The challenges in establishing a regulatory pathway for biogenerics were discussed at a recent FTC roundtable, with a FDA official saying in most cases it will be “impossible” to establish that the APIs are identical.
Competition commissioner Neelie Kroes said that some drugmakers operating in the EU are deliberately stalling the introduction of generics, costing European patients around €3bn ($3.87bn) a year more to buy medicines.
European facilities owned by Israel’s Teva Pharmaceuticals and French drugmaker Servier are among the firms raided by the EC’s competition unit earlier this week, according to media reports.
The possible sell-off of Enzon Pharmaceuticals’ biotechnology drugs business has come under fire by one of the firm’s shareholders, DellaCamera Capital Management, which says it is opposed to the move.
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.
Watson Pharmaceuticals has paid Israeli generics firm Teva $36m (€27.6m) for 17 products that the latter firm is selling under the terms of its $7.5bn acquisition of Barr Pharmaceuticals.
Contract development firm Azopharma has established a new laboratory facility in Welwyn Garden City, UK, which it hopes will facilitate its move into the European market.
King Pharmaceuticals’ $1.6bn (€1.2bn) acquisition of Alpharma heads a busy week of deals that has seen J&J agree to pay $438m for Omrix and India’s Sun further its presence in the US narcotic APIs sector through the purchase of Chattem Chemicals.
A member of the US Congress has called on the GAO to launch an investigation into the FDA’s handling of the heparin crisis, citing “unanswered questions concerning [the] deaths”.
Members of the Committee on Energy and Commerce have said that recent actions by the FDA have been politically motivated and insufficient, although they did acknowledge the moves were necessary.
Pfizer’s Exubera failure need not be the final nail in the coffin for inhaled biopharmaceuticals as long as developers focus on proving “healthcare value” and addressing payer needs, according to Bruckner Group’s David Balekdjian.
Aptuit presented a seminar at this year’s AAPS explaining how it had implemented its INDiGO programme, which takes an API to IND in 26 weeks, and how it can benefit clients.
After collecting the drug delivery award at this year's AAPS, John Santini, CEO of MicroCHIPS, was on hand to explain what the gong meant to the company.
AstraZeneca is to cut 1,400 jobs and close more manufacturing facilities by 2013, as it attempts to slim down in preparation for impending generic competition for some of its cornerstone drugs.
DPT Laboratories chose this year’s AAPS in Atlanta to showcase its research and development capability with a unique poster presentation examining the role of various excipients in nasal drug delivery applications.
Contract research group Recipharm has leased AstraZeneca Biotech Laboratory (ABL) in Sodertalje, Sweden, bolting on recombinant protein and monoclonal antibody development capabilities to its offering.
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.
Alpharma moved a step closer to bringing its morphine product Embeda to market after a US Food and Drug Administration advisory panel agreed that it is less susceptible to abuse than other opioid analgesic products.
UPS is planning on building a new facility in Puerto Rico to help establish a reliable cold-chain delivery service, suggesting a brighter future for the island’s industry.
Cost cutting has sustained pharma profits in the faltering global economy, however top executives are starting to realise that reducing R&D capacity may not have been the smartest move in an era of weak pipelines and impending patent expiry, according...
A Terre Haute, US resident has filed a lawsuit against Pfizer alleging that the company “negligently or recklessly” maintained its dam, resulting in the release of PCB.
A Californian appeals court ruling may have altered product liability in the state, which could lead to numerous court cases being brought against big pharma.
Robert Sexauer, CEO of biopharmaceuticals group RCP Therapeutics, says the R&D investment deal signed with FirstPoint Biotech shows the attractiveness of the firm’s nano-medical pipeline, particularly given the current economic climate.
Danish drugmaker Novo Nordisk has unveiled an ambitious plan to build an insulin plant in China, tapping into a major new market for diabetes treatments.
American Association of Pharmaceutical Scientist's (AAPS) president Dr Karen Habucky sets out the programme for the group's forthcoming annual meeting and exposition, which is being held in Atlanta, US between November 16- 20.
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.
Pfizer is likely to lose its crown as the world’s largest pharmaceutical company and by 2012 will be usurped by GlaxoSmithKline, according to a report from Urch Publishing.
Senator Chuck Grassley has written a letter to Andrew von Eschenbach alleging systemic mismanagement of employee pay and benefits at the US Food and Drug Administration (FDA).
UK drug major GSK is cutting approximately 1,000 US sales jobs by the end of 2008 as it reorganizes to compete in the increasingly tough pharmaceutical market.
RCP Therapeutics, a developer of regenerative medicine, hopes that its new HQ in the UK will benefit from the country’s status as a financial centre and proximity to cost effective trial sites in Eastern Europe.
Following Barack Obama’s victory in the race to the White House, in-PharmaTechnologist.com examines what this could mean for the pharmaceutical industry.
Next year, drug revenues will grow 5 per cent to $820bn according to IMS Health, as the global downturn, patent expiry and flat-lining growth rates in mature markets all make their presence felt.
India’s Shasun Pharma Solutions is to close its manufacturing facility in Annan, Scotland explaining that the site is being “underused,” according to media reports.
Taiwan’s efforts to position itself as a major biotechnology hub received a further boost today with the opening of Merck KGaA’s dedicated technology training centre in Xizhi City, Taipei County.
The NAFDAC has banned 22 firms that it says are involved in the manufacture of fake drugs from ever again selling pharmaceuticals in Nigeria, as part of a countrywide clampdown.
Irish drugmaker Elan has shelved plans to sell its contracting arm EDT in favour of improving the division’s profitability, despite receiving what it describes as “considerable interest” in the unit.
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.
