Johnson & Johnson has been offering its COVID-19 vaccine for sale on a no-profit basis since it became available, but is thinking about a possible switch to a standard commercial model next year or in 2023. That was the position stated by J&J’s executive vice president Ashley McEvoy on the company’s third-quarter results call yesterday, …
J&J mulls switch from non-profit status for COVID jab Read More »
The F.D.A. may authorize booster shots of vaccines different from the ones that Americans originally received. The science behind the move is promising.
The F.D.A. may authorize booster shots of vaccines different from the ones that Americans originally received. The science behind the move is promising.
The agency may act this week, when it is expected to authorize booster shots for recipients of the Moderna and Johnson & Johnson vaccines.
An FDA advisory committee voted unanimously in favour of a booster dose of Johnson & Johnson’s one-shot COVID-19 vaccine on Friday, as panellists suggested it should have been used as a two-dose regimen from the start. The verdict – which came the day after a third dose of Moderna’s two-shot vaccine was also backed by …
FDA panel backs booster shot for J&J COVID-19 vaccine Read More »
Johnson & Johnson won the support of an FDA advisory panel, which unanimously recommended a booster shot for adults. The backing comes one day after the panel’s affirmative vote on a Moderna vaccine in a busy week of regulatory developments for Covid-19 vaccines, therapies, and diagnostics.
Confused about who can get a booster shot of which vaccine, and what the F.D.A.’s advisers on vaccines voted on this week? This scorecard may help.
Confused about who can get a booster shot of which vaccine, and what the F.D.A.’s advisers on vaccines voted on this week? This scorecard may help.
Confused about who can get a booster shot of which vaccine, and what the F.D.A.’s advisers on vaccines are voting on this week? This scorecard may help.
Confused about who can get a booster shot of which vaccine, and what the F.D.A.’s advisers on vaccines are voting on this week? This scorecard may help.
The experts’ recommendations, though not binding, are likely to influence what the Food and Drug Administration decides on whether to authorize the boosters.
Confused about who can get a booster shot of which vaccine, and what the F.D.A.’s advisers on vaccines are voting on this week? This scorecard may help.
Paul Stoffels is bringing a nine-year tenure as head of R&D at Johnson & Johnson to a close, announcing plans to retire at the end of the year. Belgium-born Stoffels has been CSO at J&J since 2012, and was global head of pharma R&D for three years before that whilst also serving as chairman of …
J&J’s long-serving R&D chief Paul Stoffels announces retirement Read More »
Some poorer countries are paying more and waiting longer for the company’s vaccine than the wealthy — if they have access at all.
Johnson & Johnson’s COVID-19 vaccine has been a minor player in the US vaccination drive so far, but the company hopes it can have a bigger role as a booster shot. The drugmaker has filed for approval of a second dose of its one-shot Ad26.COV2.S vaccine for people aged 18 years and older, based on …
J&J joins COVID-19 booster shot drive, filing with FDA Read More »
Shots: The submission is based on the P-III ENSEMBLE 2 study that evaluates the booster dose COVID-19 vaccine in adults aged ≥18yrs with COVID-19 The results demonstrated a 94% protection against symptomatic COVID-19 in the US for booster dose @56 days after primary dose & 100% protection against severe/critical COVID-19 @14 days post-booster vaccination The …
The request, expected this week, comes after a study found the company’s vaccine was only 71 percent effective against hospitalization from Covid-19.
Clinical-stage Xencor is receiving $100 million up front and a $25 million equity investment, while Johnson & Johnson’s Janssen Biotech subsidiary gets global rights to plamotamab, a bispecific antibody. Regeneron Pharmaceuticals and Roche are also developing bispecific antibodies against the same targets, but Xencor’s drug has a feature that could be a competitive advantage.
Fresh from claiming its first bispecific antibody approval, Johnson & Johnson has delved deeper into the category with a deal to license a drug for B-cell cancers developed by Xencor. J&J’s Janssen Biotech unit is paying $100 million upfront to Xencor and making a $25 million equity investment in the biotech in return for rights …
J&J bulks up in bispecifics with $1.3bn Xencor alliance Read More »
The request, expected this week, comes after a study found the company’s vaccine was only 71 percent effective against hospitalization from Covid-19.
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 »
Janssen’s Mark Hicken, VP of strategy, EMEA, looks at what COVID-19 has taught us and how we can become stronger as we emerge from the pandemic. There’s plenty of talk about a post-COVID world right now, which can seem strange when so many places are still feeling the impact or remain in the grip of …
NICE has reversed its position on Johnson & Johnson’s oral prostate cancer therapy Erleada in patients with hormone-relapsed or hormone sensitive tumours, backing NHS use of the drug. The change of heart comes after J&J’s Janssen pharma unit offered an improved discount on Erleada (apalutamide), according to the cost-effectiveness watchdog in its final appraisal determination, …
NICE changes its mind on J&J’s Erleada in prostate cancer Read More »
Researchers ended a large trial in South Africa after finding that an experimental vaccine offered little protection.
Forte’s FB-401 Fails to Meet Primary Endpoints in P-II Clinical Trial For the Treatment of Atopic Dermatitis Published: Sept 3, 2021 | Tags: Forte, FB-401, P-II, Clinical Trial, Atopic Dermatitis Novartis Cosentyx (secukinumab) Receives NICE Recommendation for Patients with Plaque Psoriasis Published: Sept 3, 2021 | Tags: Novartis, Cosentyx, secukinumab, NICE Recommendation, Plaque Psoriasis Pfizer …
PharmaShots Weekly Snapshots (August 30 – September 03, 2021) Read More »
Forte’s FB-401 Fails to Meet Primary Endpoints in P-II Clinical Trial For the Treatment of Atopic Dermatitis Published: Sept 3, 2021 | Tags: Forte, FB-401, P-II, Clinical Trial, Atopic Dermatitis Novartis Cosentyx (secukinumab) Receives NICE Recommendation for Patients with Plaque Psoriasis Published: Sept 3, 2021 | Tags: Novartis, Cosentyx, secukinumab, NICE Recommendation, Plaque Psoriasis Pfizer …
PharmaShots Weekly Snapshots (August 30 – September 03, 2021) Read More »
Pfizer has vaulted ahead with its respiratory syncytial virus (RSV) vaccine, closing the gap with GlaxoSmithKline and Johnson & Johnson as the companies strive to bring the first licensed shot to market. The first of an anticipated 30,000 subjects have been vaccinated in Pfizer’s phase 3 RENOIR trial of its vaccine, just behind GSK and …
Pfizer raises pressure on GSK, J&J with late-stage RSV vaccine trial Read More »
One of the biggest challenges to treating schizophrenia is non-compliance with treatment, but Johnson & Johnson’s pharma unit Janssen is trumpeting a new version of its Invega drug that could solve that problem. The FDA has just approved Janssen’s Invega Hafyera (paliperidone), a twice-yearly injectable formulation that extends the company’s big-selling brand and offers the …
FDA clears J&J’s twice-yearly Invega for schizophrenia Read More »
Johnson & Johnson reported results from a mid-stage study in southern Africa showing just 25% efficacy for its HIV vaccine. J&J developed the HIV vaccine with the same technology used in its successful Ebola and Covid-19 vaccines.
