FDA grants swift review to Lynparza in first-line prostate cancer
AstraZeneca and Merck & Co’s PARP inhibitor Lynparza is already used to treat prostate cancer associated with a specific genetic mutation, but could see its […]
AstraZeneca
AstraZeneca & Daiichi drug wins another FDA approval, this time in lung cancer
On the heels of receiving a landmark FDA approval in breast cancer, AstraZeneca and Daiichi Sankyo drug Enhertu won an additional approval in non-small cell […]
Dismay as UK ‘drags its heels’ on AZ’s COVID antibody Evusheld
Half a million people in the UK with conditions like blood cancer that prevents them being protected from COVID-19 vaccines are facing another winter shielding, […]
Tagrisso paired with Hutchmed drug clears lung cancer test
EGFR inhibitors like AstraZeneca’s Tagrisso have been hugely successful in treating EGFR-positive lung cancer, but the durability of treatment is often reduced by resistance mutations. […]
AZ gets FDA nod for Enhertu in first HER2-low cancer
The FDA has approved AstraZeneca and Daiichi Sankyo’s Enhertu as the first targeted therapy for HER2-low breast cancer, a new category of the disease that […]
FDA approval of AstraZeneca drug is first for a new group of breast cancer patients
Enhertu, a breast cancer drug from AstraZeneca and Daiichi Sankyo, is now FDA approved for treating patients whose tumors express low levels of the protein […]
AZ, Merck get EU nod for Lynparza as adjuvant breast cancer therapy
The European Commission has cleared AstraZeneca and Merck & Co’s Lynparza as an adjuvant or neoadjuvant treatment for breast cancer, extending its lead over would-be […]
AstraZeneca raises 2022 guidance, names Demaré as non-exec chair
AstraZeneca chief executive Pascal Soriot said this morning that strong revenue increases in 2022 – fuelled by its COVID-19 antibody Evusheld and oncology drugs – […]
FDA verdict on Enhertu in HER2-low breast cancer due before year-end
AstraZeneca and Daiichi Sankyo will hear back from the FDA before the end of 2022 on their license application for Enhertu in HER2-low breast cancer […]
Roche’s fast-growing eye drug Vabysmo set for EU approval
Roche has been trumpeting the rapid uptake of its new eye disease drug Vabysmo as it takes on Regeneron and Bayer’s mighty Eylea in the […]
Court won’t raise Seagen damages award in Enhertu patent dispute
A Texas court has confirmed the $41.8 million damages awarded to Seagen in its patent dispute with Daiichi Sankyo over beast cancer drug Enhertu, but […]
Disappointment as Lynparza fails colorectal cancer test
AstraZeneca and Merck’s PARP inhibitor Lynparza has carved out blockbuster revenues across uses in breast, ovarian, prostate and pancreatic cancer, but colorectal cancer won’t be […]
AZ, Daiichi challenge Roche with EU okay for earlier use of Enhertu
AstraZeneca and Daiichi Sankyo have claimed approval in the EU for Enhertu as a second-line therapy for HER2-positive metastatic breast cancer, moving the drug up […]
Byondis cues up US, EU decisions on breast cancer ADC in 2023
Byondis has filed its HER2-targeting antibody-drug conjugate (ADC) trastuzumab duocarmazine in the US and Europe, setting up possible approvals next year and a showdown with […]
AstraZeneca partners Health2Sync on CKD digital support tool
Taiwan-based digital health firm Health2Sync has added another big pharma company to the roster of clients for its patient support platform. The latest partner is […]
Deep Dive: Oncology 2022
Eradicating cancer is an ambitious goal for oncologists and life science companies around the world. But, with a growing number of cancer treatments entering the […]
AstraZeneca broadens its scope in blood cancers with $100M TeneoTwo buyout
AstraZeneca is acquiring TeneoTwo in a $100 million bet on that biotech’s lymphoma drug candidate, which is designed to go after two targets. It’s the […]
AstraZeneca agrees $1.3bn deal to buy oncology player TeneoTwo
AstraZeneca has signed a deal to buy US biotech TeneoTwo in a deal worth up to $1.27 billion that will boost its position therapies for […]
AZ takes aim at BMS’ lead in neoadjuvant NSCLC
Just weeks after Bristol-Myers Squibb claimed an FDA green light for Opdivo as a neoadjuvant therapy for non-small cell lung cancer, AstraZeneca is looking to […]
Data backs AZ’s Wilson disease drug, but with a question mark
Last year, AstraZeneca reported that a new drug to treat Wilson disease developed by its Alexion rare diseases unit had hit the mark in a […]
Aiming to catch Alnylam, AstraZeneca & Ionis plan FDA filing for rare disease drug
The planned FDA submission follows the report from AstraZeneca and Ionis Pharmaceuticals that their partnered drug, eplontersen, met the main goals of a pivotal study […]
AZ preps FDA filing for $3.6bn amyloidosis drug eplontersen
Armed with new phase 3 data, AstraZeneca is preparing to file for regulatory approval of eplontersen, an antisense drug for one of the complications of […]
Rumour mill says AstraZeneca may be eyeing a takeover of Mereo
AstraZeneca is rumoured to be considering a bid to take control of its longstanding partner Mereo BioPharma, according to a report in The Times, which […]
ASCO recap: Breast cancer breakthrough, Mirati’s moves, Arcellx ascends & more
Breast cancer drugs and cell therapies were prominent in this year’s annual meeting of the American Society of Clinical Oncology. Here’s a recap of some […]
ASCO22: Enhertu aces key HER2-low test in breast cancer
In February, AstraZeneca and Daiichi Sankyo teased the results of their pivotal trial of Enhertu in HER2-low breast cancer, and, at ASCO, they finally revealed […]
AstraZeneca, Daiichi Sankyo have high hopes for drug that goes low in breast cancer
During the annual meeting of the American Society of Clinical Oncology, AstraZeneca and Daiichi Sankyo reported pivotal clinical trial data showing that their partnered cancer […]
SEC accuses former AstraZeneca exec of insider trading
The US Securities and Exchange Commission has sued a former AstraZeneca executive over alleged insider trading in connection with its 2019 deal to acquire rights […]
At ESMO, three studies show promise of antibody-drug conjugates in breast cancer
The American Society of Clinical Oncology, or ASCO, conference is just around the corner, but one subgroup of cancer researchers just had their own gathering, […]
AstraZeneca reviews diversity in trials to ensure drugs work for all
Firm aims to apply ‘equity lens’ across clinical tests to ensure diverse population groups take part The pharmaceutical giant AstraZeneca is conducting a major review […]
AstraZeneca buys into startup RQ Bio’s COVID antibodies
Brand new UK startup RQ Biotechnology has been thrust into the spotlight after signing a $157 million licensing deal with AstraZeneca for monoclonal antibodies intended […]
BenevolentAI, AstraZeneca AI-based drug discovery collaboration achieves third milestone
BenevolentAI has discovered a second novel target for idiopathic pulmonary fibrosis (IPF), which AstraZeneca has added to its drug development portfolio, resulting in a milestone […]
AstraZeneca extends oncology partnership with Proteros
AstraZeneca has boosted its research capacity by extending its oncology partnership with Proteros biostructures. German pharma firm Proteros specialises in structure-based drug discovery powered by […]
AZ, Sanofi build case for one-shot RSV antibody
A pooled analysis of data for AstraZeneca and Sanofi’s respiratory syncytial virus (RSV) antibody nirsevimab has concluded that the drug is almost 80% effective at […]
AZ bites back at rivals with new Farxiga data in heart failure
AstraZeneca’s SGLT2 inhibitor Farxiga has hit the mark in a phase 3 heart failure trial that brings it back into contention with its main rival […]
