Archive


Category: AstraZeneca

  • 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 phase 3 trial, setting it on course for regulatory filings. Now, the data has been revealed – and according to investigators could transform treatment. Wilson disease is a rare and […]

  • 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 in treating nerve pain caused by hereditary transthyretin-mediated amyloidosis. The data come one week after rival Alnylam Pharmaceuticals won FDA approval for its second drug for this rare disease.

  • 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 the disease transthyretin amyloidosis (ATTR) it licensed from Ionis in a $3.6 billion deal last year. Eplontersen – previously known as IONIS-TTR-LRX – is designed to switch off the production […]

  • 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 doesn’t provide the source of the speculation. The UK-based but US-listed biotech licensed rights to AZ’s orally-active neutrophil elastase inhibitor alvelestat for the rare disease alpha-1 antitrypsin deficiency (AATD) five […]

  • 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 the data – with the numbers every bit as good as hoped. The top-line results of DESTINY Breast-04 are impressive – in patients with HER2-low metastatic breast cancer who received […]

  • 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 drug Enhertu can treat a group of patients previously thought to be out of reach for a targeted therapy. The results suggest use of this FDA-approved drug could significantly expand […]

  • 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 to Daiichi Sankyo’s breast cancer therapy Enhertu. The complaint was filed against Hugues Pierre Joublin (54) – formerly global head of corporate affairs for oncology at AZ until his role […]

  • 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, as breast cancer researchers came together in person for the first time since the start of the pandemic at the ESMO Breast Cancer congress. pharmaphorum sat down with Sunil Verma, […]

  • 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 of diversity across its trials in an attempt to ensure its medicines work for all population groups, although it has admitted that including pregnant women is a particular challenge. The […]

  • 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 to protect vulnerable and immunosuppressed people from COVID-19. The deal covers a portfolio of early-stage antibodies targeting SARS-CoV-2, adding to the pipeline of COVID drugs following AZ’s already available Evusheld […]

  • 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 payment to the London-based research firm. This is the third novel target from the duo’s collaboration identified using the Benevolent Platform across two disease areas – IPF and chronic kidney […]

  • 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 a cutting-edge discovery engine that can unlock complex and technically challenging disease-relevant targets. Proteros’s expertise and tools speed up the research process, particularly at the initial drug discovery and development […]

  • 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 preventing lower respiratory tract infections caused by the pathogen. The data – presented this week at the European Society for Paediatric Infectious Diseases meeting – come as nirsevimab is being […]

  • 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 Jardiance from Boehringer Ingelheim and Eli Lilly. Top-line results from the DELIVER trial showed that Farxiga (dapagliflozin) was able to reduced the risk of cardiovascular deaths or worsening heart failure […]

  • 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 an immunotherapy for the group of rare and aggressive gastrointestinal tumours. The six-month review means that PD-L1 inhibitor Imfinzi (durvalumab) could get a verdict from the US regulator in the […]

  • 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 provide access to its Covid-19 medicine Evusheld, saying it’s a “sad situation” that Britain is one of the few developed nations not to have ordered the drug, designed for those […]

  • 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 by COVID-19 and oncology drugs and heart failure therapy Farxiga. The new site will be at Kendall Square and will serve as the new corporate headquarters for Alexion – which […]

  • 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 with HER2-low metastatic breast cancer. The coveted status has been awarded to the HER2-targeting antibody-drug conjugate (ADC) on the back of the DESTINY-Breast04 trial results, unveiled in February, which involved […]

  • 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 drugmaker said this morning that the FDA has started a priority review of tremelimumab alongside its PD-L1 inhibitor Imfinzi (durvalumab) or the treatment of patients with unresectable hepatocellular carcinoma (HCC), […]

  • 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 for non-small cell lung cancer (NSCLC) and add to its current uses in breast and gastric cancer. The US regulator has kicked off a priority review of Enhertu (trastuzumab deruxtecan) […]

  • 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 other rivals in the HIF-PHI class have failed. GSK has submitted daprodustat base on its ASCEND phase 3 programme, which included five trials across both dialysis and non-dialysis patients and […]

  • 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 million in damages. Seagen claims Enhertu (trastuzumab deruxtecan) – an antibody-drug conjugate (ADC) targeting HER2 – infringes a patient it holds (No. 10,808,039) covering ADCs that include auristatin compounds coupled […]

  • 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 2021, members of LV= may feel, when he got to keep his job as chief executive despite overseeing the shambles of the failed £530m sale of the mutual insurer to […]

  • 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 against new variants of the virus. The US regulator has trimmed back the emergency-use authorisation for Xevudy (sotrovimab), saying that new data suggests the current 500mg dose of the antibody […]

  • 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 to the UK startup. The two companies say they plan to launch a series of Software as a Medical Device (SaMD) companion apps for various diseases, including asthma, chronic obstructive […]

  • 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 as a first-line treatment for women with locally-advanced tumours. The CALLA trial compared Imfinzi (durvalumab) with chemoradiotherapy (CRT) to CRT alone in an all-comer cervical cancer population – regardless of […]

  • 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 was starting to panic. “We were just waking up to the reality of Covid-19 and that we would need vaccines for our very survival,” the director of the Oxford Vaccine […]

  • 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 succeed. From synthesising APIs to producing billions of plastic pre-filled syringes, the pharmaceutical industry has a significant impact on the environment. Achieving net zero, then, will take a whole-system approach […]

  • 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 of practice. Complaints upheld by the Prescription Medicines Code of Practice Authority (PMCPA) include two against AZ and Allergan – now part of AbbVie – related to promotion of medicines […]

