Sean Whooley

Johnson & Johnson’s Janssen Pharmaceutical Companies today announced a positive CHMP opinion on its Byannli schizophrenia treatment. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued the positive opinion. The committee recommended using long-acting atypical antipsychotic Byannli (6-monthly paliperidone palmitate; PP6M) therapy for the maintenance treatment of schizophrenia. The recommendation…

AB Science today touted results from a study of masitinib in combination with docetaxel in treating prostate cancer. Paris-based AB Science presented the data at the 2021 American Urological Association (AUA) annual meeting, according to a news release. Masitinib in combination with docetaxel as a first-line treatment of metastatic castrate refractory prostate cancer (mCRPC) eligible…

FDA leaders have issued a statement regarding the agency’s plan for authorizing COVID-19 vaccines for children. The FDA plans to “follow the science” with eyes on COVID-19 vaccines for children younger than 12 as schools begin to get back in session around the country, the agency said in a news release attributed to acting Commissioner…

The National Institutes of Health (NIH) announced a plan to provide approximately $185 million over five years to a consortium researching genomic variation. Initiated and funded by NIH’s National Human Genome Research Institute (NHGRI), the Impact of Genomic Variation on Function (IGVF) consortium will receive the $185 million over five years in the form of…

The FDA’s relationship with Biogen is under scrutiny following the controversial approval granted to the company’s Aduhelm Alzheimer’s drug. According to a report from Endpoints News, the House Energy & Commerce and Oversight committee chairs issued a letter this week requesting that acting FDA Commissioner Dr. Janet Woodcock and the FDA provide very specific information by…

Johnson & Johnson (NYSE:JNJ) announced that it is accepting applications for its 2022 Women in STEM2D (WiSTEM2D) Scholars Award. New Brunswick, N.J.–based Johnson & Johnson’s award aims to support assistant or associate academic professors in the disciplines of science, technology, engineering, math, manufacturing and design through three years of mentorship from leaders at the company and…

Moderna (NSDQ:MRNA) announced that it initiated its submission to the FDA for a booster dose of its COVID-19 vaccine. Cambridge, Massachusetts–based Moderna expects to submit data to the European Medicines Agency and other regulatory authorities around the world in addition to the FDA in the coming days for the booster shot at a 50 µg…

Two senior vaccine leaders within the FDA are reportedly relinquishing their positions within the administration. According to a report from Endpoints News citing a letter released internally to FDA staff first reported on by BioCentury, Marion Gruber and Phil Krause will depart in the coming months due to frustrations over the delegation of certain decisions within…

Johnson & Johnson (NYSE:JNJ) today announced results from a trial of its HIV vaccine demonstrating a lack of sufficient protection against infection. New Brunswick, N.J.–based Johnson & Johnson’s Imbokodo Phase 2b HIV vaccine clinical trial found that the investigational vaccine regimen did not provide sufficient protection against HIV infection in a 2,600-person population of young…

Signal Rx Pharmaceuticals, Crystec and ADYA are working on a dry powder drug formulation for potentially treating COVID-19-related illness. The three companies’ collaboration for the dry powder formulation of SF2523 covers the treatment of pulmonary fibrosis, lung cancer and illnesses related to SARS-CoV-2, the virus causing COVID-19. Get the full story at our sister site,…

The FDA today issued approval for Pfizer and BioNTech’s COVID-19 vaccine, making it the first to receive full approval in the U.S. The approval covers the prevention of COVID-19 in individuals 16 years of age and older. The vaccine remains available under FDA emergency use authorization (EUA) for people who are 12 years of age…

Researchers at Purdue University and Houston Methodist Research Institute are touting a novel strategy for developing a tuberculosis (TB) vaccine. Bacillus Calmette-Guérin (BCG) is widely used as a vaccine against TB, but the researchers say it has a variable protection against neonatal and adult pulmonary TB, with protection ranging from 0% to 80% among infants.…

Reify Health, a company dedicated to shortening clinical trial timelines, announced today that it raised $220 million in a Series C financing round. Coatue Management led the round, with Iconiq Growth and Adams Street Partners joining along with existing investors Sierra Ventures and Battery Ventures. The round brings the company’s valuation to $2.2 billion, according…

Inovio Pharmaceuticals (NSDQ:INO) shares took a hit this morning on second-quarter results that missed the consensus forecast. INO shares were down more than –11% at $8.53 per share in morning trading today. Get the full story at our sister site, Drug Delivery Business News.