AZ eyes Q3 FDA decision for Imfinzi in biliary tract cancer
The FDA has kicked off a priority review of AstraZeneca’s checkpoint inhibitor Imfinzi for biliary tract cancer (BTC), setting up what could be approval for […]
AstraZeneca boss calls for UK to provide new Covid-19 medicine to the vulnerable
Pharmaceutical CEO says it’s ‘sad’ that UK has failed to order Evusheld for the immunosuppressed AstraZeneca boss Pascal Soriot has called on the government to […]
AstraZeneca plans new US R&D hub as revenues rocket
AstraZeneca has revealed plans to set up a new strategic R&D hub in Cambridge, Massachusetts as it reported a massive increase in first-quarter revenues, driven […]
Enhertu gets breakthrough tag in HER2-low breast cancer
AstraZeneca and Daiichi Sankyo have claimed a fifth breakthrough designation from the FDA for Enhertu, shortly after the showing the drug extended survival in patients […]
AZ closes on FDA verdict on tremelimumab in liver cancer
AstraZeneca’s anti-CTLA4 antibody tremelimumab is moving closer to what once looked like an extremely unlikely regulatory approval, after a string of negative trial results. The […]
AstraZeneca’s long-acting Covid-19 drug keeps protecting high-risk patients at 6 months
AstraZeneca’s Covid-19 antibody drug Evusheld reduced the risk of infection by 83% after six months. These results published in the New England Journal of Medicine […]
FDA starts speedy review of Enhertu in lung cancer
AstraZeneca and Daiichi Sankyo should only have to wait for six months to hear from the FDA if it will approve their HER2 drug Enhertu […]
GSK goes for gold as FDA starts review of daprodustat
GlaxoSmithKline says the FDA has started its review of daprodustat for anaemia associated with chronic kidney disease (CKD), as it strives to succeed where two […]
Seagen wins Enhertu patent dispute with Daiichi Sankyo
A US jury has decided that Daiichi Sankyo and AstraZeneca’s breast cancer drug Enhertu infringes a patent held by US biotech Seagen, awarding almost $42 […]
LV= on board with £515,000 bonus for boss despite shambles of failed sale
Mark Hartigan has been given £515,000 bonus for 2021 – a humbler CEO would have let the dust settle Mark Hartigan had his bonus for […]
FDA restricts GSK’s Xevudy due to lower efficacy against BA.2
GlaxoSmithKline and Vir’s Xevudy has become the latest COVID-19 antibody therapy to have its use restricted by the FDA as a result of waning activity […]
AZ expands digital health plans with Huma alliance
AstraZeneca has bought a stake in digital health firm Huma Therapeutics in a deal that will see ownership of AZ’s AMAZE disease management platform transfer […]
AstraZeneca’s Imfinzi fails in cervical cancer bid
AstraZeneca’s hopes of developing its PD-L1 inhibitor Imfinzi for cervical cancer have been hit by a failed phase 3 trial of the drug alongside chemotherapy […]
Oxford Covid jab gears up for final act: saving the rest of the world
After mishaps and misinformation, jab will build ‘global wall of immunity’, says director of Oxford Vaccine Group Exactly two years ago Prof Sir Andrew Pollard […]
No room for commercial competition in sustainable pharma
With the healthcare sector accounting for around 4% of global emissions – about the same as a small country – only an ecosystem-wide effort will […]
Latest ABPI code breaches reveal the risk of ‘likes’ on LinkedIn
AstraZeneca (AZ), GlaxoSmithKline (GSK), Sanofi, Allergan and Britannia Pharma have been reprimanded for running advertisements that breached the Association of British Pharmaceutical Industry (APBI) code […]
AstraZeneca’s Evusheld Covid-prevention drug gets UK approval
Treatment aimed at people who cannot be vaccinated is boost to firm’s coronavirus portfolio AstraZeneca has received UK regulatory approval for its long-acting Covid-19 antibody […]
GlaxoSmithKline says it will not start any new clinical trials in Russia
Pharma firm joins AstraZeneca and Pfizer in saying it will not enrol new patients into studies Russia-Ukraine war: latest updates What we know on day […]
AZ pays $775m to settle patent dispute with Chugai over Ultomiris
AstraZeneca has resolved a lingering liability following its takeover of Alexion with an agreement to pay $775 million to settle a patent dispute with Chugai […]
Merck trial of Keytruda, Lynparza combo in prostate cancer fails
Merck & Co’s two powerhouse oncology drugs – Keytruda and Lynparza – have failed to show efficacy when used in combination for patients with previously […]
FDA clears first generic of AZ’s blockbuster Symbicort
Viatris (formerly Mylan) has become the first drugmaker to win full FDA approval for a generic version of AstraZeneca’s top-selling respiratory drug Symbicort, although launch […]
FDA says no to AZ’s Fasenra for nasal polyp indication
AstraZeneca has failed in its bid to get US approval for its IL-5 inhibitor Fasenra as a treatment for chronic rhinosinusitis in people with nasal […]
AZ, Merck get FDA okay for Lynparza as adjuvant breast cancer therapy
The FDA has cleared AstraZeneca and Merck & Co’s Lynparza as an adjuvant or neoadjuvant treatment for breast cancer, extending its lead over pretenders to […]
Jardiance pulls ahead of Forxiga with heart failure approval in EU
Boehringer Ingelheim and Eli Lilly’s SGLT2 inhibitor Jardiance has become the first drug in the class to be approved in the EU for all adults […]
Stage set for Jardiance to become universal heart failure drug
Boehringer Ingelheim and Eli Lilly have published data for their SGLT2 inhibitor Jardiance in acute heart failure, setting them on course to position the drug […]
After GSK stumble, Pfizer moves forward with RSV vaccine
Pfizer has been awarded breakthrough status from the FDA for its respiratory syncytial virus (RSV) vaccine in pregnant women, putting the company in pole position […]
AstraZeneca, Honeywell partner to address climate change with new inhaler tech
UK-based global pharma company AstraZeneca and US consumer products company Honeywell have announced a partnership to build a new “next generation” inhaler with a propellant […]
Big day for AZ, Daiichi as Enhertu aces HER2-low breast cancer trial
Already making inroads as a treatment for HER2-positive breast cancer, AstraZeneca and Daiichi Sankyo’s Enhertu has now shown efficacy in tumours that express lower levels […]
AZ’s Saphnelo is cleared in EU, challenging GSK’s Benlysta
lupusAstraZeneca’s Saphnelo has become the first new drug to be approved to treat the autoimmune disease systemic lupus erythematosus (SLE) in the EU for more […]
AZ halts development of Beta variant COVID-19 vaccine
AstraZeneca confirmed today that it has discontinued clinical development of a follow-up to its COVID-19 vaccine Vaxzevria targeted at the Beta variant of the virus, […]
AstraZeneca forecasts higher 2022 sales and lifts annual dividend
Drugmaker’s total revenues increased by 41% last year with help from $4bn Covid jab income AstraZeneca forecast higher 2022 sales and lifted its annual dividend […]
UCB preps filings for another challenger to AZ’s Soliris
Belgian drugmaker UCB says it will be able to file not one but two new drug therapies for autoimmune disease generalised myasthenia gravis (gMG) this […]
Chronic kidney disease: treating a silent killer
In November, NICE backed NHS use of AstraZeneca’s diabetes and heart failure drug Forxiga for the treatment of chronic kidney disease. pharmaphorum caught up with […]
NICE expands cover for AZ’s high potassium drug Lokelma
NICE has recommended extending funding via the NHS for AstraZeneca’s elevated potassium therapy Lokelma in new guidance, making it easier to receive the drug outside […]
Novavax Covid vaccine: what is it and will it make a difference?