  • 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 treatment Evusheld in a boost to its coronavirus portfolio as the British-Swedish drugmaker targets greater drug development success at its new £1bn research lab in Cambridge. Aimed at preventing Covid […]

  • 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 22 of the invasion GlaxoSmithKline has joined other drugmakers in halting new clinical trials in Russia while still providing essential medicines to the country. Like others in the sector, it […]

  • 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 Pharma, Roche’s Japanese subsidiary. The long-running disagreement focuses on Ultomiris (ravulizumab), Alexion’s long-acting complement C5 inhibitor for paroxysmal nocturnal hemoglobinuria and haemolytic uraemic syndrome (HUS). Chugai claimed that Ultomiris uses […]

  • 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 treated metastatic castration-resistant prostate cancer (mCRPC). The disappointing result comes from the KEYLYNK-010 trial, which looked at the combination of PD-1 inhibitor Keytruda (pembrolizumab) with AstraZeneca-partnered PARP inhibitor Lynparza (olaparib) […]

  • 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 plans remain uncertain for now. Viatris’ generic of Symbicort (budesonide and formoterol fumarate dihydrate) – developed by Viatris in collaboration with 3M spin-off company Kindeva Drug Delivery – has been […]

  • 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 polyps, after the FDA rejected its marketing application. The US regulator has asked for additional clinical data, according to AZ, which said it remains committed to brining the drug to […]

  • 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 its PARP inhibitor crown. The new approval is for use in patients with BRCA-mutated, HER2-negative early-stage breast cancer who have already been treated with chemotherapy – either before or after […]

  • 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 with symptomatic chronic heart failure (CHF), giving the drug an edge in its battle for market share with AstraZeneca’s rival Forxiga. The European Commission has expanded the label for Jardiance […]

  • 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 across the spectrum of patients with the condition. The results of the EMPULSE trial showed that adults hospitalised for acute heart failure were 36% more likely to see an improvement […]

  • 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 to bring a shot to market that will protect infants from the life-threatening infection. The news comes just days after GlaxoSmithKline called a halt to enrolment and vaccination in three […]

  • 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 that reduces Global Warming Potential by more than 99%.  The deal is part of a broader sustainability initiative by AstraZeneca that also includes an ambitious plan to reduce emissions and […]

  • 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 of HER2 – potentially making it an option for a much broader group of patients. It’s a key moment for the two companies, as expansion into HER2-low breast cancer has […]

  • 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 than 10 years. The European Commission has cleared the type I interferon receptor antagonist antibody as an add-on therapy to standard treatment for adults with moderate to severe SLE, four […]

  • 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, which started development before the emergence of the Delta and Omicron strains. The new vaccine – codenamed AZD2816 – started phase 2/3 trials as a booster dose for people vaccinated […]

  • 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 for the first time in a decade after beating fourth-quarter profit expectations, but warned the boost from its Covid-19 products would decline. The Anglo-Swedish drugmaker made almost $4bn (£2.9bn) from […]

  • 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 year, after its C5 inhibitor zilucoplan hit the mark in a phase 3 trial. Zilucoplan achieved a significant improvement in the Myasthenia Gravis-Activities of Daily Living Profile (MG-ADL) total score […]

  • 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 AZ’s Joris Silon to discuss unmet needs in the condition. “Many times, I have talked to nephrologists who take care of patients with chronic kidney disease in the later stages, […]

  • 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 hospital settings. The new guidance means adults living with persistently high potassium levels in the blood – a condition known as hyperkalaemia – can now get repeat prescriptions for Lokelma […]

  • 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 approved the Novavax Covid-19 vaccine for use in adults. Nuvaxovid received provisional approval from the Therapeutic Goods Administration on Thursday, making it the fourth vaccine to be included in Australia’s […]

  • 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 lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations. Lung cancer is linked to a quarter of all cancer deaths in the country, with almost half of lung […]

  • 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 well as other variants of the virus, including Alpha, Beta, Delta, and Gamma. The increased immune response was seen in people who received AZ’s shot as their primary vaccination 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 topic for drug discovery in cancer and other disease. The UK-headquartered pharma is buying into a drug discovery platform developed by Boston, US biotech Scorpion Therapeutics, paying $75 million upfront […]

  • 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 space of a couple of months. In the latest deal, the pharma group is paying $30 million upfront with another $730 million in milestone’s for global rights to Neurimmune’s NI006, […]

  • 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 cost effectiveness agency NICE. That is the conclusion of draft guidance which says that the evidence for Lynparza (olaparib) as a treatment for prostate cancer is uncertain, and therefore not […]

  • 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 designation – which is awarded to  therapies that could represent a significant improvement over standard of care in either efficacy, safety, or both – has been awarded on the strength […]

  • 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 Oxford and AstraZeneca have taken “preliminary steps” to produce an updated version of their coronavirus vaccine to specifically target the Omicron variant, a scientist at the university has said. Sandy […]

  • 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 phase 3 trial. Another phase 3 study supported the efficacy of the first-in-class TSLP inhibitor as an add-on treatment for people aged 12 and over with severe asthma, as did […]

  • 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 of drugs will float in London this week valued at £80.7m – giving its two founders a combined paper fortune of more than £33m. Aptamer Group was founded in 2008 […]

  • 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 in the US. The European Commission has cleared the complement C3 inhibitor as Aspaveli for the treatment of adults with PNH who are anaemic, but only after they have been […]

  • 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 who won’t mount a strong immune response to vaccination. The antibodies that comprise the AstraZeneca drug are engineered with technology that makes the therapy long lasting.

