AstraZeneca

Entasis antibiotic bests last-resort drug in Phase 3 trial; FDA filing planned for 2022

Entasis Therapeutics, the former anti-infectives unit of AstraZeneca, has positive Phase 3 data for its lead program, an antibiotic that could address drug-resistant strains of Acinetobacter baumannii that contribute to hospital-acquired infections. The biotech plans to seek FDA approval in 2022.

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 & …

PharmaShots Weekly Snapshots (October 11 – 15, 2021) Read More »

AstraZeneca Reports Results of Imfinzi + Tremelimumab in P-III HIMALAYA Study for 1L Treatment of Unresectable Liver Cancer

Shots: The P-III HIMALAYA study Imfinzi monothx. and the STRIDE regimen (single priming dose of tremelimumab 300mg + Imfinzi 1500mg followed by Imfinzi q4w vs sorafenib in ~1,324 patients with unresectable, advanced HCC who had not been treated with prior systemic therapy and were not eligible for locoregional therapy The combination regimen demonstrated a favorable …

AstraZeneca Reports Results of Imfinzi + Tremelimumab in P-III HIMALAYA Study for 1L Treatment of Unresectable Liver Cancer Read More »

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 …

What does the future of European healthcare look like? Read More »

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 …

Local Covid vaccines fill gap as UN Covax scheme misses target Read More »

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 …

Merck files pill for milder COVID, as AZ showcases its antibody data Read More »

AstraZeneca’s AZD7442 Meet its Primary Endpoints in P-III TACKLE Trial for the Treatment of COVID-19

Shots: The P-III TACKLE trial evaluates the safety & efficacy of AZD7442 (600mg, IM) as monothx. vs PBO in a ratio (1:1) in 903 outpatients aged ≥18yrs. who were non-hospitalized with COVID-19 & symptomatic for ≤7 days The trial met its 1EPs i.e., 50% reduction in risk of severe COVID-19 or death from any cause, …

AstraZeneca’s AZD7442 Meet its Primary Endpoints in P-III TACKLE Trial for the Treatment of COVID-19 Read More »

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 …

PharmaShots Interview: Sierra Oncology’ Dr. Barbara Klencke Shares Insight on Sierra’s Agreement with AstraZeneca for AZD5153 Read More »

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 …

AZ files for emergency use of COVID-19 antibody combo in US Read More »

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 …

AstraZeneca Seeks the US FDA’s EUA for AZD7442 to Treat COVID-19 in US Read More »

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 …

Enhertu nabs speedy FDA review for earlier use in breast cancer Read More »

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 Weekly Snapshots (September 27 – October 01, 2021) Read More »

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, …

PharmaShots’ Key Highlights of Third Quarter 2021 Read More »

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 …

AstraZeneca to Acquire Caelum for ~500M Read More »

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 …

AZ claims full control of Caelum’s AL amyloidosis drug in $500m deal Read More »

AstraZeneca’s Saphnelo (anifrolumab) Receives MHLW’s Approval for the Treatment of Systemic Lupus Erythematosus

Shots: The approval was based on the clinical program including two P-III TULIP & P-II MUSE trials evaluated the efficacy and safety of Saphnelo vs PBO in 362 & 305 patients with SLE who are receiving standard therapy The results showed a reduction in overall disease activity across organ systems, including skin and joints, and …

AstraZeneca’s Saphnelo (anifrolumab) Receives MHLW’s Approval for the Treatment of Systemic Lupus Erythematosus Read More »

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 …

PharmaShots Weekly Snapshots (September 20 – 24, 2021) Read More »

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 …

PROpel study backs Lynparza combo in first-line prostate cancer Read More »

AstraZeneca Collaborates with VaxEquity to Develop and Commercialize Self-Amplifying RNA Therapeutics

Shots: VaxEquity can receive ~$195M in development, approval, and sales-based milestones along with royalties per program & is also eligible to receive an equity investment from AstraZeneca for the development of the saRNA platform The focus of the collaboration is to optimize and validate VaxEquity’s saRNA platform to advance novel therapeutic programs AstraZeneca support VaxEquity …

AstraZeneca Collaborates with VaxEquity to Develop and Commercialize Self-Amplifying RNA Therapeutics Read More »

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 …

Amnesty says COVID jab producers are causing human rights crisis Read More »

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 …

Big pharma fuelling human rights crisis over Covid vaccine inequity – Amnesty Read More »

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 …

After Alexion buy, AZ plans $360m investment in Irish facilities Read More »

AstraZeneca Presents the Updated Results of Imfinzi (durvalumab) in P-III CASPIAN Trial for the Treatment of Extensive-Stage Small Cell Lung Cancer at ESMO 2021

Shots: The P-III CASPIAN trial evaluates Imfinzi + CT or Imfinzi + CT + tremelimumab vs CT alone in 805 patients with ES-SCLC in 200+ centers across 23 countries, including the US, EU, South America, Asia & Middle East The results showed OS benefits & sustained efficacy after a median follow-up of ≥3yrs. with a …

AstraZeneca Presents the Updated Results of Imfinzi (durvalumab) in P-III CASPIAN Trial for the Treatment of Extensive-Stage Small Cell Lung Cancer at ESMO 2021 Read More »

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 …

ESMO21: Enhertu brings it’s A game to second-line breast cancer Read More »

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 …

ICER says Amgen’s tezepelumab ‘likely to be too expensive’ Read More »

AstraZeneca Presents Results of Imfinzi (durvalumab) + Tremelimumab in P-III POSEIDON Study as 1L Treatment for Stage IV NSCLC at WCLC 2021

Shots: The P-III POSEIDON trial evaluates Imfinzi (1500mg, q3w, FD, for 4 cycles) + Pt-based CT or Imfinzi + Tremelimumab + CT vs CT alone in 1013 patients with mNSCLC The results showed an improvement in OS & PFS, 28% reduction in risk of cancer progressing or death with an m-PFS (6.2 vs 4.8mos.), 23% …

AstraZeneca Presents Results of Imfinzi (durvalumab) + Tremelimumab in P-III POSEIDON Study as 1L Treatment for Stage IV NSCLC at WCLC 2021 Read More »

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) …

MHRA clears third doses of AZ, Pfizer COVID jabs Read More »

AstraZeneca Reports Results of PT027 (albuterol and budesonide) in P-III MANDALA and DENALI Trials for the Treatment of Asthma

Shots: The P-III MANDALA & DENALI trial evaluates the efficacy & safety of PT027 (180/160mcg & 180/80mcg doses) vs albuterol & albuterol and budesonide aged ≥4yrs. in 3132 & 1001 patients with asthma Both trials met its 1EPs i.e., reductions in risk of severe exacerbations in the MANDALA trial, improvement in lung function as measured …

AstraZeneca Reports Results of PT027 (albuterol and budesonide) in P-III MANDALA and DENALI Trials for the Treatment of Asthma Read More »

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 …

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 Read More »

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 …

AZ CEO Soriot urges caution on COVID booster doses Read More »

AstraZeneca Presents Results of Fasenra in P-IIIb PONENTE Study for the Treatment of Asthma at ERS 2021

Shots: The P-IIIb PONENTE study evaluates the safety & efficacy of Fasenra (30mg, SC, q8w) in adult patients with sev. eosinophilic asthma on high-dose ICS + LABA & long-term use of OCS therapy with/out additional asthma controlled Results: 97% of patients maintained a low OCS dose of ≤5mg across blood eosinophil counts @6mos., 3% of …

AstraZeneca Presents Results of Fasenra in P-IIIb PONENTE Study for the Treatment of Asthma at ERS 2021 Read More »

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−) …

AstraZeneca and Amgen’s Tezepelumab Demonstrates 86% Reduction in Exacerbations in Patients with Asthma and Nasal Polyps Read More »

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 …

Amgen builds case for severe asthma drug tezepelumab Read More »

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 …

Australian Novavax trial participants remain unrecognised by vaccine register Read More »

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) Read More »

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) Read More »

AstraZeneca Signs a Multiyear Agreement with Thermo Fisher to Co-Develop NGS-based CDx for Targeted Therapies

Shots: The collaboration will expand AstraZeneca’s portfolio of targeted therapies for cancer & other diseases. Thermo Fisher currently offers the NGS CDx solution which is approved and reimbursed by government & commercial insurers in 15+ countries, including the US, EU, Japan, South Korea & Middle East The agreement also provides the technology, expertise & ability …

AstraZeneca Signs a Multiyear Agreement with Thermo Fisher to Co-Develop NGS-based CDx for Targeted Therapies Read More »

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: …

PharmaShots Weekly Snapshots (August 23 – 27, 2021) Read More »

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 …

After Ultomiris stumble, Alexion delivers a rare disease win for AZ Read More »

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 …

UK real-world study finds COVID-19 jab protection wanes Read More »

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 …

AZ’s Alexion takeover hits a snag, as Ultomiris flunks ALS trial Read More »

AstraZeneca drug succeeds in Covid-19 prevention; regulatory filings on the way

An AstraZeneca antibody drug for Covid-19 has clinical data showing the drug reduced the risk of infection by 77%. With the results, the pharmaceutical giant pulls ahead of other companies developing injectable versions of antibody drugs for Covid-19 prevention.

