Moderna

Moderna Reports Results of COVID-19 Vaccine in P-II/III KidCOVE Study for the Treatment of COVID-19

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 apart The study met its primary immunogenicity EPs & interim analysis showed a robust neutralizing Ab response after two 50 μg doses of mRNA-1273. The therapy was well tolerated with …

Moderna Reports Results of COVID-19 Vaccine in P-II/III KidCOVE Study for the Treatment of COVID-19 Read More »

FDA advisors mull use of Pfizer/BioNTech COVID-19 jab in kids

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. If the Vaccines and Related Biological Products Advisory Committee (VRBPAC) gives the go-ahead, the FDA could approve emergency-use of Comirnaty in five to 11-year-olds in a matter of days, extending …

FDA advisors mull use of Pfizer/BioNTech COVID-19 jab in kids Read More »

FDA okays Moderna, J&J COVID jab boosters, plus ‘mix and match’

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 shot. It has also authorised the use of different jabs as boosters than those people received for their primary vaccination – the so-called ‘mix and match’ strategy – on the …

FDA okays Moderna, J&J COVID jab boosters, plus ‘mix and match’ Read More »

Moderna unveils $500m plan for African vaccine facility

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 to find a suitable country and location. The factory will be able to supply up to 500 million doses of mRNA shots a year, and cover the full spectrum of …

Moderna unveils $500m plan for African vaccine facility 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 »

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 »

Ahead of FDA adcomm, Pfizer, Moderna say COVID jab efficacy dips

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 advisory committee meeting tomorrow, although the regulator seems less convinced. Documents published ahead of the panel by the FDA reviewers suggest that there is some evidence from observational studies that …

Ahead of FDA adcomm, Pfizer, Moderna say COVID jab efficacy dips Read More »

Moderna’s Spikevax Receives TGA’s Provisional Approval to Treat COVID-19 in Patients Aged 12-17 Years

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 to Spikevax on Aug 09, 2021 for use in individuals aged ≥18yrs. Provisional approval for this group follows the data supporting the efficacy & safety of the vaccine. The recommended …

Moderna’s Spikevax Receives TGA’s Provisional Approval to Treat COVID-19 in Patients Aged 12-17 Years Read More »

‘Endless RNA’ startup Laronde raises $440m to fuel pipeline

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 by Flagship Pioneering – which was behind the founding of mRNA specialist Moderna. Laronde is developing what it calls ‘endless’ RNA or eRNA, a circular form of the material that …

‘Endless RNA’ startup Laronde raises $440m to fuel pipeline Read More »

MHRA clears Moderna COVID vaccine for 12 to 17 year olds

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 after getting the nod from the Medicines and healthcare products Regulatory Agency (MHRA). It joins the Pfizer/BioNTech vaccine in being an option for that age group, having been approved in …

MHRA clears Moderna COVID vaccine for 12 to 17 year olds Read More »

FDA authorises COVID booster jabs for at-risk people

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 short of a broader booster campaign. The emergency use authorisation (EUA) for the two mRNA-based vaccines has been amended so they can be used for solid organ transplant recipients or …

FDA authorises COVID booster jabs for at-risk people Read More »

Moderna COVID-19 jab sales rocket to $4.2 billion in second quarter

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 $6 billion from 302 million shots. The tally makes the SpikeVax (mRNA-1273) vaccine the second biggest seller behind Pfizer/BioNTech’s Comirnaty, which pulled in $7.8 billion in the second quarter and …

Moderna COVID-19 jab sales rocket to $4.2 billion in second quarter Read More »

Germany confirms booster COVID jabs will start in September

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 delta variant of the coronavirus. Health Minster Jens Spahn said the decision was also taken because of concerns that the immune response stimulated by COVID-19 vaccines may start to diminish …

Germany confirms booster COVID jabs will start in September 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 »

Moderna plans triple vaccine targeting flu, COVID and RSV

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 flu strains.  The first patents have now been enrolled into the study of the shot – codenamed mRNA-1010 – which is designed to generate antibodies against influenza A H1N1, H3N2 …

