US government buys 66m doses of Moderna’s Omicron booster
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 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 […]
Pfizer and BioNTech have started a mid-stage trial of a new version of the COVID-19 vaccine based on a version of the spike protein that […]
The FDA has granted the Pfizer and BioNTech Covid-19 full approval for use in adolescents. In other Covid-19 news, pharmacists were granted additional prescribing powers […]
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 […]
Messenger RNA vaccine biotech CureVac is suing BioNTech, alleging that its rival’s Covid-19 vaccine infringes on intellectual property built on more than two decades of […]
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 […]
Pfizer and BioNTech have signed a new $3.2 billion supply contract with the US government for COVID-19 vaccines, covering 105 million doses that may include […]
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 […]
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 […]
Pfizer and BioNTech reported positive clinical data for a Covid-19 booster in children younger than 5, results released ahead of a June FDA advisory committee […]
The unprecedented rate of digital acceleration seen in the first two years of COVID-19 has set in train an age of digital transformation. In my […]
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 […]
Pfizer and BioNTech reported preliminary clinical data supporting use of their Covid-19 vaccine as a booster in children ages 5 to 11. In other Covid […]
Oral delivery of messenger RNA is one of the capabilities of Matinas BioPharma’s technology. BioNTech will explore that feature among others under a new research […]
Adding an mRNA vaccine to CAR-T cell therapy could be the key to unlocking activity in solid tumours, according to German biotech BioNTech. CAR-Ts have […]
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 […]
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 […]
Earlier this week, Pfizer chief executive Albert Bourla said that a second booster of its COVID-19 vaccine will be necessary to keep the pandemic under […]
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 […]
BioNTech is acquiring a preclinical T cell receptor program (TCR) from Medigene, as well as licenses to the biotech’s TCR technologies. The agreement helps BioNTech […]
England and Northern Ireland have followed Wales and Scotland in offering healthy children aged between five and 11 a low-dose COVID-19 vaccine, making vaccination an […]
We have seen a boom in biotech initial public offerings over the last two years, but many of Europe’s offerings have migrated to the United […]
Pfizer and partner BioNTech have started their clinical trial of a new version of their COVID-19 vaccine that has been specifically designed to protect against […]
Japan’s health ministry has authorised the use of Pfizer and BioNTech COVID-19 vaccine in children aged between five and 11. The vaccine, Comirnaty, is claimed […]
BioNTech and artificial intelligence startup InstaDeep say they have developed an early warning system that can predict high-risk variants of COVID-19 from their genetic sequences […]
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 […]
Pfizer is paying BioNTech $225 million to kick off a new alliance aiming to develop a shingles vaccine based on the same messenger RNA technology […]
The FDA has authorised the first COVID-19 booster vaccine for teenagers in the 12 to 15 age group, giving the okay for wider use of […]
The FDA has expanded emergency authorization of Covid-19 boosters to include children 12 to 15 vaccinated with the Pfizer and BioNTech messenger RNA shot. The […]
Data from a real-world study South Africa has indicated that the Omicron variant of COVID-19 is 29% less likely to cause hospitalisation among infected adults […]
Preliminary data suggest the BioNTech and Pfizer Covid-19 vaccine may have diminished protection against the omicron variant, but that levels of neutralizing antibodies can be […]
Preliminary study results from South Africa have suggested that antibodies stimulated by Pfizer and BioNTech’s Comirnaty are less effective against the new COVID-19 variant Omicron. […]
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 […]
With governments around the world announcing measures to curb the new B.1.1.529 variant of COVID-19 – now christened Omicron – leading vaccine manufacturers have said […]
The European Medicines Agency (EMA) has approved Pfizer and BioNTech’s COVID-19 vaccine Comirnaty for children between the ages of five and 11, as EU countries […]
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 […]
The US is now pressing ahead with plans to extend its COVID-19 vaccination campaign to younger children aged five and over, prompting a debate about […]
Rocketing sales of COVID-19 vaccine Comirnaty have allowed Pfizer to raise its full-year forecasts for the shot once again to a whopping $36 billion, more […]
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 US FDA’s VRBPAC voted 17 to 0 with 1 abstention in favor of recommending the EUA for COVID-19 vaccine in children aged 5 […]
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. […]
LEO Reports 16-week Results of Tralokinumab in P-III ECZTRA 6 Trial for the Treatment of Moderate-to-Severe Atopic Dermatitis Published: 22 Oct, 2021 | Tags: LEO, […]
Shots: The P-III trial evaluates a booster dose of COVID-19 vaccine (30µg) in a ratio (1:1) in 10000+ individuals aged ≥16yrs. with COVID-19 who previously […]
