GSK pays $100M to partner on a cancer drug with new twist on immunotherapy
GSK is partnering with Mersana Therapeutics on the development of an antibody-drug conjugate that is approaching Phase 1 testing. Unlike other ADCs that deliver a […]
GSK is partnering with Mersana Therapeutics on the development of an antibody-drug conjugate that is approaching Phase 1 testing. Unlike other ADCs that deliver a […]
A panel discussion from a recent Microsoft summit offered insights on how tech companies are closely collaborating with the pharma industry as they seek to […]
In the second of a three-part series, Ben Hargreaves looks at the importance of early-stage research into various emerging infectious disease threats and how it […]
GSK will start preparations for regulatory filings of its respiratory syncytial virus (RSV) vaccine straight away, after the shot hit the mark in the much-anticipated […]
A small Memorial Sloan Kettering Cancer Center study found that all rectal cancer patients treated with GSK drug Jemperli showed a complete response at six […]
A new drug called dostarlimab saw astonishing results in a 12-person rectal cancer trial: Every one of the dozen patients went into remission. All the […]
When consumer healthcare products joint venture Haleon spins out from GSK as an independent company next month, Pfizer will sell its minority stake in the […]
Pfizer and Merck have each won FDA approvals in the past year for new pneumococcal vaccines, but GSK aims to top both of them with […]
The UK’s National Institute for Health and Care Excellence (NICE) has recommended GlaxoSmithKline’s (GSK) ZEJULA (niraparib) for some forms of ovarian, fallopian tube, and peritoneal […]
The UK’s National Institute for Health and Care Excellence (NICE) has recommended GlaxoSmithKline’s (GSK) ZEJULA (niraparib) for some forms of ovarian, fallopian tube, and peritoneal […]
We have seen a boom in biotech initial public offerings over the last two years, but many of Europe’s offerings have migrated to the United […]
Jazz’ Sunosi (solriamfetol) Receives NICE Recommendation for the Treatment of Excessive Daytime Sleepiness Caused by Narcolepsy Published: Nov 19, 2021 | Tags: Jazz, Sunosi, solriamfetol, […]
Shots: The approvals are based on the clinical trials to evaluate mepolizumab vs PBO when added to SoC in patients with HES, EGPA & CRSwNP […]
Shots: The P-III COMET-TAIL trial evaluates the efficacy, safety & tolerability of sotrovimab (250/500mg, given as IM compared to IV) in 983 high-risk patients aged […]
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: […]
Shots: The P-III ASCEND program includes 5 studies i.e ASCEND-ND, D, ID, NHQ & TD studies evaluating efficacy & safety of daprodustat vs ESA in […]
Shots: The companies terminated their collaboration that centered around bintrafusp alfa as the drug failed to show potential in INTR@PID Lung 037 study as the […]
The third quarter of 2021 highlights the approvals, clinical data & acquisitions. The new alliance observed in third quarter includes AzurRx signed a reverse triangular […]
INVEST Digital Health kicks off today and runs through September 23. Held in a virtual format due to Covid-19, the healthcare conference brings together innovative […]
The US FDA has approved 3 BLAs and 2 NDAs in 2021, leading to treatments for patients and advances in the health care industry The […]
Forte’s FB-401 Fails to Meet Primary Endpoints in P-II Clinical Trial For the Treatment of Atopic Dermatitis Published: Sept 3, 2021 | Tags: Forte, FB-401, […]
Forte’s FB-401 Fails to Meet Primary Endpoints in P-II Clinical Trial For the Treatment of Atopic Dermatitis Published: Sept 3, 2021 | Tags: Forte, FB-401, […]
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, […]
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, […]
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 […]
When is a skinny label skinny enough to protect a generic drug from claims of patent infringement? The answer remains up to interpretation after an […]
Roche Publishes the Results of Evrysdi (risdiplam) in FIREFISH Study to Treat of Type 1 SMA at NEJM Published: July 30, 2021 | Tags: Roche, […]
Shots: The approval is based on data from the SYNAPSE study evaluating mepolizumab vs PBO in ~400 patients with CRSwNP who had a history of […]
Shots: The approval is based on studies evaluating the safety & efficacy of Shingrix in adults aged ≥18yrs. who had undergone auHSCT and those undergoing […]
Uncomplicated Urinary Tract Infections are one of the most commonly diagnosed infections in the US, with the maximum prevalence in women who are sexually active. […]
Shots: The P-III ASCEND program includes 5 studies i.e ASCEND-ND, D, ID, NHQ & TD studies evaluating efficacy & safety of daprodustat vs ESA in […]
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, […]
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, […]
Shots: iTeos to receive $625M up front & is eligible to receive up to ~$1.45B in milestone upon achievement of certain milestones & royalties on […]
Vertex and CRISPR Therapeutics Present New Data of CTX001 from 22 Patients with TDT and SCD at EMA 2021 Published: June 11, 2021 | Tags: […]
Shots: The 18mos. alliance will support two studies that will evaluate clinical tools, include proteomics & digital health for Lupus management in the US The […]