Researchers ended a large trial in South Africa after finding that an experimental vaccine offered little protection.
New guidance from NICE has rejected a combination regimen based on Johnson & Johnson’s Darzalex for a group of previously-untreated patients with multiple myeloma, a type of bone marrow cancer. The draft document covers the use of Darzalex (daratumumab) as an add-on to standard induction treatment with Takeda’s Velcade (bortezomib) plus thalidomide and dexamethasone given …
NICE rejects J&J’ Darzalex regimen for multiple myeloma Read More »
Three years ago, Johnson & Johnson set up a wide-ranging initiative with Boston University to try to improve lung cancer survival rates through prevention and early intervention. Now, its calling on artificial intelligence specialist Optellum to help with that effort. UK-based Optellum has developed an AI-powered clinical decision support – called Virtual Nodule Clinic – …
J&J lung cancer initiative will use Optellum’s ‘digital biomarker’ tech Read More »
Congress appropriated $16 billion to ramp up Covid-19 countermeasures, but a new report found that the Biden administration had spent very little of it on expanding vaccine manufacturing capacity.
As U.S. plans for Covid-19 booster shots unfold, Johnson & Johnson is angling to join the mix, reporting data that it says support a second shot of its vaccine. But the data the company points to are sparse and it’s not entirely clear they support booster shots.
The Theravance Biopharma drug is the lead program in an alliance with Johnson & Johnson subsidiary Janssen Biotech, which paid $100 million up front to develop the JAK inhibitor for intestinal diseases. Following the Phase 2 failure, Theravance said it will minimize spending on that program.
Tenemos una guía con las recomendaciones y opiniones de los expertos en salud para despejar tus dudas.
Tenemos una guía con las recomendaciones y opiniones de los expertos en salud para despejar tus dudas
Health experts say that boosters are likely to be needed eventually and that more data should be available in the next several weeks.
Johnson & Johnson has appointed Joaquin Duato as chief executive officer to replace long-serving Alex Gorsky, who has been CEO since 2012. Joaquin Duato Gorsky will stay on at the company as executive chairman, but Duato – currently vice chairman at J&J’s executive committee – will take the top job at the company on 3 …
Alex Gorsky will pass leadership of J&J to Joaquin Duato in January Read More »
Health experts say that boosters are likely to be needed eventually and that more data should be available in the next several weeks.
Johnson & Johnson is sending shots from South Africa to other parts of the world. African countries are waiting for most of the doses they’ve ordered.
Boosters may not be necessary yet, many experts say, and the pursuit of additional shots raises ethical questions.
The Food and Drug Administration’s move is expected to kick off more vaccination mandates for hospital workers, college students and federal troops.
The Food and Drug Administration’s move is expected to kick off more vaccination mandates for hospital workers, college students and federal troops.
Emergent BioSolutions, which ruined 75 million vaccine doses at its Baltimore plant, disclosed records requests from Congress and federal and state law enforcement agencies.
Emergent BioSolutions, which ruined 75 million vaccine doses at its Baltimore plant, disclosed records requests from Congress and federal and state law enforcement agencies.
Boosters may not be necessary yet, many experts say, and the pursuit of additional shots raises ethical questions.
The decision comes after state health officials were worried that doses of the company’s coronavirus shots would expire and go to waste.
The decision comes after state health officials were worried about whether doses of the Johnson & Johnson coronavirus vaccine would expire and go to waste.
Muchos de los que recibieron la vacuna pueden necesitar refuerzos, dijeron los autores. Pero las autoridades sanitarias federales no recomiendan segundas dosis.
Muchos de los que recibieron la vacuna pueden necesitar refuerzos, dijeron los autores. Pero las autoridades sanitarias federales no recomiendan segundas dosis.
The agreement would allow funds to begin flowing from the companies to states and communities to pay for addiction and prevention services.
The payout to New York will take place over the next 17 years, and joins a $26 billion deal to settle the thousands of nationwide lawsuits.
The agreement would allow funds to begin flowing from the companies to states and communities to pay for addiction and prevention services.
Many who received the shot may need to consider boosters, the authors said. But federal health officials do not recommend second doses.
Johnson & Johnson and the ‘big three’ US pharma wholesalers are on the brink of a $26 billion settlement deal covering thousands of lawsuits alleging their involvement in contributing to the US opioid crisis, according to press reports. Under the deal, J&J would be in line for a $5 billion payment over nine years, while …
Is J&J nearing the end of its opioid liability hangover? Read More »
The agreement would end thousands of lawsuits against the three largest distributors and Johnson & Johnson and require them to pay billions for addiction treatment and prevention.
Many who received the shot may need to consider boosters, the authors said. But federal health officials do not recommend second doses.
Three drug distributors and Johnson & Johnson are also on the verge of a $26 billion deal to settle the thousands of nationwide lawsuits.
The agreement would end thousands of lawsuits against the three largest distributors and Johnson & Johnson and require them to pay billions for addiction treatment and prevention.
