Top Drug Stories

China and India are working to help local manufacturers of active pharmaceutical ingredients satisfy the tough, new quality requirements in the EU’s Falsified Medicines Directive.Read More

The FDA is seeking industry comment on the litany of requirements for submitting BLAs, to gauge how burdensome the requirements are and if they can be streamlined.Read More

An industry effort to protect user fees from sequestration got a major boost Thursday as House leaders vowed to take up the issue in future budget negotiations with the Senate.Read More

The Canadian government has established a new public database of authorized clinical trials.Read More

Sandoz subsidiary Ebewe Pharma has been warned for distributing parenteral drug products to the U.S. that were made using quality control methods not included in an approved application.Read More

The FDA on Wednesday published a list of proposed “qualified pathogens” it believes most endanger the public and might be eligible for qualified infectious disease product designation under the GAIN Act provisions of the FDA Safety and Innovation Act.Read More

The European Parliament’s public health committee May 29 adopted draft rules calling for simplified clinical trial reporting procedures and enhanced authority for European Commission inspections.Read More

The FDA last month handed untitled letters to Sigma-Tau Pharmaceuticals and Validus Pharmaceuticals for downplaying risk information in marketing materials — a problem the agency last week urged consumers to look out for in an educational consumer alert.Read More

In a surprise move late Monday, the Obama Administration said it will make Teva’s Plan B One-Step available for sale over-the-counter without age or point-of-sale restrictions, ending its appeal of New York Federal Judge Edward Korman’s April 5 ruling in Tummino v. Hamburg.Read More

Oxygen Development received a Form 483 for not performing certain key quality control procedures.Read More

Generic drugmaker CorePharma created a successful formula for quality control, prompting the FDA on May 3 to close out the company’s June 2010 warning letter.Read More

The FDA has rejected AVEO’s kidney cancer candidate tivozanib in line with an advisory committee’s recent recommendations.Read More

Google searches, detailed contracts and audits-a-plenty: This is the recipe that one expert industry working group asks drugmakers to follow to guard against illegal drug diversion.Read More

A new study on direct-to-consumer (DTC) marketing of statin drugs suggests the prevalence of such ads promotes over-diagnosis in patients that may not be at risk for cardiac events.Read More

Drugmakers used comments to an FDA draft guidance on formal agency meetings for biosimilars to push for clarity on biosimilar user fees, with one company, Mylan, arguing the fees should be lower than those paid for drugs beholden to PDUFA requirements.Read More

Cardinal Health, which manufactures positron emission topography (PET) drugs at a Tampa, Fla. plant, received a Form 483 for thin investigations into batch failures.Read More

The FDA is considering making more masked and de-identified safety and efficacy data from clinical and preclinical trials available to boost opportunities for innovative drug development.Read More

A conflicted joint FDA advisory committee voted Thursday to ease restrictions on sales of GlaxoSmithKline’s (GSK) diabetes drug Avandia but stopped short of recommending removal of the drug’s strict risk evaluation and mitigation strategy (REMS) program.Read More

Ames Goldsmith is speculating whether to remain an active pharmaceutical ingredient (API) manufacturer after the company received a Form 483 for documentation issues, some of which were repeats.Read More

Merck said May 23 it is shutting down clinical trials of its once-promising Parkinson’s disease drug preladenant, after trial data showed it wasn’t any more effective at treating symptoms than a placebo.Read More

The government must make two-pill variants of Plan B emergency contraception immediately available over the counter to women of all ages, but not one-pill variants, the U.S. Court of Appeals for the 2nd Circuit said June 5.Read More

The same GMPs that finished-dose pharmaceutical companies in Canada are required to follow will soon apply to all active pharmaceutical ingredients (API) used in the country.Read More

A patient death and safety reports of hypersensitivity reactions to AMAG Pharmaceuticals’ flagship iron deficiency drug Rienso has prompted a one-batch recall.Read More

In an effort to reduce the backlog of ANDA supplements, a review team within CDER’s Office of Generic Drugs (OGD) this month will start reviewing all prior-approval supplements for drugs currently on the FDA’s shortages list.Read More

No other federal law requires one party to work as a business partner with its direct competitor, brand drugmaker Prometheus complains in a citizen petition, calling the FDA’s requirement that innovators share a single risk management plan with their generic competitors “unprecedented.”Read More

The FDA issued Shionogi an untitled letter for refusing to conduct a postmarketing study required as part of an NDA approval.Read More

The House on Monday passed legislation establishing a nationwide track-and-trace system for pharmaceuticals, sending the GOP-backed bill to the Senate floor where it awaits Democratic leaders skeptical of its purported benefits.Read More

As part of fulfilling a key user fee commitment, the FDA is asking the White House to approve plans to survey companies that submit applications to the agency to assess the effectiveness of a new drug approvals transparency initiative.Read More

Texas last week became the 12th state to reject legislation pushed by biotech giants Amgen and Genentech restricting the use of biosimilar drugs.Read More

While no additional clinical trials were requested, the FDA has rejected Endo Pharmaceuticals’ NDA for its testosterone-injection drug Aveed for a third time, asking for more information on the drug’s safety profile and the company’s risk-management plan, the company said May 30.Read More

The FDA’s draft plan for implementing standard benefit-risk templates in drug reviews lacks a process for including patient concerns, the National Organization of Rare Diseases (NORD) says.Read More

CDER is seeking public input on identifying and addressing public health concerns related to two timely issues: antibiotic drug development and the use of conversion tables in opioid product labels.Read More

CDER’s office responsible for leading stakeholder negotiations for reauthorization of user fee act commitments is getting a name change; no operations makeover is planned, however.Read More

To improve engagement between the European Medicines Agency (EMA), drugmakers and scientific committees, the agency is putting in motion planned changes discussed late last year.Read More

The FDA has hired two new executives to restructure its Office of Information Technology and address criticism by government auditors that its efforts to integrate its vast IT system have taken far too long.Read More