Ranbaxy made “untrue” statement in filings says FDA

26-Feb-2009 - 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.

Schering and WHO deal for pandemic vacc tech

25-Feb-2009 - Pandemic influenza vaccine manufacturing technology will be made available to developing countries through a collaboration between the WHO and Schering-Plough.

API monograph pilot gains momentum

25-Feb-2009 - An active pharmaceutical ingredient (API) pilot project, implemented by the Pharmacopoeial Discussion Group (PDG) last summer and aimed at harmonising API monographs, should generate its first results before the end of the year.

FDA gets funding boost and task list for 09

24-Feb-2009 - The proposed FDA funding for 2009 has given a boost to the agency, with $300m more being offered than the agency requested to ensure the safety of products.

Multinational deals set to continue in Indian pharma

23-Feb-2009 - The Indian pharmaceutical and biotech sectors may see more M&A activity this year with rumours that GSK, Sanofi Aventis and Merck KGaA are on the look out for potential deals.

Obama offering drug industry R&D "olive branch"

19-Feb-2009 - Barack Obama’s support for R&D tax credits to boost innovation is designed to assuage Big Pharma’s fears about a ban on “authorised generics,” and new “comparative effectiveness" tests, according to Datamonitor’s Sandra Reynolds.

GEA selects ACE Indian distribution network

19-Feb-2009 - Indian process technology firm ACE Technologies has won the contract to sell and service GEA Pharma Systems’ range of Courtoy tablet presses to local drug manufacturers as part of the latter company’s Asian expansion plan.

Sanofi "no comment" on deal for Brazil's Medley

17-Feb-2009 - French drug major Sanofi Aventis is in talks about taking over market leading Brazilian generics firm Medley, according to reports the country’s Valor Economico newspaper.

Bioceros joins PER.C6 network as only EU cell generation partner

11-Feb-2009 - Crucell and DSM Biologics have added fellow Dutch firm Bioceros to the PER.C6 vendor network to provide manufacturing and support capacity in line with increased demand for the cell line.

Pliva axing 790 employees; still looks to grow

10-Feb-2009 - Pliva is laying off 790 employees over the next 12 months following its acquisition by Teva but still intends to significantly increase API and finished product output over this period.

Prosecutions loom for 110 drugmakers in India

04-Feb-2009 - Regulators in India’s Maharashtra state have compiled a hit list of 110 drugmakers that they intend to prosecute for sub-standard manufacturing practices, according to media reports.

Bill calls for more inspections funded by pharma fees

04-Feb-2009 - A bill has been introduced to the US House of Representatives that would require pharmaceutical manufacturers pay a fee and have their facilities inspected more frequently.

Biological E’s new vaccine campus inaugurated

03-Feb-2009 - Dr Rajashekar Reddy, chief minister of Andhra Pradesh, India presided over the inauguration ceremony for Biological E’s new INR3bn ($61m) vaccine and biopharmaceuticals manufacturing campus.

WHO mulls comments from counterfeiting talks

02-Feb-2009 - The WHO’s review of comments during a discussion of plans to redefine “counterfeit” will focus on “public health impacts of substandard, spurious, and falsely labelled products,” according to the organisation.

CEE could gain from Asia’s reputation for fakes

22-Jan-2009 - A new report suggests the large numbers of fake drugs produced in China could drive CMO customers away and see Central and Eastern Europe (CEE) emerge as a contract manufacturing hotbed.

FDA outlines ‘best practice’ for importers

21-Jan-2009 - 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.

News in brief

Drug CEOs hope to kickstart economy at April summit

19-Jan-2009 - CEOs from Pfizer, GSK and Abbott Laboratories are among those who will meet in to discuss the new business practices that must be put in place to adapt to the challenging economic climate.

FDA launches global supply chain pilot scheme

15-Jan-2009 - In the latest part of its “beyond our borders” scheme, the US FDA is asking drugmakers to volunteer supply chain information for drugs and APIs sourced outside the USA.

Asian pack machine demand a boon US and EU industry

15-Jan-2009 - The market for packaging machinery is set to grow 5 per cent a year and be worth $40bn (€30.3bn) by 2012, driven partly by a hike in demand for drug products in “pharmerging” economies, according to a new industry report.

Teamwork future of GMP inspections, says EMEA

14-Jan-2009 - Despite criticism in certain quarters, joint GMP inspections represent the best use of resources in an increasingly globalised market, according to the EMEA.

News in brief

HHS/FDA set to open Indian offices

14-Jan-2009 - Two new HHS/FDA food and drug safety offices in Dehli and Mumbai, India are the latest outpost of the US regulators “beyond our borders” campaign that has already seen it set up shop in China and Costa Rica.

Interview with IPEC China chairman Nevin Cheng

12-Jan-2009 - Since its inauguration last year, IPEC China has been working to improve the quality of excipient manufacturing in the country. in-PharmaTechnologist spoke with organisation president Nevin Cheng about the steps the body has taken so far and what it will be doing in 2009, including its plans for a new SFDA approved Drug Master File (DMF) scheme.

News in brief

Cuban prostate cancer vac sees clinical progress.

12-Jan-2009 - Heberprovac, a prostate cancer vaccine being developed at the Camaguey Genetic Engineering and Biotechnology Centre has completed the initial phases of a clinical trial, according to the Cuban News Agency.

GSK’s high-tech vaccines packaging plant plan

12-Jan-2009 - An open house at GSK’s plant in Pennsylvania, US gave the world its first glimpse of the facility that the firm hopes will become the global hub of its vaccine packaging and filling business.