Delivery formulations

Taro recalls seizure medicine over suspension problems

24-Feb-2020 By Ben Hargreaves

Taro instigates a voluntary recall of phenytoin oral suspension after two lots are found not to re-suspend when shaken.

Formulation technology improving CBD uptake bought out

20-Feb-2020 By Vassia Barba

Bioavailability of water insoluble compounds, such as CBD, enhanced up to 15 times with the technology of Solmic, leading to its acquisition by Betterlife.

Branded generics forecast to double revenues, with US and Europe left behind

12-Feb-2020 By Vassia Barba

Global sales of branded generic drugs are expected to progress at 8% CAGR through 2029, but the US and Europe are not set to drive this growth.

US FDA finds fault with standards at Aurobindo's oral solids facility

03-Feb-2020 By Nick Taylor

Aurobindo Pharma reveals US FDA found objectionable conditions at its oral solids manufacturing facility.

FDA unanimously shuts down Nektar’s opioid painkiller

16-Jan-2020 By Ben Hargreaves

The US FDA’s advisory committee voted 27-0 against recommending approval of oxycodegol, with Nektar deciding to withdraw its application as a result.

Hikma, Arecor partner on Arestat formulation technology

13-Jan-2020 By Vassia Barba

Hikma taps Arestat, a formulation technology for protein- and peptide-based drugs, to develop an injectable medicine, ahead of filing for US FDA approval.

Catalent to formulate CBD multiple sclerosis treatment with Zydis

16-Dec-2019 By Vassia Barba

Catalent enters partnership with Ethicann on Zydis technology to formulate CBD and THC combination treatment for muscular spasticity.

Celltrion gets EMA nod for subcutaneous infliximab biosimilar

28-Nov-2019 By Vassia Barba

Celltrion receives EMA marketing authorisation for Remsima SC, the first subcutaneously-administered option for delivery of infliximab, a treatment for rheumatoid arthritis.

Cycle taps into Catalent’s Zydis tech to manufacture four products

31-Oct-2019 By Vassia Barba

Cycle looks to benefit from the advantages of Zydis oral disintegrating tablet technology, developed by Catalent, for four of its drug products treating rare diseases.

ANI launches CDMO arm after WellSpring integration

31-Oct-2019 By Vassia Barba

ANI Pharmaceuticals expands into the CDMO market and introduced its services for late-stage developers at CPhI last week.

Foamix enters commercial supply agreement for topical foam antibiotic

24-Oct-2019 By Staff Reporter

Foamix signs deal with ASM for the commercial manufacture and supply of recently approved Amzeeq and its lead candidate, FMX103.

FDA hits Glenmark with warning letter over GMP failings

22-Oct-2019 By Nick Taylor

The US FDA hits Glenmark’s manufacturing plant with a warning letter over quality problems first identified in 2010.

FDA gives nod to first transdermal patch for schizophrenia treatment

17-Oct-2019 By Vassia Barba

US FDA approves Noven’s schizophrenia treatment administered through a once-daily transdermal delivery system, able to release the antipsychotic drug for 24 hours.

Microneedle-packed capsule enables oral insulin delivery

15-Oct-2019 By Vassia Barba

Through funding by Novo Nordisk and the NIH, researchers from MIT have come up with a microneedle containing capsule able to release drug substance into the bloodstream.

AstraZeneca earns FDA nod for at-home autoinjector

09-Oct-2019 By Vassia Barba

US FDA approves AstraZeneca’s at-home autoinjector for administration of an add-on treatment for severe asthma, matching the indication of GSK’s rival product, Nucala.

FDA aims to speed naloxone generics to market

27-Sep-2019 By Ben Hargreaves

US FDA follows up the first generic approval of naloxone nasal spray by encouraging companies to apply with generic applications amid the North American opioid crisis.

UPDATED

Boehringer in $160m deal with Inflammasome on intravitreal treatments

24-Sep-2019 By Vassia Barba

Boehringer adopts Inflammasome’s intravitreal drug delivery technology to develop treatments for retinal diseases.