The EMA has given the go-ahead to the use of Pfizer and BioNTech’s COVID-19 vaccine Comirnaty as a booster for all people aged 18 or […]
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, […]
The Centre for Disease Control and Prevention (CDC) in the US has backed booster doses of Pfizer and BioNTech’s COVID-19 vaccine Comirnaty in line with […]
Shots: The US FDA has issued a EUA for the COVID-19 booster vaccine (administered at least 6mos. after completion of primary 2 doses) to prevent […]
The FDA has authorized dosing of booster shots of Pfizer and BioNTech’s Covid-19 vaccine. Consistent with the recommendations of an FDA advisory committee, the agency’s […]
Just days after its advisory committee meeting voted to approve a third dose of Pfizer and BioNTech’s COVID-19 vaccine, the FDA has followed through and […]
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 […]
With positive phase 2/3 results for their COVID-19 vaccine Comirnaty in hand for the five to 11 age group, Pfizer and BioNTech are planning to […]
With positive phase 2/3 results for their COVID-19 vaccine Comirnaty in hand for the five to 11 age group, Pfizer and BioNTech are planning to […]
A lower-dose version of Pfizer and BioNTech’s Covid-19 vaccine showed safety and efficacy results in children 5 to 11 that were comparable to those in […]
An FDA advisory panel voted down a proposal for booster shots of the Pfizer/BioNTech Covid-19 in the general population, opting instead to support third shots […]
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 […]
The UK government is due to announce a large-scale booster vaccine campaign against COVID-19 for all adults aged 50 and over later today, adding to […]
Acknowledging the demand for a Covid-19 vaccine for children, the FDA said it expects regulatory review could take weeks, not months, depending on the timing […]
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 […]
The EU regulator has started to review a marketing application filed by Pfizer and BioNTech for a third, booster dose of their Comirnaty COVID-19 vaccine […]
The FDA has said it will hold an advisory committee meeting later this month to discuss Pfizer and BioNTech’s filing for approval of a third […]
Full FDA approval of Pfizer and BioNTech’s Covid-19 vaccine was the biggest news in a busy week for coronavirus vaccines, drugs, and diagnostics. Here’s a […]
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, […]
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 […]
Full FDA approval makes the Pfizer/BioNTech Covid-19 vaccine the first to reach that milestone. But the regulatory decision also flagged a potential risk of heart […]
Pfizer and BioNTech’s COVID-19 vaccine was the first to get emergency use authorisation (EUA) from the FDA, and has also become the first to get […]
As the world’s focus has turned to getting the COVID-19 vaccines out as widely and rapidly as possible, it’s easy to almost forget about the […]
Pfizer and BioNTech have formally asked for FDA approval of a third dose of their COVID-19 vaccine BNT162b2 in people aged over 16, as the […]
Covid-19 vaccine booster shots are now authorized for organ transplant patients and others who have weakened immune systems. The FDA based its update on the […]
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 […]
The UK government has started ordering COVID-19 vaccines for a 2022 booster campaign, including a 32 million-dose order for the Pfizer/BioNTech shot, even before third […]
BioNTech has suggested that giving booster doses of its current Comirnaty (BNT162b2) COVID-19 vaccine may be a preferable strategy to modifying the Pfizer-partnered shot. The […]
The UK government has confirmed that the national COVID-19 vaccination campaign will be extended to include 16 and 17-year-old children, to tackle an increase in […]
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 […]
Roche Publishes the Results of Evrysdi (risdiplam) in FIREFISH Study to Treat of Type 1 SMA at NEJM Published: July 30, 2021 | Tags: Roche, […]
Shots: BioNTech unveils the plan to develop the first mRNA-based vaccine to prevent malaria with anticipated initiation of the clinical study by the end of […]
Flushed with the success of its COVID-19 vaccine, BioNTech has pressed the accelerator on the development of shots for other infectious diseases, and now plans […]
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 […]
Shots: Kite will receive a one-time upfront to purchase Kite’s individualized solid tumor neoantigen TCR discovery platform, R&D & clinical manufacturing facility in Gaithersburg. The […]
BioNTech has found a use for some of the windfall cash it has raked in from its COVID-19 vaccine, agreeing a deal to buy Kite […]
With the COVID-19 delta variant has become the dominant strain circulating in the US, Pfizer and BioNTech have said they will ask the FDA and […]
The Israeli Ministry of Health has reported data suggesting that the efficacy of the Pfizer/BioNTech COVID-19 vaccine has become less effective at preventing the spread […]
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 […]
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, […]
Shots: The first patient has been dosed in a P-II cancer vaccine trial evaluating the efficacy, tolerability & safety of BNT111 + Libtayo in combination […]
The US government will buy 500 million more doses of the Pfizer/BioNTech COVID-19 vaccine that will be given to around 100 countries via the COVAX […]