Moderna plans triple vaccine targeting flu, COVID and RSV Read More »

Moderna ramps up EU COVID jab capacity via Lonza deal

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 new production line at contract manufacturer Lonza. The increased capacity depends on Moderna getting approval for a half dose of an updated version of the mRNA-1273 vaccine – targeting new …

Moderna ramps up EU COVID jab capacity via Lonza deal 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 »

Moderna’s mRNA-1273 Meets its Primary Endpoint in P-II/III TeenCOVE Study to Prevent COVID 19 in Adolescents

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. in the US The study met its 1EPs i.e non-inferior immunogenicity and demonstrated 93% efficacy in seronegative participants after 14 days following the first dose, was generally well tolerated with …

Moderna’s mRNA-1273 Meets its Primary Endpoint in P-II/III TeenCOVE Study to Prevent COVID 19 in Adolescents Read More »

Moderna will file COVID-19 jab for teens after trial shows 100% protection

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 month. The results of the phase 2/3 TeenCOVE study in more than 3,700 adolescents aged 12 to 17 revealed no cases of COVID-19 after two doses of the mRNA-1273 shot, …

Moderna will file COVID-19 jab for teens after trial shows 100% protection Read More »

Moderna’s Covid vaccine shows efficacy in younger teens; regulatory filing are 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 to submit applications to regulators in early June seeking expansion of emergency authorization of the vaccine to include this younger age group.

Safety of mRNA COVID-19 jabs backed, despite myocarditis cases

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 come out in favour of the jabs. The American Heart Association (AHA) and American Stroke Association (ASA) have issued a statement saying that the benefits of the vaccines “enormously outweigh …

Safety of mRNA COVID-19 jabs backed, despite myocarditis cases 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 »

Moderna’s COVID-19 Vaccine Receives Approval for Emergency Use in Japan

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 and safety clinical trial The interim analysis showed that binding Ab and neutralizing Ab titers were elevated @28days after the second dose in 100% of people vaccinated with two 0.5ml …

Moderna’s COVID-19 Vaccine Receives Approval for Emergency Use in Japan 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 »

Moderna’s founder launches Laronde, promising new ‘Endless RNA’ drug class

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 class of drugs based on Endless RNA. Called eRNA for short, this class of medicines is programmable and can continuously express therapeutic proteins inside the body. This makes the body …

Moderna’s founder launches Laronde, promising new ‘Endless RNA’ drug class 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 »

England begins Moderna vaccine rollout as lockdown eases

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 rare kind of blood clot. The Moderna shot is the third vaccine to become available in the country, which has made considerable progress with its inoculation campaign. Its arrival is …

England begins Moderna vaccine rollout as lockdown eases 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 »

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 »

Harris Poll Finds Large Boost in Pharma Industry Reputation

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 and AstraZeneca with the same ease that they refer to their favorite brands of ketchup or peanut butter. This isn’t typical. While direct-to-consumer advertising has perhaps increased some awareness of …

Harris Poll Finds Large Boost in Pharma Industry Reputation 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 »

Sanofi/Translate start clinical trial of mRNA COVID shot

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 despite its background in vaccines. While Pfizer/BioNTech and Moderna have been able to produce mRNA vaccines in a matter of months Sanofi is considerably behind with its collaboration with Translate …

Sanofi/Translate start clinical trial of mRNA COVID shot Read More »

J&J manufacturing delays hit US vaccine rollout

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 & Johnson vaccine are available. The White House said on Tuesday that the government will distribute around 18.5 million doses of COVID-19 vaccines this week, fewer than last week because of …

J&J manufacturing delays hit US vaccine rollout Read More »

Takeda Reports NDA Submission to Import and Distribute Moderna’s mRNA-1273 in Japan

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 the safety and immunogenicity of two vaccinations of TAK-919 (100μg, given 28 days apart) in 200 participants aged ≥20yrs. followed through 12mos. after the second vaccination. Takeda has completed enrollment …

