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Johnson & Johnson Seeks Approval for Darzalex Faspro Combo in Newly Diagnosed Multiple Myeloma

Pharmaceutical Executive Editorial Staff Darzalex Faspro has previously been approved by the FDA for eight indications in multiple myeloma. The FDA will evaluate Johnson & Johnson’s supplemental Biologics License Application (sBLA) for Darzalex Faspro (daratumumab and hyaluronidase-fihj) with bortezomib, lenalidomide, and dexamethasone (D-VRd) for induction and consolidation therapy and in combination with lenalidomide (D-R) for the maintenance treatment of adults newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant (ASCT).1 Darzalex Faspro, a CD38-directed antibody, has previously been approved by the FDA for eight indications in multiple myeloma, with three in the frontline treatment of newly diagnosed patients who are transplant eligible or ineligible. “We are committed to changing the course of multiple myeloma through building combination regimens such as D-VRd with complementary mechanisms of action. The Darzalex Faspro-based quadruplet therapy demonstrated a clinically significant reduction in the risk of progression or death for transplant-eligible, newly ...
- Source: drugdu
- 129
- February 2, 2024
//www.fiercepharma.com/pharma/johnson-johnson-settles-talc-consumer-protection-claims-42-states-700m

For more than 2 years, Johnson & Johnson has been plotting its future as a two-sector company. In the wake of the company’s consumer healthcare spinoff last summer, the company’s fourth-quarter results offer plenty of signs of life from the new-look J&J.After wrapping up 2023 with a total haul of $85.2 billion, the company is heading into 2024 with “multiple catalysts for growth,” CEO Joaquin Duato said on J&J’s fourth-quarter and full-year earnings conference call. Across J&J’s innovative medicines portfolio, the company’s oncology and immunology medicines generated the lion’s share of sales in 2023’s fourth quarter, helping the unit achieve operational growth in the U.S. of 9.5% during the period. Worldwide, J&J’s pharma business reeled in $13.72 billion during the fourth quarter, a 4% increase from the same period in 2022.On the immunology front, J&J’s antibody blockbuster Stelara grew its market share and demonstrated continued strength in inflammatory bowel disease (IBD), J&J said in ...
- Source: drugdu
- 84
- January 25, 2024
Johnson & Johnson inks $700M deal to resolve talc consumer protection claims from 42 states

After failing to resolve a mountain of talcum-powder lawsuits through two unsuccessful bankruptcy attempts, Johnson & Johnson has agreed to a $700 million settlement that would free the company from some consumer protection claims—and a small part of the talc litigation that it faces. J&J plans to pay $700 million to 42 states and the District of Columbia to settle claims that the company did not warn of the potential health risks posed by its talcum-based products, including its iconic Johnson’s Baby Powder.Bloomberg first revealed the agreement two weeks ago, with the company confirming the news to the Wall Street Journal on Tuesday. “Consistent with the plan we outlined last year, the company continues to pursue several paths to achieve a comprehensive and final resolution of the talc litigation,” J&J litigation chief Erik Haas said in an emailed statement confirming the report. “We will continue to address the claims of those who do not ...
- Source: drugdu
- 188
- January 25, 2024
Who is Tim Schmid, Johnson & Johnson MedTech’s new leader?

ohnson & Johnson MedTech Worldwide Chair Tim Schmid [Photo courtesy of Johnson & Johnson] Tim Schmid is the new worldwide chair of Johnson & Johnson MedTech and EVP of Johnson & Johnson (NYSE: JNJ)+ following Ashley McEvoy’s announcement today that she plans to resign from the world’s second-largest medical device manufacturer.“We are pleased to have the depth of talent at Johnson & Johnson that allows us to transition to Tim, a respected, results-driven and Credo-based leader,” J&J Chair and CEO Joaquin Duato said in a news release.McEvoy called Schmid “a trusted friend and partner” in a LinkedIn post announcing her resignation. Schmid has worked for New Brunswick, New Jersey-based J&J for three decades, most recently serving as group chair of J&J MedTech Asia Pacific (APAC).“During his tenure, the APAC region has delivered above-market growth and further strengthened our leadership position across multiple businesses,” J&J said. “Mr. Schmid has also been instrumental in elevating the role ...
- Source: drugdu
- 144
- October 27, 2023
After launch limitations, Johnson & Johnson exec touts manufacturing progress on CAR-T drug Carvykti

As Johnson & Johnson and Legend Biotech have sought to grow the reach of their multiple myeloma CAR-T drug Carvykti since winning FDA approval last year, they’ve occasionally run into manufacturing pitfalls. Now, with an eye on a big market expansion, J&J is laying out the state of its cell therapy production writ large. Over the past several months, J&J has been “progressively adding more and more capacity” to churn out Carvykti, John Reed, M.D., Ph.D., executive vice president of pharmaceuticals R&D, said on a Tuesday conference call. Aside from the company’s original launch site in New Jersey, Reed said J&J is close to having an additional Carvykti manufacturing site “up and rolling” in Belgium. The company also plans to boost output by leveraging excess capacity from Novartis under a relatively new partnership. Reed described the lentivirus portion of Carvykti as a “rate-limiting” component of the therapy. Lentiviral vectors are pricey delivery components used to ...
- Source: drugdu
- 110
- October 20, 2023
Johnson & Johnson slashes price of tuberculosis drug Sirturo after relinquishing patent protections

