Excipients, raw materials and intermediates

Rousselot is first gelatin firm to join IPEC Europe

17-Jul-2017 By Gareth Macdonald

Gelatin firm Rousselot BV has joined IPEC Europe describing the move as an opportunity to contribute to the development of regulatory standards for pharmaceutical excipients.

US FDA slams Chinese heparin API testing facility with warning

05-Jul-2017 By Dan Stanton

Failure to establish system suitability testing for heparin and heparin-related drugs has landed Shandong Analysis and Test Center a US FDA warning letter.

Mexico legalizes medical marijuana: a boon for pharma?

28-Jun-2017 By Flora Southey

Mexican president Pena Nieto has legalised the cultivation, production and use of cannabis products with less than 1% THC for medical uses in Mexico.

Grace to start making fluorinated drug intermediates with tech from Valliscor

27-Jun-2017 By Gareth Macdonald

W.R Grace & Co has announced its intention to start making fluorinated pharmaceutical intermediates with technology obtained from Valliscor Llc.

Anhui Sunhere awarded patent for enzyme-based starch solubilization method

20-Jun-2017 By Gareth Macdonald

Anhui Sunhere Pharmaceutical Excipients has been granted a Chinese patent for an enzyme-based method of making starch soluble.

Cure & cancer: cannabis molecule blend research

12-Jun-2017 By Flora Southey

Cure Pharmaceutical has entered into a strategic collaboration to test and develop potential cancer therapeutics utilising a blend of the cannabis plant-derived terpenes.

'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.

BASF ups costs of BDO intermediates to restore margins after demand picks up

07-Jun-2017 By Staff Reporter

BASF has raised prices in Europe by as much as €300 per metric ton as demand returns for its butanediol-based chemicals.

Roquette expands into Brazilian pharma excipient space

06-Jun-2017 By Flora Southey

Ingredients manufacturer Roquette says it will acquire Blancer’s Brazil-based excipient division, Itacel, to meet market demand.

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.

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.

BPI Europe 2017

Roche on excipient inconsistencies: ‘Don’t blame suppliers, work with them’

02-May-2017 By Dan Stanton

An inconsistent lot of excipient Poloxamer 188 cut biologic yield 30%, but working with supplier BASF was key to prevent future problems, according to Roche.

Acasti strengthens IP position for krill-derived rival to GSK's Lovaza

27-Apr-2017 By Flora Southey

Acasti Pharma Inc. has been granted two additional composition and use patents for its investigational, hypertriglyceridemia drug candidate CaPre.

Pork firm Smithfield sets up organ supply unit for regenerative meds sector

13-Apr-2017 By Staff reporter

Smithfield Foods Inc. has tasked a new bioscience unit with turning byproducts from its pork business into supplies for regenerative meds and drug firms.

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.

EMA sets up inbox for pharma whistle-blowers and adopts investigation policy

11-Apr-2017 By Gareth Macdonald

The EMA has set up an email inbox for drug company employees who report improper manufacturing and trial activities.

Industry asks US FDA to "pause" data quality reporting plan

10-Apr-2017 By Gareth Macdonald

API, excipient and drug industry groups have reiterated concerns about the latest iteration of the US FDA’s “quality metrics” reporting requirements.

German Merck taps up cell-based pyrogen detection kit

21-Mar-2017 By Staff Reporter

Solvias has struck a deal with Germany’s Merck to supply a monocyte activation test (MAT) kit for detecting pyrogens in pharmaceutical raw ingredients.

Patheon ramping up former Roche site to fulfil demand for Western APIs

20-Mar-2017 By Dan Stanton

Patheon believes it can triple revenues at its recently acquired Roche facility in South Carolina due to a shortage of Western active pharmaceutical ingredient (API) capacity.

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.

Modus raises cash for Ph II trial of Sickle Cell drug in EU, Middle East and Caribbean

22-Feb-2017 By Dani Bancroft

Modus Therapeutics AB has raised an additional 32m SEK (£2.85m) for its Phase II trial for pain crises in Sickle Cell Disease, running in the Caribbean, Middle East and Europe.