Eli Lilly Signs an Agreement with Banner Alzheimer’s Institute to Evaluate Donanemab in P-III TRAILBLAZER-ALZ 3 Trial for Alzheimer’s Disease Published: July 16, 2021 | Tags: Eli Lilly, Banner Alzheimer’s Institute, Donanemab, P-III, TRAILBLAZER-ALZ 3 Trial, Alzheimer Disease AcelRx Signs a License Agreement with Aguettant to Commercialize Dzuveo in EU and for Two Pre-Filled Syringe …
PharmaShots Weekly Snapshots (July 12 – 16, 2021) Read More »
NICE has stuck with its original decision to reject NHS funding for Johnson & Johnson’s Zytiga as a treatment for men with newly diagnosed advanced prostate cancer, drawing criticism from the Institute of Cancer Research (ICR). The UK cost-effectiveness body first turned down Zytiga (abiraterone acetate) for this use in June 2020, but said four …
NICE second Zytiga rejection ‘shows need for flexible pricing models’ Read More »
The company said it had determined that daily exposure to five Neutrogena and Aveeno sprays would not cause adverse health effects, but recalled the products out of an abundance of caution.
The FDA is cautioning that the Johnson & Johnson Covid-19 vaccine may cause a rare immune response affecting the nerves. A causal link has not been established and the side effect, when observed, is rare, but the vaccine information has been updated to reflect the potential risk.
Federal regulators concluded that the risk of developing the syndrome was low, and that the benefits of the vaccine still strongly outweigh it.
In the latest shareholder lawsuit, a pension fund accused executives at Emergent BioSolutions of insider trading. The company, under investigation by Congress, has halted manufacturing of Covid-19 vaccines at its Baltimore factory at regulators’ request.
In the latest shareholder lawsuit, a pension fund accused executives at Emergent BioSolutions of insider trading. The company, under investigation by Congress, has halted manufacturing of Covid-19 vaccines at its Baltimore factory at regulators’ request.
The move brings the total number of Johnson & Johnson doses made at the troubled plant and cleared by the F.D.A. to roughly 40 million.
The move brings the total number of Johnson & Johnson doses made at the troubled plant and cleared by the F.D.A. to roughly 40 million.
The move brings the total number of Johnson & Johnson doses made at the troubled plant and cleared by the F.D.A. to roughly 40 million.
The second quarter of 2021 witnesses major acquisitions, approvals, and clinical data. There are major alliances in this quarter which include Merck signed ~$1.2B supply agreement with US Government for Molnupiravir to treat COVID-19 The big acquisition took place during the quarter including Microsoft acquired Nuance for ~$19.7B, MorphoSys acquired Constellation for ~$1.7B Our team …
PharmaShots’ Key Highlights of Second Quarter 2021 Read More »
New York’s sweeping lawsuit is the first opioid case in which a jury rather than a judge will decide the outcome.
New York’s sweeping lawsuit is the first opioid case in which a jury rather than a judge will decide the outcome.
New York’s sweeping lawsuit is the first opioid case in which a jury rather than a judge will decide the outcome.
The settlement agreement came just days before opening arguments in a sweeping trial of several defendants, including the company.
The settlement agreement came just days before opening arguments in a sweeping trial of several defendants, including the company.
The settlement agreement came just days before opening arguments in a sweeping trial of several defendants, including the company.
The agency has not decided whether to allow a troubled vaccine factory in Baltimore to reopen.
Production problems and a brief pause on its use kept the one-dose vaccine from becoming the game changer that health officials across the country believed it would be.
The failings at a Baltimore, US factory making Johnson & Johnson’s COVID-19 vaccine mean that millions of doses of the shot will have to be jettisoned, according to an FDA update. The problems at the plant run by contract manufacturer Emergent BioSolutions first emerged a few weeks ago, after an FDA inspection uncovered a string …
J&J must ditch 60m COVID jabs made at US plant, but 10m are okay, says FDA Read More »
The agency has not decided whether to allow a troubled vaccine factory in Baltimore to reopen.
Pharmaceutical Manufacturing & Packaging Congress (PHARMAP 2021) will be held on the 28th – 29th of June, 2021 at the BGS online platform. CIOs and directors of pharmaceutical companies and laboratories, research and manufacturing directors, clinicians, IT project managers, heads from manufacturing and packaging pharma technology companies will gather to discuss the Manufacturing and Packaging …
Pharmaceutical Manufacturing and Packaging Congress 2021 Read More »
Belgian biotech Argenx has lost its development partner for acute myeloid leukaemia antibody cusatuzumab, after Johnson & Johnson backed away from the alliance after two and a half years. J&J’s Cilag unit – part of its Janssen pharma division – said this morning that it had decided not to continue the collaboration after a “review …
J&J backs out of $1.6bn blood cancer antibody alliance with Argenx Read More »
AstraZeneca has thrown down the gauntlet to AbbVie and Johnson & Johnson with new data for Calquence in chronic lymphocytic leukaemia (CLL) that it says show a safety advantage over Imbruvica – currently dominating the BTK inhibitor market. In the ELEVATE-RR study, Calquence (acalabrutinib) matched Imbruvica (ibrutinib) when it came to keeping adults with previously …
ASCO21: AZ seeks to supplant Imbruvica in CLL with new Calquence data Read More »
At this year’s BIO-Europe Spring Digital, pharmaphorum founder Dr. Paul Tunnah participated in an ‘In conversation’ chat with Nerida Scott, head of Johnson & Johnson Innovation, EMEA. Nerida discussed the latest trends in healthcare and how they’ve influenced Johnson & Johnson Innovation’s (JJI’s) approach to collaboration. She highlighted the importance of digital solutions and data …
BIO-Europe Spring Digital: Nerida Scott, J&J’s EMEA Innovation Head Read More »
With concern already growing about a possible third wave of COVID-19 infections, the UK has cleared the use of a fourth vaccine from Johnson & Johnson’s Janssen division. The Medicines and Healthcare products Regulatory Agency (MHRA) gave a green light to the single-dose Ad26.COV2.S vaccine in people aged 18 and over by referencing the decision …
Janssen COVID jab cleared in UK as fears of third wave mount Read More »
The single-dose vaccine becomes the fourth vaccine to be authorized for use in Britain.
The single-dose vaccine becomes the fourth vaccine to be authorized for use in Britain.
The single-dose vaccine becomes the fourth vaccine to be authorized for use in Britain.