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: […]
Shots: The approval is based on a P-III study assessing Comirnaty (two 30μg doses) in 2,260 participants aged 12-15yrs. and showed 100% efficacy in participants […]
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 […]
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 […]
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 […]
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 […]
AzurRx BioPharma Reports Positive Interim P-II Data of MS1819 + PERT for Cystic Fibrosis Patients with Severe Exocrine Pancreatic Insufficiency Published: May 14, 2021 | […]
The FDA has authorised Pfizer/BioNTech’s vaccine for 12- to 15 year-olds under emergency rules. In a statement the regulator said it had expanded the vaccine’s […]
Shots: The FDA has expanded the EUA for Pfizer’s COVID-19 vaccine in adolescents based on the data from the P- III trial in 2,260 participants […]
The FDA has expanded emergency use of the Pfizer/BioNTech Covid-19 vaccine to include children 12 to 15 years of age. Meanwhile, the regulator is planning […]
A review of side effects reported with coronavirus vaccines by the EMA’s safety committee has uncovered cases of inflammation of the heart in people receiving […]
The messenger RNA vaccine developed by Pfizer and BioNTech has been formally submitted for FDA approval. The application comes amid calls for all vaccine companies […]
The UK has ordered an extra 60 million doses of the Pfizer/BioNTech COVID-19 vaccine, which could be used as a potential booster campaign in the […]
The EU has continued a refocus of its COVID-19 vaccination drive on mRNA shots, ordering another 100 million doses of Pfizer and BioNTech’s Comirnaty shot. […]
The coronavirus variant discovered in South Africa may evade Pfizer/BioNTech’s vaccine, according to a real-world data study conducted in Israel. Known as variant B.1.351, the […]
Pfizer and BioNTech Report Results of BNT162b2 to Prevent COVID-19 Published: Apr 2, 2021 | Tags: Pfizer and BioNTech, Report, Results, BNT162b2, Prevent, COVID-19 Acceleron […]
Based on the efficacy and safety data for their Covid-19 vaccine in younger teens, Pfizer and BioNTech plan to ask regulators to expand emergency authorization […]
European regulators questioned the integrity of early batches of Pfizer/BioNTech’s mRNA vaccine, although the matter was resolved before approval, according to information leaked online following […]
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 rollout of the US COVID-19 vaccination programme slowed up this week because manufacturing delays mean no new doses of the recently approved Johnson & […]
A laboratory study suggests Pfizer and BioNTech’s COVID-19 vaccine Comirnaty could be effective against a Brazilian variant of the SARS-CoV-2 virus – known as P.1 […]
Both the Pfizer/BioNTech and Oxford University/AstraZeneca COVID-19 vaccines are highly effective in reducing COVID-19 infections among older people, according to an emerging study data. Data […]
Pfizer and BioNTech say they have data supporting two-week storage of their vaccine at temperatures found in medical-grade freezers. They say FDA approval of an […]
Two researchers have suggested that the second dose of Pfizer and BioNTech’s COVID-19 vaccine could be delayed, as this would increase the number of people […]
The South African coronavirus variant may cut the effectiveness of Pfizer/BioNTech’s vaccine by around two thirds, according to a laboratory study. Researchers from the University […]
The European Commission has ordered another 200 million doses of the Pfizer/BioNTech COVID-19 vaccine Comirnaty, bringing the bloc’s total order to 500 million doses. Under […]
The European Union has rubber-stamped its order for a further 300 million doses of Pfizer/BioNTech’s COVID-19 vaccine, according to press reports. Citing a European Commission […]
Sanofi has said it is to begin manufacturing the COVID-19 shot from Pfizer and BioNTech in a week when supplies are in the spotlight. The […]
The EU has hit back at AstraZeneca’s plan to provide fewer doses of its COVID-19 vaccine than expected, saying it wants to see exactly where […]
Laboratory studies have confirmed that antibodies stimulated by Pfizer and BioNTech’s COVID-19 vaccine can neutralise the new, more transmissible variant of SARS-CoV-2 identified in the […]
Supplies of COVID-19 vaccines are in the spotlight as countries across the world step up their immunisation campaigns against the pandemic. As vaccine manufacturers face […]
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 […]
A promise by president-elect Joe Biden to carry out 100 million coronavirus vaccinations in his first 100 days in power is “absolutely doable”, according to […]
J&J has announced early trial results that suggest its single-shot coronavirus vaccine provides a sustained response against the virus ahead of a phase 3 trial […]
The fourth quarter of 2020 contains multiple initiations of clinical trials, big approvals, and numerous deals. COVID-19 related news remains at the peak in this […]
Hackers posted stolen confidential information about Pfizer/BioNTech’s COVID-19 vaccine online, the European Medicines Agency has said in an update. The EMA last month revealed that […]
Ugur Sahin presented a sweeping vision of the company’s goal to become a next-generation immunotherapy company leveraging the messenger RNA platform technology that has won […]
The Pfizer/BioNTech vaccine appears to work against an important mutation in the new coronavirus variants causing havoc in the UK and South Africa, according to […]
