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
Nearly 18 months on from Enzyvant’s receipt of a Complete Response Letter (CRL) relating to its initial Biologics Licensing Application (BLA) for RVT-802, the company has filed an amended submission. 28 April 2021
As anticipated, the European Union launched a legal action against AstraZeneca in the Belgian courts on Friday, alleging the British firm failed to live up to its contractual obligations on vaccine supplies. 27 April 2021
The government must support a patent waiver for COVID-19 vaccines and treatments to protect the UK’s own vaccination program, according to public health experts from the Independent SAGE group. 16 April 2021
India's famous Institute of Mental Health and Hospital in Agra is turning out to be a hotbed of pharmaceutical opioids and counterfeit drugs. 14 April 2021
The US Court of Appeals for the Fifth Circuit has upheld the Federal Trade Commission determination that Impax Laboratories engaged in an illegal pay-for-delay, or “reverse payment,” settlement to block consumers’ access to a lower-cost generic version of Endo Pharmaceuticals branded extended-release opioid pain reliever Opana ER (oxymorphone hydrochloride extended release). 14 April 2021
The Brazilian Supreme Court of Justice is expected to deliver a potentially ground-breaking verdict on the constitutionality of a provision in the country’s intellectual property (IP) law allowing patent term extensions this week, according to Médecins Sans Frontières (MSF). 6 April 2021
The US District Court for the Northern District of West Virginia has decided in favour of AstraZeneca in litigation against Mylan Pharmaceuticals and Kindeva Drug Delivery, determining that asserted claims in three of AstraZeneca’s patents protecting Symbicort (budesonide/formoterol) in the US are not invalid. 3 March 2021
In the UK, a tribunal has upheld a finding from the country’s antitrust regulator, the Competition and Markets Authority (CMA), which found that the wholesaler Lexon broke competition law. 25 February 2021
Japanese drugmaker Chugai Pharmaceutical announced today that it has refiled a patent infringement lawsuit with the Tokyo District Court, based on the substance patent owned by Chugai, regarding the generic drugs of an osteoporosis agent, active vitamin D3 derivative Edirol capsule 0.5 g / 0.75 g (eldecalcitol). 17 February 2021
The US Court of Appeals for the Federal Circuit has upheld the decision by the US District Court for the District of Delaware that Amgen's asserted patent claims directed toward PCSK9 (proprotein convertase subtilisin/kexin type 9) antibodies are invalid based on lack of enablement. 15 February 2021
Fresenius Kabi Oncology Limited (FKOL), the Indian unit of Germany-headquartered Fresenius Kabi, has agreed to plead guilty to concealing and destroying records prior to a 2013 US Food and Drug Administration plant inspection and pay $50 million in fines and forfeiture, the Department of Justice announced yesterday. 10 February 2021
Sarah Ellson, co-head of regulatory and life sciences and healthcare lawyer, Fieldfisher and her colleague Laura Penny, associate and regulatory lawyer, provide an Expert View on the topical issue of the use of medicines off-label. 8 February 2021
The US Patent and Trademark Office (USPTO) recently issued a US Patent Term Extension (PTE) certificate for Ibrance (palbociclib), US pharma giant Pfizer announced on Friday. 8 February 2021
Following the renewed request from the European Commission on January 27, 2021, UK pharma major AstraZeneca has agreed to publish the redacted contract signed between the two parties on August 27, 2020, relating to the supply of AZD1222, the COVID-19 vaccine it has developed with Oxford University. 29 January 2021
The US Federal Trade Commission (FTC) yesterday filed a new antitrust complaint accusing Endo Pharmaceuticals and Impax Laboratories, as well as the latter’s owner, Amneal Pharmaceuticals, of striking a second deal to stave off competition to the Opana ER (oxymorphone hydrochloride extended release) opioid pain medication even as an earlier FTC enforcement action over the same drug was moving forward. 26 January 2021
The US Department of Justice collected more than $2.2 billion in settlements and judgments from civil cases involving fraud and false claims against the government in the fiscal year ending September 30, 2020, Acting Assistant Attorney General Jeffrey Bossert Clark of the Department of Justice’s Civil Division announced yesterday. 15 January 2021
The International Court of Arbitration of the International Chamber of Commerce has ordered Korea’s Kolon Life Science to pay a total of $33 million to Mitsubishi Tanabe Pharma Corporation. 14 January 2021
The US Department of Health and Human Services (HHS) Office of the General Counsel this week released an advisory opinion concluding that drug manufacturers are required to deliver discounts under the 340B Drug Pricing Program (340B Program) on covered outpatient drugs when contract pharmacies are acting as agents of 340B covered entities. 31 December 2020