AstraZeneca drug acquired in Alexion acquisition falls short in pivotal ALS trial

Alexion Pharmaceuticals drug Ultomiris is already approved to treat a rare blood disorder, but the company hoped the antibody’s approach could also work in amyotrophic lateral sclerosis. Despite failing in ALS, Alexion, recently acquired by AstraZeneca, brings additional clinical-stage programs for rare diseases.

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 …

PROVENT trial puts AZ COVID antibody combo back on track Read More »

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 …

Jardiance gets parity with Farxiga in US as FDA clears use in heart failure Read More »

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, …

PharmaShots Weekly Snapshots (Aug 09 – 13, 2021) Read More »

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 …

Covid-19 vaccines: the contracts, prices and profits Read More »

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 …

FDA rejects FibroGen/AZ’s roxadustat, asking for new trial Read More »

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 …

SK Bio’s COVID vaccine will start phase 3 study versus AZ jab Read More »

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 …

HER2 heats up as Seagen licenses RemeGen ADC for $2.6bn Read More »

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 …

AZ gets European approvals for Forxiga in chronic kidney disease Read More »

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 …

PharmaShots Weekly Snapshots (Aug 02 – 06, 2021) Read More »

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 …

FDA approves AZ’s anifromulab, ending 10-year lupus drug drought Read More »

AstraZeneca’s Saphnelo (anifrolumab-fnia) Receives the US FDA’s Approval for the Treatment of Moderate to Severe Systemic Lupus Erythematosus

Shots: The approval is based on efficacy and safety data from the clinical development program, including two P- III TULIP trials and the P-II MUSE trial evaluating Saphnelo vs PBO in patients with SLE who are receiving standard therapy The result from the trials showed a reduction in overall disease activity across organ systems, including …

AstraZeneca’s Saphnelo (anifrolumab-fnia) Receives the US FDA’s Approval for the Treatment of Moderate to Severe Systemic Lupus Erythematosus Read More »

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 …

As Delta spreads, Pfizer and Moderna get set for a booster shot to profits Read More »

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 …

AstraZeneca sales of Covid vaccine triple to $1.2bn in first half of 2021 Read More »

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’s COVID-19 jab sales top $1.2bn, but come at a loss Read More »

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 …

AZ says second COVID jab dose isn’t linked to rare clot reaction Read More »

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 …

Regeneron, AZ team up on drugs for obesity “superpower” gene Read More »

AstraZeneca and Regeneron Collaborate to Research, Develop and Commercialize Therapies for Obesity

Shots: The companies collaborated to research, develop & commercialize small molecules directed against the GPR75 target with the potential to treat obesity and related co-morbidities The collaboration builds on the findings from the Regeneron Genetics Center of rare genetic mutations in the GPR75 gene associated with protection against obesity and on early joint research initiated …

AstraZeneca and Regeneron Collaborate to Research, Develop and Commercialize Therapies for Obesity Read More »

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 …

Boost for AZ as Ultomiris gets CHMP nod for expanded label Read More »

AstraZeneca’s Vaxzevria Demonstrates Effectiveness After One Dose Against Beta/Gamma and Delta Variants of SARS-CoV-2 Virus

Shots: RWE data from CIRN with support from the Public Health Agency of Canada and the Canadian Institutes of Health Research demonstrated that one dose of Vaxzevria was 82% effective against hospitalization or death caused by the Beta/Gamma variants of the SARS-CoV-2 virus The vaccine also demonstrated effectiveness against the Delta and Alpha variants with …

AstraZeneca’s Vaxzevria Demonstrates Effectiveness After One Dose Against Beta/Gamma and Delta Variants of SARS-CoV-2 Virus Read More »

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 …

Study finds jabs cut severe variant COVID disease after one shot Read More »

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 …

Pfizer puts up $1bn to buy into Arvinas breast cancer programme Read More »

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. …

AstraZeneca bags Imfinzi okay in big Chinese lung cancer market Read More »

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 …

FDA adcomm turns down FibroGen, AZ’s roxadustat for CKD anaemia Read More »

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 …

AZ, J&J tweaking COVID shots to reduce clotting risks; report Read More »

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 …

Final hurdle falls as UK backs AZ’s $39bn takeover of Alexion Read More »

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 …

PharmaShots Weekly Snapshots (July 05 – 09, 2021) Read More »

How should you respond to deep, sincere praise? There are no easy answers | Zoe Williams

On morning TV this week, two of the developers of the Oxford vaccine were faced with an outpouring of thanks. It was very much deserved – and very hard for them to reply I don’t watch much TV in the morning – I put it roughly on a par with smoking weed in the morning …

How should you respond to deep, sincere praise? There are no easy answers | Zoe Williams Read More »

AstraZeneca Signs an Exclusive License Agreement with F-star Therapeutics for Novel STING Inhibitors

Shots: F-star is eligible to receive up front and near-term payments of ~$12M & will be eligible for ~$300M as development & sales milestone along with royalties. Payments received by F-star are subject to a CVR agreement in which a portion will be payable to F-star’s investors that were previously stockholders of Spring Bank AstraZeneca …

AstraZeneca Signs an Exclusive License Agreement with F-star Therapeutics for Novel STING Inhibitors Read More »

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 …

AstraZeneca and Amgen Report the US FDA’s Acceptance of BLA and Priority Review of Tezepelumab for the Treatment of Asthma Read More »

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 …

AZ, Amgen get speedy FDA review for asthma drug tezepelumab Read More »

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 …

Boehringer, Lilly hail Jardiance data in hard-to-treat heart failure Read More »

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, …

Another hurdle down as EU clears AstraZeneca’s Alexion takeover Read More »

Centre Court ovations, limbo-dancing grans – it’s all been humbling, say Oxford vaccine creators

Sarah Gilbert and Catherine Green tell of their pioneering vaccine work but warn the battle is far from over Coronavirus – latest updates See all our coronavirus coverage Sarah Gilbert’s experiences at Wimbledon last week clearly had a profound impact on the medical researcher – though it was not the standing ovation that the vaccine …

Centre Court ovations, limbo-dancing grans – it’s all been humbling, say Oxford vaccine creators Read More »

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 …

AZ drug for hard-to-treat heart failure has mixed results in trial Read More »

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 …

PharmaShots’ Key Highlights of Second Quarter 2021 Read More »

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 …

The Oxford vaccine: the trials and tribulations of a world-saving jab Read More »

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) …

Moderna, Pfizer or AstraZeneca? The ridiculous, diverting rise of vaccine envy Read More »

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 …

Covid jabs for billions of humans will earn their makers billions of dollars Read More »

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 Read More »

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 Read More »

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 …

EU and AZ both claim victory in COVID jab supply lawsuit Read More »

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, …

PharmaShots Weekly Snapshots (June 14 – 18, 2021) Read More »

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 …

AstraZeneca vaccine price pledge omits some poor countries, contract shows Read More »

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 …

Ambrx tries another IPO as it chases down HER2 rivals Read More »

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 …

Vaccines were not part of AstraZeneca’s grand strategy, so what’s the plan now? Read More »

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 …

AZ’s COVID jab tackles delta variant, but antibody fails clinical trial Read More »

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 …

AstraZeneca’s COVID-19 Vaccine Demonstrates 92% Efficacy Against Delta (Indian) Variant Read More »

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 …

J&J must ditch 60m COVID jabs made at US plant, but 10m are okay, says FDA Read More »

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 …

PharmaShots Weekly Snapshots (June 07 – 11, 2021) Read More »

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 …

Study links AstraZeneca COVID-19 shot to bleeding disorder ITP Read More »

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), …

Scotland backs rare blood cancer drug Poteligeo rejected by NICE Read More »

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 …

Thailand starts Covid vaccine drive using jabs made by king’s firm Read More »

AstraZeneca Reports Updated Results of Imfinzi (durvalumab) in P-III PACIFIC Trial for Non-Small Cell Lung Cancer

