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Headlines > August 2013

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update

CordenPharma Owner Buys Belgian Peptide Firm to Boost API business

29-Aug-2013 - ICIG will buy the Belgian operation of peptide maker Peptisyntha SA from Solvay to expand its recently rejigged contract API business.

News in brief

If You’re App-y Now You’ll Know It With Our New iPhone Widget

29-Aug-2013 - Being pipped to the post by the cast of Sesame St  is rarely a positive, but when it means in-Pharmatechnologist.com's tech team has the time to develop an iPhone App as good...

Report: Physicians Interested in New Delivery Techs for Migraine Drugs

29-Aug-2013 - 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.

Update

US FDA Clarifies Guidance on Intermediate Stability Data for Generic Manufacturers

28-Aug-2013 - The US FDA has released a Q&A to offer more clarity to GPhA, Cipla, Akorn and other drug and API manufacturers who responded to the initial stability draft guidance for...

Who's Bought Who in the Late Summer Sales

28-Aug-2013 - Amgen spent $10.4bn (€7.8bn) this week on Onyx Pharmaceuticals, but AstraZeneca and Johnson & Johnson have also opened up their wallets this week – welcome to in-Pharmatechnologist.com’s merger & acquisition...

Eisai First London Declaration Signatory Pre-qualified by WHO to Make NTD Drugs

28-Aug-2013 - Eisai has become the first London Declaration signatory to be pre-qualified to make treatments for neglected tropical diseases by the WHO.

PTI and Eximo Launch Techs to Deal with Pharma Dust

28-Aug-2013 - Dust is rubbish, literally. And in a pharmaceutical plant it can also put employee health in danger and be the cause of product recalls.

Aoxing's Sales Soar After "Capsule Fiasco" Almost Ruined Company

27-Aug-2013 - Aoxing Pharmaceuticals reported increased sales and lower operating expenses for Q2 2013 one year on from the chromatin-tainted gelatin scandal that led to suspension of sales by China’s regulators.

Amarin Asks US FDA to OK Novasep as Vascepa API Supplier

27-Aug-2013 - Amarin wants US regulatory approval to add Novasep to the list of APIs suppliers for its fish oil heart pill, Vascepa.

EFPIA Backs MHRA Plan to Inspect APIs at Plants Not Ports

27-Aug-2013 - EFPIA has backed MHRA plans to inspect API imports at manufacturing plants rather than at UK borders.

update

Fabbrica Italiana Sintetici Expands IMCD Promotion Deal

26-Aug-2013 - IMCD Group will promote APIs made by Italian firm FIS in territories in Eastern Europe and the Southern hemisphere under a new agreement. 

People: New President at Novo Nordisk North America

26-Aug-2013 - Novo Nordisk's North American affiliate has a new President and more news from drug delivery firm Enteris - welcome to in-Pharmatechnologist.com' People on the Move.

News in brief

Amgen Acquires Onyx for $10.4bn

26-Aug-2013 - Amgen has spent $10.4bn (€7.8bn) in acquiring Onyx Pharmaceuticals saying its oncology products and pipeline will be strengthened by Amgen’s manufacturing capabilities.

Siegfried Sees 1H Profits Rise on APIs, Orders and Acquisitions

26-Aug-2013 - Swiss API manufacturer Siegfried reported that higher API sales and custom synthesis orders drove a profit increase in the first half of the year and predicted that recent capacity hike...

Manufacturing Must be Described Whether QbD or Not, say EMA and FDA

22-Aug-2013 - Description of the manufacturing process in regulatory submissions must be the same whether the applicants use Quality by Design (QbD) or the traditional approach, the FDA and EMA have concluded.

JHS Expands Sterile Manufacturing at Recently Warned Plant

22-Aug-2013 - Jubilant HollisterStier (JHS) says expansion of its sterile manufacturing capacity at its facility in Kirkland, Canada will be used to fulfill several new contracts.

Novartis Sneaking Up on Pfizer For Pharma's Top Spot

22-Aug-2013 - Pfizer has remained the world’s largest public manufacturer of pharmaceuticals, according to an industry report, though dropped revenue in 2012 has left Novartis hot on its heels.

UK MHRA to Inspect API Imports at Manufacturing Plants Not Borders

21-Aug-2013 - The MHRA says it will assess the quality of active pharmaceutical ingredients (APIs) imported from outside the EU at manufacturers’ facilities rather than at UK borders. 

Elimiating Viruses the NanoViricides Way

21-Aug-2013 - NanoViricides' nanotech drug delivery platform has the potential to eliminate viruses, the firm says as construction began on a manufacturing facility to support upcoming clinical trials.

Fresenius to Establish Indonesian Manufacturing Hub in 51% Acq

20-Aug-2013 - Fresenius Kabi will focus on intravenous generics and infusion solutions as it acquires a 51 percent stake in an Indonesian pharma company.

US FDA Seeks Applicants to Test Supply Chain Security for Drugs, APIs

20-Aug-2013 - The two-year pilot project will help the US Food and Drug Administration further assess the growing number of companies and countries involved in importing drugs to the US.

TransCelerate Aims to Ease Trial Comparator Sourcing

19-Aug-2013 - The TransCelerate BioPharma industry group has launched its clinical trial comparator network to establish a reliable means for sourcing quality drugs for clinical trials. 

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

19-Aug-2013 - Mannkind says it is looking for partners to market its inhaled insulin drug Afrezza following positive data results in Phase III clinical trials.

Codexis Denies Expression System Licence Breach

19-Aug-2013 - Codexis has denied breaching its licensing deal with Dyadic International and says losing rights to the C1 fungal expression system would hit its CodeXyme business hard.

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