The US FDA has approved Shire’s request to make rare genetic disease treatment Cinryze at its manufacturing facility in Vienna.
Portola Pharmaceuticals Inc has hired Lonza to make AndexXa (andexanet alfa), the candidate anticoagulation antidote it resubmitted for US FDA review last month.
The EMA has revised its reflection paper on API starting materials to clarify what information drug firms should provide about their starting materials under ICH Q11.
Avara Pharmaceutical Services has agreed to buy Pfizer Inc. sterile drug manufacturing facility in Liscate, Italy.
The US FDA has sought to clarify when biologics firms should inform it about minor changes to manufacturing processes in draft guidance this week.
Symbiosis has opened an office in Boston, Massachusetts citing growing demand for vial filling services for highly potent APIs and large molecule injectable formulations.
Keryx Biopharmaceuticals has hired Patheon to make the kidney disease drug Auryxia (ferric citrate) after its original contractor halted production.
Researchers have developed an “easy-to-adopt” process for removing excess additives from injectable drugs.
Dr Reddy’s Laboratories and TR-Pharma have partnered to manufacture biosimilar pharmaceuticals for the Turkish market.
CPhI Worldwide 2015
Piramal chief executive Vivek Sharma won last week’s CPhI award for the pharma industry’s CEO of the year. Outsourcing-Pharma.com spoke to Sharma about his plans for the CDMO the day after the jury’s unanimous decision.
The FDA will begin destroying drugs which are refused entry to the US instead of returning them to their sender.
Pfizer has completed its takeover of generic injectables and biosimilars firm Hospira and predicted annual cost savings of $800m by 2018.
|Dispatches from ACHEMA
EMA guidance on process validation for drugmakers is the latest update in cGMP regulations to manage a pharma world shifting from chemical to biological processing, says NNE Pharmaplan.
News from CPhI Japan
‘Epoch making’ revisions to Japanese drug laws have provided a pathway for development of safer, more innovative drugs according to MHLW director, Haruo Akagawa.
The EDQM is revising its water for injection (WFI) monograph to accomodate cheaper and greener alternatives to distillation and has called on injectable drugmakers to contribute.
Celltrion has emphasised the savings Remsima ((inflizimab) could offer at a conference in Spain as partner Napp Pharmaceuticals prepares to extend the roll out of the Remicade biosimilar to the UK.
Lonza signed a flurry of biopharma-related deals and launched a number of drug industry services in the final quarter of 2014 as its efforts to focus on pharma intensified.
The US FDA says that it “becomes concerned” when excess volume in an injectable vial is greater or less than what the US Pharmacopeia (USP) recommends without proper justification, according to new draft guidance.
Ireland is seeing a renewed interest from biotech, the Industrial Development Agency (IDA) says, as Bristol-Myers Squibbs shuts a Dublin API plant to focus on biopharmaceuticals.
Cytotoxics will be a key growth opportunity for third-party manufacturers as biopharma increases its injectables outsourcing over the next few years, an industry report has predicted.
Alexion Pharma International has recalled a single lot of its monoclonal antibody (MAb) orphan drug Soliris due to the presence of visible particles in a limited number of vials.
The US FDA has waived normal pre-approval inspection requirements and cleared CMO Cook Pharmica to make an injectable drug that is currently in short supply.
Sanofi has entered into an agreement to produce an API for French company DBV Technologies.
Royal DSM expects its pharma unit to perform better in 2013 driven by a generics and end-of-lifecycle drug-focused partnership strategy.
The US FDA has finally adopted the revised ICH Q11 guidelines on drug substance manufacturing nearly six months after European regulators embraced the guidelines.
US CMO Pharmaceutics International (Pii) has been named as the manufacturer of the cranial bleeding treatment voluntarily withdrawn by India’s Sun Pharmaceutical Industries earlier this week.
US Government must 'get a handle' on biosecurity, say experts
US biosecurity experts are calling on industry and the Government to “get a handle” on the supply chain for drugs used in times of pandemic or bio attack.
The EMA has joined the FDA in proposing to accept different biosimilar formulations and closures in revised draft guidelines.
The EMA has published draft guidelines on ensuring drug quality when producing APIs in transgenic animals.
The EMA has cleared the Roche oncology blockbuster MabThera after concluding contamination of API bioreactors poses little threat.
DSM saw some improvement for its CMO business in Q1 2012, but says the market will continue to be a challenge.
Amgen has called FDA draft guidance on API-excipient co-crystals unnecessary in its written response to the Agency.
The FDA has said biosimilars can use different drug delivery devices than their reference products in its long-awaited guidance.
EMA OK for second Shire Replagal plant
Shire has received European Medicines Agency (EMA) approval for a new US plant, doubling purification capacity for its Fabry disease drug Replagal.
NeoStem’s China antibiotics unit gets expanded SFDA approval
US stem-cell therapy firm NeoStem predicts that output of its China-based generic antibiotics subsidiary Suzhou Erye Pharmaceutical will increase after further manufacturing approval from the SFDA.
Carbon dioxide may be drug processing 'shortcut,' study
A new study suggests pressurised carbon dioxide can accelerate crystalisation during drug production, and potentially save manufacturers time and money.
Novartis’ ‘smart-pill’ may be ‘watching you’ by 2012
Novartis says it plans to submit its microchip containing ‘smart-pill’ technology to European regulators within 18 months.
FDA cGMP warning letters round up
in-PharmaTechnologist presents a round up of cGMP related warning letters issued by the FDA this week.
Prosonix agrees drug delivery deal for respiratory therapies
Prosonix has entered into an agreement with Trimel Biopharma, in which both companies will combine their respective technologies to deliver improved inhalation performance for respiratory medicines.
Anticancer APIs drive ScinoPharm gains in 2009
Contract manufacturing organization (CMO) ScinoPharm says strong anticancer API sales and growing demand in Europe and Asia were key to record performance in 2009.
Lilly’s Puerto Rico API plant issued with FDA warning letter
The FDA has issued Eli Lilly with a warning letter detailing a significant deviation from cGMP at its API production facility in Puerto Rico, which makes ingredients used in Humalog (insulin lispro), a diabetes treatment.
Cambridge Consultants “invaluable” in deal says Consort Medical
Cambridge Consultants (CC) says experience developing auto-injector technologies was critical to its contract appraisal work during Consort Medical’s £16.8m (€11.5m) takeover of The Medical House (TMH).
Roundtable discusses creating a biogeneric pathway
The challenges in establishing a regulatory pathway for biogenerics were discussed at a recent FTC roundtable, with a FDA official saying in most cases it will be “impossible” to establish that the APIs are identical.
Pharmaceutical manufacturing: news in brief
In-PharmaTechnologist.com brings you a selection of other headlines
from the pharmaceutical manufacturing industry.
Equity firm purchases Reilly and Velsicol
Arsenal Capital Partners has acquired a majority stake in Reilly
Industries for €209 million and Velsicol Chemical for an
undisclosed fee. The purchases continue a rich vein of activity for
the private equity firm, which now hold...