19-Jul-2012 By Gareth Macdonald
Approval of Qsymia - Vivus’ anti-obesity drug – may be good news for the 35 per cent of US citizens classed as obese, but it is definitely good news for Taiwan-based CMO ScinoPharm.
18-Jul-2012 By Natalie Morrison
API production in India will take a hit this week with plant closures for Aurobindo, Hetero Drugs, Divis Pharmaceuticals, and Sri Krishna Pharmaceuticals following allegations of environmental wrongdoing.
09-Jul-2012
The takeover of peptide-based actives developer Lipotec by industrial chemicals firm Lubrizol will not include the Spanish firm’s pharma business.
02-Jul-2012 By Gareth Macdonald
API maker ScinoPharm is to invest in cancer drug and injectables capacity, citing current global shortages as a driver for its decision.
27-Jun-2012 By Nick Taylor
The FDA has sent contract repackager Shamrock Medical a warning letter for labelling drugs with the wrong strength.
27-Jun-2012 By Natalie Morrison
China-based Suzhou Pharma has set up a US regulatory and QA hub in what it says is a bid to provide Western cGMP (current good manufacturing practice) know-how with low cost Asian production.
18-Jun-2012 By Nick Taylor
The US FDA has posted a closeout letter to an AkzoNobel Mexican API plant seven months after it warned the facility.
14-Jun-2012 By Nick Taylor
The Indian Government must better support modernisation efforts at small businesses to boost GMP compliance, a report found.
11-Jun-2012 By Nick Taylor
Biopharma firms can overcome a hurdle to ending drug shortages by having transparent talks with the FDA, an Agency official said.
07-Jun-2012 By Nick Taylor
The US FDA has sent warning letters to eight biopharma companies for failing to register production facilities.
05-Jun-2012 By Nick Taylor
The EMA has joined the FDA in proposing to accept different biosimilar formulations and closures in revised draft guidelines.
04-Jun-2012
The EMA has published draft guidelines on ensuring drug quality when producing APIs in transgenic animals.
31-May-2012 By Nick Taylor
Hospira has urged the FDA to create a list of critical drugs to limit the subjectivity of its draft guidance on drug shortages.
FDA warns of fake Teva ADHD drug as shortage continues
30-May-2012
The FDA has warned patients about counterfeit versions of a Teva ADHD drug that is on the drug shortage list.
28-May-2012 By Nick Taylor
The EMA has cleared the Roche oncology blockbuster MabThera after concluding contamination of API bioreactors poses little threat.
UPDATE
22-May-2012 By Natalie Morrison
Prosonix says its new ‘smart’ excipient-free drug particles can improve the delivery of inhaled combination therapies.
update
10-May-2012 By Gareth Macdonald
DSM saw some improvement for its CMO business in Q1 2012, but says the market will continue to be a challenge.
FDA approves Merck & Codexis’ Januvia API production process
30-Apr-2012
The FDA has approved a process co-developed by Merck & Co and Codexis for manufacturing the Januvia API, sitagliptin.
30-Apr-2012 By Gareth Macdonald
Penn Pharma has added clinical and commercial packing capacity to cater for recently won European contracts.
Sandoz & Cameroonian biz ally on API supply, cGMP standards
25-Apr-2012
Sandoz is supplying APIs to a Cameroonian generics firm as part of an alliance to raise standards and boost production in sub-Saharan Africa.
23-Apr-2012 By Gareth Macdonald
Indian contract manufacturer Surya Pharmaceutical has received an EDQM Certificate of Suitability (CEP) for an antibiotic API and approval for its Banur plant from Teva.
16-Apr-2012 By Nick Taylor
The EMA has released guidelines extending use of real-time release testing (RTRT) beyond terminally sterilised products.
04-Apr-2012 By Nick Taylor
The FDA has found counterfeits of a Roche oncology drug in US medical practices six weeks after the discovery of fake Avastin.
02-Apr-2012 By Nick Taylor
The FDA will assess industry responses to drug cargo thefts as part of its fight back against crimes in the pharmaceutical supply chain.
28-Mar-2012 By Nick Taylor
The FDA has hit two Mexican companies with GMP warning letters six months after inspectors visited the country.
28-Mar-2012 By Nick Taylor
In the first six months of fiscal 2011 tests of drug samples found 1,420 substandard pharmaceuticals in India.
05-Mar-2012 By Natalie Morrison
Danadams' CEO Yaw Adu Gyamfi will tomorrow meet with the Ghanaian Government urging them to establish a drugs fund which will see more meds manufacturing in the country.