Takeda Reports NDA Submission to Import and Distribute Moderna’s mRNA-1273 in Japan Read More »

‘Vaccine, vaccine’: Dolly Parton urges Americans to get COVID-19 shots

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” to pledge her support in a social media video showing her getting inoculated. Parton burst into a version of her hit, which she wrote and recorded in 1973, before receiving …

‘Vaccine, vaccine’: Dolly Parton urges Americans to get COVID-19 shots 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 »

Takeda Reports First Patients Dosing in P-I/II Study of Novavax’s COVID-19 Vaccine Candidate in Japan

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 the P-I/II study of TAK-919 in Japan The studies are designed to include 200 healthy Japanese adults followed by 12mos. after the second vaccination with primary results expected in CY2021. …

Takeda Reports First Patients Dosing in P-I/II Study of Novavax’s COVID-19 Vaccine Candidate in Japan Read More »

Allergic reactions prompt Moderna COVID vaccine pause in California

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 immunisation clinic. According to state epidemiologist Dr Erica Pan, there were a higher-than-expected number of suspected allergic reactions at a community clinic being used to administer the shot, with some …

Allergic reactions prompt Moderna COVID vaccine pause in California Read More »

Moderna’s COVID-19 vaccine is third approved in UK

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 several weeks. Moderna’s mRNA-1273 is the third COVID-19 vaccine to be approved for use by the Medicines and Healthcare products Regulatory Agency (MHRA) and is the second mRNA vaccine after …

Moderna’s COVID-19 vaccine is third approved in UK Read More »

UK left trailing as EU quickly approves Moderna’s COVID-19 vaccine

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 reeling from one of the worst outbreaks of the disease, it’s a worrying situation for one of the countries worst hit by the pandemic that is relying on vaccines to …

UK left trailing as EU quickly approves Moderna’s COVID-19 vaccine Read More »

Insights+: COVID-19 Healthcare News Monthly Updates – December 2020

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 been named “SARS-CoV-2” (severe acute respiratory syndrome coronavirus and the disease it causes has been named “Coronavirus Disease 2019” (COVID-19). The outbreak of the respiratory disease was first detected in …

Insights+: COVID-19 Healthcare News Monthly Updates – December 2020 Read More »

PharmaShots’ Most Read News of 2020

“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 biotech companies involved in M&A, option & licensing agreements, and gaining approvals. Our team has compiled a list of 30 most read life sciences news on PharmaShots in 2020. 1. …

PharmaShots’ Most Read News of 2020 Read More »

PharmaShots Weekly Snapshots (Dec 21-23, 2020)

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 Approval, HER2-positive Breast Cancer, Phesgo, receives, Roche, Treatment AMO Pharma Initiates P-II REACH-CDM study of AMO-02 (tideglusib) to treat Congenital Myotonic Dystrophy Published: Dec 22, 2020 | Tags: AMO Pharma, …

PharmaShots Weekly Snapshots (Dec 21-23, 2020) Read More »

Moderna and BioNTech – who are they?

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 companies and who is behind them, asks Richard Staines. A year ago, the names Moderna and BioNTech were known mainly to those who followed biotech and pharma dealings. But the …

Moderna and BioNTech – who are they? Read More »

Moderna’s mRNA-1273 Receives the US FDA’s EUA Against COVID-19

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 Moderna will continue to gather additional data and plans to file BLA for full licensure in 2021 Allocation and distribution will be prioritized according to populations identified by the CDC’s …

Moderna’s mRNA-1273 Receives the US FDA’s EUA Against COVID-19 Read More »

Moderna’s COVID-19 vaccine is second for US after FDA green light

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 authorisation means that around six million more vaccine doses can now be rolled out in the US coronavirus immunisation programme, adding to the almost three million doses of Pfizer/BioNTech’s already-approved …

Moderna’s COVID-19 vaccine is second for US after FDA green light Read More »

FDA gives nod to Moderna vaccine for Covid-19

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 was developed by Pfizer and BioNTech.

