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
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
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
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
Regeneron Pharmaceuticals has filed a lawsuit against Sandoz, alleging that its biosimilar to Eylea (aflibercept) infringes certain patents. 29 August 2024
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
Ardelyx has filed a lawsuit against the US Department of Health and Human Services DHSS) and the Centers for Medicare and Medicaid Services (CMS), regarding its Xpohzah. 19 July 2024
India's Zydus Lifesciences has been barred by the Delhi High Court from selling its breast cancer drug, Sigrima, a biosimilar version of Roche's pertuzumab (brand name Perjeta). 12 July 2024
Efforts to end US business deals with certain foreign biotechs considered threats are gaining traction again, with House Speaker Mike Johnson stating his intention to hold a vote on the BIOSECURE act this year. 11 July 2024
Viatris has announced that the antitrust division of the US Department of Justice (DOJ) has concluded its investigation into Mylan and its former president, Rajiv Malik. 3 July 2024
pharma.be, the umbrella organization of innovative biopharma companies active in Belgium, has highlighted the publication of the Transparency Register 2023. 1 July 2024
The European Commission (EC) has accused privately-held API manufacturer Alchem International of breaching European Union antitrust rules by participating in a long-lasting cartel concerning an important pharmaceutical product. 14 June 2024
A New Jersey, USA, federal judge has ruled that five patents covering Israel-based Teva Pharmaceutical Industries-brand asthma inhalers were improperly listed in the Food and Drug Administration’s (FDA) Orange Book, in a win for US drugmaker Amneal Pharmaceuticals. 12 June 2024
Last week, the US Court of Appeals for the District of Columbia (DC) ruled that Section 340B of the Public Health Service Act does not prohibit pharmaceutical manufacturers from imposing conditions on the distribution of discounted drugs to covered entities in the program, noted Sophia Gaulkin and Alan Kirschenbaum of law firm Hyman Phelps & McNamara. 1 June 2024
UK-based Alliance Pharma (AIM: APH) has successfully appealed against a Competition and Markets Authority (CMA) ruling that had found the company guilty of breaching competition law. 24 May 2024
Janssen Pharmaceuticals, part of US health care giant Johnson & Johnson, is considering initiating legal proceedings against Russian drugmaker Pharmsyntez for the registration of an analogue of an anti-HIV rilpivirine drug, the patent for which belongs to Janssen, reports The Pharma Letter’s local correspondent. 24 July 2018
The biopharmaceutical unit of Korea’s Samsung group deliberately kept quiet on the option that US biotech Biogen had to increase its share in their joint venture focused on biosimilars. 13 July 2018
After many years of litigation from cancer patients, a court in Missouri, USA, has ordered healthcare giant Johnson & Johnson to pay an eye-watering $4.7 billion in damages to 22 women who allege harm caused by products containing talc. 13 July 2018
DUSA Pharmaceuticals has filed trade secret misappropriation and tortious interference claims in an ongoing patent infringement lawsuit against Germany-based skin cancer specialist Biofrontera and subsidiaries in the US District Court for the District of Massachusetts. 12 July 2018
Purdue Pharmaceuticals has announced its decision to halt all marketing efforts for its opioid products — including the controversal Oxycontin (oxycodone) — in Canada. 6 July 2018
Judy Lewent, a director at UK drugmaker GlaxoSmithKline and chair of its audit and risk committee, has been named as a defendant in a lawsuit filed by the state of Massachusetts over the opioid crisis. 4 July 2018
In an Expert View piece, Andreas von Falck and Miriam Gundt, both partners at Hogan Lovells' global patent litigation practice, give an overview of the intellectual property landscape for drugmakers in Europe. 28 June 2018
The US Supreme Court yesterday granted Swiss drugmaker Helsinn’s petition for certiorari to review a Federal Circuit Panel decision, holding that certain patent claims covering Aloxi (palonosetron hydrochloride) injection are not valid and are not infringed by Israeli generics drug giant Teva Pharmaceutical Industries’ generic palonosetron product. 26 June 2018
Eli Lilly on Friday announced that the US District Court for the Southern District of Indiana ruled in favor of Lilly that the Alimta (pemetrexed for injection) vitamin regimen patent would be infringed by a competitor that had stated its intent to market alternative salt forms of pemetrexed prior to the patent's expiration in
2022. 23 June 2018
A ruling in the Supreme Court of the United States (SCOTUS) on Thursday found that foreign law deserves ‘respectful consideration’ but should not determine a class action’s outcome. 15 June 2018
Shares in Ireland-incorporated Endo International opened up on Tuesday morning following the news that all known testosterone replacement therapy product liability claims against the company had been settled. 12 June 2018
Drugmakers Pfizer and Flynn Pharma have successfully overturned fines of nearly nearly £90 million ($120 million) levied by the UK’s competition authority in 2016 over allegations of price gouging. 8 June 2018
The UK’s National Audit Office (NAO) is investigating unexpected rises in the prices of certain generic medicines bought by pharmacies for the National Health Service (NHS) last year, it was announced on Friday. 8 June 2018
Danish CNS specialist Lundbeck says its US subsidiary has reached an agreement in principle to resolve the US Department of Justice (DoJ) investigation related to Lundbeck LLC's relationship with and donations to independent patient assistance charitable foundations. 7 June 2018
Japanese pharma major Daiichi Sankyo today announced that more than 97% of eligible claimants have opted into the product liability litigation settlement program announced on March 30, 2018 for cases brought against various Daiichi Sankyo and Forest entities. 6 June 2018
In an expert view piece, Ronald Wisor and Hein van den Bos — partners at the global law firm Hogan Lovells — discuss the challenges created by Europe's evolving transparency laws. 1 June 2018
While the financial damage from a court settlement announced on Thursday will barely cause a ripple at US drug giant Pfizer, the reputational damage for paying illegal kickbacks could be more noticeable. 25 May 2018
In an Initial Decision announced on May 18, 2018, Chief Administrative Law Judge D Michael Chappell dismissed the antitrust charges in a complaint issued by the Federal Trade Commission against generic pharmaceutical company Impax Laboratories. 25 May 2018
The European Commission has decided to close its infringement procedures and the treatment of complaints in the area of parallel trade of medicines for human use against Poland, Romania and Slovakia. 18 May 2018