Hoffmann-La Roche

Pfizer and BioNTech Receive U.S. FDA Emergency Use Authorization for Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine in Children Under 5 Years

Retrieved on: 
Thursday, December 8, 2022
Science, Biotechnology, Research, Pharmaceutical, Health, FDA, COVID-19, Clinical Trials, Pfizer–BioNTech COVID-19 vaccine, Publication, Vaccination, State, BioNTech, JD, Immunotherapy, Human services, Omicron, Infection, Science, Cancer, American Animal Hospital Association, Research, United States Department of Health and Human Services, Pediatrics, FDA, Vaccine, Peer review, Regeneron Pharmaceuticals, Form, News, Health, COVID-19, Pierre Geneves, Clinical trial, RNA transfection, Safety, Originality, Hospital, EUA, American Academy of Pediatrics, Hoffmann-La Roche, BNT162, Marketing, U.S. Department of Defense Strategy for Operating in Cyberspace, Risk, Pharmaceutical industry, Medical device, Pfizer, Genentech, EU

For more than 170 years, we have worked to make a difference for all who rely on us.

Key Points: 
  • For more than 170 years, we have worked to make a difference for all who rely on us.
  • We routinely post information that may be important to investors on our website at www.pfizer.com .
  • Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
  • This press release contains forward-looking statements of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995.

New Survey Shows Many Americans Are Confused by Testing Options for COVID-19 and Flu

Retrieved on: 
Thursday, December 15, 2022
Laboratory, Virus, Severe acute respiratory syndrome coronavirus 2, Person, Gen, Roche Diagnostics, Season, Infection, RO, Hospital, Generation Z, PCR, Genentech, Roche, Urinary tract infection, Polymerase chain reaction, Parent, COVID-19, ROG, Pharma, Centers for Disease Control and Prevention, Dow Jones, Hoffmann-La Roche, RSV, Millennials, Respiratory syncytial virus, Risk, Vaccine, Beef cattle, Pharmaceutical industry, Fine chemical, Diagnosis, Generation X, Chugai Pharmaceutical Co.

Two out of three Americans are confused by the differences between PCR and rapid antigen tests in detecting viruses and when to use them.

Key Points: 
  • Two out of three Americans are confused by the differences between PCR and rapid antigen tests in detecting viruses and when to use them.
  • With at least three respiratory illnesses circulating that may have similar symptoms, it's important to know testing options ahead of holiday gatherings.
  • "It's important to know that PCR testing is the best option for early detection, when treatment is most effective."
  • "It's important to know that PCR testing is the best option for early detection, when treatment is most effective."

Curis Announces Additional Encouraging Clinical Data from TakeAim Leukemia Study of emavusertib (CA-4948) in Monotherapy R/R AML and hrMDS

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Monday, December 12, 2022
Squamous cell carcinoma, FLT3, Lymphatic system, Dana–Farber Cancer Institute, Venetoclax, Cancer, Disease, BTK, Patient, COVID-19, AML, MDS, Patent, Risk, Form 10-K, Azacitidine, B-cell lymphoma, MYD88, Myelodysplastic syndrome, Multimedia, Toxic leukoencephalopathy, NCI, Security (finance), Toll-like receptor, Webcast, Food, MD, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Genentech, Roche, U2AF1, Form, Marketing, Mutation, Therapy, IL-1R, CRS, Biomarker, Research, CRADA, FDA, BCC, Safety, Hoffmann-La Roche, Acute myeloid leukemia, NF, TLR, Pharmaceutical industry, SF3B1, Curie Institute (Paris), Vismodegib, IRAK4

LEXINGTON, Mass., Dec. 12, 2022 /PRNewswire/ -- Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, today announced positive updated clinical data from the ongoing open label Phase 1a dose escalation study of emavusertib (CA-4948), a novel, small molecule IRAK-4 inhibitor, as a monotherapy in patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) or high risk myelodysplastic syndromes (hrMDS) in both targeted and non-targeted populations. Patients in a targeted population are those with disease harboring U2AF1, SF3B1 (collectively "spliceosome") or FLT3 mutations. The company also announced positive initial data of emavusertib in combination with venetoclax in patients with AML or hrMDS that enrolled in the combination phase (Phase 1b) of the TakeAim Leukemia study prior to the partial clinical hold placed in April 2022.