Johnson & Johnson has secured a six-month FDA review for its multiple myeloma CAR-T therapy ciltacabtagene autoleucel (cilta-cel), narrowing the lead for Bristol-Myers Squibb and bluebird bio’s rival Abecma. The US regulator is now scheduled to complete its review of cilta-cel by 29 November for adults with relapsed and/or refractory multiple myeloma who have previously …
FDA sets November review date for J&J’s multiple myeloma CAR-T cilta-cel Read More »
Belgium’s Ministry of Health has paused dosing of people under the age of 41 with Johnson & Johnson’s one-shot COVID-19 vaccine, following the death of a woman from what appeared to be a blood clot-related condition. The unnamed woman – who was under the age of 40 – died on 21 May after being admitted …
Belgium halts dosing of J&J COVID vaccine in under 41s after death Read More »
With the ink barely dry on the FDA’s approval of Johnson & Johnson’s Rybrevant, its first bispecific antibody for cancer, the drugmaker is already showcasing others in its pipeline. Two of its earlier-stage bispecifics – both in development for the blood cancer multiple myeloma – will feature at the American Society of Clinical Oncology (ASCO) …
Straight after its first cancer bispecific OK, J&J highlights two more at ASCO Read More »
In an interview with PharmaShots, Dr. Allitia DiBernardo, Global Head of Medical Affairs for Neurology at the Janssen share her views on the availability of Ponvory in the US for MS patients. Shots: Ponvory offers patients superior efficacy in reducing annualized relapses and brain lesions over established oral therapy teriflunomide (Aubagio), with a safe and …
Johnson & Johnson subsidiary Janssen was awarded approval for Rybrevant, the latest in a string of decisions for targeted therapies for non-small cell lung cancer. Rybrevant is the first approved targeted therapy addressing a subset of patients whose disease is characterized by a particular mutation to cancer protein EGFR.
Johnson & Johnson’s Janssen division has claimed a first approval in the US for its bispecific antibody Rybrevant as a treatment for EGFR-mutated non-small cell lung cancer (NSCLC). Rybrevant (amivantamab) – originally developed by Danish biotech Genmab – has been cleared for NSCLC patients with exon 20 insertions, the third most common EGFR mutation in …
Janssen claims FDA okay for would-be Tagrisso rival Rybrevant Read More »
NICE has rejected Johnson & Johnson’s oral prostate cancer drug Erleada (apalutamide) in patients with hormone-relapsed or hormone sensitive disease in first draft guidance. The cost-effectiveness body is assessing Erleada, plus androgen deprivation therapy (ADT), for prostate cancer in adults who have hormone-relapsed non-metastatic disease at high risk of metastasising and hormone-sensitive metastatic disease. Hormone …
NICE rejects J&J’s prostate cancer drug Erleada in initial guidance Read More »
Emergent BioSolutions faces scrutiny in Congress for ruining Covid-19 vaccines and securing lucrative federal contracts. Executives will appear before some lawmakers who benefited from the company’s spending.
Emergent BioSolutions faces scrutiny in Congress for ruining Covid-19 vaccines and securing lucrative federal contracts. Executives will appear before some lawmakers who benefited from the company’s spending.
Es un inmenso problema: no hay suficientes vacunas y aún menos para los países pobres. ¿Tiene solución?
Es un inmenso problema: no hay suficientes vacunas y aún menos para los países pobres. ¿Tiene solución?
Es un inmenso problema: no hay suficientes vacunas y aún menos para los países pobres. ¿Tiene solución?
Es un inmenso problema: no hay suficientes vacunas y aún menos para los países pobres. ¿Tiene solución?
Es un inmenso problema: no hay suficientes vacunas y aún menos para los países pobres. ¿Tiene solución?
President Biden’s pledge to ship out doses that could have been used domestically was a step toward a global campaign, but activists say much more is needed.
President Biden’s pledge to ship out doses that could have been used domestically was a step toward a global campaign, but activists say much more is needed.
President Biden’s pledge to ship out doses that could have been used domestically was a step toward a global campaign, but activists say much more is needed.
President Biden’s pledge to ship out doses that could have been used domestically was a step toward a global campaign, but activists say much more is needed.
President Biden’s pledge to ship out doses that could have been used domestically was a step toward a global campaign, but activists say much more is needed.
When President Biden joined a push to set aside patents for Covid shots, he entered a roiling debate over how to ensure poor countries get enough vaccine.
When President Biden joined a push to set aside patents for Covid shots, he entered a roiling debate over how to ensure poor countries get enough vaccine.
When President Biden joined a push to set aside patents for Covid shots, he entered a roiling debate over how to ensure poor countries get enough vaccine.
The companies are supporting 12 culturally competent healthcare startups in a new accelerator. Two of them will get up to $200,000 in grant funding.
Millions of doses of Johnson & Johnson’s Covid-19 vaccine produced by Emergent BioSolutions have been held back in Europe, South Africa and Canada as a precaution.
Millions of doses of Johnson & Johnson’s Covid-19 vaccine produced by Emergent BioSolutions have been held back in Europe, South Africa and Canada as a precaution.
La pandemia se ha transformado en entretenimiento en Estados Unidos. Es una sociopatía supercapitalista y, también, prueba de que la experiencia pandémica ha sido deformada por internet.
La pandemia se ha transformado en entretenimiento en Estados Unidos. Es una sociopatía supercapitalista y, también, prueba de que la experiencia pandémica ha sido deformada por internet.
The step was taken after Health Canada learned that an active ingredient was made in a Baltimore plant with contamination problems.
Johnson & Johnson’s Janssen unit has filed for approval of its multiple myeloma CAR-T ciltacabtagene autoleucel in Europe, chasing after a rival therapy from Bristol-Myers Squibb. The BCMA-targeting CAR-T – also known as cilta-cel – has been filed with the EMA as a treatment for adults with relapsed/refractory multiple myeloma, an incurable form of blood …
Janssen files its first CAR-T therapy cilta-cel in Europe Read More »
Emergent BioSolutions’ C.E.O. announced several executive changes but vigorously defended the company, which is on track for record revenues.
Emergent BioSolutions’ C.E.O. announced several executive changes but vigorously defended the company, which is on track for record revenues.
Emergent BioSolutions’ C.E.O. announced several executive changes but vigorously defended the company, which is on track for record revenues.
It feels very American to turn the vaccine rollout into a branding spectacle rooted in the worship of pharmaceutical companies.
It feels very American to turn the vaccine rollout into a branding spectacle rooted in the worship of pharmaceutical companies.