  • 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 US FDA. The long-acting antibody combination, formerly known as AZD7442 (tixagevimab and cilgavimab) has been cleared for pre-exposure prophylaxis (PrEP) of COVID-19 in adults and adolescents aged 12 and older […]

  • 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 already-marketed Trodelvy. New data from the TROPION-PanTumor01 study of datopotamab deruxtecan (Dato-DXd) showed a 34% objective response rate (ORR) with AZ and Daiichi’s drug when used as a therapy for […]

  • 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 another sizeable one too, with an upfront fee of $200 million, another $485 million tied to regulatory approvals, and up to $2.9 billion in milestones depending on sales levels if […]

  • 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, with reports suggesting AstraZeneca was instrumental in blocking the deal. Tenders to the offer fell below the 90% threshold needed to drive the merger through, and a key part of […]

  • 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 coverage Scientists believe they may have found the trigger behind the extremely rare blood clot complications stemming from the Oxford/AstraZeneca’s Covid vaccine. According to a team of researchers from Cardiff […]

  • 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, after granting the application a priority review. AZ and partner Merck & Co have filed Lynparza (olaparib) for use in BRCA-mutated, HER2-negative early breast cancer in patients who have already […]

  • 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 they are poised to develop new shots if needed. News of the new variant emerged last week, and has resulted in travel bans being imposed on various African countries by […]

  • 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 clinical trials from the comfort of their own homes in an attempt to increase the diversity of participants. Recruiting volunteers to clinical trials can be difficult, but they are a […]

  • ‘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 glass and steel structure that sprouts from a once-vacant plot of land on the outskirts of Cambridge. AstraZeneca’s £1bn new research and development centre houses 16 labs and 2,200 scientists, […]

  • 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 scepticism to claims by AstraZeneca’s CEO that low uptake of the Oxford/AstraZeneca jab among elderly Europeans could explain the current surge in Covid-19 infections in mainland Europe. Pascal Soriot told […]

  • 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 of its kind in the UK. The Discovery Centre (DISC) based in the Cambridge Biomedical Campus – first given the green light in 2015 – is being officially opened today […]

  • 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, NICE, Recommendation, Excessive Daytime Sleepiness, Narcolepsy Antengene’s Selinexor (ATG-010) Receives NMPA’s IND Approval for P-I/II SWATCH Study to Treat Non-Hodgkin Lymphoma Published: Nov 19, 2021 | Tags: Antengene, Selinexor, ATG-010, […]

  • 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 slipped. When it partnered with Oxford University, it promised to sell Covid vaccines at cost while the pandemic lasted; now it is signing its first for-profit deals, saying it believes […]

  • 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 new AstraZeneca-partnered candidate for heart failure. At the American Heart Association (AHA) congress, the two partners presented results from the phase 2a EPICCURE trial that showed that injecting their AZD8601 […]

  • 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 in sales in the third quarter, after selling it at cost since it was first made available. The shift will come in the fourth quarter of the year as part […]

  • 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 sold more than $2.2bn (£1.64bn) of its Covid-19 vaccine in the first nine months of this year, as the drugmaker said it is set to move to “modest profitability” as […]

  • 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 reasons NSW Covid case numbers have stayed low since reopening Vaccine rollout tracker; Cases and data tracker NSW Covid restrictions; Victoria restrictions Download the free Guardian app; get our morning […]

  • 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 is to create a new vaccines unit as the Anglo-Swedish drugmaker plans for the future of its coronavirus shot beyond the pandemic. The company said the reorganisation would bring together […]

  • 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 AstraZeneca 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 […]

  • 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 Facility, Lexington, Massachusetts, US Amylyx Submits NDA to the US FDA for AMX0035 to Treat Amyotrophic Lateral Sclerosis Published: Nov 3, 2021 | Tags: Amylyx, NDA, US, FDA, AMX0035, ALS […]

  • 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 use of the drug in draft recommendations. AZ said that the decision is a “milestone” in the treatment of CKD, becoming the first new treatment option for patients in nearly […]

  • 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 approved the new indication for antibody-drug conjugate Enhertu (trastuzumab deruxtecan) will add to its first EU approval in advanced HER2-positive breast cancer after two or more HER2-targeted therapies. Around one […]

  • 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 related to the therapy The acquisition will strengthen Covis’ respiratory portfolio with the addition of Eklira & Duaklir. Additionally, both therapies are delivered via a Genuair device that is used […]

  • 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) in treatment-naïve patients with MET-driven advanced PRCC. The first patient was dosed on Oct 28, 2021 The 1EPs of the study is m-PFS & other EPs include m-OS, ORR, DoR, […]

  • 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, R/R Diffuse Large B-Cell Lymphoma Impact Receives US FDA’s IND Clearance for IMP9064 to Treat Solid Tumor Published: 29 Oct, 2021 | Tags: Impact, US, FDA, IND, IMP9064, Solid Tumor […]

  • 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 – so AstraZeneca and Daiichi Sankyo have forged an alliance in the hope of piggy-backing on that success. AZ and Daiichi Sankyo have agreed to partner with Merck on a second […]

  • 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 metastatic NSCLC without actionable genomic alterations over multiple sites in Asia, EU, North & South America The 1EPs of a trial are PFS & OS. Additionally, the second clinical trial […]

  • 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 group of gastro-intestinal tumours. In the TOPAZ-1 trial, PD-L1 inhibitor Imfinzi (durvalumab) added to standard chemotherapy extended overall survival compared to chemo alone, raising the hope of a new option […]

  • 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: Bristol Myers Squibb, Zeposia, ozanimod, CHMP, Positive Opinion, Adult Patients with Moderately to Severely Active Ulcerative Colitis Gan & Lee Completes P-III Studies of GL-GLA for Patients with T1D & […]

