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
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
A controversial spin is in the works with MSN Laboratories launching what it terms is the most affordable copies of Jardiance (empagliflozin), the top-selling patented anti-diabetes pills sold by German drugmaker Boehringer Ingelheim (BI) - in India. 22 October 2021
New European Union (EU) regulation requires life sciences companies’ data in the clinical trial master file (TMF) to remain secure, accessible, and usable for a period of 25 years. 15 October 2021
Sino-America immuno-oncology biotech firm BeiGene revealed in a stock exchange filing yesterday that US pharma major Bristol Myers Squibb had, on October 6, delivered a notice to the company purporting to terminate the agreement with respect to Abraxane (nanoparticle albumin-bound paclitaxel) 14 October 2021
Icelandic biosimilars company and Humira (adalimumab) challenger Alvotech has scored a major win in a lawsuit brought by AbbVie, alleging theft of trade secrets. 8 October 2021
Three generic pharmaceutical manufacturers, Taro Pharmaceuticals USA, Sandoz, the biosimilars and generics business of Novartis and Apotex Corp, have agreed to pay a total of $447.2 million to resolve alleged violations of the False Claims Act arising from conspiracies to fix the price of various generic drugs. 2 October 2021
Danish diabetes care giant Novo Nordisk has reached an agreement in principle to settle the previously disclosed securities class action litigation pending in the Federal District Court of New Jersey, USA, with the company’s US traded shares dipping 1.6% to $100.63 on the news. 25 September 2021
Court filings show that Canada-headquartered Bausch Health has agreed to pay $300 million to settle an antitrust suit related to diabetes med Glumetza (metformin hydrochloride). 13 September 2021
Shares Ireland-incorporated Endo International rose almost 18% to $2.10 in after-hours trading yesterday, after the company announced a $50 million settlement to exit a New York opioid trial. 10 September 2021
In the USA, an appeals court has overthrown an earlier ruling against Gilead Sciences, a decision which could save the company $1.2 billion in fines. 28 August 2021
While the suspension of patent extensions in Brazil could lead to lower drug prices and cheaper generic drugs, this move may deter large biopharma companies from marketing innovative drugs in Brazil in the future, says data and analytics company. 13 August 2021
The Indian subsidiary of Anglo-Swedish pharma major AstraZeneca has reported a 45.03% decline in its net profit to $1.37 million for the June ended fiscal quarter. 9 August 2021
The UK Competition and Markets Authority (CMA) has provisionally found that US pharma giant Pfizer and its UK distributor Flynn Pharma, abused their dominant positions to overcharge the NHS for vital anti-epilepsy drugs, after reassessing the case. 6 August 2021
The Federal Trade Commission (FTC) has expressed its disappointment at a Supreme Court decision relating to AndroGel (testosterone gel), a prescription medicine used to treat the symptoms of testosterone deficiency. 2 August 2021
The UK’s Competition and Markets Authority (CMA) has imposed over £100 million ($139 million) in fines after Advanz inflated the price of thyroid tablets, causing the National Health Service (NHS) and patients to lose out. 30 July 2021
A California federal jury hit Novartis with a $177.8 million verdict Thursday for selling a skin cancer drug that infringes two patents owned by Daiichi Sankyo US subsidiary Plexxikon, rejecting Novartis' arguments that the patents are invalid and awarding the entire sum the plaintiff sought. 23 July 2021
USA-based healthcare giant Johnson & Johnson, together with three major drug distributors, are ready to agree to a $26 billion settlement in connection with lawsuits over the ongoing opioid epidemic. 21 July 2021
An Expert View on the pros and cons of intellectual property (IP) protections in the pharmaceutical sector from White & Case partners' competition lawyer, James Killick, chair of the firm’s IP practice, Anita Varma, and associate and member of the Global Competition practice group, Alexander Krois. 20 July 2021
Following investigations from the UK’s Competition and Markets Authority (CMA), a fine of around £260 million ($360 million) has been imposed on several pharmaceutical firms, due to competition law breaches. 15 July 2021
Leading UK scientists have warned the government that patent protections on COVID-19 vaccines threaten the security of the country’s vaccination program and could lead to further lockdowns after July 19, when restrictions are currently due to lift. 12 July 2021