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 […]
The UK has approved AstraZeneca and Oxford University’s COVID-19 vaccine AZD1222 in another significant step forward in the fight against the pandemic, with first doses […]
NHS England’s chief executive Sir Simon Stevens has said that all vulnerable people over the age of 50 will be offered a COVID-19 vaccine by […]
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 […]
Shots: The approval is based on P-ll/lll study involve the assessment of Comirnaty (BNT162b2) vs PBO in 44,000 patients aged ≥16 yrs. in the ratio […]
BioNTech CEO Ugur Sahin has said that it is “highly likely” the company’s COVID-19 vaccine will work against the more infectious strain circulating in the […]
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 […]
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 […]
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 […]
Trials of a fifth COVID-19 vaccine have begun in the UK, as IT issues threaten to delay the roll-out of the shot from Pfizer/BioNTech. France’s […]
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 […]
The roll-out of the biggest vaccination programme in the history of the UK’s NHS is gathering pace, as family doctors and their teams begin taking […]
Shots: Pfizer & BioNTech received the US FDA’s EUA for BNT162b2 for patients aged ≥16yrs with COVID-19. The companies are gathering additional data & prepared […]
The vaccine was developed in record time, a big scientific accomplishment, even though the agency’s move follows an unusual level of pressure from President Trump’s […]
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, […]
Advisers to the FDA have voted in favour of approving Pfizer and BioNTech’s COVID-19 vaccine, with a near-unanimous backing from an expert committee. While the […]
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 […]
The European Medicines Agency (EMA) says it suffered a cyberattack, with documents relating to a Pfizer and BioNTech’s COVID-19 vaccine accessed. In a terse statement, […]
Shots: Health Canada has granted authorization under interim order for the emergency use of BNT162b2. The distribution of the vaccine in Canada will be prioritized […]
The US government’s coronavirus vaccine chief has said that Pfizer/BioNTech’s vaccine could carry a warning that it should be avoided by people who are prone […]
Reviewers from the FDA have given their blessing to the Pfizer/BioNTech COVID-19 vaccine ahead of a key meeting tomorrow – but the regulator noted that […]
A 90-year-old woman has become the first person given a COVID-19 vaccine as part of the UK’s mass vaccination programme. Margaret Keenan was given the […]
Tuesday has been dubbed “V-day” in the UK, when the first doses of Pfizer/BioNTech’s coronavirus vaccine will be distributed to the public outside of a […]
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, […]
Shots: Pfizer & BioNTech reports that the MHRA in the UK has granted a temporary authorization for the EU for BNT162b2 against COVID-19. The distribution […]
In the midst of the jubilation about the UK’s emergency approval of Pfizer/BioNTech’s COVID-19 shot in the UK came the depressingly inevitable round of anti-vaccine […]
Pfizer and BioNTech are preparing to deliver their COVID-19 vaccine to the UK after the country’s drugs regulator became the first authority in the world […]
Shots: The companies have submitted CMA to the EMA for BNT162b2, against COVID-19. The submission completes the rolling review process initiated on Oct 6, 2020 […]
Pfizer and BioNTech have filed their COVID-19 vaccine with the European medicines regulator, paving the way for a potential approval before the end of the […]
The UK has appointed Nadhim Zahawi as vaccine rollout minister as the country prepares for a potential approval of Pfizer/BioNTech’s ground-breaking COVID-19 vaccine. According to […]
Merck Collaborates with Siemens for the Digitalization of Production Published: Nov 26, 2020 | Tags: Agreement, Collaborative, Digitalization, Merck, Siemens, Sign CoSara Receives CDSCO’s Approval […]
Shots: The companies initiated the P-II study of their COVID-19 vaccine in China. The trial will generate data to support the BLA filing for approval […]
BioNTech may be deeply ensconced in the latter stages of its bid to bring a COVID-19 vaccine to market, but it’s still pushing forward on […]
The partners pooled results from two trials and two different dosing regimens, one appearing to be more effective than the other. They hope to produce […]
AstraZeneca is preparing to file its COVID-19 vaccine with regulators after phase 3 trial results showed it is up to 90% effective. AZ made the […]
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 […]
Pfizer and BioNTech have filed for emergency use of their COVID-19 vaccine candidate in the US, paving the way for a launch before year-end. The […]
Shots: The primary efficacy analysis demonstrated that BNT162b2 is 95% effective against COVID-19 beginning 28 days after the first dose. The study evaluated 170 confirmed […]
Pfizer is preparing to file its COVID-19 vaccine after a trial reached the safety milestone required by US regulators for emergency use, according to press […]
Pfizer has begun a pilot delivery programme in the US for its experimental COVID-19 vaccine, as the company seeks to overcome logistical challenges caused by […]
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.
