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Disruptors of This Industry Are Already in It

A Formula 1 racing car is no joke. It’s purpose built, at great cost, at state of the art facilities with wind tunnels to improve aerodynamic performance and speed. The goal is simple: to win on tracks like the iconic Silverstone. It would be dangerously pointless to take an F1 car to the desert, smashing it through sand and into rocks, and expect it to perform the same. But today in healthcare, a host of new entrants and stakeholders is doing exactly that.Companies built for other businesses are attempting to offroad their skills into a brand new field. These fairweather healthcare players are unprepared for the terrain. Meanwhile, the true disruptors of this industry are already in it. When you hear newbies and big tech brands hyping AI, for example, delivered via ChatGPT, Microsoft, and others, as a way to transform healthcare, listen up. The bluster is a giveaway. Sure, ...
- Source: drugdu
- 112
- October 27, 2023
Intuitive leaders weigh in on GLP-1 drugs and surgical robotics procedures

BY JIM HAMMERAND Intuitive Surgical Chief Medical Officer Dr. Myriam Curet [Photo courtesy of Intuitive Surgical] Intuitive Surgical (Nasdaq: ISRG)+ executives say they see benefits to their business from GLP-1 weight loss drugs, even if investors aren’t quite so sure. Intuitive’s stock slid in after-hours trading today after the company posted Q3 results that exceeded analysts’ expectations on profits but fell short on sales. Even if they had beat The Street on both counts, it’s not clear investors would have reacted any differently — just look at what happened to Intuitive’s stock price under that exact scenario after Q2. Related: Analysts expect minor GLP-1 impact on insulin pumps, but a boost for CGMs So it was no surprise that the very first question for Intuitive leaders from analysts on today’s Q3 earnings call focused on the impact of GLP-1 drugs on bariatric procedures. “I think in the short term, we will see patients who are considering or are ...
- Source: drugdu
- 141
- October 21, 2023
Takeda announces EC approval for Adcetris combination in Hodgkin lymphoma

Roche announces positive phase 3 results for Alecensa in early-stage lung cancer Roche has shared new results from a late-stage study of its anaplastic lymphoma kinase (ALK) inhibitor Alecensa (alectinib) in early-stage lung cancer. The phase 3 ALINA study has been evaluating the targeted drug as an adjuvant therapy in patients with completely resected stage 1B to 3A ALK-positive non-small cell lung cancer (NSCLC). Alecensa was shown to reduce the risk of disease recurrence by 76% compared with platinum-based chemotherapy, Roche said. A clinically meaningful improvement of central nervous system disease-free survival was also observed in those receiving Alecensa, and the safety and tolerability of the therapy were consistent with previous trials in the metastatic setting. Overall survival data was immature at the time of this analysis and the company has outlined that follow-up is ongoing to “report a more mature estimate”. Levi Garraway, Roche’s chief medical officer and head ...
- Source: https://www.pmlive.com/pharma_news/takeda_announces_ec_approval_for_adcetris_combination_in_hodgkin_lymphoma_1502265
- 115
- October 21, 2023
Royalty Boosts Struggling PTC with Additional $1B for Royalties on Roche’s Evrysdi

Pictured: Handshake over a deal/iStock, PeopleImages Biopharma’s biggest royalties buyer is upping its stake in a popular spinal muscular atrophy drug. Royalty Pharma announced Thursday a $1 billion upfront payment to beleaguered PTC Therapeutics for additional royalties in Evrysdi, licensed and marketed by Roche. Royalty initially bought into Evrysdi in July 2020, just before its approval by the FDA. The drug has already been used to treat over 11,000 patients worldwide. Spinal muscular atrophy (SMA) is a rare and often fatal genetic disease that typically presents in infants and young children. The deal increases Royalty’s ownership of the Evrysdi royalty from 43% to 81%, equating to 13% of the royalties Roche pays on worldwide net product sales. Roche reported $801.4 million in sales for the first half of 2023. GlobalData predicts sales to rise to just under $3 billion in 2029. In Thursday’s announced deal, PTC has the option to sell the remainder of the Evrysdi royalty to Royalty for up ...
- Source: Kate Goodwin
- 122
- October 21, 2023
AstraZeneca studies highlight burden of COVID-19 for immunocompromised

