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Generics
US specialty pharma firm Egalet says it has reached an agreement with Purdue Pharma as it relates to alleged patent infringements against Egalet and product licensor Acura Pharmaceuticals for Oxaydo (oxycodone HCl, USP) tablets CII. 23 May 2016
Biotechnology
Japanese drugmaker Chugai Pharmaceutical has revealed that a lawsuit was filed against the company at the Tokyo District Court by US biotechnology firm Baxalta. 12 May 2016
Pharmaceutical
US authorities are investigating the contracts between a number of drugmakers and companies that manage prescription benefits. 11 May 2016
Pharmaceutical
In our weekly expert view piece Dr Nick Meyers, programme director at Boyd Consultants examines the implications what the regulatory and legislative landscape in the biopharmaceutical industry could look like post-Brexit. 10 May 2016
Pharmaceutical
Canada’s Valeant Pharmaceuticals International has formed a new Patient Access and Pricing Committee that will be responsible for the pricing of the company's drugs. 6 May 2016
Pharmaceutical
The US Department of Justice revealed yesterday that pharma giant Pfizer and its legacy company Wyeth have agreed to pay $784.6 million to resolve allegations that Wyeth knowingly reported to the government false and fraudulent prices on two of its proton pump inhibitor (PPI) drugs, Protonix (pantoprazole) Oral and Protonix IV. 28 April 2016
Generics
The landscape of patent litigation related to Abbreviated New Drug Applications (ANDAs) submitted to the Food and Drug Administration under the Hatch-Waxman Act is reviewed by Lex Machina, a LexisNexis company, its second Hatch-Waxman/ANDA Report. 27 April 2016
Pharmaceutical
New European Union rules to help companies win legal redress against theft or misuse of their trade secrets were voted by Parliament today (April 14). 14 April 2016
Pharmaceutical
The USA’s Physicians Payment Sunshine Act, proposed in 2010 and started in 2013, was created to make the financial relationship between health care providers and the pharmaceutical industry more transparent. 14 April 2016
Pharmaceutical
According to media reports this morning, the US Senate Committee on Aging may soon start contempt proceedings against Canadian drugmaker Valeant Pharmaceuticals International's (TSX: VRX) Michael Pearson. 11 April 2016
Biosimilars
South Korean drug developer Samsung Bioepis is mounting a legal challenge to patents held by US pharma AbbVie on Humira (adalimumab) for rheumatoid arthritis – the world’s best-selling drug. 5 April 2016
Pharmaceutical
The move to limit tax inversions by the US government has wiped $20 billion off the share price of Ireland-incorporated Allergan, which broadly equates to the tax benefit arising from US pharma giant Pfizer merging with Allergan. 5 April 2016
Biotechnology
MorphoSys has filed a complaint at the US District Court of Delaware against Genmab and its collaboration partner Janssen Biotech, for patent infringement under US patent no 8,263,746 based on activities relating to manufacture, use and sale of Darzalex (daratumumab) in the USA. 5 April 2016
Pharmaceutical
Stronger enforcement is needed to deter pharmaceutical manufacturers from continuing to break the law and defraud federal and state health programs, according to a report from US consumer advocacy group Public Citizen released last week. 4 April 2016
Generics
The Federal Trade Commission has approved a modified final order settling charges that Jordon-headquartered Hikma Pharmaceuticals’ acquisition of the rights to various drug products and related assets from Ben Venue Laboratories was anticompetitive. 1 April 2016
Pharmaceutical
A cease-trade order has been issued to the directors and key officers of Valeant Pharmaceuticals after the company failed to file its annual financial statements on time, it has emerged. 1 April 2016
Generics
The US Generic Pharmaceutical Association (GPhA) and America’s Health Insurance Plans (AHIP) have filed an amicus brief urging the Supreme Court to preserve the inter partes review (IPR) process in promoting a competitive prescription drug market for consumers. 1 April 2016
Generics
US drugmaker Endo International saw its shares fall 6.7% to $26.54 in early trading on Thursday, after the USA’s competition regulator sued the company for violating antitrust regulations. 31 March 2016
Pharmaceutical
Pfizer and Ireland-incorporated Allergan have received a request for additional information from the US Federal Trade Commission with respect to their pending combination. 31 March 2016
