Delivery formulations

Pfizer hires Catalent to make smaller format Advil using Optigel tech

18-Jul-2017 By Gareth Macdonald

Pfizer Inc. has awarded Catalent Pharma Solutions the long-term manufacturing contract for a smaller version of its over-the-counter (OTC) painkiller Advil (ibuprofen). 

Elite halts trials of reformulated SequestOx after BE data falls short

10-Jul-2017 By Gareth Macdonald

Elite Pharmaceuticals has halted trials of its reformulated opioid painkiller SequestOx (naltrexone and oxycodone hydrochloride) after disappointing bioequivalence data from a study testing the drug in combination with a high fat meal.

Bayer ends methamphetamine abuse deterrent partnership with Acura

06-Jul-2017 By Dan Stanton

Bayer has pulled-out of a development and licensing deal for a pseudoephedrine containing product based on Acura Pharmaceuticals’ methamphetamine resistant technology, Impede.

Immediate-release formulation means fewer pills and more flexibility, says Roche

03-Jul-2017 By Flora Southey

The European Medicines Agency has approved a new tablet formulation of Esbriet (pirfenidone), which Roche says reduces pill-load and increases dosing flexibility for patients with a rare lung disease.

Patheon to spend $45m on manufacturing plants ahead of Thermo takeover

30-Jun-2017 By Gareth Macdonald

Patheon NV has announced it will spend $45m to expand and enhance its manufacturing network citing customer demand for more reliable, flexible and cost-efficient supply chains.

Zynerba starts Ph I study of cannabinoid pain patch

26-Jun-2017 By Gareth Macdonald

Zynerba Pharmaceuticals Inc has begun a Phase I trial of cannabinoid patch it is developing for fibromyalgia and peripheral neuropathic pain.

Tetraphase hires Patheon to make its synthetic antibiotic eravacycline

22-Jun-2017 By Gareth Macdonald

Tetraphase Pharmaceutical has hired Patheon UK Limited to make and test the synthetic antibiotic eravacycline.

Takeda inaugurates €100m German oral solid dose plant

20-Jun-2017 By Staff Reporter

Takeda has completed a €100m ($112m) oral solid dosage production facility in Germany.

Lubrizol invests $60m in drug production at Particle Science plant

12-Jun-2017 By Gareth Macdonald

The Lubrizol Corporation has invested $60m (€53m) in its Particle Science drug manufacturing business.

'Talking' smart pill looks to overhaul prescription opioid space and stop abuse

08-Jun-2017 By Dan Stanton

Pop Test Abuse Deterrent Technologies has received a patent for an opioid drug delivery and abuse deterrent ‘smart pill’ it says can prevent death, theft, diversion and counterfeiting.

Takeda breaks ground on $45m Ninlaro plant in Ireland

06-Jun-2017 By Staff Reporter

Takeda has begun construction of an Irish facility to support production of its orally delivered blood cancer peptide Ninlaro (ixazomib).

Rho to support NDA for Evoke Pharma’s patented nasal spray

01-Jun-2017 By Melissa Fassbender

Rho has been contracted to support Evoke Pharma’s planned NDA submission for its nasal delivery formulation of metoclopramide, Gimoti.

Spider silk challenges cost of biological lung surfactant

31-May-2017 By Flora Southey

Researchers at Sweden-based Karolinska Institutet have developed a synthetic lung surfactant using DNA sequences derived from spider silk proteins.

Long-acting insulin price concerns challenge WHO proposal

30-May-2017 By Flora Southey

Non-profit organisations have challenged the proposed addition of long-acting insulin analogues to the World Health Organisation’s Model List of Essential Medicines, citing price as a key factor.

Granules India confirms $35m US plant expansion will create jobs

24-May-2017 By Gareth Macdonald

Granules India says adding manufacturing capacity at its facility in Virginia, US will create 102 jobs.

Eye drops to replace painful injections in AMD patients

24-May-2017 By Flora Southey

The University of Birmingham has developed a cell-penetrating peptide it claims could be used to make eye drop versions of age-related macular degeneration drugs currently delivered by injection.

Aduro and Merck & Co to test Keytruda and CRS-207 in second cancer study

22-May-2017 By Gareth Macdonald

Merck & Co and Aduro Biotech have announced plans to test Keytruda combined with CRS-207 in patients suffering malignant pleural mesothelioma as a result of exposure to asbestos.

