UK advisors back Moderna’s bivalent shot for autumn COVID booster
The UK’s Joint Committee on Vaccinations and Immunisations (JCVI) has said that Moderna’s bivalent COVID-19 vaccine should be used for the autumn booster campaign in […]
The UK’s Joint Committee on Vaccinations and Immunisations (JCVI) has said that Moderna’s bivalent COVID-19 vaccine should be used for the autumn booster campaign in […]
The Biden administration has confirmed its plans to start a booster vaccination campaign in the autumn, and placed a $1.74 billion order for 66 million […]
The U.S. government has signed a supply agreement securing 66 million doses of Moderna’s Covid-19 vaccine booster shots, which are designed to address the omicron […]
Researchers in the US have started a clinical trial of a vaccine against Nipah virus, a serious infection caught from animals that has a fatality […]
BioNTech has responded to a patent infringement lawsuit filed by fellow German biotech CureVac over its COVID-19 vaccine, saying it will “vigorously” defend itself. CureVac […]
New Covid-19 vaccine booster shots are coming and they’ll likely include protection against the omicron variant. The U.S. government agreed to a purchasing contract covering […]
Future booster campaigns against COVID-19 should include vaccines with a component targeting the Omicron variant of SARS-CoV-2, according to the FDA’s Vaccines and Related Biological […]
An expert advisory vaccine panel for the Food and Drug Administration (FDA) on Tuesday voted in favor of recommending updated COVID-19 vaccines specifically designed to […]
Moderna has reported top-line data suggesting that its COVID-19 booster vaccine candidate stimulates a strong immune response against the Omicron subvariants BA.4 and BA.5, which […]
Moderna has said it will open a new R&D and manufacturing facility in the UK which could lead to improved access by NHS patients to […]
Covid-19 vaccines from Pfizer and Moderna now have FDA emergency use authorization for children as young as 6 months old. If the Centers for Disease […]
The FDA’s vaccines advisors have voted in favour of extending the use of mRNA-based COVID-19 vaccine from Moderna and Pfizer/BioNTech to include children from the […]
GSK will start preparations for regulatory filings of its respiratory syncytial virus (RSV) vaccine straight away, after the shot hit the mark in the much-anticipated […]
Moderna’s new version of its COVID-19 vaccine, which targets two virus variants including Omicron, has outperformed the company’s original Spikevax shot in a head-to-head clinical […]
Moderna has joined forces with non-profit organisation IAVI on a third phase 1 trial of its candidate HIV vaccine in Africa, where the burden of […]
Administering a fourth dose of an mRNA COVID-19 vaccine provides a stronger level of protection than a third dose, particularly in the over-70s, according to […]
Moderna’s Chief Medical Officer Paul Burton said on Sunday that his company was preparing to provide large amounts of its vaccine booster against omicron and […]
Moderna on Thursday asked the Food and Drug Administration to authorize its vaccine for children under six years of age, becoming the first company to […]
House Majority Whip James Clyburn (D-S.C.) on Monday requested a briefing from the Food and Drug Administration (FDA) on the status of COVID-19 vaccines for […]
Moderna has reported preliminary clinical results with a bivalent version of its COVID-19 vaccine that combines its original version with another targeting the Beta variant, […]
Moderna on Tuesday said new clinical data had found that its bivalent COVID-19 booster shot was more effective against all variants of concern when compared […]
It is too early to consider widespread use of a second COVID-19 vaccine booster dose, according to the European Centre for Disease Prevention and Control […]
Bavarian Nordic has licensed rights to its respiratory syncytial virus (RSV) vaccine in China and certain other Asian markets to Shanghai’s Nuance Pharma in a […]
Moderna has asked the FDA for emergency use authorisation for a fourth dose of its mRNA COVID-19 vaccine SpikeVax, following in the footsteps of Pfizer/BioNTech […]
Alnylam Pharmaceuticals has proprietary lipid nanoparticle technology used in its FDA-approved RNA therapies. The biotech company claims that the messenger RNA Covid-19 vaccines from Moderna […]
Alnylam claims it is owed a slice of the massive revenues booked by Pfizer and Moderna for their mRNA-based COVID-19 vaccines, because they are both […]
After a period where vaccine development had fallen away, suddenly it is back in the limelight. Investment has flowed back into the sector and Ben […]
Moderna has unveiled plans to start clinical trials of mRNA-based vaccines for 15 infectious diseases that pose the biggest public health risks around the world […]
There is no evidence that vaccination with either the Pfizer/BioNTech or Moderna’s mRNA-based COVID-19 vaccines led to the death of patients, says a study by […]
The World Health Organization (WHO) announced the opening of a global biomanufacturing hub located in South Korea to provide training to low- and middle-income countries […]
