Search Results for “Johnson ” – Page 21 – media

MSF, trying to secure supplies of ViiV’s Apretude, calls out new clauses in purchasing contract

As GSK’s ViiV Healthcare looks to widen the reach of its HIV franchise, Médecins Sans Frontières (MSF) has been working to secure access to the company’s long-acting HIV prevention drug, Apretude, for more than a year. Now, the organization is airing grievances about the negotiation process with an open letter to ViiV’s executive team. MSF is calling on the company to take out what it says are problematic new amendments to the proposed purchase agreement. Since last June, MSF has been stuck in contract negotiations with ViiV for Apretude, according the letter from Sidney Wong, executive co-director of MSF’s access campaign, and Philip Aruna, team leader for MSF’s southern Africa region. The sides almost reached a deal in December, but ViiV subsequently changed the terms because of supply limitations, Wong and Aruna wrote. Thanks to last-minute edits that deviate from standard MSF purchase agreements, the new contract more closely resembles ...
- Source: drugdu
- 135
- August 19, 2023
GSK stays a step ahead in RSV vaccine battle as Arexvy becomes available at US pharmacies

As companies have flocked to compete in the new respiratory syncytial virus (RSV) vaccine market, GSK has had the best timing. In May, the U.K. company was first to secure FDA approval for its shot Arexvy for adults 60 and older, beating out rivals from Pfizer and Moderna. And now—well in advance of the fall and winter RSV season—Arexvy is available in major U.S. retail pharmacies, GSK said Thursday. Under the Inflation Reduction Act, Medicare Part D patients will pay no out-of-pocket expenses for the shot, GSK said. Additionally, under the Affordable Care Act, patients with commercial insurance may be covered when Arexvy is administered in-network, GSK said. In June, the Advisory Committee on Immunization Practices (ACIP) recommended that people 60 and older decide in consultation with their healthcare provider whether to receive the RSV vaccine. As people age, their immune systems can become compromised, making them more vulnerable to ...
- Source: drugdu
- 173
- August 19, 2023
Legend exec

Johnson & Johnson and Legend Biotech’s Carvykti continues to grow in multiple myeloma despite the introduction of a more convenient option. Carvykti generated $117 million in the second-quarter sales, up from $72 million in the first three months of the year. The increase suggests the two companies’ efforts to ramp up supply are working. Manufacturing capacity has been a limiting factor for Carvykti’s performance since its launch last Spring, and expansion is key as the partners angle for earlier lines of treatment. Under a regular review timeline, the FDA has set April 5, 2024, as the target decision date for Carvykti’s application as a second- to fourth-line myeloma treatment, Legend said Tuesday. The standard review is somewhat disappointing given that industry watchers were expecting a priority review, which might’ve enabled a launch in December. But the longer timeline shouldn’t be much of a problem because J&J and Legend don’t have ...
- Source: drugdu
- 120
- August 18, 2023
Multimillion-dollar NIH grant awarded to develop advanced treatment for diabetic foot ulcers

A team of researchers from the Terasaki Institute for Biomedical Innovation (TIBI) and the University of Nebraska Medical Center (UNMC) has been awarded a multimillion-dollar grant from the National Institutes of Health to develop a superior, multi-pronged wound treatment for diabetic foot ulcers (DFUs). DFUs remain a significant complication resulting from dysregulated internal pathophysiological conditions in diabetic patients. The unresolved diabetic wounds affect patients’ quality of life and can result in amputations or death. More than 6.5 million individuals suffer from diabetic wounds worldwide. Therefore, efforts toward improving current treatment modalities via an innovative approach may promote rapid healing and increased quality of life in patients. Treatment options include growth factors, anti-bacterial agents, protease inhibitors, and anti-inflammatories. Unfortunately, currently available dressings with tiny pores limit granulation tissue formation, prevent cell migration, increase infection rates, and promote scar formation. Johnson V. John, Ph.D., TIBI scientist and principal investigator, said, “The microarchitecture ...
- Source: drugdu
- 125
- August 17, 2023
Pfizer Bispecific Drug Wins FDA Accelerated Approval for Multiple Myeloma

By Tristan Manalac Pictured: Pfizer office at its South San Francisco campus/iStock, hapabapa The FDA on Monday granted accelerated approval to Pfizer’s bispecific antibody elranatamab, to be marketed as Elrexfio, for the treatment of relapsed or refractory multiple myeloma. Elrexfio’s label covers patients who had been treated with at least four prior lines of therapy, including an anti-CD38 antibody, an immunodulatory agent and a proteasome inhibitor. According to Pfizer’s announcement, Monday’s approval makes Elrexfio the first off-the-shelf, ready-to-use fixed-dose subcutaneous therapeutic that targets the BCMA protein. “With significant responses in a patient population with highly refractory disease, we believe Elrexfio is poised to potentially become the new standard of care for multiple myeloma,” Pfizer Chief Commercial Officer Angela Hwang said in a statement, adding that the company will continue the treatment’s clinical development through its broad MagnetisMM program. The FDA’s approval was supported by data from the Phase II MagnetisMM-3 ...
- Source: drugdu
- 216
- August 17, 2023
FDA Approves J&J’s Akeega for BRCA-Positive Prostate Cancer

