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
TWi Pharmaceuticals has entered into a settlement agreement with Takeda Pharmaceuticals to settle and dismiss all outstanding patent litigation related to TWi's generic dexlansoprazole delayed release capsules for oral administration in 30 mg and 60 mg dosage strengths. 27 April 2015
Israel-based Teva Pharmaceutical Industries has agreed a $512 million settlement in a class-action law suit in which a company it owns was accused of delaying the launch of Provigil (modafinil). 21 April 2015
US pharma giant Pfizer has won its first trial in the USA relating to claims that its antidepressant Zoloft (sertraline) caused birth defects. 20 April 2015
USA-based Pacira Pharmaceuticals revealed that it has received a subpoena from the US Department of Justice, US Attorney’s Office for the District of New Jersey. 19 April 2015
US specialty drugmaker Depomed has entered into a settlement agreement with Actavis in patent infringement litigation related to Actavis' Abbreviated New Drug Application seeking approval to market generic versions of Depomed's Gralise (gabapentin). 13 April 2015
Swiss sdrug major Novartis has reached a settlement agreement with Juno Therapeutics over a chimeric antigen receptor technology (CAR-T) for oncology. 7 April 2015
US drugmaker The Medicines Company says it has settled its litigation with India’s Sun Pharmaceutical Industries and certain of its subsidiaries relating to MDCO’s US patents covering the anticoagulant Angiomax (bivalirudin). 2 April 2015
The US Supreme Court has ruled that private health care providers cannot sue states to force them to increase their Medicaid reimbursement rates in keeping with increasing medical costs. 31 March 2015
Following an in-depth investigation, the European Commission has concluded that a German scheme exempting pharmaceutical companies from mandatory rebates was in line with European Union State aid rules. 27 March 2015
South Korea's anti-trust regulator this week ordered the local subsidiary of German pharma major Bayer to sell off its oral contraceptive pill operation that was acquired when its parent bought Merck & Co (NYSE: MRK) over-the- counter medicines business. 26 March 2015
Indian drugmaker Aurobindo Pharma has received tentative approval from the US Food and Drug Administration for generic lacosamide tablets 50mg, 100mg, 150mg and 200mg. 21 March 2015
The US district court has rejected Amgen’s request for a preliminary injunction to block Sandoz’s Neupogen (fligrastim) biosimilar Zarxio (fligrastim-sndz). 20 March 2015
Ireland-headquartered generics major Actavis has confirmed that the US Court of Appeals for the Federal Circuit has granted AstraZeneca’s request for an injunction pending appeal preventing Actavis from further distribution of its generic version of Pulmicort Respules (budesonide inhalation suspension). 13 March 2015
In a ‘landmark’ case, India's Patent Office has revoked a patent on family-owned German pharma major Boehringer Ingelheim’s asthma drug Spiriva (tiotropium bromide monohydrate), after it was challenged by Indian generics company Cipla. 11 March 2015
The German Court of Appeal has ruled that US pharma major Eli Lilly’s vitamin regimen patent for its lung cancer drug Alimta (pemetrexed disodium) would not be infringed by generic competitor Actavis. 7 March 2015
The US District Court for the District of New Jersey has found that Ireland-headquartered Actavis’ US Patent Nos 7,645,459 and 7,645,460 protecting Atelvia (risedronate sodium delayed-release tablets, 35mg) in the USA are invalid. 5 March 2015
US Senators Chris Coons (Democrat, Delaware) and Dick Durbin (Democrat, Illinois), members of the Senate Judiciary Committee, and Mazie Hirono (Democrat, Hawaii), member of the Senate Committee on Small Business and Entrepreneurship, have introduced legislation to strengthen America’s patent system and target abusers. 4 March 2015
Swiss drug major Novartis has been ordered to suspend operations in Japan for 15 days as of March 5, the first penalty of its kind for a pharma company in Japan. 2 March 2015
Privately-held Italian drugmaker Chiesi Farmaceutici has been publicly reprimanded for providing inaccurate information to the UK’s Prescription Medicines Code Of Practice Authority (PMCPA), breaching the ABPI Code of Practice for the Pharmaceutical Industry. 27 February 2015
The European Patent Office (EPO) has reported an increase in the number of patent filings for the fifth consecutive year. According to the EPO’s annual report, released today, both the biotech and pharma sectors remain in the top ten for applications at eighth and tenth respectively. 26 February 2015