The clinical research industry has long struggled with participant diversity. One study found that only 5% of Black or Asian United Kingdom residents had ever […]
Moderna is reportedly in late-stage negotiations with the UK government that could result in a new research and manufacturing facility being set up in the […]
Moderna has started human trials of an Omicron version of its COVID-19 vaccine SpikeVax, just in case a modified version will be needed to boost […]
With evidence growing that the current crop of COVID-19 vaccines are less protective against infection with Omicron, both Pfizer and Moderna have announced plans to […]
The arrival of COVID-19 brought precious few positives, but one that emerged for the pharmaceutical industry was the emergence and validation of mRNA vaccine technology […]
The UK government has placed a 114 million-dose order with Pfizer/BioNTech and Moderna – sufficient to provide two doses to every person in Britain – in […]
The new Covid-19 variant, named Omicron, has mutations that could help it evade antibodies produced by the immune system. Scientists are conducting lab tests to […]
Three hurdles to allowing booster COVID-19 vaccinations for all adults in the US fell in swift succession on Friday, clearing the way for wider use […]
Jazz’ Sunosi (solriamfetol) Receives NICE Recommendation for the Treatment of Excessive Daytime Sleepiness Caused by Narcolepsy Published: Nov 19, 2021 | Tags: Jazz, Sunosi, solriamfetol, […]
Shots: The P-IIa EPICCURE trial evaluates safety, tolerability & exploratory efficacy of epicardial inj. of AZD8601 vs PBO in 11 patients (7 were treated with […]
Moderna is already riding high on the strength of its mRNA-based COVID-19 vaccine, but the broader potential of its technology has been shown in a […]
After being hailed as a triumph of public-private drug development, Moderna’s partnership with the US government on its COVID-19 vaccine looks like it may descend […]
Germany’s vaccination advisory committee has recommended that people aged under 30 should only be offered Pfizer/BioNTech’s COVID-19 vaccine Comirnaty, saying it seems less likely to […]
Lonza Collaborates with Codiak to Acquire its Exosomes Manufacturing Facility in Lexington, Massachusetts (US) Published: Nov 3, 2021 | Tags: Lonza, Codiak, Acquire, Exosomes Manufacturing […]
Shots: Metagenomi to receive an up front, equity investment & is eligible to receive target option exercise fees in addition to development, regulatory, and commercial […]
The FDA has said it needs more time to review Moderna’s application for emergency use of its COVID-19 vaccine mRNA-1273 in children aged 12 to […]
ADC Reports EMA’s Validation of MAA for Zynlonta to Treat R/R Diffuse Large B-Cell Lymphoma Published: 29 Oct, 2021 | Tags: ADC, EMA, MAA, Zynlonta, […]
The US looks set to see a big expansion of the country’s COVID-19 vaccination drive, with shots looking likely for children aged five to 11 […]
Shots: The P-II/III KidCOVE study evaluated the safety, tolerability, reactogenicity & effectivity of mRNA-1273 in 4753 children aged 6-12yrs. with COVID-19, administered as 28 days […]
FDA advisors will meet later today discuss the possibility of authorising Pfizer and BioNTech’s COVID-19 vaccine Comirnaty in children as young as five years old. […]
The FDA has authorised booster shots with Moderna and Johnson & Johnson’s COVID-19 vaccines, a month after giving the go-ahead to a third-dose of Pfizer/BioNTech’s […]
The FDA amended emergency use authorization of the Moderna and Johnson & Johnson Covid-19 vaccines, permitting booster shots. But the agency went further and said […]
Moderna has said it plans to invest $500 million in a new facility for manufacturing mRNA vaccines in Africa, and has kicked off a search […]
The third quarter of 2021 highlights the approvals, clinical data & acquisitions. The new alliance observed in third quarter includes AzurRx signed a reverse triangular […]
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 […]
Pfizer and Moderna have both reported data that they say backs up the need for booster shots of their COVID-19 vaccines ahead of an FDA […]
Shots: TGA has provisionally approved the use of Moderna’s Spikevax (elasomeran) in individuals aged ≥12yrs. The decision follows the provisional approval granted by the TGA […]
Just a few months after breaking cover with its new take on RNA therapeutics, Laronde has raised an impressive $440 million in second-round financing backed […]
The Moderna COVID-19 vaccine has become the second jab to be authorised for use in England, Scotland and Wales in children aged 12 to 17 […]
The FDA has cleared the use of third dose of either the Pfizer/BioNTech or Moderna COVID-19 vaccines for people with weakened immune systems, but stopped […]
Moderna made a massive $4.2 billion from sales of just under 200 million doses of its COVID-19 vaccine, taking its tally since approval to around […]
The short answer is that cancer vaccines represent no silver bullet but, in combination with other immunotherapy and drug cocktails, can prove potent.
