PhRMA speaks out against FDA biosimilar flexibility

30-Apr-2012 - PhRMA has spoken out against FDA plans to allow biosimilar manufacturers flexibility in delivery device and formulation choice.

West raises outlook as client conservatism drives sales

30-Apr-2012 - West has raised its outlook for 2012 after a shift in supply chain attitude by clients drove strong first quarter sales.

Penn Pharma adds packing capacity

30-Apr-2012 - Penn Pharma has added clinical and commercial packing capacity to cater for recently won European contracts.

Sub-Saharan is "attractive" emerging market, says Sandoz

26-Apr-2012 - Sub-Saharan Africa is a “very attractive market” because of local leaders’ new focus on supporting generics makers, according to Sandoz.

Single-use bioprocess demand drives Sartorius’ sales jump

26-Apr-2012 - Bioprocess sales at Sartorius jumped 20 per cent in the first quarter on strong demand for single-use filters and bags.

News in brief

Amgen to buy Turkish generics firm

26-Apr-2012 - Amgen is to buy Turkish generics company Mustafa Nevzat (MN) for $700m to build its business in the country’s rapidly expanding drug market.

Interactive map of fiscal 2011 FDA cGMP warning letters

26-Apr-2012 - In-PharmaTechnologist presents an interactive map showing the global distribution of US FDA cGMP warning letters in fiscal 2011.

Tamarisk Technologies claims to have solved the oral insulin puzzle

25-Apr-2012 - Tamarisk Technologies is in licensing talks with several Big Pharmas over a tech which it claims could solve the oral insulin puzzle and “turn the industry upside down”.

Granules’ profit up 43% in FY12 despite ‘dynamic’ raw materials prices

25-Apr-2012 - Fluctuating raw material prices mean market knowledge is a must for companies competing in the intermediates and ingredients space according to Granules India.

Half of FY11 FDA GMP warning letters tied to batch failures

25-Apr-2012 - Half the pharma firms sent FDA GMP warning letters sent fiscal 2011 were criticised for failing to thoroughly investigate the failure of a batch.

Amgen warns biosimilar draft a threat to production innovation

25-Apr-2012 - Amgen has told the FDA that draft biosimilar guidance risks inhibiting manufacturing improvements and burdening industry.

DSM confirms Percivia to halt in-house dev and predicts job losses

24-Apr-2012 - Royal DSM NV has confirmed that Percivia – its biosimilars joint venture (JV) with Crucell - is to cease in-house product development after failing to agree on future investment and...

From pharma foe to meds making friend: E.coli changes its ways

24-Apr-2012 - E.coli can be used as a cheaper and quicker way to make industrial quantities of “human-like” glycoproteins, according to new research.

in-Pharmatechnologist @ Interphex 2012

24-Apr-2012 - In-Pharmatechnologist.com has chosen Interphex - the drug industry’s biggest production and processing technology show – as the launch event for our new look, refocused news website.

FDA sent 40% more warning letters to overseas sites in ‘11

24-Apr-2012 - The FDA sent 40 per cent more GMP warning letters to biopharma facilities outside the US in fiscal 2011 than the previous year.

SFDA clamps down on chromium-tainted gel capsules

23-Apr-2012 - The SFDA has closed down 10 gel capsule factories and revoked two licenses after finding 23 batches of products tainted with “excessive levels” of the toxic metal chromium.

Surya gets EDQM CEP and TEVA OK as it tries to tackle debts

23-Apr-2012 - Indian contract manufacturer Surya Pharmaceutical has received an EDQM Certificate of Suitability (CEP) for an antibiotic API and approval for its Banur plant from Teva.

Raw material woes for Pakistan could lead to swift exit for drugsmakers, says ABC

23-Apr-2012 - The American Business Council (ABC) has warned US drugsmakers working in Pakistan to brace themselves for supply chain disruptions as the Government imposes heavy delays on the process used to...

News in brief

Copley to launch new breath simulator for inhaler testing

23-Apr-2012 - Copley Scientific says new ‘breath simulator’ will let developers predict real world DPI and MDI performance more accurately. 

Albemarle operating profit up 23% on positive pharma trends

23-Apr-2012 - Albemarle posted surging fine chemistry operating profits as a result of positive pharma trends and other tailwinds.

EC offers €2m prize for system to improve vaccine stability

19-Apr-2012 - The European Commission is offering a €2m prize to anyone who can keep vaccines stable at any ambient temperature.

Spinnovation launches NMR-based media analysis service

19-Apr-2012 - CRO Spinnovation Biologics says new media analysis service will help developers answer culture scale-up questions faster and more cheaply than currently available methods.

South Africa will only buy certain drugs if produced locally

19-Apr-2012 - South Africa aims to boost its pharmaceutical production sector by developing a 70-strong list of oral solid dose drugs that it will only buy from local manufacturers.

USP forges closer ties with South Korean FDA

18-Apr-2012 - The United States Pharmacopoeia (USP) has agreed to work with the South Korea Food and Drug Administration (KFDA) on the quality of medicines under an MOU signed this week.

CSL & Hospira both recalling drugs in separate incidents

18-Apr-2012 - CSL Biotherapies and Hospira are both separately recalling drugs due to contamination and syringe overfilling respectively.

FDA compliance IT setup needs “considerable work”, GAO says

18-Apr-2012 - The US FDA IT system for improving oversight of regulatory compliance needs “considerable work”, a GAO report found.