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 […]
Shots: The companies have started enrollment of patients in a P-III clinical study to assess the safety, efficacy & immunogenicity of COVID-19 vaccine candidate vs […]
Shots: The US FDA has granted EUA for sotrovimab for mild to mod. COVID-19 patients aged ≥12yrs. who are at high risk for progression to […]
BeiGene Reports Results of Tislelizumab + CT in P-III RATIONALE 309 Study as 1L Treatment for Recurrent or Metastatic Nasopharyngeal Cancer Published: May 21, 2021 […]
Shots: The P-II study involves assessing the safety & immunogenicity of the CoVLP vs PBO in 306 subjects aged ≥18yrs. with two age groups (18-64yrs […]
Shots: The vaccine has achieved strong rates of neutralizing antibody responses, in line with those measured in people who have recovered from COVID-19, in all […]
The US FDA has approved 3 NDAs and 2 BLAs in April 2021, leading to treatments for patients and advances in the health care industry. […]
Shots: The rolling review will assess sotrovimab in adults and adolescents (aged 12yrs.) with COVID-19 who do not require oxygen supplementation and who are at […]
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: […]
Shots: The MAA is based on a P-III BLISS-LN study assessing the efficacy and safety of belimumab (10 mg/kg, IV) + standard therapy vs PBO […]
Shots: The EC has granted conditional approval for Jemperli in women with dMMR/ MSI-H endometrial cancer that has progressed on or following prior treatment with […]
BMS’ Opdivo + Yervoy and Onureg Receive EC’s CHMP Positive Opinion for MPM and AML Published: Apr 23, 2021 | Tags: BMS, Opdivo, Yervoy, Onureg, […]
ThermoFisher to Acquire PPD for ~$17.4B Published: Apr 16, 2021 | Tags: ThermoFisher, Acquire, PPD, ~$17.4B Roche’s Evrysdi (risdiplam) Receives Health Canada’s Approval for Spinal […]
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 […]
Shots: The P-II BLAZE-4 study involves assessing bamlanivimab as monothx. and bamlanivimab (700mg) + VIR-7831 (500mg) vs PBO in 1000 participants with symptomatic low-risk COVID-19 […]
Shots: The EUA submission is based on an interim analysis of the P-III COMET-ICE study assessing VIR-7831 vs PBO for the early treatment of COVID-19 […]
Shots: EMA’s CHMP has adopted a positive opinion recommending the use of Benlysta (IV, SC) in combination with background immunosuppressive therapies for the treatment of […]
Takeda Collaborates with Anima to Discover and Develop mRNA Translation Modulators for Neurological Diseases Published: Mar 19, 2021 | Tags: Takeda, Collaborates, Anima, Discover, Develop, […]
Takeda Collaborates with Anima to Discover and Develop mRNA Translation Modulators for Neurological Diseases Published: Mar 19, 2021 | Tags: Takeda, Collaborates, Anima, Discover, Develop, […]
Shots: Boston will lead the development of selected programs through PoC. GSK gets an option to reacquire each program under pre-agreed terms for development and […]
Shots: Boston will lead the development of selected programs through PoC. GSK gets an option to reacquire each program under pre-agreed terms for development and […]
Shots: The first patient has been dosed in the P-III SWIFT-2 trial assessing the safety and efficacy of GSK3511294 (GSK’294) in SEA The planned P-III […]
Shots: The first patient has been dosed in the P-III SWIFT-2 trial assessing the safety and efficacy of GSK3511294 (GSK’294) in SEA The planned P-III […]
PhaseBio Signs a Supply Agreement with BioVectra to Support the Development and Commercialization of Bentracimab Published: Mar 12, 2021 | Tags: PhaseBio, Signs, Supply, Agreement, […]
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 […]
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, […]
Shots: The P-IIa POC OSCAR study involves assessing the efficacy and safety of otilimab (90mg, IV) + SOC vs PBO + SOC in 806 hospitalized […]
In an interview with PharmaShot, Steve Bradford, Vice President, Medicines Commercialization Leader at GSK shed light on the US FDA’s approval of Benlysta as the […]
Shots: The companies reported the initiation of a P-II dose-finding study assessing the safety, reactogenicity, and immunogenicity of two injections given 21 days apart in […]
RedHill Signs a Manufacturing Agreement with Cosmo for Movantik and RHB-204 Published: Feb 19, 2021 | Tags: RedHill, Signs, Manufacturing, Agreement, Cosmo, Movantik, RHB-204 Astellas and […]
While the pandemic has been the focus of R&D attention for much of 2020, that is slowly beginning to shift towards other projects in the […]
Shots: The first P-III AReSVi 004 study evaluates the immunogenicity, safety, reactogenicity and persistence of RSV candidate vaccine in 1650 adults ≥ aged 60 years. […]
Shots: GSK to receive $350M at closing, along with ~$150M as milestones. The transaction is expected to close in H2’21 The transaction will allow GSK […]
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, […]
Shots: CureVac to receive $90.14M up front, $90.14M as milestones on the achievement of specific milestones. GSK will be the marketing authorization holder for the […]
Shots: Lilly has expanded its ongoing BLAZE-4 trial to assess the administration of bamlanivimab (700mg) with VIR-7831 (500mg) for symptomatic COVID-19 in the outpatient setting. […]
