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Merck’s Pneumococcal Shot Claims Back-to-Back Phase III Wins

By Tristan Manalac Pictured: Merck sign at its office in California/iStock, hapabapa Merck’s investigational pneumococcal vaccine V116 aced two Phase III trials, eliciting strong immune responses in both the Phase III STRIDE-3 and STRIDE-6 trials, the company announced Thursday. Without providing specific data, the drugmaker said that in STRIDE-3, V116 significantly outperformed the standard 20-valent pneumococcal conjugate vaccine at eliciting an immune response in adults who had not been immunized before. Meanwhile, STRIDE-6 showed that Merck’s investigational shot could prime immunity against all 21 targeted pneumococcal serotypes in adults aged 50 years and above who had been vaccinated at least a year prior. Both STRIDE-3 and STRIDE-6 also demonstrated that V116’s safety profile was comparable to the standard vaccine comparator used in these studies. “Despite the availability of current pneumococcal conjugate vaccines, many adults remain vulnerable to pneumococcal disease, especially those who are older,” Merck Chief Medical Officer Eliav Barr ...
- Source: drugdu
- 169
- August 1, 2023
Biogen Boosts Neuro Pipeline with $7.3B Reata Buy Amid Layoffs

Published: Jul 28, 2023 By Tristan Manalac Pictured: Biogen sign/The Boston Globe via Getty, John Tlumacki Biogen is dropping $7.3 billion in cash to acquire Texas-based Reata Pharmaceuticals aimed at bolstering its neurological and rare disease businesses, the companies announced Friday. Reata, whose shares soared 51% in premarket trading following the buyout news, recently won the FDA’s approval for Skyclarys (omaveloxolone), the first and so far only authorized treatment for Friedrich’s ataxia in the U.S. Reata is currently working on launching Skyclarys, which it will price at $370,000 per year. Under the terms of the agreement, Biogen will pay a per-share price of $172.50, which represents an approximately 58% premium to Reata’s closing price Friday. Biogen will make the payment in cash, supplemented by the issuance of term debt. The companies expect to close the deal in the fourth quarter of 2023, though it must first pass the heightened scrutiny ...
- Source: drugdu
- 124
- August 1, 2023
FDA Adopts New Sterilization Standard to Support Switch From Ethylene Oxide

Dive Brief The U.S. Food and Drug Administration has adopted an international sterilization standard to give medical device manufacturers another alternative to ethylene oxide (EtO). Manufacturers can now make declarations of conformity to the International Organization for Standardization’s recommendations on low-temperature vaporized hydrogen peroxide in submissions to the FDA. The FDA framed the addition of the ISO test to its Recognized Consensus Standards database as a response to pressure to reduce EtO use and the need to support supply chain resiliency. Dive Insight In April, the U.S. Environmental Protection Agency proposed limiting EtO emissions from sterilization facilities by 80% to minimize the risk of people developing cancer from exposure to the gas. AdvaMed has warned the limit could halve capacity at commercial sterilizing plants, and the FDA has cautioned that there is a lack of viable alternatives to EtO for many devices. The ...
- Source: drugdu
- 187
- July 28, 2023
Study Shows 82% of Child Deaths in Low-Income Countries Could Be Prevented

Eighty-two percent of child deaths in low-income countries could be prevented, according to a study from the international CHAMPS network published in JAMA Network Open. The study, which used the minimally invasive autopsy technique developed by the Barcelona Institute for Global Health (ISGlobal), found an infectious agent in 87% of cases and identified malnutrition as the most common underlying cause of death. Ninety-nine percent of deaths in children under five years of age occur in low- and middle-income countries. “If we want to prevent these deaths, we need to know the causes, but the problem is that we lack reliable data,” says Quique Bassat, ICREA researcher at ISGlobal, an institution supported by the “la Caixa” Foundation. Clinical data and family or caregiver testimonies (verbal autopsies) are often used to determine the causes in low-resource areas, but they are not detailed enough. In addition, it is important to ...
- Source: drugdu
- 181
- July 28, 2023
Merck, Moderna Launch Pivotal Cancer Vaccine Trial for High-Risk Melanoma

Merck and Moderna announced Wednesday the initiation of a pivotal Phase III high-risk melanoma trial combining the companies’ mRNA-based personalized cancer vaccine with Merck’s blockbuster Keytruda checkpoint inhibitor. After a successful Phase IIb in stage III/IV melanoma patients with high risk of recurrence after surgery, Phase III is expanding the population to include stage IIb-IV patients. The study will enroll around 1,089 patients at more than 165 sites and in over 25 countries. The primary endpoint is recurrence-free survival. Secondary endpoints include distant metastasis-free survival and overall survival. Patients will receive either V940 (mRNA-4157), being co-developed and commercialized by Merck and Moderna, in combination with Keytruda or Keytruda alone for comparison. Phase IIb results shared earlier this year showed the cancer vaccine combined with Keytruda reduced risk of recurrence or death by 44% compared to Keytruda alone. Additional data in June 2023 showed the vaccine combo reduced risk of distant metastasis or death by 65% over ...
- Source: drugdu
- 178
- July 28, 2023
UK Probes Weight Loss, Diabetes Drugs for Suicidal Ideation and Self-Harm Risk