  • 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 proofing healthcare systems has to be everyone’s main priority in the coming years. That’s according to the speakers at a roundtable session, held as part of the Reuters Events: Pharma […]

  • 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 Covid vaccinations as the UN-backed Covax programme falls behind. While western countries roll out booster jabs to their own populations, Covax, which was set up by UN agencies, governments and […]

  • 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 or moderate COVID-19 from developing severe disease with a drug that can be delivered outside hospital. Merck & partner Ridgeback Therapeutics have filed for approval to use molnupiravir in adults […]

  • 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 AstraZeneca to treat myelofibrosis Shots: AstraZeneca signs an exclusive license agreement with Sierra for AZD5153 to expand myelofibrosis pipeline. The agreement will provide a novel compound into Sierra’s pipeline to […]

  • 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 patients. AZD7442 (tixagevimab/cilgavimab) is the first long-acting antibody drug that has demonstrated it can be used in this way, reducing the risk of symptomatic COVID-19 by 77% compared to placebo […]

  • 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 will be the first LAAB for COVID-19 prevention The filing is based on the safety and efficacy data from the P-III PROVENT & STORM CHASER trials along with the P-I […]

  • 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 status for the drug that should shorten its review time. The new designation for Enhertu (trastuzumab deruxtecan) is based on the results of the DESTINY-Breast03 trial, which showed that the […]

  • 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, EMA, MAA, Relatlimab, Nivolumab, Metastatic Melanoma Merck and Ridgeback Report Interim Results of Molnupiravir in P-III MOVe-OUT Trial for the Treatment of COVID-19 Published: Oct 1, 2021 | Tags: Merck, […]

  • 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 merger agreement to acquired First Wave Bio for ~$229M The key highlights of the big acquisition in this quarter includes Merck acquired Acceleron for ~$11.5B, Baxter acquired Hillrom for ~$10.5B, […]

  • 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 that consists of 2 P-III trials in combination with SoC therapy for AL amyloidosis Caelum to receive ~$150M as an option exercise fee in addition to ~$350M upon the achievement […]

  • 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 million. The deal gives the Anglo-Swedish drugmaker complete control of Caelum’s late-stage medicine for light chain (AL) amyloidosis, a potentially fatal disease that causes the rogue protein amyloid to build […]

  • 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, Approval, MDR Gram-Negative Bacterial Infections GE Healthcare to Acquire BK Medical for ~ $1.45B Published: Sept 24, 2021 | Tags: GE Healthcare, Acquire, BK Medical, ~ $1.45B Roche Presents Results […]

  • 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 drug’s use broadened after a positive phase 3 trial. The results of the PROpel study showed that a combination of Lynparza (olaparib) and Johnson & Johnson’s hormonal therapy Zytiga (abiraterone […]

  • 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 and share the technology behind them. The charity says AstraZeneca, BioNTech, Johnson & Johnson, Moderna, Novavax, and Pfizer are fuelling an “unprecedented human rights crisis” as a result and their […]

  • 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 International has accused six pharmaceutical companies that have developed Covid-19 vaccines of fuelling a global human rights crisis, citing their refusal to sufficiently waive intellectual property rights, share vaccine technology […]

  • 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 100 workers including scientists and engineers. The company has earmarked $360 million for the new-build project at the 41-acre campus at College Park in Blanchardstown, Dublin, which will be used […]

  • 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 reported top-line results last month – and a look at the full data set reveals why. In the DESTINY-Breast03 trial, Enhertu (trastuzumab deruxtecan) reduced the risk of disease progression or […]

  • 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 US maintains it will probably not be cost-effective. The cost effectiveness organisation has published a draft evidence report on the first-in-class TSLP inhibitor – which is currently under FDA review […]

  • 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 booster campaign ahead of the winter months. The decision means there is now no impediment to starting a booster drive – assuming the Joint Committee on Vaccination and Immunisation (JCVI) […]

  • 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 alone in patients with NSCLC whose tumors harbor EGFR mutation and overexpress MET. The first patient was dosed on Sept 7, 2021 The 1EPs of the study is m-PFS as […]

  • 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 the winter, according to AstraZeneca chief executive Pascal Soriot. In a letter to The Daily Telegraph newspaper with AZ’s head of biopharma R&D Mene Pangalos, Soriot write that the UK […]

  • 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 study showed improvements in lung function and nasal polyp symptoms The pre-specified exploratory analysis evaluated the effect of tezepelumab in NAVIGATOR patients with/ out reported nasal polyps (NP+ or NP−) […]

  • 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 common complication of the respiratory disease. Tezepelumab reduced the annualised asthma exacerbation rate (AAER) by 86% in a subgroup of people with severe, uncontrolled asthma and polyps in the NAVIGATOR […]

  • 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 news app; get our morning email briefing Australians who participated in clinical trials of the Novavax Covid vaccine are being told their vaccinations cannot currently be recognised on Australia’s immunisation […]

  • 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, P-II, Clinical Trial, Atopic Dermatitis Novartis Cosentyx (secukinumab) Receives NICE Recommendation for Patients with Plaque Psoriasis Published: Sept 3, 2021 | Tags: Novartis, Cosentyx, secukinumab, NICE Recommendation, Plaque Psoriasis Pfizer […]

  • 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, P-II, Clinical Trial, Atopic Dermatitis Novartis Cosentyx (secukinumab) Receives NICE Recommendation for Patients with Plaque Psoriasis Published: Sept 3, 2021 | Tags: Novartis, Cosentyx, secukinumab, NICE Recommendation, Plaque Psoriasis Pfizer […]

