CSL Limited says it has become aware that Bioverativ has filed complaints in the US District Court for the District of Delaware and with the International Trade Commission. 17 July 2017
The USA’s Federal Trade Commission has approved a sub-license submitted by UK-incorporated Mallinckrodt, granting West Therapeutic Development certain rights to develop and market the specialty drug Synacthen Depot (tetracosactide) in the USA. 17 July 2017
US RNAi therapeutics company Alnylam Pharmaceuticals last week announced that, along with Sanofi Genzyme, it was starting a Phase III program investigating the use of fitusiran in patients with hemophilia A and B with or without inhibitors. 10 July 2017
The UK Supreme Court has decided in the litigation relating to alternative salt forms of Alimta (pemetrexed disodium) that Actavis' products directly infringe US pharma major Eli Lilly's vitamin regimen patents in the UK, France, Italy and Spain. 7 July 2017
The European Commission has sent three separate Statements of Objections to Germany’s Merck KGaA and its subsidiary Sigma-Aldrich, General Electric and Canon alleging they breached EU merger rules. 6 July 2017
UK novel RNA therapeutics specialist Silence Therapeutics has issued a claim in the UK High Courts of Justice against US biotech firm Alnylam Pharmaceuticals. 5 July 2017
The Cyprus Association of Research and Development Pharmaceutical Companies (KEFEA) has welcomed the vote on the National Health Service (NHS) bill by the House of Representatives Plenum. 3 July 2017
Mitsubishi Tanabe Pharma has announced that the US District Court of Delaware has ruled that its patent covering Gilenya is valid, and that no generic drug may be approved in the USA before February 2019. 21 June 2017
The UK Competition and Markets Authority (CMA) has published the full non-confidential decision following its investigation into unfair pricing for phenytoin sodium capsules in the UK. 16 June 2017
The US Supreme Court has given a potential boost to the biosimilars industry with its ruling in a high-profile case involving the US biotech major Amgen and Sandoz, the generics division of the Swiss pharma giant Novartis. 13 June 2017
Maryland will become the first state in the USA to enact a law prohibiting “price gouging” by generic pharmaceutical manufacturers, according to a posting on law firm Hyman, Phelps & McNamara’s FDA Law Blog by David Gibbons and Alan Kirschenbaum. 2 June 2017
A US government estimate suggests that Netherlands-incorporated drugmaker Mylan overcharged American taxpayers by as much as $1.27 billion for its EpiPen (epinephrine) auto-injectors. 1 June 2017
Ohio is to become the second US state to sue the pharmaceutical industry over its role in the opioid epidemic currently facing America, after Mississippi. 1 June 2017
A cloud is hanging over UK-registered biotech Akari Therapeutics after inaccuracies came to light in a trial comparing its lead product to a rival drug and questions arose over the role of its chief executive in a related report. 31 May 2017
Another New York county has filed a lawsuit against pharma companies and physicians over what it calls ‘aggressive and fraudulent marketing of prescription opium-like painkillers.’ 16 May 2017
South African drugmaker Aspen Pharma has confirmed that the European Commission has opened proceedings to investigate certain actions of Aspen Holdings and certain of its European subsidiaries. 16 May 2017
Japanese drug major Chugai Pharmaceutical says that a lawsuit was filed against the company at the US District Court for the District of Delaware. 12 May 2017
The US Court of Appeals for the Federal Circuit has affirmed judgment in favor of Indian drugmaker Zydus Cadila’s US subsidiary holding that its proposed generic version of Lialda (mesalamine) does not infringe US Patent No 6,773,720. 10 May 2017
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