The US Patent and Trademark Appeal Board (PTAB) has ruled in favor of Netherlands-based drugmaker Mylan as it invalidated Sanofi’s Lantus (insulin glargine 100 Units/mL) formulation patents. 14 December 2018
A European court on Wednesday reduced a fine by 102.67 million euros ($116.73 million) that enforcers levied against independent French drugmaker Servier over allegations it reached several anti-competitive agreements to delay cheaper versions of blood pressure medicine perindopril, but rejected appeals of fines from most of the other companies involved. 13 December 2018
The US House of Representatives has approved a bill that would prevent drugmakers from overcharging Medicaid in the way Mylan (Nasdaq: MYL) was famously accused of doing. 12 December 2018
Fresenius saw its worst share price fall ever on Friday, after the German healthcare group issued a profit warning, the previous day. Its share plunged 17.71% to 38.00 euros by close. 8 December 2018
Johnson & Johnson subsidiary Actelion has agreed to pay $360 million to resolve claims that it illegally used a foundation as a conduit to pay the co-pays of thousands of Medicare patients taking Actelion’s pulmonary arterial hypertension drugs, in violation of the False Claims Act, the US Department of Justice announced yesterday. 7 December 2018
A more robust approach will be taken to enforcing intellectual property (IP) in China, new punishments announced by the National Development and Reform Commission show. 6 December 2018
Charlotte Tillett, partner, and Emily Hocken, trainee, at Stevens & Bolton, offer an Expert View on the significance of the UK Supreme Court ruling in Warner-Lambert (WL) v Generics relating to WL’s best-selling pain relief drug, Lyrica (pregabalin). 28 November 2018
In its latest warning over the proposed Supplementary Protection Certification (SPC) manufacturing waiver, the European Federation of Pharmaceutical Industries and Associations (EFPIA) has claimed that these proposals suggest that Europe is weakening its commitment to intellectual property (IP). 28 November 2018
The European Court of Justice will not stand in the way of Roche’s cancer drug Avastin (bevacizumab) being prescribed for an unlicensed indication. 23 November 2018
Shares in Johnson & Johnson tumbled 3% on Wednesday after a US appeals court ruled against blocking generic versions of the blockbuster therapy Zytiga (abiraterone acetate). 22 November 2018
Shares in London-listed Indivior have plummeted after the firm lost a court battle in the USA aimed at stopping Dr Reddy's Laboratories from marketing a generic version of its opioid use disorder therapy Suboxone Film (buprenorphine/naloxone). 21 November 2018
In an Expert View column, Stephen Bennett (pictured) and Mary Foord-Weston, from UK-based law firm Hogan Lovells, consider the questions that new oncology treatments raise around the current intellectual property (IP) system. 16 November 2018
Generic drugmakers Actavis and Mylan have prevailed in a patent dispute against Warner-Lambert, part of the Pfizer group of companies. 14 November 2018
The UK BioIndustry Association (BIA) has been granted permission by the UK Supreme Court to intervene in a case that could have far-reaching impacts on the life sciences sector. The BIA is arguing that medical innovations should be patentable irrespective of how the invention is made. 5 November 2018
The US District Court, District of New Jersey on Friday issued a ruling invalidating all asserted claims of US Patent No 8,822,438 for Zytiga (abiraterone acetate). 27 October 2018
Danish biopharma Forward Pharma says it is considering its options after the US Court of Appeals for the Federal Circuit denied the company rights to royalties relating to the blockbuster multiple sclerosis drug Tecfidera (dimethyl fumarate). 25 October 2018
Israeli drugmaker Teva Pharmaceutical Industries has asked the US Federal Trade Commission (FTC) to modify the ruling that it made in relation to the 2012 merger of Watson Pharmaceuticals and Actavis. 24 October 2018
Israeli drugmaker Teva Pharmaceutical Industries looks likely to see declining sales of its leading multiple sclerosis drug Copaxone (glatiramer acetate) plummet further following a court ruling on Friday. 15 October 2018
Japan’s Chugai Pharmaceutical filed a lawsuit to the Tokyo District Court as of October 12, and has also filed a petition for provisional disposition order, demanding the suspension of manufacturing and distribution of the biosimilar of anti-HER2 monoclonal antibody Herceptin (trastuzumab). 15 October 2018
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
The USA’s House Committee on Oversight and Accountability held a markup meeting yesterday to consider a series of bills that address federal agency procurement of biotechnology equipment, safeguarding taxpayer dollars, improving federal cybersecurity, and more. 16 May 2024
Norwich Pharmaceuticals has submitted to the US regulator for approval to market a generic version of Xifaxan (rifaximin), a treatment for irritable bowel syndrome. 15 May 2024
A new version of a congressional bill, dubbed the BIOSECURE Act, that would restrict US business with certain Chinese biotechnology companies would give US companies until 2032 to end work with the firms, extending the amount of time to find new partners. 11 May 2024
Catalent and the Novo Nordisk Foundation (as the ultimate parent entity of Novo Holdings and Novo Nordisk) announced that, on May 2, they each received a request for additional information and documentary materials (the second request) from the US Federal Trade Commission (FTC) in connection with the proposed merger. 7 May 2024
Swiss generic and biosimilar medicines company Sandoz has reached agreement with US biotech major Amgen to resolve all patent disputes between the two companies relating to the former company’s US Food and Drug Administration (FDA)-approved denosumab biosimilars. 30 April 2024
A commercial stage biopharmaceutical R&D company, focused on the development of products that address the medical challenges in the therapeutic area of anti-infectives.