PharmaShots Weekly Snapshots (Dec 14-18, 2020)

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 (biosimilar, rituximab) Receives the US FDA’s Approval for Multiple Diseases Published: Dec 17, 2020 | Tags: Adult, Amgen, approval, Biosimilar, CLL, GPA, MPA, NHL, patients, receives, RIABNI, Rituxan, Rituximab, rituximab-arrx, …

PharmaShots Weekly Snapshots (Dec 14-18, 2020) Read More »

FDA aims for fast approval of Moderna’s COVID-19 shot after panel vote

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 20-0 in favour of approving Moderna’s vaccine and although the vote is non-binding, you could probably bet your house on the FDA backing the shot as it rarely goes against …

FDA aims for fast approval of Moderna’s COVID-19 shot after panel vote Read More »

Moderna’s mRNA-1273 Receives the US FDA’s Advisory Committee Vote Supporting EUA Against COVID-19

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 recommendation is based on data analysis from the pivotal P-III clinical study that demonstrated 94.1% efficacy The US FDA’s committees provide non-binding recommendations. The FDA will take the VRBPAC’s recommendation …

Moderna’s mRNA-1273 Receives the US FDA’s Advisory Committee Vote Supporting EUA Against COVID-19 Read More »

Precision measurement in 2021: Why accuracy is key to the vaccine ‘cold chain’ and disrupting the spread of Covid-19

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 the crucial role that precision measurement will have to play.

FDA backs Moderna COVID-19 shot ahead of emergency use vote

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 its safety and rating its efficacy at 94.5%. The document has been published just after the US started the rollout of Pfizer and BioNTech’s vaccine after it got an emergency …

FDA backs Moderna COVID-19 shot ahead of emergency use vote Read More »

Pfizer/BioNTech COVID-19 vaccinations start across the US

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 new cases reported yesterday. Shipments of Pfizer/BioNTech’s mRNA vaccine BNT-162b are being shipped to hundreds of hospitals and other distribution facilities across the US, with the first three million doses …

Pfizer/BioNTech COVID-19 vaccinations start across the US Read More »

PharmaShots Weekly Snapshots (Dec 7-11, 2020)

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, Support, Suspected, Test, Testing, Volume Chugai In-Licenses Roche’s Antibody Cocktail for COVID-19 in Japan Published: Dec 10, 2020 | Tags: Casirivimab, Chugai, Commercialization, COVID-19, Development, Imdevimab, In-License Agreement, Japan, Roche, …

PharmaShots Weekly Snapshots (Dec 7-11, 2020) Read More »

Roche Collaborate with Moderna to include SARS-CoV-2 Ab Test in COVID-19 Vaccine Trials

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 Abs and help to establish a correlation b/w vaccine-induced protection and levels of anti-RBD Abs The alliance follows US FDA’s EUA for the Elecsys anti-SARS-CoV-2 S Ab test. Moderna’s vaccine …

Roche Collaborate with Moderna to include SARS-CoV-2 Ab Test in COVID-19 Vaccine Trials Read More »

Roche Collaborate with Moderna to include SARS-CoV-2 Ab Test in COVID-19 Vaccine Trials

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 Abs and help to establish a correlation b/w vaccine-induced protection and levels of anti-RBD Abs The alliance follows US FDA’s EUA for the Elecsys anti-SARS-CoV-2 S Ab test. Moderna’s vaccine …

Roche Collaborate with Moderna to include SARS-CoV-2 Ab Test in COVID-19 Vaccine Trials Read More »

PharmaShots Weekly Snapshot (Nov 30 – Dec 04, 2020)

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, Transdermal Contraceptive Patch Assets, Treat Jazz Pharma and PharmaMar’s Zepzelca Fail to Meet its Primary Endpoint in P-III ATLANTIS Study for SCLC Published: Dec 3, 2020 | Tags: ATLANTIS, Doxorubicin, …