  • 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, Pediatric Growth Hormone Deficiency Amgen Presents Results of Repatha (evolocumab) in P-III HUYGENS Study for the Treatment of Acute Coronary Syndrome at ESC 2021 Published: Aug 27, 2021 | Tags: […]

  • 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 months. The FoCus study of ALXN1840 showed that once-daily oral drug met its primary objective in improving a key biomarker in Wilson disease, a rare and progressive genetic condition in […]

  • 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 advisor says there’s no need to rush into a large-scale booster campaign. The results of the ZOE COVID study found that initial protection against infection a month after the second […]

  • 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 dropped development of its Ultomiris drug in amyotrophic lateral sclerosis (ALS), chalking up the first clinical failure for the drug since AZ took control. The phase 3 CHAMPION-ALS trial showed […]

  • 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 long-acting antibody-based drug. The results of the almost 5,200-patient PROVENT study show that pre-exposure prophylaxis using the antibody combination reduced the risk of developing symptomatic COVID-19 by 77% compared to […]

  • 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 market tussle with AstraZeneca’s Farxiga. The US regulator has cleared a 10mg daily dose of Jardiance (empagliflozin) to reduce the risk of cardiovascular death plus hospitalisation for heart failure in […]

  • 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, Toripalimab, US, FDA, Breakthrough Therapy Designation, Nasopharyngeal Carcinoma Celltrion’s Regdanvimab (CT-P59) Receives the ANVISA’s EUA for the Treatment of COVID-19 in Brazil Published: Aug 13, 2021 | Tags: Celltrion, Regdanvimab, […]

  • 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 companies, Pfizer and Moderna, have raised the prices of their Covid-19 vaccines after data from clinical trials showed their mRNA formula was more effective than cheaper vaccines from Britain’s AstraZeneca […]

  • 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, setting up a lengthy delay to the programme. The need for a new trial is something of a worst-case scenario for roxadustat, although a rejection was expected after an FDA […]

  • 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 directly with AstraZeneca’s Vaxzevria. It is the first COVID-19 vaccine developed in South Korea to reach the pivotal trial stage, and from the earliest stages of its development has been […]

  • 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 Sankyo and Roche. The US company is paying $200 million upfront for rex-Asian rights to RemeGen’s disitamab vedotin, with another $2.4 billion in possible future payments tied to future successes […]

  • 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 rival drugs in the class. The European Commission has cleared Forxiga (dapagliflozin) for CKD in adults with or without diabetes, and the drug becomes the first new drug treatment for […]

  • 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 Develop Allogeneic Cell Therapies for the Treatment of Cancer Published: Aug 6, 2021 | Tags: Kite, Appia, Allogeneic Cell Therapies, Cancer Polpharma & Bioeq Report BLA Submission to the US […]

  • 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 for adults with the autoimmune disease. Anifrolumab was all-but written off in 2018 after failing the phase 3 TULIP-1 trial, but bounced back with positive data from a second study […]

  • 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 of deaths and allowing a return to more normal life, Covid vaccines will also substantially benefit some pharmaceutical companies. In June, analysts estimated the global market for the vaccines could […]

  • 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 vaccine has brought in $1.2bn (£900m) in the first half of this year, with sales tripling in the second quarter from the first – but its earnings remained significantly below […]

  • 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 making it available at no profit had weighed on its profit margins. R&D expenses leaped 28% in the period, an increase that AZ said was “primarily” a result of its […]

  • 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 study in The Lancet examined cases of thrombosis with thrombocytopenia syndrome (TTS) from an AZ database encompassing around 5.62 million people who had received two doses of Vaxzevria in 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 at the Regeneron Genetics Centre. AZ’s buy into the programme comes a few weeks after Regeneron published findings in the journal Science suggesting that people with certain GPR75 mutations have […]

  • 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 the main assets behind the $39 billion merger. The EMA’s Committee for Medicinal Products for Human Use (CHMP) has backed the approval of Ultomiris (ravulizumab) for children and adolescents with […]

  • 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 from variants of concern dramatically, even after a single dose. AstraZeneca’s Vaxzevria was found to 87% effective after against the delta variant, which is now thought to be one of […]

  • 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’ natural protein-denaturing machinery to remove rogue proteins associated with disease. The deal focuses on ARV-471, currently in phase 2 testing for advanced breast cancer patients whose tumours expresses oestrogen receptors […]

  • 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 all lung cancer cases. The green light from the National Medical Products Administration (NMPA) covers the use of Imfinzi (durvalumab) alongside platinum-based chemotherapy in previously untreated patients with extensive-stage SCLC. […]

  • 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) in the US, after FDA advisors voted comprehensively against the drug yesterday. Just one of the 14-member panel thought that roxadustat should be approved for non-dialysis-dependent CKD patients, and only […]

  • 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 seen – albeit rarely – in some people receiving the jabs. At the same time, the UK’s National Institute for Health and Care excellence (NICE) is developing guidance to help […]

  • 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 from the Competition and Markets Authority (CMA) after an initial assessment means that it concluded no antitrust risks were associated with the deal. It was the final needed from a […]

  • 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, Fast Track Designation, LYS-GM101 Gene Therapy, GM1 Gangliosidosis Jazz’s Vyxeos (daunorubicin and cytarabine liposome) for Injection Receives Health Canada Approval for the Treatment of High-risk Acute Myeloid Leukemia Published: July […]

  • 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.) & adolescents (12–17yrs.) with severe & uncontrolled asthma who receive treatment with medium/high dose ICS + at least 1 additional controller medication with/out OCS The results demonstrated superiority in 1EP […]

  • 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 of 2022. If approved, TSLP inhibitor tezepelumab could reach the market with a broader label than currently-used asthma antibodies, which are approved to treat patient with severe asthma characterised by […]

