BD Forms Pharmaceutical Wing with New Prefilled Generic Injectables

28-Mar-2013 - BD says a brand new facility and sustainable pricing will allow the company to compete as it enters the generics market following FDA approval of its first injectable drug. 

China’s FDA: New Name, New Ministerial Level

28-Mar-2013 - Following its re-elevation to a ministerial level, the Chinese drug regulatory body has rebranded itself the China Food and Drug Administration (CFDA).

ACRO Calls for Clarity on FDA Draft Guidance on eSource Trial Data

28-Mar-2013 - ACRO (Association of Contract Research Organizations) is calling on the FDA to clarify draft guidance attempting to mitigate the possible pitfalls in transitioning to electronic source data for clinical investigations.

Updated Excipient Package User Guide Aims to Reduce Redundancy for Suppliers

27-Mar-2013 - As excipient suppliers are inundated with similar requests from users regarding quality and raw material sources, IPEC (International Pharmaceutical Excipients Council) is looking to streamline the exchange of information between...

MHRA: Simplification Plans to Strengthen Industry and Cut Red Tape

27-Mar-2013 - Sale of medicines on trains and planes is just one reform being considered in a series of simplification measures aimed at increasing industry efficiency by the MHRA.

Pfizer Manufacturing Issues Cause TB Injection Shortage, Discoloured Vials

27-Mar-2013 - Pfizer’s Rifampin injections used to treat TB (tuberculosis) are in short supply as the company says manufacturing issues caused some vials and solutions of the drug to be possibly contaminated....

Gore PharmBIO: New Gaskets Can Reduce Risk of Contamination

27-Mar-2013 - Two new nonreactive product contact components can control contamination and meet regulatory requirements according to their makers, Gore PharmBIO.

GSK Developing Low-Cost Polio Vax Manufacturing Tech with NIBSC

26-Mar-2013 - GSK is working on a low-cost manufacturing platform it will use to produce inactivated polio vaccines (IPV) for developing countries.

Update

Propofol Lethal Injections Blocked as Teva and Hospira Re-Enter Market

26-Mar-2013 - Both Teva and Hospira have pledged to restrict distribution of propofol as a lethal injection ingredient while production of the drug recommences.

CRO’s China Lab Hit With Form 483 Under US FDA’s HSP/BIMO Initiative

26-Mar-2013 - Philadelphia-based CRO Frontage has received a Form 483 for “minor” issues related to its bioanalytical lab in Shanghai, China, a spokesman told us. 

Shire's Vision Strengthened with $160m Acquisition

26-Mar-2013 - Shire says it is laying down a foundation into the specialty ophthalmology field following its second acquisition in a matter of weeks.

FDA Wants New Regulations to Target Compounding Pharmacies

25-Mar-2013 - The FDA says compounding pharmacies need to be regulated under new legislation following a string of product recalls due to contamination threats.

Excipients Top List of Hot Topics at The Bioavailability Challenge

25-Mar-2013 - Formulators still think of excipients first when faced with drug bioavailability difficulties judging by trends that emerged at our online event.

New Micron Technologies Owner Plans Investment and Acqusitions

25-Mar-2013 - Micron Technologies’ new private-equity owner says it plans to grow the particle engineering firm through investment and acquisitions.

People on the Move: Jobs in Pharma

25-Mar-2013 - In-PharmaTechnologist.com presents its latest round-up of the movers and shakers in the world of pharmaceuticals, including news from AstraZeneca, Royal DSM and the FDA.

FDA Warns Apotex over cGMP Violations at Two Canadian Facilities

21-Mar-2013 - The US FDA listed failure to ensure product sterility or explain why some batches were only partially released among criticisms of Apotex in a warning letter  published this week....

Health Canada Moves to Regulatory E-Submissions System

21-Mar-2013 - Health Canada says moving to an electronic filing system for regulatory submissions will reduce costs but warned drugmakers not to include their credit card details.

Drug Industry says Tax Cuts and Credits in UK Budget Good for Manufacturing

21-Mar-2013 - Drug industry groups welcomed corporate tax cuts and increased research credits set out in the UK budget last night suggesting they are good news for manufacturers.

Novo Nordisk One Step Closer to Long-Acting Oral Insulin

20-Mar-2013 - Novo Nordisk says its long-acting oral insulin could become a lead product following the successful completion of an early-stage trial.

Drugmakers Seeking Approval Under FDASIA Must Keep Manufacturing In Mind; FDA

20-Mar-2013 - Planning for manufacturing scale up is a critical step that biotech drug developers often overlook according to US FDA Commissioner, Margaret Hamburg. 

