Covid vaccines: US regulator sceptical over AstraZeneca model
Vaccine developed in Oxford criticised by FDA with efficacy rates and trials delaying official take-up Coronavirus – latest updates See all our coronavirus coverage For […]
AstraZeneca
CLL patients in England to get AZ’s Calquence after okay from NICE
NHS England is to grant immediate access to AstraZeneca’s cancer drug Calquence (acalabrutinib) for certain patients with chronic lymphocytic leukaemia (CLL) after NICE backed it […]
Sanofi on notice as FDA reviews GSK’s Nucala for nasal polyps
Sanofi and Regeneron’s Dupixent has had the US market for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) mainly to itself since June 2019, […]
Nine out of 10 in poor nations to miss out on inoculation as west buys up Covid vaccines
Billions unlikely to get jabs as rich countries secure 53% of most promising vaccines Coronavirus – latest updates See all our coronavirus coverage Nine out […]
The vaccine miracle: how scientists waged the battle against Covid-19
We trace the extraordinary research effort, from the discovery of the virus’s structure to the start of inoculations this week Coronavirus – latest updates See […]
Covid vaccines offer chance for big pharma to improve its image
They make life-saving medicines, but no one likes them. Could this year be a turning point? Coronavirus – latest updates See all our coronavirus coverage […]
4th Antigen Specific Immune Tolerance Summit
The 4th Antigen Specific Immune Tolerance Digital Summit (ASIT) brings together industry representatives from the fields of autoimmunity, allergy, immuno-oncology and transplantation to tackle the complexities behind autoimmune […]
J&J files lung cancer bispecific amivantamab for FDA approval
Johnson & Johnson has filed its bispecific antibody amivantamab to the FDA, hoping to muscle into the big market for drugs that are used to […]
Insights+ Key Biosimilars Events of November 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 […]
AstraZeneca to Divest European Rights of Crestor (rosuvastatin) to Grünenthal for ~$350M
Shots: Grünenthal to acquire EU rights (Ex- Spain and the UK) of Crestor & its associated brands for ~$350M and will take over bulk production […]
AstraZeneca Initiates P-IIb Study of ION449 (AZD8233) to Lower LDL-cholesterol
Shots: The P-IIb study will evaluate three dose levels of ION449 (once a month, SC) vs PBO and will enroll ~108 patients aged 18-75yrs., who […]
AstraZeneca sells rights to cholesterol drug Crestor to Grunenthal
AstraZeneca is to sell European rights to its cholesterol drug Crestor (rosuvastatin) to Germany’s Grunenthal. Crestor is a statin and at its peak generated annual […]
AstraZeneca’s Forxiga (dapagliflozin) Receives MHLW’s Approval for Chronic Heart Failure
Shots: The approval is based on a DAPA-HF trial assessing Forxiga (10mg, qd) + SOC vs PBO + SOC in 4,744 patients with HFrEF (LVEF […]
Different age groups may get different Covid vaccines, experts say
Oxford/AstraZeneca planning new trial of lower-dose jab to see how well it works in older people Coronavirus – latest updates See all our coronavirus coverage […]
AZ mulls trial of new COVID-19 vaccine dose as UK regulator begins review
AstraZeneca is to run an additional global trial to test its COVID-19 vaccine at a lower dosage, as the UK regulator begins to review trial […]
Concerns emerge after AZ’s lucky vaccine trial ‘mistake’
AstraZeneca may have tried a positive spin on the trial mistake that led to the accidental discovery of the low dose COVID-19 vaccine regime with […]
A vaccine revolution | podcast
Results from clinical trials have shown that the world has three apparently highly effective vaccines for Covid-19. With the race now on for regulatory approval, […]
Russian Sputnik COVID-19 vaccine ‘will cost less than $10 a dose’
The developer of Russia’s COVID-19 vaccine Sputnik V has pledged to make it available for less than $10 per dose – or $20 per two-dose […]
AstraZeneca, Oxford are latest to unveil Covid-10 vaccine results