Russia clears Saneca Pharma to supply dosage forms made at Slovakian site

16-May-2017 By Gareth Macdonald

Russian Regulators have issued Saneca Pharma with a cGMP certificate after inspecting its facility in Hlohovec, Slovakia.

Coming to America: Evolving pharma landscape brings CPhI to Philadelphia

16-May-2017 By Dan Stanton

With almost 40% of attendees coming from outside the US, the political climate has had no effect on the latest CPhI franchise which starts today in Philadelphia.

Thermo Fisher Scientific Inc to buy Patheon NV for $7.2bn

15-May-2017 By Gareth Macdonald

Thermo Fisher Scientific Inc has announced its intention to buy Patheon NV in a deal agreed by both firms’ boards.

Dr Reddy's: No production halt at Bachupally plant hit with Form 483

02-May-2017 By Gareth Macdonald

The US FDA has identified problems at Dr Reddy’s generic drug manufacturing site in Bachupally, India according to a filing on the Bombay Stock Exchange (BSE).

MPP to make hep C drug affordable for low and middle income countries

26-Apr-2017 By Flora Southey

Pharco Pharmaceuticals has granted a license to make, sell and export the hepatitis C drug ravidasvir (RAV) to Medicines Patent Pool (MPP). 

LabCorp to relocate and expand UK CMC business

25-Apr-2017 By Gareth Macdonald

LabCorp will relocate its UK CMC services unit to a larger site and has said it is confident the Government will maintain its commitment to the drug industry after Brexit.

Partnering key to deliver next-gen drug delivery tech, say industry experts

19-Apr-2017 By Melissa Fassbender

Partnering and collaborating to advance drug delivery innovation is essential, now more than ever, say industry experts from Boehringer-Ingelheim and Merck.

Aurobindo Pharma gets Form 483 from US FDA after Bachupally inspection

19-Apr-2017 By Gareth Macdonald

The US FDA completed an inspection of Aurobindo Pharma Limited’s manufacturing plant in Bachupally, Hyderabad yesterday, issuing the Indian drug firm with a Form 483 detailing six observations.

Cadila and Arecor team to develop longer-acting insulin glargine

13-Apr-2017 By Dan Stanton

Arecor has entered a £45m ($56m) agreement to develop once daily injection of Cadila Pharmaceuticals’ basal insulin product using its reformulation technology.

Teva's Austedo is first 'heavy hydrogen' drug to win US FDA approval

12-Apr-2017 By Gareth Macdonald

The US FDA has approved its first deuterated drug, clearing Teva’s Austedo (deutetrabenazine) for Huntington’s disease-related movement disorders.

Fresenius Kabi in talks to buy Akorn

10-Apr-2017 By Gareth Macdonald

Akorn Inc is in takeover talks with German injectable drug specialist Fresenius SE & Co. KGaA.

Ferring teams up with Alrise in latest drug delivery tech deal

10-Apr-2017 By Staff reporter

Ferring Pharmaceuticals has agreed to help Alrise Biosystems develop its drug delivery technology in its latest encapsulation-focused agreement.

Shire success will support polysialic acid drug delivery platform, says Xenetic

06-Apr-2017 By Dan Stanton

Xenetic Biosciences says success for Shire’s haemophilia A candidate SHP656 will validate its PolyXen drug delivery technology platform and could net the firm up to $100m.

US FDA accepts Evoke's CMC and PK trial plan for nasal metoclopramide

05-Apr-2017 By Gareth Macdonald

The US FDA has accepted a manufacturing and trial plan for Evoke Pharma's Gimoti, the nasal metoclopramide formulation that fell short in a Phase III trial last year.

US FDA hits Indoco with warning due to leaky glaucoma drug

05-Apr-2017 By Dan Stanton

Leakage problems for of an ophthalmic drug has landed contract manufacturer Indoco Remedies with a US FDA warning letter at its plant in Goa.

Emisphere set to benefit as Novo Nordisk pushes oral diabetes pipeline

30-Mar-2017 By Dan Stanton

Novo Nordisk’s focus on developing oral versions of semaglutide and four other diabetes drugs could net drug delivery firm Emisphere over $200m.