Germany’s health ministry has said it will start offering booster COVID-19 vaccines to vulnerable people from next month, amid concerns about rising cases of the […]
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 […]
Buoyed by the success of its COVID-19 vaccine, Moderna has started a phase 1/2 trials of its mRNA-based shot for seasonal influenza, targeting four different […]
Capacity to supply Moderna’s COVID-19 vaccine in Europe could be swelled by round 300 million doses a year, following an agreement to set up a […]
Seelos’ SLS-005 (Trehalose) Receives EC’s Orphan Drug Designation to Treat Amyotrophic Lateral Sclerosis Published: May 28, 2021 | Tags: Seelos, SLS-005, Trehalose, EC, Orphan Drug […]
Shots: The P-II/III TeenCOVE study involves assessing mRNA-1273 (two 100 µg doses) vs PBO in 3700+ participants in a ratio (2:1) aged 12 to <18yrs. […]
Moderna’s COVID-19 vaccine has joined the Pfizer/BioNTech jab in showing efficacy in younger patients in clinical trials, setting up an emergency use filing early next […]
Moderna released preliminary clinical data showing its Covid-19 vaccine produced efficacy in adolescents that was comparable to what was seen in adults. The company plans […]
As US and EU health regulators review cases of heart inflammation seen in young people administered mRNA-based COVID-19 vaccines from Pfizer/BioNTech and Moderna, cardiologists have […]
BeiGene Reports Results of Tislelizumab + CT in P-III RATIONALE 309 Study as 1L Treatment for Recurrent or Metastatic Nasopharyngeal Cancer Published: May 21, 2021 […]
Shots: MHLW has granted special approval under article 14-3 of the PMDA for emergency use of Moderna’s mRNA COVID-19 vaccine based on Takeda’s P-I/II immunogenicity […]
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 […]
Flagship Pioneering, the VC fund run by Moderna’s co-founder Noubar Afeyan has launched a new biotech Laronde, with an ambitious plan to create a new […]
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 […]
England is beginning its rollout of the Moderna COVID-19 vaccine, offering an alternative to the AstraZeneca/Oxford University jab following a potential link to a very […]
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 […]
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 […]
The FDA increased the maximum number of doses permitted for each vial of Moderna’s Covid-19 vaccine, a change intended to make more doses available. The […]
As the COVID-19 vaccine roll-out gains in intensity, it has become common to hear people toss out the names of pharmaceutical companies like Pfizer, Moderna […]
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. […]
Sanofi and Translate BIO have begun a clinical trial of their potential mRNA COVID-19 shot, as the French pharma struggles to keep pace with rivals […]
The rollout of the US COVID-19 vaccination programme slowed up this week because manufacturing delays mean no new doses of the recently approved Johnson & […]
Shots: Takeda has submitted an NDA to MHLW to import and distribute Moderna’s (mRNA-1273/ TAK-919) in Japan Takeda is conducting a P- I/II study assessing […]
Efforts to encourage US citizens to take their COVID-19 vaccines received a boost from country music legend Dolly Parton, who updated her hit song “Jolene” […]
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. […]
Shots: Takeda is providing rapid & sustained access to COVID-19 vaccines in Japan through partnerships with Novavax and Moderna. Earlier, Takeda has completed enrollment in […]
Public health authorities in California are seeking a halt on dosing of one lot of Moderna’s COVID-19 vaccine after reports of allergic reactions at one […]
The CEOs of Pfizer, Moderna, McKesson and CVS Health explained that the distribution effort has gone well but the administration of the vaccine has now […]
The UK has approved the Moderna coronavirus vaccine, hard on the heels of its go-ahead in Europe, although supplies are not expected to arrive for […]
The European Union has approved the coronavirus vaccine from Moderna, leaving the UK trailing because of changes to post-Brexit drug approval rules. With the UK […]
Our planet is facing a major pandemic outbreak due to COVID-19 and health agencies are taking every measure to stop it. The COVID-19 virus has […]
“Lockdown’ declared Collins Dictionary word of the year. The year 2020, well known as COVID-19 year has been a busy year for global pharma and […]