Key Points: 
  • This represents 11 additional patients treated in targeted monotherapy populations and 13 additional patients in the non-targeted monotherapy population.
  • In addition to the monotherapy data, there are 4 patients with AML/hrMDS who have been treated with emavusertib in combination with venetoclax.
  • Previous data presented by Curis highlighted preliminary efficacy data of emavusertib in R/R AML/MDS patients whose disease is characterized by spliceosome or FLT3 mutation.
  • TakeAim Leukemia Study (NCT04278768) - This study is only enrolling in the monotherapy dose finding phase (phase 1a) of the study.

Curis to Host Webcast to Discuss Updated Emavusertib Clinical Data in Leukemia

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Tuesday, December 6, 2022
FLT3, Therapy, Lymphatic system, SF3B1, Dana–Farber Cancer Institute, Hematology, Webcast, Food, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Azacitidine, Society, Patient, Cancer, B-cell lymphoma, Genentech, Roche, U2AF1, FDA, BTK, Vismodegib, Myelodysplastic syndrome, Multimedia, IRAK4, Hoffmann-La Roche, Acute myeloid leukemia, Mobile phone, Pharmaceutical industry, Curie Institute (Paris)

LEXINGTON, Mass., Dec. 5, 2022 /PRNewswire/ -- Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, today announced that it will host a webcast on Monday, December 12, 2022, at 10:00 a.m. ET to discuss new data from the TakeAim Leukemia trial of emavusertib, including data presented at the 64th American Society of Hematology Annual Meeting.

Key Points: 
  • ET to discuss new data from the TakeAim Leukemia trial of emavusertib, including data presented at the 64th American Society of Hematology Annual Meeting.
  • This presentation will include data for 28 additional evaluable AML/MDS patients:
    Patients in a targeted population are those with FLT3, U2AF1, or SF3B1 mutations.
  • A live webcast will be available under "Events & Presentations" in the Investors section of the Company's website at www.curis.com .
  • A replay of the webcast will be available on the Curis website shortly after completion of the call.

Wave of FDA Fast Track Designations Sparks Renewed Interest in Biotech Sector That's Heating Up

Retrieved on: 
Thursday, December 1, 2022
Aravalli Range, Therapy, Progression-free survival, Neoplasm, Assistant professor, Roche, Breast, OTC, Communication, MUC, Gemcitabine, PDAC, Patient, Hematology, Fast Track, CMBC, KTRA, PD-L1, Bladder cancer, Division, Hoffmann-La Roche, Metastatic breast cancer, FDA, ORR, PD-1, Pancreatic cancer, News, Reindeer, PFS, CRISPR, TSX, National Cancer Institute, Rachel Haurwitz, Ministry, OTCQX, Ministry of Food and Drug Safety, Global Innovation through Science and Technology initiative, ONC, Cancer, Fast track (FDA), Vanderbilt University Medical Center, Pharmaceutical industry, Medical imaging, Agency, Oncolytics Biotech, Food, Atezolizumab

VANCOUVER, British Colombia , Dec. 1, 2022 /PRNewswire/ -- USA News Group  -  A series of new Fast Track designations have been handed out by the United States Food and Drug Administration (FDA) this week, causing a flurry of activity in the markets for the worthy recipients. The most recent to gain such a designation is pelareorep from Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) in combination with atezolizumab, an anti-PD-L1 checkpoint inhibitor from Roche Holding AG (OTCQX: RHHBY) for the treatment of advanced/metastatic pancreatic ductal adenocarcinoma (PDAC). Among the small handful of other companies that recently received this distinction for their platforms have been Aravive, Inc. (NASDAQ: ARAV), Caribou Biosciences, Inc. (NASDAQ: CRBU), and Kintara Therapeutics, Inc. (NASDAQ: KTRA).

Key Points: 
  • The Fast Track process is designed to facilitate the development and expedite the review of investigational drugs to treat serious conditions and fill an unmet medical need.
  • Drugs that receive Fast Track designation may be eligible for more frequent communications and meetings with the FDA to discuss the drug's development plan.
  • Drugs with Fast Track designation may also qualify for accelerated and priority review of new drug applications if relevant criteria are met.
  • This represents the second FDA Fast Track designation in Oncolytics' history, with the first being for pelareorep in Metastatic Breast Cancer back in May 2017 .

