Eli Lilly announces positive Phase 2 results for Muvalaplin against heart disease
Muvalaplin significantly lowered lipoprotein(a) levels, reducing the risk of cardiovascular events in high-risk adults.
Ingredients
Abbisko’s pimicotinib hits primary endpoint in phase 3 TGCT trial
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.
FDA grants accelerated approval to Novartis’ Scemblix as a first-line leukemia therapy
Scemblix is the first drug to show superiority over all standard of care therapies for a rare type of leukemia.
GSK beefs up US manufacturing site with $800 million investment
The big pharma company GlaxoSmithKline will inject up to $800 million into its manufacturing site in Marietta, Pennsylvania, to double its size and capacity.
PTC Therapeutics’ Translarna misses European regulatory hurdle again
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).
Seaport Therapeutics closes $225 million Series B to develop neuropsychiatric drugs
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.
Sanofi abandons phase 2 trial of Denali’s multiple sclerosis candidate
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.
How a CDMO is staying on top of API and drug product manufacturing trends
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.
Women in Science: Sharmeen Roy - 'pharmacy is the perfect blend of all my favourite subjects'
At the forefront of precision dosing, Sharmeen leads DoseMe's efforts to transform personalized medicine from lab research to bedside application.
AstraZeneca licenses CSPC’s cardiovascular drug in $2 billion deal
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 pharmteco to strengthen small molecule and peptide capacity with $260 million investment
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
CBD-based formulations from dsm-firmenich at 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.
Biohaven’s real-world trial shows positive results for spinocerebellar ataxia drug
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.
Boehringer Ingelheim score with phase 3 idiopathic pulmonary fibrosis win
The German big pharma will submit a new drug application to the US FDA after success at phase 3 for nerandomilast.
F2G raises $100 million to combat innovation 'paucity' in antifungals
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.
‘We’re here and we’re ready’ - Dalgety secures UK licence to supply medical cannabis
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 Connect links doctors to global humanitarian missions
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.
First severe plaque psoriasis oral therapy for ages 6-17 available in the US
Amgen has announced the US availability of Otezla (apremilast) for pediatric patients aged 6 to 17 with moderate to severe plaque psoriasis.
Ayvakit's explosive 185% revenue growth: A game-changer in rare disease treatment
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 boosts clinical services with new bottling capabilities
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.
FDA to decide on Lykos' MDMA therapy for PTSD, offering hope for millions
The FDA is expected to make a pivotal decision on Sunday (August 11) regarding the approval of Lykos Therapeutics’ MDMA-assisted therapy for PTSD.
How CDMOs can optimize operations and balance costs ahead of the 2032 BioSecure Act
As the BioSecure Act approaches its 2032 implementation, Contract Development and Manufacturing Organizations (CDMOs) must prepare for significant industry shifts.
FDA approves Rusan Pharma’s manufacturing facility in India, paving the way for expanded US presence
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 oral GLP-1 receptor agonist shows promising early weight loss results in phase 1
Roche’s recent $2.7 billion acquisition of Carmot Therapeutics is paying off, with positive results for new oral GLP-1 receptor agonist.
Psychedelic drug investments surge in 2024: Key startups raising funds and closing deals
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.
Celadon Pharmaceuticals celebrates eighth harvest, poised for 15 a 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.
NIH awards Cellibre $2M to advance sustainable cannabinoid ingredient production
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 expanding Girona plant to enhance the production of APIs
Esteve Pharmaceuticals has announced a substantial investment of €100 million ($108 million) to build a new manufacturing unit at its Girona plant.
Ketaki Patwardhan - from experiments with her dad to excipients and manufacturing at Roquette
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.
Could this be the end of condoms and will men embrace the hormone-free birth control pill?
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 launches CBtru, revolutionizing CBD drug development with enhanced bioavailability
dsm-firmenich has announced the launch of CBtru – an advanced formulated cannabidiol (CBD) drug product intermediate designed for oral solid delivery formats.
Tyra Biosciences' TYRA-300 shows promise for hypochondroplasia treatment
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.
Esteve invests €100 million in Spanish API manufacturing muscle
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).
The top 5 emerging startups fuelling drug discovery with AI
Artificial intelligence is showing great promise in the quest to unearth new drug candidates and disease targets faster than ever before.
Inside the FDA's Accelerated Approval: How it’s extending lives and improving patient care
Last week, OSP had the pleasure of speaking with Ginny Beakes-Read at the DIA Global conference.
NIH awards Cellibre $2M to advance sustainable cannabinoid ingredient production
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).
Is Combogesic IV revolutionizing pain management in the US healthcare market?
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.
Sonara Health: Transforming methadone treatment access for opioid use disorder patients
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.
Does Stardog AI hold the key to faster pharma success?
In today's fast-paced pharmaceutical industry, major players are seeking innovative solutions to accelerate the drug development process.
Interview: Has Cybin hit the biggest breakthrough in 40 years to treat psychiatric disorders?
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 company selling breakthrough cannabis-based medicines now supplying the US
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 expands to Latin America through strategic acquisition of Biopas
Swixx BioPharma AG, a platform dedicated to unlocking access to e medicines, has announced its strategic expansion into Latin America.
First oral treatment for chronic kidney disease launched in China by Everest Medicine
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 solving toughest drug development challenges with new capsules
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's €1BN investment to enhance health sovereignty in France
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 to be used as clinical trial sites focusing on obesity and type 2 diabetes
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.
UK health offers course for professionals to learn from the forefront of psychedelic research hub
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.
Unlocking Synergies: LGM Pharma's strategic approach to sourcing and growth in India
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
How Biosynth is coming to CPHI North America with an 'even bigger toolbox'
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.
Edinburgh's Kynos Therapeutics reveals significant findings from trial of leading drug candidate
Kynos Therapeutics Ltd, based in Edinburgh, UK, focuses on developing small molecule kynurenine 3-monooxygenase (KMO) inhibitors for inflammatory disorders.