Shots: The P-III PACIFIC trial involves assessing Imfinzi vs PBO in 713 patients with unresectable, stage III NSCLC whose disease had not progressed following concurrent platinum-based CRT in 235 centers across 26 countries The updated post-hoc analyses demonstrated OS @5yrs. (42.9% vs 33.4%), m-OS (47.5 vs 29.1mos); at the treatment course of one year patients …

AstraZeneca Reports Updated Results of Imfinzi (durvalumab) in P-III PACIFIC Trial for Non-Small Cell Lung Cancer Read More »

AstraZeneca Reports Results of Calquence (acalabrutinib) in P-III Head-to-Head ELEVATE-RR Trial for Chronic Lymphocytic Leukemia

Shots: The P-III head-to-head ELEVATE-RR trial evaluating Calquence (100mg, PO, bid) vs ibrutinib (420mg, PO, qd) in a ratio (1:1) in 533 patients with previously treated CLL The trial met its 1EPs i.e PFS non-inferiority with an m-PFS of 38.4 mos. @median follow up (40.9mos.). The 2EPs include lower incidence of all-grade atrial fibrillation (9.4% …

AstraZeneca Reports Results of Calquence (acalabrutinib) in P-III Head-to-Head ELEVATE-RR Trial for Chronic Lymphocytic Leukemia Read More »

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 …

ASCO21: AZ seeks to supplant Imbruvica in CLL with new Calquence data Read More »

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: …

PharmaShots Weekly Snapshots (May 31 – June 4, 2021) Read More »

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 …

ASCO21: Lynparza aces adjuvant breast cancer therapy trial Read More »

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. …

Fears of side-effects fuel reluctance to get Covid jabs, survey finds Read More »

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 …

UK is talking to AstraZeneca about beta variant COVID jab Read More »

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, …

What HCPs think about blood clots linked to COVID-19 vaccines Read More »

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 …

PharmaShots Weekly Snapshots (May 24 – 28, 2021) Read More »

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

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

AstraZeneca’s Tagrisso (osimertinib) Receives EU’s Approval for the Adjuvant Treatment of Patients with Early-Stage EGFR-Mutated Lung Cancer Read More »

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 …

Taiwan accuses China of interfering with Covid vaccine deals Read More »

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 …

German scientists say they can help improve Covid vaccines to prevent blood clots Read More »

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 …

Has Marks and Spencer really got it right at last? | Nils Pratley Read More »

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 …

EU asks court to fine AstraZeneca over missing COVID jab shipments Read More »

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 competition watchdog probes AstraZeneca, Alexion merger Read More »

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, …

UK says Pfizer, AZ COVID-19 vaccines work against Indian variant Read More »

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 …

AstraZeneca chief hits back at ‘armchair generals’ after criticism Read More »

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 …

PharmaShots Weekly Snapshots (May 17 – 21, 2021) Read More »

AstraZeneca’s Vaxzevria (AZD1222) Receives Approval for Emergency Use in Japan to Treat COVID-19

Shots: MHLW has granted EUA for Vaxzevria (ChAdOx1-S [Recombinant]) for active immunization of individuals aged ≥18yrs. to prevent COVID-19. The EUA is based on P-III data from the Oxford University-led clinical trial in the UK, Brazil and South Africa, and a P-I/II trial in Japan PMDA recommends the use of Vaxzevria should be limited to …

AstraZeneca’s Vaxzevria (AZD1222) Receives Approval for Emergency Use in Japan to Treat COVID-19 Read More »

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 …

UK booster trial will test value of third COVID jab dose Read More »

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 …

Poorer countries face long delays in receiving Covid vaccines Read More »

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 …

With FDA approval, Apellis can challenge AstraZeneca in rare blood disorder Read More »

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 …

Apellis set to take on Alexion as FDA clears PNH drug Empaveli Read More »

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 …

We’re all the poorer for shareholders’ loss of nerve on executive pay Read More »

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: …

PharmaShots Weekly Snapshots (May 10 – 14, 2021) Read More »

AstraZeneca and Amgen Present Results of Tezepelumab in P-III NAVIGATOR Study for Severe Asthma at ATS2021

Shots: The P-III NAVIGATOR study involves assessing Tezepelumab + SOC vs PBO + SOC in adults (18–80 yrs.) & adolescents (12–17 yrs.) with severe uncontrolled asthma The results demonstrate superiority in 1EP & 2EP in a broad population i.e., 77% reduction in AAER with blood eosinophil counts (≥300 cells/ microlitre) and FeNO levels (≥25 parts/ …

AstraZeneca and Amgen Present Results of Tezepelumab in P-III NAVIGATOR Study for Severe Asthma at ATS2021 Read More »

AstraZeneca’s boss is a boardroom superstar but a potential £2m cherry is pushing the point

Fund managers tried to vote down Pascal Soriot’s package for fear of more boardroom pay inflation A majority is a majority, but a rebellion of 40% against an executive pay policy is too large to be pinned solely on those brain-dead fund managers who outsource their thinking to proxy voting agencies. At AstraZeneca some serious …

AstraZeneca’s boss is a boardroom superstar but a potential £2m cherry is pushing the point Read More »

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 …

Nearly 40% of AstraZeneca investors reject boss’s bonus rise Read More »

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 …

AstraZeneca and Amgen Submit BLA to US FDA for Tezepelumab to Treat Severe Asthma Read More »

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 …

Scotland backs NHS use of Alexion’s Ultomiris for rare disease aHUS Read More »

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 chief executive’s pay rise in doubt ahead of investor vote Read More »

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 …

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 Read More »

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 …

Patients in England get fast access to AZ’s Tagrisso in early lung cancer Read More »

The Guardian view on waiving Covid vaccine patents: protect the world, not big pharma | Editorial

The US is now backing plans that could help billions more access vaccines. The UK should follow suit The rapid emergence of Covid vaccines has been a remarkable yet bittersweet success, pointing to both humanity’s scientific achievements and its social and economic failures. Experts created them at extraordinary speed; yet as the pandemic rages, many …

The Guardian view on waiving Covid vaccine patents: protect the world, not big pharma | Editorial Read More »

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 …

EU wants to mass produce three ‘course-changing’ Covid drugs from October Read More »

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 …

Sunak’s stamp duty holiday extension has merely inflamed the housing market Read More »

‘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 …

‘Obscene’ bonus hike for AstraZeneca boss prompts investor anger Read More »

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 …

AstraZeneca’s Farxiga claims first SGLT2 kidney disease OK from FDA Read More »

AstraZeneca’s Farxiga (dapagliflozin) Receives the US FDA’s Approval for Chronic Kidney Disease

Shots: The approval is based on P-III DAPA-CKD trial assessing Farxiga (qd, 10 mg) + SOC vs PBO in 4304 patients with CKD stages 2-4 and elevated urinary albumin excretion, with/out T2D Results: 39% reduction in relative risk of worsening of renal function or risk of CV or renal death, ARR (5.3%) @2.4yrs., and reduction …

AstraZeneca’s Farxiga (dapagliflozin) Receives the US FDA’s Approval for Chronic Kidney Disease Read More »

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 …

AZ posts solid Q1 results as Alexion merger looms Read More »

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 …

AstraZeneca revenues up as it delivers jab to 120 countries via Covax Read More »

India wants access to cheap copies of Covid vaccines. So why is Australia holding out?

More than 100 countries are pushing for a temporary waiver of IP rules to boost vaccine access for developing nations. Why hasn’t it been approved? As India grapples with a devastating Covid wave that has overwhelmed its hospitals, offers of aid, including from Australia, have flooded in from around the world. The help on offer …

India wants access to cheap copies of Covid vaccines. So why is Australia holding out? Read More »

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 …

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

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 …

European Commission legal battle with AZ over COVD vaccines contract Read More »

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 …

EU starts legal action against AstraZeneca over vaccine shortfalls Read More »

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

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 …

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

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, …

What Covid vaccines does the UK have and which are in the works? Read More »

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 …

GlaxoSmithKline faces dose of strong medicine from US investor Read More »

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’s legal pursuit of AstraZeneca looks short-sighted Read More »

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 …

EU asks states to back legal action against AstraZeneca Read More »

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 …

PharmaShots’ Key Highlights of First Quarter 2021 Read More »

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 …

Revealed: big shortfall in Covax Covid vaccine-sharing scheme Read More »

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 …

FDA pens stinging report on Emergent COVID vaccine plant Read More »

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 …

Enhertu cleared for NHS use via Cancer Drugs Fund Read More »

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 …

UK Vaccine Taskforce head lifts lid on Novavax deal Read More »

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 …

PharmaShots Weekly Snapshots (Apr 12 – 16, 2021) Read More »

