10 – 14, 2020)
Sequent Research Ltd Recruitment August 2020. SeQuent is looking towards the future with courage and confidence, because of the critical role it can play to help make a difference in global economic progress and social wellbeing. Ever since inception in 2002 SeQuent has emerged as an integrated… Read More »Sequent Research Hiring Mpharma Msc for Senior Manager Quality Assurance
Gilead Sciences had said in its second-quarter earnings that it would partner with companies in North America, Europe and Asia to manufacture the antiviral drug, which received an emergency use authorization from the FDA in May.
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… Read More »Insights+ Key Biosimilars Events of July 2020
Pfizer has taken a big step towards positioning Lorbrena as a worthy heir to its big-selling Xalkori drug in lung cancer, after beating its parent in a phase 3 trial. The CROWN trial pitted Lorbrena (lorlatinib) against Xalkori (crizotinib) in patients with previously-untreated ALK-positive non-small… Read More »Will new data make Pfizer’s Lorbrena a ‘no-brainer’ in early lung cancer?
1. Oxford Biomedica Signs Three Year Clinical Supply Agreement with Axovant to Manufacture and Supply AXO-Lenti-PD for Parkinson’s Disease Published: Jul 31, 2020 | Tags: Oxford Biomedica, Signs, Three Year, Clinical Supply Agreement, Axovant, Manufacture, Supply, AXO-Lenti-PD, Parkinson’s Disease 2. Johnson & Johnson Initiates P-I/IIa Study… Read More »PharmaShots Weekly Snapshot (Jul 27- 31, 2020)
Financial terms of the deal were not disclosed, but it follows a $1.95 billion contract between the two companies and the U.S. government. Assuming clinical trial success and regulatory approval, they would supply the vaccines in early 2021, ahead of the rescheduled Tokyo Olympics.
Our planet is facing a major pandemic outbreak due to COVID-19 and health agencies are taking every measure to stop it. The COVID-19 virus has been named “SARS-CoV-2” (severe acute respiratory syndrome coronavirus 2) and the disease it causes has been named “Coronavirus Disease 2019”… Read More »Insights+ Exclusive: COVID-19 Healthcare News Monthly Updates – July 2020
NICE has said a combination of Merck KGaA’s Bavencio and Pfizer’s Inlyta should be available as a first line option for kidney cancer patients for NHS patients in England. The cost-effectiveness body okayed interim reimbursement from the Cancer Drugs Fund (CDF) in final guidance for… Read More »NICE backs kidney cancer combination from Merck KGaA and Pfizer
Pfizer has cautiously upped its guidance despite second quarter figures showing a slip in sales and profitability compared with the same period last year. Revenues for Q2 were $11.8 billion, down 11% compared with the corresponding period in 2019, and adjusted income fell 3% to… Read More »Pfizer ups guidance as it prepares to sell off generics division
The companies said they had started a Phase II/III trial BNT162b2. The news comes the day after Moderna announced the launch of its Phase III study and days after Pfizer and BioNTech signed a nearly $2 billion vaccine supply deal with the federal government.
Pfizer and BioNTech Initiate P-II/III Global Study of its Lead mRNA Vaccine Candidate Against COVID-19
Shots: The companies commence global (Ex- China) P-II/III study to evaluate a modRNA candidate (BNT162b2, 30µg dose level in a 2 dose regimen) from their BNT162 mRNA-based vaccine program against SARS-CoV-2 The P-II/III study follows the US FDA’s guidance on clinical trial design, will evaluate… Read More »Pfizer and BioNTech Initiate P-II/III Global Study of its Lead mRNA Vaccine Candidate Against COVID-19
1. Gilead and Galapagos’ Jyseleca (filgotinib) Receive the CHMP’s Positive Opinion for Moderate to Severe Rheumatoid Arthritis Published: Jul 24, 2020 | Tags: Gilead, Galapagos, Jyseleca, filgotinib, Receive, CHMP, Positive Opinion, Moderate, Severe, Rheumatoid Arthritis 2. Synaffix Expands its Existing Collaboration with ADC Therapeutics to Explore… Read More »PharmaShots Weekly Snapshot (Jul 20- 24, 2020)
The US government has agreed to pay Pfizer and BioNTech $1.95 billion to secure access to 100 million doses of their coronavirus vaccine on approval, just days after promising results in a clinical trial. The deal – part of the Trump administration’s Operation Warp Speed… Read More »US places $1.95 billion order for Pfizer/BioNTech’s COVID-19 vaccine
The companies will supply 100 million doses of the vaccine by the end of the year, and the government will have the option to acquire 500 million more. However, the FDA must grant an authorization based on its safety and efficacy, for which there are… Read More »Pfizer, BioNTech get $1.95B from HHS to supply Covid-19 vaccine
Concerns have emerged about access to some potential COVID-19 vaccines after pharma executives from three companies said they expect to make profits from their products in evidence to a US Congressional panel. Moderna, Merck & Co, and Pfizer said they expect to profit from coronavirus… Read More »Controversy as pharma execs predict profits from COVID-19 vaccines
Shots: The companies reported that most advanced of four COVID-19 vaccine candidates from their BNT162 mRNA-based vaccine program demonstrated the ability to elicit high SARS-CoV-2 neutralizing titers following the second dose in an ongoing P-I/II study in Germany The results divulge that BNT162b1 candidate induced… Read More »Pfizer and BioNTech Elicits Strong T-cell Response in P-I/II Study Against COVID-19
The UK has secured 90 million doses of two different COVID-19 vaccines from BioNTech/Pfizer and Valneva, with an option of 40 million doses if they check out in trials. There is no approved COVID-19 vaccine, but governments across the world are busy signing deals with developers to gain access should trial results… Read More »UK announces COVID-19 vaccine deals with BioNTech/Pfizer and Valneva
1. Eli Lilly Reports Results of Mirikizumab in P-III OASIS-2 Study to Treat Moderate to Severe Plaque Psoriasis Published: Jul 17, 2020 | Tags: Eli Lilly, Reports, Results, Mirikizumab, P-III, OASIS-2, Study, Treat, Moderate, Severe, Plaque Psoriasis 2. Oncorus Initiates P-I Study of ONCR-177 in Patients… Read More »PharmaShots Weekly Snapshot (Jul 13- 17, 2020)
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
Shots: NCCN and Pfizer have issued an open RFP that develop and validate enduring approaches to improve the safe, effective, and efficient adoption of biosimilars in oncology The RFP supports approaches to improve the processes related to biosimilar adoption in oncology. Letters of Intent are… Read More »NCCN Collaborates with Pfizer to Explore Adoption of Biosimilars in Oncology
The companies anticipate releasing more clinical data from the BNT162 messenger RNA vaccine program and potentially starting a 30,000-participant Phase IIb/III study this month.
ViiV’s twice-monthly injected PrEP drug superior in HIV prevention to Gilead daily pill, analysis shows
The company said Tuesday that a final analysis of its Phase IIb/III study of cabotegravir showed greater efficacy in HIV prevention than Gilead’s Truvada. The study, among men and transgender women who have sex with men, was stopped in May following an interim analysis.