PharmaShots Weekly Snapshot (Nov 30 – Dec 04, 2020) Read More »

Pfizer cut vaccine production targets because of raw material shortage – reports

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 big pharma has said in recent weeks that it expects to produce 50 million doses of the vaccine it developed with the German BioNTech, down from an earlier target of …

Pfizer cut vaccine production targets because of raw material shortage – reports Read More »

The known unknowns of COVID-19 vaccines

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 don’t know,” says Maria Sundaram, a postdoctoral fellow at the Centre for Vaccine Preventable Diseases at the University of Toronto. Health Canada is currently reviewing early findings from Moderna, Pfizer/BioNTech …

The known unknowns of COVID-19 vaccines Read More »

Moderna to Seek the FDA and EMA’s EUA for mRNA-1273 and Shows 100% Efficacy in P-III COVE-Study

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 concerns identified to date Moderna plans to submit an EUA to the FDA & an application for CMA with the EMA and to progress with the rolling reviews, which have …

Moderna to Seek the FDA and EMA’s EUA for mRNA-1273 and Shows 100% Efficacy in P-III COVE-Study Read More »

Moderna seeks COVID vaccine okay as data backs 94% efficacy

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 for the shot. The primary analysis from the 30,000-subject COVE trial of mRNA-1273 – based on 196 confirmed cases of COVID-19 – has come in at 94% efficacy, with 185 …

Moderna seeks COVID vaccine okay as data backs 94% efficacy Read More »

Moderna Amends its Agreement with UK Government for an Additional 2M Doses of COVID-19 Vaccine

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 secured 7M doses of mRNA-1273 The agreement reflects Moderna’s commitment to making its vaccine available in multiple countries. Moderna ramp up its global manufacturing to be able to deliver ~500M …

Moderna Amends its Agreement with UK Government for an Additional 2M Doses of COVID-19 Vaccine Read More »

Concerns emerge after AZ’s lucky vaccine trial ‘mistake’

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 the highest efficacy– but the revelation has drawn a mixed response from commentators. The company’s share price has tumbled since the announcement of the trial results from AZD-1222 at the …

Concerns emerge after AZ’s lucky vaccine trial ‘mistake’ Read More »

PharmaShots Weekly Snapshot (Nov 16-20, 2020)

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 Lilly, Emergency Use Authorization, FDA’s, Incyte, receives, Remdesivir Novartis Signs a License Agreement with Mesoblast to Develop and Commercialize Remestemcel-L for ARDS Published: Nov 20,2020 | Tags: Agreement, ARDS, Commercialize, …

PharmaShots Weekly Snapshot (Nov 16-20, 2020) Read More »

Moderna’s mRNA-1273 Demonstrates 94.5% Efficacy in Preventing Symptomatic COVID-19

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 > 18 yrs. in the US The study met the statistical criteria pre-specified in the study protocol for efficacy, with a vaccine efficacy of 94.5% in the first interim analysis …

Moderna’s mRNA-1273 Demonstrates 94.5% Efficacy in Preventing Symptomatic COVID-19 Read More »

UK eyes access deal as Moderna’s COVID-19 shot hits the mark

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 an efficacy of 94.5% in the 30,000-patient COVE study. The results set up an emergency use authorisation (EUA) filing in the US “within weeks” according to the company, and the …

UK eyes access deal as Moderna’s COVID-19 shot hits the mark Read More »

PharmaShots Weekly Snapshots (Nov 09-13, 2020)

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 Medicago Initiate P-II/III Study of its Plant-Derived COVID-19 Vaccine Published: Nov 13,2020 | Tags: COVID-19, GSK, Initiate, Medicago, P-II/III, Plant- Derived study, vaccine BD Acquires the Medical Business Assets of …

PharmaShots Weekly Snapshots (Nov 09-13, 2020) Read More »

Moderna Report Results of mRNA-4157 + Keytruda in Interim P-l Study for HNSCC and MSS-CRC