Mylan confirms plan to close Meda Soma plant in Illinois

28-Mar-2017 By Gareth Macdonald

Mylan will close a manufacturing site in Decatur, Illinois that it gained when it bought Swedish drug maker Meda last year.

Alexion licenses mRNA delivery tech from Arbutus in potential $82.5m deal

27-Mar-2017 By Dan Stanton

Alexion Pharmaceuticals will use the LNP delivery licensed from Arbutus Biopharma as part of its messenger RNA therapeutics development partnership with Moderna Therapeutics.

Compounding firm looks at NDA opportunity for reformulation of Mallinckrodt's H.P. Acthar

23-Mar-2017 By Dan Stanton

Imprimis Pharmaceuticals says it is evaluating pursuing New Drug Application (NDA) status for some of its product reformulations through the US FDA 505(b)(2) development pathway.

Pulmatrix secures EU patent for dry powder delivery tech

22-Mar-2017 By Gareth Macdonald

Pulmatrix Inc has extended its IP portfolio with a European patent for its particle-based drug delivery technology.

Cannabinoid-based chewing gum enrolls patients in Ph II trial

16-Mar-2017 By Melissa Fassbender

Axim Biotech has enrolled patients in its Phase II trial for Canchew Plus chewing gum – a delivery method with a “cumulative effect,” says CEO.

Heptares, Daiichi Sankyo to develop small molecules for pain treatment

15-Mar-2017 By Melissa Fassbender

Heptares Therapeutics has entered into a drug discovery and licensing agreement with Daiichi Sankyo – providing further validation of the company’s structure-based drug design approach, says CEO.

Opioid API firm Noramco moves into cannabinoids

08-Mar-2017 By Gareth Macdonald

Noramco has added cannabinoids to its portfolio of opioid APIs.

US FDA says Wockhardt's oversight of drug production inadequate

07-Mar-2017 By Gareth Macdonald

The US FDA has told Wockhardt its quality issues are company-wide, citing problems at subsidiary Morton Grove as an example in a warning letter published today.

Noramco planning formulation tech unit alongside opioid API business

07-Mar-2017 By Gareth Macdonald

Former J&J controlled substance API unit Noramco is to rejig its business to cater for branded and generic drug firms and companies looking for formulation tech solutions.

update

Wockhardt says Ireland's HPRA has recommended GMP cert renewal for Shendra site

07-Mar-2017 By Gareth Macdonald

Wockhardt says Irish regulators have recommended renewal of its Shendra, Aurangabad facility's GMP certificate.

US FDA lifts hold on Seattle Genetics' blood cancer ADC candidate

07-Mar-2017 By Gareth Macdonald

The US FDA has cleared Seattle Genetics to restart trials of its blood cancer candidate vadastuximab talirine that were halted last year after patient deaths. 

Vaxess granted $6m to develop sustained release vaccine patches

07-Mar-2017 By Dan Stanton

Two Bill & Melinda Gates Foundation grants will be used to develop a polio and measles rubella vaccine delivered through microneedles on a sustained-dermal patch.

Nemus hires Catalent to formulate second chemo-induced nausea drug

06-Mar-2017 By Gareth Macdonald

Catalent Pharma Solutions has been hired to formulate Nemus Bioscience’s synthetic cannabinoid based chemotherapy induced nausea drug.

Keryx: Patheon and Norwich sites will ensure supply of iron-based Auryxia

06-Mar-2017 By Dan Stanton

Keryx Biopharmaceuticals will continue to work with Norwich Pharmaceuticals despite bringing Patheon on board to manufacture Auryxia (ferric citrate).

Turmeric bioavailability enhancer could be used with APIs, Wacker

02-Mar-2017 By Staff Reporter

Wacker Biosolutions says an excipient shown to increase the bioavailability of a food supplement by a factor of 40 could have implications in the API space.

Titan puts Parkinson's disease implant trial on hold after FDA asks for more data

28-Feb-2017 By Gareth Macdonald

Titan Pharmaceuticals has put plans for a trial of its candidate Parkinson’s disease implant ropinirole after the US FDA asked for additional information.

Ohr Pharmaceutical Inc. shuts sustained release tech lab

23-Feb-2017 By Gareth Macdonald

Ohr Pharmaceutical Inc. has halted activities at the laboratory in San Diego, California where research on its sustained release delivery technology was carried out.