The partners pooled results from two trials and two different dosing regimens, one appearing to be more effective than the other. They hope to produce […]
Vaccine results bring us a step closer to ending Covid, says Oxford scientist
Latest breakthrough comes as PM says he hopes most at-risk could be immunised by Easter Coronavirus – latest updates See all our coronavirus coverage The […]
Why AstraZeneca’s reward for Covid vaccine is a share price slump | Nils Pratley
Despite the promising trial data, a viable – and profitable – vaccine is still some way off The stock market is cruel. AstraZeneca’s reward for […]
Oxford/AstraZeneca vaccine ‘likely first to be widely used in UK’
Experts say Pfizer/BioNTech product faces more logistical challenges and obstacles Coronavirus – latest updates See all our coronavirus coverage The Oxford vaccine is likely to […]
‘It’s a great day’: Oxford coronavirus vaccine volunteers on trial data
Trial participants react to news that Oxford AstraZeneca Covid vaccine has up to 90% efficacy Coronavirus – latest updates See all our coronavirus coverage Dan […]
AstraZeneca’s AZD1222 Meets its Primary Endpoint in Preventing COVID-19
Shots: Interim analysis results of COV002 & COV003 study of AZD1222 in the UK & Brazil showed the vaccine is effective in preventing COVID-19 and […]
Oxford AstraZeneca results open up Covid vaccine to developing countries
Jab can be kept in fridge and is part of global initiative to distribute doses at limited cost Coronavirus – latest updates See all our […]
AZ preps filings for COVID-19 jab, UK nears decision on Pfizer rival
AstraZeneca is preparing to file its COVID-19 vaccine with regulators after phase 3 trial results showed it is up to 90% effective. AZ made the […]
Regeneron’s COVID-19 antibody cocktail gets US emergency licence
Regeneron’s antibody cocktail is the latest COVID-19 drug to receive Emergency Use Authorization in the US, becoming the first therapy of this kind to become […]
The Guardian view on coronavirus and vaccine scepticism: time to act | Editorial
Plans for mass immunisation against Covid-19 are developing fast, but concerns must be addressed In the 1960s, academics studying rumours drew inspiration from epidemiology. They […]
Trials to begin in UK for Covid antibody cocktail drug treatment
Scientists say jab could be used to protect those who cannot be given vaccines Coronavirus – latest updates See all our coronavirus coverage Major trials […]
Encouraging data from AZ/Oxford coronavirus shot
The coronavirus vaccine being developed by Oxford University and AstraZeneca produces a strong immune response in higher risk older patients, a study has found. The […]
Easier distribution may make Moderna’s vaccine much more valuable | Nils Pratley
While Pfizer/BioNTech’s version requires -75C storage, Moderna’s could be easier to roll out A second coronavirus vaccine candidate was always likely to struggle to match […]
Moderna vaccine’s effectiveness bodes well for Oxford/AstraZeneca jab
Phase 3 success rate of 95% for US firm’s treatment is promising for UK vaccine trial Coronavirus – latest updates See all our coronavirus coverage […]
Where will poorer countries stand in the queue for a Covid-19 vaccine? | Clare Wenham and Mark Eccleston-Turner
The lion’s share of the potential Pfizer vaccine is already claimed by high-income nations The news that joint efforts by the US pharmaceutical company Pfizer […]
AZ drug hunter Garry Pairaudeau joins AI specialist Exscientia
Drug discovery firm Exscientia has beefed up its leadership team with the appointment of former AstraZeneca scientist Dr Garry Pairaudeau as its chief technology officer. […]
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 […]
With 90% efficacy against Covid-19, Pfizer/BioNTech’s vaccine jumps ahead in global race
The news sent the stock market soaring as it represents a key milestone in developing and distributing a vaccine for the virus. Still public confidence […]
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