BMS’ Opdivo + Yervoy and Onureg Receive EC’s CHMP Positive Opinion for MPM and AML Published: Apr 23, 2021 | Tags: BMS, Opdivo, Yervoy, Onureg, Receive, EC, CHMP, Positive Opinion, MPM, AML Gilead Reports NDA Submission of Filgotinib to PMDA for Ulcerative Colitis in Japan Published: Apr 23, 2021 | Tags: Gilead, Reports, NDA, Submission, …
PharmaShots Weekly Snapshots (Apr 19 – 23, 2021) Read More »
Shots: The P-III ENSEMBLE trial involves assessing COVID-19 vaccine vs PBO in 43,783 enrolled participants aged ≥18yrs. with both mod. and sev. COVID-19 disease The trial met all 1EP & 2EPs i.e 85% efficacy in preventing disease, vaccine efficacy was consistent against symptomatic infection including in South Africa and Brazil that showed a high prevalence …
Johnson & Johnson Publishes Results of COVID-19 Single Shot Vaccine in NEJM Read More »
Emergent BioSolutions’ difficult month has been made worse by an FDA report into its facility in Baltimore, which has been blamed for the wastage of millions of doses of Johnson & Johnson’s COVID-19 vaccine. The US regulator says it completed an inspection of the Bayview plant run by the contract manufacturing organisation (CMO) which uncovered …
FDA pens stinging report on Emergent COVID vaccine plant Read More »
Last month, up to 15 million doses of Johnson & Johnson’s vaccine had to be discarded at Emergent’s factory in Baltimore. A new report says problems were not fully investigated and other doses may be compromised.
Last month, up to 15 million doses of Johnson & Johnson’s vaccine had to be discarded at Emergent’s factory in Baltimore. A new report says problems were not fully investigated and other doses may be compromised.
The benefits of Johnson & Johnson’s COVID-19 vaccine outweigh a tiny risk of unusual blood clots forming, Europe’s drugs regulator has said. In a decision that will allow the rollout of vaccines in certain EU states, the European Medicines Agency’s safety committee said there appears to be a link to unusual blood clots combined with …
EU safety regulators clear J&J COVID shot despite tiny clot risk Read More »
The European Union drug regulator said that the Johnson and Johnson vaccine should carry a warning of potential risk for rare blood clots on the label, but did not recommend stopping the vaccine, saying the benefits of the vaccine outweighed the risks.
Johnson & Johnson’s single-dose Covid-19 shots were halted across the United States on Tuesday after federal health agencies called for a pause in their use because of a rare blood clotting disorder in six people.
Johnson & Johnson’s single-dose Covid-19 shots were halted across the United States on Tuesday after federal health agencies called for a pause in their use because of a rare blood clotting disorder in six people.
Blood clots found in six people given Johnson & Johnson’s Covid-19 vaccine have led federal health officials to recommend a pause on dosing with that shot. A CDC advisory committee on vaccine practices is meeting Wednesday to review the cases, which so appear similar cases observed in Europe with AstraZeneca’s vaccine.
Confusion over AstraZeneca’s vaccine threatens to hurt the E.U. campaign just as it gathers momentum. And on Tuesday, Johnson & Johnson said it was pausing the rollout of its shot on the continent.
Confusion over AstraZeneca’s vaccine threatens to hurt the E.U. campaign just as it gathers momentum. And on Tuesday, Johnson & Johnson said it was pausing the rollout of its shot on the continent.
Federal health agencies made the decision to halt the use of the Johnson and Johnson vaccine after six women between the ages of 18 and 48 experienced blood clots within one to three weeks of vaccination.
Confusion over AstraZeneca’s vaccine threatens to hurt the E.U. campaign just as it gathers momentum. And on Tuesday, Johnson & Johnson said it was pausing the rollout of its shot on the continent.
US health authorities have recommended pausing dosing with Johnson & Johnson’s COVID-19 vaccine as they investigate cases of blood clots also observed in some people taking the AstraZeneca shot. The FDA said there had been reports of six cases of cerebral venous sinus thrombosis (CVST) associated with low blood platelet counts (thrombocytopenia) out of more …
US seeks halt on J&J COVID vaccine rollout as clot concerns spread Read More »
With supplies from Johnson & Johnson set to fall 86 percent, a White House official warned that the vaccine would be scarce until a troubled Baltimore plant gains regulatory approval.
An Operation Warp Speed report last June flagged staffing and quality control concerns at Emergent BioSolutions’ factory in Baltimore. The troubled plant recently had to throw out up to 15 million doses.
An Operation Warp Speed report last June flagged staffing and quality control concerns at Emergent BioSolutions’ factory in Baltimore. The troubled plant recently had to throw out up to 15 million doses.
An Operation Warp Speed report last June flagged staffing and quality control concerns at Emergent BioSolutions’ factory in Baltimore. The troubled plant recently had to throw out up to 15 million doses.
AstraZeneca is shifting production of its COVID-19 vaccine away from a plant in Baltimore which also makes Johnson & Johnson’s shot, after human error resulted in the contamination of 15 million doses. The mix-up at the facility operated by contract manufacturer Emergent BioSolutions resulted in ingredients destined for AZ’s AZD1222 jab being mixed into vials …
AZ exits US vaccine plant after mix-up spoils J&J’s COVID jab Read More »
The EU looks set to approve emergency use of a third antibody therapy for COVID-19 after its human medicines committee backed use of Celltrion’s regdanvimab at its March meeting. Regdanvimab (CT-P59) – which is currently under a rolling review at the EMA – can be used for the treatment of COVID-19 in adults who don’t …
CHMP backs Celltrion’s regdanvimab antibody for COVID-19 Read More »
Shots: The MHLW has approved Acuvue Theravision with Ketotifen as the first combination contact lens that provides vision correction and an antihistamine drug to relieve symptoms for people experiencing itchy allergy eyes Data demonstrated that 8 out of 10 contact lens wearers feel frustrated when their eye allergies interfere with normal contact lens wear. The …
Takeda Collaborates with Anima to Discover and Develop mRNA Translation Modulators for Neurological Diseases Published: Mar 19, 2021 | Tags: Takeda, Collaborates, Anima, Discover, Develop, mRNA Translation Modulators, Neurological Diseases Kiniksa’s Arcalyst (rilonacept) Receives the US FDA’s Approval for the Treatment of Pericarditis Published: Mar 19, 2021 | Tags: Kiniksa, Arcalyst (rilonacept), Receives, US, FDA, …
PharmaShots Weekly Snapshots (Mar 15 – 19, 2021) Read More »
Takeda Collaborates with Anima to Discover and Develop mRNA Translation Modulators for Neurological Diseases Published: Mar 19, 2021 | Tags: Takeda, Collaborates, Anima, Discover, Develop, mRNA Translation Modulators, Neurological Diseases Kiniksa’s Arcalyst (rilonacept) Receives the US FDA’s Approval for the Treatment of Pericarditis Published: Mar 19, 2021 | Tags: Kiniksa, Arcalyst (rilonacept), Receives, US, FDA, …
PharmaShots Weekly Snapshots (Mar 15 – 19, 2021) Read More »
The EU’s medicines regulator has recommended granting conditional approval to a fourth COVID-19 vaccine – a single-dose shot from Johnson & Johnson’s Janssen unit – after a review by its human medicines committee. The CHMP has concluded that the Ad26.COV2.S vaccine can be used in people aged over 18, saying that “the data on the …
J&J’s COVID-19 shot backed for emergency use in EU Read More »
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 …
Trump administration officials grumble that they laid the groundwork for surging vaccinations, but some hard work in the trenches has helped pick up the pace of production.
