Northwest Biotherapeutics has agreed with CMO Cognate Bioservices to begin a large-scale expansion of the manufacturing, storage, handling and distribution of its personalized immune therapies for solid tumor cancers.
The end of Lonza’s biosimilar joint venture with Teva will not affect manufacturing capacity, the firm says, as it reports a drop in overall revenue for 2013.
PharmaCell, the CMO that makes Provenge for Dendreon in Europe, has agreed to buy a facility from TiGenix to add capacity and a manufacturing contract for a second commercial product.
Higher earnings and improved margins did not impress investors in Lonza, which saw its share price tumble today after revealing that sales to the drug sector fell in 2013.
Increased in-house API production and manufacturing in India will lower the costs of Hospira’s injectables, the firm says, as it looks past current remediation efforts.
US FDA audits are a lot tougher than customer inspections according to CMO Regis, which has just passed two agency assessments with no 483 observations.
Novartis says it intends to shutter a New York manufacturing site due to reduced demand following the loss of exclusivity on its one-time topseller Diovan.
Efforts to address the current shortage of IV fluids in the US are a placing a strain on manufacturing capabilities according to Baxter, which is investing to try and increase production capacity.
AMRI says it intends to expand its fill/finish capability and progress its business into higher value technology following the recent all clear at its once troubled Burlington facility.
The US FDA is positioned to increase drug plant inspections in China after US President Barack Obama signed a $1.1tr (€881bn) budget for fiscal 2014 into law on Saturday.
The combination cholesterol drug Liptruzet will be unavailable in the US for the foreseeable future, says Merck & Co., after packaging defect at CMO led to a total product recall.
Chinese authorities have given Thermo Fisher Scientific the green light to buy Life Technologies on the condition it discounts certain products sold in the coutry.
Current economic problems may have hit Spanish drugmakers hard, but the downturn has not dampened demand for contract manufacturing services according to IDIFarma.
Boehringer Ingelheim says it was well-prepared for the expiration of its blockbuster drug Micardis (telmisartan) with staff and capacity transfers as Actavis prepares to launch a generic version.
Roche has asked Tamiflu distributors to prioritize US regions hardest hit by flu as it works to address packaging delays expected to limit supplies of the oral suspension version of the antiviral for the rest of the month.
The European Medicines Agency (EMA) has published for the first time details of manufacturers who have violated GMP as part of its transparency initiative.
Catalent has been contracted to make supplies of an extended-release drug for Parkinson’s disease (PD) patients set to enter Phase III trials by developer Adamas Pharmaceuticals.
Patheon is the world’s largest pharmaceutical development services (PDS) provider and third largest contract manufacturer, according to a report released yesterday.
Injectable device manufacturer Unilife has announced a contract with a pharmaceutical multinational for the use of its Ocu-ject eye syringe, marking its fifth major contract in four months.
Boehringer Ingelheim (BI) has warned that latest efforts to ensure continued Doxil production at Ben Venue's troubled sterile injectables plant in Bedford, Ohio must still be approved.
A Hospira plant in India that was issued with a US FDA warning letter last summer has been criticised by the agency again following an inspection last month.
At this time of year science may play second fiddle to opening presents and drinking mulled wine, but in-Pharmatechnologist.com has leveled the field with its interactive nativity card.
Encap has collaborated with Lipocine to manufacture its oral testosterone product and says it expects continued growth in demand for HPAPI formulation services.
CMO Recipharm has set out to sell a new own-brand infectious disease medication it developed in partnership with fellow Sweden-based firm Astimex Pharma.
Eli Lilly is scaling back manufacturing of Cymbalta but says there will be no major loss of production jobs as a number of firms begin producing generic versions.
Elder Pharmaceuticals has agreed to sell its branded drug portfolio to Torrent Pharmaceuticals in a deal that will refocus the firm as a CMO and anti-infectives producer.
Novartis has recalled 37 batches of over-the-counter (OTC) cough syrup after its contract manufacturer, BCM, detected a fault on a packaging line at its UK plant.
Pharmacy chain Boots UK has expanded a recall of some own-brand drugs after detecting a fault in a manufacturing line that applies tamper evident seals.
ANVISA has set out what it expects of contractors that provide manufacturing, quality control services and drug storage in the Federal Official Gazette of Brazil (DoU) and invited stakeholders to comment.
A lawsuit alleging that the US FDA unlawfully detained a batch of acetaminophen API destined for CMO Gemini Pharmaceuticals could have significant impact on the drug industry's definition of an ‘end user.'
Soon to be merged CMO DSM Pharmaceutical Products (DPP) has been contracted to provide process development for a protein allergy drug being developed by Tunitas Therapeutics.
The climate for biomanufacturing has changed according to Pfizer, which has set out to win more contracting work for its hormone plant in Sweden and says it will even consider making large molecule drugs for Big Pharma rivals.