Shots: The approval is based on P-III THALES study involves assessing Brilinta (180mg as a loading dose followed by 90mg, bid) + aspirin vs aspirin […]
AstraZeneca and MSD’s Lynparza (olaparib) Receive EU’s Approval as 1L Maintenance Treatment for HRD-Positive Advanced Ovarian Cancer
Shots: The approval is based on a biomarker subgroup analysis of P-III PAOLA-1 study assessing Lynparza + bevacizumab vs bevacizumab alone as 1L maintenance treatment in […]
AZ’s Q3 results disappoint – but COVID19 vaccine trial is still on track
AstraZeneca has posted an uninspiring set of quarterly results as it gears up for results from its closely watched coronavirus vaccine trial. AZ said in […]
Genprex cancer gene therapy paired with AZ, Merck lung cancer drugs
An experimental gene therapy developed by Texas biotech Genprex will be paired with AstraZeneca’s Tagrisso and Merck & Co’s Keytruda – both leading their respective […]
AstraZeneca and Fusion Collaborate to Develop and Commercialize Radiopharmaceuticals and Combination Therapies for Cancer
Shots: Fusion to receive up front, as well as development milestones and other payments. The companies will jointly discover, develop, and have an option to […]
UK could get COVID-19 vaccines early next year, ahead of European countries
COVID-19 vaccines could be approved and available early next year in the UK ahead of European countries, after its national regulator began its own rolling […]
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, […]
AstraZeneca’s Forxiga (dapagliflozin) Receive NMPA’s Approval for Label Update to Include Data of P-III DECLARE-TIMI 58 Study
Shots: The updated label includes P-III DECLARE-TIMI 58 study that assesses the effect of Forxiga vs PBO on CV outcomes in 17000+ patients with T2D […]
Oxford Covid vaccine works in all ages, trials suggest
Vaccine being trialled by Oxford University and AstraZeneca offers hope for all age groups Coronavirus – latest updates See all our coronavirus coverage One of […]
Bayer data for kidney disease hope finerenone sets up filings
Bayer’s blockbuster ambitions for diabetic kidney disease (DKD) drug candidate finerenone look a lot firmer with the publication of data from the phase 3 FIDELIO-DKD […]
AstraZeneca Presents Results of Farxiga (dapagliflozin) in P-lll DAPA-CKD Study for Chronic Kidney Disease at ASN Kidney Week 2020
Shots: The P-lll DAPA-CKD study involves the assessing of Farxiga (qd, 10 mg) + SOC vs PBO in 4304 patients with CKD stages 2-4 and […]
AZ, J&J COVID-19 vaccine trials okay to restart in US
US trials of AstraZeneca’s experimental COVID-19 vaccine AZD1222 have been cleared to restart by the FDA, several weeks after testing was suspended following a serious […]
AstraZeneca Resumes P-III Study of AZD1222 Against COVID-19 in the US
Shots: The US FDA authorizes the restart of the P-III clinical study in the US following the resumption of trials in other countries in recent […]
AZ’s COVID-19 vaccine trial ready to resume – reports
AstraZeneca’s COVID-19 vaccine trial could be ready to resume this week in the US after a seven-week hiatus while the FDA completed its review of […]
AstraZeneca’s Tagrisso (osimertinib) Receives the US FDA’s Priority Review for the Adjuvant Treatment of Patients with Early-Stage EGFR-Mutated Lung Cancer
Shots: AstraZeneca’s Tagrisso has received sNDA’s acceptance and has been granted PR in the US for the adjuvant treatment of patients with early-stage (IB, II, […]
FDA grants fast review for AstraZeneca’s Tagrisso in early-stage lung cancer
The FDA has granted a fast review for AstraZeneca’s Tagrisso oncology drug in certain patients with early-stage lung cancer. Results from the phase 3 ADAURA […]
UK government signs contract for COVID-19 challenge trial
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 […]
AstraZeneca’s Trixeo Aerosphere Receives CHMP’s Recommendation for Approval to Treat COPD
Shots: The CHMP’s positive opinion is based on P-III ETHOS & KRONOS studies, which are a part of AstraZeneca’s P-III ATHENA program assessing Trixeo Aerosphere […]
Are we near to having a vaccine for Covid-19?
