Outsourcing-Pharma presents its latest round-up of movements in the pharmaceutical outsourcing sector, including appointments at AAIPharma, NextPharma and Catalent.
The FDA and EMEA are launching an 18 month pilot programme focused on good clinical practice (GCP), which is intended to increase collaboration and reduce the burden on the agencies.
Eli Lilly is among the organisations partnering to provide training for the Rozdravnadzor, Russia’s equivalent of the FDA, which is seeking to improve its knowledge of manufacturing standards.
The financial impact of Caraco’s cGMP compliance issues have been revealed in its Q1 results, which saw a $14m (€9.9m) operating income in 2008 turn into a $14m loss this year.
French biopharmaceutical group LFB has contracted Lonza’s biopharmaceuticals division to make trial supplies of its candidated monoclonal anti-RhD antibody.
US drugmaker Oscient Pharmaceuticals has filed for chapter 11 bankruptcy and will sell its bronchitis therapy Factive (gemifloxacin mesylate) to North Carolina-based Cornerstone Therapeutics for $5m (€3.5m).
US genomic services specialist Cogenics has launched a new DMET analysis service that it believes will improve patient genotyping during clinical trials, helping drug industry sponsors target the development of new products and reduce costs.
US drug firms’ qualification of overseas API vendors will be subject to increased FDA scrutiny in the coming years according to a new industry report by analysts Hogan & Hartson (H&H).
The FDA plans to increase field tests in imported drugs by over 100 per cent and has requested a 19 per cent rise in its budget for 2010 to enable it to achieve this and other targets.
Actavis has reintroduced Oxycodone 15 mg and 30 mg tablets to the US market having resolved the manufacturing difficulties discovered by the US Food and Drug Administration (FDA).
Cincinnati, US site management organisation (SMO) Radiant Research says that growing industry demand for trials outside the US is the key motivation for the link up with India’s Spectrum Clinical Research.
Almac claims it can bring drugs to trial faster using an automated approach to compliance that cuts the time taken to validate manufacturing processes by several months.
MDRNA is selling its manufacturing business to US generics firm Par Pharmaceuticals in a bid to boost its coffers and complete its transformation into a purely RNAi focused organisation.
US generic drugmaker Caraco Pharmaceutical Laboratories has recalled batches of its heart drug digoxin after tests revealed the tablets may vary in size and dosage.
Operations at SAFC Biosciences’ facility in Kansas, US have been made animal component-free (ACF) under a division-wide strategy to keep pace with customer demands and changing regulations.
US CMO Formatech has brought a new Virtis Benchmark 3000 luophilizer into service at its manufacturing facility in Andover, Massachusetts, boosting capacity by 13,000 vials per production run.
The FDA has found “significant objectionable conditions” at the Genzyme manufacturing facility that makes Lumizyme, creating another issue in the product’s approval process.
Two approvals in a week for drugs made at Ranbaxy’s New Jersey OHM Laboratories subsidiary have eased the generics firm’s North American regulatory woes and strengthened its position in the expanding US market.
PPD says it is unlikely to receive a $25m (€20m) milestone for US approval of Takeda’s diabetes drug alogliptin this year after the FDA said that cardio vascular (CV) safety data filed as part of the NDA are insufficient.
Daiichi Sankyo, the Japanese drug firm that bought a controlling stake in India’s Ranbaxy last year, says it had no knowledge of FDA concerns that led to a block on ANDA reviews for drugs made at the latter’s Paonta Sahib facility.
It is not compulsory to respond to form 483s detailing deficiencies at a facility but the FDAs latest guidance fully recommends companies do so to avoid being issued with a warning letter.
Ranbaxy’s problems with the US FDA were ratcheted up a notch yesterday when the agency halted its review of products made at the firm’s plant in Paonta Sahib, India after uncovering “untrue statements” in ANDA’s and NDA filings.
Japanese chemicals firm Asahi Kasei has ramped up its bioprocessing operations with the acquisition of US industrial processing specialist TechniKrom’s biopharmaceuticals business.