Risk of brain clots higher with COVID than vaccine, study suggests

A study has suggested that the risk of getting a serious brain clot is eight to 10 times higher in people with COVID-19 than those who get a vaccine. There are some big caveats with the research from Oxford University – it was based on data from people in the US who had received either …

Risk of brain clots higher with COVID than vaccine, study suggests Read More »

NICE recommends Alexion’s long-acting Ultomiris for PNH

NICE has recommended Alexion’s long-acting Ultomiris (ravulizumab) for the rare disease paroxysmal nocturnal haemoglobinuria (PNH) in final draft guidance. Ultomiris is Alexion’s follow-up to its rare diseases blockbuster Soliris (eculizumab), which allows for  an eight-week dosing schedule after a loading phase. This is more patient-friendly than Soliris, which requires infusions every two weeks, a considerable …

NICE recommends Alexion’s long-acting Ultomiris for PNH Read More »

Czech Republic swoops for Denmark’s 2.4m unwanted AZ COVID shots

The Czech Republic wants to buy around 2.4 million doses of the AstraZeneca/Oxford University vaccine ditched by Denmark, which has said it will stop using it because of concerns about rare blood clotting side-effects. Czech deputy prime minister Jan Hamacek said on twitter that he had instructed the country’s ambassador in Denmark to try to …

Czech Republic swoops for Denmark’s 2.4m unwanted AZ COVID shots Read More »

Will Covid vaccines protect us against new variants? | Julian Tang

New strains such as the South African variant that’s emerged in south London will require constant vigilance as lockdown eases All viruses mutate. They do this to adapt and survive better in their specific host. The virus that causes Covid-19 is no different: it has moved from the animal realm, where it most likely originated …

Will Covid vaccines protect us against new variants? | Julian Tang Read More »

AZ aims at Pfizer, GSK with potential new PARP cancer drug

AstraZeneca’s Lynparza (olaparib) blazed a trail for the new class of PARP drugs when it was approved in 2014 to treat ovarian cancer.  The drug has gone on to become a huge success, generating sales of nearly $1.8 billion in 2020 alone as part of a partnership with Merck & Co after expanded use in …

AZ aims at Pfizer, GSK with potential new PARP cancer drug Read More »

AstraZeneca’s Tagrisso (osimertinib) Receives the NMPA’s Approval for the Adjuvant Treatment of Patients with Early-Stage EGFR-Mutated Lung Cancer

Shots: The approval is based on results from the P-III ADAURA trial assessing Tagrisso (80mg, qd) vs PBO in 682 patients with stage IB, II, IIIA EGFRm NSCLC following complete tumor resection and adjuvant chemotherapy as indicated for three years or until disease recurrence Results: Improvement in DFS in all population, 83% reduction in the …

AstraZeneca’s Tagrisso (osimertinib) Receives the NMPA’s Approval for the Adjuvant Treatment of Patients with Early-Stage EGFR-Mutated Lung Cancer Read More »

UK strategy of backing several Covid vaccines seems to be paying off

Analysis: buying new and existing technologies ensured alternatives if a vaccine failed or had supply issues Coronavirus – latest updates See all our coronavirus coverage The government has said the decision by Johnson & Johnson to delay the supply of its Covid vaccine to Europe, while the US investigates reports of six cases of unusual …

UK strategy of backing several Covid vaccines seems to be paying off Read More »

African health workers left without Covid jabs as paltry supplies dwindle

Fear of third wave and new variants as sub-Saharan vaccine distribution is dogged by supply disruption Coronavirus – latest updates See all our coronavirus coverage Millions of healthcare workers in sub-Saharan Africa continue to risk their lives to fight Covid-19 as authorities across the continent struggle to obtain and distribute vaccines to frontline medical staff. …

African health workers left without Covid jabs as paltry supplies dwindle Read More »

Australia reports second blood clot case ‘likely’ linked to AstraZeneca Covid vaccine

Woman in her 40s in Western Australia reported to be in hospital in a stable condition after developing clot Health authorities have concluded a second case of a rare blood clot syndrome in Australia “is likely” linked to the AstraZeneca vaccine. The case occurred in a woman in her 40s who received the AstraZeneca Covid-19 …

Australia reports second blood clot case ‘likely’ linked to AstraZeneca Covid vaccine Read More »

AstraZeneca’s Farxiga fails phase 3 COVID-19 test

Hope that AstraZeneca’s diabetes and heart failure drug Farxiga might treat patients hospitalised with COVID-19 have been dashed after the drug failed to make an impact in a phase 3 trial.  The DARE-19 trial showed that giving Farxiga (dapagliflozin) to COVID-19 patients at risk of developing severe complications wasn’t able to reduce the risk of …

AstraZeneca’s Farxiga fails phase 3 COVID-19 test Read More »

AstraZeneca’s Farxiga (dapagliflozin) Fails to Meet its Primary Endpoint in P-III DARE-19 Trial for COVID 19

Shots: The P-III DARE-19 trial involves assessing the efficacy and safety of Farxiga vs PBO in addition to SoC therapy in 1,250 hospitalized patients with COVID-19 who are at high risk of developing serious complications The trial fails to meet its 1EP of prevention measures organ dysfunction, all-cause mortality, and recovery measuring a change in …

AstraZeneca’s Farxiga (dapagliflozin) Fails to Meet its Primary Endpoint in P-III DARE-19 Trial for COVID 19 Read More »

EU agency examines reports of blood clots with J&J Covid vaccine

EMA says four serious cases reported, one fatal, and also expands inquiry into AstraZeneca vaccine Coronavirus – latest updates See all our coronavirus coverage The EU’s drug regulator is reviewing reports of rare blood clots in four people who received Johnson & Johnson’s Covid-19 vaccine and has expanded its inquiry into AstraZeneca’s shot to include …

EU agency examines reports of blood clots with J&J Covid vaccine Read More »

Clarity and openness are key to vaccine confidence | Letters

Readers respond to the latest recommendations about the AstraZeneca Covid vaccine Your editorial calling for clarity on the AstraZeneca vaccine’s side-effects risks both being unclear and undermining confidence (The Guardian view on the AstraZeneca vaccine: confidence from clarity, 7 April). You imply that the rate of potentially serious cerebral venous sinus thrombosis is 0.0001%. The …

Clarity and openness are key to vaccine confidence | Letters Read More »

PharmaShots Weekly Snapshots (Apr 05 – 09, 2021)

Evotec and Exscientia Initiate Human Clinical Trials of their Novel Immuno-Oncology Drug Published: Apr 9, 2021 | Tags: Evotec and Exscientia, Initiate, Human Clinical Trials, Novel, Immuno-Oncology Drug PlantForm Signs Research and Development Agreement with Bio-Manguinhos/Fiocruz to Develop Biosimilar Pembrolizumab Published: Apr 9, 2021 | Tags: PlantForm, Signs, Research, Development Agreement, Bio-Manguinhos/Fiocruz, Develop, Biosimilar Pembrolizumab …

PharmaShots Weekly Snapshots (Apr 05 – 09, 2021) Read More »

What does Australia’s new advice on the AstraZeneca Covid vaccine mean and what is the risk?

Experts say the development of blood clots after getting the jab is still an ‘exceedingly rare’ side effect. So what triggered the government’s change in position? Australia’s vaccine rollout is facing a major shake-up after the federal government heeded the advice of its independent health expert advisory body to avoid giving the AstraZeneca vaccine to …

What does Australia’s new advice on the AstraZeneca Covid vaccine mean and what is the risk? Read More »

Top 20 BioPharma Companies based on 2020 Total Revenue

Despite having the global pandemic, the biopharma companies were involved in multiple M&A, licensing deals. The major focus of the year remains the production and distribution of vaccines to combat the COVID-19 globally All the companies on our list are on the front line to combat this global crisis. The top 20 companies on the …

Top 20 BioPharma Companies based on 2020 Total Revenue Read More »

Coronavirus: UK expert urges people in 20s to keep getting vaccine

Prof David Spiegelhalter says advantages of vaccinating young people far outweigh risks Coronavirus – latest updates See all our coronavirus coverage People in their 20s should continue to get vaccinated against Covid despite the very rare cases of blood clotting linked to the Oxford/AstraZeneca vaccine because of the wider benefit to their families, friends and …

Coronavirus: UK expert urges people in 20s to keep getting vaccine Read More »

UK ministers silent on AstraZeneca vaccine shipment to Australia

Downing Street will not confirm or deny report that more than 700,000 Covid jabs were sent after EU blocked export Coronavirus – latest updates See all our coronavirus coverage British ministers and officials did not deny that more than 700,000 shots of the AstraZeneca vaccine were secretly dispatched from the UK to Australia a few …