Even a once bullish PM is now not so optimistic but there are promising signs of a vaccine on the horizon Coronavirus – latest updates […]
Pfizer to wait until after election to file COVID-19 vaccine in US
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 […]
PharmaShots Weekly Snapshot (Oct 12-16, 2020)
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, […]
Race for COVID-19 vaccine hots up as EMA begins review of BioNTech/Pfizer jab
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 […]
GSK and AstraZeneca Plan to Deploy NVIDIA’s Supercomputer for Drug Development
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 […]
Older people first to receive COVID-19 vaccine in UK, says government
As European regulators begin a rolling review of AstraZeneca’s COVID-19 vaccine, the focus in the UK has shifted to the government’s plans to distribute any […]
AstraZeneca Resumes Clinical Study of its COVID-19 Vaccine in Japan
Shots: The P-I/II study of AZD1222 has resumed in Japan following the discussion with the PMDA. Additionally, the company is in talks with the US […]
European regulators begin rolling review of AZ’s COVID-19 vaccine
European regulators have started a first ‘rolling review’ of a COVID-19 vaccine, which is being developed by AstraZeneca in collaboration with the University of Oxford. […]
Report: FDA takes closer look at adverse event that occurred in AstraZeneca Covid-19 vaccine study
Reuters reported Wednesday that U.S. regulators would look at data from previous clinical trials that came from the same scientists who created the vaccine, AZD1222, […]
UK doing more than most to help poor get Covid vaccine, study finds
Campaign scoring countries for global access efforts calls for more British transparency Coronavirus – latest updates See all our coronavirus coverage The UK is doing […]
Oxford University resumes Covid-19 vaccine trials
Trials of vaccine being developed with AstraZeneca had been paused after participant fell ill Coronavirus – latest updates See all our coronavirus coverage The closely […]
Show more empathy to boost confidence in vaccines, scientists told
Expert behind vaccine confidence report points to halting of Oxford Covid trial as example Doctors and scientists need to show more empathy towards volunteers in […]
Oxford Covid-19 vaccine is still possible this year, says AstraZeneca chief
Pharmaceutical firm’s boss says 2020 deadline possible if regulators move fast Coronavirus – latest updates See all our coronavirus coverage AstraZeneca’s coronavirus vaccine could still […]
Oxford Covid vaccine trial suspension: what happens next?
Tests have been paused after a UK volunteer became ill. How will it affect the search for a cure? The AstraZeneca vaccine trial has been […]
Oxford University Covid vaccine trial put on hold due to possible adverse reaction in participant
A spokesman for AstraZeneca, the company working on the coronavirus vaccine, said pausing trials was common during vaccine development The development of a promising Covid-19 […]
AstraZeneca expands Covid-19 vaccine deal as final trials begin
UK drugmaker and Oxford Biomedica to produce more of potential coronavirus product Coronavirus – latest updates See all our coronavirus coverage AstraZeneca has expanded an […]
PharmaShots Weekly Snapshot (Aug 24 -28, 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 | […]
Insights+: The US FDA New Drug Approvals in July 2020
The US FDA has approved multiple NDAs and BLAs in July 2020, leading to treatments for patients and advances in the health care industry. The […]