The quality control systems in place at Isreali drugmaker Taro Pharmaceutical’s manufacturing facility in Ontario, Canada are the subject of a US FDA warning letter following an inspection carried out last year.
Two months after the European Union (EU) released antitrust findings the FTC is suing Solvay Pharmaceuticals and two other companies for illegally agreeing to a delay generic’s release.
The US Food and Drug Administration (FDA) has issued a draft guidance on the measures pharmaceutical and other manufacturers should take to make sure imported FDA-regulated products are in line with federal statutes and regulations.
The FDA is calling for all drugs to be labelled using a standardised numerical identifier (SNI) similar to the one suggested in the delayed California e-Pedigree guidelines in a bid to tighten up supply chain security.
A US HHS report on FDA oversight during trials has found that, with current procedures, the agency cannot tell whether drugmakers are disclosing complete financial information from all investigators who worked on a particular study.
Two contract manufacturing organisations PrimaPharm have been cited by the US Food and Drug Administration for not adhering to Good Manufacturing Practice standards.
Valeant continues its spending spree with the $285m acquisition of California-based research dermatology specialist Dow Pharmaceutical Sciences (DPS), in a further bid to cement its market position.
The MHRA has renewed its approval of Almac’s facility in North Carolina, bringing an end to a busy and successful four months of inspections at the clinical services group’s facilities.
Haemacure is calling for the International Court of Arbitration in Paris, France to force CSL Behring to make a $1.5m milestone payment that it believes is now due under a 2002 settlement related to firms’ disputed Hemaseel project.
A study in the Journal of the American Medical Association (JAMA) claiming there is no evidence that brandname cardiovascular drugs are superior to their generic counterparts, despite claims to the contrary.
The US Food and Drug Administration has opened offices in three Chinese cities – Beijing, Shanghai and Guangzhou – to help improve the safety of medicines and ingredients imported into the US.
Isogen will start operations in January at a new contract facility in Delaware that will provide small-scale sterile filling services to the pharmaceutical industry.
The US authorities are turning up the heat on Icelandic generic drugmaker Actavis over manufacturing problems at the New Jersey plant which makes its recalled Digitek brand of the cardiac drug digoxin.
Ethex has initiated its third recall of the year as yet again the spectre of dangerous oversized tablets casts its shadow over the St Louis-headquartered company’s manufacturing operations.
Cost pressure and the increasing complexity of trials is forcing drugmakers to increasingly turn to outsourcing experts for clinical development, according to a Kalorama Information report.
Caraco Pharmaceutical Laboratories, in which India’s Sun Pharmaceuticals holds a 76 per cent stake, has joined the list of generics manufacturers issued with an FDA warning on quality control issues.
Contracting giant Catalent says its pre-filled syringe facility in Brussels, Belgium has received Food and Drug Administration approval for the manufacture of products for the US market.
Sun Pharmaceutical has posted a strong set of results for the second quarter of fiscal 2009, driven by improved performance by both its Indian branded drug and US generics businesses.
Ethex has withdrawn three lots of its generic drug dextroamphetamine sulphate, which is used to treat ADHD and narcolepsy, after analysis revealed that some oversized tablets had been produced.
A domino effect appears to have been started by the FDA blocking Ranbaxy imports, with other regulatory bodies paying close attention to the generics giant.
in-PharmaTechnologist.com's latest round-up of developments in pharmaceutical manufacturing features news of the world’s “biggest pharmaceutical allergen production unit”, Lentigen’s relocation and a cytotoxic robot.
Companies have failed to provide the information needed under the USP’s new chapter regarding residual solvents, causing them to incorrectly file ANDAs, according to the Office of Generic Drugs (OGD).
The FDA has granted sNDA approval for Akorn’s IC-Green injection dye, which is the first lyophilised product manufacturered at the firm’s Decatur facility to gain such status.
in-PharmaTechnologist.com’s latest round up of products launched in the pharmaceutical manufacturing sector includes new offerings from Genevac, Lock and AdvantaPure.