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 […]
The European Union has ordered 300 million doses of BioNTech/Pfizer’s COVID-19 vaccine following this week’s landmark announcement that it was effective in more than 90% […]
Shots: The companies sign an agreement with the EC to supply 200M doses of BNT162b2 mRNA-based vaccine candidate against SARS-CoV-2 to EU member states, with […]
The news sent the stock market soaring as it represents a key milestone in developing and distributing a vaccine for the virus. Still public confidence […]
As the death toll from COVID19 inexorably mounts, Pfizer and BioNTech have announced that their COVID-19 vaccine candidate is more than 90% effective at countering […]
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 now has hundreds of thousands of doses of BioNTech’s COVID-19 vaccine coming off the production line at a facility in Belgium, ready for delivery […]
The UK government has signed a contract to develop a controversial COVID-19 human challenge trial, where participants will be deliberately infected in a controlled environment […]
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 […]
Shots: The Rolling Submission is based on the preliminary results from pre-clinical and early clinical studies in adults, which shows that BNT162b2 triggers the production […]
The European Medicines Agency has begun a second “rolling review” of a potential coronavirus vaccine jointly developed by BioNTech and Pfizer, setting up a race […]
1. Taysha Gene Therapies’ TSHA-101 Receives the US FDA’s Orphan Drug Designation and Rare Pediatric Disease Designation for GM2 Gangliosidosis Published: Aug 27, 2020 | […]
Shots: BioNTech and Fosun collaborated to supply 10M doses of their BNT162 mRNA-based vaccine candidate against COVID-19 to Hong Kong SAR and Macao SAR, once […]
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 companies also said their Phase II/III study, slated to enroll about 30,000 participants, had already dosed more than 11,000.
1. BioMarin Reports NDA Submission to the US FDA for Vosoritide to Treat Children with Achondroplasia Published: Aug 20, 2020 | Tags: BioMarin, Reports, NDA, […]
New insights into smell and taste loss symptoms, artificial intelligence and further encouraging data from a vaccine candidate hit the headlines this week as the […]
Pfizer and BioNTech have said their COVID-19 vaccine could be ready for regulators to review by October and approved by the end of the year […]
Shots: The companies have shared additional P-I safety and immunogenicity data from their ongoing US study of the BNT162b2 against SARS-CoV-2, which has advanced into […]
Shots: The P-I study will evaluate the safety and immunogenicity of the vaccine as well as confirm dose selection in ~144 healthy subjects aged 18-55 […]
Regeneron and Sanofi’s PD-1 inhibitor Libtayo will be tested in tandem with a cancer vaccine developed by BioNTech in melanoma in people who have failed […]
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 […]
Financial terms of the deal were not disclosed, but it follows a $1.95 billion contract between the two companies and the U.S. government. Assuming clinical […]
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 companies said they had started a Phase II/III trial BNT162b2. The news comes the day after Moderna announced the launch of its Phase III […]
Shots: The companies commence global (Ex- China) P-II/III study to evaluate a modRNA candidate (BNT162b2, 30µg dose level in a 2 dose regimen) from their […]
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, […]
The US government has agreed to pay Pfizer and BioNTech $1.95 billion to secure access to 100 million doses of their coronavirus vaccine on approval, […]
The companies will supply 100 million doses of the vaccine by the end of the year, and the government will have the option to acquire […]
Shots: The companies reported that most advanced of four COVID-19 vaccine candidates from their BNT162 mRNA-based vaccine program demonstrated the ability to elicit high SARS-CoV-2 […]
The UK has secured 90 million doses of two different COVID-19 vaccines from BioNTech/Pfizer and Valneva, with an option of 40 million doses if they check out in trials. There […]
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, […]
The companies anticipate releasing more clinical data from the BNT162 messenger RNA vaccine program and potentially starting a 30,000-participant Phase IIb/III study this month.
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