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 17 patients with MSS-CRC, presented at the SITC 2020. Results: in the HPV(-) HNSCC group, ORR (50% vs 14.6%) with 2 patients achieving CR & 3 patients achieving PR; mPFS …

Moderna Report Results of mRNA-4157 + Keytruda in Interim P-l Study for HNSCC and MSS-CRC Read More »

UK could get COVID-19 vaccines early next year, ahead of European countries

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 reviews of shots from AstraZeneca and Moderna. AstraZeneca has confirmed that the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has begun a fast-track rolling review of its AZD1222, the …

UK could get COVID-19 vaccines early next year, ahead of European countries Read More »

Moderna banks $1.1bn in COVID-19 vaccine deposits, signs Japan supply deal

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 $1.1 billion in deposits for the shot. The figure was revealed by CEO Stéphane Bancel in Moderna’s third-quarter results call on which he also highlighted a new agreement to supply …

Moderna banks $1.1bn in COVID-19 vaccine deposits, signs Japan supply deal Read More »

Moderna nears COVID-19 vaccine finish line as it wraps up study enrolment

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 also revealed that more than 25,000 of them have already received the second dose of the shot in the COVE study, putting it in contention to be the first coronavirus …

Moderna nears COVID-19 vaccine finish line as it wraps up study enrolment Read More »

Pfizer to wait until after election to file COVID-19 vaccine in US

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 data to become available. The vaccine is being developed by Pfizer and development partner BioNTech and will wait until late November to make its application with the FDA. In a …

Pfizer to wait until after election to file COVID-19 vaccine in US Read More »

PharmaShots Weekly Snapshot (Oct 12-16, 2020)

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, Canada, health, Inherited Retinal Disease, Luxturna, Novartis, receives, voretigene neparvovec Galapagos & Servier’s GLPG1972/S201086 Fails to Meet its Primary Endpoint in P-II ROCCELLA Study for Knee Osteoarthritis Published: Oct 15, …

PharmaShots Weekly Snapshot (Oct 12-16, 2020) Read More »

PharmaShots Weekly Snapshot (Sept 28 – Oct 1, 2020)

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 Study, Important Clinical Improvement, P-II, patients, reports, results, SEL-212, Selecta Biosciences, Sobi 2. Moderna’s mRNA-1273 COVID-19 Vaccine Demonstrate Immune Responses in Older Adults Published: Oct 1, 2020 | Tags: COVID-19, …

PharmaShots Weekly Snapshot (Sept 28 – Oct 1, 2020) Read More »

Moderna’s mRNA-1273 COVID-19 Vaccine Demonstrate Immune Responses in Older Adults

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 vaccination schedule of mRNA-1273 given 28 days apart in 40 adults across two dose levels (25/100µg) in two age cohorts (56-70/ 71+) and reports results @Day 57 (1mos. following the …

Moderna’s mRNA-1273 COVID-19 Vaccine Demonstrate Immune Responses in Older Adults Read More »

Moderna’s Covid-19 vaccine shows antibody, T-cell responses a month after second dose in interim Phase I data

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 younger adults. The vaccine is being tested in a 30,000-participant Phase III trial.

Moderna’s COVID vaccine works in older people, according to new data

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 the age groups most susceptible to COVID-19. An analysis of the latest data from a phase 1 trial showed that in 20 older adults given the vaccine – ten between …

Moderna’s COVID vaccine works in older people, according to new data Read More »

Is COVID the Rx for the Pharmaceutical Industry’s Reputation?

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 Pharma industry appears to be the shining hope to help us return to a new normal. Could the industry’s response to this global public health crisis be the Rx …

Is COVID the Rx for the Pharmaceutical Industry’s Reputation? Read More »

Anger at US deal for Moderna’s ‘taxpayer-funded’ COVID-19 vaccine

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 billion –around $15 per dose or $30 per course. That’s a steep discount on the $32 to $37 price per dose in its earlier smaller deals, revealing that purchasing power …

Anger at US deal for Moderna’s ‘taxpayer-funded’ COVID-19 vaccine Read More »

Moderna secures more than $1.5B federal government deal to provide Covid-19 vaccine

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 company has received from the federal government for its vaccine efforts to nearly $2.5 billion.