Eli Lilly and Incyte Report Results of Olumiant (baricitinib) in P-III BRAVE-AA2 Study for Severe Alopecia Areata Published: Mar 5, 2021 | Tags: Eli Lilly and Incyte, Report, Results, Olumiant (baricitinib), P-III, BRAVE-AA2, Study, Severe, Alopecia Areata Takeda Reports NDA Submission to Import and Distribute Moderna’s mRNA-1273 in Japan Published: Mar 5, 2021 | Tags: …
PharmaShots Weekly Snapshots (Mar 01 – 05, 2021) Read More »
Johnson & Johnson’s one-shot vaccine is allowing states to rethink distribution, even as health officials and experts worry some will view it as inferior.
As President Biden accelerates plans for manufacturing vaccines and several states move to reopen, we check in on the virus.
As President Biden accelerates plans for manufacturing vaccines and several states move to reopen, we check in on the virus.
As President Biden accelerates plans for manufacturing vaccines and several states move to reopen, we check in on the virus.
President Biden used the Defense Production Act to direct Merck to convert two of its facilities into production sites for Johnson & Johnson’s Covid-19 vaccine. In addition, he said J&J will run its own vaccine production sites 24/7.
The pharmaceutical giant Merck & Co. agreed to help manufacture Johnson & Johnson’s coronavirus vaccine, in a deal partly brokered by the White House.
Much is still to be determined about how this new tool will be used, but some things are already clear.
Much is still to be determined about how this new tool will be used, but some things are already clear.
Much is still to be determined about how this new tool will be used, but some things are already clear.
Much is still to be determined about how this new tool will be used, but some things are already clear.
Shots: The FDA has issued a EUA for a single-shot COVID-19 vaccine to prevent COVID-19 in individuals aged ≥18yrs. The company plans to file BLA to the US FDA in 2021 The EUA is based on a P-III ENSEMBLE study that demonstrated 85% efficacy in preventing severe disease across all regions and protect against COVID-19 …
Johnson & Johnson Receives the US FDA’s EUA for COVID-19 Vaccine Read More »
The company’s coming trials will also involve pregnant women and people whose immune systems are compromised.
The company’s coming trials will also involve pregnant women and people whose immune systems are compromised.
The FDA has approved emergency use of a third COVID-19 vaccine from Johnson & Johnson’s Janssen Biotech unit, the day after an advisory committee concluded it was safe and effective. Janssen’s Ad26.COV2.S vaccine has been authorised for use in people aged 18 or over after a “comprehensive evaluation of available safety, effectiveness and manufacturing quality …
FDA clears third emergency COVID-19 vaccine from J&J Read More »
The company’s coming trials will also involve pregnant women and people whose immune systems are compromised.
Johnson & Johsnon’s Covid-19 vaccine is now the third one granted FDA emergency authorization. The company expects to deliver enough vials to for vaccinating more than 200 million people in the U.S. by the middle of this year.
The committee voted 22-0 on the question of whether the benefits of Johnson & Johnson’s Covid-19 vaccine outweigh its risks. FDA emergency use authorization would bring the public a third vaccine for the novel coronavirus.
By most measures the single largest pharma company in the world, US-based Johnson & Johnson (J&J) is also arguably one of the most well-known drugmakers among the general public. Both these factors can be tied in part to J&J’s strong presence in the consumer sector – but behind household name products is a strong pharmaceutical …
Johnson & Johnson’s one-shot coronavirus vaccine is due to be reviewed by an FDA advisory committee on Friday, and according to the regulator meets the requirements for emergency use authorisation. In a briefing document published ahead of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting, the FDA says the Ad26.COV2.S vaccine – developed …
FDA reviewer backs J&J COVID jab for emergency OK Read More »
Shares in Swiss biotech AC Immune have risen sharply after it said a vaccine in development for Alzheimer’s disease (AD) hit the mark in a phase 1/2 trial. ACI-35.030, partnered with Johnson & Johnson, is designed to stimulate the body to generate antibodies against tau protein, one of the factors though to play a role …
Early data back J&J and AC Immune’s Alzheimer’s jab Read More »
Johnson & Johnson’s Covid-19 vaccine offers storage and distribution advantages compared to mRNA vaccines, and is the only single-shot vaccine to reach late-stage testing. The next stop is a Feb. 26 FDA advisory panel meeting.
Reistone Report Results for SHR0302 in P-II Study to Treat Ulcerative Colitis Published: Feb 5, 2020 | Tags: Reiston, Report, Result, SHR0302, P-II, Study, Treat, Ulcerative Colitis Enzene Receives Marketing Authorization for Teriparatide (biosimilar) in India Published: Feb 5, 2020 | Tags: Enzene, Receives, Marketing Authorization, Teriparatide (biosimilar), India Johnson & Johnson Reports EUA Submission …
Shots: The EUA submission is based on P-III ENSEMBLE trial assessing the safety and efficacy of the COVID-19 vaccine in protecting adults aged ≥18yrs. against both mod. and sev. COVID-19 disease with assessment of efficacy as of day 14 and as of day 28 as co-1EPs The study demonstrated that single-dose vaccine met all 1EPs …
Shots: The P-III ENSEMBLE trial to evaluate the efficacy and safety of Janssen’s COVID-19 vaccine candidate in protecting mod-to-severe COVID-19 in 43,783 participants accruing 468 symptomatic cases with assessment of efficacy as of day 14 and as of day 28 as co-primary endpoints Results: The level of protection against mod-to-severe COVID-19 infection was 72% in …
Johnson & Johnson Report Results from P-III ENSEMBLE Trial for COVID-19 Vaccine Read More »
Johnson & Johnson’s vaccine works, but it was less effective on a new, more contagious variant.