The UK’s Medicines and Healthcare products Regulatory Agency said Wednesday that it is reviewing a class of drugs used for obesity and diabetes treatment after reports of self-injury and suicidal thoughts in patients. The probe by the MHRA comes shortly after the European Medicines Agency (EMA) expanded its own investigation into the GLP-1 receptor agonist class of drugs. This includes medications like Saxenda (liraglutide), Wegovy (semaglutide) and Ozempic (semaglutide) produced by Danish pharma company Novo Nordisk. According to reporting by Reuters, the MHRA also confirmed AstraZeneca’s Bydureon (exenatide), Sanofi’s lixisenatide, and Eli Lilly’s dulaglutide were also being included in the review. Novo Nordisk told Reuters that it had received a request from the MHRA about the investigation. “The review is ongoing and a response will be provided within the requested timelines,” Novo Nordisk said in a statement. The MHRA review kicked off July 12, though the agency could not specify when it would ...
- Source: drugdu
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- July 28, 2023
Trial Investigating Peanut Allergy Immunotherapy Hits Final Milestone

A trial investigating desensitisation immunotherapy delivered as toothpaste for adults with peanut allergy reached a final milestone after Intrommune Therapeutics completed the last patient’s last visit. The Phase I OMEGA clinical trial (NCT04603300) is a multi-centre, randomised, placebo-controlled double-blind study involving splitting 32 participants with peanut allergy into two groups to receive either an escalating dose of the company’s candidate INT301 or placebo. The primary outcome is the safety of the drug compared to placebo. Safety is measured by the percentage of participants able to tolerate the highest dose and incidence of adverse reactions. Intrommune Therapeutics’ candidate utilises the company’s oral mucosal immunotherapy (OMIT) platform to deliver the therapy in fully functional toothpaste. OMIT’s simple administration allows for improved adherence, which is important for desensitising a patient to a specific allergy. Allergy immunotherapy requires consistent exposure. Peanut allergy is one of the most common allergies that ...
- Source: drugdu
- 154
- July 28, 2023
Octapharma Secures FDA Nod for Warfarin Reversal Agent Balfaxar

More than 2.4 million people in the United States use warfarin to keep their blood from clotting after a heart attack, stroke or other serious thromboembolic complication. But using a blood thinner carries risks of its own as patients become prone to bleeding, particularly during urgent surgery or other invasive procedures. To combat the risk, Swiss plasma specialist Octapharma has developed a treatment that rapidly restores the blood’s ability to coagulate. On Wednesday, the FDA signed off on the company’s Balfaxar (prothrombin complex concentrate, human-lans). Already marketed as Octaplex in Europe and Canada, Balfaxar is for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonists such as warfarin. Balfaxar, which is a lyophilized powder for reconstitution, is provided with sterile water for injection by way of a new transfer device called Nextaro. The drug earned approval based on a phase 3 trial that ...
- Source: drugdu
- 168
- July 28, 2023
Alkermes, Nearing Oncology Split, Posts Big Q2 Sales Gain After Winning J&J Arbitration Case

With winnings from its arbitration battle against Johnson & Johnson in hand—alongside a jump in its own product sales—Alkermes seems to be feeling itself heading into the second half of 2023. After the Dublin-based drugmaker won a high-stakes case versus J&J last month, the company bumped up its 2023 sales forecast by $425 million to between $1.55 billion and $1.68 billion. In revealing second-quarter results, the company provided some details behind the new guidance. Alkermes expects J&J’s royalties and interest on late payments for 2022 to come in at around $197 million, while 2023 royalties should land between $265 to $280 million, the company said in an investor presentation (PDF). Those payments relate to J&J’s schizophrenia drug Invega, which uses Alkermes’ NanoCrystal technology and delivered sales of $4.1 billion last year. With the arbitration win in tow, Alkermes generated $617 million this quarter, including $248 million of back royalties and interest from ...
- Source: drugdu
- 146
- July 28, 2023
GSK Tamps Down Short-Term Expectations for RSV Shot Arexvy, but Still Boosts 2023 Guidance

Expectations are sky high for GSK’s entry this fall into the new respiratory syncytial virus (RSV) vaccine market. The company forecasts peak sales of £3 billion ($3.9 billion) for its shot Arexvy, while Global Data sees the vaccine as the market leader through 2029. But with Arexvy set to launch in the United States later this year, GSK is tamping down the anticipation. On Wednesday, CEO Emma Walmsley said that Arexvy will not hit the ground running as quickly as GSK’s shingles shot Shingrix, which generated £784 million ($1.05 billion) in its first full year on the market (2018). “It won’t be the same rate of build as Shingrix was,” Walmsley said as GSK presented its second-quarter earnings (PDF). “But we do think it is a really key pillar.” The competitive landscape was more favorable for Shingrix to thrive early on, Walmely said. She also noted that the newly established market for ...
- Source: drugdu
- 150
- July 28, 2023

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