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
Two US district courts – Maryland and the Northern District of California - recently dealt what may become fatal blows to the Trump administration’s Most Favored Nation (MFN) rule for Medicare Part B drug payment on procedural grounds, according to a posting on Hyman, Phelps & McNamara’s (HP&M) FDA Law Blog. 31 December 2020
Hyderabad, India-based Natco Pharma is seeking to file a compulsory licensing application for a generic version of Eli Lilly's arthritis drug baricitinib, in a move that could potentially lead to a legal battle over intellectual property rights (IPR), reports The Pharma Letter’s local correspondent. 23 December 2020
US biotech major Biogen has agreed to pay $22 million to resolve claims that it violated the False Claims Act by illegally using charitable foundations as a conduit to pay the co-pays of Medicare patients taking Biogen’s multiple sclerosis drugs, Avonex (interferon beta 1a) and Tysabri (natalizumab), according to the US Justice Department. 19 December 2020
President-elect Joe Biden has nominated former Congressman and California Attorney General Xavier Becerra for the position of HHS Secretary. 7 December 2020
UK-headquartered Indivior says it has reviewed the £1.07 billion ($1.4 billion) claim by former parent Reckitt Benckiser Group filed against the company in the Commercial High Court in London on November 13, 2020. 1 December 2020
The European Commission has fined the pharmaceutical companies Israel-based Teva Pharmaceutical Industries 60.5 million euros ($72 million) for agreeing to delay for several years the market entry of a cheaper generic version of Cephalon's drug for sleep disorders, modafinil, after Cephalon's main patents had expired. 26 November 2020
The UK Competition and Markets Authority (CMA) launched a competition law investigation into Essential Pharma last month because of suspicions that the firm may have abused its dominant position by proposing to withdraw the supply of bipolar drug, lithium-based Priadel, to UK patients. 26 November 2020
American pharma giant Pfizer and its group companies have filed a petition in a US court against Aurobindo Pharma and Dr Reddy’s Laboratories, alleging the Indian generic drugmakers were planning separately to come out with generic versions of its blockbuster drug Ibrance (palbociclib) before expiration of its patent. 25 November 2020
Quality control hardware specialist Elementar UK is urging pharmaceutical manufacturers and suppliers to bolster product testing procedures in the face of a growing threat from counterfeit drugs. 25 November 2020
Opioid drug OxyContin manufacturer Purdue Pharma has pleaded guilty in federal court in Newark, New Jersey, to conspiracies to defraud the United States and violate the anti-kickback statute, the US Department of Justice announced yesterday. 25 November 2020
Lawsuits for patent infringement require a showing that an accused product or process includes each and every element of an asserted claim, write Jonathan Roses, counsel, Wolf, Greenfield & Sacks, and Alexander Lee, associate, Hoffmann Eitle, in an Expert View piece. 20 November 2020
French drugmaker Sanofi will face trial in a US court over claims that it misleadingly promoted off-label uses for a cancer drug, Law360 reports. 13 November 2020
A new white paper has explored the misuse of certain intellectual property (IP) tools that block generic and biosimilar medicines for the first time since the findings of the European Commission Pharmaceutical Sector Enquiry in 2009. 6 November 2020
The US Federal Trade Commission (FTC) has accepted a proposed consent order, agreeing certain asset divestments, which concludes the FTC’s review of the proposed combination of Netherlands-incorporated generics drugmaker Mylan and US pharma giant Pfizer’s Upjohn Business. 2 November 2020
The European Patent Office (EPO) Technical Boards of Appeal has ruled in French pharma major Sanofi and US partner Regeneron Pharmaceutical’s favor, invalidating certain claims of Amgen’s European patent (EP 2 215 124) directed to PCSK9 (proprotein convertase subtilisin/kexin type 9) antibodies relevant to Praluent (alirocumab). 30 October 2020
Jonathan Roses, counsel Wolf, Greenfield & Sacks and Matthew Birkett, partner, Hoffmann Eitle, provide an Expert View on general treatment of salt and polymorphic forms in the US Patent and Trademark Office, the European Patent Office and the courts. 23 October 2020
India has initiated a probe into alleged dumping of an active pharmaceutical ingredient (API), ceftriaxone sodium sterile, from China, following complaints by domestic manufacturers. 7 October 2020
The UK’s Competition and Markets Authority (CMA) will investigate whether the pharmaceutical company Essential Pharma, which was recently bought by a Swiss private equity firm Gyrus Capital, has abused a dominant position in relation to lithium-based medicines for treating bipolar disorder. 7 October 2020
Privately-held US biotech Allele Biotechnology and Pharmaceuticals has filed two patent infringement lawsuits – one in New York against Regeneron Pharmaceuticals and the other in California against Pfizer and BioNTech. 6 October 2020