  • 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 fraction (HFpEF), a form of chronic heart failure associated with high hospitalisation rates, poor quality of life and increased mortality. The results of the much-anticipated EMPEROR-Preserved trial found that SGLT2 […]

  • 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 getting the deal across the line. The EU approval comes after the merger has already been okayed by the US, Japan and a number of other countries around the world, […]

  • 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 wasn’t able to provide any clinical benefit to patients.  Daily doses of AZD4831 were able to reduce the activity of myeloperoxidase (MPO), an enzyme linked to tissue and blood vessel […]

  • 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 agreement with US Government for Molnupiravir to treat COVID-19 The big acquisition took place during the quarter including Microsoft acquired Nuance for ~$19.7B, MorphoSys acquired Constellation for ~$1.7B Our team […]

  • 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 – latest updates See all our coronavirus coverage In January 2020, when most of the world slept soundly in ignorance of the pandemic coming its way, a group of scientists at […]

  • 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 is at the heart of the conversation Last week, I had cause to go searching for images of men getting vaccinated (it’s not a fetish – it was for work) […]

  • 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 Coronavirus – latest updates See all our coronavirus coverage Drugmakers led by US firms Pfizer and Moderna stand to make tens of billions of dollars from their Covid-19 vaccines this […]

  • 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 has failed in a legal attempt to secure an urgent 120m vaccine doses from AstraZeneca by the end of this month, while securing a judgment that sites in Oxford […]

  • 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 has failed in a legal attempt to secure an urgent 120m vaccine doses from AstraZeneca by the end of this month, while securing a judgment that sites in Oxford […]

  • 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 than the amount sought by the European Commission. The EU had requested 120 million doses by the end of this month and 300 million by end-September, but the judge in […]

  • 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, Amasa Therapeutics, Clinical-Grade Hystem BioNTech Reports First Patient Dosing in P-II Clinical Trial of BNT111 to Treat Advanced Melanoma Published: June 18, 2021 | Tags: BioNTech, P-II, Clinical Trial, BNT111, […]

  • 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 coronavirus coverage AstraZeneca can charge a higher price for its Covid-19 vaccine in dozens of poor countries once the pharmaceutical company decides the pandemic has ended, according to a copy […]

  • 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 part to fund clinical development of ARX-788, its HER2-targeting antibody drug conjugate (ADC). The Scripps Research spinout could be just 18 months away from licensee NovoCodex reporting results of a […]

  • 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 in Covid treatments? In the short term, there is no confusion: the company will continue pumping out vaccine doses, will keep signing partnerships and will try to ignore churlishness in […]

  • 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/Oxford University vaccine seems to offer a high level of protection against it. Real-world data from Public Health England (PHE) suggests that the vaccine prevents 92% of hospitalisations in patients […]

  • 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 deaths among the vaccinated The vaccine was highly effective against the Alpha variant (kent variant) with an 86% reduction of hospitalizations and no reported deaths. Vaccine effectiveness against the symptomatic […]

  • 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 jettisoned, according to an FDA update. The problems at the plant run by contract manufacturer Emergent BioSolutions first emerged a few weeks ago, after an FDA inspection uncovered a string […]

  • 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: Vertex, CRISPR Therapeutics, CTX001, TDT, SCD, EMA 2021 AbbVie Reports Results of Four-Year Follow-Up Analysis in P-III CLL14 Trial for Venclyxto/Venclexta to Treat Chronic Lymphocytic Leukemia Published: June 11, 2021 […]

  • 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 real-world public health data from all individuals in Scotland who received either the AZ or Pfizer/BioNTech vaccines up until 14 April and found a possible association between the AZ shot […]

  • 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 few weeks after the drug was turned in England by NICE. Poteligeo (mogamulizumab) has been backed by the SMC for adults living with mycosis fungoides (MF) and Sézary syndrome (SS), […]

  • 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 Thailand has started its Covid vaccination campaign amid concerns over the supply of doses, which are mainly being produced locally by a royal-owned company that has no prior experience of […]

  • 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 show a safety advantage over Imbruvica – currently dominating the BTK inhibitor market. In the ELEVATE-RR study, Calquence (acalabrutinib) matched Imbruvica (ibrutinib) when it came to keeping adults with previously […]

  • 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: Tonix Pharmaceuticals, TNX-102 SL, P-III, RELIEF Study, Fibromyalgia, ASCP 2021 Dermavant Submits NDA to the US FDA for Tapinarof Cream to Treat Plaque Psoriasis 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 could extend the time for the cancer to return when used as adjuvant therapy. Giving Lynparza (olaparib) to women with BRCA-positive, HER2-negative breast cancer straight after chemotherapy and surgery to […]

  • 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 coverage Most people who are reluctant to be vaccinated against Covid are worried about side-effects and whether the vaccines have been adequately tested, a survey in 15 countries has shown. […]

  • 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 identified in South Africa, according to Health Secretary Matt Hancock. The AZ/Oxford University vaccine and other shots from Pfizer/BioNTech and Moderna are known to have less efficacy against the beta […]

  • 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 formation of blood clots is a necessary process in order for the body to repair damage caused by injury and to slow down bleeding. However, when blood clots form inappropriately, […]

  • 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 Designation,  Amyotrophic Lateral Sclerosis The US FDA’s EMDAC Supports Provention Bio’s Teplizumab in Delaying Diabetes Published: May 28, 2021 | Tags: US, FDA, EMDAC, Provention Bio, Teplizumab, Delaying Diabetes uniQure […]

  • 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 accused China of interfering in its vaccine acquisition programme, as the island continues to battle hundreds of daily new cases of Covid-19 with low supplies of vaccines. Taiwan has received […]

