AstraZeneca is acquiring Icosavax, which has technology well-suited for multivalent vaccines. Icosavax’s pipeline includes a Phase 3-ready program that protects against two pathogens that cause severe respiratory infections in older adults. By FRANK VINLUAN AstraZeneca is already in the respiratory syncytial virus market with two products, including the drug Beyfortus, approved earlier this year. An M&A deal will give AstraZeneca an RSV vaccine candidate based on technology that could help the company compete where new vaccines are going. AstraZeneca is acquiring clinical-stage Icosavax for $800 million up front, the pharmaceutical giant announced Tuesday. Under the deal terms, AstraZeneca will pay $15 for each Icosavax share, which is a nearly 43% premium to the stock’s closing price on Monday. AstraZeneca could pay an additional $5 per share depending on the progress of Icosavax’s vaccine candidates. That payout could bring the value of the deal to $1.1 billion. The vaccines of Seattle-based ...
After many years of tracking the pharmaceutical industry’s pricing tactics, the Institute for Clinical and Economic Review (ICER) is once again placing a spotlight on the price increases that end up costing the U.S. healthcare system the most. In an annual report (PDF) on “unsupported price increases” (UPIs), the independent nonprofit has placed scrutiny on hikes that it says aren’t supported by evidence of new clinical benefit, ranking the medicines by their contributions to excess healthcare spending. This year’s edition saw the return of AbbVie’s superstar Humira, which last year enjoyed a break from the annual list after being included in every other report since the series began in 2019. The fifth annual version, released Monday, evaluates the industry’s pricing moves in 2022. For Humira, 2022 was the last year of market exclusivity before the med’s dive off of the patent cliff. Humira captured ICER’s top spot on its UPI ...
If you can’t beat them, join them. After Bristol Myers Squibb’s Opdivo topped Seagen’s classical Hodgkin lymphoma (cHL) therapy Adcetris in a head-to-head trial, Seagen has trotted out new datasets suggesting the two drugs—a PD-1 inhibitor and an antibody-drug conjugate—hold potential when paired together as part of a combination. In a midstage study, all patients with early-stage cHL who received a combination of Adcetris, Opdivo and the chemotherapy regimen AD (doxorubicin and dacarbazine) were alive without disease progression after one year of treatment. The analysis came from 150 patients enrolled in part C of the phase 2 SGN35-027 trial and was shared at the 65th American Society of Hematology annual meeting. The data look promising, but cHL is known to be relatively easy to treat. In an interview, Megan O’Meara, M.D., Seagen’s head of clinical development, acknowledged that people want to see longer-term data—and ultimately a survival benefit—in frontline cHL. ...
The FDA has granted fast track designation to Solid Biosciences’s gene therapy SGT-003 for the treatment of DMD. The US-based company received clearance from the FDA to start Phase I/II trial for the gene therapy on 14 November. SGT-003 uses a novel capsid AAV-SLB101 to deliver the DNA sequence encoding the shortened form of the dystrophin protein (microdystrophin). It also has R16 and R17 nNOS binding protein domains. DMD is a rare genetic condition that causes progressive muscle weakness. It affects approximately six in 100,000 individuals across Europe and North America, as per the US Muscular Dystrophy Association. The first gene therapy for treating DMD was approved earlier this year. In June, Sarepta Therapeutics’s gene therapy Elevidys (delandistrogene moxeparvovec-rokl) received accelerated approval by the FDA for treating ambulatory patients aged 4-5 years with a confirmed mutation in the DMD gene. There has been an increased interest in developing gene therapies ...
Roche has shared positive results from a late-stage study of its investigational therapy, inavolisib, as part of a combination treatment for advanced breast cancer. The phase 3 INAVO120 trial has been evaluating the targeted drug alongside Pfizer’s CDK4/6 inhibitor Ibrance (palbociclib) and fulvestrant as a potential first-line treatment option for patients with PIK3CA-mutated, hormone receptor (HR)-positive, HER2-negative, endocrine-resistant, locally advanced or metastatic breast cancer. The study met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival compared to palbociclib and fulvestrant alone. A “clear positive trend” towards improved survival was also observed for the inavolisib combination, Roche said, although overall survival data was immature at the time of the analysis and will continue to be analysed. Breast cancer is the most common cancer worldwide, with more than 290,000 people in the US expected to be diagnosed with the disease in 2023. HR-positive breast cancer is ...
