The U.S. Food and Drug Administration in a letter released Thursday rejected Amgen Inc.’s request that biosimilars makers be forced to share their applications and manufacturing processes with competitors, exacerbating the company’s recent defeat in litigation with Sandoz Inc.
FedEx Corp. on Wednesday urged a California federal judge to kick an indictment accusing it of helping illegal online pharmacies ship generic versions of Valium, Xanax and other drugs, arguing it was shielded from trafficking and conspiracy charges because it was a common carrier.
Walgreen Co., The Kroger Co., Safeway Inc. and other grocery chains on Wednesday filed a joint complaint against Teva Pharmaceuticals USA Inc. and Boehringer Ingelheim Pharmaceuticals Inc. in Pennsylvania federal court over an alleged $120 million pay-for-delay deal for a generic version of stroke drug Aggrenox.
The Eleventh Circuit on Wednesday upheld a lower court’s dismissal of claims against the former chief financial officer of Chinese drugmaker Jiangbo Pharmaceuticals Inc. and a former auditing firm for the company from a securities class action, finding the plaintiffs’ theory of fraud was too vague.
ZS Pharma Inc., a biopharmaceutical company developing treatments for renal, cardiovascular and liver metabolic disorders, announced an upsized public offering on Tuesday that could fetch up to $213.6 million, joining the wave of biopharmaceuticals tapping the public markets.
Ariad Pharmaceuticals Inc. beat a securities fraud action Wednesday after a Boston federal judge said allegations that the company and four officers hid evidence suggesting a promising leukemia drug would fail were insufficient despite a "cogent argument" from investor-plaintiffs that defendants including CEO Harvey Berger engaged in insider trading.
Utah is close to approving legislation that would prevent contact lens manufacturers from entering into agreements that restrict the price retailers may charge for their products, a controversial issue that has embroiled the industry in a wave of antitrust litigation.
Alps South LLC has urged the Federal Circuit to affirm a finding that Ohio Willow Wood Co. engaged in inequitable conduct during re-examination of a prosthetic patent and asked it to hold Ohio Willow liable for even more misconduct.
A federal judge pared a suit Tuesday alleging Kilpatrick Townsend & Stockton LLP helped a client steal confidential information about a medication-dispensing device and excluded its inventors from the patent application, tossing conspiracy and fraudulent concealment claims but keeping the fraud and negligence claims in play.
A Massachusetts-based life sciences company was ordered Wednesday to pay $17.9 million to the U.S. Securities and Exchange Commission in a lawsuit accusing the company of selling investors millions of dollars' worth of stock by falsely suggesting that its products would soon secure the necessary regulatory approvals.
Faegre Baker Daniels has recruited nine partners from four firms to bolster its investment management, intellectual property, product liability and employment practices, as part of a broader strategy to expand in Chicago, the firm said Tuesday.
France-listed Cellectis SA beat expectations in its U.S. debut led by Jones Day, raising $228 million in an upsized initial public offering before listing Wednesday on the Nasdaq alongside the growing number of biopharmaceutical companies developing immunotherapy treatments for cancer.
Otsuka Pharmaceutical Co. slammed the U.S. Food and Drug Administration Tuesday for expanding the scope of its antipsychotic drug Abilify to treat Tourette's syndrome in patients of all ages rather than only in children, calling it a ploy to admit generic versions when the company's patent expires next month.
A Pennsylvania federal judge on Monday refused to certify a proposed class action accusing drugmaker Cephalon Inc. of unjustly enriching itself by marketing a painkiller for off-label uses, ruling the plaintiffs failed to show that a class action was the best way to resolve their claims.
A dietary supplement company on Tuesday accused an agency for Pittsburgh Steelers wide receiver Antonio Brown of inducing the NFL star to breach an endorsement deal he signed in November by inking a new agreement with a competitor.