AstraZeneca starts Phase I study of long-acting double-antibody cocktail for Covid-19
The drug, AZD7442, is designed to potentially provide at least six months of protection from Covid-19. The trial, which is funded by federal defense and […]
Best not to look like your passport photo | Brief letters
AstraZeneca | Sizes of cities | Starlings | Mickey Mouse degrees | Passport photos As a participant in the Oxford University Covid-19 vaccine trial, I’d […]
Chasing Regeneron, AZ starts trials of its COVID-19 antibody cocktail
The first patients have been dosed in a trial of two AstraZeneca antibodies, collectively known as AZD7442, that are being developed to both treat and […]
AstraZeneca Initiates P-I Study of AZD7442 Against COVID-19
Shots: The first participants have been dosed in a P-I trial of AZD7442 to assess safety, tolerability, and PK of the combination mAbs in up […]
AstraZeneca starts Covid-19 antibody drug trial in UK
Volunteers are receiving doses of drug, which has potential both as a vaccine and a treatment Coronavirus – latest updates See all our coronavirus coverage […]
Oxford University Covid-19 vaccine firm denies Trump talks
AstraZeneca says it has not discussed ‘emergency use authorisation’ with the US Coronavirus – latest updates See all our coronavirus coverage The company manufacturing the […]
AstraZeneca Collaborates with RenalytixAI to Develop Precision Medicine for Chronic Diseases
Shots: The two companies will develop and launch precision medicine strategies for CV, renal, and metabolic diseases. The first stage in the collaboration will use […]
PharmaShots Weekly Snapshot (Aug 17 -21 2020)
1. BioMarin Reports NDA Submission to the US FDA for Vosoritide to Treat Children with Achondroplasia Published: Aug 20, 2020 | Tags: BioMarin, Reports, NDA, […]
AstraZeneca’s Imfinzi (durvalumab) Receives MHLW’s Approval for Extensive-Stage Small Cell Lung Cancer
Shots: The approval is based on P-III CASPIAN study assessing Imfinzi + etoposide and either carboplatin/ cisplatin CT or Imfinzi & CT+ tremelimumab vs CT […]
AstraZeneca’s Imfinzi (durvalumab) Receives the US FDA’s Priority Review for Less Frequent Fixed-Dose Use in NSCLC and Bladder Cancer
Shots: The US FDA has accepted sBLA and granted PR to Imfinzi (1500mg) for a new 4wks. FD regimen to treat patients with unresectable Stage […]
AZ aims to cut cancer clinic visits with new Imfinzi regimen
The FDA is to review data supporting AstraZeneca’s Imfinzi (durvalumab) cancer immunotherapy in a new four-week regimen that will halve the number of required clinic […]
AstraZeneca Collaborates with mAbxience to Produce COVID-19 Vaccine in Latin America
Shots: mAbxience will produce ~200M + doses of AZD1222 and will supply it to all Latin American countries, except Brazil The company will produce API […]
EU places firm order for AZ/Oxford Uni’s ChAdOx1 COVID-19 vaccine
The European Commission has placed its first advance order for a coronavirus vaccine, snapping up 300 million doses of AstraZeneca’s ChAdOx1 candidate developed by the […]
PharmaShots Weekly Snapshot (Aug 10 – 14, 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, […]
AstraZeneca to Initiate Production of its COVID-19 Vaccine Early in 2021
Shots: AstraZeneca collaborates with the Mexican and Argentinean governments to initially produce 150M doses of the vaccine and eventually make at least 400M for distribution […]
Guardant scores FDA approval for liquid biopsy test
In a phone interview, Guardant Health CEO Helmy Eltoukhy said he expected the approval to encourage coverage by those payers still on the sidelines.