Bosch completes Eisai Machinery takeover

17-Apr-2012 - Bosch Packaging Technologies has completed the acquisition of Eisai’s machinery business, expanding its inspection technology portfolio.

Ashland launches integrated tablet excipients pipeline

17-Apr-2012 - More post-acquisition integration in the pharma excipients space this week with Ashland launching a new product line combining its own techs with coatings it bought with International Specialty Products (ISP) in...

EMA posts guideline to support continuous process verification

17-Apr-2012 - The EMA has released draft continuous process verification guidelines to bring its policies in line with ICH Q8, Q9 and Q10.

Novo Nordisk warns FDA of biosimilar delivery safety fears

17-Apr-2012 - Novo Nordisk has told the FDA allowing alternative delivery devices for biosimilars creates “significant safety implications”.

RNA drug firm Arrowhead buys Alvos for delivery tech

16-Apr-2012 - RNA therapeutics developer Arrowhead Research has bought Alvos Therapeutics in the hope that peptide targeting technology will help it overcome delivery challenges.

EMA extends real-time release testing role in new guidelines

16-Apr-2012 - The EMA has released guidelines extending use of real-time release testing (RTRT) beyond terminally sterilised products.

Merck tells FDA a clearer crude heparin definition is needed

16-Apr-2012 - Merck & Co has asked the FDA for a “clear and unambiguous” definition of crude heparin to improve draft guidance.

BASF renames solubilisation and dermatology excipients

12-Apr-2012 - BASF has developed a new naming scheme for the solubilisation and dermatology excipients it gained with the acquisition of Cognis .

Gerresheimer grows sales on syringe & insulin pen demand

12-Apr-2012 - Demand for insulin pens and ready-to-fill syringes helped Gerresheimer post double-digit first quarter sales growth and raise its outlook.

News in brief

Lonza and Agennix form tactical alliance

12-Apr-2012 - Lonza and Agennix have made a tactical alliance over the Phase III production of a non-small cell lung cancer therapy in the hopes it will improve the chance of joint manufacturing after the...

Manufacturing expansions round-up

12-Apr-2012 - in-PharmaTechnologist brings you a round-up of the latest new facilities and expansions for drugsmakers, including added cytotoxic capabilities for BTL, Jubilant’s launch of a special economic zone in India and plans...

EMA collates biosimilars advice to guide firms towards approval

12-Apr-2012 - The EMA has collated its biosimilars advice into one document to tell firms when to expect a GMP inspection and other events.

Pharmaniaga lays plans for API plant in "promising" Indonesia

11-Apr-2012 - Malaysian drugmaker Pharmaniaga wants to buy an API plant in Indonesia, touting the country as the most “promising” of the pharmerging economies.

FDA posts media fill guidance to help PET drug manufacturers

11-Apr-2012 - The US FDA has posted guidance to help PET drug manufacturers comply with media fill rules ahead of a clampdown in June.

update

GE teams with Refine Technologies on bioprocessing integration

10-Apr-2012 - A new filtration cartridge supply deal between GE Healthcare and Refine Technologies is a further indication of Biopharma’s desire for greater connectivity between processing techs.

USP plans Ghana lab to offer QC services & training in Africa

10-Apr-2012 - USP plans to open a laboratory and training centre in Ghana to strengthen quality control and offer services in sub-Saharan Africa.

FDA debars four QC officials over Able Labs recall scandal

10-Apr-2012 - The US FDA has debarred four former quality control officials who worked at Able Laboratories when it recalled all its products.

Catalent and BASF team up to solve the bioavailability problem

05-Apr-2012 - Catalent and BASF have joined forces to tackle bioavailability challenges from feasibility studies to commercial supply.

IOM calls on G20 to strengthen emerging market regulators

05-Apr-2012 - The G20 should add investment in developing countries’ regulatory systems to its agenda to secure the drug supply chain, an IOM report said.

IPEC Fed says drugmaker requests for metal impurity data are premature

04-Apr-2012 - Drugmakers should not ask excipient suppliers for metal impurity data until exposure limits are agreed according to industry group IPEC Federation.

FDA finds more counterfeit Roche oncology drugs in US

04-Apr-2012 - The FDA has found counterfeits of a Roche oncology drug in US medical practices six weeks after the discovery of fake Avastin.

FDA welcomes joiners to API regulatory sharing scheme

04-Apr-2012 - The FDA says it expects more boards to join an inter-regulatory API (active pharmaceutical ingredient) inspection programme after simplifying the sign-up process.

UPDATE

New Turkish manufacturing plant for Novartis?

03-Apr-2012 - Novartis has established a new headquarters in Turkey, and and says its hopes to build a manufacturing plant in the area.

IHolland teams on anti-stick tablet tooling research

03-Apr-2012 - IHolland has set out to solve a major tableting industry sticking point, namely sticking during tablet production.

Industry responses to cargo thefts face greater FDA scrutiny

02-Apr-2012 - The FDA will assess industry responses to drug cargo thefts as part of its fight back against crimes in the pharmaceutical supply chain.

India claims 40% drop in fake drugs despite uptick in testing

02-Apr-2012 - The number of fake or adulterated drugs found in India fell 40 per cent from 2008 to 2010 despite an uptick in testing, government data claims.