Private Equity Backs Micron Technologies Management Buyout

20-Mar-2013 - US-based particle engineering services frim Micron Technologies has been acquired in a private-equity backed management buyout. 

Dispatches from Outsourcing in Clinical Trials East Coast, Philadelphia

Merck, Eisai Reap Savings from Off-Shoring, Outsourcing in China and India

20-Mar-2013 - Drugmakers Merck & Co and Eisai have both substantially cut internal data management costs through two unique off-shoring operations in China and India, respectively.

$2.25m Settlement as Teva Pushed to Address API Site's Green issues

19-Mar-2013 - The US Environmental Protection Agency (EPA) says Teva still needs to address environmental issues at Missouri API plant landed with a $2.3m civil penalty.

AstraZeneca R&D rejig will impact commercial and manufacturing ops

19-Mar-2013 - The ‘R&D’ reorganisation announced by AstraZeneca yesterday will impact manufacturing and commercial operations as well drug development activities.

News in brief

Sanofi Manufacturing ‘Delays’ Cause Shortage of TB Drug

19-Mar-2013 - Manufacturing “delays” at an unidentified Sanofi-Aventis plant have caused a new shortage of a tuberculosis (TB) drug , according to the US FDA.

FDA’s Tablet ‘Scoring’ Guidance Aims to Bridge Generic, Brand Divide

19-Mar-2013 - Marketed drugs will not need to be tested under final guidelines  on 'tablet scoring' for branded and generic medicines issued by the US Food and Drug Administration (FDA) this week....

Correction

'Flying Syringe' Puts Buzz Into Drug Delivery

18-Mar-2013 - A High School is using mosquitos to deliver vaccines as part of a project to develop a ‘flying syringe.’

US FDA: $10M in CR to Add More Capacity in China for Inspections

18-Mar-2013 - Proposed US government funding plans include $10m the FDA will use to increase oversight of drug manufacturing and research in China.

update

Battling Bioavailability? Find Your Solubility Solution at BAC 2013!

18-Mar-2013 - Drug solubility science, technology and solutions will take centre stage at “The Bioavailability Challenge” a free to attend online event in-Pharmatechnologist.com is hosting on Wednesday, March 20. 

People on the Move - Jobs in Pharma

18-Mar-2013 - In-PharmaTechnologist.com presents its latest round-up of the movers and shakers in the world of pharmaceuticals, including news from Glide, BASF and Pall.

API Corp. Invests in Neuland for More API, Intermediate Manufacturing

14-Mar-2013 - Tokyo-based API Corporation, a unit of Mitsubishi Chemical Holdings Group, is making an investment in API and pharmaceutical manufacturer Neuland Laboratories’ facilities.

World API Market Growth Slows, CPA Report Finds

14-Mar-2013 - Cost competition and the financial crisis have slowed the growth of the global API marker over the past four years according to new data released by the CPA (Italian Chemical...

Actavis Shutters Unit Following Watson Takeover R&D Double-Up

14-Mar-2013 - Following an analysis of its global R&D business Actavis says it will close its Maltese R&D unit at a cost of 60 jobs.

Novo Nordisk: 90 Years of Insulin and Still "Room for Improvement"

13-Mar-2013 - Novo Nordisk says “there is still room for improvement” in the development and delivery of insulin as it awaits FDA approval of its challenge to Lantus.

Major Pharma Companies Fund Interpol Counterfeit Drug Initiative

13-Mar-2013 - Pfizer, GlaxoSmithKline, Roche and 26 other large pharmaceutical companies will provide about $5.85m (3.5m Euros) over three years to fund an Interpol initiative to combat pharmaceutical counterfeits and crime.

Catalent Focuses on Softgel in One of Two Chinese Ventures

13-Mar-2013 - Catalent says it has acquired a Chinese softgel producer to expand its drug delivery offerings and expects more investments to come as part of a two-pronged plan into China.

Maquet and GSK Boost Novozymes’ Albumin Business

12-Mar-2013 - Novozymes says a recombinant albumin product usually used to stabilize vaccines has been approved in Japan as part of a coating for medical devices.

Patheon to Shutter Manufacturing Plant as Part of Banner Integration

12-Mar-2013 - Patheon says the shuttering of one of Banner’s manufacturing sites is necessary in integrating the recent acquisition into its global business structure.

South Korean OK for BASF's Scottish Omega-3 plant

12-Mar-2013 - South Korean regulators have cleared BASF to produce pharmaceutical grade omega-3 at its facility in Scotland.

For Sale: Another Merck & Co API Plant - Cost, 280 Irish Jobs

11-Mar-2013 - MSD says plans to shutter an Irish API facility are not part of an outsourcing strategy and intends to relocate both staff and manufacturing.

