Johnson & Johnson

J&J mulls switch from non-profit status for COVID jab

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 »

F.D.A. to Allow ‘Mix and Match’ Approach for Covid Booster Shots

The agency may act this week, when it is expected to authorize booster shots for recipients of the Moderna and Johnson & Johnson vaccines.

FDA panel backs booster shot for J&J COVID-19 vaccine

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 »

FDA panel supports J&J Covid-19 vaccine booster; no vote on mixing and matching

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.

F.D.A. Vaccine Booster Panel: Here’s Who Is on the Roster

The experts’ recommendations, though not binding, are likely to influence what the Food and Drug Administration decides on whether to authorize the boosters.

J&J’s long-serving R&D chief Paul Stoffels announces retirement

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 »

J&J joins COVID-19 booster shot drive, filing with FDA

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 »

Johnson & Johnson Reports EUA Submission to the US FDA for Supporting the Booster of its Single Shot COVID-19 Vaccine Candidate

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 …

Johnson & Johnson Reports EUA Submission to the US FDA for Supporting the Booster of its Single Shot COVID-19 Vaccine Candidate Read More »

Johnson & Johnson to Seek F.D.A. Authorization for Booster Shot

The request, expected this week, comes after a study found the company’s vaccine was only 71 percent effective against hospitalization from Covid-19.

J&J commits $125M in bet that Xencor’s bispecific antibody has an edge in blood cancers

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.

J&J bulks up in bispecifics with $1.3bn Xencor alliance

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 »

Johnson & Johnson to Seek F.D.A. Authorization for Booster Shot

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 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 »

Preparing for a post-pandemic world

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 …

Preparing for a post-pandemic world Read More »

NICE changes its mind on J&J’s Erleada in prostate cancer

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 »

PharmaShots Weekly Snapshots (August 30 – September 03, 2021)

Forte’s FB-401 Fails to Meet Primary Endpoints in P-II Clinical Trial For the Treatment of Atopic Dermatitis Published: Sept 3, 2021 | Tags: Forte, FB-401, P-II, Clinical Trial, Atopic Dermatitis Novartis Cosentyx (secukinumab) Receives NICE Recommendation for Patients with Plaque Psoriasis Published: Sept 3, 2021 | Tags: Novartis, Cosentyx, secukinumab, NICE Recommendation, Plaque Psoriasis Pfizer …

PharmaShots Weekly Snapshots (August 30 – September 03, 2021) Read More »

PharmaShots Weekly Snapshots (August 30 – September 03, 2021)

Forte’s FB-401 Fails to Meet Primary Endpoints in P-II Clinical Trial For the Treatment of Atopic Dermatitis Published: Sept 3, 2021 | Tags: Forte, FB-401, P-II, Clinical Trial, Atopic Dermatitis Novartis Cosentyx (secukinumab) Receives NICE Recommendation for Patients with Plaque Psoriasis Published: Sept 3, 2021 | Tags: Novartis, Cosentyx, secukinumab, NICE Recommendation, Plaque Psoriasis Pfizer …

PharmaShots Weekly Snapshots (August 30 – September 03, 2021) Read More »

Pfizer raises pressure on GSK, J&J with late-stage RSV vaccine trial

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 »

FDA clears J&J’s twice-yearly Invega for schizophrenia

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 »

NICE rejects J&J’ Darzalex regimen for multiple myeloma

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 »

J&J lung cancer initiative will use Optellum’s ‘digital biomarker’ tech

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 »

Biden Falls Short on Pledge for U.S. to Be the World’s Vaccine ‘Arsenal,’ Experts Say

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.

Scant on details, J&J claims it has data supporting Covid-19 booster shots

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.

Theravance’s Janssen Biotech-partnered ulcerative colitis drug flops in Phase 2

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.

Alex Gorsky will pass leadership of J&J to Joaquin Duato in January

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 »

Covid Vaccines Produced in Africa Are Being Exported to Europe

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.

Some Are Chasing Extra Vaccine Shots, While Scientists Debate

Boosters may not be necessary yet, many experts say, and the pursuit of additional shots raises ethical questions.

F.D.A. Aims to Give Final Approval to Pfizer Vaccine by Early Next Month

The Food and Drug Administration’s move is expected to kick off more vaccination mandates for hospital workers, college students and federal troops.

F.D.A. Aims to Give Final Approval to Pfizer Vaccine by Early Next Month

The Food and Drug Administration’s move is expected to kick off more vaccination mandates for hospital workers, college students and federal troops.

