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
Eli Lilly has announced that it had received a positive UK court ruling on the patent for its blockbuster cancer drug Alimta (pemetrexed disodium). 26 June 2015
The former head of cybercrime at the US department of Homeland Security has warned of the increased threat to pharma and biotech companies in this area. 25 June 2015
The USA’s Federal Trade Commission last week filed an amicus brief in the US Court of Appeals for the First Circuit urging the court to reject a district court decision in a reverse-payment patent settlement case. 22 June 2015
US Representative Steve Stivers (Republican, Ohio) yesterday joined Rep Peter Welch (Democrat, Vermont) to re-introduced the Fair Access for Safe and Timely (FAST) Generics Act to increase consumer access to generic drugs, boost market competition and ultimately save consumers money. 19 June 2015
The US Court of Appeals for the Federal Circuit has again found that US Patent No 5,800,808, related to a method of manufacturing glatiramer acetate, the active ingredient of Israel-based Teva Pharmaceutical Industries blockbuster multiple sclerosis drug Copaxone, is invalid as indefinite. 18 June 2015
Health Action International, the non-profit that represents the interests of consumers in drug policy, has expressed its disappointment at the European Parliament Committee on Legal Affairs (JURI) voting to adopt the rapporteur’s report on the European Union Trade Secrets Directive. 18 June 2015
A state court jury in the USA has ruled that pharma giant Pfizer was not responsible for the birth defects in a child whose mother used Zoloft (sertraline) during pregnancy. 12 June 2015
Debbie Feinstein, the Director of the Federal Trade Commission’s Bureau of Competition, issued the following statement regarding this week’s decision by the US Court of Appeals for the District of Columbia Circuit upholding a November 2013 FTC rulemaking that deems the transfers of pharmaceutical patent rights to be reportable assets under the Hart-Scott-Rodino Act – even if the sellers retain some manufacturing rights. 11 June 2015
Orexigen Therapeutics and partner, Japan’s Takeda Pharma have filed a law suit in the US District Court for the District of Delaware against generics major Actavis. 6 June 2015
The federal district court for the District of Columbia has granted US biotech firm Amarin’s motion for summary judgment in the company's law suit against the US Food and Drug Administration. 30 May 2015
The US Federal Trade Commission has reached a settlement resolving its antitrust suit charging Cephalon with illegally blocking generic competition to its blockbuster sleep-disorder drug Provigil (modafinil). 29 May 2015
The US Court of Appeals for the Federal Circuit has upheld the District Court of Delaware’s earlier ruling on Par Pharmaceuticals’ generic of Exelon (rivastigmine transdermal system), manufactured by Novartis. 27 May 2015
A panel of the US Court of Appeals for the Second Circuit has issued a ruling upholding a December 15, 2014, preliminary injunction requiring Ireland-headquartered generics major Actavis to continue distribution of its Alzheimer’s disease drug Namenda (memantine HCl) immediate-release tablets. 25 May 2015
US law firm Shernoff Bidart Echeverria Bentley yesterday filed a law suit in the Los Angeles Superior Court accusing health insurer Blue Cross of withholding a cure for hepatitis C based only upon profits, in violation of California law. 19 May 2015
Ireland-headquartered generics major Actavis yesterday said that it will immediately re-launch its generic version of AstraZeneca's Pulmicort Respules (budesonide inhalation suspension) following a decision from the US Court of Appeals. 8 May 2015
The US Court of Appeals for the Federal Circuit issued an injunction this week blocking Swiss pharma major Novartis’ US generics subsidiary Sandoz Inc from selling a biosimilar version of Amgen’s drug Neupogen (filgrastim) 7 May 2015
Japanese drug major Eisai has entered into a settlement agreement with Indian drugmaker Glenmark Pharmaceuticals and its US subsidiaries to resolve their patent litigation relating to Eisai's Banzel (rufinamide) in the USA. 1 May 2015
Japan’s largest drugmaker Takeda Pharmaceutical and its US subsidiary, have reached an agreement expected to resolve the vast majority of Actos (pioglitazone) product liability law suits pending against Takeda in the USA. 29 April 2015