Takeda’s Alunbrig (brigatinib) Receives MHLW’s Approval as a 1L and 2L Treatment for ALK+ Advanced or Recurrent NSCLC Published: Jan 22, 2020 | Tags: Takeda, […]
The COVID-19 pandemic has brought healthcare guidelines and scientific advances front-of-mind on a global scale, in the process highlighting long-standing gaps in health literacy as […]
Shots: Merck KgaA provides an update on its P-III INTR@PID Lung 037 study and the extensive INTR@PID clinical trial program assessing bintrafusp alfa for patients […]
Shots: The ongoing P-I GARNET study involves assessing dostarlimab as monothx. in patients with advanced solid tumors. Cohort F of the GARNET trial enrolled patients […]
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 […]
Pharma’s reputation is currently riding high as the industry comes together to tackle COVID-19, but GSK’s UK general manager Neale Belson says there is always […]
Shots: The companies signed an agreement with to evaluate VIR-7832 vs PBO in P-Ib/IIa AGILE study in patients with mild to mod. COVID-19. The trial […]
In a recent interview with PharmaShots, Dr. Riju Ray, MD, PhD, Senior Medical Lead at GSK, leading US medical affairs across asthma and COPD shared […]
“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 […]
Roche’s Phesgo (Perjeta + Herceptin) Receives EC’s Approval for the Treatment of HER2-Positive Breast Cancer Published: Dec 23, 2020 | Tags: (Perjeta + Herceptin), EC’s […]
Shots: Sosei Heptares to receive $44M as upfront, near-term development milestones, and funding and is eligible to receive $437M as development, regulatory, and commercialization along […]
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 […]
Shots: The approval follows BTD and PR & is based on P-lll BLISS-LN study involves assessing Benlysta (IV, 10 mg/kg) + SOC vs PBO + […]
Shots: Surface Oncology to receive ~$85 M upfront and ~$730 M as milestones along with royalties on net sales of SRF813 GSK to get an […]
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 […]
Shots: Following the positive P-I results, Medicago has decided to launch the Phase 2/3 clinical trial with GSK’s pandemic adjuvant The study will evaluate the […]
GlaxoSmithKline’s Nucala (mepolizumab) last month became the first and only biologic treatment approved in the US for Hypereosinophilic Syndrome (HES). It’s part of the company’s […]
Shots: The approval is based on PRIMA study assessing Zejula (300mg qd), later amended to incorporate an individualised starting dose of Zejula (200 mg or […]
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, […]
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, […]
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 […]
Shots: GSK reported that its RSV vaccines for maternal immunization (GSK3888550A) and older adults (GSK3844766A) were well-tolerated and highly immunogenic in P-I/II clinical studies. Both […]
A few months into the pandemic, the world is now moving beyond managing the crisis, with more focus on addressing the collateral damages and shaping […]
Shots: GSK will make equity investment to gain access to Vir’s technology of $250M, priced at $37.73 (a 10% premium to closing share price on […]
Shots: The approval is based on P-III PRIMA study assessing Zejula in patients with newly diagnosed advanced ovarian cancer with complete/partial response to Pt.-based CT […]
Shots: NVIDIA reports that it is building the “Cambridge-1” supercomputer, which will be an NVIDIA DGX SuperPOD system capable of delivering 400+ petaflops of AI […]
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 | […]
Shots: The EC’s approval is based on DREAMM-2 study assessing Blenrep (2.5/ 3.4 mg/kg, q3w) as monothx. in adult patients prior treated with 4 therapies […]
Darlene Dobry, Strategic Advisor, Medical Devices and Pharmaceuticals As the COVID-19 pandemic continues to bring the world’s economies, healthcare systems, and communities to their knees, […]
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, […]
The FDA has approved GlaxoSmithKline’s multiple myeloma drug Blenrep, a first-in-class potential blockbuster that will be used in advanced disease. Blenrep (belantamab mafodotin) has been […]
Shots: The US government will provide ~$2.1B to support the development of the vaccine, including clinical trials with some amount to be used for ramping […]
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 […]
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 […]
Shots: The two global companies will supply up to ~60M doses of a vaccine to the UK’s government to combat COVID-19 Sanofi leads the clinical […]
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, […]
What if we could look at cancer treatment from a completely fresh perspective? This is the philosophy GSK’s UK country medical head for oncology, John […]
Shots: GSK will invest $163M (€150m) in CureVac for a 10% stake to collaborate for the research, development, manufacturing, and commercialization of up to five […]
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, […]
Career as Regulatory Specialist MSR Coordination Senior at GSK India GlaxoSmithKline Pharmaceuticals Ltd. (GSK Rx India) is one of the oldest pharmaceuticals company and employs […]
Copyright © 2024 | WordPress Theme by MH Themes