U.S. Authorities Seek Documents From Troubled Covid Vaccine Manufacturer

Emergent BioSolutions, which ruined 75 million vaccine doses at its Baltimore plant, disclosed records requests from Congress and federal and state law enforcement agencies.

U.S. Authorities Seek Documents From Troubled Covid Vaccine Manufacturer

Emergent BioSolutions, which ruined 75 million vaccine doses at its Baltimore plant, disclosed records requests from Congress and federal and state law enforcement agencies.

Some Are Chasing Extra Vaccine Shots, While Scientists Debate

Boosters may not be necessary yet, many experts say, and the pursuit of additional shots raises ethical questions.

Johnson & Johnson podría ser menos eficaz contra la variante delta

Muchos de los que recibieron la vacuna pueden necesitar refuerzos, dijeron los autores. Pero las autoridades sanitarias federales no recomiendan segundas dosis.

Johnson & Johnson podría ser menos eficaz contra la variante delta

Muchos de los que recibieron la vacuna pueden necesitar refuerzos, dijeron los autores. Pero las autoridades sanitarias federales no recomiendan segundas dosis.

Drug Distribution Companies to Pay N.Y. More Than $1 Billion to Settle Opioid Lawsuit

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.

Is J&J nearing the end of its opioid liability hangover?

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 »

States and Cities Near Tentative $26 Billion Deal in Opioids Cases

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.

Drug Companies to Pay N.Y. More Than $1 Billion to Settle Opioid Lawsuit

Three drug distributors and Johnson & Johnson are also on the verge of a $26 billion deal to settle the thousands of nationwide lawsuits.

States and Cities Near Tentative $26 Billion Deal in Opioids Cases

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.

PharmaShots Weekly Snapshots (July 12 – 16, 2021)

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 second Zytiga rejection ‘shows need for flexible pricing models’

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 »

FDA update warns of potential rare nerve side effect for J&J Covid vaccine

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.

F.D.A. Attaches Warning of Rare Nerve Syndrome to Johnson & Johnson Covid Vaccine

Federal regulators concluded that the risk of developing the syndrome was low, and that the benefits of the vaccine still strongly outweigh it.

Emergent BioSolutions Faces Investor Revolt Over Botched Vaccines

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.

Biotech Company That Botched Vaccines Faces Investor Revolt

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.

PharmaShots’ Key Highlights of Second Quarter 2021

The second quarter of 2021 witnesses major acquisitions, approvals, and clinical data. There are major alliances in this quarter which include Merck signed ~$1.2B supply agreement with US Government for Molnupiravir to treat COVID-19 The big acquisition took place during the quarter including Microsoft acquired Nuance for ~$19.7B, MorphoSys acquired Constellation for ~$1.7B Our team …

PharmaShots’ Key Highlights of Second Quarter 2021 Read More »

Major Trial Against Opioid Suppliers Begins in New York

New York’s sweeping lawsuit is the first opioid case in which a jury rather than a judge will decide the outcome.

Major Trial Against Opioid Suppliers Begins in New York

New York’s sweeping lawsuit is the first opioid case in which a jury rather than a judge will decide the outcome.

Major Trial Against Opioid Suppliers Begins in New York

New York’s sweeping lawsuit is the first opioid case in which a jury rather than a judge will decide the outcome.

High Hopes for Johnson & Johnson’s Covid Vaccine Have Fizzled in the U.S.

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.

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

The failings at a Baltimore, US factory making Johnson & Johnson’s COVID-19 vaccine mean that millions of doses of the shot will have to be jettisoned, according to an FDA update. The problems at the plant run by contract manufacturer Emergent BioSolutions first emerged a few weeks ago, after an FDA inspection uncovered a string …

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

Pharmaceutical Manufacturing and Packaging Congress 2021

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 »

J&J backs out of $1.6bn blood cancer antibody alliance with Argenx

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 »

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

AstraZeneca has thrown down the gauntlet to AbbVie and Johnson & Johnson with new data for Calquence in chronic lymphocytic leukaemia (CLL) that it says show a safety advantage over Imbruvica – currently dominating the BTK inhibitor market. In the ELEVATE-RR study, Calquence (acalabrutinib) matched Imbruvica (ibrutinib) when it came to keeping adults with previously …

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

BIO-Europe Spring Digital: Nerida Scott, J&J’s EMEA Innovation Head

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 »

Janssen COVID jab cleared in UK as fears of third wave mount

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 »

FDA sets November review date for J&J’s multiple myeloma CAR-T cilta-cel

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 halts dosing of J&J COVID vaccine in under 41s after death

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 »

Straight after its first cancer bispecific OK, J&J highlights two more at ASCO

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 »

ViewPoints Interview: Janssen’s Dr. Allitia DiBernardo Shares Insights on the Availability of Ponvory in the US

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 …

ViewPoints Interview: Janssen’s Dr. Allitia DiBernardo Shares Insights on the Availability of Ponvory in the US Read More »

FDA approval of J&J drug is first for lung cancer with particular genetic mutation

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.

