Delivery formulations

Noxopharm cancer drug secures Orphan Drug Designation from FDA

05-Apr-2022 By Jenni Spinner

The Australian biotechnology company has been granted ODD status from the agency for Veyonda, a therapy intended for the treatment of soft-tissue sarcoma.

UCB’s Fintepla oral seizure treatment receives FDA approval

28-Mar-2022 By Jenni Spinner

The drug has received the agency’s seal of approval to treat seizures associated with difficult-to-treat seizures associated with Lennox-Gastaut syndrome.

Nipah research to support vaccine development

28-Mar-2022 By Rachel Arthur

A new study will seek to understand the body’s response to the Nipah virus in order to support development of vaccines.

Pfizer to supply up to 4m COVID-19 treatment courses to UNICEF

22-Mar-2022 By Jenni Spinner

The pharmaceutical company has agreed to provide its Paxlovid oral COVID-19 treatment to the global charity, covering 95 low- and middle-income countries.

Tech Innovations: March 2022

17-Mar-2022 By Jenni Spinner

The latest news on software, manufacturing solutions, partnerships, and more includes IQVIA, TFF Pharmaceuticals, Quotient Sciences and other key companies.

AbbVie, Gedeon Richter to partner on developing neuropsychiatric drugs

15-Mar-2022 By Jenni Spinner

The US- and Hungary-based pharma firms will work on research, development, and commercialization of dopamine receptor modulators for potential treatments.

DCAT week 2022

DCAT Week 2022 to explore ‘what’s next for the industry’

03-Mar-2022 By Jenni Spinner

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.

Viiv weighs in on FDA approval of long-acting HIV treatment

22-Feb-2022 By Jenni Spinner

A representative from the HIV-centered pharmaceutical company shares thoughts and perspective on the every-two-month treatment and how it might help patients.

Collaboration to advance development of cancer therapies

14-Feb-2022 By Jenni Spinner

Cullinan Oncology has formed a strategic partnership with the Icahn School of Medicine at Mount Sinai to research and develop targeted therapies for cancer.

TFF completes enrollment in early-phase trial of inhaled COVID-19 therapy

10-Feb-2022 By Nick Taylor

The pharmaceutical company, which uses thin-film freezing to develop inhalable therapies, has completed enrollment in the first phase for its drug candidate.

ViiV Healthcare long-acting HIV treatment secures FDA approval

07-Feb-2022 By Jenni Spinner

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.

Altimmune obesity drug candidate lands IND clearance from the FDA

31-Jan-2022 By Jenni Spinner

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.

FDA approves IND for clinical trial evaluating CBD-based drug

25-Jan-2022 By Jenni Spinner

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.

Pfizer: COVID-19 treatment shows promise against omicron variant

18-Jan-2022 By Jenni Spinner

The pharmaceutical company reports studies have demonstrated the main protease inhibitor of Paxlovid maintains in vitro efficiency against the variant.

WHO grants seal of approval to two new COVID-19 treatments

14-Jan-2022 By Jenni Spinner

The World Health Organization has recommended the drugs for COVID-19 patients, broadening the range of therapies to combat the virus behind the pandemic.

NervGen Pharma sets sights on trial for spinal-cord injury treatment

12-Jan-2022 By Jenni Spinner

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.

Road ahead paved with innovation, opportunities: Syneos Health

04-Jan-2022 By Jenni Spinner

A forward-looking report from company experts includes a breakdown of the top trends to watch for in pharmaceutical development and in healthcare overall.

Purchases, pandemic, and potential treatments: 2021’s greatest hits

22-Dec-2021 By Jenni Spinner

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.

2021 year-end wrapup

Pandemic leads to challenges, opportunities in drug development: ACD/Labs

16-Dec-2021 By Jenni Spinner

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.

Insilico Medicine launches trial for AI-discovered drug

15-Dec-2021 By Jenni Spinner

The artificial intelligence-driven drug discovery company has dosed its first healthy volunteer in a trial for a candidate to treat idiopathic pulmonary fibrosis.

Pfizer shares more promising results from COVID-19 study

14-Dec-2021 By Jenni Spinner

According to the company, the latest Phase II/III study results show its novel oral treatment candidate is effective in reducing hospitalizations and deaths.

ASH 2021 sees Novartis launch a 'next-generation' CAR-T platform

14-Dec-2021 By Jane Byrne

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.

Pfizer buys immuno-inflammatory firm Arena Pharmaceuticals for $6.7b

13-Dec-2021 By Jenni Spinner

The pharmaceutical company currently has several promising treatments in development for gastroenterological, dermatological, and cardiological conditions.

New inhaled SARS-CoV-2 antibody treatment set to enter clinical trials

13-Dec-2021 By Rachel Arthur

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.

Roquette plans to open doors of new US innovation center

08-Dec-2021 By Jenni Spinner

Sited in Pennsylvania, the excipients specialist’s new facility reportedly will work toward advancing drug delivery research and boosting speed to market.

GSK and University of Oxford launch new institute, embracing advanced technologies for drug discovery

02-Dec-2021 By Rachel Arthur

The Oxford-GSK Institute of Molecular and Computational Medicine has been created via a five-year collaboration between GlaxoSmithKline and the University of Oxford.