Two AstraZeneca studies have highlighted the continued significant and disproportionate burdens of COVID-19 on immunocompromised (IC) individuals.Covering almost 30 million individuals, the INFORM and EPOCH real-world studies showed that IC individuals have a higher rate of severe outcomes from COVID-19 compared to the general population. Including around 12 million participants aged 12 years and older in England, the INFORM study aimed to assess clinical outcomes and utilisation of healthcare resources in relation to COVID-19.The EPOCH study conducted an extensive insurance claims database of around 17 million people, providing real-world data on COVID-19 risks and outcomes in IC and non-IC populations within the US.The data revealed that 22% of all COVID-19 hospitalisations consisted of IC individuals, along with 28% of ICU admissions and 25% of deaths in England. People who are IC have a weakened immune system and are more susceptible to illness with COVID-19 or could be sick for a ...
- Source: drugdu
- 192
- October 20, 2023
FDA approves UCB’s inflammatory disease drug Bimzelx for plaque psoriasis

The US Food and Drug Administration (FDA) has approved UCB’s inflammatory disease drug to treat moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.The decision makes Bimzelx (bimekizumab-bkzx) the first and only approved psoriasis treatment designed to selectively inhibit IL-17A and IL-17F, two key cytokines driving inflammatory processes. More than 7.5 million adults in the US are affected by some form of psoriasis, a chronic inflammatory condition caused by dysfunction of the immune system, which results in skin cells reproducing at a faster rate than normal.Up to 90% of patients with psoriasis have plaque psoriasis, characterised by dry, raised, red skin lesions (plaques) covered with silvery scales. The plaques may be itchy or painful and can occur anywhere on the body, including the scalp, elbows, knees and lower back. As well as its physical manifestations, psychological impact has been increasingly recognised as a significant part of ...
- Source: drugdu
- 139
- October 20, 2023
Mirum’s plans to expand Livmarli’s market get hit as FDA pushes approval date

The US Food and Drug Administration (FDA) has announced an extended review of the Supplemental New Drug Application (sNDA) for Mirum Pharmaceutical’s Livmarli (maralixibat) to treat patients with cholestatic pruritus in progressive familial intrahepatic cholestasis (PFIC). The company announced that the FDA extended the prescription drug user fee act (PDUFA) date to allow time for a full review of a submission provided in response to an FDA information request, which is deemed to be a major amendment. The date has been pushed from 13 December to 13 March, 2024. The news was announced after markets closed on 17 October. Earlier today, Mirum’s stock opened more than 4% lower than the previous day. Mirum submitted the sNDA in February of this year based on the Phase III MARCH trial. The study was the largest randomised trial conducted for patients with PFIC. A statistically significant difference in efficacy was reported between the ...
- Source: drugdu
- 159
- October 20, 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
- 112
- October 20, 2023
Ardelyx Nabs FDA Approval for First Phosphate Absorption Blocker in CKD

Pictured: Test-tube containing a blood sample for measuring serum phosphorus levels/iStock, Md Saiful Islam Khan The FDA on Tuesday gave the greenlight to Ardelyx’s tenapanor, now to be marketed under the brand name Xphozah, indicated to reduce serum phosphorus levels in patients with chronic kidney disease. Tuesday’s approval covers chronic kidney disease (CKD) patients on dialysis who had previously shown an inadequate response to phosphate binders, or who are otherwise intolerant to such therapies. Xphozah’s label bears no boxed warning but carries a precaution against severe diarrhea, the most common observed adverse event during the drug’s development. Ardelyx CEO Mike Raab called Tuesday’s approval an “important milestone” for dialysis patients, their families and the larger nephrology care community. Xphozah “represents a new mechanism and new option for patients who, despite treatment with phosphate binders, continue to have elevated phosphorus.” Xphozah is taken as 30-mg oral tablets twice-daily, before the morning and evening meals. Its ...
- Source: drugdu
- 111
- October 20, 2023
Ultimovacs Rebounds on New Universal Cancer Vaccine Data for Mesothelioma

Pictured: Artistic rendering of doctor diagnosing lungs on screen/iStock, greenbutterfly Despite missing the primary endpoint mark in June 2023, Ultimovacs hasn’t given up on trying to prove its universal cancer vaccine has a benefit for deadly mesothelioma. The Norwegian biotech reported new data Tuesday, proving strong clinical responses with extended overall survival in a follow up analysis. When combined with Bristol Myers Squibb’s Opdivo and Yervoy as a second-line treatment to platinum chemotherapy, Ultimovacs’ UV1 reduced risk of death by 27% for patients with malignant pleural mesothelioma, a cancer in the lining of the lungs. Caused by asbestos fibers that have embedded in the pleura, eventually leading to mesothelioma tumors, this cancer is aggressive and often incurable. The five-year survival rate for localized pleural mesothelioma, the most treatable type, is 24%. Median overall survival for patients receiving the vaccine combined with the checkpoint inhibitors was 15.4 months, compared to 11.1 months on the immunotherapy treatments alone. ...
- Source: drugdu
- 107
- October 20, 2023

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