  • 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 See all our coronavirus coverage A team of German scientists believe that they have worked out why some people given the AstraZeneca and Johnson & Johnson vaccines against Covid-19 develop […]

  • 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 Norman’s boast as he peered through the thicket of exceptional charges that dominated yet another set of annual results and turned a small headline pre-tax profit of £41.6m into a […]

  • 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 of its contract to supply COVID-19 vaccines to the EU. Rafael Jafferali Counsel for the Commission – Rafael Jafferali – insisted during the hearing at the Brussels Court of First […]

  • 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 Markets Authority (CMA) is starting the first phase of the probe today, and said it should wrap it up by 21 July, deciding at that point whether to start a […]

  • 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 new UK data. The Pfizer/BioNTech shot provided 88% protection against the B.1.617.2 variant first identified in India and currently gaining ground across the UK and other countries around the world, […]

  • 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 coronavirus coverage The chief executive of AstraZeneca has defended the company against “armchair generals” and said its vaccine has a future. Pascal Soriot disclosed the UK had priority access to […]

  • 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 | Tags: BeiGene, Tislelizumab, CT, P-III, RATIONALE 309 Study, Recurrent, Metastatic Nasopharyngeal Cancer Aurinia to Present Results of Lupkynis (voclosporin) in AURORA 2 Continuation Study for Lupus Nephritis at EULAR […]

  • 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 a third booster dose to protect against new variants.  The Cov-Boost trial is thought to be the first in the world to try to generate data on the value of […]

  • 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 our coronavirus coverage Vaccine programmes across Africa and much of the developing world will suffer big delays after the world’s biggest producer said it would not be exporting the Oxford/AstraZeneca […]

  • 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 Pharmaceuticals, a biotech being acquired by AstraZeneca. But Apellis’s drug beat Alexion drug Soliris in a head-to-head test, and the smaller company aims to steal market share from its larger […]

  • 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 will allow it to challenge Alexion’s established therapies directly.  There had been speculation that the FDA might approve Empaveli (pegcetacoplan) only as a backup option for patients who don’t see […]

  • 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 backbone last week, as a number of eye-popping pay packages overcame the threat of voter rebellions at annual general meetings. The board of AstraZeneca asked shareholders to support their decision […]

  • 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 | Tags: AzurRx BioPharma, P-II, MS1819, PERT, Cystic Fibrosis, Severe, Exocrine Pancreatic Insufficiency Goldfinch Bio Initiates P-I Clinical Trial of GFB-024 for the Treatment of Severe Insulin Resistant Diabetic Nephropathy Published: […]

  • 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 nearly 40%voted against the policy, which could hand him payand perks of up to £17.8m for 2021. At the company’s annual meeting in Cambridge, the Anglo-Swedish drugmaker managed to pass […]

  • 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 (18–80yrs.) & adolescents (12–17yrs.) with severe and uncontrolled asthma The study demonstrated 56% reduction in AAER @52wks. in the overall population. The study also met 1EPs in the subgroup of […]

  • 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 their counterparts in England and Wales.  aHUS is an ultra-rare disease that can cause progressive injury to the kidneys via damage to the walls of blood vessels and blood clots […]

  • 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 to boost the pay of its chief executive, Pascal Soriot, as investors prepare to vote on proposals that could take his remuneration after nearly a decade at the helm of […]

  • 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 in patients with mNSCLC The study demonstrated improvement in OS and combination also showed improvement in PFS, as previously reported in Oct 2019. In a previous analysis, patients treated with […]

  • 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 access to patients on England’s NHS. The arrangements under Project Orbis, a global project run by the FDA that the Medicines and Healthcare products Regulatory Authority is supporting, aim to […]

  • 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 medicines with the potential to “change the course” of the pandemic will be authorised for mass production and use in the EU by October under a European Commission plan. Stella […]

  • 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 deadline to save a few thousand pounds on stamp duty, buyers rushed to complete their house purchases. Mortgage lending in the month reached a new record. It requires no imagination […]

  • ‘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 over its plans to award its chief executive, Pascal Soriot, a big increase in bonuses, with two investor advisory groups calling on shareholders to vote against the policy. Glass Lewis […]

  • 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 approval in chronic kidney disease (CKD).  The US regulator has cleared Farxiga (dapagliflozin) to reduce the risk of kidney damage, end-stage kidney disease, cardiovascular, death and hospitalisation for heart failure […]

  • AZ posts solid Q1 results as Alexion merger looms

    AstraZeneca’s not-for-profit coronavirus vaccine has bit into margins in Q1, although revenues were ahead of expectations as the company heads towards completion of its $39bn acquisition of Alexion.  The company posted Q1 product sales of $7.26bn, ahead of consensus forecasts of around $6.84 billion, with total revenues up 15% compared with last year’s Q1 to […]

  • AstraZeneca revenues up as it delivers jab to 120 countries via Covax

    Quarterly results from Anglo-Swedish producer of Covid vaccine show better-than-expected 15% rise Coronavirus – latest updates See all our coronavirus coverage AstraZeneca has generated $275m (£197m) in revenues from its Covid vaccine in the first three months of the year and shipped 48m doses to 120 countries through the global vaccine-sharing initiative Covax. Most of […]

  • Miracles may not be in the pipeline at GSK but it’s too soon to panic | Nils Pratley

    The CEO’s best policy is to ignore the noise. The decluttering demerger plan looks solid and is backed by shareholders It was not a knockout quarter to put Elliott Management, the big, aggressive and newly arrived US activist hedge fund, back in its box. GlaxoSmithKline’s revenues fell 18% as patients, sensibly, delayed their GSK shingles […]