Wave of FDA Fast Track Designations Sparks Renewed Interest in Biotech Sector That's Heating Up

Retrieved on: 
Thursday, December 1, 2022
Aravalli Range, Therapy, Progression-free survival, Neoplasm, Assistant professor, Roche, Breast, OTC, Communication, MUC, Gemcitabine, PDAC, Patient, Hematology, Fast Track, CMBC, KTRA, PD-L1, Bladder cancer, Division, Hoffmann-La Roche, Metastatic breast cancer, FDA, ORR, PD-1, Pancreatic cancer, News, Reindeer, PFS, CRISPR, TSX, National Cancer Institute, Rachel Haurwitz, Ministry, OTCQX, Ministry of Food and Drug Safety, Global Innovation through Science and Technology initiative, ONC, Cancer, Fast track (FDA), Vanderbilt University Medical Center, Pharmaceutical industry, Medical imaging, Agency, Oncolytics Biotech, Food, Atezolizumab

VANCOUVER, British Colombia, Dec. 1, 2022 /PRNewswire/ -- USA News Group  -  A series of new Fast Track designations have been handed out by the United States Food and Drug Administration (FDA) this week, causing a flurry of activity in the markets for the worthy recipients. The most recent to gain such a designation is pelareorep from Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) in combination with atezolizumab, an anti-PD-L1 checkpoint inhibitor from Roche Holding AG (OTCQX: RHHBY) for the treatment of advanced/metastatic pancreatic ductal adenocarcinoma (PDAC). Among the small handful of other companies that recently received this distinction for their platforms have been Aravive, Inc. (NASDAQ: ARAV), Caribou Biosciences, Inc. (NASDAQ: CRBU), and Kintara Therapeutics, Inc. (NASDAQ: KTRA).

Key Points: 
  • The Fast Track process is designed to facilitate the development and expedite the review of investigational drugs to treat serious conditions and fill an unmet medical need.
  • Drugs that receive Fast Track designation may be eligible for more frequent communications and meetings with the FDA to discuss the drug's development plan.
  • Drugs with Fast Track designation may also qualify for accelerated and priority review of new drug applications if relevant criteria are met.
  • This represents the second FDA Fast Track designation in Oncolytics' history, with the first being for pelareorep in Metastatic Breast Cancer back in May 2017 .

AC Immune’s Alzheimer’s Disease Vaccine-candidate ACI-35.030 Selected for Further Development

Retrieved on: 
Wednesday, November 30, 2022
Neurodegeneration, Hoffmann-La Roche, AC, RU, Janssen Pharmaceuticals, Antibody, Conference, AU, Alpha-synuclein, Neurotoxicity, AD, SG, Janssen, Liposome, Clinical trial, Eli Lilly, Vaccination, Vaccine, Precision medicine, KR, NO, CH, GB, Johnson & Johnson, Pharmaceutical industry, Genentech, EU

Dr. Andrea Pfeifer, CEO of AC Immune SA, commented: The selection of ACI-35.030 for further development is a significant step for this collaboration.

Key Points: 
  • Dr. Andrea Pfeifer, CEO of AC Immune SA, commented: The selection of ACI-35.030 for further development is a significant step for this collaboration.
  • The selection of ACI-35.030 is supported by new clinical data from the Phase 1b/2a trial presented at the Clinical Trials on Alzheimers Disease (CTAD) Conference 2022.
  • AC Immune SAis a clinical-stage biopharmaceutical company that aims to become a global leader in precision medicine for neurodegenerative diseases, including Alzheimers disease, Parkinsons disease, and NeuroOrphan indications driven by misfolded proteins.
  • Morphomer is a registered trademark of AC Immune SA in CN, CH, GB, JP, KR, NO and RU.

BioNTech and Ryvu Therapeutics Enter into Global Collaboration to Develop and Commercialize Immuno-Modulatory Small Molecule Candidates

Retrieved on: 
Wednesday, November 30, 2022
BioNTech, United Kingdom, Hoffmann-La Roche, RVU, Saskatchewan River Sturgeon Management Board, European, Acute myeloid leukemia, EC, Advertising, Lymphatic system, Infection, Regeneron Pharmaceuticals, Prospectus, Carla Geneve, Warsaw Stock Exchange, Drug discovery, Autoimmune disease, DNA, Myelodysplastic syndrome, RNA transfection, Research, Form, Immunity, Immunotherapy, Acquisition, AACR, Haplotype, BNTX, Knowledge, Council, Cancer, SITC, European Parliament, Pharmaceutical industry, Vaccine, Medical device, Audit, Pfizer, EU, Genentech

The global collaboration will consist of two parts: BioNTech will receive a global, exclusive license to develop and commercialize Ryvus STING agonist portfolio as standalone small molecules, including as monotherapy and in therapeutic combinations.

