AstraZeneca and the Bellvitge University Hospital plan to launch the first pilot program for the Cordio Medical HearO app. The HearO smartphone app provides widespread access to medical-grade technology for patients with congestive heart failure (CHF). It enables the patient to monitor symptoms, manage treatment and improve quality of life. Astrazeneca said the pilot program aims to…
This RNA sensor could trigger cells to turn on a synthetic gene
Engineers at MIT designed a new way to trigger cells that could lead to targeted therapies for cancer and other diseases. Using an RNA sensor for the trigger, the researchers ensure that synthetic genes activate only in specific cells. They demonstrated that the sensor could accurately identify cells expressing a mutated version of the p53…
FDA accepts NDA for intranasal epinephrine from ARS Pharmaceuticals
ARS Pharmaceuticals announced today that the FDA accepted its new drug application (NDA) for neffy, its intranasal epinephrine. The offering covers the emergency treatment of severe type I allergic reactions in children and adults weighing 30 kg (66 pounds) or more. The company set an anticipated target action date of mid-2023 for its PDUFA (Prescription…
Lilly completes acquisition of Akouos
Eli Lilly and Company (NYSE:LLY) announced today that it successfully completed its acquisition of Akouos (Nasdaq:AKUS). Indianpolis-based Eli Lilly’s acquisition expands its efforts in genetic medicines. Akouos offers a portfolio of potential first-in-class adeno-associated viral gene therapies. The gene therapies treat inner ear conditions, including sensorineural hearing loss. The company initially announced the acquisition in…
Fujifilm spending $188M on new cell culture media plant
Fujifilm announced today that it invested $188 million to establish a cell culture media manufacturing facility in Research Triangle Park, North Carolina. Tokyo-based Fujifilm said it plans for its Fujifilm Irvine Scientific subsidiary to operate the new site. The subsidiary offers the development and manufacturing of advanced cell culture solutions for life science research, bioproduction,…
Illumina is cutting 5% of its workforce
Illumina (Nasdaq:ILMN) announced that it commenced a headcount reduction totaling approximately 5% of its global workforce. The company said yesterday that it is proactively realigning its core operating expenses in response to the current macroeconomic environment. It seeks to maintain its focus on its innovation roadmap and sustainable long-term growth, according to an SEC filing. Earlier…
Pfizer reports positive data from RSV vaccine candidate trial
Pfizer (NYSE:PFE) today announced positive topline data from a Phase 3 clinical trial for its bivalent respiratory syncytial virus (RSV) prefusion vaccine candidate. The MATISSE (Maternal Immunization Study for Safety and Efficacy) study investigates Pfizer’s RSVpreF vaccine candidate. It observed the vaccine when administered to pregnant participants to help protect their infants from RSV disease…
Olympus’ Evident opens new Asia-Pacific HQ
Olympus‘ Evident announced that it opened its new Asia-Pacific headquarters in Singapore as it looks to expand in the APAC region. In April, Olympus completed the separation of its Scientific Solutions Division into a wholly-owned subsidiary called Evident. The move aimed to provide more room to focus on the continued growth of the company’s Medical Business. Get the…
Illumina’s new NovaSeq X can sequence 20,000 genomes a year
Illumina (Nasdaq:ILMN) announced last week that it launched its new NovaSeq X series of production-scale sequencers. San Diego-based Illumina said its new sequencers “push the limits of what is possible with genomic medicine.” NovaSeq X and NovaSeq X Plus offer faster, more powerful and more sustainable sequencing. The latter can generate more than 20,000 whole…
Eisai and Biogen report positive Phase 3 trial results for new Alzheimer’s drug
Eisai and Biogen (Nasdaq:BIIB) today announced positive topline data from a Phase 3 trial of lecanemab for Alzheimer’s disease. BIIB shares are skyrocketing on the back of the data today. They are up 37.6% at $272.12 apiece in mid-afternoon trading. Lecanemab is an investigational anti-amyloid beta (Aβ) protofibril antibody. The global Phase 3 confirmatory Clarity…
Analysts are bullish on Eli Lilly with its ‘transformative’ drugs
UBS recently issued a report upgrading Eli Lilly (NYSE:LLY) to a “Buy” rating as its diabetes and Alzheimer’s drugs present lucrative opportunities. According to the report, the pharmaceutical giant’s Mounjaro (tirzepatide) “could be the biggest drug ever.” The type 2 diabetes treatment received FDA approval in May. GlobalData said at the time that tirzepatide could…
Medtronic appoints Pfizer EVP as independent board director
Medtronic (NYSE:MDT) announced today that it appointed Lidia Fonseca to its board of directors as an independent director. Fonseca, who serves as EVP and chief digital and technology officer at Pfizer, will become a director effective today. She will serve on the board’s Compensation Committee and Science and Technology Committee. Get the full story on our…
Pfizer completes ReViral acquisition
Pfizer (NYSE:PFE) announced today that it completed its previously announced $525 million acquisition of ReViral. ReViral, a biopharmaceutical company, discovers, develops and commercializes novel antiviral therapeutics designed to target respiratory syncytial virus (RSV). Its portfolio includes the sisunatovir oral inhibitor for blocking the fusion of the RSV virus to the host cell. Sisunatovir has fast track…
