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
A coalition of several European organizations, including the European Federation of Pharmaceutical Industries and Associations (EFPIA), have been closely monitoring the developments regarding the EU Commission proposal for a regulation on European Union compulsory licensing for crisis management. 17 May 2024
US pharma major Eli Lilly has provided an update on compounding litigation relating to tirzepatide, its drug for type 2 diabetes and weight loss that is marketed as Mounjaro and Zepbound. 16 May 2024
US pharma company Esperion Therapeutics on Wednesday announced a $125 million deal with Japanese drugmaker Daiichi Sankyo’s European subsidiary (DSE) to resolve Esperion's demand for $300 million from the company over Esperion's cholesterol reduction drugs. 4 January 2024
With sales of lucrative immunology medicine Rinvoq (upadacitinib) topping $1 billion in the third quarter, developer AbbVie is taking action to shore up its patent estate. 23 November 2023
The USA’s Federal Trade Commission (FTC) says it has filed an amicus brief to address the anticompetitive harm that stems from improperly listed patents in the Food and Drug Administration’s (FDA) publication of “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known as the “Orange Book.” 21 November 2023
The European Commission has unconditionally approved the proposed $43 billion acquisition of US biotech Seagen by pharma giant Pfizer, under the EU Merger Regulation. 21 October 2023
Japanese drugmaker Daiichi Sankyo revealed that it has been ordered by a Texas district court to pay royalties on its antibody-drug conjugate (ADC) to US biotech Seagen. 19 October 2023
One big challenge for pharma companies doing cross-border businesses in China and the USA is the respective cybersecurity law imposed by the two countries. 12 October 2023
Privately-held Swiss dermatology company Galderma has announced some bad news relating to its pending Biologics License Application (BLA) for relabotulinumtoxinA (QM-1114) to the US Food and Drug Administration (FDA). 3 October 2023
In the USA, British drugmaker AstraZeneca has brought to an end certain product liability lawsuits for the gastrointestinal meds Nexium (esomeprazole) and Prilosec (omeprazole). 3 October 2023
The US Court of Appeals for the Federal Circuit has quashed an appeal from the Takeda unit Baxalta in relation to Roche’s hemophilia treatment Hemlibra (emicizumab). 22 September 2023
US pharma major Eli Lilly has revealed it suing spas, wellness centers and compounding pharmacies selling unapproved and compounded versions of its type 2 diabetes drug Mounjaro (tirzepatide). 20 September 2023
Following scrutiny from Democratic senators in Congress, the US Federal Trade Commission has issued a policy statement on the proper listing of pharmaceutical patents. 18 September 2023
While legal challenges surrounding the implementation of the Inflation Reduction Act (IRA) continue to mount, the Centers for Medicare & Medicaid Services (CMS) has touted the success of the program. 15 September 2023
Swiss drugmaker Novartis has launched legal action against the US government, after administrators revealed the first drugs to be subject to pricing regulations mandated by the Inflation Reduction Act (IRA). 7 September 2023
Japanese pharma major Astellas Pharma revealed that it has requested that the Court dismiss the company’s lawsuit challenging the constitutionality of certain provisions of the US government’s Inflation Reduction Act (IRA). 7 September 2023
The US Federal Trade Commission today announced it has reached a proposed consent order with Amgen to address what the agency saw as potential competitive harm that would result from the biotech major’s $27.8 billion acquisition of Horizon Therapeutics. 1 September 2023
Ireland-incorporated specialty pharma firm Mallinckrodt Pharmaceuticals said last week that it planned to file for bankruptcy for the second time in three years. 27 August 2023
US trade body the Biotechnology Innovation Organization (BIO) said on Friday that it has filed an amicus brief opposing the Federal Trade Commission (FTC) lawsuit to block Amgen’s proposed acquisition of Horizon Therapeutics for $27.8 billion, arguing that the FTC’s overreach threatens the merger and acquisition activity that is the lifeblood of biotech innovation. 26 August 2023