Janssen claims FDA okay for would-be Tagrisso rival Rybrevant

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 rejects J&J’s prostate cancer drug Erleada in initial guidance

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 »

Troubled Vaccine Maker and Its Founder Gave $2 Million in Political Donations

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.

Troubled Vaccine Maker and Its Founder Gave $2 Million in Political Donations

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.

¿Qué se necesita para vacunar a todo el mundo contra la covid?

Es un inmenso problema: no hay suficientes vacunas y aún menos para los países pobres. ¿Tiene solución?

¿Qué se necesita para vacunar a todo el mundo contra la covid?

Es un inmenso problema: no hay suficientes vacunas y aún menos para los países pobres. ¿Tiene solución?

¿Qué se necesita para vacunar a todo el mundo contra la covid?

Es un inmenso problema: no hay suficientes vacunas y aún menos para los países pobres. ¿Tiene solución?

¿Qué se necesita para vacunar a todo el mundo contra la covid?

Es un inmenso problema: no hay suficientes vacunas y aún menos para los países pobres. ¿Tiene solución?

¿Qué se necesita para vacunar a todo el mundo contra la covid?

Es un inmenso problema: no hay suficientes vacunas y aún menos para los países pobres. ¿Tiene solución?

Why Vaccinating the World Against Covid-19 Will Be Hard

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.

Why Vaccinating the World Against Covid-19 Will Be Hard

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.

Why Vaccinating the World Against Covid-19 Will Be Hard

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.

J&J, Village Capital unveil 12 startups building culturally competent care in new accelerator

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. 

Baltimore Vaccine Plant’s Troubles Ripple Across Africa, Europe and Canada

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.

Janssen files its first CAR-T therapy cilta-cel in Europe

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 »

PharmaShots Weekly Snapshots (Apr 19 – 23, 2021)

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 »

Johnson & Johnson Publishes Results of COVID-19 Single Shot Vaccine in NEJM

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 »

FDA pens stinging report on Emergent COVID vaccine plant

Emergent BioSolutions’ difficult month has been made worse by an FDA report into its facility in Baltimore, which has been blamed for the wastage of millions of doses of Johnson & Johnson’s COVID-19 vaccine.  The US regulator says it completed an inspection of the Bayview plant run by the contract manufacturing organisation (CMO) which uncovered …

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

Federal Inspectors Fear More Vaccines Exposed to Contamination

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.

Federal Inspectors Say More Vaccines at Troubled Plant May Be Contaminated

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.

EU safety regulators clear J&J COVID shot despite tiny clot risk

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 »

FDA & CDC “pause” J&J Covid-19 vaccine to launch inquiry into rare blood clot cases

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.

US seeks halt on J&J COVID vaccine rollout as clot concerns spread

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 »

Emergent BioSolutions: Top Official Warned That Vaccine Plant Had to Be ‘Monitored Closely`

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.

Emergent BioSolutions: Top Official Warned That Vaccine Plant Had to Be ‘Monitored Closely`

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.

Top Official Warned That Covid Vaccine Plant Had to Be ‘Monitored Closely’

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.

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

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

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

CHMP backs Celltrion’s regdanvimab antibody for COVID-19

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 »

J&J Visions’ Acuvue Theravision with Ketotifen Receives MHLW’s Approval for Vision Correction and Allergic Eye Itch

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 …

J&J Visions’ Acuvue Theravision with Ketotifen Receives MHLW’s Approval for Vision Correction and Allergic Eye Itch Read More »

PharmaShots Weekly Snapshots (Mar 15 – 19, 2021)

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 »

PharmaShots Weekly Snapshots (Mar 15 – 19, 2021)

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 »

J&J’s COVID-19 shot backed for emergency use in EU

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 »

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 »

Biden Got the Vaccine Rollout Humming, With Trump’s Help

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.