Australia’s government is hoping the protein-based vaccine – approved by the TGA – will sway the hesitant to get the jab Australia’s medicines regulator has […]
Scotland backs AstraZeneca drug as first-line treatment for NSCLC
Scotland has approved AstraZeneca’s Tagrisso (osimertinib) as a monotherapy for the for the first-line treatment of adult patients with locally advanced or metastatic non-small cell […]
AstraZeneca bets $75M on Scorpion’s precision approach to tough cancer targets
AstraZeneca’s partnership with Scorpion Therapeutics will focus on transcription factors that are known to play a role in cancer but have been difficult to target […]
Third dose of AZ’s COVID jab boosts Omicron antibodies
Preliminary data from an ongoing trial of AstraZeneca’s COVID-19 vaccine Vaxzevria has shown that a booster dose stimulates an increase in antibodies against Omicron, as […]
AZ, Scorpion strike deal on elusive transcription factor targets in cancer
AstraZeneca has expanded its efforts to develop new therapies targeting transcription factors – proteins that regulate processes in the cell that have become a hot […]
AstraZeneca goes bigger in amyloidosis with Neurimmune deal
AstraZeneca has clearly made the rare disease transthyretin amyloidosis (ATTR) a key component of its rare disease pipeline, licensing a second drug candidate in the […]
After a Scottish aye, NICE says no to Lynparza for prostate cancer
AstraZeneca’s PARP inhibitor Lynparza should not be made available routinely on the NHS n England and Wales as a treatment for prostate cancer, according to […]
Ovid Therapeutics adds to epilepsy drug pipeline with new AstraZeneca alliance
Ovid Therapeutics is acquiring global rights to AstraZeneca molecules that address a novel target to treat epilepsy. The AstraZeneca deal comes 10 months after Takeda […]
Leo Pharma’s FDA nod adds a challenger to Dupixent’s dominance in eczema
With FDA approval for its atopic dermatitis drug Adbry, LEO Pharma will reach the U.S market ahead of an Eli Lilly atopic dermatitis drug that […]
FDA gives Daiichi Sankyo’s HER3 drug a breakthrough tag
Daiichi Sankyo has been granted breakthrough status by the FDA for patritumab deruxtecan, a HER3-targeted antibody-drug conjugate (ADC) in clinical trials for lung cancer. The […]
Steps taken to target Omicron with AstraZeneca jab, scientist says
Sandy Douglas, from Oxford University, says updated vaccine could ‘respond to any new variant more rapidly’ Coronavirus – latest updates See all our coronavirus coverage […]
Relief for AZ, Amgen as FDA okays severe asthma hope tezepelumab
The FDA has approved AstraZeneca and Amgen’s severe asthma hope tezepelumab, exonerating the drugmakers’ decision to press ahead with a regulatory filing despite a failed […]
UK biotech firm Aptamer to float valued at £80.7m
York-based company makes synthetic antibodies for pharmaceutical firms including AstraZeneca A British biotechnology firm that supplies big pharmaceutical firms with synthetic antibodies for targeted delivery […]
EU gives narrower label to Apellis, Sobi’s PNH drug
Apellis Pharma and partner Sobi have won EU approval for their paroxysmal nocturnal haemoglobinuria (PNH) drug pegcetacoplan in Europe, with a more restricted label than […]
AstraZeneca’s long-acting antibody drug lands FDA authorization for Covid-19
FDA authorization of AstraZeneca drug Evusheld makes it the first antibody therapy for preventing infection before exposure to Covid-19, providing an option for immunocompromised patients […]
AZ’s antibody first to be cleared by FDA for COVID prevention
AstraZeneca’s antibody cocktail for COVID-19, now called Evushield, has become the first drug in the class to be authorised for prevention of infection by the […]
AZ, Daiichi take aim at Gilead in triple-negative breast cancer
AstraZeneca and Daiichi Sankyo have reported new data with their antibody-drug conjugate for triple-negative breast cancer (TNBC), as they build a case to challenge Gilead’s […]
AZ gets closer to Ionis, licensing amyloidosis drug in $3.6bn deal
AstraZeneca has snapped up another Ionis-discovered drug for its pipeline, this time phase 3 candidate eplontersen for the disease transthyretin amyloidosis (ATTR). The deal is […]
Did AZ scupper Sobi’s $8bn private equity buyout?
