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
Concordia Pharmaceuticals and Par Pharmaceutical have settled Federal Trade Commission charges that they entered into an unlawful agreement not to compete in the sale of generic versions of Kapvay (clonidine hydrochloride). 19 August 2015
US biotech company Amgen has reached an agreement to pay $71 million to 48 US states and the District of Columbia over the marketing of Enbrel (etanercept) and Aranesp (darbepoetin alfa). 19 August 2015
Avanir Pharmaceuticals has received a favorable ruling from the US Court of Appeals regarding Nuedexta (dextromethorphan hydrobromide/quinidine sulfate). 19 August 2015
Mylan has confirmed that it has been sued by BTG and Johnson & Johnson subsidiaries in connection with the filing of an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration for abiraterone acetate tablets, 250mg. 18 August 2015
The District Court for the Southern District of New York has issued a ruling upholding two Endo International patents covering its top-selling opioid analgesic Opana ER (oxymorphone hydrochloride). 15 August 2015
US pharma giant Pfizer said today that it has been granted approval from the Canadian Competition Bureau with respect to its pending $17 billion acquisition of Hospira. 14 August 2015
Dutch biotechnology company Merus, a developer of bispecific antibody therapeutics to treat cancer patients, says that it won its inequitable conduct trial against US biotech major Regeneron Pharmaceuticals. 11 August 2015
The Russian Parliament (State Duma) has started the design of legislation that will allow Russia to produce patented imported drugs of those global producers who refuse further drug imports to Russia, due to sanctions or other unfounded circumstances, according to an official representative of the Duma, reports The Pharma Letter’s local correspondent. 5 August 2015
Government authorities in Romania are investigating charges of corruption against domestic units of nearly a dozen big pharma companies including Roche (SIX: ROG), GlaxoSmithKline, Pfizer and Novartis, according to reports. 3 August 2015
In a US federal court victory for Indian drugmaker Ranbaxy, in a suit that was the first test of what antitrust limits may be placed on reverse payment deals among drugmakers. 2 August 2015
Mylan says it has received regulatory clearance from the European Commission under the European Union Merger Regulation (EUMR) for its proposed, unsolicited acquisition of Ireland-based Perrigo. 29 July 2015
Ansun BioPharma, a San Diego-based biotech company formerly known as NexBio, says that an investigation by the US Attorney's Office over the misconduct of its former chief executive and chief financial officer has been dismissed. 27 July 2015
Neuralstem said yesterday that the US District Court for the District of Maryland dismissed StemCells’ patent infringement case with prejudice in StemCells Inc v Neuralstem Inc in favor of Neuralstem, on July 22, 2015. 24 July 2015
The US Court of Appeals for the Federal Circuit has rejected arguments by US biotech major Amgen that Novartis failed to properly follow regulations when it sought to launch Zarxio (filgrastim-sndz). 22 July 2015
The Ensuring Access to Clinical Trials Act of 2015, which was introduced by Senators Ron Wyden (Democrat, Oregon), Orrin Hatch (Republican, Utah), Edward Markey (Democrat, Maryland) and Sherrod Brown (Democrat, Ohio) and co-sponsored by an additional 12 Senators, was passed yesterday. 17 July 2015
The Delhi High Court of India has upheld the patent of US pharma major Bristol Myers Squibs for Sprycel (dasatinib), reports The Economic Times of India. 14 July 2015
Anglo-Swedish pharma major AstraZeneca has agreed to pay the United States and participating states a total of $46.5 million, plus interest, to resolve allegations that it knowingly underpaid rebates owed under the Medicaid Drug Rebate Program, the Justice Department has announced. 8 July 2015
The US Court of Appeals for the Federal Circuit Court has ruled against The Medicines Company in its anticoagulant Angiomax (bivalirudin) patent litigation with Hospira. 4 July 2015
The US Department of Justice has filed a lawsuit in federal court to hit Novartis with $3.35 billion in damages and civil fines over alleged kickback schemes for Exjade (deferasirox) and Myfortic (mycophenolic acid). 1 July 2015