Key Points: 
  • The global collaboration will consist of two parts: BioNTech will receive a global, exclusive license to develop and commercialize Ryvus STING agonist portfolio as standalone small molecules, including as monotherapy and in therapeutic combinations.
  • BioNTech has the option to license global development and commercialization rights to these programs at the development candidate stage.
  • The collaboration with Ryvu provides us with the opportunity to complement our immunotherapy pipeline with a portfolio of potent immunomodulatory molecules.
  • BioNTech will fund all discovery, research and development activities, including Ryvus discovery and research activities under the multi-target research collaboration.

Lineage to Present at BTIG Ophthalmology Day and the Cantor Fitzgerald Medical & Aesthetic Dermatology, Ophthalmology & MedTech Conference

Retrieved on: 
Tuesday, November 29, 2022
Professional Services, Health, Finance, Banking, Optical, Biotechnology, Cantor, Infection, Dermatology, Severe cognitive impairment, Fontainebleau Miami Beach, Auditory neuropathy, Geographic atrophy, Hoffmann-La Roche, Cell, VAC2, Compte rendu, Conference, Lineage Cell Therapeutics, NYSE American, Large-cell lung carcinoma, Therapy, Patient, Medtech, Injury, Annual report, Eastern Time Zone, Research, Ophthalmology, Cantor Fitzgerald, Disease, Direct Corporate Access, Health, Security (finance), AMD, Degenerative disease, Cancer, Roche, TASE, Equity, Medicine, Secondary research, FDA, Pharmaceutical industry, Genentech

The panel will be hosted by Jennifer Kim, Vice President, Equity Research at Cantor Fitzgerald, and the conference is taking place at the Fontainebleau Miami Beach hotel, December 7-8, 2022.

Key Points: 
  • The panel will be hosted by Jennifer Kim, Vice President, Equity Research at Cantor Fitzgerald, and the conference is taking place at the Fontainebleau Miami Beach hotel, December 7-8, 2022.
  • Atrophic AMD is a progressive disease that if left untreated can ultimately rob a person of their vision.
  • The Cantor Medical & Aesthetic Dermatology, Ophthalmology & MedTech conference will feature one-on-ones with leading companies in the Medical & Aesthetic Dermatology, Ophthalmology & MedTech industries, as well as key opinion leaders in the dermatology and ophthalmology space.
  • Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements.

Lineage Announces Launch of Phase 2a Study by Genentech of RG6501 (OpRegen®) in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration

Retrieved on: 
Monday, November 28, 2022
Stem Cells, Biotechnology, Pharmaceutical, Optical, Surgery, General Health, Health, Clinical Trials, Infection, Incidence, European Medicines Agency, Severe cognitive impairment, Auditory neuropathy, Geographic atrophy, Hoffmann-La Roche, SD, Food, Cell, VAC2, Compte rendu, Lineage Cell Therapeutics, EMA, Safety, NYSE American, Large-cell lung carcinoma, Therapy, Patient, Macular degeneration, Retina, Injury, Annual report, Security (finance), AMD, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Optical coherence tomography, Degenerative disease, Cancer, Roche, TASE, Eye, Trial of the century, FDA, Probability, Pharmaceutical industry, Genentech

The study is intended to optimize subretinal surgical delivery and evaluate the safety and activity of OpRegen in approximately 30, and up to 60 patients with geographic atrophy (GA) secondary to age-related macular degeneration.

Key Points: 
  • The study is intended to optimize subretinal surgical delivery and evaluate the safety and activity of OpRegen in approximately 30, and up to 60 patients with geographic atrophy (GA) secondary to age-related macular degeneration.
  • RG6501 (OpRegen) is currently being developed under an exclusive worldwide collaboration between Lineage, Roche and Genentech.
  • In our Phase 1/2a clinical trial, RG6501 (OpRegen) demonstrated the potential to slow, stop, or reverse the progression of GA in patients with GA.
  • Geographic atrophy (GA) is an advanced form of age-related macular degeneration (AMD) characterized by severe loss of visual function.