Insurers suing GlaxoSmithKline over adulterated drugs from a now-defunct Puerto Rican factory said Tuesday a recent Third Circuit case that gave union health funds the ability to sue the drugmaker under the Racketeer Influenced and Corrupt Organizations Act supports their ability to bring similar claims.
Investors suing KaloBios, which hit Chapter 11 weeks after its ousted CEO Martin Shkreli was charged with securities fraud, have taken aim at the embattled and bankrupt drug developer’s employee bonus plan, arguing it’s unnecessary for a company with uncertain prospects for any future revenues.
A New Jersey federal judge on Wednesday released Nymox Pharmaceutical Corp. and its founder from a class action securities suit, concluding that shareholders failed to demonstrate a purposeful scheme to misrepresent the prospects of a prostate drug when trials showed the medication was doomed to fail.
Mylan announced on Wednesday that it has agreed to acquire Swedish drug company Meda AB in a $9.9 billion cash-and-stock deal guided by Cravath Swaine & Moore LLP, three months after it ditched a hostile takeover attempt of fellow generic-drug maker Perrigo.
Steptoe & Johnson LLP said Wednesday it has strengthened its national intellectual property group and life sciences capabilities with the hire of an intellectual property partner in New York who comes from Ropes & Gray LLP.
Smartphone makers remain irresistible targets for patent litigation plaintiffs, with Samsung and Apple topping Law360's list of frequently named defendants in patent lawsuits filed in 2015. But increasingly ferocious intellectual property battles over generic drugs mean industry giants like Mylan Pharmaceuticals are starting to give smartphone makers some competition for that dubious honor.
U.K. drugmaker Hikma said Wednesday it has slashed nearly 20 percent from its $2.7 billion offer to buy Boehringer’s U.S. generics business, after discovering the unit's 2015 revenue would be lower than expected.
Generic-drug maker Mylan Pharmaceuticals Inc. has urged the Third Circuit to resurrect its suit against Warner Chilcott PLC for allegedly tweaking the formula of its acne medication Doryx in order to block generic competition, saying Warner's defenses "amount to a call to abandon all antitrust review of product changes."
Private equity-backed food distributor US Foods and two life sciences companies are planning to go public in the U.S., venturing into a volatile market that has recently seen some companies nix their initial public offering plans, according to regulatory documents filed Tuesday and Wednesday.
Hundreds of Massachusetts and Mississippi cases are eligible to join multidistrict litigation against Fresenius over GranuFlo's and NaturaLyte's alleged side effects, because there was no proof patients or their physicians knew about a 2012 FDA warning about the dialysis drugs, a court was told Wednesday.
A Philadelphia jury returned a $13.5 million verdict against a Johnson & Johnson unit on Wednesday in a case over allegations that the company’s faulty pelvic mesh implants left a woman with near constant pain and discomfort and an inability to have sex.
An Oklahoma federal judge has ended a man’s lawsuit accusing medical device maker Corin of skirting federal regulations and defectively designing a metal-on-metal hip implant system that led directly to his injuries, finding that he simply lacked any proof to support his negligence claims.
The U.S. Food and Drug Administration on Tuesday said that it is seeking a $5.1 billion budget for 2017, including $211 million to fund the implementation of sweeping new food safety laws and $41.2 million to improve medical product safety.
The Third Circuit on Tuesday dismissed Hagens Berman Sobol Shapiro LLP’s appeal of sanctions imposed on it by a district court judge for litigating three time-barred thalidomide birth-defect suits against Grunenthal GmbH, saying it lacked jurisdiction to hear the matter because related claims are still pending in the lower court.
The U.S. Food and Drug Administration set its sights on companies selling cannabis products that claim they relieve medical symptoms such as nausea and inflammation and can treat serious conditions including diabetes and schizophrenia. The agency also targeted an animal feed manufacturer in Florida and a seafood company in Queens, New York, whose frozen fish imports were allegedly contaminated.
After a grueling debate, an independent panel on Tuesday advised the U.S. Food and Drug Administration to approve Celltrion’s copy of Janssen Biotech’s blockbuster immunosuppressant Remicade, the latest step forward for the emerging biosimilars industry.