U of Maryland scientist to set up NIH’s new Advanced Research Projects Agency for Health
U.S. Dept. of Health and Human Services (HHS) announced that it formed a new research project agency for health. HHS Secretary Xavier Becerra announced the formal establishment of the Advanced Research Project Agency for Health (ARPA-H) as an independent entity within the National Institutes of Health (NIH). Adam H. Russell was appointed as acting deputy…
Pfizer ticks up on Street-beating Q1, lessens full-year guidance
Pfizer (NYSE:PFE) shares rose today on first-quarter financial results that came in ahead of the consensus forecast. The New York-based pharmaceutical company posted profits of $7.9 billion, or $1.37 per share, on sales of $25.7 billion for the three months ended April 3, 2022, for a 61.2% bottom-line gain on sales growth of 76.8%. Adjusted…
FDA issues draft guidance for increasing racial and ethnic diversity in clinical trials
The FDA today issued a new draft guidance outlining plans for increased diversity in clinical trials in the U.S. Expanding upon previous guidances for improving clinical trial diversity, this latest draft guidance — “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Subgroups in Clinical Trials” — recommends that sponsors of medical…
Dentsply CFO Jorge Gomez leaves to assume same role at Moderna
Moderna (Nasdaq:MRNA) announced today that it appointed Jorge Gomez as its new chief financial officer. Gomez resigned as CFO of Dentsply Sirona (Nasdaq:XRAY), effective May 6, to assume the same role at Cambridge, Massachusetts-based Moderna. He will join effective May 9. Dentsply Sirona said in a news release that it is initiating a search process…
Pfizer to Acquire ReViral and Its Respiratory Syncytial Virus Therapeutic Candidates
Pfizer (NYSE:PFE) announced today that it entered into an agreement to acquire biopharmaceutical company ReViral. ReViral discovers, develops and commercializes novel antiviral therapeutics designed to target respiratory syncytial virus (RSV). “At Pfizer, we have a strong heritage in, and commitment to, fighting infectious diseases, most recently evidenced by our delivery of the first authorized vaccine…
Janssen reports positive clinical trial data for its Xarelto to treat PAD effects
Johnson & Johnson’s (NYSE:JNJ) Janssen Pharmaceutical Companies recently announced analysis data on the benefits of Xarelto. The Phase 3 Voyager PAD clinical trial evaluated the Xarelto (rivaroxaban) vascular dose (2.5 mg twice daily plus aspirin 100 mg once daily) in reducing severe vascular events in patients with peripheral artery disease (PAD) after lower-extremity revascularization (LER).…
Johnson & Johnson is bringing the world’s first drug-eluting contact lens to market
Johnson & Johnson has a potential alternative to eye drops with its drug-eluting Acuvue Theravision contact lens. As far back as the early 1960s, researchers toyed with the idea of delivering medication through contact lenses. Johnson & Johnson Vision (NYSE:JNJ) Director of Clinica Science Dr. Brian Pall told Drug Delivery Business News that patents back then disclosed how…
PhysIQ and CellCarta think wearables and AI could produce vaccine insights
PhysIQ announced today that it will collaborate with CellCarta to undertake a study using AI in vaccine development. Enrollment is now complete in the VIII (Vaccine-induced inflammation investigation), which will monitor individual differences in physiologic changes associated with immune system activation in patients receiving vaccinations, including those developed to combat diseases like COVID-19. According to…
NIH to study allergic reactions to COVID-19 mRNA vaccine
Researchers from the NIH’s National Institute of Allergy and Infectious Diseases (NIAID) are conducting a clinical trial on allergic reactions to mRNA-based COVID-19 vaccines. The single-site trial will enroll up to 100 people between 16 and 69 years old who had an allergic reaction to a first dose of COVID-19 mRNA vaccines. NIAID seeks participants…
J&J expands it long-acting injectables partnership with Midatech
Midatech Pharma (Nasdaq:MTP) announced today that it extended its R&D collaboration with Johnson & Johnson’s (NYSE:JNJ) Janssen Pharmaceuticals. Cardiff, United Kingdom-based Midatech, a drug delivery technology company focused on the biodelivery and biodistribution of medicines, initially entered into the R&D collaboration with Janssen on July 21, 2020. Get the full story at our sister site, Drug Delivery Business News.
MIT researchers come up with new strategy to create a potential antibiotic
Researchers at MIT are touting a novel method to synthesize a natural compound that has shown potential as an antibiotic. The chemists produced himastatin using the synthesis method and also managed to generate variants of the molecule, some of which showed antimicrobial activity, according to a news story from the university’s website. The compound appears…
Moderna skyrockets on Street-beating Q4 driven by COVID-19 vaccine sales
Moderna (NSDQ:MRNA) shares are on the rise on fourth-quarter results that came in ahead of the consensus forecast. MRNA shares were up 11.7% at $161.51 per share in midday trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — was up 1.1%. The Cambridge, Massachusetts-based company posted…