In a lawsuit filed in federal court in Missouri, USA, Health insurer Cigna (NYSE: CI) and its pharmacy benefit manager (PBM) Express Scripts demanded that the Federal Trade Commission (FTC) retract its July 2024 report. 18 September 2024
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
Indivior Reckitt Benckiser face legal action in the USA for allegedly abusing its monopoly to keep generic versions of the opioid addiction drug Suboxone (buprenorphine and naloxone) off the market. 23 September 2016
Sanofi said today that it filed a patent infringement suit against US peer Merck & Co on September 16, 2016 in the USA District Court for the District of Delaware. In its suit Sanofi alleges infringement of 10 patents relating to its blockbuster diabetes treatment Lantus (insulin glargine). 19 September 2016
Cancer and other patients in Australia could potentially have access to some new medicines two years earlier than at present under changes to the regulation of medicines and medical devices announced today by the Turnbull government. 15 September 2016
Australia’s Turnbull government has today introduced important legislation to ensure security and law and order is maintained, as the Coalition leads the way in allowing for the cultivation of a safe, legal and reliable local supply of cannabis for medicinal products. 14 September 2016
On September 8, 2016, Taro Pharmaceuticals USA Inc, as well as two senior officers in its commercial team, received grand jury subpoenas from the US Department of Justice, Antitrust Division, the Israel-headquartered company revealed in a Securities and Exchange Commission filing. 12 September 2016
Announcing an “unprecedented” positive court decision in its patent Infringement litigation against Amgen concerning its Grastofil (filgrastim) – a biosimilar of Amgen’s Neupogen - and Lapelga (pegfilgrastim) – Amgen’s Neulasta - products, Apobiologix also indicates that the company has filed a Petition for Certiorari with the US Supreme Court. 10 September 2016
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has come out in support of the Danish company, saying it regrets the General Court (GC) of the European Union’s decision to uphold the European Commission’s classification of the Lundbeck patent settlement agreements as restrictions of competition “by object” thereby judging them to be unlawful. 9 September 2016
The General Court of the European Union has upheld a 2013 decision to fine the Danish central nervous system specialist Lundbeck for violating competition law over its anti-depressant drug Cipramil (citalopram). 8 September 2016
In the wake of steep price increases and Congressional investigations, New York Attorney General Eric Schneiderman announced that his office has commenced an investigation into the US unit of Netherlands-incorporated Mylan the maker of EpiPens. 7 September 2016
Netherlands-incorporated Mylan has received another boost in its aim to market a generic version of Teva Pharmaceutical Industries' multiple sclerosis (MS) treatment Copaxone (glatiramer acetate) 40 mg/mL. 2 September 2016
Ireland-incorporated Allergan and its partner Adamas Pharmaceuticals have come to a settlement with privately-held US generics drugmaker Amneal Pharmaceuticals over a copy of Alzheimer’s disease drug Namzaric (memantine and donepezil hydrochloride). 31 August 2016
The US Patent and Trademark Office (PTO) has ruled in favor of Netherlands-incorporated Mylan by invalidating two of Teva Pharmaceutical Industries' patents for the multiple sclerosis (MS) treatment Copaxone (glatiramer acetate). 25 August 2016
Canada's battered drugmaker Valeant Pharmaceuticals International has had some good news in the shape of lender consent for an amendment to its credit facility, but it comes in the midst of accusations from its former shareholder T Rowe Price. 22 August 2016
Proposed new legislation which aims to promote faster patient access to effective new cellular therapies fails to adequately address safety and efficacy concerns, according to the International Society for Cellular Therapy (ISCT). 19 August 2016
Johnson & Johnson has confirmed a negative US court ruling relating to a biosimilar version of its blockbuster rheumatoid arthritis drug Remicade (infliximab). 18 August 2016
In the USA, the Delaware District Court confirmed the validity of US patent RE38,551 related to Vimpat (lacosamide), Belgian pharma company UCB’s anti-epileptic drug. 15 August 2016
Beleaguered Canadian drugmaker Valeant is being investigated by prosecutors over claims that it conned insurers by hiding its ties to the mail-order pharmacy Philidor Rx Services to boost drug sales. 12 August 2016
US drugmaker AbbVie has launched legal proceedings to prevent rival company Amgen from marketing a biosimilar version of its blockbuster arthritis drug Humira (adalimumab). 8 August 2016
The US Chamber of Commerce and the Texas Association of Business have filed a legal challenge to the Internal Revenue Service’s immediately effective Multiple Acquisition Rule, which attempts to prevent certain corporate mergers that are otherwise permitted under the inversion rules under Section 7874 of the Internal Revenue Code. 5 August 2016