Cellectis SA boosted the target for its U.S. initial public offering to nearly $200 million Tuesday, increasing the number of American depositary shares it plans to sell as the France-listed company’s common stock climbs on the Paris Euronext and U.S.-listed cancer immunotherapy treatment developers' shares rally.
Venture capital-backed Blueprint Medicines Corp., led by a Goodwin Procter LLP team, filed Monday to raise $100 million in an initial public offering, making it the latest biopharmaceutical working toward a breakthrough in cancer treatments to plan a Nasdaq listing.
Bristol-Myers Squibb Co. announced on Tuesday that it has acquired an autoimmune disease research program from Denmark-based Novo Nordisk AS for an undisclosed amount.
The Third Circuit declined Monday to rehear en banc a whistleblower's case accusing Express Scripts Inc. and various pharmacies, retailers and drug wholesalers of violating the False Claims Act by overbilling the federal government for prescription drugs.
A pharmaceutical industry group on Tuesday told a D.C. Circuit panel to toss a Federal Trade Commission rule requiring disclosure of more exclusive patent licenses for approval under federal merger law, saying the law does not allow the agency to target a particular industry.
A festering but virtually unnoticed circuit split over a legal doctrine the U.S. Supreme Court first recognized early last century may provide the Roberts court with the opportunity to grant corporate persons privilege against self-incrimination for the first time in U.S. history, says Ramzi Abadou of Kahn Swick & Foti LLP.
What will spring bring for the Judicial Panel on Multidistrict Litigation? Will it continue to close the door on new MDL proceedings? Will it decide to throw the baby out with the bathwater and decline to create a baby wipe MDL? asks Alan Rothman of Kaye Scholer LLP.
As just the latest in a series of companies facing additional scrutiny from U.S. regulators following the settlement of an enforcement action involving violations of the Foreign Corrupt Practices Act, Biomet Inc.’s current plight highlights the risks of continuing reporting and disclosure obligations contained in most deferred and nonprosecution agreements, say Amy Riella and Carla Jordan-Detamore of Vinson & Elkins LLP.
A California federal court's recent ruling in Amgen Inc. v. Sandoz Inc. is the first to interpret two key provisions of the Biologics Price Competition and Innovation Act and, if upheld on appeal, will have a tremendous impact on the patent litigation strategies of both reference product sponsors and biosimilar applicants going forward, say attorneys with Cantor Colburn LLP.
A Texas federal court's recent decision in U.S. v. Solvay SA curtails whistleblowers’ ability to bring successful False Claims Act claims by expanding the scope of the public disclosure bar and the parameters of voluntary disclosure, says Allyson Singel Aldous of Buchanan Ingersoll & Rooney PC.
A spate of recent multimillion-dollar settlements has shown that medical device manufacturers are subject to substantial liability under the False Claims Act if they misstate the country of origin of their products in violation of the Trade Agreements Act, say attorneys with Reed Smith LLP.
Practitioners should take note of the New Jersey Supreme Court's recent decision in Townsend v. Pierre when seeking to exclude expert testimony that is based on factual scenarios that have no support in the record, says Timothy Freeman of Sedgwick LLP.
In recent litigations, biosimilar applicants who have sought to circumvent the Biologics Price Competition and Innovation Act have been unsuccessful in their efforts to obtain early resolution of their patent disputes in district court. Thus, biosimilar applicants will increasingly look to post-grant patent challenges as a mechanism for obtaining early and fast patent certainty, say Paul Calvo and Eldora Ellison of Sterne Kessler G... (continued)
From an economic perspective, there are three guiding questions that can be useful for companies facing litigation related to off-label promotion claims, say Dr. Sophie Yang and Dr. Saul Helman of Navigant Consulting Inc.
The U.S. Supreme Court's recent decision in Teva Pharmaceuticals USA Inc. v. Sandoz Inc. will likely induce patent litigators to raise factual disputes regarding the meaning of patent terms not only to get the benefit of the deferential standard of review, but also to decrease the chances of appeal on a ruling on this issue, says Mini Kapoor of Haynes and Boone LLP.