Delivery formulations

Top manufacturers seek clarity on delaying, denying FDA inspections

07-Oct-2013 By Zachary Brennan

Merck, Novartis, GlaxoSmithKline, Celgene and industry groups are taking issue with recent FDA draft guidance on how manufacturers can reject or limit agency inspectors.

140 jobs to go as Pfizer announces Aus plant closure

30-Sep-2013 By Dan Stanton

Pfizer says 140 jobs will be lost at an Australian manufacturing plant as the firm continues to review its global network in light of expired patents.

B-I expanding China plant, says: 'Industry still sore from scandals'

26-Sep-2013 By Dan Stanton

In the wake of recent bribery scandals, Boehringer Ingelheim (B-I) has called for stricter regulations in China, as it plans to triple production at its Shanghai manufacturing site.

Pfizer teams with GEA and G-CON to 'transform' oral solid dose industry

26-Sep-2013 By Dan Stanton

A collaboration to develop portable, flexible and continuous processing systems has the potential to transform oral solid dose (OSD) manufacturing, according to Pfizer, GEA and G-CON.

EU Nod for AZ's Nasal Flu Vaccine For Children

24-Sep-2013

AstraZeneca has received positive opinion from the EU for use of its nasal spray vaccine Fluenz Tetra in children.

Consent decree halts operations of Ohio drug manufacturer

24-Sep-2013 By Zachary Brennan

A federal judge in the Southern District of Ohio has approved a US FDA consent decree against Shamrock Medical Solutions for drug manufacturing and labeling violations.

Hikma JV to Build Pharma Plant in Ethiopia

23-Sep-2013

Hikma Pharmaceuticals has signed onto a joint venture with MIDROC Pharmaceuticals to establish a presence in the Ethiopian pharmaceutical market.  

Capsugel expands manufacturing capacity at three FDF plants

23-Sep-2013 By Zachary Brennan

Capsugel’s DFS Unit has upgraded three FDF (finished dose form) manufacturing facilities in the US and Europe.

Aurobindo gives more info on injectables rejig and ingredient M&As

16-Sep-2013 By Gareth Macdonald

Aurobindo Pharma has given more details of a planned expansion of its API and antibiotics businesses and has confirmed its intention to rejig its injectables operations.

Cargill: Pharma Increases Interest in Seaweed-Derived Excipients

12-Sep-2013 By Dan Stanton

Cargill says interest from the pharma industry for its seaweed-derived excipient is growing as it invests $15m (€11.3m) into its French alginate production plant.

AstraZeneca Tight-Lipped on New UK Manufacturing Plant

10-Sep-2013 By Dan Stanton

AstraZeneca has received planning permission to build a finished formulation facility at its manufacturing site in Macclesfield, UK.

Mylan Doubles Capacity at Transdermal Patch Facility

09-Sep-2013 By Dan Stanton

Mylan Technologies has expanded its US transdermal patch facility, doubling capacity as part of a global investment of more than $600m (€455m).

Edible Silica Microtags: Eating Away at Counterfeit Drugs

09-Sep-2013 By Zachary Brennan

Pharma manufacturers may turn to a new technology -- edible microtags -- as way to help manufacturers root out counterfeit drugs and protect patients.

GSK in Talks with Several Firms for Romanian Oral Dose Plant

05-Sep-2013 By Dan Stanton

GlaxoSmithKline is in talks with a number of companies interested in buying its Romanian manufacturing facility that was recently earmarked for closure.

Mylan Cleared to Acquire Agila as Foreign Investment Concerns in India Fester

05-Sep-2013 By Zachary Brennan

Mylan announced on Tuesday that it received approval from Indian regulators to acquire Agila for $1.6B just as a recent report from India’s Parliament criticizes foreign companies’ increasing control of the industry in the country.

US Awards $7.8M to Further Develop Nitric Oxide-Based Thermal Burn Therapy

04-Sep-2013 By Zachary Brennan

The US Biomedical Advanced Research and Development Authority (BARDA) has awarded Novan $7.8 million to aid the development of what the company hopes will be the first FDA-approved drug with a burn healing indication.