Merck (NYSE:MRK) announced today that it received FDA approval for Keytruda for treating high-risk, early-stage, triple-negative breast cancer (TNBC). Kenilworth, N.J.-based Merck’s Keytruda anti-PD-1 therapy received approval for use in combination with chemotherapy as neoadjuvant treatment, then continued as a single agent as adjuvant treatment after surgery, according to a news release. Approval was based…

PerkinElmer (NYSE:PKI) today posted Street-beating second-quarter revenues and announced the $5.3 billion acquisition of BioLegend. The Waltham, Mass.-based company posted profits of $245.9 million, or $2.19 per share, on sales of $1.2 billion for the three months ended July 4, 2021, for a 79.3% bottom-line gain on sales growth of 51.3%. Get the full story at…

An accelerated rebound in medical device sales helped drive Johnson & Johnson (NYSE:JNJ) second-quarter results that topped the consensus forecast. The New Brunswick, N.J.-based company posted profits of $6.3 billion, or $2.35 per share, on sales of $23.3 billion for the three months ended June 30, 2021, for a 73.1% bottom-line gain on sales growth of 27.1%…

Eli Lilly (NYSE:LLY) announced today that it acquired peptide- and protein-engineering platform developer Protomer Technologies. The potential value of the transaction is over $1 billion, depending on the achievement of future development and commercial milestones. Pasadena, Calif.–based Protomer Technologies develops next-generation protein therapeutics designed to identify and synthesize molecules that can sense glucose or other endogenous…

Thermo Fisher Scientific (NYSE:TMO) announced today that it appointed Alan Sachs to chief medical officer and Karen E. Nelson to chief scientific officer. Sachs served as Waltham, Mass.-based Thermo Fisher’s CSO since 2016 and will be succeeded by Nelson as he assumes the newly established CMO position at the company. Both will join the company’s leadership…

Investment firm Carlyle and Inova today announced a long-term funding partnership to accelerate growth, product innovation and M&A activities. Lyon, France-based Inova develops software platforms dedicated to life sciences to enable pharmaceutical and biotech companies to collaborate on workstreams across organizations. Inova touts its flagship product, “Inova Enterprise,” as a collaborative tool used to manage…

Charles River Laboratories (NYSE:CRL) announced that it completed a $292.5 million acquisition of Vigene Biosciences. Rockville, Md.-based Vigene, a gene therapy contract development and manufacturing organization (CDMO), develops viral vector-based gene delivery systems, with a primary area of expertise in CGMP viral vector manufacturing for gene therapies and gene-modified cell therapies. Get the full story…

Boston Children’s Hospital announced today that it partnered with ElevateBio for a five-year cell and gene therapy advancement program. The collaborative agreement will seek to advance cell and gene therapy programs originating out of Boston Children’s Hospital with an introduction to Boston Children’s translational research capabilities. Get the full story at our sister site, Drug Delivery Business…

Sanofi (NYSE:SNY) announced today that it plans to invest approximately $476.3 million (€400 million) per year on mRNA vaccine development. Paris-based Sanofi’s intends for its annual investment to go toward a first-of-its-kind vaccine “mRNA Center of Excellence” to accelerate the development and delivery of next-generation vaccines. Approximately 400 employees will integrate end-to-end mRNA vaccine capabilities…

A new study shows that the Pfizer and Moderna COVID-19 vaccines create an immune response that may protect recipients for years. The study, published in Nature, revealed that those who received the two-dose mRNA vaccines developed by Pfizer/BioNTech and Moderna could provide immunity for years or even a lifetime in those who were infected with COVID-19…

Roche announced today that it received FDA emergency use authorization (EUA) for intravenous Actemra/RoActemra in treating COVID-19. Basel, Switzerland-based Roche’s Actemra/RoActemra (tocilizumab) drug received authorization to treat COVID-19 in hospitalized adults and pediatric patients (two years of age and older) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation or…