  • European Commission legal battle with AZ over COVD vaccines contract

    The European Commission has officially begun legal proceedings against AstraZeneca over supplies of COVID vaccines. The legal action marks an escalation in the dispute between the EU and AZ over the supply of coronavirus vaccines. Under pressure to roll out vaccinations, the European Commission has accused AZ of failing to live up to a contract […]

  • EU starts legal action against AstraZeneca over vaccine shortfalls

    Firm says it will ‘strongly defend itself’ against claim it breached agreement to supply Covid jab Coronavirus – latest updates See all our coronavirus coverage AstraZeneca said it would “strongly defend itself in court” and highlighted its supply of 50m Covid vaccine doses to European countries as Brussels launched legal action against the pharmaceutical company […]

  • AstraZeneca’s Tagrisso (osimertinib) Receives EU’s CHMP Positive Opinion for the Adjuvant Treatment of Patients with Early-Stage EGFR-Mutated Lung Cancer

    Shots: The recommendation is based P-III ADAURA trial assessing Tagrisso (80mg, qd, PO) vs PBO in 682 patients with stage IB, II, IIIA EGFRm NSCLC following complete tumor resection and adjuvant CT as indicated for 3 yrs. or until disease recurrence The study showed improvement in DFS in all primary analysis population of patients with […]

  • AstraZeneca and MSD’s Selumetinib Receive EU’s CHMP Positive Opinion as the First Therapy for Pediatric Patients with Neurofibromatosis Type 1 Plexiform Neurofibromas

    Shots: EMA’s CHMP has recommended conditional marketing authorization of Selumetinib in the EU. The recommendation is based on the results from the P-I/II SPRINT Stratum 1 trial evaluating selumetinib as a monothx (PO, bid) in pediatric patients aged ≥3yrs. with NF1 and symptomatic, inoperable PNs The trial showed 66% ORR which is defined as the […]

  • What Covid vaccines does the UK have and which are in the works?

    As Valneva recruits volunteers for final stage trials of its vaccine, here is the current state of play in Britain Coronavirus – latest updates See all our coronavirus coverage Vaccines to protect against the coronavirus were designed, tested and manufactured in record time, and several have been approved for use in the UK vaccination programme, […]

  • GlaxoSmithKline faces dose of strong medicine from US investor

    This week’s lacklustre results will strengthen boss Emma Walmsley’s case for reform – but also inspire her critics When the American hedge fund Elliott Management took a sizeable stake in GlaxoSmithKline this month, the drugmaker’s shares jumped 5% on speculation of a possible shake-up at the company. GSK’s chief executive, Emma Walmsley, will face questions […]

  • EU’s legal pursuit of AstraZeneca looks short-sighted

    Only semi-guaranteed outcome is that big pharma will never again agree to work for no profit during a pandemic It’s been hard to keep up with the European commission and EU leaders’ changing stances on the Oxford/AstraZeneca coronavirus vaccine. But the ferocity of complaints about delayed deliveries seemed to have lessened in recent weeks. When […]

  • EU asks states to back legal action against AstraZeneca

    Commission move causes concern about bringing case against key supplier of Covid vaccines Coronavirus – latest updates See all our coronavirus coverage EU capitals have been asked by the European commission to back legal action against AstraZeneca by the end of the week over an alleged breach of its contractual obligations to supply member states […]

  • PharmaShots’ Key Highlights of First Quarter 2021

    The first quarter of 2021 highlights new approvals, M&A, and the clinical data of COVID-19 vaccines. The companies expand their working in COVID-19 by targeting South African & Brazil variants along with other emerging variants Starting with the latest acquisition, Amgen acquired Five Prime for $1.9B, Jazz acquired JW while Boston acquired Preventice. This quarter […]

  • Revealed: big shortfall in Covax Covid vaccine-sharing scheme

    Only a fifth of doses expected by May delivered as export bans, hoarding and supply shortages bite Coronavirus – latest updates See all our coronavirus coverage The global vaccine-sharing initiative Covax has so far delivered about one in five of the Oxford/AstraZeneca doses it estimated would arrive in countries by May, according to a Guardian […]

  • FDA pens stinging report on Emergent COVID vaccine plant

    Emergent BioSolutions’ difficult month has been made worse by an FDA report into its facility in Baltimore, which has been blamed for the wastage of millions of doses of Johnson & Johnson’s COVID-19 vaccine.  The US regulator says it completed an inspection of the Bayview plant run by the contract manufacturing organisation (CMO) which uncovered […]

  • Enhertu cleared for NHS use via Cancer Drugs Fund

    NICE has recommended the use of AstraZeneca and Daiichi Sankyo’s Enhertu in draft guidance, the first time the drug has been commissioned in any European country.  The UK health technology assessment (HTA) agency has backed Enhertu (trastuzumab deruxtecan) as a therapy for HER2 positive breast cancer which can’t be surgically removed or which has spread […]

  • UK Vaccine Taskforce head lifts lid on Novavax deal

    The UK’s unique offering as a life sciences research hub helped convince US biotech Novavax to develop its COVID-19 jab there, according to the head of the country’s Vaccines Taskforce.  Last August the UK government finalised a deal with Novavax to purchase 60 million doses of the NVX-CoV2373 vaccine, which will also be manufactured in […]

  • PharmaShots Weekly Snapshots (Apr 12 – 16, 2021)

    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 Muscular Atrophy in Adults and Children Published: Apr 16, 2021 | Tags: Roche, Evrysdi (risdiplam), Receives, Health Canada, Approval, Spinal Muscular Atrophy, Adults, Children GSK Discontinues the P-II Trials of […]