The agency has approved an expanded indication for Qelbree extended-release capsules to treat attention deficit hyperactivity disorder in younger patients.
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 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 maker of active pharmaceutical ingredients for inhaled treatments is investing €9m ($9.8m USD) to expand its manufacturing plant in Barcelona, Spain.
The company’s recent purchase by Drug Safety and Pharmacovigilance Services Solutions reportedly will fuel expansion of its Reportum PV platform technology.
This month’s news includes hiring, promotions, expansions, and acquisitions at H Clinical, Charles River, DHL Supply Chain, X-Chem, and other key companies.
The excipients, equipment, and API companies have joined forces on Inhalation Together, an initiative aimed at advancing dry-powder inhalation solutions.
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 drug company has renewed its arrangement with the artificial intelligence specialist, centered on using AI to improve understanding of the immune system.
This month’s announcements include hiring, expansion, and acquisition news from companies like DFE Pharma, ClinOne, Novartis, LEGO, Benchling, and more.
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.
The AI-centered genomics company is joining with Don’t Forget Morgan, a group for patients with BPAN, to explore treatments for the neurodegenerative condition.
A representative from the HIV-centered pharmaceutical company shares thoughts and perspective on the every-two-month treatment and how it might help patients.
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.
This month’s announcements include new hires, promotions, acquisitions, and other events from Saama, Javara, Firma, GlaxoSmithKline, and other companies.
Biogen releases further details on how its Phase 4 post-marketing confirmatory study for Alzheimer’s drug, Aduhelm, will run: including increased enrolment and enhanced efforts to encourage diversity.
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.
This month’s list of new technology, partnerships, and other announcements includes items from ObvioHealth, Datavant, HumanFirst, and other industry players.
The pharmaceutical company reports studies have demonstrated the main protease inhibitor of Paxlovid maintains in vitro efficiency against the variant.
A leader from health tech solutions company Vytal examines supply chain challenges faced in the pharmaceutical field and shares some potential solutions.
A representative from IFF Pharma Solutions talks about significant challenges in drug development and improvements the industry can implement to overcome them.
It has been a pleasure for the OSP team to connect with a long list of fascinating industry minds and share the stories; here are a few of our favorites.
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.
The pharmaceutical company has announced GMP-related challenges with a manufacturer contracted to fill syringes for Wegovy pens headed to the US market.
A leader from the company discusses how advanced analytical tools can be put to work to help tackle adverse event case processing and compliance issues.
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.
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.
Stevanato Group is showcasing its SG Alina disposable, variable-dose pen injector platform, available with customizable features, at CPhI Worldwide 2021.
This capsule of industry news features Amcor, High Purity New England, MG America, and other firms offering packaging and labeling products and services.
This month’s announcements of programs, names, appointments, hires, and other happenings includes items from Emmes, Science 37, Cerner and other companies.
CPhI Worldwide will see Gerresheimer showcase its latest developments in primary packaging, drug delivery systems for newly developed biologics along with medical and diagnostic products.
A leader from Medicines for Europe will share with CPhI Worldwide attendees a look at medicine production and offer solutions for elevating the industry.
An expert from the specialty chemicals firm (and CPhI Worldwide speaker) explains trends and developments in excipients and how they drive advancements.
The global pharmaceutical industry event is returning to the real world November 9-11 this year, with online content for professionals opting not to travel.
The trial will evaluate a weekly regimen of islatravir and lnecapavir in HIV patients who are virologically suppressed while on antiretroviral therapies.
Appili Therapeutics reports it has enrolled the last patient for its Phase III study of Avigan/Reeqonus (favipiravir), developed in alliance with AiPharma.
The conference (with online and in-person content) is slated to gather professionals for deep conversations and lively collaboration on important topics.
The AI technology firm and pharma services company are joining to help one of the country’s leading pharmaceutical firms develop a promising drug candidate.
Organizers of the drug delivery and packaging event have shared an industry report that reveals what is likely to push innovation forward in the future.
This month’s news on appointments, expansions, acquisitions and other events includes Nanoform, Elligo Health Research, Curavit, and other organizations.
A report from the industry event’s organizers indicates American companies have an edge on drug delivery innovation but lag in operational sustainability.