Johnson & Johnson’s vaccine works, but it was less effective on a new, more contagious variant.
Infectious disease doctors say getting a shot of the J&J vaccine, which has a lower efficacy against the virus than other vaccines, would still be well worthwhile.
The EMA has approved AstraZeneca’s COVID-19 vaccine for use in the EU in all adults aged over 18, despite assertions in Germany this week that it shouldn’t be used in elderly people. The conditional marketing authorisation makes AZD1222 the third coronavirus vaccine to be approved for EU use after the Pfizer/BioNTech and Moderna shots, and …
EMA approves AZ’s COVID-19 vaccine – including for over-65s Read More »
Data analytics startup Verana Health struck a partnership with Janssen Research & Development. They’ll focus on exploring better treatments for diabetic retinopathy and macular edema.
AstraZeneca’s fast-growing BTK inhibitor Calquence is already challenging class leader Imbruvica from Johnson & Johnson/AbbVie in the treatment of chronic lymphocytic leukaemia (CLL). Now, AZ has new data suggesting its drug is less likely to cause a serious cardiac side effect. The latest study in AZ’s ELEVATE trial series showed that Calquence (acalabrutinib) matched Imbruvica …
AZ says Calquence is a safer drug than Imbruvica Read More »
The FDA has approved Cabenuva, a long-acting HIV treatment from ViiV and Johnson & Johnson that keeps the virus at bay with a monthly injection instead of daily pill regimen. It follows a surprise rejection at the end of 2019, due to the information in the dossier related to chemistry, manufacturing and controls (CMC). The …
ViiV/J&J’s long-acting HIV regimen finally approved in US Read More »
One in 11 adults aged over 65 have reported a lack of willingness to receive a COVID-19 vaccine, according to a US-based survey. The findings are concerning given that adults in this group are at highest risk for complications from the disease. Findings from part of the Heartline clinical study, sponsored by Johnson & Johnson …
One in 11 over-65s unwilling to take COVID-19 shot Read More »
Johnson & Johnson’s Darzalex Faspro has become the first product approved by the FDA to treat light chain (AL) amyloidosis, a rare and often fatal blood cell disorder. The new indication is the second for Darzalex Faspro, a subcutaneous version of blockbuster intravenous therapy Darzalex (daratumumab) which is used to treat multiple myeloma on its …
J&J’s Darzalex Faspro is first US therapy for rare blood disorder Read More »
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 readout due later this month. The UK has caused controversy in recent weeks by tinkering with the dosing regimens for coronavirus vaccines from AstraZeneca and Pfizer/BioNTech, which are being rolled …
J&J single-shot COVID-19 vaccine shows early promise Read More »
US cost effectiveness watchdog ICER found 10 examples of substantial price rises for top-selling medicines in 2019, and concluded that seven of those were not backed by any clinical evidence. The cost to the American taxpayer from those increases? Around $1.2 billion for the seven drugs alone, says the organisation, which also found that for …
Amgen’s Enbrel heads ICER list of unjustified US price rises Read More »
Scientists have developed dozens of Covid vaccines at record speed. Here are the leading products.
Scientists have developed dozens of Covid vaccines at record speed. Here are the leading products.
Scientists have developed dozens of Covid vaccines at record speed. Here are the leading products.
Scientists have developed dozens of Covid vaccines at record speed. Here are the leading products.
Scientists have developed dozens of Covid vaccines at record speed. Here are the leading products.
Biopharma merger and acquisition activity in 2020 was mainly filled with late-stage, bolt-on acquisitions, which were orders of magnitude smaller than the mega M&A deals of prior years. AstraZeneca holds the top rank by acquiring Alexion Pharmaceuticals among the top 20 acquisitions with a total deal value of $39B at a 1-day premium of 45% …
Top 20 Biopharma M&A of 2020 by Total Deal Value Read More »
The company agreed to deliver the additional doses of its coronavirus vaccine by the end of July, helping address a looming shortage.
The company could provide at least tens of millions of additional doses of a coronavirus vaccine under an agreement that would give it better access to the supplies it needs to expand manufacturing.
The company could provide at least tens of millions of additional doses of a coronavirus vaccine under an agreement that would give it better access to the supplies it needs to expand manufacturing.
The company could provide at least tens of millions of additional doses of a coronavirus vaccine under an agreement that would give it better access to the supplies it needs to expand manufacturing.
The company could provide at least tens of millions of additional doses of a coronavirus vaccine under an agreement that would give it better access to the supplies it needs to expand manufacturing.
Johnson & Johnson’s Janssen unit has filed a rolling submission for its multiple myeloma CAR-T ciltacabtagene autoleucel (cilta-cel) to the FDA, in hot pursuit of Bristol-Myers Squibb’s delayed rival therapy. Cilta-cel – which targets B-cell maturation antigen (BCMA) – has been submitted as a treatment for patients with relapsed or refractory myeloma, an incurable form …
Chasing BMS, J&J files BCMA CAR-T for multiple myeloma to FDA Read More »
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.
The Trump administration is discussing helping the drug maker get the raw materials it would need to produce tens of millions of extra doses of its Covid-19 vaccine in the spring.
Queasy Americans, fighting upset stomachs and worries about the pandemic, have stocked up on prescription and over-the-counter medications, making them scarce in some parts of the country.