UK ministers silent on AstraZeneca vaccine shipment to Australia Read More »

UK will offer under-30s alternative to AZ’s COVID jab

The UK drugs regulator has said people aged under 30 should be offered an alternative to the AstraZeneca COVID-19 vaccine, because of evidence linking it to rare blood clots.  Updated figures from the Medicines and Healthcare products Regulatory Agency (MHRA) reveal 79 people experienced blood clots after receiving a dose of Vaxzevria (AZD1222), with 19 …

UK will offer under-30s alternative to AZ’s COVID jab Read More »

AstraZeneca jab worry may play into hands of anti-vaxxers, say Tories

Iain Duncan Smith, former leader, and another MP, warn of eroded confidence in vaccine plan after ‘messy’ MHRA advice Coronavirus – latest updates See all our coronavirus coverage A decision to offer people under 30 an alternative vaccine to the AstraZeneca jab has prompted concern that some could shun the injection over fears about its …

AstraZeneca jab worry may play into hands of anti-vaxxers, say Tories Read More »

Under-30s may have ‘small delay’ in getting Covid jab, says Jonathan Van-Tam

England’s deputy chief medical officer says delay would be precaution against rare side-effect of blood clots Coronavirus – latest UK updates See all our coronavirus coverage People under 30 have been told there may be a “small delay” to when they will receive a coronavirus vaccine, given adults in that age group are now being …

Under-30s may have ‘small delay’ in getting Covid jab, says Jonathan Van-Tam Read More »

AstraZeneca Collaborates with MGH to Accelerate Digital Health Solutions

Shots: The companies collaborated to accelerate digital health solutions with the goal of improving the patient’s outcomes and care with chronic illness MGH will utilize AstraZeneca’s AMAZE disease management platform for heart failure and asthma management studies. The companies plan to expand the use of AMAZE across multiple chronic diseases, following the success of heart …

AstraZeneca Collaborates with MGH to Accelerate Digital Health Solutions Read More »

AstraZeneca jab: UK government says concerns being investigated thoroughly

People urged to keep getting Covid vaccine, with EMA and MHRA expected to give updates on investigation into rare blood clots Coronavirus – latest updates See all our coronavirus coverage Government advisers say concerns over the Oxford/AstraZeneca jab are being taken “very seriously” and “very thoroughly” investigated, before an imminent announcement by the vaccines regulator. …

AstraZeneca jab: UK government says concerns being investigated thoroughly Read More »

Paediatric trial of AZ COVID jab ‘halted as a precaution’

Oxford University has suspended a clinical trial of its AstraZeneca-partnered COVID-19 vaccine in children and adolescents while a possible link to rare cases of blood clotting is investigated by the UK drugs regulator.  Around 300 volunteers have been enrolled into the trial, but investigators have decided to pause dosing with the Oxford/AZ vaccine while they …

Paediatric trial of AZ COVID jab ‘halted as a precaution’ Read More »

AstraZeneca Covid vaccine: weighing up the risks and rewards

Despite scientific advice to continue getting the jab, answers about fatal blood clots are urgently needed Coronavirus – latest updates See all our coronavirus coverage Vaccines have side-effects, as do all medicines. Most often, jabs cause sore arms, a headache or a bit of nausea – none of which would be very significant when weighed …

AstraZeneca Covid vaccine: weighing up the risks and rewards Read More »

EU blames AstraZeneca ‘failure’ for sluggish Covid vaccine rollout

Anglo-Swedish company ‘solely’ to blame, says EU commissioner as bloc misses April vaccination target AstraZeneca has been squarely blamed by the EU for its comparatively slow Covid vaccine rollout after the bloc of 27 states failed to achieve its target to vaccinate 80% of older people by the end of March. Thierry Breton, the EU …

EU blames AstraZeneca ‘failure’ for sluggish Covid vaccine rollout Read More »

Could Moderna shot save UK’s under-50s COVID vaccination push?

People in the UK will start receiving doses of Moderna’s COVID-19 vaccine in around two weeks’ time, according to vaccines minister Nadhim Zahawi. The roll-out of the third coronavirus shot will come as the UK exits its second lockdown round, and in time to offset an anticipated dip in supply of the Oxford University/AstraZeneca AZD1222 …

Could Moderna shot save UK’s under-50s COVID vaccination push? Read More »

AZ exits US vaccine plant after mix-up spoils J&J’s COVID jab

AstraZeneca is shifting production of its COVID-19 vaccine away from a plant in Baltimore which also makes Johnson & Johnson’s shot, after human error resulted in the contamination of 15 million doses.  The mix-up at the facility operated by contract manufacturer Emergent BioSolutions resulted in ingredients destined for AZ’s AZD1222 jab being mixed into vials …

AZ exits US vaccine plant after mix-up spoils J&J’s COVID jab Read More »

Medicines watchdog says no decision made AstraZeneca jab for under-30s

Medicines Healthcare products Regulatory Authority was considering restricting vaccine amid concerns over rare blood clots Coronavirus – latest updates See all our coronavirus coverage The UK’s medicines regulatory body has said that no decision has been made on any regulatory action relating to the Oxford/AstraZeneca vaccine following reports it is considering restricting use of the …

Medicines watchdog says no decision made AstraZeneca jab for under-30s Read More »

Blood clot cases ‘could dent faith of young women in AstraZeneca’

Experts urge public to go for inoculations as benefits far outweigh potential complications Coronavirus – latest updates See all our coronavirus coverage Health officials are becoming increasingly worried that younger people will reject Covid jabs as concerns about the AstraZeneca vaccine continue to grow. A total of 30 cases of rare blood clots have been …

Blood clot cases ‘could dent faith of young women in AstraZeneca’ Read More »

Two new vaccines on the way – with more to follow this year

Half of UK adults have had a first jab, and future supplies of millions of doses look assured Coronavirus – latest updates See all our coronavirus coverage Two very different jabs have been responsible for inoculating Britain’s strikingly high number of vaccine recipients – with more than half of the country’s adult population having now …

Two new vaccines on the way – with more to follow this year Read More »

The world’s poorest countries are at India’s mercy for vaccines. It’s unsustainable | Achal Prabhala and Leena Menghaney

This is what happens when a third of humanity depends on one manufacturer for Covid jabs. We need to waive patents now As the UK’s vaccination programme was “knocked off course” due to a delay in receiving five million doses of the AstraZeneca vaccine from India, a far more chilling reality was unfolding: about a …

The world’s poorest countries are at India’s mercy for vaccines. It’s unsustainable | Achal Prabhala and Leena Menghaney Read More »

EMA backs safety of AZ COVID-19 jab in all age groups

The head of the EMA has reiterated that there is no evidence to limit the use of AstraZeneca’s COVID-19 vaccine in any age group, after Germany and Canada imposed restrictions in younger patients.  “Our position has not changed” from a safety update two weeks ago, said Emer Cooke at an EMA press conference today. “According …

EMA backs safety of AZ COVID-19 jab in all age groups Read More »

Canada suspends use of AstraZeneca Covid vaccine for those under 55

Immunisation panel says there is ‘substantial uncertainty about the benefit’ of the vaccine given risk of rare type of blood clot See all our coronavirus coverage Canada on Monday suspended the use of the Oxford/AstraZeneca coronavirus vaccine for people under 55 following concerns it might be linked to rare blood clots. The pause was recommended …

Canada suspends use of AstraZeneca Covid vaccine for those under 55 Read More »

Safe, stable, sold at cost: AstraZeneca’s vaccine deserves celebration, not scorn

The company has struggled, like its rivals, to keep up with demand. But it has achieved great things at low prices AstraZeneca is one of the shining stars of the pandemic. Not only did it produce a vaccine where other big players failed, the UK-Swedish company has pledged to sell it at cost until it …

Safe, stable, sold at cost: AstraZeneca’s vaccine deserves celebration, not scorn Read More »

‘Vaccine prince’: the Indian billionaire set to make Covid jabs for the UK

Serum Institute boss Adar Poonawalla has rented a Mayfair mansion for £50,000 a week Coronavirus – latest updates See all our coronavirus coverage The AstraZeneca vaccine has made Prof Sarah Gilbert – who led the Oxford team that created it – one of the UK’s most famous modern scientists and turned the Anglo-Swedish pharmaceutical company …

‘Vaccine prince’: the Indian billionaire set to make Covid jabs for the UK Read More »

How the AstraZeneca vaccine became a political football – and a PR disaster

Newly accused of data manipulation by the US, AstraZeneca has faced unprecedented scrutiny over the past six months Coronavirus – latest updates See all our coronavirus coverage It was billed as the vaccine to deliver the world from Covid. But over the last six months, AstraZeneca – whose jab was designed to save thousands of …

