The US agency has approved Enhertu for patients diagnosed with HER2-positive metastatic breast cancer previously treated with an anti-HER2-based regimen.
The CRO has paired with the drug discovery technology firm on Logica, an artificial intelligence tool designed to accelerate development of new treatments.
The thin-film freezing specialist reports positive safety and pharmacokinetic data coming out of the Phase I trial of its niclosamide inhalation powder.
This month’s news on partnerships, appointments, expansions, and investment includes Javara, ACG, Phastar, Elligo Health Research, and other notable companies.
An expert from the organization discusses ahead of his CPhI North America presentation how tomorrow’s drugs can’t all be formulated with yesterday’s excipients.
An expert from Pharmatech Associates offers a glimpse into the evolution of CM and previews a lively discussion during the upcoming CPhI North America event.
A leader from the organizer of the pharmaceutical event discusses what’s in store for the upcoming conference, and for the drug development industry itself.
The agency has approved an expanded indication for Qelbree extended-release capsules to treat attention deficit hyperactivity disorder in younger patients.
Newly launched life sciences company Sionna Therapeutics has secured funding to fuel discovery and development of drug candidates to treat cystic fibrosis.
The US agency has expanded its approval of Veklury to include use in pediatric patients 28 days and older who have tested positive for the COVID-19 virus.
The company’s Precision Olfactory Delivery technology, currently combined with its Trudhesa migraine treatment, reportedly facilitates high absorption rates.
The 2022 edition of the Highly Potent Active Pharmaceutical Ingredients Summit (June 28 to 30 in Boston) will take on a range of topics, including safety.
The US Food and Drug Administration has approved a move to make the oral lead-in period for ViiV Healthcare’s once-every-other-month drug Cabenuva optional.
Catalent has announced a multi-year $350m investment at its facility in Bloomington, Indiana, to expand biologics drug substance and drug product manufacturing capabilities.
The pharma manufacturing specialist is increasing capacity at its development and manufacturing labs to meet growing global demand for highly potent APIs.
An expert from the health tech company explains how AI, natural language processing, and other tools can improve pharmaceutical product safety reporting.
The maker of active pharmaceutical ingredients for inhaled treatments is investing €9m ($9.8m USD) to expand its manufacturing plant in Barcelona, Spain.
The excipients, equipment, and API companies have joined forces on Inhalation Together, an initiative aimed at advancing dry-powder inhalation solutions.
The Australian biotechnology company has been granted ODD status from the agency for Veyonda, a therapy intended for the treatment of soft-tissue sarcoma.
The drug has received the agency’s seal of approval to treat seizures associated with difficult-to-treat seizures associated with Lennox-Gastaut syndrome.
The pharmaceutical company has agreed to provide its Paxlovid oral COVID-19 treatment to the global charity, covering 95 low- and middle-income countries.
The latest news on software, manufacturing solutions, partnerships, and more includes IQVIA, TFF Pharmaceuticals, Quotient Sciences and other key companies.
The US- and Hungary-based pharma firms will work on research, development, and commercialization of dopamine receptor modulators for potential treatments.
Returning to an in-person format March 21-24, the industry event is bringing a range of networking, educational, and social programming to New York City.
A representative from the HIV-centered pharmaceutical company shares thoughts and perspective on the every-two-month treatment and how it might help patients.
Cullinan Oncology has formed a strategic partnership with the Icahn School of Medicine at Mount Sinai to research and develop targeted therapies for cancer.
The pharmaceutical company, which uses thin-film freezing to develop inhalable therapies, has completed enrollment in the first phase for its drug candidate.
The HIV-focused pharma company announced the agency has approved Cabenuva for administration as few as six times a year for adults living with the virus.
The pharma firm has announced the agency has approved the company’s investigational new drug application for its Phase II trial of pemvidutide for obesity.
The agency has given the go-ahead on an IND application for a study evaluating Ananda Scientific’s Nantheia ATL5, a candidate for treating opioid use disorder.
The pharmaceutical company reports studies have demonstrated the main protease inhibitor of Paxlovid maintains in vitro efficiency against the variant.
The World Health Organization has recommended the drugs for COVID-19 patients, broadening the range of therapies to combat the virus behind the pandemic.
The company plans to launch a Phase Ib/II study of its compound NVG-291 in collaboration with researchers at Northwestern University’s Shirley Ryan AbilityLab.
A forward-looking report from company experts includes a breakdown of the top trends to watch for in pharmaceutical development and in healthcare overall.
OSP’s list of the year’s most-read stories shows readers are interested in M&A activities, new drug candidates, COVID-19 developments, and other hot news.
A leader from the R&D tech provider discusses the obstacles faced by drug development professionals in recent months, and ways they rose to the occasion.
The artificial intelligence-driven drug discovery company has dosed its first healthy volunteer in a trial for a candidate to treat idiopathic pulmonary fibrosis.
According to the company, the latest Phase II/III study results show its novel oral treatment candidate is effective in reducing hospitalizations and deaths.
Novartis has introduced its T-Charge platform at ASH 2021, which it says will serve as the foundation for various new investigational CAR-T cell therapies in its pipeline.
The pharmaceutical company currently has several promising treatments in development for gastroenterological, dermatological, and cardiological conditions.
Memo Therapeutics AG will receive CHF 10.5m (US $11.4m) from the Swiss government to clinically develop a SARS-CoV-2 antibody against COVID-19, allowing it to start Phase 1 studies in Q1, 2022.
Sited in Pennsylvania, the excipients specialist’s new facility reportedly will work toward advancing drug delivery research and boosting speed to market.
The Oxford-GSK Institute of Molecular and Computational Medicine has been created via a five-year collaboration between GlaxoSmithKline and the University of Oxford.
The US agency has granted approval to Voxzogo, an injectable drug designed to aid growth in children with achondroplasia, the most common form of dwarfism.
According to the pharma firm, Saphnelo (anifrolumab) combined with standard therapy resulted in reduction of systemic lupus erythematosus disease activity.
CRISPR Therapeutics and ViaCyte, Inc. have received the green light from Health Canada for their Clinical Trial Application for VCTX210: an allogeneic, gene-edited, immune-evasive, stem cell-derived therapy for the treatment of type 1 diabetes (T1D)....
The pact between the drug firm and the group is aimed at giving equitable access to treatments and vaccines for people in disadvantaged parts of the world.