Roche’s Phesgo (Perjeta + Herceptin) Receives EC’s Approval for the Treatment of HER2-Positive Breast Cancer Published: Dec 23, 2020 | Tags: (Perjeta + Herceptin), EC’s […]
Moderna is using a Roche antibody test in clinical trials of its Covid-19 vaccine. The test can measure the antibodies created through vaccination, offering a […]
Moderna and BioNTech, two rising stars in biotech, were in the limelight this year with their pioneering mRNA vaccines against COVID-19. Just who are these […]
Shots: The US FDA has authorized EUA of mRNA-1273 vaccine against COVID-19 in individuals ≥18yrs. The delivery to the US govt. will begin imminently while […]
As expected, the FDA has moved swiftly ahead with emergency approval of Moderna’s COVID-19 vaccine after a positive assessment at its vaccines advisory committee. The […]
The company’s vaccine is the second approved for emergency use by the FDA. It is expected to pose fewer logistical challenges than the first, which […]
Sandoz to Launch Hyrimoz (biosimilar, adalimumab) in Canada Published: Dec 17, 2020 | Tags: Authorization, Biosimilar, canada, health, Humira, Hyrimoz, Launch, receives, Sandoz Amgen’s Riabni […]
The FDA is looking to quickly approve Moderna’s COVID-19 vaccine after it was unanimously backed by a panel of experts. Yesterday’s advisory panel meeting voted […]
Shots: The VRBPAC voted 20-0, with one abstention that the benefits of the Moderna’s vaccine outweighed its risks for use in people aged ≥18yrs The […]
By creating new networks for 24/7 temperature monitoring, alerts and reporting, the challenges of deploying transportation at ultra-low temperatures can be overcome. This also illustrates […]
Moderna looks odds on to claim emergency use authorisation from the FDA for its COVID-19 vaccine this week, after the regulator published a report endorsing […]
Hospitals in the US have started vaccinating their front-line staff against COVID-19, as deaths in the country crossed the 300,000 threshold with more than 200,000 […]
Roche Launches Elecsys SARS-CoV-2 Antigen Test to Support High-Volume COVID-19 Testing Published: Dec 11, 2020 | Tags: Antigen, COVID-19, High, Laboratory, Launch, patients, Roche, SARS-CoV-2, […]
The nonbinding recommendation is a final hurdle before an official emergency use authorization for the vaccine, which could be the first shot approved for use […]
Shots: Roche allied with Moderna to utilize the Elecsys anti-SARS-CoV-2 S Ab test in mRNA-1273 study. The collaboration will facilitate the quantitative measurement of SARS-CoV-2 […]
Shots: Roche allied with Moderna to utilize the Elecsys anti-SARS-CoV-2 S Ab test in mRNA-1273 study. The collaboration will facilitate the quantitative measurement of SARS-CoV-2 […]
Richter Acquires Janssen’s Evra Transdermal Contraceptive Patch Assets for $263.5M Published: Dec 3, 2020 | Tags: Asset Purchase Agreement, Evra, Gedeon Richter, Janssen Pharmaceutical, Signs, […]
Pfizer slashed its production targets for its COVID-19 vaccine because of a lack of raw materials for its supply chain, according to press reports. The […]
News that COVID-19 vaccines are up to 95 per cent effective has scientists cautiously optimistic. But questions remain. “There’s a long list of things we […]
Shots: The P-III COVE study demonstrated 94.1% efficacy against COVID-19 and 100% efficacy against severe COVID-19. The vaccine was well tolerated with no serious safety […]
Moderna has said it will file for US, European and UK emergency approval of its coronavirus vaccine straight away, after reporting updated phase 3 results […]
Shots: Moderna amended its current supply agreement with the UK govt. for an additional 2M doses of mRNA-1273 against COVID-19. The UK govt. has now […]
AstraZeneca may have tried a positive spin on the trial mistake that led to the accidental discovery of the low dose COVID-19 vaccine regime with […]
Eli Lilly and Incyte Receive FDA’s EUA for Baricitinib + Remdesivir to Treat Hospitalized Patients with COVID-19 Published: Nov 20,2020 | Tags: baricitinib, COVID-19, Eli […]
Shots: The P-lll COVE study involves the assessing of mRNA-1273 (100 µg dose level) in 30,000 patients with COVID-19 in the ratio of (1:1) aged […]
The company is the second this month to report promising results for a Covid-19 vaccine even as the virus rages across the U.S.
