APIs (active pharmaceutical ingredients)

CPHI 2024

One2Treat - observing emerging trends and reshaping approaches to R&D

25-Apr-2024 By Liza Laws

Last month, OSP was excited to write about One2Treat, a progressive startup specializing in digital health solutions, which has launched a forward-thinking approach aimed at tackling key challenges in the biopharma industry.

European Commission approves Astellas’ drug for expanded prostate cancer Treatment

24-Apr-2024 By Liza Laws

Today (April 24), Astellas Pharma Inc. revealed that XTANDITM (enzalutamide) has received a label extension from the European Commission, marking it as the inaugural and only novel hormone therapy endorsed for high-risk biochemical recurrent non-metastatic...

Edinburgh's Kynos Therapeutics reveals significant findings from trial of leading drug candidate

22-Apr-2024 By Liza Laws

Kynos Therapeutics Ltd, based in Edinburgh, UK, focuses on developing small molecule kynurenine 3-monooxygenase (KMO) inhibitors for inflammatory disorders.

Pacylex Pharma's phase one trial: Zelenirstat safety in heavily pre-treated patients

22-Apr-2024 By Liza Laws

Pacylex Pharmaceuticals Inc. has announced the presentation of phase 1 safety and efficacy findings for small molecule drug zelenirstat for cancer treatment.

NICE recommends Nexpovio for multiple myeloma patients, addressing treatment gaps

22-Apr-2024 By Liza Laws

In a significant development for the multiple myeloma community, Menarini Stemline UK today welcomed the final draft guidance from the National Institute for Health and Care Excellence (NICE).

Catching up with LGM Pharma ahead of CPhI North America to find out about its pipeline

19-Apr-2024 By Liza Laws

LGM Pharma is a leading CDMO provider of comprehensive API sourcing and drug product contract development and manufacturing solutions to the pharmaceutical, biotechnology, and compounding pharmacy industries.

CPhI NA 2024

Giving the gift of health by finding solutions to the cost and complexity of prescription drugs

19-Apr-2024 By Liza Laws

Gifthealth began operations just under four years ago to provide a scalable solution for the cost and complexity of prescription drugs.

Vox Pop Pharma - companies keen to find alternatives to animal testing - read their views

19-Apr-2024 By Liza Laws

Earlier this week, Charles River Laboratories International, Inc. revealed its Alternative Methods Advancement Project (AMAP), which it said is a strong initiative aimed at changing drug discovery and development by exploring alternatives to animal testing.

GSK's Gepotidacin shows promise as new treatment for gonorrhoea amid rising resistance

17-Apr-2024 By Liza Laws

GSK plc unveiled encouraging results from its pivotal Eagle-1 phase 3 trial for gepotidacin, a potential breakthrough oral antibiotic for uncomplicated urogenital gonorrhoea (GC) in adolescents and adults.

Production of tree-saving transformative vaccine adjuvant with in-lab plants

17-Apr-2024 By Liza Laws

During DCAT this year, CEO Gaston Salinas from Botanical Solution Inc., (BSI), sat down with Liza Laws, the senior editor of OSP and BPR to discuss his company’s pioneering work in revolutionizing vaccine adjuvant production.

Qinecsa Solutions acquires Insife to strengthen pharmacovigilance technology

16-Apr-2024 By Liza Laws

Qinecsa Solutions (Qinecsa), a lead company in technology-driven end-to-end pharmacovigilance solutions has announced its acquisition of Insife ApS (Insife), a Danish-based firm specializing in innovative pharmacovigilance platforms.

Innovating drug development: Charles River embracing alternatives to animal testing

16-Apr-2024 By Liza Laws

Charles River Laboratories International, Inc. has unveiled its Alternative Methods Advancement Project (AMAP), a strong initiative aimed at changing drug discovery and development by exploring alternatives to animal testing.

Nxera Pharma's oral receptor agonist advances in schizophrenia trials with successful preclinical milestone

16-Apr-2024 By Liza Laws

Nxera Pharma Co., Ltd is celebrating a significant milestone in its collaboration with Neurocrine Biosciences Inc.

DCAT

DCAT Debrief: Lonza's perspective on pharma's path forward with AI and drug development

16-Apr-2024 By Liza Laws

In a recent discussion with Jan Vertommen, vice president and head of commercial development for the small molecules division at Lonza, key insights were shared regarding the pharmaceutical industry's current landscape and future trajectory.

European Commission offers hope for misunderstood intellectual disability and autism condition, FXS

12-Apr-2024 By Liza Laws

The European Commission has granted Orphan Medicinal Product designation for zatolmilast an investigational treatment for Fragile X syndrome (FXS), a leading cause of inherited intellectual disability and autism.

Good news for migraine sufferers but access to treatment could still cause a headache

12-Apr-2024 By Liza Laws

Yesterday's migraine treatment breakthrough, though amidst a complex journey to find a cure, still promises a dramatic impact despite the absence of a 'magic bullet.'