An $8 billion attempt by two private equity companies to acquire Swedish rare disease specialist Sobi and take it back into private ownership has collapsed, […]
Covid: scientists find possible trigger for AstraZeneca jab blood clots
Experts hope better understanding of rare side effect of vaccine could help ‘turn the tide’ on pandemic Coronavirus – latest updates See all our coronavirus […]
AZ eyes FDA verdict on Lynparza in adjuvant breast cancer in Q1
The FDA will deliver a verdict on AstraZeneca’s PARP inhibitor Lynparza as an adjuvant treatment for breast cancer in the first quarter of next year, […]
Pharma pledges rapid response to Omicron COVID variant
With governments around the world announcing measures to curb the new B.1.1.529 variant of COVID-19 – now christened Omicron – leading vaccine manufacturers have said […]
AstraZeneca to run more clinical trials in people’s homes to improve diversity
Experts say shifting data collection to the home may break down barriers to participation in research AstraZeneca is to let more people take part in […]
‘Follow the science’: AstraZeneca unveils £1bn R&D centre
Anglo-Swedish pharmaceutical company has come a long way since it fought off a takeover bid in 2014 Little expense has been spared at the giant […]
UK-wide whole genome sequencing for newborns is feasible – but there are some key questions to answer first
Genomics England, the Department of Health and Social Care’s genome-sequencing hub, has this year announced that support for whole genome sequencing (WGS) has reached a […]
AstraZeneca CEO links Europe’s Covid surge to rejection of its vaccine
Scientists sceptical about Pascal Soriot’s suggestion Oxford jab may give longer-lasting protection Coronavirus – latest updates See all our coronavirus coverage Scientists have reacted with […]
AstraZeneca cuts the ribbon on its $1bn R&D lab in Cambridge
After years of delays and rising costs, AstraZeneca has formally unveiled its $1 billion R&D facility in Cambridge, said to be the biggest science lab […]
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, […]
AstraZeneca Reports Results of AZD7442 in P-III PROVENT and TACKLE Trial for the Treatment of COVID-19
Shots: The P-III PROVENT & TACKLE trial evaluates AZD7442 (IM) vs PBO in a ratio (2:1) & (1:1) in 5197 & 903 patients with COVID-19 […]
AstraZeneca’s Lokelma Receives Fast Track Designation for the Treatment of Chronic Haemodialysis with Hyperkalaemia
Shots: The designation is based on the ongoing P-III DIALIZE-Outcomes trial to evaluate the effect of Lokelma on arrhythmia-related CV outcomes in patients with chronic […]
The Guardian view on vaccine justice: what the world needs now | Editorial
While some in the west are triple-dosed, the vast majority of health workers in Africa remain unprotected. Gestures won’t close the gulf AstraZeneca’s halo has […]
AstraZeneca and Moderna Present Results of AZD8601 in P-IIa EPICCURE Trial for the Treatment of Heart Failure at AHA 2021
Shots: The P-IIa EPICCURE trial evaluates safety, tolerability & exploratory efficacy of epicardial inj. of AZD8601 vs PBO in 11 patients (7 were treated with […]
AZ, Moderna say mRNA drug is promising in heart failure
Moderna is already riding high on the strength of its mRNA-based COVID-19 vaccine, but the broader potential of its technology has been shown in a […]
AstraZeneca will make ‘modest’ profit from COVID vaccine
AstraZeneca has said it plans to start making a small profit from sales of its COVID-19 vaccine Vaxzevria, which brought in just over $1 billion […]
AstraZeneca sells $2.2bn of Covid vaccine in first nine months
Drugmaker says it expects to transition to ‘modest profitability’ as it receives new orders Coronavirus – latest updates See all our coronavirus coverage AstraZeneca has […]
AstraZeneca’s new Covid treatment: what is it and how does it work?
Evusheld could offer higher protection against variants and help vulnerable people ward off virus Follow our Australia news live blog for the latest updates Five […]
AstraZeneca to create dedicated Covid vaccines unit
Move intended to make it easier to continue producing coronavirus shot over the long term Coronavirus – latest updates See all our coronavirus coverage AstraZeneca […]
PharmaShots Interview: Thermo Fisher Scientific’ Garret Hampton Shares Insight on Thermo Fisher’s Agreement with AstraZeneca for NGS-based CDx
In an interview with PharmaShots, Garret Hampton, President of Clinical Next-Generation Sequencing and Oncology at Thermo Fisher Scientific share his views on multiyear agreement with […]
PharmaShots Weekly Snapshots (November 01 – 03, 2021)
Lonza Collaborates with Codiak to Acquire its Exosomes Manufacturing Facility in Lexington, Massachusetts (US) Published: Nov 3, 2021 | Tags: Lonza, Codiak, Acquire, Exosomes Manufacturing […]
Cautious welcome as NICE backs Forxiga for chronic kidney disease
Tens of thousands of people with chronic kidney disease in England could be eligible for treatment with AstraZeneca’s SGLT2 inhibitor Forxiga, after NICE backed NHS […]
EMA starts review of Enhertu for HER2+ gastric cancer
The EMA has started its review of AstraZeneca and Daiichi Sankyo’s Enhertu for a second indication, as a second-line treatment for HER2-positive gastric cancer. If […]
AstraZeneca Reports Results of Saphnelo in P-III TULIP Clinical Trial Program for the Treatment of Systemic Lupus Erythematosus
Shots: The P-III TULIP clinical trial program consists of 2 trials, TULIP-1 & 2 that evaluates the efficacy & safety of Saphnelo (150/300mg, q4w) vs […]
AstraZeneca to Divest Global Rights of Eklira and Duaklir to Covis Pharma in $270M Deal
Shots: AstraZeneca to receive $270M on completion. The transaction is expected to be close in Q4’21 while Covis will also pay an ongoing development cost […]
AstraZeneca and Hutchmed Initiate P-III SAMETA Trial of Imfinzi (durvalumab) + Orpathys (savolitinib) for Advanced Papillary Renal Cell Carcinoma
Shots: The companies initiate P-III SAMETA study to evaluate the efficacy and safety of Hutchmed’s savolitinib (MET tyrosine kinase inhibitor) + AstraZeneca’s Imfinzi (PD-L1 inhibitor) […]
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, […]
AZ/Daiichi partner with Merck on first-line lung cancer trial
The dominance of Merck & Co’s Keytruda in the treatment of previously-untreated non-small cell lung cancer (NSCLC) means it will be hard to dislodge – […]
Daiichi Sankyo and AstraZeneca Entered into a Second Clinical Trial Collaboration with Merck for Datopotamab Deruxtecan (Dato-DXd) + Keytruda (pembrolizumab)
Shots: The companies collaborated to evaluate datopotamab deruxtecan + Keytruda vs Keytruda alone in P-III TROPION-Lung08 trial in ~740 patients with PD-L1 high advanced or […]
AZ’s Imfinzi is first immunotherapy to raise survival in biliary tract cancer
AstraZeneca’s checkpoint inhibitor Imfinzi has become the first cancer immunotherapy to improve survival in previously-untreated patients with biliary tract cancer (BTC), a rare and aggressive […]
Entasis antibiotic bests last-resort drug in Phase 3 trial; FDA filing planned for 2022
Entasis Therapeutics, the former anti-infectives unit of AstraZeneca, has positive Phase 3 data for its lead program, an antibiotic that could address drug-resistant strains of […]
PharmaShots Weekly Snapshots (October 11 – 15, 2021)
Bristol Myers Squibb’s Zeposia (ozanimod) Receives CHMP’s Positive Opinion for Adult Patients with Moderately to Severely Active Ulcerative Colitis Published: 15 Oct, 2021 | Tags: […]
AstraZeneca Reports Results of Imfinzi + Tremelimumab in P-III HIMALAYA Study for 1L Treatment of Unresectable Liver Cancer
Shots: The P-III HIMALAYA study Imfinzi monothx. and the STRIDE regimen (single priming dose of tremelimumab 300mg + Imfinzi 1500mg followed by Imfinzi q4w vs […]
What does the future of European healthcare look like?