PharmaShots Weekly Snapshots (Mar 01 – 05, 2021)

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

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

Biden Vows Enough Vaccine ‘for Every Adult American’ by End of May

The pharmaceutical giant Merck & Co. agreed to help manufacture Johnson & Johnson’s coronavirus vaccine, in a deal partly brokered by the White House.

Johnson & Johnson Receives the US FDA’s EUA for COVID-19 Vaccine

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 »

FDA clears third emergency COVID-19 vaccine from J&J

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 »

A history of Johnson & Johnson

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 …

A history of Johnson & Johnson Read More »

FDA reviewer backs J&J COVID jab for emergency OK

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 »

Early data back J&J and AC Immune’s Alzheimer’s jab

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 »

PharmaShots Weekly Snapshot (Feb 01-05, 2021)

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 …

PharmaShots Weekly Snapshot (Feb 01-05, 2021) Read More »

Johnson & Johnson Reports EUA Submission to US FDA’s for its Single Shot COVID-19 Vaccine Candidate

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 …

Johnson & Johnson Reports EUA Submission to US FDA’s for its Single Shot COVID-19 Vaccine Candidate Read More »

Johnson & Johnson Report Results from P-III ENSEMBLE Trial for COVID-19 Vaccine

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 »

EMA approves AZ’s COVID-19 vaccine – including for over-65s

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 »

AZ says Calquence is a safer drug than Imbruvica

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 »

ViiV/J&J’s long-acting HIV regimen finally approved in US

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 over-65s unwilling to take COVID-19 shot

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 »

J&J’s Darzalex Faspro is first US therapy for rare blood disorder

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 single-shot COVID-19 vaccine shows early promise

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 »

Amgen’s Enbrel heads ICER list of unjustified US price rises

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 »

Top 20 Biopharma M&A of 2020 by Total Deal Value

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 »

U.S. and Pfizer Seal Deal for 100 Million More Vaccine Doses

The company agreed to deliver the additional doses of its coronavirus vaccine by the end of July, helping address a looming shortage.

Pfizer Nears Deal to Provide More Vaccine Doses

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.

Pfizer Nears Deal to Provide More Vaccine Doses

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.

Pfizer Nears Deal to Provide More Vaccine Doses

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.

Pfizer Nears Deal to Provide More Vaccine Doses

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.

Chasing BMS, J&J files BCMA CAR-T for multiple myeloma to FDA

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 »

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.

U.S. and Pfizer Are Negotiating Deal for More Vaccine Doses Next Year

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.

ASH: Lilly builds case for its BTK drug LOXO-305 in lymphoma

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 »

J&J files lung cancer bispecific amivantamab for FDA approval

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 »

Janssen adds Hemera’s AMD gene therapy to pipeline

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 »

Johnson & Johnson Initiates Second Global P-III Study of its COVID-19 Vaccine

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 »

J&J begins trial of two-dose COVID-19 vaccine regimen

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 »

With 90% efficacy against Covid-19, Pfizer/BioNTech’s vaccine jumps ahead in global race

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.

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

Bayer data for kidney disease hope finerenone sets up filings

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 »

AZ, J&J COVID-19 vaccine trials okay to restart in US

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 »

EU ramps up supply of COVID-19 vaccine, drugs

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 …

EU ramps up supply of COVID-19 vaccine, drugs Read More »

J&J settles 1,000 talc lawsuits for $100m+; report

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 »

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 »

J&J to buy Momenta Pharmaceuticals for $6.5B

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.

J&J pays $6.5bn for Momenta and its inflammatory disease hopeful

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 »

Johnson & Johnson to Acquire Momenta Pharmaceuticals for $6.5B

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 »

UK signs coronavirus vaccine deals with J&J and Novavax

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 »

EC Concludes Exploratory Talks with J&J to Supply 200M Doses of COVID-19 Vaccine

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 »

Johnson & Johnson Signs an Agreement with the US Government to Supply 100M Doses of COVID-19 Vaccine Worth ~$1B

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 …

Johnson & Johnson Signs an Agreement with the US Government to Supply 100M Doses of COVID-19 Vaccine Worth ~$1B Read More »

Johnson & Johnson Initiates P-I/IIa Study of its Ad26.COV2.S Against COVID-19 in the US and Belgium

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 …

Johnson & Johnson Initiates P-I/IIa Study of its Ad26.COV2.S Against COVID-19 in the US and Belgium Read More »

Top 20 Prescription Drugs Based on 2019 Revenue

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 …

Top 20 Prescription Drugs Based on 2019 Revenue Read More »