Sanofi's ImmuCyst available in next year, Alliance Pharma says
A bladder cancer drug that has been in short supply after FDA inspectors cited a Sanofi plant in Canada for mold problems will be available again in the second half of next year.
Hikma New Jersey plant back in production
Hikma is getting quality issues at a plant in New Jersey under control, reintroducing products and paying for the work by riding an unexpected surge in sales tied to a shortage of the antibacterial drug doxycycline.
Impax to get new CEO as it tries to right manufacturing issues
A team of outside experts has been taking steps to help Impax Laboratories get back on track after manufacturing issues sidetracked a key drug application and a key partnership with GlaxoSmithKline.
U.S. gets EU waiver on APIs in the nick of time
U.S. API makers couldn't imagine that the European Commission would not give them a pass on the new rule for proving that their manufacturing is equal to standards in Europe. But it took almost up to the last minute for regulators to acknowledge it.
Supply chain issues slow distribution of anticipated Biogen Idec MS drug
Most drug shortages are the result of quality issues tied to manufacturing problems, but once in awhile it is the result of demand overwhelming supply.
U.K. relents on July deadline for API certifications
The U.K. has acknowledged what drugmakers have been warning of for months: There could be a shortage of ingredients if it doesn't give a little on the European Union's July 2 deadline for requiring imported APIs be certified as meeting EU standards.
FedEx vows not to settle with feds on online pharmacy shipments
In April, UPS agreed to pay $40 million to U.S. authorities and admitted doing business with illegal online pharmacies in a deal that kept it from being prosecuted. Competitor FedEx is also a target of the investigation but does not intend to roll over so easily.
Australia packager gets FDA warning letter
A warning letter has been issued to Contract Pharmaceutical Services of Australia, which does drug packaging at a plant in the Sydney suburb of New Ryde.
J&J manufacturing problems lead to contraceptive recall in 43 countries
Already facing a criminal probe in South Korea over problems with its Janssen over-the-counter plant there, as well as issues in India and Brazil, it is now recalling 32 million boxes of its Cilest birth control pills because of solubility issues.
Track-and-trace taking shape in U.S.
The industry is headed toward some form of track-and-trace in the U.S. but what shape it will take and whether it will get to the unit level is the question on everyone's mind. A bill advancing in the U.S. Senate would make that happen sooner than later, but the U.S. House has pushed through a proposal that would put off that level of drug monitoring for more than a decade.