Excipients, raw materials & intermediates

Big Pharma has improved access to meds since 2012 but marketing practices still a concern says AMF

17-Nov-2014 By Gareth Macdonald

Ongoing concerns about marketing practices have taken the shine of a report suggesting Big Pharma efforts have improved parients' access to drugs in developing countries over the past two years.

Dispatches from AAPS

Inhaler delivered peptide could prevent LDC deaths during childbirth, says GSK

04-Nov-2014 By Dan Stanton

Inhaled delivery of the labour inducing peptide oxytocin could help prevent millions of deaths in the lesser-developed countries (LDC), according to a GSK scientist.

Pharma Action crude heparin plant due to open next week

28-Oct-2014 By Gareth Macdonald

A plant being set up by Pharma Action and meat supplier Toennies will produce 15 tonnes of 100% traceable crude heparin a year.

Starting debate: EMA says rules on API materials need clarification

23-Oct-2014 By Gareth Macdonald

Drugmakers’ clashes with regulators over the suitability of API starting materials suggest ICH Q11 is open to interpretation and that clarification is needed according to the EMA.

NEWS FROM CPHI

The key to market exclusivity? Forget molecules, patent your tests

21-Oct-2014 By Fiona BARRY

Makers of branded drugs are finding ways to extend their marketing authorisation by patenting not only molecules, but patient screening methods and ways of proving bioequivalence.

News from edqm 50th anniversary conference

IPEC calls for inclusion of excipient compound monographs in Ph. Eur.

14-Oct-2014 By Gareth Macdonald

'Excipient compound' monographs should be included in the European Pharmacopoeia according to IPEC, which argues they would help manufacturers and promote acceptance of the standards outside Europe.

News from CPhI

DSM cuts out China's ATS-8 intermediate middlemen with enzyme-made statin APIs

14-Oct-2014 By Gareth Macdonald

Royal DSM has launched a statin API it claims is made using a green production method that reduces reliance on intermediate suppliers.

News from EDQM 50th anniversary conference

Drug complexity will change how Big Pharma uses Ph. Eur. says Pfizer expert

13-Oct-2014 By Gareth Macdonald

Growing drug complexity will soon make the European pharmacopoeia’s general chapters more valuable to innovative drugmakers than individual monographs according to Pfizer quality and compendial affairs expert, Graham Cook.

Capsugel’s French and Belgian Sites Receive EXCiPACT Certification

13-Oct-2014 By Agnes Shanley

The auditing company, SGS, recently certified that Capsugel’s manufacturing sites in Colmar, France and Bornem, Belgium meet Good Manufacturing Practice (GMP) standards set by EXCiPACT for pharmaceutical excipients manufacturing.

News from CPhI

Halal: accessing the untapped $30bn pharma market

13-Oct-2014 By Fiona BARRY

The pharmaceutical industry must change its ingredients and manufacturing methods to cash in on the enormous purchasing power of European Muslims, says an expert.

Lonza goes with the Flow Chemistry with latest API platform

07-Oct-2014 By Fiona BARRY

Lonza has launched an API-making platform that uses chemical microreaction technology for continuous processing.

$Laser diffraction a key pharma tool$

dispatches from technopharm

Malvern launches imaging tool for its laser diffraction tech

02-Oct-2014 By Dan Stanton

A laser diffraction imaging tool could be used by quality controllers to help measure particle size in a suspension according to Malvern Instruments.

Pre CPhI Special

How green was my Valium? Not very, despite industry claims

01-Oct-2014 By Gareth Macdonald

Making active pharmaceutical ingredients (API) is a dirty business and you’d have to be pretty green to believe claims drug industry 'demand' will create a $100bn market for environmentally-friendly production methods by 2020.

FDA says no to anti-addiction rule on Ritalin, painkillers

29-Sep-2014 By Fiona Barry

The US Food and Drug Administration has rejected a petition to force drugmakers to reformulate CNS-acting drugs like Adderall, Ritalin, and painkillers to prevent illegal use, but experts say the rule is only a matter of time.

Pharmacies banned from compounding for docs without prescription

23-Sep-2014 By Fiona Barry

The US Food and Drug Administration (FDA) says compounding pharmacies must not manufacture medicines for hospitals and doctors’ offices, except for named patients.

Breaking news

Merck KGaA: $17bn 'Rolls Royce' Sigma-Aldrich to keep major St Louis site

22-Sep-2014 By Dan Stanton & Gareth Macdonald

The $17bn (€13.2bn) acquisition of Sigma-Aldrich is “not just a milestone but a quantum leap” for Merck KGaA, the firm says.

Dispatches from ChemOutsourcing

ICH elemental impurities guideline expected to be finalized at end of September

18-Sep-2014 By Zachary Brennan

After much discussion and some confusion, the ICH’s (International Conference on Harmonization) Q3D guideline, which will govern elemental impurities in final drug products, is expected to be finalized at the end of this month.

Mannkind looks to Sanofi for secondary supply of inhalable insulin API

16-Sep-2014 By Dan Stanton

Mannkind says Sanofi could become a second API supplier for its recently approved inhalable insulin drug Afrezza following its commercialisation partnership last month.