After the “stress test” of COVID, how can the sector create resilient, sustainable healthcare systems for the long term? COVID has taught us that future […]
Local Covid vaccines fill gap as UN Covax scheme misses target
India, Egypt and Cuba among first states to develop and make their own vaccines as Covax falls behind Developing countries are increasingly turning to homegrown […]
Merck files pill for milder COVID, as AZ showcases its antibody data
As expected, Merck & Co has moved ahead swiftly with an emergency use application for its oral antiviral molnupiravir, aiming to protect people with mild […]
AstraZeneca’s AZD7442 Meet its Primary Endpoints in P-III TACKLE Trial for the Treatment of COVID-19
Shots: The P-III TACKLE trial evaluates the safety & efficacy of AZD7442 (600mg, IM) as monothx. vs PBO in a ratio (1:1) in 903 outpatients […]
PharmaShots Interview: Sierra Oncology’ Dr. Barbara Klencke Shares Insight on Sierra’s Agreement with AstraZeneca for AZD5153
In an interview with PharmaShots, Dr. Barbara Klencke, MD, Chief Medical Officer at Sierra Oncology share her views on the license agreement for AZD5153 with […]
AZ files for emergency use of COVID-19 antibody combo in US
AstraZeneca has sought emergency use authorisation for its antibody combination AZD7442, following trial results indicating it can prevent symptomatic COVID-19 infection when given to healthy […]
AstraZeneca Seeks the US FDA’s EUA for AZD7442 to Treat COVID-19 in US
Shots: AstraZeneca has submitted a request to the US FDA seeking EUA for its AZD7442 to treatprophylaxis of symptomatic COVID-19. If EUA is granted, AZD7442 […]
Enhertu nabs speedy FDA review for earlier use in breast cancer
Hard on the heels of impressive new data for Enhertu as a second-line therapy for breast cancer, AstraZeneca and Daichi Sankyo have claimed FDA breakthrough […]
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, […]
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 […]
AstraZeneca to Acquire Caelum for ~500M
Shots: Alexion has exercised its option to acquire all remaining equity in Caelum for CAEL-101 which is currently being evaluated in P-III CARES clinical program […]
AZ claims full control of Caelum’s AL amyloidosis drug in $500m deal
AstraZeneca’s newly acquired Alexion will buy the remaining equity in rare disease specialist Caelum Biosciences in a deal that could be worth up to $500 […]
AstraZeneca’s Saphnelo (anifrolumab) Receives MHLW’s Approval for the Treatment of Systemic Lupus Erythematosus
Shots: The approval was based on the clinical program including two P-III TULIP & P-II MUSE trials evaluated the efficacy and safety of Saphnelo vs […]
PharmaShots Weekly Snapshots (September 20 – 24, 2021)
Everest’s SPR206 Receives the NMPA’s IND Approval for the Treatment of MDR Gram-Negative Bacterial Infections Published: Sept 24, 2021 | Tags: Everest, SPR206, NMPA, IND, […]
PROpel study backs Lynparza combo in first-line prostate cancer
AstraZeneca and Merck & Co PARP inhibitor Lynparza is already used to treat prostate cancer associated with a specific genetic mutation, but could see the […]
AstraZeneca Collaborates with VaxEquity to Develop and Commercialize Self-Amplifying RNA Therapeutics
Shots: VaxEquity can receive ~$195M in development, approval, and sales-based milestones along with royalties per program & is also eligible to receive an equity investment […]
Amnesty says COVID jab producers are causing human rights crisis
Amnesty International has slammed the six pharma companies behind the bulk of COVID-19 vaccine supplies of for not agreeing to waive their intellectual property rights […]
Big pharma fuelling human rights crisis over Covid vaccine inequity – Amnesty
Six companies warned not to put profit before lives as report shows less than 1% of almost 6bn doses have gone to low-income countries Amnesty […]
After Alexion buy, AZ plans $360m investment in Irish facilities
AstraZeneca has unveiled plans to build a brand new manufacturing facility at a site in Ireland operated by recent acquisition Alexion, providing employment for around […]
AstraZeneca Presents the Updated Results of Imfinzi (durvalumab) in P-III CASPIAN Trial for the Treatment of Extensive-Stage Small Cell Lung Cancer at ESMO 2021
Shots: The P-III CASPIAN trial evaluates Imfinzi + CT or Imfinzi + CT + tremelimumab vs CT alone in 805 patients with ES-SCLC in 200+ […]
ESMO21: Enhertu brings it’s A game to second-line breast cancer
AstraZeneca and Daiichi Sankyo were clearly excited by data from a trial pitting their HER2 antibody-drug conjugate (ADC) Enhertu against Roche’s rival Kadcyla when they […]
ICER says Amgen’s tezepelumab ‘likely to be too expensive’
Amgen and AstraZeneca haven’t won approval or announced a price for their severe asthma therapy tezepelumab should it reach the market, but ICER in the […]
AstraZeneca Presents Results of Imfinzi (durvalumab) + Tremelimumab in P-III POSEIDON Study as 1L Treatment for Stage IV NSCLC at WCLC 2021
Shots: The P-III POSEIDON trial evaluates Imfinzi (1500mg, q3w, FD, for 4 cycles) + Pt-based CT or Imfinzi + Tremelimumab + CT vs CT alone […]
MHRA clears third doses of AZ, Pfizer COVID jabs
The UK medicines regulator has cleared the use of a third dose of both the AstraZeneca and Pfizer COVID-19 vaccines, in readiness for a possible […]
AstraZeneca Reports Results of PT027 (albuterol and budesonide) in P-III MANDALA and DENALI Trials for the Treatment of Asthma
Shots: The P-III MANDALA & DENALI trial evaluates the efficacy & safety of PT027 (180/160mcg & 180/80mcg doses) vs albuterol & albuterol and budesonide aged […]
AstraZeneca and Hutchmed Initiate P-III SANOVO Trial for Orpathys (savolitinib) + Tagrisso (osimertinib) as a 1L Therapy for Non-small Cell Lung Cancer in China
Shots: The companies initiate P-III SANOVO study to evaluates the efficacy & safety of Orpathys in combination with AstraZeneca’s Tagrisso (irreversible EGFR TKI) vs Tagrisso […]
AZ CEO Soriot urges caution on COVID booster doses
The UK should think twice before backing widespread use of COVID-19 booster vaccinations, as to do so could place unnecessary burden on the NHS over […]
AstraZeneca Presents Results of Fasenra in P-IIIb PONENTE Study for the Treatment of Asthma at ERS 2021
Shots: The P-IIIb PONENTE study evaluates the safety & efficacy of Fasenra (30mg, SC, q8w) in adult patients with sev. eosinophilic asthma on high-dose ICS […]
AstraZeneca and Amgen’s Tezepelumab Demonstrates 86% Reduction in Exacerbations in Patients with Asthma and Nasal Polyps
Shots: The P-III NAVIGATOR study involves assessing Tezepelumab + SOC vs PBO +SOC in adults (18–80yrs.old) and adolescents (12–17yrs. old) with severe, uncontrolled asthma. The […]
Amgen builds case for severe asthma drug tezepelumab
Amgen and partner AstraZeneca have said their recently filed severe asthma drug tezepelumab has shown impressive results in patients who also have nasal polyps, a […]
Australian Novavax trial participants remain unrecognised by vaccine register
Covid vaccination status of hundreds in limbo because the US company’s jab is yet to be approved in Australia Vaccine rollout tracker; get our free […]
PharmaShots Weekly Snapshots (August 30 – September 03, 2021)