Novo Nordisk gets nod for oral diabetes drug

23-Sep-2019 By Ben Hargreaves

US FDA provides the first ever approval of an oral GLP-1 treatment to Novo Nordisk, for the treatment of type 2 diabetes.

Purdue aims to end litigation with bankruptcy, but not all states onboard

16-Sep-2019 By Ben Hargreaves

Purdue reaches agreement to settle opioid litigation it is facing in the US by pursuing bankruptcy and providing a suggested $10bn towards the opioid crisis.

Mundipharma bets $568m on antifungal treatment

09-Sep-2019 By Ben Hargreaves

Mundipharma signs agreement to progress an antifungal candidate through to commercialization, with the potential for it to become the first approved treatment in 13 years.

Kiel University and Hovione to develop high-dose inhalation formulations

03-Sep-2019 By Vassia Barba

Hovione to work with Kiel University on a dry-powder inhaler, enabling large-dose drug administration under a collaboration agreement.

Strides acquires US capsule facility, set to invest further $10m

03-Sep-2019 By Vassia Barba

Strides acquires the only FDA-approved integrated soft gel capsule manufacturing facility in the US, owned by Micelle, to support its operations in India.

Lupin sells its Japan injectables business to Neopharma

02-Sep-2019 By Vassia Barba

Lupin to divest its Japanese injectables business to a subsidiary of Neopharma group in the UAE, aiming to streamline its Japan operations.

Genentech to advance on-body drug delivery platform

26-Aug-2019 By Maggie Lynch

Genentech enters a manufacturing and development agreement with Enable Injections to advance the latter’s patient-administered subcutaneous drug delivery system.

GSK releases positive data on long-acting HIV treatment

22-Aug-2019 By Ben Hargreaves

GSK announces that its injectable HIV treatment was able to suppress the virus when administered every two months.

Topical drug delivery market to reach $123bn by 2024

21-Aug-2019 By Vassia Barba

High prevalence of skin disease and diabetes to boost the global revenues of the topical drug delivery market, with uptake in China and India boosting growth.

Tiny bottles create controlled release system to deliver chemo

20-Aug-2019 By Maggie Lynch

Nanoscale silica bottles, a five-hundredth of the diameter of a hair, could be used to deliver cancer drugs to specific disease sites in the body, avoiding debilitating side effects.

Activated carbon ‘acts like a slow-release drug capsule’ in drug delivery study

19-Aug-2019 By Maggie Lynch

Researchers at the University of Illinois at Chicago reported that combining activated charcoal with herpes treatment acyclovir, improves the drug’s efficacy.

Novartis licenses small molecule treatment for a genetic ultra-rare disease

15-Aug-2019 By Maggie Lynch

Novartis enters a licensing and development agreement with Pharming group for ultra-rare disease treatment for more than $20m.

FDA approves treatment for the ‘world’s deadliest infectious disease’

15-Aug-2019 By Maggie Lynch

FDA approves the third anti-TB drug in more than 40 years after the compound showed significantly higher success rates in patients with multi drug-resistant and extensively drug-resistant TB.

Reports of deathly errors spark the EMA to order name changes

08-Aug-2019 By Vassia Barba

The EMA demands drug developers to change the name of medicines containing liposomal, following reports of ‘serious medication errors’, some leading to death.

Narcan-like drug delivery system approved for emergency treatment

05-Aug-2019 By Maggie Lynch

Aptar’s needle-free, emergency powder formulation treatment for patients with diabetes and severe hypoglycemia is the company’s first combination drug delivery device with active packaging.

Zambon’s acquisition creates position to ‘achieve advances’ for respiratory diseases

05-Aug-2019 By Maggie Lynch

Zambon acquires Breath Therapeutics for €140m to accelerate the commercialization of treatments for severe respiratory diseases.