Techs can help Ireland compete on costs says team behind new hub

15-Sep-2014 By Gareth Macdonald

Ireland once was a drug making nexus,Making meds sold from Cairo to Texas.But with key patents gone,Firms are keen to move on,And a new Limerick tech hub reflects this, says director.

Molecular Profiles buys tech for liquid capsule manufacture

10-Sep-2014 By Fiona BARRY

Molecular Profiles has expanded its capsule-filling services from solids to liquids with investment in equipment at its UK site.

Seaweed: the secret ingredient to HIV drug delivery?

09-Sep-2014 By Fiona Barry

Food scientists may have hit on a novel delivery method for HIV antiretrovirals: a vaginal suppository made with seaweed.

Evonik invests in Japanese silica capacity

08-Sep-2014 By Dan Stanton

Chemicals firm Evonik has expanded its capacity in Japan to cope with high demands for specialty silica, used in various drugmaking operations.

Novo Nordisk snaps up Olympus plant and rehires laid off NH workers

29-Aug-2014 By Dan Stanton

Novo Nordisk has bought a biomanufacturing facility earmarked for closure by Olympus Biotech and begun rehiring staff in order to support its haemophilia product pipeline.

Baxter donates IVs to aid groups fighting Ebola in Africa

29-Aug-2014 By Gareth Macdonald

Baxter International has donated intravenous fluids to aid organisations treating Ebola infected patients in Liberia and Sierra Leone.

GSK: GM yeast breakthrough won't kill off poppy-based opium

28-Aug-2014 By Gareth Macdonald

Poppies will continue to be the main source of industrial opiates long-term according to GSK, despite a recent breakthrough in efforts to produce it in GM yeast.

EMD Millipore to supply Samsung's Yervoy plant in 10-year deal

26-Aug-2014 By Gareth Macdonald

EMD Millipore has been contracted to supply raw materials to the Samsung Biologics plant where ingredients for BM-S’ anticancer monoclonal antibody Yervoy (ipilimumab) are made.

Sanofi in $150m deal to commercialise Mannkind's inhaled insulin

11-Aug-2014 By Dan Stanton

Mannkind has partnered Sanofi for the marketing and commercialisation of its inhaled insulin drug Afrezza, recently approved by the US FDA.

Hep C biocatalyst sales slump as Codexis feels Sovaldi impact

07-Aug-2014 By Dan Stanton

Codexis has felt the impact of Gilead’s Sovaldi with product revenues tumbling almost 60% due to the reduction in its hepatitis C biocatalyst and intermediate business.

AstraZeneca coughs up $875m for Almirall to support asthma/COPD pipeline

04-Aug-2014 By Dan Stanton

AstraZeneca has bolstered its respiratory portfolio and added new bronchodilator technologies through the $875m (€650m) acquisition of Almirall.

Ireland looks to switch 12 APIs from prescription to OTC medicines

04-Aug-2014 By Anthony King

The Health Products Regulatory Authority (HPRA) of Ireland has published a list of 12 active substances contained in medicines that could potentially be switched from prescription-only to over the counter sale.

Generics: change in pill shape makes patients 66% more likely to quit

23-Jul-2014 By Fiona Barry

Switching patients to generic pills of a different shape and colour increases the chances they will end their course of medicine early, according to research.

European Pharmacopoeia plans revisions of elemental impurities guideline

23-Jul-2014 By Zachary Brennan

As the International Conference on Harmonisation (ICH) signs off on a new tripartite guideline related to elemental impurities, the European Pharmacopoeia Commission will revise its texts to ensure consistency.

New nanotech excipient offers cheaper solubility option say scientists

22-Jul-2014 By Gareth Macdonald

Scientists in Sweden have developed a magnesium carbonate-based excipient they claim is a low-cost nanotech alternative to silica for drugmakers struggling to formulate insoluble APIs.

FDA proposed rule could delay import of excipients, PhRMA says

15-Jul-2014 By Zachary Brennan

Although industry group PhRMA has called for the full implementation of a proposed rule that would allow the US FDA to destroy detained drugs deemed to be counterfeit or unapproved, the group also warns that such destruction could lead to manufacturing...

Bulk ingredient prices skyrocket in US as payers clamp down

03-Jul-2014 By Zachary Brennan

Bulk pharmaceutical ingredients increasingly used by compounding pharmacies have seen astronomical price hikes over the past two years and now payers are catching on to the trend and stepping in.

Afrezza approval: US FDA validation for Mannkind's drug and delivery tech

01-Jul-2014 By Gareth Macdonald

The US FDA approved Afrezza last weekend after deeming that the inhaled insulin drug and the dry powder delivery technology used to get it deep into the lungs is effective.

IMCD expands IPO citing demand and desire for deals

26-Jun-2014 By Gareth Macdonald

Dutch API and excipients distributor IMCD has increased the number of shares it will make available in its initial public offering (IPO), citing demand.

Oasmia's vitamin A excipient tech attract global pharma collaborator

26-Jun-2014 By Gareth Macdonald

Oasmia Pharmaceutical AB has teamed up with a “global pharmaceutical company” interested in its vitamin A-based nanoparticle formulation tech in a move that expands its business model to drug development partnering.

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