AstraZeneca Collaborates with Daiichi Sankyo to Evaluate the Combination of Patritumab Deruxtecan (U3-1402) + Tagrisso for EGFR-Mutated Non-Small Cell Lung Cancer
Shots: Daiichi Sankyo to conduct two-part P-I study assessing U3-1402+ Tagrisso as both a 1L and 2L dual regimen in patients with advanced or mNSCLC […]
AstraZeneca Collaborates with Eko to Advance the Digital Health Tools for the Diagnosis of CV Diseases
Shots: The two companies collaborated to facilitate the development of digital health tools for the earlier screening of cardiovascular diseases, including HF AstraZeneca and Eko […]
AstraZeneca Signs a License Agreement with Redx Pharma for RXC006 to Treat Idiopathic Pulmonary Fibrosis
Shots: Redx to receive $17M in early payment by the time of successful commencement of a P-I study, $360M as development, a regulatory and commercial […]
AstraZeneca, Eko Collaborate to Advance Innovation Around Heart Failure
What You Should Know: – Eko today announced a global collaboration with AstraZeneca to accelerate the development of digital health tools for the earlier screening […]
Redx shares soar after IPF drug licence deal with AstraZeneca
Shares in Redx Pharma were soaring this morning after it licensed its preclinical fibrotic disease drug RXC006 to AstraZeneca. The company’s shares were valued as […]
PharmaShots Weekly Snapshot (Jul 27- 31, 2020)
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 […]
Insights+ Exclusive: COVID-19 Healthcare News Monthly Updates – July 2020
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 […]
Return to work: a sector-by-sector look at the plans of England’s major employers
Companies can return to work from 1 August, but many employers are making their own plans Companies ready to defy Boris Johnson’s planned return to […]
Study puts Jardiance in hot pursuit of AZ’s Farxiga in heart failure
The FDA’s approval of AstraZeneca’s SGLT2 inhibitor Farxiga in heart failure was a first for the class, but Boehringer Ingelheim and Eli Lilly are closing […]
AstraZeneca’s Tagrisso (osimertinib) Receives the US FDA’s BT Designation for the Adjuvant Treatment of Patients with Stage IB-IIIA EGFR-Mutated Lung Cancer
Shots: The BT designation is based on P-III ADAURA trial which involves assessing Tagrisso (80 mg) vs PBO in 682 patients with Stage IB, II, […]
AstraZeneca beats expectations in Q2, while GSK struggles during pandemic
AstraZeneca has beaten analysts’ expectations in its second quarter results, outshining its UK counterpart GlaxoSmithKline, which has been hit by disruption caused by the COVID-19 […]
AstraZeneca Report Results of Farxiga in P-III DAPA-CKD Study for Patients with Chronic Kidney Disease
Shots: The P-III DAPA-CKD involve assessing of Farxiga ((dapagliflozin, 10mg, qd) + SOC vs PBO in 4,304 patients with CKD Stages 2–4 and elevated urinary […]
AstraZeneca Signs an Agreement with Emergent BioSolutions to Expand Manufacturing of AZD1222 for COVID-19
Shots: Emergent will provide CDMO services for AstraZeneca’ AZD1222. The agreement valued ~174M through 2021 and follows an $87M agreement signed in June for development […]
Trial shows AZ’s Farxiga slows onset of chronic kidney disease and cuts mortality
AstraZeneca’s Farxiga could be on course for another use, after trial results showed it slowed the worsening of renal function and cut the risk of […]
AstraZeneca, Daiichi Sankyo sign $6B deal for antibody-drug conjugate
The companies will share development and commercialization of DS-1062 in solid tumors. They already have a similar deal in place, the $6.9 billion agreement signed […]
AstraZeneca Signs an Agreement with Daichii Sankyo to Develop and Commercialize DS-1062 Worth Up to $6B
Shots: Daichii Sankyo to receive $1B as upfront of which $350M is due upon execution, $325M after 12mos. and $325M after 24 mos., ~$5B as […]
AstraZeneca inks $6bn cancer drug deal with Daiichi Sankyo
AstraZeneca has begun a new agreement with Daiichi Sankyo to develop and market an antibody to treat cancer, worth up to $6 billion. The deal […]
AstraZeneca signs deal worth up to £4.7bn for cancer treatment
Pharmaceuticals company buys global rights to new technology from Japan’s Daiichi Sankyo Drugmaker AstraZeneca could pay up to $6bn (£4.7bn) for the global rights to […]
PharmaShots Weekly Snapshot (Jul 20- 24, 2020)
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, […]
Covid-19 is Big Pharma’s chance to impress. But who’ll do best?