Seven weeks after saying it would allow generic competition for drug-resistant tuberculosis (TB) treatment Sirturo (bedaquiline) in low- and middle-income countries (LMICs), Johnson & Johnson has slashed its own drug’s price in those markets. Under the new pricing structure, J&J’s drug will cost $130 for a six-month course in LMICs, a 55% discount from its prior price. Lupin also has reduced the cost of its generic version of bedaquiline by 33% to $194. The United Nations-backed Stop TB Partnership revealed the new prices on Wednesday. Last month, J&J said it would not enforce secondary patents on Sirturo in LMICs, paving the way for generic competition in many countries around the globe. The primary patent for Sirturo—which in 2012 became the first new TB drug approved in more than four decades—expired last month. But J&J had also patented improvements to its formulation, extending its protection for Sirturo into 2027. The reduced ...
- Source: drugdu
- 165
- September 4, 2023
Chasing AstraZeneca and Pfizer, Johnson & Johnson snags FDA nod for prostate cancer combo Akeega

Following FDA approvals for fellow PAPR inhibitors made by AstraZeneca/Merck and Pfizer, Johnson & Johnson has got its own combo approval in prostate cancer. The tablet treatment, known commercially as Akeega, combines J&J’s androgen-directed Zytiga (abiraterone acetate) and the PARP inhibitor niraparib, which is sold by GSK as Zejula in other indications. The FDA has signed off on its use along with the corticosteroid prednisone, but only in a subset of mCRPC patients—those with BRCA mutations. Akeega will compete with AstraZeneca and Merck’s Lynparza as well as Pfizer’s Talzenna in the indication. Eleven weeks ago, the FDA gave Lynparza the same narrow label for those with the BRCA-positive tumors. Talzenna’s approval covers a broader population, including other mutations in the homologous recombination deficiency family. Under a 2016 deal with Zejula’s developer Tesaro, J&J carved out rights to the drug in prostate cancer. GSK then bought out Tesaro in 2019. The ...
- Source: drugdu
- 118
- August 16, 2023
Johnson & Johnson to Reduce Its Kenvue Stake by at Least 80% Through Exchange Offer

Johnson & Johnson on Monday said it plans to reduce by at least 80% its stake in Kenvue, the consumer health business it spun out as an independent company earlier this year, via a stock exchange offer. J&J owns 89.6% of Kenvue’s common stock, which amounts to more than 1.72 billion shares. The exchange offer, also known as a split-off, will allow J&J shareholders to swap all or a portion of their shares for Kenvue’s common stock at a 7% discount. The offer is expected to be tax-free, J&J said in a release. The company noted that the split-off is voluntary for investors and is slated to close on Aug. 18, which is far earlier than expected. J&J said it received a waiver that dismisses the share lockup period associated with Kenvue’s initial public offering in May. That lockup agreement would have required J&J to ...
- Source: drugdu
- 124
- July 26, 2023
Johnson & Johnson Becomes 4th Drugmaker to File Suit Against IRA’s Drug Price Negotiations

Johnson & Johnson has hopped on the litigation bandwagon, becoming the fourth large drugmaker to sue the U.S. government over drug price negotiations in the Inflation Reduction Act (IRA).In U.S. District Court in New Jersey, J&J claimed (PDF) that price negotiations by Medicare would violate the First and Fifth Amendments of the U.S. Constitution. Merck, Bristol Myers Squibb and Astellas have made the same argument in separate lawsuits. Last week in federal court in Washington, D.C., Merck applied more pressure, filing for a decision in its case without a trial. The U.S. Chamber of Commerce and industry association PhRMA have also filed suits with similar claims. “The government is forcing (J&J) to provide its innovative, patented medicines on pricing terms that by law must be significantly below market prices,” J&J said in a release. “This would upend the current self-sustaining cycle of pharmaceutical innovation that provides patients with access ...
- Source: drugdu
- 279
- July 20, 2023
In Talc Defense, Johnson & Johnson Sues 4 doctors Over Their ‘Junk Litigation Opinions’

As Johnson & Johnson awaits a decision on its second attempt to resolve talc lawsuits through a bankruptcy ploy, the company is attempting another legal tactic to free itself from those liabilities—suing doctors who say that its iconic baby powder can cause cancer.In federal district court in New Jersey, J&J’s talc subsidiary LTL Management has filed two suits against four doctors who authored studies that described a link between J&J’s talc-based products and cancer. Last week, J&J filed suit against New Hampshire physician Richard Lawrence Kradin and Virginia doctors Theresa Swain Emory and John Coulter Maddox. In a separate suit in May, J&J sued New York physician Jacqueline Miriam Moline. In the most recent suit, J&J claims that the three doctors cited 75 people with malignant mesothelioma who had been exposed to cancer-causing asbestos only by using Johnson’s Baby Powder or another J&J talc product, Shower to Shower. ...
- Source: drugdu
- 108
- July 18, 2023

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