News & Analysis on Clinical Trial Services & Contract Research And Development
Abbisko’s small molecule drug pimicotinib has smashed the primary goal of a phase 3 trial for the treatment of tenosynovial giant cell tumor (TGCT), taking the asset a step further to the market in China and elsewhere.
Scemblix is the first drug to show superiority over all standard of care therapies for a rare type of leukemia.
The big pharma company GlaxoSmithKline will inject up to $800 million into its manufacturing site in Marietta, Pennsylvania, to double its size and capacity.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has once again snubbed Translarna (ataluren), PTC Therapeutics’ treatment for the genetic disease Duchenne muscular dystrophy (DMD).
The Boston-based biotech will use the new fundraise to develop its pipeline of drug candidates for conditions such as major depressive disorder and generalized anxiety disorder.
The big pharma company Sanofi has discontinued a phase 2 trial of U.S. partner Denali Therapeutics’ oditrasertib for the treatment of multiple sclerosis after the drug failed to perform.
As active pharmaceutical ingredients (APIs) and medicines become more complex and the demand for efficiency rises, drug developers and manufacturers must adapt their strategies to keep pace with the evolving landscape.
At the forefront of precision dosing, Sharmeen leads DoseMe's efforts to transform personalized medicine from lab research to bedside application.
The big pharma company AstraZeneca has forged a licensing pact worth $2 billion with the Chinese firm CSPC Pharmaceutical Group for access to an experimental small molecule treatment for dyslipidemia.
SK Group’s contract development and manufacturing organization (CDMO) arm SK pharmteco is spending $260 million to expand its small molecule and peptide manufacturing muscle in South Korea.
CPHI 2024
At this October’s CPHI event being held in Milan, dsm-firmenich, is inviting stakeholders across the pharmaceutical market to immerse themselves in its patient-inspired innovations.
The US biotech’s neurological drug candidate showed a reduction in disease progression of at least 50% and the company will now file with the FDA.
The German big pharma will submit a new drug application to the US FDA after success at phase 3 for nerandomilast.
One year after a rejection by the US Food and Drug Administration (FDA), the UK firm F2G has raised $100 million to push its candidate olorofim to the market for the treatment of rare fungal infections in 2026.
Dalgety, one of the UK's leading medical cannabis cultivators, has achieved a significant milestone by securing a Home Office licence to supply medical cannabis within the UK.
H1's decision to partner with GRM for this critical initiative in Ukraine was driven by a strong commitment to harness the power of global healthcare networks to provide humanitarian aid in regions that need it most.
Amgen has announced the US availability of Otezla (apremilast) for pediatric patients aged 6 to 17 with moderate to severe plaque psoriasis.
Ayvakit, a groundbreaking therapy developed by Blueprint Medicines, has witnessed a remarkable 185% year-over-year revenue growth in the second quarter of this year (2024).
Lonza, a global leader in the pharmaceutical, biotech, and nutraceutical markets, has announced a significant expansion of its clinical manufacturing services at its small molecules site in Bend, Oregon.
The FDA is expected to make a pivotal decision on Sunday (August 11) regarding the approval of Lykos Therapeutics’ MDMA-assisted therapy for PTSD.
As the BioSecure Act approaches its 2032 implementation, Contract Development and Manufacturing Organizations (CDMOs) must prepare for significant industry shifts.
Rusan Pharma Private Limited has announced that its active pharmaceutical ingredient (API) manufacturing facility in Ankleshwar, Gujarat, has been granted Good Manufacturing Practice (GMP) approval by the FDA.
Roche’s recent $2.7 billion acquisition of Carmot Therapeutics is paying off, with positive results for new oral GLP-1 receptor agonist.
Psychedelic therapeutics have rapidly gained popularity in the pharma industry in a matter of just a few years. Here are five psychedelic drug discovery startups that have received investment this year.
Today (July 16) Celadon Pharmaceuticals Plc, a trailblazer in the UK’s pharmaceutical industry, has achieved a significant milestone with the successful completion of its eighth cannabis harvest of 2024.