Landmark study validates Cystic Fibrosis drug for infants as young as four weeks old

11-Apr-2024 By Liza Laws

In a groundbreaking revelation, a study conducted by RCSI University of Medicine and Health Sciences and Children’s Health Ireland has confirmed the safety and efficacy of a Cystic Fibrosis drug in newborns as young as four weeks old.

Adragos Pharma - poised to make a lasting impact in the pharmaceutical industry

11-Apr-2024 By Liza Laws

Adragos Pharma is a contract development and manufacturing organization (CDMO) that provides development and manufacturing services for drug products. It concentrates on small molecule dosage forms including sterile and non-sterile liquids, solids, and...

NHS England and Gilead Sciences final push to eradicate hepatitis C with extended partnership

09-Apr-2024 By Liza Laws

In a bid to combat hepatitis C, Gilead Sciences Ltd. has announced the extension of its collaboration with NHS England.

Enrollment completed for trial of drug to treat children with rare primary immunodeficiency

08-Apr-2024 By Liza Laws

Pharming Group N.V. has declared the successful enrollment completion in its phase 3 clinical trial of leniolisib, an investigational drug designed for children aged 4 to 11 years with activated phosphoinositide 3-kinase delta syndrome (APDS).

Quotient Sciences' Vanessa Zann on the company's fascinating updates in drug development

08-Apr-2024 By Liza Laws

In an exclusive interview with Dr Vanessa Zann, (pictured below) executive drug development consultant at Quotient Sciences, OSP delved into the forefront of pharmaceutical research and development.

Pluss unveils Celsure XL VIP pallets - a game-changer for the pharma industry?

03-Apr-2024 By Liza Laws

Pluss, a leading provider of temperature-controlled packaging solutions, today (April 3) launched its latest innovation, the Celsure XL VIP pallets.

Molecure reports accelerated progress in clinical and preclinical programs for 2023

03-Apr-2024 By Liza Laws

Molecure S.A., a leading biotechnology company focused on drug discovery and development, has unveiled its annual report for 2023 at the start of the new financial year.

Advancements in endometrial treatment - Hutchmed & Innovent's cancer combo NDA accepted with Priority Review

02-Apr-2024 By Liza Laws

In an important announcement today (April 2), Hutchmed and Innovent jointly revealed the acceptance of their New Drug Application (NDA) in China for the combination of Fruquintinib with Sintilimab.

Can psychedelics with shorter yet more intense experiences cure people with alcohol dependence?

27-Mar-2024 By Liza Laws

In an exciting collaboration, modern mental health company, Clerkenwell Health, and Beckley Psytech, a clinical-stage biotechnology company, have launched a phase 2a study aimed at investigating a potential breakthrough treatment for alcohol use disorder...

Johnson & Johnson announces approval of OPSYNVI for pulmonary arterial hypertension patients

25-Mar-2024 By Liza Laws

In a significant milestone for pulmonary arterial hypertension (PAH) patients, Johnson & Johnson has announced the approval of OPSYNVI.

Merck announces €300 million investment in new life science facility in Korea

21-Mar-2024 By Liza Laws

Merck set to invest over €300 million in new production center in South Korea.

DCAT 2024

What are the global pharma giants' goals at DCAT 2024? A written roundtable reveals all

19-Mar-2024 By Liza Laws

The curtains have risen on DCAT 2024 in the vibrant heart of New York City, and leading pharmaceutical companies from around the world have converged for a week of innovation, collaboration, and strategic dialogue.

Negev Capital fuels psychedelic medicine breakthroughs worldwide with three companies

11-Mar-2024 By Liza Laws

Venture Capital firm, Negev Capital, holds a portfolio of companies creating neuropsychiatric drugs based on psychedelic molecules.

Pain is reduced by almost half with cannabis-based medicines – report finds

11-Mar-2024 By Liza Laws

On March 7, Celadon Pharmaceuticals plc, a leading UK-based pharmaceutical company specializing in cannabis-based medicines, unveiled promising findings from an early economic analysis of its chronic pain clinical trial, dubbed CANPAIN.

Clerkenwell Health calling for volunteers with PTSD to trial new psychoactive drug

05-Mar-2024 By Liza Laws

Clerkenwell Health, a company that delivers clinical trials for the treatment of complex mental health volunteers for trials into the use of psychoactive medications for treating PTSD, is in search of 40 ex-military volunteers.

Form Bio and Ginkgo Bioworks collaborate to revolutionize AAV gene therapy development

05-Mar-2024 By Liza Laws

Form Bio and Ginkgo Bioworkshave joined forces in what they call a groundbreaking partnership aimed at advancing AAV gene therapy design and development.

GI-targeted ROCK inhibitor for fibrostenotic Crohn’s disease in phase 1 study

29-Feb-2024 By Liza Laws

Yesterday, (February 28), a clinical-stage biotechnology company, Redx, announced that the first participant has been dosed in a phase 1 clinical trial for RXC008.