Eli Lilly’s buyout of Loxo Oncology last year has already yielded one approved drug, and it now has a path to market for a second after BTK inhibitor LOXO-305 after reporting promising data at the American Society of Haematology (ASH) meeting. Updated results from the phase 1/2 BRUIN trial suggest that LOXO-305 could become a …
ASH: Lilly builds case for its BTK drug LOXO-305 in lymphoma Read More »
Johnson & Johnson has filed its bispecific antibody amivantamab to the FDA, hoping to muscle into the big market for drugs that are used to treat EGFR-positive non-small cell lung cancer (NSCLC). J&J’s Janssen unit is seeking approval of the drug in a specific patient group – those with exon 20 insertion mutations whose disease …
J&J files lung cancer bispecific amivantamab for FDA approval Read More »
Johnson & Johnson’s pharma unit Janssen has bought rights to an investigational gene therapy for a severe form age-related macular degeneration from specialist biotech Hemera Biosciences. Financial details of the deal have not been disclosed and will add Hemera’s gene therapy HMR59 to Janssen’s pipeline of ophthalmology drugs. The privately-held biotech has developed the gene …
Janssen adds Hemera’s AMD gene therapy to pipeline Read More »
Shots: In addition to the single-dose regimen ENSEMBLE study, Janssen has now initiated the two-dose regimen ENSEMBLE 2 trial in collaboration with the UK NIHR The P-lll ENSEMBLE 2 study will evaluate the safety and efficacy of a two-dose regimen of the investigational Janssen vaccine for the prevention of COVID-19 in ~30,000 patients across the …
Johnson & Johnson Initiates Second Global P-III Study of its COVID-19 Vaccine Read More »
Johnson & Johnson has begun a second phase 3 trial of its potential COVID-19 vaccine, including sites in the UK, testing whether it works as a two-dose regimen. The company’s Janssen pharmaceuticals and vaccines unit has already begun the ENSEMBLE study testing the single-dose vaccine and plans to enrol up to 60,000 participants worldwide. It …
J&J begins trial of two-dose COVID-19 vaccine regimen Read More »
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 in vaccines need to be boosted, an expert noted.
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+: COVID-19 Healthcare News Monthly Updates – October 2020 Read More »
Bayer’s blockbuster ambitions for diabetic kidney disease (DKD) drug candidate finerenone look a lot firmer with the publication of data from the phase 3 FIDELIO-DKD trial. Bayer teased the top-line result from the study back in July, providing the first clue that its sizeable investment in the finerenone programme could pay off, but kept the …
Bayer data for kidney disease hope finerenone sets up filings Read More »
US trials of AstraZeneca’s experimental COVID-19 vaccine AZD1222 have been cleared to restart by the FDA, several weeks after testing was suspended following a serious adverse reaction in one patient who received the shot. Separately, Johnson & Johnson has also announced it is resuming recruitment in a phase 3 trial of its coronavirus candidate JNJ-78436735, …
AZ, J&J COVID-19 vaccine trials okay to restart in US Read More »
The European Commission has taken its advance orders for potential COVID-19 vaccines to more than 1.1 billion, after signing a supply deal for up to 400 million doses of Johnson & Johnson’s experimental candidate. The agreement is the third for coronavirus vaccine supply for the EU, coming after earlier deals with AstraZeneca and Sanofi/GlaxoSmithKline, and …
Johnson & Johnson has agreed to pay more than $100 million to settle over 1,000 lawsuits that allege the company’s Baby Powder talc products caused cancer, according to Bloomberg. Citing people close to the matter, the news agency said the settlement marks the first time that J&J has opted to settle litigation in bulk, rather …
J&J settles 1,000 talc lawsuits for $100m+; report Read More »
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 »
The drugmaker emphasized the full global rights it would acquire to Momenta’s lead asset, nipocalimab, which it is developing for several autoantibody-driven diseases and that in certain indications could have peak sales of more than $1 billion.
Johnson & Johnson is to buy Momenta Pharmaceuticals for $6.5 billion, adding potential inflammatory diseases blockbuster nipocalimab to the pipeline at its Janssen pharmaceuticals unit. J&J thinks that Momenta’s lead drug nipocalimab could be a kind of Swiss army knife drug that could be used across a range of inflammatory diseases including maternal-foetal disorders, neuro-inflammatory …
J&J pays $6.5bn for Momenta and its inflammatory disease hopeful Read More »
Shots: J&J acquires Momenta in all-cash transaction at a price of $52.50/ share, making a total deal value as $6.5B. The transaction is expected to be closed in H2’20 The acquisition allows J&J to expand its portfolio for autoimmune diseases with the addition of Momenta’s Nipocalimab (M281) to its pipeline. In addition to nipocalimab, Janssen …
Johnson & Johnson to Acquire Momenta Pharmaceuticals for $6.5B Read More »
The UK is to buy millions more doses of potential coronavirus vaccines from Johnson & Johnson and Novavax, with the latter expanding its manufacturing operation in the country. Johnson & Johnson’s Janssen pharmaceuticals unit will supply an initial 30 million doses on a not-for-profit basis for emergency use in the pandemic, with an option for …
UK signs coronavirus vaccine deals with J&J and Novavax Read More »
Shots: The EC has the contractual framework in place to purchase the initial 200M doses on behalf of all EU Member States once the vaccine has proven safe and effective. The agreement includes an option to purchase up to an additional 200M dose If approved, the EC expects to facilitate a process for the allocation …
EC Concludes Exploratory Talks with J&J to Supply 200M Doses of COVID-19 Vaccine Read More »
Shots: The US government will pay over $1B for 100M doses of its potential COVID-19 vaccine, Ad26.COV2.S, for use in the US following the US FDA’s EUA The government may also purchase additional 200M doses of Ad26.COV2.S under a subsequent agreement. The company is evaluating one- and two-dose regimens, in its clinical program for the global …
Under the agreement with BARDA and the Department of Defense, the drugmaker would supply 100 million doses of its vaccine, for which it published preclinical data last and is currently running a first-in-human clinical trial.
Shots: J&J’s Ad26 vector-based vaccine demonstrated robust immune response in the pre-clinical study by neutralizing Abs, preventing infection and provide complete/ near-complete protection in the lungs from the virus in NHPs Based on the preclinical studies, the company has commenced the P-I/IIa study of Ad26.COV2.S, in healthy volunteers in the US and Belgium with expected …
The average life expectancy span of Human Beings are increased due to better medical facilities and drugs developed by Biopharma companies. Pharmaceutical products or drugs or medicines are being produced for a wide range of medical sectors. It includes the lifesaving drugs or the major therapy area including immunology, cardiology, and neurology but are they …
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