Moderna is the third group in a week to report encouraging phase 3 data with a coronavirus vaccine, saying today that its mRNA-1273 shot had […]
Qiagen Launches Portable Digital SARS-CoV-2 Antigen Test in the US Published: Nov 13,2020 | Tags: Antigen Test, Digital, Launches, Portable, Qiagen, SARS-CoV-2, US GSK and […]
Shots: The expansion cohort of P-l study involves assessing of mRNA-4157 + Keytruda (pembrolizumab) vs Keytruda monothx. in 10 patients with HPV (-) HNSCC and […]
COVID-19 vaccines could be approved and available early next year in the UK ahead of European countries, after its national regulator began its own rolling […]
Moderna is still preparing for the launch of its COVID-19 vaccine mRNA-1273 – assuming phase 3 trials go to plan – but has already received […]
Moderna is close to completing its phase 3 trial of COVID-19 vaccine candidate mRNA-1273 after completing recruitment of the 30,000 subjects in the trial. It’s […]
Pfizer said it will wait until after the US election to file its COVID-19 vaccine with the US regulator, as it waits for important safety […]
Novartis’s Luxturna (voretigene neparvovec) Receives Health Canada Approval as the First Gene Replacement Therapy for Inherited Retinal Disease Published: Oct 15, 2020 | Tags: approval, […]
Sobi & Selecta Report Results of SEL-212 in P-II COMPARE Study for Chronic Refractory Gout Published: Oct 1, 2020 | Tags: Chronic Refractory Gout, COMPARE […]
Shots: Moderna reported the publication of the second interim analysis of the open-label P-I study of mRNA-1273 in the NEJM. The study evaluated a 2dose […]
The company published interim data from the Phase I study of mRNA-1273 in 40 older and elderly adults, showing responses comparable to those seen in […]
Moderna has said that its coronavirus vaccine stimulated an immune response in older people in phase 1 trials, suggesting that the jab is effective in […]
Darlene Dobry, Strategic Advisor, Medical Devices and Pharmaceuticals As the COVID-19 pandemic continues to bring the world’s economies, healthcare systems, and communities to their knees, […]
The biotech company reached a deal with the European Commission to supply an initial 80 million doses, while European Union member states will have the […]
The US government has signed another big coronavirus vaccine supply deal, snapping up 100 million doses of Moderna’s mRNA jab for a little over $1.5 […]
The agreement, which includes 100 million doses of mRNA-1273 and an option to acquire 400 million more, brings the total amount of money the biotech […]
Shots: For smaller volume agreements, the company has priced its COVID-19 vaccine ranging from $32-$37/ dose, higher than the price of Pfizer’s vaccine candidate The […]
1. Oxford Biomedica Signs Three Year Clinical Supply Agreement with Axovant to Manufacture and Supply AXO-Lenti-PD for Parkinson’s Disease Published: Jul 31, 2020 | Tags: Oxford […]
Our planet is facing a major pandemic outbreak due to COVID-19 and health agencies are taking every measure to stop it. The COVID-19 virus has […]
The company had received $483 million from BARDA in April to fund the development of the vaccine, mRNA-1273, through Phase III, but that amount was […]
A US government agency is to give a further $472 million to biotech Moderna, after it announced plans to expand a phase 3 trial for […]
1. Gilead and Galapagos’ Jyseleca (filgotinib) Receive the CHMP’s Positive Opinion for Moderate to Severe Rheumatoid Arthritis Published: Jul 24, 2020 | Tags: Gilead, Galapagos, Jyseleca, […]
Concerns have emerged about access to some potential COVID-19 vaccines after pharma executives from three companies said they expect to make profits from their products […]
JP Morgan has downgraded its valuation of Moderna, saying its $37 billion market cap is way too high even if its COVID-19 vaccine mRNA-1273 succeeds […]
1. Eli Lilly Reports Results of Mirikizumab in P-III OASIS-2 Study to Treat Moderate to Severe Plaque Psoriasis Published: Jul 17, 2020 | Tags: Eli Lilly, […]
Amid fears of a premature emergency use authorization for a Covid-19 vaccine granted for political reasons, the guidance that the FDA released at the beginning […]
Evaluation of durability is still under evaluation, but the responses to mRNA-1273 show neutralizing antibody titers multiple times higher than those of recovered patients. Additionally, […]
The company said it is on track to start its 30,000-participant Phase III trial this month and has finished manufacturing enough supplies of the vaccine […]
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