Moderna Prices its COVID-19 Vaccine at $32-$37 per Dose for Smaller Volume Agreements

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 company is in talks with several countries for supply agreements of its vaccine, adding that it had already received about $400M for supply. The P-III study of mRNA-1273 is being …

Moderna Prices its COVID-19 Vaccine at $32-$37 per Dose for Smaller Volume Agreements Read More »

PharmaShots Weekly Snapshot (Jul 27- 31, 2020)

 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 Biomedica, Signs, Three Year, Clinical Supply Agreement, Axovant, Manufacture, Supply, AXO-Lenti-PD, Parkinson’s Disease 2.  Johnson & Johnson Initiates P-I/IIa Study of its Ad26.COV2.S Against COVID-19 in the US and Belgium …

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Insights+ Exclusive: COVID-19 Healthcare News Monthly Updates – July 2020

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 been named “SARS-CoV-2” (severe acute respiratory syndrome coronavirus 2) and the disease it causes has been named “Coronavirus Disease 2019” (COVID-19). The outbreak of the respiratory disease was first detected …

Insights+ Exclusive: COVID-19 Healthcare News Monthly Updates – July 2020 Read More »

Moderna snags another $472M from BARDA, launches Phase III Covid-19 vaccine trial

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 based on a smaller anticipated number of participants than the 30,000 it now plans to enroll into the trial, named COVE.

Moderna gets further $472m as expanded phase 3 COVID-19 trial begins

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 its potential COVID-19 jab. The latest funding from the Biomedical Advanced Research and Development Authority follows a tranche worth $483 million, awarded to kick-start development of Moderna’s mRNA-based vaccine codenamed …

Moderna gets further $472m as expanded phase 3 COVID-19 trial begins Read More »

PharmaShots Weekly Snapshot (Jul 20- 24, 2020)

 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, filgotinib, Receive, CHMP, Positive Opinion,  Moderate, Severe, Rheumatoid Arthritis 2.  Synaffix Expands its Existing Collaboration with ADC Therapeutics to Explore Two Additional Programs Published: Jul 24, 2020 | Tags: Synaffix, Expands, …

PharmaShots Weekly Snapshot (Jul 20- 24, 2020) Read More »

Controversy as pharma execs predict profits from COVID-19 vaccines

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 in evidence to a US Congressional panel. Moderna, Merck & Co, and Pfizer said they expect to profit from coronavirus vaccines if they are approved, although AstraZeneca and Johnson & …

Controversy as pharma execs predict profits from COVID-19 vaccines Read More »

Moderna’s $37B market cap is too high, despite COVID-19 vaccine; analyst

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 in clinical trials. Moderna’s share price has rocketed 385% this year, driven by the development of mRNA-1273, but the analysts think there are too many unknowns surrounding the coronavirus pandemic …

Moderna’s $37B market cap is too high, despite COVID-19 vaccine; analyst Read More »

PharmaShots Weekly Snapshot (Jul 13- 17, 2020)

 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, Reports, Results, Mirikizumab, P-III, OASIS-2, Study, Treat, Moderate, Severe, Plaque Psoriasis 2.  Oncorus Initiates P-I Study of ONCR-177 in Patients with Advanced / Refractory Cutaneous Subcutaneous or Metastatic Nodal Solid …

PharmaShots Weekly Snapshot (Jul 13- 17, 2020) Read More »

FDA guidance eases some Covid-19 vaccine concerns, but others remain

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 of the month sets much tougher standards. But trial enrollment, anti-vaccine sentiment and other potential problems persist.

Moderna publishes Phase 1 Covid-19 vaccine data showing robust immune responses

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, T-cell responses suggest potentially lower risk of enhanced respiratory disease.