Sanofi in manufacturing deal for cannabinoid overdose treatment

01-Aug-2019 By Vassia Barba

Sanofi to manufacture and commercialize Opiant’s investigational treatment for acute cannabinoid overdose, which could become the first treatment for the condition.

Acquisition of two treatments ‘rounds out’ Upsher-Smiths migraine portfolio

01-Aug-2019 By Maggie Lynch

The acquisition of two migraine therapies from Dr Reddy’s has been completed by Upsher-Smith, adding different drug delivery treatment options to its migraine product portfolio.

Mapi to establish $13m manufacturing plant for Copaxone generic

30-Jul-2019 By Vassia Barba

Mapi to turn a facility previously owned by J&J into a manufacturing plant for the production of GA Depot, a long-acting generic of Teva’s Copaxone.

Investment from AI Fund enables development of non-traditional drug candidates for depression

29-Jul-2019 By Maggie Lynch

O2h Ventures and AI Fund invest in Small Pharma, as it works to complete studies for its lead program, a metabolite of ketamine as an oral anti-depressant.

Biohaven’s application rejected due to Apotex manufacturing issues

22-Jul-2019 By Ben Hargreaves

Biohaven’s sublingual Riluzole treatment for ALS receives a CRL from the US FDA due to the API being supplied by Apotex.

Lonza enters a collaborative agreement with Auxly for capsule formulation

01-Jul-2019 By Maggie Lynch

Lonza will supply Auxly with materials and proprietary manufacturing equipment for capsule filling and sealing through collaborative agreement.

Migraine treatment ‘on track’ for NDA after site qualification

25-Jun-2019 By Maggie Lynch

Zosano completes site qualification batches for its subcutaneous investigational migraine treatment and readies itself for NDA submission by the end of year.

AMPAC re-opens 50,000 gallon API facility in Virginia

24-Jun-2019 By Maggie Lynch

After being acquired by SK Holdings, AMPAC re-opens its API manufacturing facility in Virginia as part of a growing investment in its US capabilities.

Dr Reddy’s in 'timely divestiture' of neurology products for $110m

18-Jun-2019 By Ben Hargreaves

Dr Reddy’s enters asset purchase agreement with Upsher-Smith to sell rights for its neurology products, Zembrace and Tosymra.

‘Significant benefit’ to drug delivery excipient leads to deal

13-Jun-2019 By Ben Hargreaves

PeptiDream agrees a strategic partnership with PharmaIN to utilise its PGC delivery technology for its peptide discovery and development programs.

Aptar scoops up two pharma services firms in $50m deal

11-Jun-2019 By Melissa Fassbender

Aptar Group acquires two pharmaceutical services companies, Nanopharm and Gateway Analytical, to boost its analytical, testing, and development capabilities.

KD Pharma adds to omega-3 API production supply chain with UK site

04-Jun-2019 By Maggie Lynch

KD Pharma adds manufacturing site in Seal Sands, UK, to manufacture omega-3-based intermediates for use in API production.

Lilly joins the push for non-opioid painkillers

03-Jun-2019 By Maggie Lynch

Eli Lilly acquires exclusive worldwide rights for non-opioid treatment for chronic pain from Centrexion through a licensing agreement.

Iovance builds gene therapy manufacturing facility in Philadelphia

30-May-2019 By Maggie Lynch

Iovance amps up clinical and commercial immunotherapy production with a $75m (€67.3m), 136,000 square-foot build in Philadelphia’s Navy Yard.

Amgen acquires Nuevolution after 'high-speed' development progress

27-May-2019 By Vassia Barba

Amgen acquires Nuevolution for $167m to boost its drug discovery platform, following a previous three-year collaboration.

Scancell utilises nanotechnology to amp up solid tumour vaccine

23-May-2019 By Ben Hargreaves

Scancell and Cancer Research UK use nanodelivery technology to activate the body’s immune system, boosting its ability to target and destroy cancer cells.