A Pennsylvania federal judge Monday ruled that direct purchasers of Suboxone who accuse manufacturer Indivior of engaging in a product-hopping scheme to stifle generic competition of the opiate addiction treatment need not turn over information about resales of the drug until a decision on the issue is reached.
A Philadelphia jury will begin deliberating Wednesday whether a Johnson & Johnson unit could be held liable for a New Jersey woman's pain and inability to have sexual intercourse, in the second case to be tried in the jurisdiction's mass tort program for pelvic mesh implants.
Two biotechs nixed stock offerings totaling $155 million on Monday, including an estimated $86 million initial public offering by rare-disease treatment developer Apellis Pharmaceuticals Inc., providing fresh evidence that issuers are skittish to tap volatile public markets.
The U.S. Senate Committee on Health Education, Labor and Pensions on Tuesday approved seven medical innovation bills, the first step in its piecemeal approach to its version of the 21st Century Cures Act, but most debate focused on whether or not the approach was appropriate.
Companies — and their investors — continue to face a myriad of risks associated with uncertainty over future regulatory developments concerning the marijuana industry. As large states like California and Ohio prepare for legalization initiatives, however, the trend toward increasing liberalization and associated comfort levels of investors seems likely to continue, say John Bessonette and Tai Aliya of Kramer Levin Naftalis & Frankel LLP.
Analyzing the reasons why clients choose certain firms reveals a great deal about what is important and valued in the marketplace. Based on interviews with a random sample of over 600 heads of legal in the largest U.S. organizations, Elizabeth Duffy, vice president of Acritas US Inc., identifies the core brand drivers of Skadden Arps Slate Meagher & Flom LLP.
In a recent Law360 article it was suggested that promotion to partner was a competition between associates and that taking maternity, paternity or family medical leave could impact an associate's chances at promotion. But this sort of ethos — which may have contributed to law firms’ success in the past — is not the best way to secure the industry's future, says Daniel Butcher, managing partner of Strasburger & Price LLP.
Certain actions, like off-label promotion, and violations of broad health care laws, like the Sunshine Act, can make life sciences companies and individuals targets of government enforcement action — but there are steps companies can take to minimize this risk, say attorneys at Wilson Sonsini Goodrich & Rosati PC.
Evanston Insurance v. Gene By Gene Ltd. in Texas district court addresses a new twist on an insurer's Telephone Consumer Protection Act exclusion, in effect limiting it to underlying marketing claims involving junk faxes or spam email. Some might herald this decision as a judicial scaling back of the exclusion, but such proclamations would be premature, says Joshua Mooney at White and Williams LLP.
During the drafting process leading to the recent Federal Rules amendments, some participants expressed concern that the relocation of the proportionality provisions might be interpreted as placing a burden on the requesting party to demonstrate the proportionality of the discovery it seeks. A California federal court's recent decision in Gilead v. Merck indicates that these concerns may indeed come to fruition, says Henry Kelston of Milberg LLP.
After more than 50 structured conversations with health care private equity and investment banking professionals at the recent J.P. Morgan health care conference, we can conclude that there is a deep — almost ubiquitous — interest in finding and structuring the next provider services consolidation, say attorneys with McGuireWoods LLP.
In order to balance the competing priorities of developing new and innovative interoperable medical devices and protecting patient safety and privacy laid out in its recent guidance, the U.S. Food and Drug Administration should conduct a fact-based technical analysis to assess the costs and potential burdens for medical device manufacturers and others in the health information technology marketplace, say attorneys at Mayer Brown LLP.
The Bipartisan Budget Act of 2015 poses an unexpected threat to the 340B Drug Pricing Program — even though it doesn't even mention the program — as it changes the way new off-campus hospital outpatient departments are paid, which could have a substantial impact on 340B Program child site eligibility. But covered entities shouldn't throw in the towel just yet, say Alyce Katayama and Elizabeth Gebarski at Quarles & Brady LLP.
The U.S. Food and Drug Administration’s most recent draft guidance on postmarket cybersecurity for medical devices may be "nonbinding" but it is clear that the FDA will at some point start policing and enforcing cybersecurity issues in marketed medical devices, so pharmaceutical companies should be on their guard, say Elaine Tseng and Alexander Haas at King & Spalding LLP.