AstraZeneca and GSK both release results this week. But picking winners in the sector may be complicated It was the press announcement heard around the […]
AstraZeneca’s Breztri Aerosphere Receives the US FDA’s Approval for the Maintenance Treatment of COPD
Shots: The approval is based on P-III ETHOS study assessing of Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate) vs dual therapies [Bevespi Aerosphere (glycopyrronium/formoterol fumarate) and PT009 (budesonide/formoterol […]
AZ’s COPD triple therapy approved in the US
AstraZeneca’s triple therapy for chronic obstructive pulmonary disease (COPD), Breztri Aerosphere (budesonide+glycopyrrolate+formoterol fumarate), has been approved in the US following a rejection last year. Approval […]
The world needs a ‘people’s vaccine’ for coronavirus, not a big-pharma monopoly | Helen Clark and Winnie Byanyima
AstraZeneca and others should not own a lucrative patent on a medicine that is needed by poor as well as rich nations • See all […]
Controversy as pharma execs predict profits from COVID-19 vaccines
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 […]
AstraZeneca and Oxford University’s AZD1222 Delivers Dual Immune Response in its P-II/III COV001 Study Against COVID-19
Shots: The P-II/III COV001 designed to determine the safety, immunogenicity, and efficacy of the AZD1222 (single dose or two doses of AZD1222 at 5×1010 viral […]
GlaxoSmithKline makes bold move with £130m Covid-19 investment | Nils Pratley
GSK’s share price has been left standing by AstraZeneca’s high-risk success in cancer treatments Monday’s most important vaccine news was the promising early data from […]
‘Promising’ data on Oxford/AZ, CanSino coronavirus vaccines
Data from more than 1,000 healthy volunteers dosed with a coronavirus vaccine developed at Oxford University and AstraZeneca suggest the shot is safe and stimulates […]
AstraZeneca Covid-19 vaccine shows antibody levels comparable to recovered patients
The company announced the publication of interim data from the Phase I/II study of a vaccine it is developing with the University of Oxford. The […]
PharmaShots Weekly Snapshot (Jul 13- 17, 2020)
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, […]
FDA guidance eases some Covid-19 vaccine concerns, but others remain
Amid fears of a premature emergency use authorization for a Covid-19 vaccine granted for political reasons, the guidance that the FDA released at the beginning […]
Call for COVID-19 ‘challenge trial’ ahead of AstraZeneca vaccine readout
Press reports suggest that there is good news about AstraZeneca and Oxford University’s COVID-19 vaccine due from an early stage trial in the coming days […]
Chasing Brilinta payoff, AZ details THALES data in ischemic stroke
AstraZeneca has lifted the veil on the large-scale THALES trial of its antiplatelet drug Brilinta in stroke, the company’s last big hope for recouping its […]
AstraZeneca Report Results of Brilinta (ticagrelor) in P-III THALES Study for Patients with Acute Ischemic Stroke or Transient Ischemic Attack
Shots: The P-III THALES study involves assessing of Brilinta (180mg as a loading dose followed by 90mg, bid) + aspirin vs aspirin as monothx. in […]
Oxford offers best hope for Covid-19 vaccine this year, MPs told
University is leading rivals but first drugs may not work fully, says vaccine taskforce chair Coronavirus – latest updates See all our coronavirus coverage Oxford […]
What on earth is the boss of AstraZeneca up to with his approach to Gilead? | Nils Pratley
Pascal Soriot heroically defended the company against Pfizer, but now he needs to calm his investors It’s hard to keep AstraZeneca out of the headlines. […]
AstraZeneca and Merck & Co’s Lynparza Receive the US FDA’s Approval as a 1L Maintenance Treatment of Germline BRCA-Mutated Metastatic Pancreatic Cancer
Shots: The approval follows the US FDA Oncologic drugs Advisory Committee (ODAC) on 17 Dec based on P-III POLO trial, which involves assessing of Lynparza […]