How the AstraZeneca vaccine became a political football – and a PR disaster Read More »

PharmaShots Weekly Snapshots (Mar 22 – 26, 2021)

Pfizer and BioNTech Initiate COVID-19 Vaccine Trial in Children Under 12 Published: Mar 26, 2021 | Tags: Pfizer and BioNTech, Initiate, COVID-19 Vaccine Trial, Children, Under 12 Tetra Bio-Pharma Initiates Additional Studies of ARDS-003 in Neuroinflammation and Antiviral Diseases Published: Mar 26, 2021 | Tags: Tetra Bio-Pharma, Initiates, Additional Studies, ARDS-003,  Neuroinflammation, Antiviral Diseases Immunai …

PharmaShots Weekly Snapshots (Mar 22 – 26, 2021) Read More »

EU stops short of vaccine export controls after summit

The European Union has stopped short of export controls on vaccines after leaders met at a summit to discuss the issue of shortfalls in supply. At the meeting of the European Council leaders said that toughening export controls was an option but a post-summit statement emphasised the importance of global supply chains to produce vaccines. …

EU stops short of vaccine export controls after summit Read More »

AZ issues revised efficacy figures for COVID-19 shot

AstraZeneca has issued revised efficacy figures from the US trial of its COVID-19 vaccine following a complaint from independent monitors that figures from an interim analysis published earlier this week were out of date. The new figures from AZ, which developed the vaccine in partnership with Oxford University, give an efficacy at preventing symptomatic COVID-19 …

AZ issues revised efficacy figures for COVID-19 shot Read More »

AstraZeneca Reports Results of AZD1222 in Primary Analysis of P-III Trial for the Prevention of COVID-19

Shots: The P-III D8110C00001 study involves assessing AZD1222 vs PBO in 32,449 participants in a ratio (2:1) aged ≥18yrs. across 88 trial centers in the US, Peru and Chile to prevent COVID-19. his primary efficacy analysis included the accrual of 190 symptomatic cases of COVID-19 from total participants The study showed 76% efficacy against symptomatic …

AstraZeneca Reports Results of AZD1222 in Primary Analysis of P-III Trial for the Prevention of COVID-19 Read More »

Why a fresh AstraZeneca fightback is required in Covid vaccine info row | Nils Pratley

Drugmaker isn’t entirely blameless but making it a political football for EU’s failures is simply ugly The European Union ought to be delighted. The “discovery” of a “stockpile” of 29m vaccine doses in Italy is really a non-discovery. The consignment is held at an authorised plant, available for inspection, and is merely awaiting quality sign-off. …

Why a fresh AstraZeneca fightback is required in Covid vaccine info row | Nils Pratley Read More »

AstraZeneca dismisses claim 29m vaccine doses in Italy were bound for UK

Batches were found when Italian police searched factory at request of European commission Coronavirus – latest updates See all our coronavirus coverage AstraZeneca has dismissed as “inaccurate” a report in the Italian press that 29m doses of its Covid-19 vaccine found in factory near Rome were destined for the UK. La Stampa reported on Wednesday …

AstraZeneca dismisses claim 29m vaccine doses in Italy were bound for UK Read More »

ViewPoints Interview: Fusion Pharma’s John Valliant Shares Insight on its Collaboration with AstraZeneca

In an interview with PharmaShots, John Valliant, CEO at Fusion Pharma shared his views on the company’s agreement with AstraZeneca, signed in Nov 2020. He also shared in-depth information about the company’s TATs platform & Fast-Clear linker technology and provide a glance at Fusion’s portfolio. Shots: Fusion to receive $5M up front and $40M as …

ViewPoints Interview: Fusion Pharma’s John Valliant Shares Insight on its Collaboration with AstraZeneca Read More »

AstraZeneca vaccine: Australia’s drug regulator dismisses questions raised in US about outdated data

Worldwide focus on Covid-19 means a ‘minor issue’ is getting media attention, experts say Australia’s Covid vaccine rollout would be ‘dire’ without local AstraZeneca production, health chief says Australia’s drug regulator, the Therapeutic Goods Administration, has dismissed questions raised about “outdated information” in AstraZeneca vaccine data by the US Data and Safety Monitoring Board. On …

AstraZeneca vaccine: Australia’s drug regulator dismisses questions raised in US about outdated data Read More »

EU to widen criteria for possible Covid vaccine export bans

Bloc expected to assess countries’ Covid vaccination coverage and record in facilitating exports to EU Coronavirus – latest updates See all our coronavirus coverage The EU is expected to take into account the level of vaccination coverage in a country and its record in facilitating exports to the bloc when deciding on whether to prohibit …

EU to widen criteria for possible Covid vaccine export bans Read More »

US agency questions AstraZeneca’s Covid vaccine trial data

Drug firm may have provided incomplete view of efficacy data from US trial, says safety monitor Coronavirus – latest updates See all our coronavirus coverage The Oxford/AstraZeneca vaccine against Covid has been dealt another blow within hours of AstraZeneca posting excellent results from its long-awaited big trial in the US. Questions have been raised in …

US agency questions AstraZeneca’s Covid vaccine trial data Read More »

AstraZeneca’s Covid-19 vaccine data may have ‘outdated information,’ NIH cautions

Federal health authorities say safety observers are concerned AstraZeneca did not release complete information about the efficacy of its Covid-18 vaccine. The company responded by saying its data were from a pre-specified analysis and it will provide the most up to date efficacy data within 48 hours.

Doubts emerge over AZ’s ‘outdated’ US vaccine trial data

AstraZeneca has been rebuked by a US health authority after a trial monitoring board said data published from a large study of its COVID-19 vaccine may be out of date and may not give a representative view of its efficacy. The company’s share price ticked down after the statement on Monday from the US National …

Doubts emerge over AZ’s ‘outdated’ US vaccine trial data Read More »

The Guardian view on pandemic politics: we need cooperation, not confrontation | Editorial

Vaccinating the world is the only way out of Covid, but a mixture of nationalism and protectionism is blocking the exit Covid-19 has proved to be the greatest humanitarian and economic disaster of the century. A reported 2.7 million people have already died from the pathogen. Its recession is estimated to be twice as deep …

The Guardian view on pandemic politics: we need cooperation, not confrontation | Editorial Read More »

Boris Johnson: vaccine cooperation vital to help combat third Covid wave

PM stresses need to work with EU and says surge in infections is likely to ‘wash up on our shores’ Coronavirus – latest updates See all our coronavirus coverage Boris Johnson has urged international cooperation over vaccines, saying a third wave of coronavirus elsewhere in Europe would inevitably affect the UK. The prime minister’s remarks …

Boris Johnson: vaccine cooperation vital to help combat third Covid wave Read More »

AstraZeneca’s AZD1222 Meets its Primary Endpoint in Preventing COVID-19

Shots: The P-III D8110C00001 study assessing AZD1222 (2 doses either 5 x1010 viral particles or saline PBO 4 wks. apart) vs PBO for the prevention of COVID-19. The interim analysis for efficacy was based on 32,449 participants aged ≥18 yrs. accruing 141 symptomatic infections in a ratio (2:1) across ~88 trial centers in and outside …

AstraZeneca’s AZD1222 Meets its Primary Endpoint in Preventing COVID-19 Read More »

Vaccine wars: the week that rocked the UK’s Covid jab rollout

After a week of bans, U-turns and warnings of supply shortfalls, public confidence in vaccination has been dented. Can Britain get back on the fast track out of lockdown? Coronavirus – latest updates See all our coronavirus coverage For Stacey Harris, the hardest part of organising vaccinations over the last couple of months has been …

Vaccine wars: the week that rocked the UK’s Covid jab rollout Read More »

France limits AstraZeneca Covid jab to over-55s as Europe treads cautiously

Three Scandinavian countries reserve judgment one day after EMA says shot is safe and effective Coronavirus – latest updates See all our coronavirus coverage France has said only people aged 55 and over should receive the AstraZeneca Covid-19 vaccine, and three Scandinavian countries have reserved judgment until next week, a day after Europe’s health regulator …

France limits AstraZeneca Covid jab to over-55s as Europe treads cautiously Read More »

France limits AstraZeneca Covid jab to over-55s as Europe treads cautiously

Three Scandinavian countries reserve judgment one day after EMA says shot is safe and effective Coronavirus – latest updates See all our coronavirus coverage France has said only people aged 55 and over should receive the AstraZeneca Covid-19 vaccine, and three Scandinavian countries have reserved judgment until next week, a day after Europe’s health regulator …

France limits AstraZeneca Covid jab to over-55s as Europe treads cautiously Read More »