Shasun Plant Gets Third Regulatory Thumbs Up in As Many Months

03-Sep-2013 By Gareth Macdonald

The UK MHRA has given Shansun Pharmaceutical’s drug formulation plant in Puducherry, India a clean bill of health after an inspection last month.

Fighting Back Against Breaking Bad: Using Acura's Pill to Stop Smurfs

02-Sep-2013 By Gareth Macdonald

An anti-abuse formulation developed by Acura Pharmaceuticals is gaining in popularity in the US with Ohio-based Fruth Pharmacy becoming the latest firm to say it will stock the Sudafed rival Nexafed.

Report: Physicians Interested in New Delivery Techs for Migraine Drugs

29-Aug-2013 By Zachary Brennan

Many physicians would switch migraine patients from oral treatments if the same drugs were available as a nasal inhalation, topical, or transdermal patch according to a new report.

Giant Leap for Mannkind: Positive data from Ph III Afrezza trial

19-Aug-2013 By Dan Stanton

Mannkind says it is looking for partners to market its inhaled insulin drug Afrezza following positive data results in Phase III clinical trials.

Aurobindo Focuses on Injectables with Plans for Spin-Off Subsidiary

13-Aug-2013 By Dan Stanton

Consolidating its Indian injectable business under a new subsidiary will improve focus and align quality control, says Aurobindo who has invested in two manufacturing companies to support such plans.

Adamis Looks to Dry Powder Inhaler Tech Following $3m License From 3M

12-Aug-2013 By Dan Stanton

The licensing and potential purchase of the Taper Dry Powder Inhaler (DPI) technology from 3M complements Adamis’ portfolio and future formulation expansion, Adamis says.

Novozymes' HA Delays API Release and Boosts Drug Half-Life

01-Aug-2013 By Gareth Macdonald

Delays are annoying. Whether you are a journalist trying to ask a few quick questions without involving teams of public relations people or a driver stuck in a traffic jam, delays are normally a bad thing.

Aesica Adds Stealthy Anti-Abuse Tech to Controlled Drug Offering

25-Jul-2013

Aesica has licensed an anti-abuse technology from QRxPharma that it claims outperforms all other solutions currently on the market.

New Particle Tech May Let Formulators Cut Out Costly Lactose says Pulmatrix

24-Jul-2013 By Gareth Macdonald

Dry powder inhaler firms may soon be able to eliminate lactose from formulations if a new high dispersibility particle production platform is successful in trials.

Aussie Team Uses Hot Ethanol to Make Smaller API Particles

24-Jul-2013 By Gareth Macdonald

Appreciating warm alcohol, like being rubbish at cricket, is no longer a solely British preserve with researchers in Australia developing a hot ethanol-based manufacturing method that, they claim, produces smaller, more uniform API particles.

Intertek Buys Melbourn for Delivery Device and Formulation Knowhow

10-Jul-2013 By Gareth Macdonald

Intertek has acquired Melbourn Scientific, citing its capabilities in delivery device testing and formulation services as the key drivers for the deal.

Dry Syrup Formulation Aims to Ease Alzheimer’s Drug’s Delivery

08-Jul-2013 By Zachary Brennan

A new high-intensity sweetener-based reformulation approach could improve compliance among Alzheimer’s patients and make dose adjustment easier says Tokyo drugmaker, Eisai.

3D Printing Could Create Better Pills say UK Researchers

25-Jun-2013 By Gareth Macdonald

3D printing could be used to optimize tablet designs and make drug delivery more effective according to UK additive manufacturing researchers.  

India’s Roselabs Invests $67M in New Pre-Filled Syringe Facility

24-Jun-2013 By Zachary Brennan

Roselabs Bioscience has invested $67M into a pre-filled syringe facility in India and is exploring the option of exporting the products to 35 countries in unregulated markets in southeast Asia, Latin America and Africa.

Belrose Buys Enzon's Pegylation Platform and Drug Candidates

20-Jun-2013 By Gareth Macdonald

Drugmakers have been slow to adopt releasable PEGylation according to Belrose Pharma, which plans to use a tech it has bought from Enzon to expand the market.