FDA approves BioMarin drug to treat dwarfism in children

22-Nov-2021 By Jenni Spinner

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.

AstraZeneca: lupus drug candidate shows promise in Phase III trial

16-Nov-2021 By Jenni Spinner

According to the pharma firm, Saphnelo (anifrolumab) combined with standard therapy resulted in reduction of systemic lupus erythematosus disease activity.

Gene-edited cell replacement therapy for diabetes set to enter the clinic

16-Nov-2021 By Rachel Arthur

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)....

Pfizer inks COVID-19 treatment licensing agreement with MPP

16-Nov-2021 By Jenni Spinner

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.

TFF completes dosing in Phase Ib clinical study for asthma drug

15-Nov-2021 By Jenni Spinner

The firm is investigating viability of voriconazole inhalation powder, intended to treat and prevent invasive pulmonary aspergillosis in asthma patients.

Biohaven wraps patient enrollment for ALS clinical trial arm

15-Nov-2021 By Jenni Spinner

The pharma company has completed enrollment of amyotrophic lateral sclerosis patients in its study investigating drugs like verdiperstat, an oral treatment.

Baxter investing $100m to bolster German sterile fill/finish facility

11-Nov-2021 By Jenni Spinner

The infusion of funds in the Halle/Westfalen, Germany manufacturing complex is intended to help meet growing global demand for injectable pharmaceuticals.

CPHI WORLDWIDE

Carrier solution addresses challenging liquid APIs: W.R. Grace

03-Nov-2021 By Jenni Spinner

The CPhI Worldwide exhibitor will show Syloid XDP, a silica carrier designed to convert liquid, waxy, or oily active ingredients into free-flowing powders.

CPhI Worldwide

Gerresheimer develops delivery device for drugs with higher viscosity

03-Nov-2021 By Jane Byrne

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.

CPHI WORLDWIDE

Hybrid CPhI Worldwide 2021 a ‘celebration’ of pharma industry

02-Nov-2021 By Jenni Spinner

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.

Gilead, Merck launch Phase II trial evaluating oral regimen for HIV-1 treatment

01-Nov-2021 By Jenni Spinner

The trial will evaluate a weekly regimen of islatravir and lnecapavir in HIV patients who are virologically suppressed while on antiretroviral therapies.

Potential COVID-19 treatment to wrap up Phase III trial

26-Oct-2021 By Jenni Spinner

Appili Therapeutics reports it has enrolled the last patient for its Phase III study of Avigan/Reeqonus (favipiravir), developed in alliance with AiPharma.

Digital revolution transforming drug development: West Pharma

18-Oct-2021 By Jenni Spinner

A leader from the drug development and manufacturing firm talks about the ways in which advanced digital tools stand to revolutionize the pharma field.

AAPS PharmSci 360

PharmSci 360 invites industry pros to ‘rethink and evolve’

14-Oct-2021 By Jenni Spinner

The conference (with online and in-person content) is slated to gather professionals for deep conversations and lively collaboration on important topics.

CytoReason, Summit tap into AI on Japanese drug development effort

12-Oct-2021 By Jenni Spinner

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.

Data advances, environmental factors driving device innovation: Pharmapack

11-Oct-2021 By Jenni Spinner

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.

Generics price fixing charges land pharma firms $447.2m penalty

05-Oct-2021 By Jenni Spinner

The US Department of Justice reports three generic drug manufacturers have been socked with the hefty fine to resolve alleged False Claims Act violations

Merck: COVID-19 oral antiviral drug reduces risk of death

01-Oct-2021 By Jenni Spinner

The pharma firm reports molnupiravir was shown to cut risk of hospitalization or death by 50% compared to placebos in a positive interim Phase III analysis.

Merck to acquire Acceleron Pharma, strengthening cardiovascular pipeline

30-Sep-2021 By Rachel Arthur

Merck (MSD outside the US and Canada) will acquire Acceleron in a deal worth around $11.5bn.

Update on FDA COVID approvals, actions, and advice

24-Sep-2021 By Jenni Spinner

As COVID-19 and its variants continue their attack, the agency maintains its position of overseer and giver of advice on various treatments and vaccines.

FDA approves IND application for peanut allergy drug candidate

16-Sep-2021 By Jenni Spinner

The US agency has given the go-ahead to Cour Pharmaceuticals to evaluate the safety and efficacy of CNP-201, a drug intended to treat peanut allergies.

GSK rhinosinusitis drug receives thumbs up from the FDA

09-Sep-2021 By Jenni Spinner

Nucala, a monoclonal antibody indicated for patients with chronic rhinosinusitis with nasal polyps, has been approved by the Food and Drug Administration.

Inflammasome develops combo HIV/birth control implant

23-Aug-2021 By Jenni Spinner

Thanks in part to grants from the Gates Foundation, the company has come up with a bioerodible implant that combines HIV prevention and birth control.

SPI launches UltraBurst excipient designed for ODT formulation

18-Aug-2021 By Jenni Spinner

The pjarmaceutical excipient, intended for use in the formulation of flash orally dissolving tablets, is designed to disintegrate in less than 10 seconds.