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Provectus seeking Indian PV-10 API patent and says it is “more than a match” for skin cancer competitors

29-Jan-2015 - Provectus Biopharmacetuicals is seeking an Indian patent and partner for PV-10 and says it is 'more than a match' for skin cancer competitors like Merck & Co and Bristol-Myers Squibb.

Johnson Matthey posts higher Q3 API profits; Pfizer patent spat continues

28-Jan-2015 - Johnson Matthey saw demand for ADHD APIs increase in the third quarter, while sales of its pain management ingredients and bulk opiates declined.

China patent gives Provectus green light to find partner for melanoma candidate, PV-10

27-Jan-2015 - China has told Provectus Biopharmaceuticals it will grant a patent for the method used to make the API in its skin cancer drug candidate, PV-10.

BASF to take on Asian PVP producers and target generics firms with new capacity in China

23-Jan-2015 - BASF will spend €56m ($62m) to increase production capacity for the excipient PVP by expanding existing plants and introducing manufacturing capabilities at its facility in Shanghai, China.

Lonza benefits from outsourcing growth as Swiss franc fluctuations stall 2015 projections

22-Jan-2015 - Biopharma outsourcing growth has helped to boost the bottom line of Lonza, the world’s largest manufacturer of drug ingredients, though a topsy-turvy Swiss franc has caused the company to hold off on making any projections for 2015.

Insulin in sea snail venom could be used by drug developers

20-Jan-2015 - Venom produced by sea snails could be used in designing human insulin analogues or as painkiller drugs, according to a University of Utah scientist.

USP pushes back deadline for elemental impurities compliance to 2018

20-Jan-2015 - In order to align more closely with ICH’s Q3D guideline for elemental impurities, USP has pushed back until 2018 when its chapter on elemental impurities will apply to industry.

Bile duct cancer breakthrough will not stretch paclitaxel supplies says analyst

14-Jan-2015 - Synthetic paclitaxel production methods can support expanding market and new indications according to market analysis group.

Resistance is…years away: New compound could delay post antibiotic era

08-Jan-2015 - Discovering a new antibiotic candidate and finding out how it kills superbugs without letting resistant mutants escape involved advanced chemistry according to the scientists who determined its structure.

Oil's well that ends well? Low Brent crude price a boon for pharma says analyst

07-Jan-2015 - Falling oil prices will cut drug industry materials, manufacturing and logistics costs, and protect firms at risk of generic competition in 2015 according to one industry analyst.

China-based paracetamol maker hit with US FDA warning letter

06-Jan-2015 - Novacyl Wuxi Pharmaceutical has received a US FDA warning letter for failing to investigate the origin of metal particles found in drugs made at its paracetamol plant in China.

API supplier issues again cause FDA to reject Pozen drug candidates

18-Dec-2014 - For the second time the US FDA has rejected two versions of Pozen’s investigational drug candidate because of issues with a supplier’s foreign manufacturing facility.

News in brief

US FDA issues Form 483 to Hovione API facility in Portugal

18-Dec-2014 - The US FDA’s pre-approval inspection at Hovione’s API plant in Loures, Portugal, covering two NDA filings, resulted in a Form 483 with three inspectional observations. 

IPEC-Americas aims to make drug excipient users TUPP aware

15-Dec-2014 - Manufacturers should profile the "black specks" created during excipient production and share details with customers according to guidance finalised by IPEC-Americas, which says the unavoidable particles are starting to earn drugmakers 483s.

AstraZeneca shutting asthma drug plant as pipeline shifts to biologics

12-Dec-2014 - AstraZeneca has continued the Big Pharma trend away from small molecule blockbusters and towards a biologics-heavy pipeline, announcing the closure of its Pulmicort facility in Massachusetts.

Sun closes in on Ranbaxy deal with CCI approval

10-Dec-2014 - The Competition Commission of India (CCI) has approved Sun Pharma’s $3.2bn acquisition of Ranbaxy.

Foreign investment in UK drugmaking down; ABPI tasks ex-GSK exec with reversing trend

10-Dec-2014 - An ex-GSK staffer charged with winning manufacturing investments for the UK says fostering innovation and “fiscal attractiveness” are vital.

Merck & Co set to be superbug-busting superstar despite US Cubicin ruling, analyst

10-Dec-2014 - Cubist will give Merck & Co leadership of the antibiotics sector according to one analyst who says renewed interest expressed by GSK, Roche and Sanofi has not produced any Ph III candidates.

From CPHI India 2014

Indian manufacturing problems spur growth... for testing companies

03-Dec-2014 - SGS has doubled testing capacity at its Mumbai facility, explaining that Indian API makers’ failure to invest in quality has been good for business.

Johnson Matthey acquires API capacity in Scotland

03-Dec-2014 - Johnson Matthey has completed its acquisition of API and pharmaceutical intermediate manufacturing capacity in Scotland. 

EMA seeking drugmaker feedback on cyclodextrin and propylene glycol labelling plan

03-Dec-2014 - The EMA has called for feedback on plans to require drugmakers to state whether their drugs contain solubility-enhancing cyclodextrin excipients.

Live from CPhI India

02-Dec-2014 - [View the story "Live from CPHI India" on Storify]

Dr Reddy's API plant receives USFDA 483 with nine observations

27-Nov-2014 - Dr Reddy’s says an API plant in India is unlikely to be subject to further regulatory enforcement after receiving a US FDA 483 with nine observations.

Chinese excipient market set to more than double by 2017

26-Nov-2014 - With more than 90 excipient manufacturers in China dedicated to the pharma industry, the country expects its output of excipients to more than double to about $8.9bn (€7.1bn), according to a new report.

Johnson Matthey: APIs down but Sigma-Aldrich acq could bring opportunities

24-Nov-2014 - The acquisition of Sigma-Aldrich by Merck KGaA could provide some opportunities for Johnson Matthey, the fine chemical company says as it reports a flat first half 2014/15.

Spotlight

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Did you know that throughout the nineteenth century, vaccination left a scar known as “the mark of...

Illicit vendors using YouTube to advertise fake drugs, says MHRA

Illicit vendors using YouTube to advertise fake drugs, says MHRA

Regulatory enforcement saw fewer counterfeit drug websites in 2014 but sellers are turning to YouTube and social...

Resistance is…years away: New compound could delay post antibiotic era

Resistance is…years away: New compound could delay post antibiotic era

Discovering a new antibiotic candidate and finding out how it kills superbugs without letting resistant mutants escape...

Oil's well that ends well? Low Brent crude price a boon for pharma says analyst

Oil's well that ends well? Low Brent crude price a boon for pharma says analyst

Falling oil prices will cut drug industry materials, manufacturing and logistics costs, and protect firms at risk...

Gilead strikes back at AbbVie with exclusive payer deal for hep C drug

US pharmacy deals could cut costs of AbbVie and Gilead's HCV treatments

Gilead and AbbVie’s exclusive deals with payers CVS and Express Scripts could help cut the cost of...

Not prepared for track & trace? US FDA grants amnesty until May

Not prepared for track & trace? US FDA grants amnesty until May

The US FDA will give drugmakers and distributors until May to comply with new track and trace...

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