MicroDose of Fresh Air for Teva with Respiratory Acquisition

18-Jun-2013 By Dan Stanton

Teva has affirmed its respiratory drug delivery strategy with the purchase of MicroDose Therapeutx for a potential $165m (€123m).

Capsugel Launches Lipidex Encapsulating Platform from New Dosage Form Unit

17-Jun-2013 By Dan Stanton

The latest technology platform from Capsugel's four-month old DFS Unit offers greater bioavailabilty and stability in oral dose formulation, says the company.

AstraZeneca to Buy Pearl Therapeutics for LAMA/LABA Inhaler and Particle Tech

11-Jun-2013 By Gareth Macdonald

AstraZeneca has announced its second bolt-on acquisition in as many months, unveiling a $1.5bn move for respiratory drug developer Pearl Therapeutics.

Capsugel: Micro-Dosing Tech Can Cut Drug Development by 6 Months

06-Jun-2013 By Dan Stanton

Capsugel says its Xcelodose Precision Powder Micro-Dosing System can shorten drug development time by up to six months. 

Industry-Led Biosciences Centre to Target Global Diabetes & Obesity in Indiana

05-Jun-2013 By Dan Stanton

The state of Indiana has unveiled a new industry-led Biosciences Research Institute though it is unclear how companies will divide intellectual property and product patents.

GSK's €250m Acquisition Brings T-Cell Vaccine Tech In-House

30-May-2013 By Dan Stanton

GlaxoSmithKline has brought its vaccine development in-house with the purchase of Okairos and its supplementary technology platform.

Oral Insulin: All Mouth, or an Injection of Hope for Type 1 Diabetes?

23-May-2013

Can oral insulin succeed where other alternative delivery methods have failed? Dan Stanton, from in-Pharmatechnologist.com assesses its chances. 

Updated

Pharma Companies Buzz Over Auto-Injectors Showing Success with High Viscosity Drugs

02-May-2013 By Zachary Brennan

New auto-injector technology that is user-friendly and capable of delivering high viscosity drugs may be the next big thing for pharma and biotech companies pushing further into niche biologics and biosimilars.

Live from Interphex

Regulatory and Financial Burdens Slow IR/MR Approvals, Says Expert

24-Apr-2013 By Dan Stanton

Efforts to update SUPAC guidance on immediate and modified release dosage forms will end in faster approvals, if regulatory and financial hurdles can be overcome, says expert.

Fujifilm's Cell Banking Facilitates "Larger Slice" of Biologics Pie

23-Apr-2013 By Dan Stanton

Third-party manufacturers of biologics are seeing increased demand but more short term contracts, according to Fujifilm.

Novaliq Secures Funds to Develop Ocular Delivery Tech

15-Apr-2013

Novaliq has raised funds to further development of its bioavailability boosting delivery technology and take its candidate dry eye drug into Phase I trials.

BMS Plant Expansion to Push Biologics Development and Manufacturing

15-Apr-2013 By Dan Stanton

Bristol Myers-Squibb says its $250m (€191m) expansion of its US biologics facility will centralize its processes and become a springboard to launch new products.

GSK Developing Low-Cost Polio Vax Manufacturing Tech with NIBSC

26-Mar-2013 By Gareth Macdonald

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

New Micron Technologies Owner Plans Investment and Acqusitions

25-Mar-2013 By Gareth Macdonald

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

Novo Nordisk One Step Closer to Long-Acting Oral Insulin

20-Mar-2013 By Dan Stanton

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

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. 

Maquet and GSK Boost Novozymes’ Albumin Business

12-Mar-2013 By Gareth Macdonald

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

Mylan Buys Agila Citing Global Injectable Drug Shortages as Driver

04-Mar-2013 By Dan Stanton

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

GOED: Pharma is important for omega-3 but growing slowly

25-Feb-2013 By Shane Starling

Pharmaceutical omega-3 products are important but will grow more slowly than some expect because of the long timeframe for drug approval, says the chief of the Global Organisation for EPA and DHA Omega-3s (GOED).