"The consumer healthcare market has experienced a steady stream of mergers and acquisitions in recent years. Some of this has created small ripples — like pebbles being gently tossed into still waters. Then there are the mega-mergers that have had a tsunami-like effect," writes Dave Wendland, Hamacher Resource Group VP, in his latest blog entry.
The Food and Drug Administration will be hosting an all-day hearing on Sept. 17 seeking public comment on five draft guidance documents related to the implementation of the Generic Drug User Fee Amendments of 2012, as well as input on future policy priorities.
The European Union is leading an international pilot project through which, upon request from a generic pharmaceutical company, it will share the assessment reports generated as part of the decentralized procedure in real time with collaborating regulatory agencies outside the EU.
Mylan on Thursday announced that the U.S. District Court for the district of New Jersey granted its motion for a permanent injunction against GlaxoSmithKline in relation to paroxetine CR, the generic version of GSK's Paxil CR.
RetireSafe, a grassroots organization advocating on behalf of America’s seniors on Tuesday released a survey finding that seniors overwhelmingly support strong patient safeguards for biosimilar medications.
Current programs to dispose of unused medicines in the home are sufficient, argued representatives of industry in appealing a provision put into place by a San Francisco-area county that would place the burden of recapturing these medicines on the manufacturer.
As lifetime earnings for pharmaceuticals decrease, commercialization expenses increase and payers tighten their belts on reimbursement, life science companies will be faced with shrinking margins over the next few years. In order to maintain basic operating margin levels and continue investing in research and development at current levels, life science manufacturers will be forced to reduce costs by more than $35 billion by 2017, according to results from a new survey of 70 life science organizations from the IMS Institute for Healthcare Informatics.
Roche on Wednesday announced that Genentech, a member of the Roche Group, has entered into a definitive agreement to acquire Seragon Pharmaceuticals, a privately held biotechnology company based in San Diego.
The Food and Drug Administration on Tuesday issued several policy documents regarding compounding as part of the agency’s continuing effort to implement the compounding provisions of the Drug Quality and Security Act enacted in November 2013.
America’s biopharmaceutical research companies are developing 435 innovative new medicines to target 15 leading chronic conditions affecting the Medicare population, according to a new report released by the Pharmaceutical Research and Manufacturers of America last week.
Actavis confirmed that the U.S. District Court for the District of Delaware found certain claims of U.S. Patent Nos. 6,335,031 and 6,316,023 valid and infringed by the company's rivastigmine transdermal system, a generic version of Exelon Patch from Novartis.
Canada’s Federal Court ruled recently that the country’s Patented Medicine Prices Review Board — a federal tribunal that regulates pricing on branded medicines — could not extend price-control measures to cover generic drug companies, according to published reports.
A survey co-released on Wednesday by the Generic Pharmaceutical Association and the National Coalition on Healthcare reveals that the healthcare providers patients rely on most to explain safety information about their prescription drugs have serious concerns about a proposed FDA rule on generic drug labeling.
A survey co-released Wednesday by the Generic Pharmaceutical Association and the National Coalition on Healthcare reveals that 8-in-10 healthcare providers have serious concerns about a proposed Food and Drug Administration rule on generic drug labeling.