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, […]
PharmaShots Weekly Snapshots (August 30 – September 03, 2021)
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, […]
AstraZeneca Signs a Multiyear Agreement with Thermo Fisher to Co-Develop NGS-based CDx for Targeted Therapies
Shots: The collaboration will expand AstraZeneca’s portfolio of targeted therapies for cancer & other diseases. Thermo Fisher currently offers the NGS CDx solution which is […]
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, […]
After Ultomiris stumble, Alexion delivers a rare disease win for AZ
A drug for Wilson disease developed by AstraZeneca’s Alexion rare disease unit has cleared a phase 3 trial, setting up regulatory filings in the coming […]
UK real-world study finds COVID-19 jab protection wanes
A study has found evidence that protection from the AstraZeneca and Pfizer/BioNTech COVID-19 vaccines starts fall off after a few months, but a UK government […]
AZ’s Alexion takeover hits a snag, as Ultomiris flunks ALS trial
It has only been a month since AstraZeneca’s $39 billion takeover of Alexion was completed, but the merger has already had a setback. Alexion has […]
AstraZeneca drug succeeds in Covid-19 prevention; regulatory filings on the way
An AstraZeneca antibody drug for Covid-19 has clinical data showing the drug reduced the risk of infection by 77%. With the results, the pharmaceutical giant […]
AstraZeneca drug acquired in Alexion acquisition falls short in pivotal ALS trial
Alexion Pharmaceuticals drug Ultomiris is already approved to treat a rare blood disorder, but the company hoped the antibody’s approach could also work in amyotrophic […]
PROVENT trial puts AZ COVID antibody combo back on track
AstraZeneca’s AZD7442 has shown that it can prevent COVID-19 infection when given to healthy patients – the first time this has been demonstrated by a […]
Jardiance gets parity with Farxiga in US as FDA clears use in heart failure
Eli Lilly and Boehringer Ingelheim have claimed FDA approval for their diabetes therapy Jardiance in heart failure with reduced ejection fraction (HFreF), setting up a […]
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, […]
Covid-19 vaccines: the contracts, prices and profits
Raised charges and Covax deals on order books of Pfizer, BioNTech, Moderna and AstraZeneca Coronavirus – latest updates See all our coronavirus coverage Two US […]
FDA rejects FibroGen/AZ’s roxadustat, asking for new trial
The FDA has demanded another clinical trial of FibroGen and AstraZeneca’s roxadustat for anaemia caused by chronic kidney disease (CKD) before it will consider approval, […]
SK Bio’s COVID vaccine will start phase 3 study versus AZ jab
South Korea’s SK Bioscience has been given the all-clear to start a phase 3 trial of its COVID-19 vaccine GBP510 that will compare the shot […]
HER2 heats up as Seagen licenses RemeGen ADC for $2.6bn
Seagen is a specialist in antibody-drug conjugates, but has looked to Chinese biotech RemeGen for a HER2-targeting candidate that could challenge rival drugs from AstraZeneca/Daiichi […]
AZ gets European approvals for Forxiga in chronic kidney disease
AstraZeneca’s Forxiga has become the first SGLT2 inhibitor to be approved in Europe for use in people with chronic kidney disease, extending its lead over […]
PharmaShots Weekly Snapshots (Aug 02 – 06, 2021)
Medtronic to Acquire Intersect ENT for ~$1.1B Published: Aug 6, 2021 | Tags: Medtronic, Intersect ENT, ~$1.1B Kite Signs a License Agreement with Appia to […]
FDA approval of AstraZeneca lupus drug sets up competition with GSK’s Benlysta
An AstraZeneca lupus drug has been awarded FDA approval for treating the most common form of the autoimmune disorder. The regulatory decision gives AstraZeneca a […]
FDA approves AZ’s anifromulab, ending 10-year lupus drug drought
AstraZeneca has completed the resurrection of its anifrolumab drug for systemic lupus erythematosus (SLE) after claiming FDA approval for the drug as an add-on therapy […]
AstraZeneca’s Saphnelo (anifrolumab-fnia) Receives the US FDA’s Approval for the Treatment of Moderate to Severe Systemic Lupus Erythematosus
Shots: The approval is based on efficacy and safety data from the clinical development program, including two P- III TULIP trials and the P-II MUSE […]
As Delta spreads, Pfizer and Moderna get set for a booster shot to profits
The firms are already taking the lion’s share of earnings from the market, as this week’s results will show Praised for preventing hundreds of thousands […]
AstraZeneca sales of Covid vaccine triple to $1.2bn in first half of 2021
Not-for-profit pledge sees British firm’s sales revenue fall significantly short of US rival Pfizer Coronavirus – latest updates See all our coronavirus coverage AstraZeneca’s Covid-19 […]
AZ’s COVID-19 jab sales top $1.2bn, but come at a loss
AstraZeneca said this morning that it has made $1.2 billion in sales from its COVID-19 vaccine Vaxzevria in the first half of this year, but […]
AZ says second COVID jab dose isn’t linked to rare clot reaction
A new analysis has suggested that the rare blood clot side effects linked to AstraZeneca’s COVID-19 vaccine Vaxzevria don’t occur after a second dose. The […]
Regeneron, AZ team up on drugs for obesity “superpower” gene
AstraZeneca has formed a partnership with Regeneron to investigate the potential of treating obesity using drugs directed at GPR75, a protective gene identified by scientists […]
AstraZeneca and Regeneron Collaborate to Research, Develop and Commercialize Therapies for Obesity
Shots: The companies collaborated to research, develop & commercialize small molecules directed against the GPR75 target with the potential to treat obesity and related co-morbidities […]
Boost for AZ as Ultomiris gets CHMP nod for expanded label
Fresh from its takeover of Alexion, AstraZeneca has picked up a recommendation in the EU for an expansion of the label of Ultomiris, one of […]
AstraZeneca’s Vaxzevria Demonstrates Effectiveness After One Dose Against Beta/Gamma and Delta Variants of SARS-CoV-2 Virus
Shots: RWE data from CIRN with support from the Public Health Agency of Canada and the Canadian Institutes of Health Research demonstrated that one dose […]
Study finds jabs cut severe variant COVID disease after one shot
A real-world study carried out in Canada had found that COVID-19 vaccines from AstraZeneca, Pfizer/BioNTech and Moderna reduce the chances of being hospitalised or dying […]
Pfizer puts up $1bn to buy into Arvinas breast cancer programme
Pfizer has pledged a whopping $11 billion upfront for rights to an Arvinas drug for breast cancer from its protein degrader platform, which harnesses cells’ […]
AstraZeneca bags Imfinzi okay in big Chinese lung cancer market
China has approved AstraZeneca’s PD-1/PD-L1 inhibitor Imfinzi to treat small-cell lung cancer (SCLC), an aggressive form of the disease that accounts for around 15% of […]
FDA adcomm turns down FibroGen, AZ’s roxadustat for CKD anaemia
Safety concerns seem to have scuppered any hope of a near-term approval for FibroGen and AstraZeneca’s roxadustat for anaemia associated with chronic kidney disease (CKD) […]
AZ, J&J tweaking COVID shots to reduce clotting risks; report