The EU’s AstraZeneca vaccine stance will cost lives, here in Spain and all over Europe

Pooling the European Covid vaccine effort was a noble idea. In practice, it has been a disaster In the race between vaccines and new Covid-19 variants, I am on the losing team. There is a simple reason for this, and it is because I live in the European Union – in my case, in Spain. …

The EU’s AstraZeneca vaccine stance will cost lives, here in Spain and all over Europe Read More »

The EU’s AstraZeneca vaccine stance will cost lives, here in Spain and all over Europe

Pooling the European Covid vaccine effort was a noble idea. In practice, it has been a disaster In the race between vaccines and new Covid-19 variants, I am on the losing team. There is a simple reason for this, and it is because I live in the European Union – in my case, in Spain. …

The EU’s AstraZeneca vaccine stance will cost lives, here in Spain and all over Europe Read More »

European countries to resume AstraZeneca jabs after safety backing

EMA says benefits outweigh risks but it is continuing to study possible link with very rare blood clotting disorder Coronavirus – latest updates See all our coronavirus coverage Italy, France, Germany and several other countries will resume administering AstraZeneca jabs from Friday after Europe’s medicines regulator said the vaccine was “safe and effective” and its …

European countries to resume AstraZeneca jabs after safety backing Read More »

European countries to resume AstraZeneca jabs after safety backing

EMA says benefits outweigh risks but it is continuing to study possible link with very rare blood clotting disorder Coronavirus – latest updates See all our coronavirus coverage Italy, France, Germany and several other countries will resume administering AstraZeneca jabs from Friday after Europe’s medicines regulator said the vaccine was “safe and effective” and its …

European countries to resume AstraZeneca jabs after safety backing Read More »

AstraZeneca vaccine ‘safe and effective’, says European Medicines Agency – video

The Oxford/AstraZeneca coronavirus vaccine is ‘safe and effective’ and its benefits outweigh the risks, Europe’s medicines regulator has said. The director of the European Medicines Agency, Emer Cooke, said the agency’s safety committee had reached ‘a clear scientific conclusion’ and had not found that the vaccine was associated with an increase in the overall risk of …

AstraZeneca vaccine ‘safe and effective’, says European Medicines Agency – video Read More »

AstraZeneca vaccine ‘safe and effective’, says European Medicines Agency – video

The Oxford/AstraZeneca coronavirus vaccine is ‘safe and effective’ and its benefits outweigh the risks, Europe’s medicines regulator has said. The director of the European Medicines Agency, Emer Cooke, said the agency’s safety committee had reached ‘a clear scientific conclusion’ and had not found that the vaccine was associated with an increase in the overall risk of …

AstraZeneca vaccine ‘safe and effective’, says European Medicines Agency – video Read More »

EU to send formal letter to AstraZeneca in Covid vaccine dispute

Bloc hopes to resolve row as it emerges big member states back threat to halt jab exports Coronavirus – latest updates See all our coronavirus coverage The EU is to send a formal letter to AstraZeneca in an attempt to resolve its dispute over vaccine supplies, a spokesperson has said, as it emerged that capitals …

EU to send formal letter to AstraZeneca in Covid vaccine dispute Read More »

EU to send formal letter to AstraZeneca in Covid vaccine dispute

Bloc hopes to resolve row as it emerges big member states back threat to halt jab exports Coronavirus – latest updates See all our coronavirus coverage The EU is to send a formal letter to AstraZeneca in an attempt to resolve its dispute over vaccine supplies, a spokesperson has said, as it emerged that capitals …

EU to send formal letter to AstraZeneca in Covid vaccine dispute Read More »

Oxford vaccines spinout Vaccitech raises $168M, laying groundwork for an IPO

The Series B round of funding for University of Oxford spinout Vaccitech includes the type of financial backers that could support an IPO. While Vaccitech might be best known for its association with AstraZeneca’s Covid-19 vaccine, the startup also has programs for other infectious diseases and cancer.

The FCA’s criminal prosecution of NatWest could cause real damage

Civil cases lost by other banks only led to financial penalties, but the verdict here may hit its reputation NatWest had “resolved all its major legacy issues”, declared Sir Howard Davies, the chairman, 18 months ago, speaking far too soon. Here comes another potential nasty one. The Financial Conduct Authority is bringing criminal charges under …

The FCA’s criminal prosecution of NatWest could cause real damage Read More »

The FCA’s criminal prosecution of NatWest could cause real damage

Civil cases lost by other banks only led to financial penalties, but the verdict here may hit its reputation NatWest had “resolved all its major legacy issues”, declared Sir Howard Davies, the chairman, 18 months ago, speaking far too soon. Here comes another potential nasty one. The Financial Conduct Authority is bringing criminal charges under …

The FCA’s criminal prosecution of NatWest could cause real damage Read More »

AstraZeneca presses forward with digital approach to managing chronic conditions

AstraZeneca is turning to digital technology to help patients and clinicians manage the treatment of chronic diseases. Though this technology isn’t tied to any AstraZeneca drug, the company believes such digital tools will become part of the new standard of care.

States halting AZ jab a ‘disaster’ for EU’s COVID vaccination programme

The decision by around a dozen EU countries to suspend dosing with AstraZeneca’s COVID-19 vaccine is facing criticism, amid fears that it could undermine the response to the pandemic in Europe.  Germany, France, Italy and Spain are among the member states that have announced a suspension of dosing with AZD1222 in the last 24 hours …

States halting AZ jab a ‘disaster’ for EU’s COVID vaccination programme Read More »

Benefits of Oxford/AstraZeneca vaccine outweigh any risk, says EMA

European agency seeks to allay blood clot fears as Germany, France and Italy temporarily suspend use Coronavirus – latest updates See all our coronavirus coverage Europe’s medicines regulator has moved to stifle spiralling concern about the Oxford/AstraZeneca vaccine, saying the shot’s benefits outweigh the risks after four major EU countries announced they were suspending its …

Benefits of Oxford/AstraZeneca vaccine outweigh any risk, says EMA Read More »

Ireland suspends AstraZeneca Covid vaccine over blood clot concerns

Deployment of Oxford vaccine temporarily deferred after latest reports from Norway Coronavirus – latest updates See all our coronavirus coverage Ireland is suspending use of the Oxford/AstraZeneca vaccine against Covid as a precautionary measure following further reports of blood clots in people who have received it, this time from Norway. The deputy chief medical officer, …

Ireland suspends AstraZeneca Covid vaccine over blood clot concerns Read More »

EU probes low platelet safety issue with COVID-19 shots

EU regulators are reviewing reports of low blood platelets in patients who received any of the three approved COVID-19 vaccines from Pfizer/BioNTech, AstraZeneca and Moderna. The experts have also recommended a safety update on the label of Oxford University/AstraZeneca’s COVID-19 vaccine, which has been linked to anaphylactic reactions, in what has turned out to be …

EU probes low platelet safety issue with COVID-19 shots Read More »

Insights+: Breakthrough Therapy Designation by the US FDA in 2020

Breakthrough Therapy (BT) Designation is an expedited review program introduced in Section 902 of the Food and Drug Safety and Innovation Act of 2012 The Breakthrough Designation is granted to the drug candidates as monotherapy or in combination with other drugs intended to treat serious or life-threatening diseases and has shown substantial improvement over available …

Insights+: Breakthrough Therapy Designation by the US FDA in 2020 Read More »

EU regulators probe safety of AstraZeneca vaccine batch after blood clot reports

European safety regulators have launched an investigation into the safety of a batch of the Oxford University/AstraZeneca COVID-19 vaccine, as countries including Denmark suspended its use as a precaution following reports of blood clots. Initial findings showed no issue with the shots suspended by Austrian authorities after a person was diagnosed with severe blood clotting …

EU regulators probe safety of AstraZeneca vaccine batch after blood clot reports Read More »

Denmark pauses use of AstraZeneca vaccine to investigate blood clot reports

Health agency suspends use of Covid jab but says no conclusive link has been established Coronavirus – latest updates See all our coronavirus coverage Denmark’s national health agency has said it is temporarily suspending inoculations with the AstraZeneca vaccine after blood clots formed in several people who had the jab, one of whom has reportedly …

Denmark pauses use of AstraZeneca vaccine to investigate blood clot reports Read More »

At AstraZeneca, we know that until everyone is safe from Covid, no one is safe | Pascal Soriot

The scientific community are rising to the challenge, undertaking an unprecedented global health programme Pascal Soriot is the chief executive officer of AstraZeneca Coronavirus – latest updates See all our coronavirus coverage Covid-19 is a virus that knows no boundaries and has inflicted terrible suffering across the world. Now more than ever, we must remember …

