U.S. public health regulators have expanded oversight of drug compounders choosing to register with the U.S. Food and Drug Administration, but the agency will help boost participation despite its voluntary nature by urging hospitals and doctors to work with FDA-registered facilities, FDA officials said Monday.
The Pennsylvania Superior Court said Wednesday that there was no evidence that GlaxoSmithKline PLC had fraudulently concealed information from a woman about the risk of taking its antidepressant drug Paxil while pregnant and agreed that her claims against the drugmaker were barred by a two-year statute of limitations.
A New Jersey judge has dismissed 15 lawsuits over Novartis Pharmaceuticals Corp.’s bone-strengthening drug Zometa, based on a failure to file certain documents intended to show that the cases belonged in the multicounty litigation.
A Massachusetts federal judge on Wednesday rejected AstraZeneca PLC and Ranbaxy Inc.'s bid to dismiss as time-barred certain claims in multidistrict litigation alleging the companies violated antitrust laws by agreeing to delay entry of a generic version of AstraZeneca’s heartburn drug Nexium.
Biosig Instruments Inc. urged the U.S. Supreme Court recently to reject an appeal by Nautilus Inc. in a case over a heart monitor patent, saying that contrary to Nautilus' arguments, the Federal Circuit does not have an overly permissive standard for deciding whether patents are indefinite.
The wife of Google Inc. co-founder Sergey Brin responded Tuesday to a letter from the U.S. Food and Drug Administration that ordered her firm to halt sales of genetic tests, acknowledging the company has been behind schedule on its responses to the regulator, but standing by the tests' veracity.
Troubled Indian drug manufacturer Wockhardt Ltd. found itself on Wednesday in regulatory hot water once again, as the U.S. Food and Drug Administration issued an alert restricting the import of various human and animal drugs from one of its top production facilities.
The Wisconsin Alumni Research Foundation and a consumer group challenging its patent on stem cells recently sparred over whether the group has standing at the Federal Circuit, raising an issue that could limit the ability some patent challengers have to appeal decisions by the U.S. Patent and Trademark Office.
Abbott Laboratories Inc. has been hit with a lawsuit alleging it overcharged the nonprofit AIDS Healthcare Foundation by at least $2 million for Kaletra and Norvir, the HIV drugs it owns and markets.
Novartis Pharmaceuticals Corp. hit Accord Healthcare Inc. with a patent infringement lawsuit in New Jersey federal court on Tuesday, saying Accord asked the U.S. Food and Drug Administration to approve generic versions of Novartis’ bone drug Zometa prior to the expiration of a patent that protects it.
The U.S. Trade Representative's office said Wednesday it will seek a “flexible” approach to pharmaceutical intellectual property provisions in the Trans-Pacific Partnership, attempting to allow access to lifesaving medicine while also retaining incentives for new drugs to be developed.
A Staten Island man recently hit Rite Aid Corp. with a proposed class action in New York federal court, alleging the pharmacy chain falsely advertises that its store-brand glucosamine and chondroitin supplements can ease arthritis symptoms, despite overwhelming scientific evidence to the contrary.
Drugstore chain CVS Caremark Corp. will put up $2.1 billion for the private equity-backed infusion unit of Apria Healthcare Group Inc. in a move that will help flesh out its specialty pharmacy offerings and drive new growth, CVS said Wednesday.
South Korea-based biotherapeutics and contract research company SillaJen Inc. will acquire San Francisco clinical-stage biotechnology firm Jennerex Inc. for about $150 million, SillaJen said Tuesday, in a merger that would bring together two companies that have previously partnered in the quest against cancer.
The fate of the Affordable Care Act’s contraception mandate now rests with the U.S. Supreme Court, but access to birth control could end up a mere subplot if the justices hand down a sweeping decision recognizing corporate religious rights, something that could weaken federal laws and build on the landmark Citizens United decision, experts say.
A New Jersey federal judge on Tuesday declined to split into two phases any such trial in Depomed Inc.’s suit alleging Purdue Pharma LP's pain reliever OxyContin infringed on three of its patents for extended-release drug technology, saying bifurcation isn’t warranted.