Webinar: Innovations in drug delivery - tune in and join our excellent panel

27-Feb-2024 By Liza Laws

As the landscape of healthcare continues to evolve, so too does the field of drug delivery.

Biogen's Qalsody receives positive opinion from CHMP for ALS treatment in Europe

27-Feb-2024 By Liza Laws

Biogen Inc. has announced a significant advancement in the treatment of amyotrophic lateral sclerosis (ALS), commonly known as motor neuron disease (MND).

CymaBay's seladelpar has the potential to raise the bar in treatment for PBC

25-Feb-2024 By Liza Laws

Results from a phase 3 trial looking at treatment for primary biliary cholangitis (PBC) are 'genuinely exciting' and support the potential for seladelpar to raise the bar in treatment of the disease.

NICE Recommends GSK's Omjjara as treatment option for myelofibrosis patients with anaemia

22-Feb-2024 By Liza Laws

The National Institute for Health and Care Excellence (NICE) has issued guidance recommending GSK's Omjjara (momelotinib) as a treatment option for disease-related splenomegaly.

First patient dosed using oral PROTAC in development for neurodegenerative diseases

20-Feb-2024 By Liza Laws

A clinical-stage biotechnology company creating a new class of drugs today (Feb 20) announced that a first subject has been dosed in a phase 1 clinical trial.

Patients with treatment-resistant depression sought for trial of psychedelic drug

20-Feb-2024 By Liza Laws

Some forms of depression cannot be cured by current treatments including antidepressants or going to psychological counselling or psychotherapy.

AstraZeneca’s Tagrisso that delays lung disease progression by nine months gets FDA approval

19-Feb-2024 By Liza Laws

Patients in the US with epidermal growth factor receptor mutated (EGFRm) advanced lung cancer can now receive an important new treatment option delaying disease progression by nearly nine additional months.

European Commission grants approval for first therapy to treat Friedreich’s ataxia

13-Feb-2024 By Liza Laws

Biogen Inc. has taken a step closer to bringing its ‘groundbreaking treatment’ to patients with a rare, genetic, life-shortening, debilitating, and neurodegenerative disorder.

Repare Therapeutics takes back

Roche says decision to end camonsertib agreement with Repare Therapeutics was not taken easily

13-Feb-2024 By Liza Laws

Swiss multinational healthcare company, Roche, has terminated its worldwide license and collaboration agreement with Repare Therapeutics despite the company earning a $40 million milestone payment from Roche.

FDA gives fast-track status to Pfizer and Arvinas' breast cancer drug

08-Feb-2024 By Liza Laws

A small molecule oral treatment for breast cancer has been granted fast-track designation by the US Food and Drug Administration (FDA).

With half of alcoholics refusing to abstain, Kinnov's new drug to fight addiction couldn't come soon enough

05-Feb-2024 By Liza Laws

No new treatments to combat the major public health issue of alcohol use disorder (AUD), have been brought to market for ten years - and with half of heavy drinkers refusing the abstinence route, new drug could be the answer.

£9.6M for NeoPhore's small molecule inhibitors targeting MMR pathway that could prevent cancer

01-Feb-2024 By Liza Laws

A company building a pipeline of small molecule drugs targeting novel proteins across the DNA mismatch repair (pathway) has announced a further extension to its series B financing round.

MHRA authorises GSK’s Omjjara for treating symptoms in adult myelofibrosis with anaemia

31-Jan-2024 By Liza Laws

GSK plc’s small molecule Omjjara (momelotinib), was granted marketing authorization (MA) yesterday (January 31) by the Medicines and Healthcare products Regulatory Agency (MHRA).

Treatment approved for Hong Kong's second most common cancer

30-Jan-2024 By Liza Laws

With colorectal cancer (MRC) being the second biggest cancer type in Hong Kong, it is positive news that Hutchmed has received marketing approval for its Elunate (fruquintinib) small molecule treatment.

Key achievement for Repare Therapeutics after receipt of $40 million Roche payment

29-Jan-2024 By Liza Laws

Clinical-stage precision oncology company, Repare Therapeutics Inc., has received a $40 million milestone payment from Roche after dosing the first patient in a clinical trial.

Inceptua and Cycle partnership brings hope to patients at the end of the treatment road

18-Jan-2024 By Liza Laws

Inceptua Group and Cycle Pharmaceuticals partnership will give access to Free Goods Partnership that gets medicine to patients with extremely rare genetic conditions, which they would be unable to access otherwise.

Alliance to improve two complex and critical aspects of drug development and manufacturing

16-Jan-2024 By Liza Laws

An alliance between KBI Biopharma Inc., and Argonaut Manufacturing Services Inc., has been formed so biopharma clients can receive end-to-end drug substance and drug product manufacturing solutions.