Granules to expand Indian API plants and US dosage form site

21-Feb-2017 By Gareth Macdonald

Granules India will build an API production facility in Bonthapally, Telangana and expand other manufacturing sites in a project backed by the Word Bank.

Tilray begins shipping medical marijuana to more countries

20-Feb-2017 By Dani Bancroft

Medical marijuana developer Tilray has begun shipping to overseas patients and trial sites outside Canada after partnering with local distributors to comply with regional regulations.

Stada confirms €3.5bn bid from Cinven and interest from Advent

14-Feb-2017 By Dani Bancroft

API manufacturer Stada Arzeneimittel AG has received an acquisition offer from private equity firm Cinven Ltd., and an expression of interest from Advent International Corp.

Pfizer to shut Australian Neulasta biosimilar plant and move production to Croatia

10-Feb-2017 By Gareth Macdonald

Pfizer will close the Australian plant which produces the API for HSP-130, a candidate version of Amgen’s Neulasta, and shift production to Croatia.

Pot luck? Medical marijuana's 'questionable quality’ no threat to pharma R&D

08-Feb-2017 By Dan Stanton

Pharma firms using cannabis-derived ingredients have hit out at the lack of standardization and the questionable quality of medical marijuana.

Catalent confident it has US capacity to respond to Trump's border tax

07-Feb-2017 By Dan Stanton

Catalent says it is prepared to take on additional capacity in the US in response to a proposed border tax.

Cambrex riding high on demand for Western innovator APIs

06-Feb-2017 By Dan Stanton

Limited US manufacturing capacity and a growing demand for innovator APIs will drive continued growth, says Cambrex.

Enteris to work on Sanofi oral type 2 diabetes candidate & metabolic peptide for Nordic Bioscience

Sanofi and Nordic Bioscience deals ‘validate’ oral delivery tech, Enteris

25-Jan-2017 By Dan Stanton

Enteris Biopharma has secured two deals in as many days to use its excipient-based platform to enhance delivery of preclinical peptide candidates.

EDQM outlines ICH Q3D impurities testing guideline integration plan

23-Jan-2017 By Gareth Macdonald

The EDQM has set out how it will integrate risk-based elemental impurities testing into the European Pharmacopoeia.

Improving solubility: MilliporeSigma opens dedicated meglumine site

19-Jan-2017 By Dan Stanton

MilliporeSigma has opened a facility in Spain dedicated to the manufacture of the solubility-enhancing excipient meglumine.

Q&A with CEO and CMO

Medical marijuana chewing gum to treat IBS in Dutch trial

18-Jan-2017 By Dani Bancroft

AXIM Biotechnologies, Inc. will start 40-person clinical trial in the Netherlands for a mint-flavoured medical marijuana chewing gum to treat Irritable bowel syndrome (IBS).

Catalent to assess resveratrol formulation across softgel platforms

11-Jan-2017 By Dan Stanton

Catalent will assess Jupiter Orphan Therapeutics’ resveratrol across its softgel technologies in an effort to improve the bioavailability of the rare disease candidate.

US DEA finalises controlled substance and equipment revisions

09-Jan-2017 By Dan Stanton

Drugmakers must include a transaction identification number when buying or selling machinery for tabletting or encapsulating controlled substances, according to a final ruling from the US DEA.

Out with the old, in with the new? Lonza sells peptide biz, Recipharm adds Indian ops

05-Jan-2017 By Dan Stanton

Recipharm receives approval to buy Kemwell’s Indian operations and PolyPeptides completes the acquisition of Lonza’s peptide business. Welcome to in-Pharmatechnologist’s 2017 M&A round-up.

Wacker adding cysteine capacity through Spanish acquisition

21-Dec-2016 By Dan Stanton

Wacker says it is buying a large-scale fermentation facility in Spain to support growing demand for the amino acid cysteine.

update

Sugar lumps? Excipient impurities may be risk to patients says researcher

14-Dec-2016 By Gareth Macdonald

Newly identified impurities in sugar excipients pose a risk to patients and could explain why some drugs fail safety tests according to scientists from the Netherlands.