05-Mar-2012 By Nick Taylor
Amgen has called FDA draft guidance on API-excipient co-crystals unnecessary in its written response to the Agency.
29-Feb-2012 By Nick Taylor
The US FDA has sent APP Pharmaceuticals a warning letter after insects were found in production areas and finished products.
22-Feb-2012 By Nick Taylor
The US FDA is allowing Sun Pharma to import a version of Doxil to ease the drug shortage created by manufacturing failings at Ben Venue.
16-Feb-2012 By Nick Taylor
The US FDA has sent West-Ward Pharmaceuticals a warning letter and asked for forewarning of any actions that may worsen drug shortages.
13-Feb-2012 By Nick Taylor
The FDA has said biosimilars can use different drug delivery devices than their reference products in its long-awaited guidance.
06-Feb-2012 By Nick Taylor
A US drug shortages act aims to make drug production more efficient by quickening review of post-approval manufacturing changes.
31-Jan-2012 By Natalie Morrison
Ingredient maker Dishman Pharmaceuticals has confirmed that it may offload its Chinese API (active pharmaceutical ingredients) factory.
26-Jan-2012 By Nick Taylor
Europe is considering forcing API manufacturers to verify the source of starting materials as part of GMP revisions.
17-Jan-2012 By Nick Taylor
J&J has enough Doxil to meet the needs of patients on its waiting list but warned CMO Ben Venue is unlikely to resume supply until late 2012.
12-Jan-2012 By Natalie Morrison
NantWorks has unveiled plans to pump $85.5m into a new oncology and critical care injectables manufacturing plant in Terre Haute, Indiana.
pSivida signs tech evaluation agreement for injectable implant
23-Nov-2011 By Natalie Morrison
pSivida has inked a technology evaluation agreement with an unnamed global pharma over its Durasert drug delivery technology.
Ashland predicts ISP buy will accelerate pharma unit growth
17-Nov-2011 By Nick Taylor
Ashland expects integration of ISP and demand for pharma ingredients to drive “accelerated growth” in the next few years.
Ongoing quality problems at injectables plant hurt Hospira in Q3
19-Oct-2011 By Gareth Macdonald
Hospira says ‘quality actions’ taken to fix problems at key injectable drug manufacturing plant in US reduced its third quarter earnings.
Rusnano and Nearmedic team on nanomedicine manufacturing plant
18-Oct-2011 By Gareth Macdonald
Rusnano and Nearmedic Plus will build a ‘nanomedicine’ production facility in Russia in a collaboration that fits with Government efforts to boost local drug manufacturing.
FDA awards $35m to improve US drug production
05-Oct-2011 By Nick Taylor
The FDA has awarded a $35m (€26m) grant to make US drug production less expensive and reverse the offshoring trend.
DaVita launches FDA advisory committee prep service
29-Sep-2011
DaVita Clinical Research will help sponsors prepare for US FDA advisory committee meetings through a new contract offering introduced this week.
FDA hits Indian API plant with warning letter & import alert
22-Sep-2011 By Nick Taylor
The FDA has issued a warning letter and import alert to an Indian API manufacturer after finding major cGMP failings.
Reformulation targeted in FDA unapproved drug plan
20-Sep-2011 By Nick Taylor
The FDA is targeting companies that reformulate drugs to evade enforcement as it tries to crackdown on the 1000s of products marketed without approval.
Lonza MA plant sent FDA GMP warning letter about Eisai API
14-Sep-2011 By Nick Taylor
The FDA has sent a warning letter to Lonza’s Hopkinton, MA plant after inspectors found faults with how it produces an oncology API for Eisai.
Lonza and Fosun strike up joint venture in Shanghai
12-Sep-2011
Lonza Group and Fosun Pharmaceuticals will pump $15.6m (100m yuan) into a joint venture in the Zhangjiang High-Tech Industry Zone, China.
Aurobindo forms Russian manufacturing JV
08-Sep-2011 By Gareth Macdonald
Contract manufacturing organisation (CMO) Aurobindo Pharma has teamed up with Russian supplement maker OJSC Diod to establish a manufacturing joint-venture.
Onyx Scientific aims for growth in US CMO sector
06-Sep-2011
Ipca Laboratories has added scale to the Phase II support services offered by recent acquisition Onyx Scientific in a bid to build in the US contract manufacturing sector.
USP opens expanded Indian testing lab
05-Sep-2011 By Gareth Macdonald
The US Pharmacopeial Convention (USP) has expanded its quality testing laboratory in Hyderabad in an effort to further strengthen ties with Indian drugmakers and regulators.