AstraZeneca and Johnson & Johnson are both exploring ways to modify their COVID-19 vaccines to minimise the risk of severe blood clotting reactions that are […]
Final hurdle falls as UK backs AZ’s $39bn takeover of Alexion
The UK’s competition regulator has approved AstraZeneca’s $39 billion acquisition of US-based drugmaker Alexion, without opting for a broader inquiry into the deal. The nod […]
PharmaShots Weekly Snapshots (July 05 – 09, 2021)
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, […]
How should you respond to deep, sincere praise? There are no easy answers | Zoe Williams
On morning TV this week, two of the developers of the Oxford vaccine were faced with an outpouring of thanks. It was very much deserved […]
AstraZeneca Signs an Exclusive License Agreement with F-star Therapeutics for Novel STING Inhibitors
Shots: F-star is eligible to receive up front and near-term payments of ~$12M & will be eligible for ~$300M as development & sales milestone along […]
AstraZeneca and Amgen Report the US FDA’s Acceptance of BLA and Priority Review of Tezepelumab for the Treatment of Asthma
Shots: The BLA is based on PATHFINDER clinical program, including P-III NAVIGATOR study evaluating Tezepelumab + SOC vs PBO + SOC in 1,061 adults (18–80yrs.) […]
AZ, Amgen get speedy FDA review for asthma drug tezepelumab
The FDA has started a priority review of AstraZeneca and Amgen’s severe asthma antibody tezepelumab, setting a date for a decision in the first quarter […]
Boehringer, Lilly hail Jardiance data in hard-to-treat heart failure
Boehringer Ingelheim and Eli Lilly have the results they were hoping for in a large-scale study of Jardiance therapy in heart failure with preserved ejection […]
Another hurdle down as EU clears AstraZeneca’s Alexion takeover
The European Commission has given competition clearance to the $39 billion acquisition of Alexion by AstraZeneca, leaving the UK as the last remaining obstacle to […]
Centre Court ovations, limbo-dancing grans – it’s all been humbling, say Oxford vaccine creators
Sarah Gilbert and Catherine Green tell of their pioneering vaccine work but warn the battle is far from over Coronavirus – latest updates See all […]
AZ drug for hard-to-treat heart failure has mixed results in trial
AstraZeneca has reported the first phase 2 results with a drug for heart failure with preserved ejection fraction (HFpEF), showing it worked as expected but […]
PharmaShots’ Key Highlights of Second Quarter 2021
The second quarter of 2021 witnesses major acquisitions, approvals, and clinical data. There are major alliances in this quarter which include Merck signed ~$1.2B supply […]
The Oxford vaccine: the trials and tribulations of a world-saving jab
Amid bemusement from scientists at the deluge of often undeserved criticism, the Guardian pieces together the story behind the vaccine’s successes and failures Coronavirus – […]
Moderna, Pfizer or AstraZeneca? The ridiculous, diverting rise of vaccine envy
Casual vaccine chat is today’s only form of small talk, so it’s not surprising it would take a lightheartedly tribal turn. Ultimately, of course, gratitude […]
Covid jabs for billions of humans will earn their makers billions of dollars
We look at the drug firms – led by Pfizer and Moderna – that are set to profit most in an unprecedented global vaccination drive […]
EU fails in court action to secure urgent 120m doses of Oxford Covid vaccine
But Brussels court says AstraZeneca should earlier have used UK plants to fulfil EU deliveries Coronavirus – latest updates See all our coronavirus coverage The […]
EU fails in court action to secure urgent 120m doses of Oxford Covid vaccine
But Brussels court says AstraZeneca should earlier have used UK plants to fulfil EU deliveries Coronavirus – latest updates See all our coronavirus coverage The […]
EU and AZ both claim victory in COVID jab supply lawsuit
A court in Belgium has ordered AstraZeneca to deliver additional doses of its COVID-19 vaccine to EU member states by 27 September, although far fewer […]
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, […]
AstraZeneca vaccine price pledge omits some poor countries, contract shows
Exclusive: firm could charge more in places such as Zimbabwe and Sri Lanka once Covid pandemic is over Coronavirus – latest updates See all our […]
Ambrx tries another IPO as it chases down HER2 rivals
California biotech Ambrx Biopharma is hoping to raise $126 million from a listing on the New York Stock Exchange (NYSE) that will be used in […]
Vaccines were not part of AstraZeneca’s grand strategy, so what’s the plan now?
Having built a big operation during the pandemic it could stick or twist but either way investors will soon want a decision What’s AstraZeneca’s strategy […]
AZ’s COVID jab tackles delta variant, but antibody fails clinical trial
The delta variant of COVID-19 may be holding back the lifting of lockdown restrictions in the UK, but there is some good news – the […]
AstraZeneca’s COVID-19 Vaccine Demonstrates 92% Efficacy Against Delta (Indian) Variant
Shots: Real world data from PHE demonstrated two doses of AZ’s vaccine are 92% effective against hospitalization due to the Delta variant and showed no […]
J&J must ditch 60m COVID jabs made at US plant, but 10m are okay, says FDA
The failings at a Baltimore, US factory making Johnson & Johnson’s COVID-19 vaccine mean that millions of doses of the shot will have to be […]
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: […]
Study links AstraZeneca COVID-19 shot to bleeding disorder ITP
Researchers in Scotland have identified a possible link between the Oxford University/AstraZeneca COVID-19 and a mostly mild and generally treatable bleeding disorder. The scientists examined […]
Scotland backs rare blood cancer drug Poteligeo rejected by NICE
A north-south divide has emerged in UK medicines access after the Scottish Medicines Consortium (SMC) okayed Kyowa Kirin’s Poteligeo for two rare blood cancers, a […]
Thailand starts Covid vaccine drive using jabs made by king’s firm
Country aims to vaccinate 70% of people this year but experts express doubts amid supply concerns Coronavirus – latest updates See all our coronavirus coverage […]
AstraZeneca Reports Updated Results of Imfinzi (durvalumab) in P-III PACIFIC Trial for Non-Small Cell Lung Cancer
Shots: The P-III PACIFIC trial involves assessing Imfinzi vs PBO in 713 patients with unresectable, stage III NSCLC whose disease had not progressed following concurrent […]
AstraZeneca Reports Results of Calquence (acalabrutinib) in P-III Head-to-Head ELEVATE-RR Trial for Chronic Lymphocytic Leukemia
Shots: The P-III head-to-head ELEVATE-RR trial evaluating Calquence (100mg, PO, bid) vs ibrutinib (420mg, PO, qd) in a ratio (1:1) in 533 patients with previously […]
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 […]
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: […]
ASCO21: Lynparza aces adjuvant breast cancer therapy trial
AstraZeneca and Merck & Co’s Lynparza is primed for even wider use in the treatment of breast cancer after a phase 3 trial showed it […]
Fears of side-effects fuel reluctance to get Covid jabs, survey finds
Imperial College London survey in 15 countries also reveals worries that vaccines had not been tested enough Coronavirus – latest updates See all our coronavirus […]