Update

Ashland to Expand Delaware Formulation and Contract Manufacturing

11-Mar-2013 - Ashland says it is expanding its contract manufacturing business in order to offer its customers greater scope in drug solubilization.

FDA Faces Uncertainty with Sequester, Continuing Resolution

11-Mar-2013 - The US FDA’s ability to inspect facilities, trial sites, and deal with all but its most pressing priorities will be restricted by mandatory government spending cuts according to the Alliance for a Stronger...

People on the Move: Jobs in Pharma

11-Mar-2013 - In-PharmaTechnologist.com presents its latest round-up of the movers and shakers in the world of pharmaceuticals, including news from Merck, BASF and Tenex.

EC says Drugmakers Have Time to Mark Risky Drugs with Black Triangle

11-Mar-2013 - The European Commission (EC) says timelines for new laws requiring that risky drugs are marked for extra safety monitoring take industry practicalities into account.

News in brief

Kyowa Hakko Kirin to Build Injectables Plant

07-Mar-2013 - Kyowa Hakko Kirin says commercial production of biopharmaceuticals will begin rolling out of its new plant in 2017.

Merck Serono: Fresh Pipeline Leads Growth but More Jobs Cuts to Come

07-Mar-2013 - Merck Serono says “fast progress” in its restructure programme helped double its net savings guidance for 2012 though headcount dropped by almost 2,000 with more cuts to come. 

update

EMA Expects OK for 2.6% Fees Hike in 2013

07-Mar-2013 - Pharmaceutical firms targeting the European market should expect drug review fees to increase by 2.6 per cent from April according to the European Medicines Agency (EMA).

Canadian CMO Hit with FDA Warning Letter for cGMP Violations

07-Mar-2013 - A Canadian subsidiary of India’s largest CMO (contract manufacturing organization) was cited by the US FDA for failing to investigate rejected batches of product or implement further preventive actions.

Partnership Could Forge Path for Oncology Drug Delivery, Development

07-Mar-2013 - A new partnership between a niche cancer drug discovery company and biotech powerhouse Celgene could pave the way for the future of cancer drug discovery and delivery.

EMA proposes virus testing for food sector-derived trypsin used in drugmaking

06-Mar-2013 - Food industry controls do not ensure porcine trypsin is virus-free according to the EMA, which proposes testing procedures for drugmakers which use the reagent in a new consultation document.

Peptide 'Passport' Fools Macrophages to Aid Drug Delivery

06-Mar-2013 - Researchers say a synthetic ‘passport’ peptide may allow drugs to function with greater efficacy by evading the body’s immune system.

Ajinomoto Wins ‘Top-Tier’ Pharma Licensee; Plans to Buy Althea Technologies

06-Mar-2013 - Ajinomoto says its flexible approach to tech licensing differs from rivals who are more focused on locking customers into manufacturing services contracts.

SFDA Aims to Stimulate R&D, Accelerate Approvals and Improve Distribution Practices

05-Mar-2013 - Chinese regulators want to improve how drugs are developed, reviewed and distributed in the country.

update

SAFC Expands Manufacturing Capacity to Meet Growing EU Needs

05-Mar-2013 - SAFC will expand manufacturing capacity at its facility in Irvine, Scotland, to include large-scale production of bulk dry powder media and reagents to save EU clients’ money in shipment costs.

Inspections Can't Solve Import-Related API Shortage Concerns says MHRA

05-Mar-2013 - Inspections in countries not expected to confirm API quality or seek exemption from new EU import regs “cannot be seen as a solution” to shortage concerns says the MHRA.

News in brief

Sanofi to Provide API for Allergy Therapies

05-Mar-2013 - Sanofi has entered into an agreement to produce an API for French company DBV Technologies.

Qualitest Expands in Light of Product Recalls

05-Mar-2013 - Endo says it will expand capacity at its generic manufacturing subsidiary Qualitest in light of quality lapses and product recall.

300 API Plant Inspections Needed Before July says HMA

04-Mar-2013 - As many as 300 API manufacturing sites will need to be inspected to prevent drug shortages after new EU import regulations come into effect this summer according to pan-European group...

Mylan Buys Agila Citing Global Injectable Drug Shortages as Driver

04-Mar-2013 - Mylan says its acquisition of Agila puts the generics company in a “leading position” in the injectables market.

People on the Move: Jobs in Pharma

04-Mar-2013 - In-Pharmatechnologist.com presents its latest round-up of the movers and shakers in the world of pharmaceuticals.

Capsugel Buys Encap as Part of Dosage Form Solution Strategy

01-Mar-2013 - Capsugel says the acquisition of Encap is part of its recently announced Dosage Form Solutions (DFS) strategy.