At AstraZeneca, we know that until everyone is safe from Covid, no one is safe | Pascal Soriot Read More »

The Alderley Park Discovery Podcast: The journey to accessing science funding and investment

Episode 3 of the Alderley Park Discovery Podcast covers how to successfully access life science funding and investment, highlighting a range of ways companies can attract investors. In this instalment, Dominic Tyer is joined by Kinomica CEO Jane Theaker, BioCity investment director Claire Brown, Redx Pharma CEO Lisa Anson and Dr Kath Mackay, managing director at Bruntwood …

The Alderley Park Discovery Podcast: The journey to accessing science funding and investment Read More »

BioNTech co-founder says gender equality made vaccine possible

Özlem Türeci credits firm’s more than 50% female workforce for speed at which first viable jab created The co-founder and chief medical officer of BioNTech has credited its speed at producing a viable vaccine to the fact its workforce is more than 50% female. Speaking on International Women’s Day, Özlem Türeci also said the fact …

BioNTech co-founder says gender equality made vaccine possible Read More »

Austria safety officials suspend batch of AZ vaccines after death

Austrian health officials have withdrawn a batch of Oxford University/AstraZeneca’s COVID-19 vaccine after two cases of severe coagulation, one of which was fatal. Both patients were treated from the same batch, codenamed ABV 5300, in the district of Zwettl. In a statement the Austrian Federal Office for Safety in Health Care (BASG) said a 49 …

Austria safety officials suspend batch of AZ vaccines after death Read More »

NICE says no to AZ’s Lynparza for prostate cancer

NHS patients in England will not be able to get access to AstraZeneca’s PARP inhibitor Lynparza if they have BRCA-positive advance prostate cancer, according to draft guidance from NICE. The cost-effectiveness agency is assessing use of Lynparza (olaparib) in patients with tumours that carry BRCA1 or BRCA2 mutations who have previously been treated with the …

NICE says no to AZ’s Lynparza for prostate cancer Read More »

From Pfizer to Moderna: who’s making billions from Covid vaccines?

The companies in line for the biggest gains – and the shareholders who have already made fortunes Coronavirus – latest updates See all our coronavirus coverage The arrival of Covid-19 vaccines promises a return to more normal life – and has created a global market worth tens of billions of dollars in annual sales for …

From Pfizer to Moderna: who’s making billions from Covid vaccines? Read More »

PharmaShots Weekly Snapshots (Mar 01 – 05, 2021)

Eli Lilly and Incyte Report Results of Olumiant (baricitinib) in P-III BRAVE-AA2 Study for Severe Alopecia Areata Published: Mar 5, 2021 | Tags: Eli Lilly and Incyte, Report, Results, Olumiant (baricitinib), P-III, BRAVE-AA2, Study, Severe, Alopecia Areata Takeda Reports NDA Submission to Import and Distribute Moderna’s mRNA-1273 in Japan Published: Mar 5, 2021 | Tags: …

PharmaShots Weekly Snapshots (Mar 01 – 05, 2021) Read More »

Australia requests review of Italy’s block of vaccine export

Italian government said the 250,000 doses of AstraZeneca vaccine must be kept in EU Coronavirus – latest updates See all our coronavirus coverage Australia has asked for a review of Italy’s decision to block the export of 250,000 doses of the AstraZeneca vaccine to its shores. In the first such intervention under the EU’s controversial …

Australia requests review of Italy’s block of vaccine export Read More »

Italy blocks export of 250,000 AstraZeneca vaccine doses to Australia

Row continues between EU and drug firm after shortfall in vaccine deliveries to bloc Coronavirus – latest updates See all our coronavirus coverage Italy has blocked the export of 250,000 doses of the Oxford/AstraZeneca vaccine to Australia in an escalation of a row with the Anglo-Swedish company. In the first such intervention under the EU’s …

Italy blocks export of 250,000 AstraZeneca vaccine doses to Australia Read More »

Germany backtracks on AZ COVID vaccine age restriction

Germany has decided that AstraZeneca’s COVID-19 vaccine should be approved for use in the over-65s after all, reversing its earlier restriction in that age group.  The country’s drugs regulator previously limited use of the vaccine to the under-65s only, claiming that the data in the older age group was inadequate, even though the European Commission …

Germany backtracks on AZ COVID vaccine age restriction Read More »

How digital health impacts the development and adoption of cancer immunotherapies [Sponsored]

In an interview, BrightInsight Co-founder and CEO Kal Patel, MD, offered a preview of the report, The Role of Digital Health in Immuno-oncology Therapy Development and Adoption.

AstraZeneca breathes sigh of relief as court blocks US Symbicort generic

A US court has upheld AstraZeneca’s patents on its respiratory drug Symbicort, blocking cheaper competition for the ageing blockbuster. The US District Court for the Northern District of West Virginia has decided in favour of AZ in litigation against Mylan Pharmaceuticals and Kindeva, the company said in a statement. Mylan, which is now part of …

AstraZeneca breathes sigh of relief as court blocks US Symbicort generic Read More »

Covid: Germany and France under pressure to shift Oxford vaccine

Both countries urged to take action to avoid pile-up of unused AstraZeneca vaccine doses Coronavirus – latest updates See all our coronavirus coverage Authorities in Germany and France are under pressure to come up with creative solutions to shift the AstraZeneca vaccine at higher speed in order to avoid a pile-up of unused doses over …

Covid: Germany and France under pressure to shift Oxford vaccine Read More »

AstraZeneca Collaborates with Junshi to Commercialize Toripalimab in China

Shots: AstraZeneca to get exclusive promotion rights for toripalimab in mainland China for the urothelial carcinoma indications and all indications in non-core areas Junshi will continue responsible for the promotion of other approved indications and to be approved excluding urothelial carcinoma in core areas The companies will continue to explore overseas business collaborations including emerging …

AstraZeneca Collaborates with Junshi to Commercialize Toripalimab in China Read More »

Evotec, Chinook Teams Up for CKD Therapy; HitGen & UPPTHERA in Drug Delivery Research; Artiva’s $120 M Coup of NK Cell Therapy; Junshi & AZ with Toripalimab in China

Evotec, Chinook Therapeutics to Advance Chronic Kidney Diseases Therapy Market Evotec and Chinook Therapeutics have collaborated to develop and discover precision medicine therapies for patients with chronic kidney diseases (CKD). The duo plans to jointly identify, characterize and validate novel mechanisms and discover and develop precision medicines. The deal will help leverage Evotec’s proprietary PanOmics …

Evotec, Chinook Teams Up for CKD Therapy; HitGen & UPPTHERA in Drug Delivery Research; Artiva’s $120 M Coup of NK Cell Therapy; Junshi & AZ with Toripalimab in China Read More »

AZ sells stake in Moderna for more than $1billion

AstraZeneca has sold its stake in Moderna for more than $1 billion as the US biotech’s shares soared in value following its coronavirus vaccine breakthrough. The UK-based pharma has disposed of its 7.7% holding in the mRNA technology pioneer, The Times reported (behind paywall). Moderna was among the first companies to get a COVID-19 vaccine …

AZ sells stake in Moderna for more than $1billion Read More »

AstraZeneca and Amgen Report Results of Tezepelumab in P-III NAVIGATOR Trial for Severe Asthma

Shots: The P-III NAVIGATOR study involves assessing Tezepelumab + SOC vs PBO + SOC in 1061 adults (18–80yrs.) & adolescents (12–17yrs.) with severe, uncontrolled asthma, who were receiving treatment with medium/high dose ICS + at least 1 additional controller medication with/ out OCS The trial met its 1EPs i.e. 56% reduction in AAER @52wks. in …

AstraZeneca and Amgen Report Results of Tezepelumab in P-III NAVIGATOR Trial for Severe Asthma Read More »

Germany signals AstraZeneca vaccine may be approved for over-65s

Healthcare regulator says it will update recommendations ‘very soon’ in wake of row over jab’s effectiveness in older candidates Coronavirus – latest updates See all our coronavirus coverage Germany could soon authorise the use of the AstraZeneca vaccine for seniors after the head of the country’s vaccination committee said his body’s advice to give the …

Germany signals AstraZeneca vaccine may be approved for over-65s Read More »

AZ trumpets tezepelumab data as filing for severe asthma looms

AstraZeneca says full data from the NAVIGATOR trial of tezepelumab in severe asthma keep it on course to file for approval in the first half of this year, with a broader indication than rival biologic drugs.  Top-line data were reported last year, but a presentation at the American Academy of Asthma Allergy & Immunology (AAAAI) …

AZ trumpets tezepelumab data as filing for severe asthma looms Read More »