UK is talking to AstraZeneca about beta variant COVID jab
The UK government is talking to AstraZeneca about ordering additional doses of its COVID-19 vaccine that will target the beta variant of SARS-CoV-2 virus first […]
What HCPs think about blood clots linked to COVID-19 vaccines
In the latest edition of What HCPs Think, CREATION.co’s Laura Marsh looks at what healthcare professionals are saying about blood clots linked to COVID-19 vaccines. The […]
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 […]
AstraZeneca’s Tagrisso (osimertinib) Receives EU’s Approval for the Adjuvant Treatment of Patients with Early-Stage EGFR-Mutated Lung Cancer
Shots: The approval is based on P-III ADAURA trial assessing Tagrisso (80mg, qd, PO) vs PBO in 682 patients with stage IB, II, IIIA EGFRm […]
Taiwan accuses China of interfering with Covid vaccine deals
President says agreement with German firm BioNTech has been delayed after Beijing intervention Coronavirus – latest updates See all our coronavirus coverage Taiwan’s president has […]
German scientists say they can help improve Covid vaccines to prevent blood clots
AstraZeneca and Johnson & Johnson jabs have caused rare blood clots but scientists say they can be redesigned to avoid problem Coronavirus – latest updates […]
Has Marks and Spencer really got it right at last? | Nils Pratley
We’ve heard the argument before, but now it does seem the moment of maximum danger has passed Green shoots at M&S? That was chairman Archie […]
EU asks court to fine AstraZeneca over missing COVID jab shipments
Lawyers for the European Commission asked a court in Brussels today to fine AstraZeneca millions of euros for its “obvious” failure to meet the terms […]
UK competition watchdog probes AstraZeneca, Alexion merger
The antitrust authority in the UK has launched an investigation into the proposed $39 billion takeover of US firm Alexion by AstraZeneca. The Competition and […]
UK says Pfizer, AZ COVID-19 vaccines work against Indian variant
People who have received two doses of the AstraZeneca or Pfizer/BioNTech COVID-19 vaccines have good protection against the Indian variant of SARS-CoV-2 , according to […]
AstraZeneca chief hits back at ‘armchair generals’ after criticism
Pascal Soriot defends firm and says its booster jab has performed well against new Covid variants in trials Coronavirus – latest updates See all our […]
PharmaShots Weekly Snapshots (May 17 – 21, 2021)
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 […]
AstraZeneca’s Vaxzevria (AZD1222) Receives Approval for Emergency Use in Japan to Treat COVID-19
Shots: MHLW has granted EUA for Vaxzevria (ChAdOx1-S [Recombinant]) for active immunization of individuals aged ≥18yrs. to prevent COVID-19. The EUA is based on P-III […]
UK booster trial will test value of third COVID jab dose
All seven COVID-19 vaccines ordered by the UK government will be tested in a new trial that will see whether they can be used as […]
Poorer countries face long delays in receiving Covid vaccines
Efforts in Africa and elsewhere hit by decision not to export AstraZeneca jab from India until end of year Coronavirus – latest updates See all […]
With FDA approval, Apellis can challenge AstraZeneca in rare blood disorder
The FDA approved Apellis Pharmaceuticals drug pegcetacoplan (Empaveli) as a treatment for a rare blood disorder that is currently treated with medicines sold by Alexion […]
Apellis set to take on Alexion as FDA clears PNH drug Empaveli
Apellis Pharma has secured FDA approval for its complement C3 inhibitor Empaveli as a treatment for paroxysmal nocturnal hemoglobinuria (PNH) – with a label that […]
We’re all the poorer for shareholders’ loss of nerve on executive pay
AstraZeneca’s vaccine effort is remarkable, but investors should not have let it divert them from the job of moderating bonuses Investors failed another test of […]
PharmaShots Weekly Snapshots (May 10 – 14, 2021)
AzurRx BioPharma Reports Positive Interim P-II Data of MS1819 + PERT for Cystic Fibrosis Patients with Severe Exocrine Pancreatic Insufficiency Published: May 14, 2021 | […]
AstraZeneca and Amgen Present Results of Tezepelumab in P-III NAVIGATOR Study for Severe Asthma at ATS2021
Shots: The P-III NAVIGATOR study involves assessing Tezepelumab + SOC vs PBO + SOC in adults (18–80 yrs.) & adolescents (12–17 yrs.) with severe uncontrolled […]
AstraZeneca’s boss is a boardroom superstar but a potential £2m cherry is pushing the point
Fund managers tried to vote down Pascal Soriot’s package for fear of more boardroom pay inflation A majority is a majority, but a rebellion of […]
Nearly 40% of AstraZeneca investors reject boss’s bonus rise
Covid vaccine maker passes its remuneration policy but suffers sizeable rebellion AstraZeneca investors narrowly approved pay package proposals for its chief executive, Pascal Soriot, after […]
AstraZeneca and Amgen Submit BLA to US FDA for Tezepelumab to Treat Severe Asthma
Shots: The submission is based on PATHFINDER clinical program including P-III NAVIGATOR that involves assessing Tezepelumab + SOC vs PBO + SOC in 1061 adults […]
Scotland backs NHS use of Alexion’s Ultomiris for rare disease aHUS
NHS patients in Scotland with the rare disease atypical haemolytic uremic syndrome (aHUS) will now be able to access treatment with Alexion’s Ultomiris, ahead of […]
AstraZeneca chief executive’s pay rise in doubt ahead of investor vote
Investors are lining up to oppose pay-and-perks plan for Pascal Soriot worth up to £17.8m for 2021 AstraZeneca could be forced to rip up plans […]
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
Shots: The P-III POSEIDON study involves assessing Imfinzi + platinum-based CT or Imfinzi + Tremelimumab + CT vs CT as monothx as a 1L treatment […]
Patients in England get fast access to AZ’s Tagrisso in early lung cancer
The UK’s drugs regulator has swiftly granted a licence extension for AstraZeneca’s Tagrisso in certain patients with early stage lung cancer, with NICE allowing fast […]
The Guardian view on waiving Covid vaccine patents: protect the world, not big pharma | Editorial
The US is now backing plans that could help billions more access vaccines. The UK should follow suit The rapid emergence of Covid vaccines has […]
EU wants to mass produce three ‘course-changing’ Covid drugs from October
Health commissioner says plan is to reduce hospitalisation and tackle long-term impact of Covid Coronavirus – latest updates See all our coronavirus coverage Three Covid […]
Sunak’s stamp duty holiday extension has merely inflamed the housing market
Throwing money at an already heated market looks nonsensical and could lose the Treasury £2bn Surprise, surprise. Presented, or so they thought, with an end-March […]
‘Obscene’ bonus hike for AstraZeneca boss prompts investor anger
Advisory groups ask shareholders to oppose bid to raise Pascal Soriot’s maximum share bonus to 650% of £1.3m basic pay AstraZeneca is facing mounting opposition […]
AstraZeneca’s Farxiga claims first SGLT2 kidney disease OK from FDA
AstraZeneca is already seeing sales rocket for its SGLT2 inhibitor Farxiga in heart failure, and is expected to gather even more momentum after claiming FDA […]