Cellibre, a leader in sustainable biochemical manufacturing, has secured a $2 million grant from the National Center for Complementary and Integrative Health (NCCIH) at the National Institutes of Health (NIH).
Esteve Pharmaceuticals has announced a substantial investment of €100 million ($108 million) to build a new manufacturing unit at its Girona plant.
Ketaki Patwardhan, a global technical developer at Roquette, has built a remarkable career in the pharmaceutical industry by leveraging her curiosity and passion for science.
In an exclusive interview, Akash Bakshi, CEO of YourChoice Therapeutics, delves into the inspiration and journey behind developing a hormone-free birth control pill for men.
dsm-firmenich has announced the launch of CBtru – an advanced formulated cannabidiol (CBD) drug product intermediate designed for oral solid delivery formats.
Preclinical results show promise for Tyra Bioscience’s lead drug candidate for the treatment for hypochondroplasia, a condition for which there are currently no therapeutic options available.
The Spanish company Esteve Pharmaceuticals is building a manufacturing unit in its Girona plant with the aim to expand its production of active pharmaceutical ingredients (APIs).
Artificial intelligence is showing great promise in the quest to unearth new drug candidates and disease targets faster than ever before.
Last week, OSP had the pleasure of speaking with Ginny Beakes-Read at the DIA Global conference.
Cellibre, a pioneer in sustainable biochemical manufacturing, has received a $2 million grant from the National Center for Complementary and Integrative Health (NCCIH) at the National Institutes of Health (NIH).
Hikma Pharmaceuticals PLC has made a significant announcement, marking the US launch of Combogesic IV, an intravenous, opioid-free pain relief medication providing a multimodal approach to managing pain in adults.
In an inspiring conversation with Liza Laws, Dr. Michael Giles, MD, and chief executive officer of Sonara Health, shares the innovative journey of creating a platform to enhance the accessibility of methadone treatment for opioid use disorder patients.
In today's fast-paced pharmaceutical industry, major players are seeking innovative solutions to accelerate the drug development process.
In an intriguing interview with Cybin’s CEO, Doug Drysdale, OSP senior editor, Liza Laws found out how second-generation psychedelics could be the biggest breakthrough in psychiatry in 40 years.
UK based Celadon Pharmaceuticals Plc, that specializes in the development, production, and sale of breakthrough cannabis-based medicines, announced that it has begun shipping to the US.
Swixx BioPharma AG, a platform dedicated to unlocking access to e medicines, has announced its strategic expansion into Latin America.
Today (May 14) Everest Medicines, a biopharmaceutical company focused on progressive medicines and vaccines, announced the successful launch of small molecule Nefecon, a delayed-release capsule, in China, with the first prescription issued.
Roquette, a global leader in plant-based ingredients and a key provider of pharmaceutical and nutraceutical excipients, announced today (May 14) the launch of its innovative Lycagel Flex hydroxypropyl pea starch premix for softgel capsules.
Sanofi, a global pharmaceutical giant, has announced a significant investment of over €1 billion ($1.08 billion) in new bioproduction capacity at three manufacturing sites in France.
Walgreens and Boehringer Ingelheim have joined forces in a move to enhance diversity and accessibility in clinical trials, aiming to make participation more inclusive and equitable.
Clerkenwell Health is proud to announce the launch of its foundation course for Psychedelic-Assisted Therapy, a comprehensive 30-hour program that brings together leading experts in the field.
In an extensive and enlightening chat with Prasad Raje, the CEO of LGM Pharma, OSP gained profound insights into the company's trajectory within the pharmaceutical industry.
CPHI North America
After two major acquisitions, Biosynth is coming to CPHI North America ready to tell the industry about its enhanced capabilities and connect with new and existing customers.
Kynos Therapeutics Ltd, based in Edinburgh, UK, focuses on developing small molecule kynurenine 3-monooxygenase (KMO) inhibitors for inflammatory disorders.
Pacylex Pharmaceuticals Inc. has announced the presentation of phase 1 safety and efficacy findings for small molecule drug zelenirstat for cancer treatment.