A California federal judge sanctioned dental implant company Implant Direct Mfg. LLC for destroying evidence in rival Zest IP Holdings LLC's patent infringement case, saying Monday that he would warn the jury about missing emails and order Implant Direct to pay Zest's attorneys' fees.
Public policy groups warned the Ninth Circuit Friday that a California state law requiring drugmakers to pay for the environmentally safe disposal of unused drugs could force jurisdictions to foot cleanup costs for other communities.
The widow of a Bristol-Myers Squibb Co. employee filed a putative class action against the company Tuesday, accusing it of taking out a $6 million insurance policy against her husband without his knowledge or consent.
The European Medicines Agency and Pfizer Ltd., Novartis Pharma AG and other drugmakers joined an initiative Tuesday designed to create a continentwide framework for assessing the benefits and drawbacks of vaccines after they have been approved for use.
It has been 20 years in the making, but a new regulatory scheme is quickly moving into force, which may impact the development of, and intellectual property rights surrounding, an array of products, including pharmaceuticals, biotech products, agricultural products, nutritionals, supplements, cosmetics, perfumes and fragrances and industrial enzymes, says Bruce Manheim of WilmerHale.
As health care companies contemplate how to best leverage text messaging, information security should remain a key focus in light of recent upticks in mobile device data breaches and a concomitant rise in Health Insurance Portability and Accountability Act enforcement, say Alaap Shah and Ali Lakhani of Epstein Becker Green PC.
In light of the recent trial against MicroAire Surgical Instruments LLC, which had purchased assets from Coapt Systems, it is recommended that practitioners defending a claim of alter ego and/or successor liability strongly consider a bench trial on these issues as a means of resolving the case early, says Frederick Ufkes of Hinshaw & Culbertson LLP.
As recent decisions dismissing Avandia class actions highlight, defendants should be familiar with the essential elements of consumer class actions involving pharmaceuticals, such as the requirements for a plaintiff to state a cognizable claim and what is and is not considered as having alleged causation, says Jessica Rickabaugh of Pepper Hamilton LLP.
Among 10 battle-proven strategies for getting your witnesses ready for trial is to role-play the cross-examiner. For instance, if you expect the cross-examiner to yell, get in the witness’ face or use scathing sarcasm, do that during practice to minimize surprises at trial, say Dawn Solowey and Lynn Kappelman of Seyfarth Shaw LLP.
While physician interaction was no doubt subject to considerable company oversight before, the Indiana Court of Appeals' recent decision in Medtronic Inc. v. Malander provides additional incentive for device and pharmaceutical companies to erect appropriate safeguards, say Andrew Campbell and Joseph Winebrenner of Faegre Baker Daniels LLP.
Recent events, from the Westgate Mall attack in Nairobi to the Lac-Mégantic train derailment in Quebec, underscore the need for in-house counsel to keenly weigh risks and benefits for their companies doing business on a multinational scale. There are a number of best practices to consider that set the right tone for mitigating risk, whether you are doing business in one or hundreds of locations around the world, says Veta Richardson, president and CEO of the Association of Corporate Counsel.
The U.S. Supreme Court recently acted on two False Claims Act cases with pending petitions for certiorari, calling for the views of the solicitor general. If the court grants the petition in the KBR Inc. case, that would be good news for potential FCA defendants, but a review by the court of the Takeda Pharmaceuticals North America Inc. case could be bad news for potential defendants, say Dave Nadler and Joseph Berger of Dickstein Shapiro LLP.
Because those who purchase misbranded medications can be subject to criminal fines and imprisonment, physicians need to watch for the red flags these medications carry, such as product packaging and handling, say Yvonne McKenzie and Colleen Kelly of Pepper Hamilton LLP.
The general lack of state regulation regarding urgent care is likely a direct result of urgent care’s historical outgrowth of the physician practice. However, as the urgent care model continues to evolve and proliferate, and strategic buyers continue to vertically integrate with urgent care facilities as a cost containment mechanism, there is likely to be an uptick in regulation, say attorneys with McGuireWoods LLP.