Study Finds Researchers recently tested ChatGPT’s ability to answer patient questions about medication, finding that the AI model gave wrong or incomplete answers about 75% of the time. Providers should be wary of the fact that the model does not always give sound medical advice, given many of their patients could be turning to ChatGPT to answer health-related questions. By KATIE ADAMS Researchers recently tested ChatGPT’s ability to answer patient questions about medication, finding that the viral chatbot came up dangerously short. The research was presented at the American Society of Health-System Pharmacists’ annual meeting, which was held this week in Anaheim. The free version of ChatGPT, which was the one tested in the study, has more than 100 million users. Providers should be wary of the fact that the generative AI model does not always give sound medical advice, given many of their patients could be turning to ChatGPT ...
Several pharmaceutical industry advocacy and lobby organisations have bandied together to release a joint industry statement supporting the Declaration on Climate and Health released at the ongoing COP28 meeting. The joint statement is from associations in Europe, US, Canada, and Japan, like the Association of the British Pharmaceutical Industry (ABPI), European Federation of Pharmaceutical Industries and Associations (EFPIA), Pharmaceutical Research and Manufacturers of America (PhRMA), as well as The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) which represents over 90 pharmaceutical companies worldwide. The declaration highlights the negative impacts of climate change on health, and details objectives to ensure better health outcomes, such as implementing adaptation interventions against climate-sensitive disease and health risks. The aim of the declaration is to strengthen the implementation of policies to protect populations most vulnerable to the health impact of climate change. The COP 28 meeting is an international gathering of national leaders, regulators, ...
By Tyler Patchen AbbVie is the latest big pharma to target the hot antibody-drug conjugate market by acquiring ImmuoGen and its Elahere ADC for platinum-resistant ovarian cancer. The deal worth $10.1 billion was announced Thursday. Under the terms of the agreement, AbbVie will acquire all outstanding shares of ImmunoGen for $31.26 per share. The board of directors of AbbVie and Immunogen have approved the acquisition, which is expected to close sometime in the middle of 2024. The deal will give AbbVie access to Elahere (mirvetuximab soravtansine-gynx), which was granted FDA accelerated approval last year, and ImmunoGen’s follow-on pipeline of ADCs. ImmunoGen currently has several ADCs in development for treatments such as solid tumors, acute myeloid leukemia and blastic plasmacytoid dendritic cell neoplasm, among other conditions. “The acquisition of ImmunoGen demonstrates our commitment to deliver on our long-term growth strategy and enables AbbVie to further diversify our oncology pipeline across solid ...
By Tristan Manalac The European Patent Office has decided that a hotly contested mRNA patent held by Moderna pertaining to its COVID-19 vaccine is invalid, Reuters reported on Tuesday. The patent in question covers betacoronavirus vaccines that use at least one RNA polynucleotide with an open reading frame that encodes at least one betacoronavirus antigenic peptide, according to its claims document listed in the European Patent Register. While the patent battle is over the use of this technology to produce COVID-19 vaccines, the claims document also seeks to protect its use for other viral respiratory infections, including MERS and SARS. Several biopharma companies have lodged their opposition to these claims, including BioNTech and Pfizer—Moderna’s chief competitors in the coronavirus vaccine market—as well as Sanofi, according to the patent’s listing on the register. A BioNTech spokesperson in a statement to Fierce Pharma said that the company “welcomes” the European Patent Office’s ...
Novartis has withdrawn its request to access Takeda’s documents as part of an investigation over potential trade secrets theft. Novartis originally filed the complaint in Massachusetts Superior Court in October. The Swiss pharma wanted to find out whether a former employee in Egypt took sensitive documents to his new job with Takeda. After being “stonewalled” by Takeda, Novartis resorted to legal action, attempting to subpoena the Japanese pharma’s business records and depose an employee. Takeda, on Nov. 10, filed a motion to dismiss the complaint for recovery. According to Novartis, a former employee named Khaled Shams Eldin transferred some 10,000 files to his personal email before departing the company in May. After leaving his post as operations lead for cell and gene therapy at Novartis’ Egyptian unit, Eldin joined Takeda in July in a similar position, the company said. Earlier this week, Novartis dropped the case, according to a court ...
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