By Tristan Manalac Pictured: Janssen headquarters in California/iStock, Sundry Photography The FDA on Friday signed off on Janssen Pharmaceutical’s niraparib and abiraterone acetate tablets, now to be marketed as Akeega, for the treatment of metastatic castration-resistant prostate cancer in patients carrying the BRCA mutation. According to Janssen’s announcement, Akeega is the first dual-action tablet that combines the activity of a PARP inhibitor with abiraterone acetate, an androgen biosynthesis inhibitor sold by the company under the brand name Zytiga. Janssen is a subsidiary of Johnson & Johnson. The approval covers a combination regimen of Akeega with prednisone and is based on data from the Phase III MAGNITUDE study, a randomized, double-blinded and placebo-controlled trial with 765 participants. Compared with Zytiga plus prednisone, the Akeega-based regimen significantly improved radiographic progression-free survival by 47% in BRCA-positive patients. Akeega also led to a trend toward better overall survival, though this effect fell short of ...
- Source: drugdu
- 187
- August 16, 2023
Janssen’s Talvey granted FDA accelerated approval for difficult-to-treat blood cancer

Janssen, a Johnson & Johnson company, has announced that its bispecific antibody has been granted accelerated approval by the US Food and Drug Administration (FDA) for use in certain patients with relapsed or refractory multiple myeloma (RRMM). The authorisation for Talvey (talquetamab-tgvs) specifically applies to adult RRMM patients who have received at least four prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody. Multiple myeloma is a difficult-to-treat blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow. Despite recent advances, Janssen has reported that an unmet need remains for more therapeutic options with different modes of action, including for those treated with prior bispecific or CAR-T cell therapies, to better address the unique characteristics of every patient’s individual needs. Talvey, which is administered as a weekly or bi-weekly subcutaneous injection after an initial step-up phase, ...
- Source: drugdu
- 170
- August 15, 2023
Supreme Court blocks Purdue Pharma’s bankruptcy settlement, threatening immunity to Sackler family

It’s been a rough summer for pharmaceutical companies trying to resolve lawsuits by declaring bankruptcy. Last month, a federal bankruptcy judge denied Johnson & Johnson’s second effort to Texas two-step its way to an $8.9 billion settlement to resolve talc claims. And now, the Supreme Court has blocked (PDF) Purdue Pharma’s bankruptcy settlement, which granted the company’s former owners—the Sackler family—immunity from civil suits related to the opioid crisis. The action is temporary as it allows the court to hear the Justice Department’s claim that a reorganization of a company under Chapter 11 can’t be used to extinguish lawsuits against “third party non-debtors”—in this case, the Sacklers—without consent of the claimants. The court will hear oral arguments in December. “We are confident in the legality of our nearly universally supported Plan of Reorganization, and optimistic that the Supreme Court will agree,” Purdue said in an email. “Even so, we are ...
- Source: drugdu
- 110
- August 15, 2023
Boston Scientific receives FDA approval for cryoablation system

Dive Brief Boston Scientific on Thursday received approval from the Food and Drug Administration for a new heart ablation device to treat atrial fibrillation, according to a company announcement. The POLARx Cryoablation System can accommodate two balloon sizes in one catheter, which Boston Scientific said allows physicians to tailor care to individual patients. The device has been selling well in Europe and Japan, where it is cleared for use, CEO Mike Mahoney said in an earnings call last month. Boston Scientific has been competing with companies like Johnson & Johnson and Medtronic, which are also bringing new cardiac ablation devices to market. Dive Insight Cryoablation is a minimally invasive procedure that uses a balloon catheter to freeze tissue near the pulmonary vein. Scars then block irregular electric signals that can cause atrial fibrillation. Switching between two balloon sizes, clinicians can adjust the device to a patient’s anatomy during a procedure, ...
- Source: drugdu
- 150
- August 12, 2023
J&J signs Stelara biosimilar settlement deal with Formycon and Fresenius

Johnson & Johnson (J&J) has reached a settlement with Formycon and Fresenius over their Stelara biosimilar FYB202, setting its US launch date to 15 April 2025. The companies confirmed that they are on track to submit the biosimilar’s biologics license application (BLA) later this year, based on the 7 August announcement. This marks the third settlement reached by J&J and pharma companies that are trying to market Stelara’s biosimilars this year so far. In May, J&J settled its patent lawsuit with Amgen, setting the biosimilar’s launch to no later than 1 January 2025. A month later, J&J reached a settlement with the producers Alvotech and Teva Pharmaceuticals, with a US licence entry date for their Stelara biosimilar AVT04 of no later than 21 February 2025. Also known as ustekinumab, Stelara was first approved by the US Food and Drug Administration (FDA) for the treatment of adult patients with moderate to ...
- Source: drugdu
- 194
- August 10, 2023

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