Pharmaceutical
Shire said Tuesday that the US District Court for Southern Florida has upheld its patent for Lialda (mesalamine), and the company has prevailed in its litigation against Watson Pharma and Watson Laboratories. 29 March 2016
Biotechnology
India’s Sun Pharma has been blocked in its efforts to launch its JAK inhibitor Leqselvi (deuruxolitinib) in the USA. 6 November 2024
article
The European Union's antitrust enforcer hit Israeli drugmaker Teva Pharmaceutical Industries (NYSE: TEVA) with a 463 million-euro ($502 million) fine Thursday for launching a smear campaign against a rival multiple sclerosis drug and misusing the patent system to thwart the competitor's attempt to entering the market. 31 October 2024
Biotechnology
UK pharma major GSK has sued USA-based Moderna this week, accusing the latter of violating patents protecting GSK’s COVID-19 vaccine. 16 October 2024
Generics
Two US units of Israel’s Teva Pharmaceutical Industries have agreed to pay $450 million to resolve two matters that allege Teva violated the Anti-Kickback Statute (AKS) and the False Claims Act (FCA), the US Department of Justice (DoJ) announced yesterday. 11 October 2024
Pharmaceutical
GSK has reached a settlement with 10 plaintiff firms, resolving 93% of the Zantac (ranitidine) product liability cases it faced in state courts across the USA. 10 October 2024
Pharmaceutical
Cardiopulmonary diseases specialist Liquidia Corporation closed Monday’s trading 11% higher following a favorable court ruling. 8 October 2024
Generics
Novo Nordisk has reached a settlement with Mylan Pharmaceuticals, now part of Viatris, putting an end to a US patent lawsuit over blockbuster diabetes treatment Ozempic (semaglutide). 8 October 2024
Pharmaceutical
Texas Attorney General Ken Paxton has filed a lawsuit against major pharmaceutical companies, including Eli Lilly (NYSE: LLY), alleging a conspiracy to artificially inflate the prices of insulin by up to 1,000%. 7 October 2024
Biotechnology
Bristol Myers Squibb has scored a major legal victory as a judge in New York dismissed a $6.4 billion lawsuit related to its acquisition of cancer company Celgene. 5 October 2024
Pharmaceutical
The US Department of Health and Human Services (HHS) has released final guidance for the second cycle of Medicare drug price negotiations. 3 October 2024
Pharmaceutical
Texas-based Cassava Sciences was trading 13% lower in Friday’s pre-market trading. 27 September 2024
Pharmaceutical
The Pharmaceutical Research and Manufacturers of America (PhRMA) is continuing its legal challenge against the US government’s drug pricing reforms. 24 September 2024
Pharmaceutical
On Friday, the USA’s Federal Trade Commission (FTC) brought action against the three largest prescription drug benefit managers (PBMs) - Caremark Rx, Express Scripts (ESI), and OptumRx 23 September 2024
Pharmaceutical
In a lawsuit filed in federal court in Missouri, USA, Health insurer Cigna (NYSE: CI) and its pharmacy benefit manager (PBM) Express Scripts demanded that the Federal Trade Commission (FTC) retract its July 2024 report. 18 September 2024
Generics
Several pharma companies that had moved the Delhi High Court against the government’s recent notification banning 156 fixed-dose combination (FDC) drugs have got a breather. 10 September 2024
Generics
Glenmark Pharmaceuticals has agreed to pay $25 million, based on its ability to pay, to resolve its alleged liability under the False Claims Act for conspiring to fix the price of a generic drug, the US Department of Justice announced. 5 September 2024
Generics
German pharma major Bayer has filed a lawsuit against the Russian drugmaker Promomed to protect the patent rights for Xarelto (rivaroxaban), its treatment for stroke prevention which is the best-selling drug in the Russian market at present, The Pharma Letter’s local correspondent reports. 2 September 2024
Biosimilars
Regeneron Pharmaceuticals has filed a lawsuit against Sandoz, alleging that its biosimilar to Eylea (aflibercept) infringes certain patents. 29 August 2024
Pharmaceutical
Ireland-headquartered Avadel Pharmaceuticals has updated on litigation with USA-based Jazz Pharmaceuticals. 29 August 2024
Pharmaceutical
Liquidia Corporation announced Thursday that it has filed litigation in the US District Court of the District of Columbia (Case No. 1:24-cv-02428) that challenges the recent decision by the US Food and Drug Administration (FDA) to grant three-year new clinical investigation (NCI) exclusivity to Tyvaso (treprostinil) DPI.9.6. 23 August 2024
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